Metadate CD

Generic Name: methylphenidate (Oral route)

meth-il-FEN-i-date

Oral route(Tablet;Tablet, Extended Release;Tablet, Chewable;Solution)

Use cautiously in emotionally unstable patients, such as those with a history of drug dependence or alcoholism, due to abuse potential. Chronic abuse can lead to marked tolerance and psychic dependence with varying degrees of abnormal behavior including psychotic episodes. Careful supervision during drug withdrawal, since severe depression as well as the effects of chronic overactivity can be unmasked .

Commonly used brand name(s)

In the U.S.

• Concerta


• Metadate CD


• Metadate ER


• Methylin


• Methylin ER


• Ritalin


• Ritalin LA


• Ritalin-SR

Available Dosage Forms:

• Tablet, Extended Release


• Capsule, Extended Release


• Tablet, Chewable


• Solution


• Tablet

Therapeutic Class: CNS Stimulant

Chemical Class: Amphetamine Related

Uses For Metadate CD

Methylphenidate belongs to the group of medicines called central nervous system (CNS) stimulants. It is used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy. Narcolepsy is an uncontrollable desire for sleep or a sudden attack of deep sleep.

Methylphenidate works in the treatment of ADHD by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although not specifically included in product labeling, methylphenidate may be used in certain patients with the following condition:

• Depressive disorder secondary to physical illness in patients who cannot take antidepressant medicines.

Before Using Metadate CD

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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of methylphenidate in children. Safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies on the relationship of age to the effects of Concerta® extended release tablets have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.

No information is available on the relationship of age to the effects of Ritalin® and Ritalin LA® in geriatric patients.

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. 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Brofaromine


• Clorgyline


• Furazolidone


• Iproniazid


• Isocarboxazid


• Lazabemide


• Linezolid


• Moclobemide


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Rasagiline


• Selegiline


• Toloxatone


• Tranylcypromine

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.

• Carbamazepine

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:

• Agitation, severe or


• Anxiety, severe or


• Glaucoma or


• Motor tics (repeated muscle movements) or


• Tension, severe or


• Tourette's syndrome, or family history of—Should not be used in patients with these conditions.

• Alcohol abuse, history of or


• Drug abuse or dependence, history of—Dependence may be more likely to develop.

• Bipolar disorder (manic-depressive illness), history of or


• Blood vessel problems or


• Coronary artery disease or


• Depression, history of or


• Heart attack, recent or


• Heart disease (e.g., cardiomyopathy) or


• Heart failure or


• Heart rhythm problems (e.g., ventricular arrhythmia), history of or


• Hypertension (high blood pressure) or


• Hyperthyroidism (overactive thyroid) or


• Psychosis (mental illness), history of or


• Seizures, history of or


• Stroke, history of or


• Tachycardia (rapid heart rate)—Use with caution. May make these conditions worse.

• Cystic fibrosis or


• Stomach or bowel problems (e.g., bowel blockage, Meckel's diverticulum, peritonitis, short gut syndrome) or


• Trouble with swallowing—Concerta® extended release tablets should not be given in patients with these conditions.

Proper Use of methylphenidate

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

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming. If you or your child think this medicine is not working properly after you have taken it for several weeks, check with your doctor first and do not increase the dose.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

To help prevent trouble with sleeping, take the last dose of the short-acting tablets before 6 p.m., unless your doctor gives you or your child a different time.

If you or your child are taking the long-acting forms of this medicine:

• The Concerta® extended release tablets, Ritalin LA® capsules, and Ritalin SR® tablets are to be swallowed whole with water or other liquids. Do not break, open, crush, or chew them before swallowing.


• If you or your child are unable to swallow the Ritalin LA® extended-release capsule whole, carefully open the capsule and sprinkle the small beads over a spoonful of applesauce. The mixture of drug and applesauce should be taken right away without chewing. The drug and applesauce mixture can not be stored for future use.


• If you are taking the Concerta® extended-release tablets, you may sometimes notice what looks like a tablet in your stool. This is the empty tablet shell that is left after the medicine has been absorbed into your body.


• You may take Concerta® extended release tablets with or without food.

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 attention deficit hyperactivity disorder (ADHD):
  
  • For short-acting oral dosage form (tablets):
    
    • Adults—5 to 20 milligrams (mg) two or three times a day, taken 30 to 45 minutes before meals.
    
    
    • Teenagers and children 6 years of age and older—At first, 5 mg two times a day, taken before breakfast and lunch. If needed, your doctor may increase the dose once a week by 5 to 10 mg a day until symptoms improve or a maximum dose of 60 mg is reached.
    
    
    • Children up to 6 years of age—Use and dose must be determined by the doctor.
    
