Imperim

Generic Name: loperamide (Oral route)

loe-PER-a-mide

Commonly used brand name(s)

In the U.S.

• Diamode


• Imodium


• Imodium A-D


• Imogen


• Imotil


• Imperim


• Kaodene A-D


• Kao-Paverin Caps

Available Dosage Forms:

• Tablet


• Capsule


• Liquid


• Tablet, Chewable


• Solution


• Capsule, Liquid Filled

Therapeutic Class: Antidiarrheal

Uses For Imperim

Loperamide is a medicine used along with other measures to treat diarrhea. Loperamide helps stop diarrhea by slowing down the movements of the intestines.

In the U.S., loperamide capsules are available only with your doctor's prescription.

Before Using Imperim

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine should not be used in children under 6 years of age unless directed by a doctor. Children, especially very young children, are very sensitive to the effects of loperamide. This may increase the chance of side effects during treatment. Also, the fluid loss caused by diarrhea may result in a serious health problem (dehydration). Loperamide may hide the symptoms of dehydration. For these reasons, do not give medicine for diarrhea to children without first checking with their doctor. If you have any questions about this, check with your health care professional.

Geriatric

The fluid loss caused by diarrhea may result in a serious health problem (dehydration). Loperamide may hide the symptoms of dehydration. For this reason, elderly persons with diarrhea, in addition to using medicine for diarrhea, must receive a sufficient amount of liquids to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Saquinavir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Gemfibrozil


• Itraconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Colitis (severe)—A more serious problem of the colon may develop if you use loperamide

• Dysentery—This condition may get worse; a different kind of treatment may be needed

• Liver disease—The chance of severe central nervous system (CNS) side effects may be greater in patients with liver disease

Proper Use of loperamide

This section provides information on the proper use of a number of products that contain loperamide. It may not be specific to Imperim. Please read with care.

Do not use loperamide to treat your diarrhea if you have a fever or if there is blood or mucus in your stools. Contact your doctor.

For safe and effective use of this medicine:

• Follow your doctor's instructions if this medicine was prescribed.


• Follow the manufacturer's package directions if you are treating yourself.

Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

Importance of diet and fluid intake while treating diarrhea:

• In addition to using medicine for diarrhea, it is very important that you replace the fluid lost by the body and follow a proper diet. For the first 24 hours, you should eat gelatin, and drink plenty of caffeine-free clear liquids, such as ginger ale, decaffeinated cola, decaffeinated tea, and broth. During the next 24 hours you may eat bland foods, such as cooked cereals, bread, crackers, and applesauce. Fruits, vegetables, fried or spicy foods, bran, candy, caffeine, and alcoholic beverages may make the condition worse.


• If too much fluid has been lost by the body due to the diarrhea, a serious condition (dehydration) may develop. Check with your doctor as soon as possible if any of the following signs or symptoms of too much fluid loss occur:
  
  • Decreased urination
  
  
  • Dizziness and lightheadedness
  
  
  • Dryness of mouth
  
  
  • Increased thirst
  
  
  • Wrinkled skin
  
  

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For diarrhea:
  
  • For oral dosage form (capsules):
    
    • Adults and teenagers—The usual dose is 4 milligrams (mg) (2 capsules) after the first loose bowel movement, and 2 mg (1 capsule) after each loose bowel movement after the first dose has been taken. No more than 16 mg (8 capsules) should be taken in any twenty-four-hour period.
    
    
    • Children 8 to 12 years of age—The usual dose is 2 mg (1 capsule) three times a day.
    
    
    • Children 6 to 8 years of age—The usual dose is 2 mg (1 capsule) two times a day.
    
    
    • Children up to 6 years of age—Use is not recommended unless directed by your doctor.
    
    
  
  
  • For oral dosage form (oral solution):
    
    • Adults and teenagers—The usual dose is 4 teaspoonfuls (4 mg) after the first loose bowel movement, and 2 teaspoonfuls (2 mg) after each loose bowel movement after the first dose has been taken. No more than 8 teaspoonfuls (8 mg) should be taken in any twenty-four-hour period.
    
    
    • Children 9 to 11 years of age—The usual dose is 2 teaspoonfuls (2 mg) after the first loose bowel movement, and 1 teaspoonful (1 mg) after each loose bowel movement after the first dose has been taken. No more than 6 teaspoonfuls (6 mg) should be taken in any twenty-four-hour period.
    
    
    • Children 6 to 8 years of age—The usual dose is 2 teaspoonfuls (2 mg) after the first loose bowel movement, and 1 teaspoonful (1 mg) after each loose bowel movement after the first dose has been taken. No more than 4 teaspoonfuls (4 mg) should be taken in any twenty-four-hour period.
    
    
    • Children up to 6 years of age—Use is not recommended unless directed by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults and teenagers—The usual dose is 4 mg (2 tablets) after the first loose bowel movement, and 2 mg (1 tablet) after each loose bowel movement after the first dose has been taken. No more than 8 mg (4 tablets) should be taken in any twenty-four-hour period.
    
    
    • Children 9 to 11 years of age—The usual dose is 2 mg (1 tablet) after the first loose bowel movement, and 1 mg (½ tablet) after each loose bowel movement after the first dose has been taken. No more than 6 mg (3 tablets) should be taken in any twenty-four-hour period.
    
    
    • Children 6 to 8 years of age—The usual dose is 2 mg (1 tablet) after the first loose bowel movement, and 1 mg (½ tablet) after each loose bowel movement after the first dose has been taken. No more than 4 mg (2 tablets) should be taken in any twenty-four-hour period.
    
    
    • Children up to 6 years of age—Use is not recommended unless directed by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Imperim

Loperamide should not be used for more than 2 days, unless directed by your doctor. If you will be taking this medicine regularly for a long time, your doctor should check your progress at regular visits.

Check with your doctor if your diarrhea does not stop after two days or if you develop a fever.

Imperim Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Bloating


• constipation


• loss of appetite


• stomach pain (severe) with nausea and vomiting

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

• Skin rash

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

• Dizziness or drowsiness


• dryness of mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Imperim side effects (in more detail)

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More Imperim resources

• Imperim Side Effects (in more detail)
• Imperim Use in Pregnancy & Breastfeeding
• Drug Images
• Imperim Drug Interactions
• Imperim Support Group
• 8 Reviews for Imperim - Add your own review/rating

Compare Imperim with other medications

• Diarrhea
• Diarrhea, Acute
• Diarrhea, Chronic
• Lymphocytic Colitis
• Traveler's Diarrhea

Interferon Alfanative

Interferon Alfanative may be available in the countries listed below.

