Friday, 9 March 2012

Monomax XL 60mg Prolonged Release Tablets





1. Name Of The Medicinal Product



SLOMON XL 60



MONOMAX XL 60 mg Tablets


2. Qualitative And Quantitative Composition



Each prolonged release tablet contains 60mg of isosorbide mononitrate.



For excipients, see 6.1



3. Pharmaceutical Form



Prolonged release tablets



White, oval convex tablets with a score line between "SL" and "60", which are embossed on one side



4. Clinical Particulars



4.1 Therapeutic Indications



For the prophylactic treatment of angina pectoris



4.2 Posology And Method Of Administration



Route of Administration



Oral use



Tablets may be taken with or without food, and should be swallowed whole and not chewed.



Dosage



Adults: Usual adult dose is one isosorbide mononitrate XL 60mg tablet per day (taken in the morning). If necessary, the dosage may be increased to 120mg once daily (i.e. 2 x 60mg tablets taken in the morning).The dosage can be titrated to minimise the possibility of headache by initiating treatment with 30mg (half a tablet), for the first two to four days.



Children: Safety and efficacy in children have not been established.



Elderly: There is no evidence of a need for routine dosage adjustment in the elderly, but special care may be needed in those with increased susceptibility to hypotension or marked hepatic or renal insufficiency.



4.3 Contraindications



This product should not be given to patients with a known sensitivity to nitrates and a known hypersensitivity to the constituents of the tablets.



Relative contraindications to the use of isosorbide mononitrate are severe cerebral vascular insufficiency and hypotension.



Sildenafil has been shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitrates or nitric oxide donors is therefore contraindicated.



Isosorbide mononitrate is contraindicated in patients with constrictive cardiomyopathy and pericarditis, aortic stenosis, cardiac tamponade, mitral stenosis and severe anaemia.



4.4 Special Warnings And Precautions For Use



Isosorbide mononitrate XL 60 mg tablets are not indicated for relief of acute angina attacks; in the event of an acute attack, sublingual or buccal glyceryl trinitrate tablets / sprays should be used.



Isosorbide mononitrate should be used with caution in patients who are predisposed to closed angle glaucoma.



Isosorbide mononitrate should be used with caution in patients suffering from head trauma, cerebral haemorrhage, recent history of myocardial infarction, hypothyroidism, hypothermia, malnutrition, severe liver or renal disease.



Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Only limited information is available on the possible interaction between isosorbide mononitrate and other drugs.



Some of the effects of alcohol may be potentiated by this agent.



Vasodilators, antihypertensives and diuretics may potentiate the hypotension caused by nitrates particularly in the elderly.



The hypotensive effects of nitrates are potentiated by concurrent administration of sildenafil.



There is no evidence of interaction with food.



4.6 Pregnancy And Lactation



Since its safety and efficacy have not been established, this product should not be used during pregnancy or lactation unless considered essential by the physician.



4.7 Effects On Ability To Drive And Use Machines



Since postural hypotension with symptoms such as dizziness has been reported, patients should be advised to be careful when driving or operating machinery if they suffer from these symptoms.



4.8 Undesirable Effects



Most of the adverse reactions are pharmacodynamically mediated and dose dependent. Side effects including flushing, postural hypotension and dry skin rashes may occur occasionally. Headache may occur at the onset of treatment but may be minimised by commencing with low doses of 30mg and gradually increasing the dose. Hypotension, with symptoms such as dizziness and nausea, has occasionally been reported. These symptoms generally disappear during continued treatment. Pruritis has been reported rarely and myalgia, reported very rarely.



4.9 Overdose



Symptoms



A pulsating headache is the commonest.



More serious symptoms are excitation, flushing, cold perspiration, nausea, vomiting, vertigo, syncope, tachycardia and a fall in blood pressure.



Management



Induce emesis. Use activated charcoal.



If pronounced hypotension, place the patient in the supine position with legs raised. If necessary, intravenous fluids should be administered.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Anatomical Therapeutic Chemical (ATC) code: C01D A14;



Vasodilators used in cardiac diseases, organic nitrates



The principal pharmacological action of isosorbide mononitrate, an active metabolite of isosorbide dinitrate, is relaxation of vascular smooth muscle, producing vasodilation of both arteries and veins with the venous effect predominating. The effect of the treatment is dependent on the dose. Low plasma concentrations lead to venous dilation, resulting in peripheral pooling of blood, decreased venous return and reduction in left ventricular end



The net effect, when administering isosorbide mononitrate, is therefore a reduced workload on the heart and an improved oxygen supply / demand balance in the myocardium.