    
  
  
  • For long-acting oral dosage form (extended-release tablets):
    
    • For patients who have not been treated with Concerta®:
      
      • Adults—At first, 18 to 36 milligrams (mg) once a day in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 72 mg a day.
      
      
      • Teenagers and children 6 years of age and older—At first, 18 mg once a day in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 72 mg a day.
      
      
      • Children up to 6 years of age—Use and dose must be determined by your doctor.
      
      
    
    
    • For patients already using Concerta®:
      
      • Adults, teenagers, and children 6 years of age and older—At first, 18 to 72 milligrams (mg) once a day in the morning, depending on your previous dose of methylphenidate. Your doctor may increase your dose as needed. However, the dose is usually not more than 72 mg a day.
      
      
      • Children up to 6 years of age—Use and dose must be determined by your doctor.
      
      
    
    
  
  
  • For long-acting oral dosage form (sustained-release tablets):
    
    • Adults, teenagers, and children 6 years of age and older—The dose must be determined by the doctor.
    
    
    • Children up to 6 years of age—Use and dose must be determined by the doctor.
    
    
  
  
  • For the long-acting oral dosage form (extended-release capsules):
    
    • Adults, teenagers, and children 6 years of age and older—10 to 20 milligrams (mg) once a day, taken in the morning before breakfast. If needed, your doctor may increase the dose once a week by 10 mg a day as needed up to 60 mg a day.
    
    
    • Children up to 6 years of age—Use and dose must be determined by the doctor.
    
    
  
  


• For narcolepsy:
  
  • For short-acting oral dosage form (tablets):
    
    • Adults—5 to 20 milligrams (mg) two or three times a day, taken 30 to 45 minutes before meals.
    
    
    • Teenagers and children 6 years of age and older—At first, 5 mg two times a day, taken before breakfast and lunch. If needed, your doctor may increase the dose once a week by 5 to 10 mg a day until symptoms improve or a maximum dose of 60 mg is reached.
    
    
    • Children up to 6 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For long-acting oral dosage form (sustained-release tablets):
    
    • Adults and teenagers and children 6 years of age and older—The dose must be determined by the doctor.
    
    
    • Children up to 6 years of age—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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Metadate CD

Your doctor should check you or your child's progress at regular visits to make sure this medicine is working properly and to decide if you or your child should continue to take it. Blood tests may be needed to check for unwanted effects.

You or your child will also need to have your blood pressure measured before starting this medicine and while you or your child are using it. If you notice any change to you or your child's recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

You or your child should not use this medicine if you have used a drug for depression called an MAO inhibitor (MAOI), such as Eldepryl®, Marplan®, Nardil®, or Parnate®, in the past 14 days.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, herbal or vitamin supplements, and medicine for appetite control, asthma, colds, cough, hayfever, or sinus problems.

Methylphenidate may cause dizziness, drowsiness, or changes in vision. Do not drive a car, ride a bicycle, operate machinery, or do other things that might be dangerous until you know how this medicine affects you.

Methylphenidate may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you or your child have chest pain, shortness of breath, or fainting while using this medicine.

Tell your doctor right away if you or your family notices any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you or your child have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.

This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly.

Metadate CD 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:

More common

• Fast heartbeat

Less common

• Chest pain


• fever


• joint pain


• skin rash or hives

Rare

• Black, tarry stools


• blood in the urine or stools


• blurred vision or other changes in vision


• convulsions


• crusting, dryness, or flaking of the skin


• muscle cramps


• pinpoint red spots on the skin


• scaling, severe redness, soreness, or swelling of the skin


• uncontrolled vocal outbursts or tics (uncontrolled and repeated body movements)


• unusual bleeding or bruising

Incidence not known

• Confusion


• cracks in the skin


• delusions (false beliefs)


• depersonalization (feeling like surroundings are not real)


• depression (severe)


• hallucinations (seeing, hearing, or feeling things that are not there)


• hives or welts


• loss of heat from the body


• mood changes


• numbness of the hands


• painful or difficult urination


• pale skin


• red, irritated eyes


• red, swollen, or scaly skin


• severe or sudden headache


• shortness of breath


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• sudden loss of coordination


• sudden slurring of speech


• swollen glands


• troubled breathing with exertion


• unusual behavior


• unusual tiredness or weakness


• weight loss


• yellow skin or eyes

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Agitation


• confusion (severe)


• convulsions


• dryness of the mouth or mucous membranes


• false sense of well-being


• fast, pounding, or irregular heartbeat


• fever


• flushing


• hallucinations (seeing, hearing, or feeling things that are not there)


• headache (severe)


• increased sweating


• large pupils


• muscle twitching


• overactive reflexes


• sweating


• trembling or shaking


• vomiting

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

• Loss of appetite


• nervousness


• sleeplessness


• stuffy nose


• trouble with sleeping


• unable to sleep


• unusually warm skin

Less common

• Anger


• dizziness


• drowsiness


• fear


• headache


• irritability


• muscle aches


• nausea


• nervousness


• runny nose


• scalp hair loss


• stomach pain


• talking, feeling, and acting with excitement

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: Metadate CD 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 Metadate CD resources