Ingredient matches for Interferon Alfanative

Interferon alfa

Interferon alfa is reported as an ingredient of Interferon Alfanative in the following countries:

• Indonesia

International Drug Name Search

Lozol

Pronunciation: in-DAP-a-mide
Generic Name: Indapamide
Brand Name: Lozol

Lozol is used for:

Treating high blood pressure alone or along with other medicines. It is also used to treat salt and water retention (swelling) associated with congestive heart failure.

Lozol is a diuretic. It works by causing the kidneys to eliminate large amounts of water and salts.

Do NOT use Lozol if:

• you are allergic to any ingredient in Lozol or to a sulfonamide medicine (eg, sulfamethoxazole)


• you are unable to urinate


• you are taking ketanserin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Lozol:

Some medical conditions may interact with Lozol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have heart problems (eg, irregular heartbeat, heart failure), liver problems (eg, cirrhosis), kidney disease, gout, lupus, problems urinating, or swelling


• if you have severe or persistent vomiting, or low blood levels of sodium or potassium, or if you are on a low-salt (sodium) diet


• if you have had a certain neurosurgical procedure (sympathectomy)


• if you are receiving fluids through a vein (parenteral fluids)

Some MEDICINES MAY INTERACT with Lozol. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because they may decrease Lozol's effectiveness


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) because the risk of kidney problems may be increased


• Diazoxide because the risk of high blood glucose levels, high uric acid levels, or low blood pressure may be increased


• Adrenocorticotropin hormone (ACTH) or corticosteroids (eg, prednisone) because they may increase the risk of Lozol's side effects


• Amantadine, antineoplastic agents (eg, cyclophosphamide), digitalis glycosides (eg, digoxin), ketanserin, lithium, or other blood pressure medicines because the risk of their side effects may be increased by Lozol

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lozol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Lozol:

Use Lozol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Lozol by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Lozol may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.


• If you miss a dose of Lozol and you are taking 1 dose daily, take the missed dose if you remember the same day. Skip the missed dose if you do not remember until the next day. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Lozol.

Important safety information:

• Lozol may cause drowsiness, dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Lozol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Lozol may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Your doctor may check your blood electrolytes while you take Lozol to check for a fluid or electrolyte imbalance. Tell your doctor right away if you experience decreased urination; dry mouth; fainting; fast or irregular heartbeat; increased thirst; muscle pain, weakness, or cramping; restlessness; severe dizziness or drowsiness; stomach problems; or unusual tiredness or weakness.


• Your doctor may have also prescribed a potassium supplement for you. If so, follow the dosing carefully. Do not start taking additional potassium on your own or change your diet to include more potassium without first checking with your doctor.


• Lozol may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Lozol. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Tell your doctor or dentist that you take Lozol before you receive any medical or dental care, emergency care, or surgery.


• Diabetes patients - Lozol may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Lozol may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Lozol.


• Lab tests, including blood electrolyte, glucose, and uric acid levels, and kidney function, may be performed while you use Lozol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Lozol with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium or potassium.


• Lozol should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lozol while you are pregnant. It is not known if Lozol is found in breast milk. Do not breast-feed while taking Lozol.

Possible side effects of Lozol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; constipation; diarrhea; dizziness or lightheadedness when siting up or standing; drowsiness; headache; nausea; nervousness; runny nose; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; chest pain; dark urine; decreased urination or urination problems; dry mouth; fainting; fast heartbeat; fatigue; fever, chills, cough, or sore throat; increased thirst; loss of appetite; numbness of the hands or feet; pale stools; red, swollen, blistered, or peeling skin; severe or persistent dizziness, drowsiness, or lightheadedness; severe stomach pain; swelling of the hands, ankles, or feet; symptoms of low blood potassium (eg, irregular heartbeat; muscle pain, weakness, or cramping); symptoms of low blood sodium (eg, confusion, mental or mood changes, seizures, sluggishness); unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Lozol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include nausea; vomiting; weakness.

Proper storage of Lozol:

Store Lozol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lozol out of the reach of children and away from pets.

General information:

• If you have any questions about Lozol, please talk with your doctor, pharmacist, or other health care provider.


• Lozol is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Lozol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Lozol resources

• Lozol Side Effects (in more detail)
• Lozol Use in Pregnancy & Breastfeeding
• Drug Images
• Lozol Drug Interactions
• Lozol Support Group
• 0 Reviews for Lozol - Add your own review/rating

• Lozol Prescribing Information (FDA)


• Lozol Advanced Consumer (Micromedex) - Includes Dosage Information


• Lozol Concise Consumer Information (Cerner Multum)


• Lozol Monograph (AHFS DI)


• Indapamide Prescribing Information (FDA)


• Indapamide Professional Patient Advice (Wolters Kluwer)

Compare Lozol with other medications

• Edema
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Hydramine

Generic Name: diphenhydramine (DYE fen HYE dra meen)

Brand Names: Aler-Tab, Allergy, Allermax, Altaryl, Benadryl Allergy, Benadryl DF, Benadryl Dye Free Allergy, Benadryl Ultratab, Children's Allergy, Diphen Cough, Diphenhist, Dytuss, PediaCare Children's Allergy, Q-Dryl, Q-Dryl A/F, Siladryl, Siladryl Allergy, Silphen Cough, Simply Sleep, Sleep-ettes, Sleep-ettes D, Sominex Maximum Strength Caplet, Theraflu Thin Strips Multi Symptom, Triaminic Thin Strips Cough & Runny Nose, Unisom Sleepgels Maximum Strength, Valu-Dryl

What is Hydramine (diphenhydramine)?

Diphenhydramine is an antihistamine. Diphenhydramine blocks the effects of the naturally occurring chemical histamine in the body.

Diphenhydramine is used to treat sneezing; runny nose; itching, watery eyes; hives; rashes; itching; and other symptoms of allergies and the common cold.

Diphenhydramine is also used to suppress coughs, to treat motion sickness, to induce sleep, and to treat mild forms of Parkinson's disease.