5.2 Pharmacokinetic Properties



In man, isosorbide mononitrate is absorbed completely and rapidly following oral administration.



Isosorbide mononitrate is not subject to the hepatic first-pass effect, and provides a low degree of inter-individual variation of blood levels, leading to predictable and reproducible clinical effects.



Isosorbide mononitrate XL 60mg tablets have all the pharmacokinetic characteristics of a true modified-release dosage form. Compared with an immediate-release dosage form, the peak plasma concentration obtained is lower and occurs later, while the apparent elimination half-life is unchanged. Thus compared to ordinary tablets, the absorption phase is prolonged and the duration of effect is extended.



Isosorbide mononitrate is effective in monotherapy as well as in combination with long term beta



The clinical effects of nitrates may be reduced following repeated administration due to too high and/or constant plasma levels. This can be avoided by allowing low plasma levels for a certain period between doses. Isosorbide mononitrate XL 60mg tablets, when administered once daily in the morning, produces a plasma profile of high levels during the day and low levels during the night. Thus, no development of tolerance should be seen with Isosorbide mononitrate XL, when 60mg or 120mg is taken once daily in the morning.



5.3 Preclinical Safety Data



Isosorbide mononitrate produces very few toxic effects and is less toxic than isosorbide dinitrate. After chronic administration at high doses (60mg/kg), signs of toxicity have been detected in canine liver and kidneys. Tests conducted have shown no evidence of a teratogenic or mutagenic potential.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Lactose monohydrate



Hypromellose



Glyceryl palmitostearate



Maize starch



Magnesium stearate



6.2 Incompatibilities



Not applicable



6.3 Shelf Life



36 months



6.4 Special Precautions For Storage



Store in the original container. Do not store above 25°C.



6.5 Nature And Contents Of Container



The tablets are enclosed in blisters composed of 250μm PVC film/25μm aluminium foil.



The blisters are packed into folded printed cardboard cartons with a patient information leaflet. Packs contain 28 or 30 prolonged release tablets.



6.6 Special Precautions For Disposal And Other Handling



None



ADMINISTRATIVE DATA


7. Marketing Authorisation Holder



Chiesi Limited



Cheadle Royal Business Park



Highfield



Cheadle



SK8 3GY



United Kingdom



8. Marketing Authorisation Number(S)



PL 08829/0102



9. Date Of First Authorisation/Renewal Of The Authorisation



24th February 2000



10. Date Of Revision Of The Text



09/06/2009



11. LEGAL CATEGORY


P




Taxol


Pronunciation: PAK-li-TAX-el
Generic Name: Paclitaxel
Brand Name: Generic only. No brands available.

Taxol must be administered in an appropriate medical setting. Serious allergic reactions, some fatal, have occurred with the use of Taxol. DO NOT use Taxol again if you have experienced a severe allergic reaction to it. Stop using Taxol and notify your doctor immediately if you develop signs of an allergic reaction, such as rash; itching; fainting; severe dizziness or light-headedness; swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness.


Certain patients with solid tumors or AIDS-related Kaposi sarcoma should not use Taxol. Frequent blood tests should be performed while you are using Taxol because of the risk of bone marrow suppression and serious infection.


Do not substitute or interchange Taxol with other forms of paclitaxel.





Taxol is used for:

Treating certain types of ovarian, lung, or breast cancer in certain patients. It is also used to treat AIDS-related Kaposi sarcoma in certain patients. It may also be used for other types of cancers as determined by your doctor.


Taxol is a chemotherapy medicine. It works by slowing or stopping cancer cells from dividing and growing, so they eventually die.


Do NOT use Taxol if:


  • you are allergic to any ingredient in Taxol or medicines that contain polyoxyethylated castor oil (eg, cyclosporine injection, teniposide injection)

  • you have extremely low white blood cell counts (eg, extremely low neutrophil counts)

  • you have shingles or chickenpox

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



Before using Taxol:


Some medical conditions may interact with Taxol. 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 bacterial or viral infection, or HIV infection

  • if you have a history of a heart attack or other heart problems (eg, irregular heartbeat), high or low blood pressure, liver or kidney problems, bone marrow problems, or blood problems (eg, low blood platelet or neutrophil counts)