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

• Metadate CD Prescribing Information (FDA)


• Metadate CD Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Concerta Consumer Overview


• Concerta Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Concerta Prescribing Information (FDA)


• Daytrana Prescribing Information (FDA)


• Daytrana Consumer Overview


• Daytrana System MedFacts Consumer Leaflet (Wolters Kluwer)


• Metadate ER Prescribing Information (FDA)


• Methylin MedFacts Consumer Leaflet (Wolters Kluwer)


• Methylin Prescribing Information (FDA)


• Methylin ER Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Methylphenidate Hydrochloride Monograph (AHFS DI)


• Ritalin Consumer Overview


• Ritalin Prescribing Information (FDA)


• Ritalin LA Prescribing Information (FDA)


• Ritalin LA Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Metadate CD with other medications

• ADHD

Carbodex DM Elixir

Pronunciation: brome-fen-IR-a-meen/dex-troe-meth-OR-fan/sue-do-eh-FED-rin
Generic Name: Brompheniramine/Dextromethorphan/Pseudoephedrine
Brand Name: Examples include Bromfed DM and Carbodex DM

Carbodex DM Elixir is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Carbodex DM Elixir is a decongestant, antihistamine, and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing while the cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Carbodex DM Elixir if:

• you are allergic to any ingredient in Carbodex DM Elixir


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you take sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Carbodex DM Elixir:

Some medical conditions may interact with Carbodex DM Elixir. 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 a fast, slow, or irregular heartbeat


• if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; or an overactive thyroid


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

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

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Carbodex DM Elixir's side effects


• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Carbodex DM Elixir


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Carbodex DM Elixir

This may not be a complete list of all interactions that may occur. Ask your health care provider if Carbodex DM Elixir 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 Carbodex DM Elixir:

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

• Take Carbodex DM Elixir by mouth with or without food.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Carbodex DM Elixir, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Carbodex DM Elixir.

Important safety information:

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


• Do not take diet or appetite control medicines while you are taking Carbodex DM Elixir without checking with you doctor.


• Carbodex DM Elixir has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


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


• If you are scheduled for allergy skin testing, do not take Carbodex DM Elixir for several days before the test because it may decrease your response to the skin tests.


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


• Use Carbodex DM Elixir with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Carbodex DM Elixir in CHILDREN; they may be more sensitive to its effects.


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

Possible side effects of Carbodex DM Elixir:

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:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; 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); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.

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.

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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Carbodex DM Elixir:

Store Carbodex DM Elixir at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Carbodex DM Elixir out of the reach of children and away from pets.

General information:

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


• Carbodex DM Elixir 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 Carbodex DM Elixir. 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 Carbodex DM resources

• Carbodex DM Use in Pregnancy & Breastfeeding
• Carbodex DM Drug Interactions
• 0 Reviews for Carbodex DM - Add your own review/rating

Compare Carbodex DM with other medications

• Cough and Nasal Congestion

Children's Tylenol Meltaway

Generic Name: acetaminophen (oral) (a SEET a MIN oh fen)

Brand Names: Acetaminophen Quickmelt, Actamin, Adprin B, Anacin AF, Apra, Bromo Seltzer, Children's Tylenol, Children's Tylenol Meltaway, Ed-APAP, Elixsure Fever/Pain, Genebs, Infants Tylenol Concentrated Drops, Leader 8 Hour Pain Reliever, Little Fevers, Little Fevers Children's Fever/Pain Reliever, Mapap, Mapap Arthritis Pain, Mapap Extra Strength Rapid Burst, Mapap Infant Drops, Mapap Infants', Mapap Meltaway, Mapap Rapid Release Gelcaps, Mapap Rapid Tabs, Medi-Tabs, Q-Pap, Q-Pap Extra Strength, Silapap Childrens, Silapap Infants, St. Joseph Aspirin-Free, Tactinal, Tempra, Tempra Quicklets, Triaminic Fever & Pain, Triaminic Infant Drops, Tycolene, Tylenol, Tylenol Arthritis Caplet, Tylenol Arthritis Gelcap, Tylenol Caplet, Tylenol Caplet Extra Strength, Tylenol Childrens, Tylenol Cool Caplet Extra Strength, Tylenol Extra Strength, Tylenol Extra Strength Cool Caplet, Tylenol Extra Strength EZ, Tylenol Gelcap Extra Strength, Tylenol Geltab Extra Strength, Tylenol Infant's Drops, Tylenol Junior Meltaway, Tylenol Rapid Release Gelcap, Tylenol Sore Throat Daytime, Vitapap

What is acetaminophen?