Diphenhydramine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Hydramine (diphenhydramine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Diphenhydramine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking diphenhydramine.

What should I discuss with my healthcare provider before taking Hydramine (diphenhydramine)?

Do not take diphenhydramine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• 
  

  glaucoma or increased pressure in the eye;

  
  


• 
  

  a stomach ulcer;

  
  


• 
  

  an enlarged prostate, bladder problems or difficulty urinating;

  
  


• 
  

  an overactive thyroid (hyperthyroidism);

  
  


• 
  

  hypertension or any type of heart problems; or

  
  


• 
  

  asthma.

  
  

You may not be able to take diphenhydramine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Diphenhydramine is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not take diphenhydramine without first talking to your doctor if you are pregnant. Infants are especially sensitive to the effects of antihistamines, and side effects could occur in a breast-feeding baby. Do not take diphenhydramine without first talking to your doctor if you are nursing a baby. If you are over 60 years of age, you may be more likely to experience side effects from diphenhydramine. You may require a lower dose of this medication.

How should I take Hydramine (diphenhydramine)?

Take diphenhydramine exactly as directed on the package or as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Diphenhydramine can be taken with or without food.

For motion sickness, a dose is usually taken 30 minutes before motion, then with meals and at bedtime for the duration of exposure.

As a sleep aid, diphenhydramine should be taken approximately 30 minutes before bedtime.

To ensure that you get a correct dose, measure the liquid forms of diphenhydramine with a special dose-measuring spoon or cup, not with a regular tablespoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Never take more of this medication than is prescribed for you. The maximum amount of diphenhydramine that you should take in any 24-hour period is 300 mg.

Store diphenhydramine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a diphenhydramine overdose include extreme sleepiness, confusion, weakness, ringing in the ears, blurred vision, large pupils, dry mouth, flushing, fever, shaking, insomnia, hallucinations, and possibly seizures.

What should I avoid while taking Hydramine (diphenhydramine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Diphenhydramine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking diphenhydramine.

Hydramine (diphenhydramine) side effects

Stop taking diphenhydramine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take diphenhydramine and talk to your doctor if you experience

• 
  

  sleepiness, fatigue, or dizziness;

  
  


• 
  

  headache;

  
  


• 
  

  dry mouth; or

  
  


• 
  

  difficulty urinating or an enlarged prostate.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Hydramine (diphenhydramine)?

Do not take diphenhydramine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Talk to your pharmacist before taking other over-the-counter cough, cold, allergy, or insomnia medications. These products may contain medicines similar to diphenhydramine, which could lead to an antihistamine overdose.

Before taking this medication, tell your doctor if you are taking any of the following medicines:

• 
  

  anxiety or sleep medicines such as alprazolam (Xanax), diazepam (Valium), chlordiazepoxide (Librium), temazepam (Restoril), or triazolam (Halcion);

  
  


• 
  

  medications for depression such as amitriptyline (Elavil), doxepin (Sinequan), nortriptyline (Pamelor), fluoxetine (Prozac), sertraline (Zoloft), or paroxetine (Paxil); or

  
  


• 
  

  any other medications that make you feel drowsy, sleepy, or relaxed.

  
  

Drugs other than those listed here may also interact with diphenhydramine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More Hydramine resources

• Hydramine Side Effects (in more detail)
• Hydramine Use in Pregnancy & Breastfeeding
• Hydramine Drug Interactions
• Hydramine Support Group
• 0 Reviews for Hydramine - Add your own review/rating

• Banophen MedFacts Consumer Leaflet (Wolters Kluwer)


• Ben-Tann Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Benadryl Consumer Overview


• Benadryl Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Benadryl Allergy Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Children's Allergy Prescribing Information (FDA)


• Diphen Advanced Consumer (Micromedex) - Includes Dosage Information


• Diphenhydramine MedFacts Consumer Leaflet (Wolters Kluwer)


• Diphenhydramine Prescribing Information (FDA)


• Diphenhydramine Hydrochloride Monograph (AHFS DI)


• Diphenoxylate Hydrochloride Monograph (AHFS DI)


• Dytuss Elixir MedFacts Consumer Leaflet (Wolters Kluwer)


• Simply Sleep MedFacts Consumer Leaflet (Wolters Kluwer)


• Sominex MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Hydramine with other medications

• Allergic Reactions
• Cold Symptoms
• Cough
• Extrapyramidal Reaction
• Hay Fever
• Insomnia
• Motion Sickness
• Nausea/Vomiting
• Pruritus
• Urticaria

Where can I get more information?

• Your pharmacist can provide more information about diphenhydramine.

See also: Hydramine side effects (in more detail)

Seconal Sodium

Generic Name: secobarbital (SEE koe BAR bi tal)

Brand Names: Seconal Sodium

What is Seconal Sodium (secobarbital)?

Secobarbital is in a group of drugs called barbiturates (bar-BIT-chur-ates). Secobarbital slows the activity of your brain and nervous system.

Secobarbital is used short-term to treat insomnia, or as a sedative before surgery.

Secobarbital may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Seconal Sodium (secobarbital)?

Secobarbital may cause a severe allergic reaction. Stop taking secobarbital and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Take secobarbital only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Some people using this medicine have engaged in activity such as driving, and later having no memory of the activity. If this happens to you, stop taking secobarbital and talk with your doctor about another treatment for your sleep disorder.

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Do not use secobarbital without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Secobarbital can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking secobarbital. Secobarbital may be habit-forming and should be used only by the person it was prescribed for. Secobarbital should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

What should I discuss with my healthcare provider before taking Seconal Sodium (secobarbital)?

Some people using this medicine have engaged in activity such as driving, and later having no memory of the activity. If this happens to you, stop taking secobarbital and talk with your doctor about another treatment for your sleep disorder.

Do not take this medication if you are allergic to secobarbital, or if you have porphyria.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take secobarbital:

• 
  

  severe asthma, chronic obstructive pulmonary disorder (COPD), or other breathing disorder;

  
  


• 
  

  a blood cell disorder such as anemia (lack of red blood cells);

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• liver disease;


• 
  

  heart disease;

  
  


• 
  

  overactive thyroid;

  
  


• 
  

  a history of depression, mental illness, or suicide attempt; or

  
  


• 
  

  a history of drug or alcohol addiction.