  • if you are undergoing radiation therapy

  • if you have ever had an allergic reaction to an insect sting

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


  • Azole antifungals (eg, itraconazole, ketoconazole), benzodiazepines (eg, midazolam, triazolam), buspirone, cimetidine, cisplatin, eletriptan, felodipine, fluoxetine, gemfibrozil, HIV protease inhibitors (eg, indinavir, ritonavir), HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), macrolides (eg, clarithromycin, erythromycin), nefazodone, repaglinide, rosiglitazone, sildenafil, or telithromycin because they may increase the risk of Taxol's side effects

  • Carbamazepine, efavirenz, nevirapine, phenytoin, or rifampin because they may decrease Taxol's effectiveness

  • Anticoagulants (eg, warfarin) or doxorubicin because the risk of their side effects may be increased by Taxol

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


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


  • An extra patient leaflet is available with Taxol. Talk to your pharmacist if you have questions about this information.

  • Taxol is usually given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.

  • If nausea, vomiting, diarrhea, or loss of appetite occurs, do not discontinue your medicine. Ask your doctor or pharmacist for ways to lessen these effects.

  • You should receive certain other medicines, such as corticosteroids (eg, prednisone), diphenhydramine, and H2 blocker (eg, famotidine), before each treatment with Taxol to decrease the chance of an allergic reaction. Discuss any questions with your doctor.

  • Wear gloves while handling Taxol.

  • If you get Taxol on your skin, rinse the area thoroughly with soap and water. If you get Taxol in your eyes, nose, or mouth, flush the area thoroughly with water.

  • If you miss a dose of Taxol, contact your doctor right away.

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



Important safety information:


  • Serious allergic reactions, some fatal, have occurred with the use of Taxol. You will need to take certain other medicines before using Taxol in order to lessen the risk of having an allergic reaction. Stop using Taxol and notify your doctor immediately if you develop signs of an allergic reaction, such as rash; itching; severe dizziness or light-headedness; swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness.

  • Some patients develop redness or sores in the mouth or on the lips. These symptoms may occur a few days after treatment with Taxol and usually decrease or disappear in 1 week. Talk with your doctor about proper mouth care and other ways to prevent or reduce this side effect.

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

  • Taxol has alcohol in it and may interact with other medicines. Alcohol in drinks or other medicines may increase the effects of Taxol. Before you start any new medicine, check the label to see if it has alcohol in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Taxol may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.

  • Taxol may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

  • If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does.

  • Talk with your doctor before you receive any vaccine.

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

  • Lab tests, including complete blood cell counts, vital signs (such as pulse and blood pressure), and liver function, may be performed while you use Taxol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Taxol with caution in the ELDERLY; they may be more sensitive to its effects, especially effects on the bone marrow (myelosuppression), nerve problems, or heart problems.

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

  • Women who may become pregnant should use effective birth control (eg, condoms) while using Taxol. Talk with your doctor if you have questions about effective birth control.

  • Men who use Taxol should talk with their doctor about the use of effective birth control when having sex with a woman who may become pregnant.

  • PREGNANCY AND BREAST-FEEDING: Taxol has been shown to cause harm to the fetus. Avoid becoming pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Taxol while you are pregnant. It is not known if Taxol is found in breast milk. Do not breast-feed while using Taxol.


Possible side effects of Taxol:


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:



Cough; diarrhea; general feeling of discomfort; hair loss; mild discomfort, redness, or swelling at the injection site; mild joint or muscle pain; nausea; numbness, tingling, or burning of the arms, hands, legs, or feet; redness and/or sores on the mouth or lips; weakness or tiredness; vomiting.



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

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; flushing; swelling of the mouth, face, lips, tongue, or throat; hoarseness); blistering, swelling, redness, severe pain, or open sores on your skin or at the injection site; calf or leg redness, swelling, pain, or tenderness; change in the amount of urine produced; chest pain; fainting; fast, slow, or irregular heartbeat; hearing trouble or loss of hearing; pale appearance; ringing in the ears; seizures; severe or persistent joint or muscle pain; severe or persistent nausea, vomiting, or diarrhea; severe or persistent numbness, tingling, or burning in the arms, hands, legs, or feet; severe or persistent stomach pain; sudden or severe dizziness, light-headedness, or headache; swelling of the arms, hands, legs, or feet; symptoms of infection (eg, fever, chills, sore throat); symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, yellowing of the skin or eyes); unusual bruising or bleeding; unusual tiredness or weakness; vision changes (eg, blurred vision).