There are many brands and forms of acetaminophen available and not all brands are listed on this leaflet.

Acetaminophen is a pain reliever and a fever reducer.

Acetaminophen is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

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

What is the most important information I should know about acetaminophen?

There are many brands and forms of acetaminophen available and not all brands are listed on this leaflet.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Know the amount of acetaminophen in the specific product you are taking.

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver disease or a history of alcoholism.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What should I discuss with my healthcare provider before taking acetaminophen?

You should not take acetaminophen if you are allergic to it.

Ask a doctor or pharmacist if it is safe for you to take acetaminophen if you have:

• liver disease; or


• 
  

  a history of alcoholism.

  
  

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen. It is not known whether acetaminophen will harm an unborn baby. Before taking acetaminophen, tell your doctor if you are pregnant. Acetaminophen 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. Do not give the medication to a child younger than 2 years old without the advice of a doctor.

How should I take acetaminophen?

Take exactly as directed on the label, or as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

If you are treating a child, use a pediatric form of acetaminophen. Use only the special dose-measuring dropper or oral syringe that comes with the specific pediatric form you are using. Carefully follow the dosing directions on the medicine label. Acetaminophen made for infants is available in two different dose concentrations, and each concentration comes with its own medicine dropper or oral syringe. These dosing devices are not equal between the different concentrations. Using the wrong device may cause you to give your child an overdose of acetaminophen. Never mix and match dosing devices between infant formulations of acetaminophen. You may need to shake the liquid before each use. Follow the directions on the medicine label.

The chewable tablet must be chewed thoroughly before you swallow it.

Make sure your hands are dry when handling the acetaminophen disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

To use the acetaminophen effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Stop taking acetaminophen and call your doctor if:

• 
  

  you still have a fever after 3 days of use;

  
  


• 
  

  you still have pain after 7 days of use (or 5 days if treating a child);

  
  


• 
  

  you have a skin rash, ongoing headache, or any redness or swelling; or

  
  


• 
  

  if your symptoms get worse, or if you have any new symptoms.

  
  

This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using acetaminophen.

Store at room temperature away from heat and moisture.

What happens if I miss a dose?

Since acetaminophen is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

What should I avoid while taking acetaminophen?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Acetaminophen 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. Stop taking this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  nausea, upper stomach pain, itching, loss of appetite;

  
  


• 
  

  dark urine, clay-colored stools; or

  
  


• 
  

  jaundice (yellowing of the skin or eyes).

  
  

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 acetaminophen?

Ask a doctor or pharmacist if it is safe for you to use acetaminophen if you are also using any of the following drugs:

• 
  

  an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

  
  


• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  cancer medications;

  
  


• 
  

  cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

  
  


• 
  

  gout or arthritis medications (including gold injections);

  
  


• 
  

  HIV/AIDS medications;

  
  


• 
  

  medicines to treat psychiatric disorders;

  
  


• 
  

  an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

  
  


• 
  

  seizure medications.

  
  

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

More Children's Tylenol Meltaway resources

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

• acetaminophen Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Acetaminophen MedFacts Consumer Leaflet (Wolters Kluwer)


• Acetaminophen Monograph (AHFS DI)


• Acetazolamide Monograph (AHFS DI)


• Apra Advanced Consumer (Micromedex) - Includes Dosage Information


• Apraclonidine Hydrochloride Monograph (AHFS DI)


• Genapap Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Mapap Suppositories MedFacts Consumer Leaflet (Wolters Kluwer)


• Ofirmev Consumer Overview


• Ofirmev Injection MedFacts Consumer Leaflet (Wolters Kluwer)


• Ofirmev Prescribing Information (FDA)


• Paracetamol Consumer Overview


• Tempra 1 Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Tylenol Consumer Overview


• Tylenol MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Children's Tylenol Meltaway with other medications

• Fever
• Pain

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen.

See also: Children's Tylenol Meltaway side effects (in more detail)

Nicorette Microtab Lemon 2 mg sublingual tablets.

1. Name Of The Medicinal Product

Nicorette Microtab Lemon 2 mg sublingual tablets.

2. Qualitative And Quantitative Composition

Nicotine bitartrate equivalent to 2.0 mg nicotine per tablet.

Nicotine Microtab Lemon also contains the ingredient aspartame. Please see section 4.4.

For a full list of excipients see section 6.1

3. Pharmaceutical Form

Sublingual tablet.

White to off-white flat round, bevel-edged tablets engraved on one side with 'N2'.

4. Clinical Particulars

4.1 Therapeutic Indications

Nicorette Microtab Lemon is indicated for the relief of nicotine withdrawal symptoms as an aid to smoking cessation in adults and children over 12 years of age. It is also indicated in pregnant and lactating women (see section 4.6).