  
  

Secobarbital may be habit-forming and should be used only by the person it was prescribed for. Secobarbital should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use secobarbital without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Secobarbital can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking secobarbital. Secobarbital can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Seconal Sodium (secobarbital)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take secobarbital only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine. Take this medicine with a full glass of water.

If you are taking this medicine to treat insomnia, take it only at bedtime. Do not use secobarbital for longer than 2 weeks to treat insomnia, unless your doctor has told you to.

Do not change your dose of secobarbital without your doctor's advice. Tell your doctor if the medication does not seem to work as well in treating your condition.

Store secobarbital at room temperature away from moisture and heat.

Keep track of how many pills have been used from each new bottle of this medicine. Secobarbital is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

See also: Seconal Sodium dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Take secobarbital only when you are getting ready for several hours of sleep. If you do not have time to get a full night's sleep after taking the medication, skip the missed dose and take the medicine at your next regularly scheduled sleep time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of secobarbital can be fatal.

Overdose symptoms may include slow or shallow breathing, blurred vision, extreme drowsiness, feeling light-headed, or fainting.

What should I avoid while taking Seconal Sodium (secobarbital)?

Secobarbital can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by secobarbital. Tell your doctor if you regularly use any of these other medicines. Avoid drinking alcohol. It can increase some of the side effects of secobarbital.

Seconal Sodium (secobarbital) side effects

Secobarbital may cause a severe allergic reaction. Stop taking secobarbital and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  restless muscle movements in your eyes, tongue, jaw, or neck;

  
  


• 
  

  slow heartbeat, shallow breathing;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  a fever or a sore throat;

  
  


• 
  

  sores in your mouth;

  
  


• 
  

  easy bruising or bleeding; or

  
  


• 
  

  ongoing nightmares or increased dreaming.

  
  

Less serious side effects may include:

• 
  

  drowsiness or dizziness;

  
  


• 
  

  problems with memory or concentration;

  
  


• 
  

  excitement (especially in children or older adults);

  
  


• 
  

  upset stomach, constipation;

  
  


• 
  

  headache; or

  
  


• 
  

  "hangover" effect (drowsiness the day after a dose).

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Seconal Sodium (secobarbital)?

Many drugs can interact with secobarbital. Below is just a partial list. Tell your doctor if you are using:

• 
  

  acetaminophen (Tylenol);

  
  


• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  an antibiotic such as doxycycline (Adoxa, Doryx, Mondox, Oracea, Vibramycin, and others), griseofulvin (Grisactin, Fulvicin PG, Grifulvin V), or metronidazole (Flagyl);

  
  


• 
  

  birth control pills or estrogen hormone replacement, including estrogen (Premarin), estradiol (Estrace, Femtrace, and others), progesterone (Progest, Prometrium), and others;

  
  


• 
  

  theophylline (Theo-Dur, Theochron, Theolair, Slo-Bid, others);

  
  


• 
  

  a heart rhythm medication such as quinidine (Cardioquin, Quinidex, Quinora, Quinaglute);

  
  


• 
  

  seizure medications such as carbamazepine (Carbatrol, Tegretol), divalproex (Depakote), phenytoin (Dilantin), or valproic acid (Depakene);

  
  


• 
  

  heart or blood pressure medication such as atenolol (Tenormin), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), felodipine (Plendil) nifedipine (Procardia, Adalat), verapamil (Calan);

  
  


• 
  

  an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate); or

  
  


• 
  

  steroids such as prednisone (Orasone, Deltasone), prednisolone (Prelone, Delta Cortef), methylprednisolone (Medrol), and others.

  
  

This list is not complete and there may be other drugs that can interact with secobarbital. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Seconal Sodium resources

• Seconal Sodium Side Effects (in more detail)
• Seconal Sodium Dosage
• Seconal Sodium Use in Pregnancy & Breastfeeding
• Drug Images
• Seconal Sodium Drug Interactions
• Seconal Sodium Support Group
• 2 Reviews for Seconal Sodium - Add your own review/rating

• Seconal Sodium Prescribing Information (FDA)


• Secobarbital MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Seconal Sodium with other medications

• Insomnia
• Light Sedation
• Sedation

Where can I get more information?

• Your pharmacist can provide more information about secobarbital.

See also: Seconal Sodium side effects (in more detail)

Salagen

Generic Name: pilocarpine (Oral route)

pye-loe-KAR-peen

Commonly used brand name(s)

In the U.S.

• Salagen

Available Dosage Forms:

• Tablet

Therapeutic Class: Dental Agent

Pharmacologic Class: Cholinergic

Uses For Salagen

Pilocarpine tablets are used to treat dryness of the mouth and throat caused by a decrease in the amount of saliva that may occur after radiation treatment for cancer of the head and neck or in patients with Sjogren's syndrome. This medicine may help you speak without having to sip liquids. It may also help with chewing, tasting, and swallowing. This medicine may reduce your need for other oral comfort agents, such as hard candy, sugarless gum, or artificial saliva agents.

Pilocarpine may also be used to treat dryness of the eyes caused by Sjogren's syndrome

This medicine is available only with your doctor's prescription.

Before Using Salagen

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients and there is no specific information comparing use of pilocarpine in children with use in other age groups.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma, bronchitis, or other breathing problems, or


• Gallbladder problems or


• Glaucoma, angle closure, or


• Heart or blood vessel disease or


• Iritis (inflammation of the iris [colored part] of the eye) or


• Kidney problems or


• Mental problems or


• Peptic ulcer disease, acute—Pilocarpine may make the condition worse

• Retinal detachment, tendency for, or


• Retinal disease—Pilocarpine may increase the risk of a detached retina

Proper Use of Salagen

Take this medicine only as directed. Do not take it more often and do not take a larger dose than directed. To do so may increase the chance of side effects.

It is important that you visit your dentist regularly even though this medicine may make your dry mouth feel better. Having a dry mouth condition makes you more likely to have dental and other mouth problems.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For dryness of eyes:
    
    • Adults—5 milligrams (mg) three or four times a day.
    
    
  
  
  • For dryness of mouth and throat:
    
    • Adults—5milligrams (mg) three or four times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Salagen

This medicine may cause difficulty in reading or other vision problems, especially at night. It may also cause some people to become dizzy or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see well. If these reactions are especially bothersome, check with your doctor.