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: Taxol 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 burning, numbness, or tingling; redness and/or sores on the mouth or lips; symptoms of infection (eg, fever, chills, persistent sore throat); unusual bruising or bleeding; unusual tiredness or weakness.


Proper storage of Taxol:

Store Taxol as directed on the prescription label. Keep Taxol out of the reach of children and away from pets.


General information:


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

  • Taxol 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 Taxol. 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 Taxol resources


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


  • Taxol Consumer Overview

  • Taxol Prescribing Information (FDA)

  • Taxol Advanced Consumer (Micromedex) - Includes Dosage Information

  • Onxol Prescribing Information (FDA)

  • Paclitaxel Prescribing Information (FDA)

  • Paclitaxel Professional Patient Advice (Wolters Kluwer)

  • Paclitaxel Monograph (AHFS DI)



Compare Taxol with other medications


  • Breast Cancer
  • Breast Cancer, Adjuvant
  • Breast Cancer, Metastatic
  • Kaposi's Sarcoma
  • Non-Small Cell Lung Cancer
  • Ovarian Cancer
  • Wilms' Tumor

Wednesday, 7 March 2012

InfectoDell




InfectoDell may be available in the countries listed below.


Ingredient matches for InfectoDell



Potassium Hydroxide

Potassium Hydroxide is reported as an ingredient of InfectoDell in the following countries:


  • Germany

International Drug Name Search

clindamycin Oral, Injection, Intravenous



klin-da-MYE-sin


Intravenous route(Solution)

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Because clindamycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of therapy with clindamycin .


Oral route(Powder for Solution)

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Because clindamycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of therapy with clindamycin .


Oral route(Capsule)

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Because clindamycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of therapy with clindamycin .



Commonly used brand name(s)

In the U.S.


  • Cleocin HCl

  • Cleocin Pediatric

  • Cleocin Phosphate IV

In Canada


  • Dalacin C Palmitate

Available Dosage Forms:


  • Solution

  • Powder for Solution

  • Capsule

Therapeutic Class: Antibiotic


Chemical Class: Lincosamide


Uses For clindamycin


Clindamycin is used to treat bacterial infections. It will not work for colds, flu, or other virus infections.


Clindamycin is available only with your doctor's prescription.


Before Using clindamycin


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 clindamycin, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to clindamycin 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


clindamycin has been tested in children and, in effective doses, has not been reported to cause different side effects or problems than it does in adults.


Geriatric


Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of clindamycin in the elderly with use in other age groups.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersBAnimal 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 clindamycin, 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 clindamycin 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.


  • Erythromycin

Using clindamycin 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.


  • Atracurium

  • Cyclosporine

  • Metocurine

  • Tubocurarine

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 clindamycin. Make sure you tell your doctor if you have any other medical problems, especially:


  • Kidney disease (severe) or

  • Liver disease (severe)—Severe kidney or liver disease may increase blood levels of clindamycin, increasing the chance of side effects

  • Stomach or intestinal disease, history of (especially colitis, including colitis caused by antibiotics, or enteritis)—Patients with a history of stomach or intestinal disease may have an increased chance of side effects

Proper Use of clindamycin


For patients taking the capsule form of clindamycin:


  • The capsule form of clindamycin should be taken with a full glass (8 ounces) of water or with meals to prevent irritation of the esophagus (tube between the throat and stomach).

For patients taking the oral liquid form of clindamycin:


  • 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.

  • Do not use after the expiration date on the label. The medicine may not work properly after this date. Check with your pharmacist if you have any questions about this.

To help clear up your infection completely, keep taking clindamycin for the full time of treatment, even if you begin to feel better after a few days. If you have a ``strep'' infection, you should keep taking clindamycin for at least 10 days. This is especially important in "strep" infections. Serious heart problems could develop later if your infection is not cleared up completely. Also, if you stop taking clindamycin too soon, your symptoms may return.


clindamycin works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take each dose at evenly spaced times day and night. For example, if you are to take 4 doses a day, doses should be spaced about 6 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.


Dosing


The dose of clindamycin 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 clindamycin. 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 bacterial infection:
    • For oral dosage forms (capsules and solution):
      • Adults and teenagers—150 to 300 milligrams (mg) every six hours.

      • Children—
        • Infants up to 1 month of age: Use and dose must be determined by your doctor.

        • Infants and children 1 month of age and older: Dose is based on body weight. The usual dose is 2 to 5 mg per kilogram (kg) (0.9 to 2.3 mg per pound) of body weight every six hours; or 2.7 to 6.7 mg per kg (1.2 to 3.0 mg per pound) of body weight every eight hours.