In smokers currently unable or not ready to stop smoking abruptly, Nicorette Microtab Lemon may also be used as part of a programme to reduce smoking prior to stopping completely.

If possible, Nicorette Microtab Lemon should be used in conjunction with a behavioural support programme.

4.2 Posology And Method Of Administration

Behavioural therapy, advice and support will normally improve the success rate.

Smoking cessation

Adults (over 18 years of age)

The patient should make every effort to stop smoking completely during treatment with Nicorette Microtab Lemon.

The initial dose is based on the individual's nicotine dependence. The tablet is used sublingually with a recommended dose of one tablet per hour or, for heavy smokers (smoking more than 20 cigarettes per day), two tablets per hour. Increasing to two tablets per hour may be considered for patients who fail to stop smoking with the one tablet-per-hour regimen or for those whose nicotine withdrawal symptoms remain so strong as to foresee a relapse.

Most smokers require 8 to 12 or 16 to 24 tablets per day, not to exceed 40 tablets. The duration of treatment depends on the individual, but up to three months of treatment is recommended. The nicotine dose should then be gradually reduced, by decreasing the total number of tablets used per day. The treatment should be stopped when the daily consumption is down to one or two tablets.

Adults who use nicotine replacement therapy (NRT) beyond 9 months are recommended to seek additional help and advice from a healthcare professional.

Adolescents (12 to 18 years)

The patient should make every effort to stop smoking completely during treatment with Nicorette Microtab Lemon.

The initial dose is based on the individual's nicotine dependence. The tablet is used sublingually with a recommended dose of one tablet per hour or, for heavy smokers (smoking more than 20 cigarettes per day), two tablets per hour. Increasing to two tablets per hour may be considered for patients who fail to stop smoking with the one tablet-per-hour regimen or for those whose nicotine withdrawal symptoms remain so strong as to foresee a relapse.

Most smokers require 8 to 12 or 16 to 24 tablets per day, not to exceed 40 tablets. Use for up to 8 weeks to break the habit of smoking, then gradually reduce the dose over a 4 week period. The treatment should be stopped when the daily consumption is down to one or two tablets. As data are limited in this age group, the recommended duration of treatment is 12 weeks. If longer treatment is required, advice from a healthcare professional should be sought.

Children (under 12 years)

There is no relevant indication for the use of Nicorette Microtab Lemon in children under 12.

Smoking reduction

Adults (over 18 years of age)

Use Nicorette Microtab Lemon between smoking episodes to manage the urge to smoke, to prolong smoke-free intervals and with the intention to reduce smoking as much as possible. If a reduction in number of cigarettes per day has not been achieved after 6 weeks, professional advice should be sought.

A quit attempt should be made as soon as the smoker feels ready, but not later than 6 months after start of treatment. If a quit attempt cannot be made within 9 months after starting treatment, professional advice should be sought.

When making a quit attempt the smoking cessation instructions above can be followed.

Adolescents (12 to 18 years)

Where adolescents are motivated to stop smoking abruptly, smoking cessation should be recommended. However, smoking reduction can be considered where adolescents are not ready or able to stop smoking abruptly. As data are limited in this age group, and the recommended duration of NRT is 12 weeks, adolescents should consult a healthcare professional before starting the “smoking reduction prior to stopping” regimen.

Use Nicorette Microtab Lemon between smoking episodes to manage the urge to smoke, to prolong smoke-free intervals and with the intention to reduce smoking as much as possible. If a reduction in number of cigarettes per day has not been achieved after 6 weeks, professional advice should be sought.

A quit attempt should be made as soon as the smoker feels ready, but not later than 6 months after start of treatment. If a quit attempt cannot be made within 9 months after starting treatment, professional advice should be sought.

When making a quit attempt the smoking cessation instructions for adolescents (12 to 18 years) given above can be followed.

Children (under 12 years)

There is no relevant indication for the use of Nicorette Microtab Lemon in children under 12.

4.3 Contraindications

Hypersensitivity to nicotine or any other component of the sublingual tablet.

4.4 Special Warnings And Precautions For Use

Any risks that may be associated with NRT are substantially outweighed by the well established dangers of continued smoking.

Nicorette Microtab Lemon contains the ingredient aspartame which is a source of phenylalanine and may be harmful for people with phenylketonuria.

Underlying cardiovascular disease: In stable cardiovascular disease Nicorette Microtab Lemon presents a lesser hazard than continuing to smoke. However dependent smokers currently hospitalised as a result of myocardial infarction, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, Nicorette Microtab may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision.

Diabetes mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

GI disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.

Renal or hepatic impairment: Nicorette Microtab Lemon should be used with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.

Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children.

Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes release of catecholamines, Nicorette Microtab Lemon should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma.

Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Stopping smoking: See section 4.5

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically relevant interactions between nicotine replacement therapy and other drugs have definitely been established. However nicotine may possibly enhance the haemodynamic effects of adenosine i.e. increase in blood pressure and heart rate and also increase pain response (angina-pectoris type chest pain) provoked by adenosine administration.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e.g. theophylline, clozapine and ropinirole.

4.6 Pregnancy And Lactation

Pregnancy

NRT is not contraindicated in pregnancy. The decision to use NRT should be made on a risk-benefit assessment as early on in the pregnancy as possible with the aim of discontinuing use as soon as possible.

Smoking during pregnancy is associated with risks such as intra-uterine growth retardation, premature birth or stillbirth. Stopping smoking is the single most effective intervention for improving the health of both pregnant smoker and her baby. The earlier abstinence is achieved the better.

Ideally smoking cessation during pregnancy should be achieved without NRT. However for women unable to quit on their own, NRT may be recommended to assist a quit attempt.

Nicotine passes to the foetus affecting breathing movements and has a dose-dependent effect on placental/foetal circulation. However the risk of using NRT to the foetus is lower than that expected with tobacco smoking, due to lower maximal plasma nicotine concentration and no additional exposure to polycyclic hydrocarbons and carbon monoxide.

Intermittent dosing products may be preferable as these usually provide a lower daily dose of nicotine than patches. However, patches may be preferred if the woman is suffering from nausea during pregnancy. If patches are used they should be removed before going to bed.

Lactation

NRT is not contraindicated in lactation. Nicotine from smoking and NRT is found in breast milk. However the amount of nicotine the infant is exposed to is relatively small and less hazardous than the second-hand smoke they would otherwise be exposed.

Using intermittent dose NRT preparations, compared with patches, may minimize the amount of nicotine in the breast milk as the time between administrations of NRT and feeding can be more easily prolonged.

4.7 Effects On Ability To Drive And Use Machines

This medicinal product has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable Effects

Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can include; irritability/aggression, dysphoria/depressed mood, anxiety, restlessness, poor concentration, increased appetite/weight gain, urges to smoke (cravings), night-time awakenings/sleep disturbance and decreased heart rate.

Increased frequency of aphthous ulcer may occur after abstinence from smoking. The causality is unclear.

Nicorette Microtab Lemon may cause adverse reactions similar to those associated with nicotine given by other means, including smoking, and these are mainly dose-dependent. At recommended doses Nicorette Microtab Lemon has not been found to cause any serious adverse effects. Excessive consumption of Nicorette Microtab Lemon by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.

Most of the undesirable effects associated with Nicorette Microtab Lemon occur during the first 3-4 weeks after starting treatment.

Reported adverse events associated with Nicorette Microtab Lemon include:

Body System	Incidence*	Reported adverse event
Nervous system disorders:	Common:	Dizziness, headache
Cardiac disorders:	Common:	Palpitations
	Very rare:	Reversible atrial fibrillation
Respiratory, thoracic and mediastinal disorders:	Common:	Coughing
Gastrointestinal disorders:	Common:	Gastrointestinal discomfort, hiccups, nausea
General disorders and administration site disorders:	Common:	Sore mouth or throat, dry mouth, burning sensation in the mouth, rhinitis
	Rare:	Allergic reactions including angioedema

* Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1 000, <1/100); rare (>1/10 000, <1/1 000); very rare (<1/10 000), including isolated reports.

4.9 Overdose

Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.

Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group: Drug for treatment of addiction

ATC code: N07B A01

The pharmacological effects of nicotine are well documented. Those resulting from using Nicorette Microtab Lemon are comparatively small. The response at any one time represents a summation of stimulant and depression actions from direct, reflex and chemical mediator influences on several organs. The principal pharmacological actions are central stimulation and/or depression; transient hyperpnoea; peripheral vasoconstriction (usually associated with a rise in systolic pressure); suppression of appetite and stimulation of peristalsis.

5.2 Pharmacokinetic Properties

The amount of nicotine absorbed from a nicotine sublingual tablet depends on the amount of nicotine released in the oral cavity and the amount thereof that is swallowed. Most of the absorption of nicotine from Nicorette Microtab Lemon occurs directly through the buccal mucosa. The absolute bioavailability, after sublingual administration of the tablet, is approximately 50%. The systemic bioavailability of swallowed nicotine is lower due to the amount removed initially by the liver (the first-pass effect). Hence, the high and rapidly rising nicotine concentrations seen after smoking are rarely produced by treatment with nicotine sublingual tablets.

Steady-state trough nicotine plasma concentrations, achieved after ten hourly doses of one tablet, are in the order of magnitude of 10 ng/mL, which is about 50% of normal smoking levels.

There is a slight deviation from dose-linearity of AUC_inf and C_max when single doses of one, two and three tablets are given. This deviation may be explained by a larger fraction of the higher doses being swallowed and subject to first-pass elimination.