This medicine may cause you to sweat more than is usual. If you do, it is important that you drink extra liquids to offset this sweating so you do not lose too much fluid and become dehydrated. Check with your doctor if you are not sure how much extra liquid to drink or if you cannot drink as much liquid as you should.

Salagen Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Symptoms of overdose

• Chest pain


• confusion


• diarrhea (continuing or severe)


• fainting


• fast, slow, or irregular heartbeat (continuing or severe)


• headache (continuing or severe)


• nausea or vomiting (continuing or severe)


• shortness of breath or troubled breathing


• stomach cramps or pain


• tiredness or weakness (continuing or severe)


• trembling or shaking (continuing or severe)


• trouble seeing (continuing or severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Chills


• cough


• diarrhea


• feeling of warmth or heat


• fever


• flushing or redness of skin especially on face and neck


• increased need to urinate


• indigestion


• joint pain


• muscle aches and pains


• nausea


• passing urine more often


• runny nose


• unusual tiredness or weakness


• Sweating

Less common or rare

• fast heartbeat


• headache


• holding more body water


• swelling of face, fingers, ankles, or feet


• trembling or shaking


• trouble swallowing


• trouble seeing


• unusual weak feeling


• voice change


• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Salagen side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Salagen resources

• Salagen Side Effects (in more detail)
• Salagen Dosage
• Salagen Use in Pregnancy & Breastfeeding
• Drug Images
• Salagen Drug Interactions
• Salagen Support Group
• 0 Reviews for Salagen - Add your own review/rating

• Salagen Prescribing Information (FDA)


• Salagen MedFacts Consumer Leaflet (Wolters Kluwer)


• Salagen Concise Consumer Information (Cerner Multum)


• Pilocarpine Monograph (AHFS DI)


• Pilocarpine Prescribing Information (FDA)


• Pilocarpine Professional Patient Advice (Wolters Kluwer)

Compare Salagen with other medications

• Xerostomia

Epiduo 0.1% / 2.5% Gel

Epiduo 0.1% / 2.5% Gel

adapalene / benzoyl peroxide

GEL

cutaneous use

Epiduo 0.1% / 2.5% gel

Adapalene/Benzoyl Peroxide

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Epiduo is and what it is used for

2. Before you use Epiduo

3. How to use Epiduo

4. Possible side effects

5. How to store Epiduo

6. Further information

What Epiduo is and what it is used for

Epiduo is used for the treatment of acne.

This gel combines two active ingredients, Adapalene and Benzoyl peroxide which work together but in different ways:

Adapalene belongs to a group of products known as retinoids and acts specifically on the skin processes that cause acne.

The other active ingredient, benzoyl peroxide, works as an antimicrobial agent and by softening and peeling the outer layer of the skin.

Before you use Epiduo

Do not use Epiduo:

• if you are allergic (hypersensitive) to any of the ingredients in Epiduo.

Take special care with Epiduo:

• You should not use Epiduo on areas where you have cuts, scrapes or eczema.


• Make sure Epiduo does not get into your eyes, mouth or nostrils, and other very sensitive areas of the body. Should this occur wash these areas immediately with plenty of warm water.


• Avoid excessive exposure to sunlight and UV lamps.


• Avoid getting Epiduo on your hair or coloured fabrics as it may bleach them and wash your hands thoroughly after you have used the medicine.

Using other medicines

• Do not use other acne products (containing benzoyl peroxide and / or retinoids) at the same time as Epiduo.


• Avoid using Epiduo at the same time as cosmetics that are irritant, drying or exfoliate the skin.

Pregnancy and breast-feeding

Epiduo should not be used during pregnancy.

If you fall pregnant while taking Epiduo, the treatment must be discontinued and you should inform your doctor as soon as possible for a further follow-up.

Epiduo can be used during breast-feeding. To avoid contact exposure of the infant, application of Epiduo to the chest should be avoided.

Ask your doctor or pharmacist for advice before taking any medicine.

Important information about some of the ingredients of Epiduo

Epiduo also contains an ingredient known as propylene glycol (E1520) that may cause skin irritation.

How to use Epiduo

Always use Epiduo exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.

Epiduo is only intended for use in adults and adolescents aged 12 years and over.

Apply a thin film of gel evenly over acne affected areas once a day at bedtime, avoiding the eyes and lips. The skin should be clean and dry before application. You should wash your hands thoroughly after you have used Epiduo.

Your doctor will tell you how long you will need to use Epiduo.

If you feel that the effect of Epiduo is too strong or too weak, talk to your doctor or pharmacist.

If you experience persistent irritation when applying Epiduo, contact your doctor.

You may be asked to apply a moisturizer to use the gel less often or to stop for a short time, or to stop using the gel altogether.

If you use more Epiduo than you should

If you use more Epiduo than you should on your skin, you will not get rid of your acne quicker, but your skin may become irritated and red.

Please contact your doctor or the hospital:

• If you have used more Epiduo than you should.


• if a child has accidentally taken this medicine.

Your doctor will advise you on action to be taken.

If you forget to use Epiduo:

Do not apply a double dose to make up for forgotten individual doses.

Possible side effects

Like all medicines, Epiduo can cause side effects, although not everybody gets them.

Epiduo may cause the following side effects at the site of application.

Common side effects (occur in less than 1 in 10 patients)

• dry skin


• local skin rash (irritative contact dermatitis)


• burning sensation


• irritation of the skin

Uncommon side effects (occur in less than 1 in 100 patients)

• itching of the skin (pruritus)


• sunburn

If skin irritation appears after application of Epiduo, it is generally mild to moderate, with local signs as redness, dryness, scaling and burning, which peak during the first week and resolve without additional treatment.

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Epiduo

• Keep out of the reach and sight of children.


• Do not use Epiduo after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.


• Discard the tube 6 months after first opening.


• Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

These measures will help to protect the environment.

Further information

What Epiduo contains:

The active substances are: Adapalene and benzoyl peroxide. 1 g of gel contains 1 mg adapalene and 25 mg benzoyl peroxide.

The other ingredients are: docusate sodium, disodium edetate, glycerin, poloxamer, propylene glycol (E1520), Simulgel 600 PHA (copolymer of acrylamide and sodium acryloyldimethyltaurate, isohexadecane, polysorbate 80, sorbitan oleate) and purified water.

What Epiduo looks like and contents of the pack:

Epiduo is a white to very pale yellow opaque gel.

Epiduo is available in plastic tubes containing 2g, 15g, 30g, 45g, 60g or 90g (not all pack sizes may be marketed).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Galderma (UK) Ltd.

Meridien House

69-71 Clarendon Road

Watford

Herts

WD17 1DS

UK

Manufacturer

Laboratoires Galderma

ZI – Montdésir

74 540 Alby sur Chéran

France

PL 10590/0057

This medicinal product is authorised in the Member States of the EEA under the following names:

Denmark: Epiduo

France: Epiduo, gel

Spain: Epiduo 1mg/g + 25 mg/g gel

Austria, Belgium, Finland, Germany, Greece, Italy, Ireland, Iceland, Luxembourg, Netherlands, Norway, Poland, Portugal, Sweden, UK:
Epiduo 0.1% / 2.5% gel

This leaflet was last approved in April 2009.

P24569-0

Citracal Caplets Plus

Generic Name: calcium and vitamin D combination (KAL see um and VYE ta min D)

Brand Names: Calcarb with D, Calcet, Calcio Del Mar, Calcitrate with D, Calcium 600+D, Caltrate 600 with D, Caltrate 600 with D Plus Soy, Caltrate Colon Health, Citracal + D, Citracal 250 mg + D, Citracal Creamy Bites, Citracal Maximum + D, Citracal Petites, Citrus Calcium with Vitamin D, Dical-D, Os-Cal 250 with D, Os-Cal 500 + D, Os-Cal with D, Oysco 500 with D, Oysco D, Oyst-Cal-D, Oyster Shell Calcium with Vitamin D, Oyster-D, Oystercal-D, Posture-D H/P, Risacal-D

What is Citracal Caplets Plus (calcium and vitamin D combination)?

Calcium is a mineral that is found naturally in foods. Calcium is necessary for many normal functions of your body, especially bone formation and maintenance.

Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Calcium and vitamin D combination is used to prevent or to treat a calcium deficiency.

Calcium and vitamin D combination may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Citracal Caplets Plus (calcium and vitamin D combination)?

Before you take calcium and vitamin D combination, tell your doctor if you have kidney disease, past or present kidney stones, heart disease, circulation problems, a parathyroid disorder, or if you are pregnant or breast-feeding.

Avoid taking any other vitamin or mineral supplements that contain calcium or vitamin D without first talking to your doctor.

Before taking calcium and vitamin D combination, tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

What should I tell my healthcare provider before taking Citracal Caplets Plus (calcium and vitamin D combination)?

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take calcium and vitamin D combination, tell your doctor if you have:

• kidney disease;


• past or present kidney stones;


• 
  

  heart disease;

  
  


• 
  

  circulation problems; or

  
  


• 
  

  a parathyroid gland disorder.

  
  

Talk to your doctor before taking calcium and vitamin D combination if you are pregnant. Talk to your doctor before taking calcium and vitamin D combination if you are breast-feeding.

How should I take Citracal Caplets Plus (calcium and vitamin D combination)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take the calcium and vitamin D regular tablet with a full glass of water.

The chewable tablet should be chewed before you swallow it.

Store calcium and vitamin D combination at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include irregular heartbeat, stomach pain, nausea, vomiting, dry mouth, a metallic taste in your mouth, confusion, loss of appetite, constipation, weakness, headache, confusion, or fainting.

What should I avoid while taking Citracal Caplets Plus (calcium and vitamin D combination)?

Avoid taking any other vitamin or mineral supplements that contain calcium or vitamin D without first talking to your doctor.

Citracal Caplets Plus (calcium and vitamin D combination) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

• 
  

  an irregular heartbeat;

  
  


• 
  

  nausea, vomiting, or decreased appetite;

  
  


• 
  

  dry mouth;

  
  


• 
  

  constipation;

  
  


• 
  

  weakness;

  
  


• 
  

  headache;

  
  


• 
  

  a metallic taste;

  
  


• 
  

  muscle or bone pain; or

  
  


• 
  

  drowsiness.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Citracal Caplets Plus (calcium and vitamin D combination)?

Before taking calcium and vitamin D combination, tell your doctor if you are taking:

• 
  

  digoxin (Lanoxin, Lanoxicaps);

  
  


• 
  

  antacids containing calcium, aluminum, or magnesium;

  
  


• 
  

  other calcium supplements;

  
  


• 
  

  calcitriol (Rocaltrol) or other vitamin D supplements; or

  
  


• 
  

  a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

  
  

This list is not complete and there may be other drugs that can interact with calcium and vitamin D combination. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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Cefadroxil 500mg Capsules (Sandoz Limited)

1. Name Of The Medicinal Product

Cefadroxil 500 mg Capsules

2. Qualitative And Quantitative Composition

One capsule contains 500mg of cefadroxil (as monohydrate).

For excipients, see section 6.1

3. Pharmaceutical Form

capsules, hard

Description: white, opaque capsule containing white to slightly yellowish powder

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of following infections caused by cefadroxil-susceptible organisms, when an oral therapy is indicated:

- streptococcal pharyngitis and tonsillitis

- bronchopneumonia, bacterial pneumonia

- urinary tract infections: pyelonephritis, cystitis

- skin and soft tissue infections: abscesses, furunculosis, impetigo, erysipela, pyoderma, lymphadenitis

Consideration should be given to official local guidance regarding the appropriate use and prescription of antibacterial agents.

Regarding treatment of meningitis, Streptococcus pyogenes infections and prevention of rheumatic fever see section 4.4 ('Special Warnings and Special Precautions for Use')

4.2 Posology And Method Of Administration

The dosage depends on the susceptibility of the pathogens, the severity of the disease and on the clinical status of the patient (renal and hepatic function).

Indication	Adults and adolescents > 40 kg with normal renal function	Children (< 40 kg) with normal renal function
Streptococcal pharyngitis / tonsillitis	Dosage may be decreased to 1 g once a day over at least 10 days	30 mg/kg/day once a day over at least 10 days
Bronchopneumonia,bacterial pneumonia	1g twice a day	30-50 mg/kg/day twice a day
Urinary tract infections	1g twice a day	30-50 mg/kg/day twice a day
Skin & soft tissue infections	1g twice a day	30-50 mg/kg/day twice a day

Children may benefit of increased posology up to 100mg/Kg/day.