The volume of distribution following i.v. administration of nicotine is about 2 to 3 l/kg. Plasma protein binding of nicotine is less than 5%. Therefore, changes in nicotine binding from use of concomitant drugs or alterations of plasma proteins by disease states would not be expected to have significant effects on nicotine kinetics.

The major eliminating organ is the liver, and average plasma clearance is about 70 l/hour and the half-life approximately 2 hours. The kidney and lung also metabolise nicotine. More than 20 metabolites of nicotine have been identified, all of which are believed to be less active than the parent compound.

The primary metabolite of nicotine in plasma, cotinine, has a half-life of 15 to 20 hours and concentrations that exceed nicotine by 10-fold.

The primary urinary metabolites are cotinine (15% of the dose) and trans-3-hydroxy-cotinine (45% of the dose). About 10% of nicotine is excreted unchanged in the urine. As much as 30% of nicotine may be excreted unchanged in the urine with high flow rates and acidification of the urine below pH 5.

Renal impairment

Progressive severity of renal impairment is associated with decreased total clearance of nicotine. Nicotine clearance was decreased by on average 50% in subjects with severe renal impairment. Raised nicotine levels have been seen in smoking patients undergoing haemodialysis.

Hepatic impairment

The pharmacokinetics of nicotine are unaffected in cirrhotic patients with mild liver impairment (Child-Pugh score 5) and decreased by 40-50% in cirrhotic patients with moderate liver impairment (Child-Pugh score 7). There is no information available in subjects with a Child-Pugh score>7.

5.3 Preclinical Safety Data

Preclinical data indicate that nicotine is neither mutagenic or genotoxic.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Mannitol (E421)

Microcrystalline cellulose

Povidone

Methylcellulose

Silicified microcrystalline cellulose

Magnesium stearate

Lemon flavour

Aspartame (E951)

Flavour

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Do not store above 25ºC.

6.5 Nature And Contents Of Container

Pack sizes

Cardboard box of 30 and 100 sublingual tablets with a package insert/booklet.

AL/AL blister strips of 10 sublingual tablets.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

UK

8. Marketing Authorisation Number(S)

PL 15513/0156

9. Date Of First Authorisation/Renewal Of The Authorisation

30th June 2009

10. Date Of Revision Of The Text

30^th June 2009

Nicotine Transdermal System

Drug Facts

Active ingredient Step 1 (in each patch)

Nicotine, 21mg delivered over 24 hours

Active ingredient Step 2 (in each patch)

Nicotine, 14mg delivered over 24 hours

Active ingredient Step 3 (in each patch)

Nicotine, 7mg delivered over 24 hours

Purpose

Stop smoking aid

Use

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Warnings

If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Do not use

• if you continue to smoke, chew tobacco, use snuff, or use a nicotine gum or other nicotine containing products

Ask a doctor before use if you have

• heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.


• high blood pressure not controlled with medication. Nicotine can increase your blood pressure.


• an allergy to adhesive tape or have skin problems because you are more likely to get rashes

Ask a doctor or pharmacist before use if you are

• using a non-nicotine stop smoking drug


• taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

When using this product

• do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your blood stream for several hours after you take off the patch.


• If you have vivid dreams or other sleep disturbances remove this patch at bedtime

Stop use and ask a doctor if

• skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash


• irregular heartbeat or palpitations occur


• you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, weakness, and rapid heartbeat

Keep out of reach of children and pets.

Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Dispose of the used patches by folding sticky ends together. Replace in pouch and discard.

Directions

• if you are under 18 years of age, ask a doctor before use


• before using this product, read the enclosed User’s Guide for complete directions and other information


• stop smoking completely when you begin using the patch


• if you smoke more than 10 cigarettes per day, use according to the following 10-week schedule:


• 
  
  
  
  
  
  
  
  
  
  

  STEP 1	STEP 2	STEP 3
  Use one 21mg patch/day	Use one 14mg patch/day	Use one 7mg patch/day
  Weeks 1-6	Weeks 7-8	Weeks 9-10

• if you smoke 10 or less cigarettes per day, do not use STEP 1 (21mg). Start with STEP 2 (14mg) for 6 weeks, then STEP 3 (7mg) for 2 weeks and then stop.


• steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chances of quitting successfully.


• apply one new patch every 24 hours on skin that is dry, clean and hairless. Save pouch for disposing of the patch after use.


• remove backing from patch and immediately press onto skin. Hold for 10 seconds.


• wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. Replace in its pouch and discard. See enclosed User’s Guide for safety and handling.


• you may wear the patch for 16 or 24 hours.


• if you crave cigarettes when you wake up, wear the patch for 24 hours.