Depending on the severity of the infection, adults may require increased posology.

Chronic urinary tract infection may require a prolonged and intensive treatment with continued testing of susceptibility and clinical monitoring.

*Elderly

As cefadroxil is excreted by renal route, the dosage should be adjusted if necessary as described under impaired renal function.

*Dosage in renal insufficiency:

The dosage should be adjusted according to creatinine clearance rates to prevent accumulation of cefadroxil. In patients with creatinine clearance of 50 ml/min or less, the following reduced dosage schedule is recommended as a guideline:

Creatinine clearance (ml/ min/ 1,73 m2)	Initial dose	Following dose	Dosage interval
50 - 25	1000 mg	500 mg –1000mg+	every 12 hours
25 - 10	1000 mg	500 mg –1000mg+	every 24 hours
10 - 0	1000 mg	500 mg –1000mg+	every 36 hours

⁺Consideration should be given to official local guidelines regarding the appropriate use of antibacterial agents.

*Dosage in hepatic insufficiency:

No adjustment of posology is necessary.

*Dosage for haemodialysis patients:

Haemodialysis eliminates 63% of 1g of cephalosporin after 6 to 8 hours of haemodialysis. Elimination half-life of cephalosporin is about 3 hours during dialysis.

Patients with haemodialysis should receive one additional dose of 500mg – 1000mg at the end of the haemodialysis.

Mode of administration

Bioavailability is not affected by food and cefadroxil may be taken with meals or on an empty stomach. In case of gastro-intestinal disturbances, it may be administered with food.

The capsules are taken unchewed with a liberal quantity of fluid.

Duration of therapy:

Treatment should be applied for 2 to 3 further days after regression of the acute clinical symptoms or evidence of bacterial eradication has been obtained. In infections caused by Streptococcus pyogenes up to 10 days treatment may be considered.

4.3 Contraindications

− History of or suspected hypersensitivity to cephadroxil, to any other cephalosporin or to any of the excipients.

− History of severe reactions to penicillins or to any other beta-lactam dru gs.

4.4 Special Warnings And Precautions For Use

− Cefadroxil does not penetrate in the CSF and is not indicated for the treatment of meningitis (see section 5.2).

− Penicillin is the first drug of choice for the treatment of the Streptococcus pyogenes and for the prevention of rheumatic fever. Data for cefadroxil are not sufficiently substantial for prophylaxis therapy.

− Special caution should be exercised in patients with history of severe allergies or asthma.

− In patients with a history of non severe hypersensitity to penicillins, or other non-cephalosporin beta –lactam drugs, cefadroxil should be used with special caution as cross allergies occur (incidence 5-10%).

− Renal impairment. Caution is necessary in patients with renal impairment; the dosage must be adjusted according to the grade of renal impairment (see § 4.2 "Posology").

− History of gastro-intestinal disturbances. Cefadroxil should be used with caution in patients with a history of gastro-intestinal disturbances particularly colitis.

− Allergic reactions. Treatment must be discontinued at once if allergic reactions occur (urticaria, exanthema, pruritus, fall of blood pressure and increased heart rate, respiratory disturbances, collapse, etc.) and suitable countermeasures should be taken (sympathomimetics, corticosteroids and/or antihistaminics).

− Prolonged use. Particularly on prolonged use frequent checks on the blood count and regular hepatic and renal function tests are advisable. Superinfections with fungi (e.g. candida) can occur on prolonged treatment with cefadroxil.

− In case of severe and persistent diarrhoea, an antibiotic-associated pseudomembranous colitis should be considered. In that case Cefadroxil must be discontinued immediately and a suitable therapy should be started (e.g. oral vancomycin, 250 mg q.i.d.). Antiperistaltics are contraindicated.

− Severe life-threatening infections or those which require higher posology or repetitive administrations per day may benefit of parenteral cephalosporins.

− The result of the Coombs' test can be transiently positive during or after treatment with cefadroxil.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Contraindication of concomitant use

− Cefadroxil should not be combined with bacteriostatic antibiotics (e.g. tetracycline, erythromycin, sulfonamides, chloramphenicol) since an antagonistic effect is possible.

− Treatment with Cefadroxil in combination with aminoglycoside antibiotics, polymyxin B, colistin or high-dose loop diuretics should be avoided since such combinations can potentiate nephrotoxic effects.

Concomitant use not recommended

− Frequent checks on coagulation parameters are necessary during concomitant long term use of anticoagulants or thrombocyte aggregation inhibitors to avoid haemorrhagic complications.

Precautions

− The concomitant administration of probenicid can produce higher and sustained concentrations of cefadroxil in the serum and in the bile.

− The occurence of diarrhoea may impair the resorption of other medicaments and therefore lead to an impairment of their efficacy.

− Forced diuresis leads to a decrease of cefadroxil blood levels.

− Cefadroxil may attenuate the effect of oral contraceptives.

− Cefadroxil binds to cholestyramine which may lead to reduced bioavailability of cefadroxil.

− The result of the direct Coombs' test can be transiently positive during or after treatment with cefadroxil. This also applies to Coombs' tests carried out in newborns whose mother received treatment with cephalosporins before delivery.

− Urinary sugar should be determined enzymatically (e.g. with test strips) during treatment with cefadroxil since reduction tests can furnish falsely elevated values.

4.6 Pregnancy And Lactation

Although animal studies and clinical experience have not shown any evidence of teratogenicity, the safe use during pregnancy has not been established.

Cefadroxil is present in low concentrations in breast milk; sensitization, diarrhoea or colonization of the infants' mucosa with fungi are possible.

The use of cefadroxil during pregnancy and in lactating mothers should therefore be handled very strictly.

4.7 Effects On Ability To Drive And Use Machines

No effect is known so far.

4.8 Undesirable Effects

Adverse drug reactions occur in about 6% to 7%* of treated patients.

Hypersensitivity reactions:

Common (>1/100, < 1/10)

Pruritus, rash, allergic exanthema, urticaria.

Rare (>1/10 000, < 1/1000)

Angioneurotic oedema, drug fever, serum sickness-like reactions, arthralgia, intertitial nephritis.

Very rare (<1/10 000)

Immediate allergic reaction (anaphylactic shock).

Isolated cases of Stevens Johnson syndrome and erythema multiforma have been reported.

Blood disorders:

Rare (>1/10 000, < 1/1000)

Eosinophilia, thrombocytopenia, leucopenia, neutropenia, agranulocytosis: rare cases during prolonged used, which subside upon discontinuation of therapy.

Very rare (<1/10 000)

Isolated cases of haemolytic anaemia of immunologic origin.

Gastrointestinal disorders:

Common (>1/100, < 1/10)

Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, glossitis.

Very rare (<1/10 000)

Isolated cases of pseudomenbranous colitis have been reported.

Liver disorders:

Rare (>1/10 000, < 1/1000)

Minor elevation of serum transaminases (ASAT, ALAT) and alkaline phosphatases.

Cases of cholestase and idiosyncratic hepatic failure have been reported.

CNS disorders

Very rare (<1/10 000)

Headache, dizziness, nervousness, sleeplessness, fatigue.

Other undesirable effects:

Uncommon (>1/1000, <1/100)

Clinical pictures due to a growth of opportunistic organisms (fungi), such as vaginal mycoses, thrush.

*incidence of suspected adverse reactions in an observational post-marketing study in 904 patients.

4.9 Overdose

No clinical reports are as yet available on cefadroxil in this respect. However in view of experience gained with other cephalosporins the following symptoms are possible: nausea, hallucinations, hyperreflexia, extrapyramidal symptoms, clouded consciousness, or even coma and renal functional impairment. First aid after intake of toxic doses: induce vomiting at once or gastric lavage, if necessary haemodialysis. Monitor and if necessary correct the water and electrolyte balance, monitor renal function.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

General properties

ATC-Code: J01AD09

Pharmacotherapeutic group: Beta-lactam antibiotics, cephalosporins.

Cefadroxil is a cephalosporin for oral administration which inhibits bacterial wall synthesis of actively dividing cells by binding to one or more penicillin-binding proteins. The result is formation of a defective cell wall that is osmotically unstable, and bacterial cell lysis.

Breakpoints

The following MIC (Minimal Inhibitory Concentration) breakpoints according to NCCLS (National Committee for Clinical Laboratory Standards) separate susceptible (S) from intermediately susceptible and intermediately susceptible from resistant ( R) organisms:

S

Susceptibility

The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. The information in the table gives only approximate guidance as to whether microorganisms will be susceptible to cefadroxil.

Micro-organism

Range of acquired resistance

Susceptible Gram-positive aerobes Staphylococcus aureus (methicillin-susceptible) Streptococci Group B, C and G Streptococcus pneumoniae Streptococcus pyogenes Gram-negative aerobes Moraxella catarrhalis Intermediately susceptible Gram-negative aerobes Citrobacter diversus E. coli H. influenzae K. pneumoniae K. oxytoca P. mirabilis Salmonella Shigella Resistant Gram-positive aerobes Enterococci Staphylococcus aureus (Methicillin-resistant) Staphylococcus epidermidis (Methicillin-resistant) Streptococcus pneumoniae (penicillin-resistant) Gram-negative aerobes Acinetobacter spp. Citrobacter freundii Enterobacter spp. Morganella morganii P. vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Serratia marcescens

0 - 11 %   5,4 - 12,6 % (a)     (2 %)       0 - 80 % 50 - 57 % 2 - 50 % 7 - 22 % 0 - 90 %

(a) prevalence of penicillin-resistance in Concerned Member States

Resistance

Cefadroxil may be active against organisms producing some types of beta-lactamase, for example TEM-1, in low to moderate quantities. However, it is inactivated by beta-lactamases that can efficiently hydrolyse cephalosporins, such as many of the extended-spectrum beta-lactamases and chromosomal cephalosporinases, such as AmpC type enzymes.

Cefadroxil cannot be expected to be active against bacteria with penicillin-binding proteins that have reduced affinity for beta-lactam drugs. Resistance may also be mediated by bacterial impermeability or by bacterial drug efflux pumps. More than one of these four means of resistance may be present in the same organism.

In vitro, oral first generation cephalosporins are less active than penicillins G and V on Gram-positive microorganisms and are less active than aminopenicillins on H. influenzae.

5.2 Pharmacokinetic Properties

General characteristics

− After oral administration cefadroxil is practically completely absorbed.

− Simultaneous intake of food has practically no effect on absorption (AUC).

− After oral doses of 500 mg (1 g) peak plasma concentrations of about 16 (30) g/ml are obtained after 1-1.3 hours.

− Between 18 and 20% of cefadroxil is bound to plasma proteins.

− Cefadroxil is not metabolised.

− Cefadroxil is eliminated far more slowly than comparable oral cephalosporins (half life: about 1.4 h to 2.6 h) so that intervals between doses can be prolonged to 12-24 hours.

− Roughly 90% of the substance is eliminated in unchanged form through the kidneys within 24 hours.

− Cefadroxil may be eliminated from the organism through haemodialysis.

− Cephalosporins do not penetrate in the CSF and should not be used for the treatment of meningitis (see section 4.1 – Therapeutic Indications).

Characteristics in patients with highgrade renal functional impairment

Elimination is retarded, so that interval between doses must be prolonged (see Posology).

5.3 Preclinical Safety Data

Pre-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and reproductive toxicology.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Content:	Magnesium stearate
	Sodium lauryl sulfate
	Cellulose, microcrystalline
Shell:	Titanium dioxide (E-171)
	Gelatin

6.2 Incompatibilities

None known

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Store in the original container. Keep container in the outer carton.

6.5 Nature And Contents Of Container

single packs of 10, 12, 14, 16, 20, 30, 40, and 100 (100x1) capsules

hospital packs of 100 (10x10) and 1000 (100x10) capsules

in polyvinylchloride/polyvinylidene (PVC/PVDC)-Alu-blister strips

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Sandoz Ltd

Frimley Business Park,

Frimley,

Camberley,

Surrey,

GU16 7SR.

United Kingdom

8. Marketing Authorisation Number(S)

PL 4416/0433.

9. Date Of First Authorisation/Renewal Of The Authorisation

24 October 2002

10. Date Of Revision Of The Text

11/2010