• if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning


• the used patch should be removed and a new one applied to a different skin site at the same time each day


• do not wear more than one patch at a time


• do not cut patch in half or into smaller pieces


• do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours


• stop using the patch at the end of 10 weeks. If you started with STEP 2, stop using the patch at the end of 8 weeks. If you still feel the need to use the patch, talk to your doctor.

To increase your success in quitting:

1. You must be motivated to quit.


2. Complete the full treatment program, applying a new patch every day.


3. Use with a support program as described in the enclosed User's Guide.

• Not for sale to those under 18 years of age.


• Proof of age required.


• Not for sale in vending machines or from any source where proof of age cannot be verified.

Inactive ingredients

ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between clear polyester backings

Other information

store at 20 – 25oC (68 – 77oF)

*NICODERM is a licensed trademark of GlaxoSmithKline group of companies.

Distributed by Target Corporation

Minneapolis, MN 55403

Made in Switzerland

© 2010 Target Brands, Inc.

All Rights Reserved. Shop Target.com

What is the nicotine patch and how is it used?

The nicotine patch is a small, nicotine-containing patch. When you put on a nicotine patch, nicotine passes through the skin and into your body. The nicotine patch is very thin and uses special material to control how fast nicotine passes through the skin. Unlike the sudden jolts of nicotine delivered by cigarettes, the amount of nicotine you receive remains relatively smooth throughout the 24 or 16 hour period you wear the nicotine patch. This helps to reduce cravings you may have for nicotine.

For your family's protection, nicotine patches are supplied in child-resistant pouches. Do not use if individual pouch/packet is damaged or open.

Read carton and enclosed User's Guide before using this product. Keep the carton and User's Guide. They contain important information.

Questions and comments?

call toll-free 1-888-367-7919

(English/Spanish) weekdays

Send comments/questions to:

GCSP 5.4376.4C

Consumer Relations

P.O Box 13398

Research Triangle Park, NC 27709-9627

Principal Display Panel

NDC 11673-194-02

nicotine patch

Nicotine Transdermal System

21mg delivered over 24 hours

stop smoking aid

Compare to NicoDerm® CQ®*

Includes User's Guide with behavior support program enrollment form

If you smoke more than 10 cigarettes per day: start with step 1

If you smoke 10 or less cigarettes per day: start with step 2

up & up

STEP 1

14 PATCHES

14 CLEAR PATCHES, 21 mg EACH

Principal Display Panel

NDC 11673-195-02

nicotine patch

Nicotine Transdermal System

14mg delivered over 24 hours

stop smoking aid

Compare to NicoDerm® CQ®*

Includes User's Guide with behavior support program enrollment form

If you smoke more than 10 cigarettes per day: start with step 1

If you smoke 10 or less cigarettes per day: start with step 2

up & up

STEP 2

14 PATCHES

14 CLEAR PATCHES, 14 mg EACH

Principal Display Panel

NDC 11673-196-02

nicotine patch

Nicotine Transdermal System

7mg delivered over 24 hours

stop smoking aid

Compare to NicoDerm® CQ®*

Includes User's Guide

FOR USE AFTER COMPLETING STEP 2

If you smoke more than 10 cigarettes per day: start with step 1

If you smoke 10 or less cigarettes per day: start with step 2

up & up

STEP 3

14 PATCHES

14 CLEAR PATCHES, 7 mg EACH

NICOTINE  TRANSDERMAL SYSTEM nicotine  patch, extended release

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11673-194 Route of Administration TRANSDERMAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 21 mg  in 24 h

Inactive Ingredients Ingredient Name Strength HIGH DENSITY POLYETHYLENE   ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 11673-194-02 14 PATCH In 1 CARTON contains a PATCH 1 24 h In 1 PATCH This package is contained within the CARTON (11673-194-02) 2 11673-194-01 7 PATCH In 1 CARTON contains a PACKET 2 24 h In 1 PACKET This package is contained within the CARTON (11673-194-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020165	02/16/2000

NICOTINE  TRANSDERMAL SYSTEM nicotine  patch, extended release

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11673-195 Route of Administration TRANSDERMAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 14 mg  in 24 h

Inactive Ingredients Ingredient Name Strength HIGH DENSITY POLYETHYLENE   ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 11673-195-02 14 PATCH In 1 CARTON contains a PATCH 1 24 h In 1 PATCH This package is contained within the CARTON (11673-195-02)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020165	02/16/2000

NICOTINE  TRANSDERMAL SYSTEM nicotine  patch, extended release

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11673-196 Route of Administration TRANSDERMAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 7 mg  in 24 h

Inactive Ingredients Ingredient Name Strength HIGH DENSITY POLYETHYLENE   ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 11673-196-02 14 PATCH In 1 CARTON contains a PATCH 1 24 h In 1 PATCH This package is contained within the CARTON (11673-196-02)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020165	02/16/2000

Labeler - Target (006961700)

Revised: 02/2010Target

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