    • For injection dosage form:
      • Adults and teenagers—300 to 600 mg every six to eight hours injected into a muscle or vein; or 900 mg every eight hours injected into a muscle or vein.

      • Children—
        • Infants up to 1 month of age: Dose is based on body weight. The usual dose is 3.75 to 5 mg per kg (1.7 to 2.3 mg per pound) of body weight every six hours injected into a muscle or vein; or 5 to 6.7 mg per kg (2.3 to 3.0 mg per pound) of body weight every eight hours injected into a muscle or vein.

        • Infants and children 1 month of age and older: Dose is based on body weight. The usual dose is 3.75 to 10 mg per kg (1.7 to 4.5 mg per pound) of body weight every six hours injected into a muscle or vein; or 5 to 13.3 mg per kg (2.3 to 6.0 mg per pound) of body weight every eight hours injected into a muscle or vein.




Missed Dose


If you miss a dose of clindamycin, 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.


Do not refrigerate the oral liquid form of clindamycin. If chilled, the liquid may thicken and be difficult to pour. Follow the directions on the label.


Precautions While Using clindamycin


It is important that your doctor check your progress at regular visits.


If your symptoms do not improve within a few days, or if they become worse, check with your doctor.


In some patients, clindamycin may cause diarrhea.


  • Severe diarrhea may be a sign of a serious side effect. Do not take any diarrhea medicine without first checking with your doctor . Diarrhea medicines, such as loperamide (Imodium A-D) or diphenoxylate and atropine (Lomotil), may make your diarrhea worse or make it last longer.

  • For mild diarrhea, diarrhea medicine containing attapulgite (e.g., Kaopectate tablets, Diasorb) may be taken. However, attapulgite may keep clindamycin from being absorbed into the body. Therefore, these diarrhea medicines should be taken at least 2 hours before or 3 to 4 hours after you take clindamycin by mouth.

  • If you have any questions about this or if mild diarrhea continues or gets worse, check with your health care professional.

Before having surgery (including dental surgery) with a general anesthetic, tell the medical doctor or dentist in charge that you are taking clindamycin.


clindamycin 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

(the above side effects may also occur up to several weeks after you stop taking clindamycin)


  • Abdominal or stomach cramps and pain (severe)

  • abdominal tenderness

  • diarrhea (watery and severe), which may also be bloody

  • fever

Less common
  • Sore throat and fever

  • skin rash, redness, and itching

  • unusual bleeding or bruising

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
  • Diarrhea (mild)

  • nausea and vomiting

  • stomach pain

Less common
  • Itching of rectal, or genital (sex organ) areas

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.



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 clindamycin Oral, Injection, Intravenous resources


  • Clindamycin Oral, Injection, Intravenous Use in Pregnancy & Breastfeeding
  • Drug Images
  • Clindamycin Oral, Injection, Intravenous Drug Interactions
  • Clindamycin Oral, Injection, Intravenous Support Group
  • 79 Reviews for Clindamycin Oral, Injection, Intravenous - Add your own review/rating


Compare clindamycin Oral, Injection, Intravenous with other medications


  • Aspiration Pneumonia
  • Babesiosis
  • Bacteremia
  • Bacterial Endocarditis Prevention
  • Bacterial Infection
  • Bacterial Vaginitis
  • Bone infection
  • Deep Neck Infection
  • Diverticulitis
  • Intraabdominal Infection
  • Joint Infection
  • Malaria
  • Pelvic Inflammatory Disease
  • Peritonitis
  • Pneumocystis Pneumonia
  • Pneumonia
  • Prevention of Perinatal Group B Streptococcal Disease
  • Sinusitis
  • Skin Infection
  • Surgical Prophylaxis
  • Toxoplasmosis
  • Toxoplasmosis, Prophylaxis

Sunday, 4 March 2012

Quartuss Syrup



dextromethorphan hydrobromide, chlorpheniramine maleate, phenylephrine hydrochloride, and guaifenesin

Dosage Form: oral syrup
Quartuss™ Syrup

Cough Suppressant/Antihistamine/Nasal Decongestant/Expectorant

Alcohol Free • Sugar Free

Quartuss Syrup Description


Quartuss™ Syrup is a cough suppressant, antihistamine, nasal decongestant syrup available for oral administration. Each teaspoonful (5mL.) contains:










Dextromethorphan Hydrobromide, USP15 mg
Chlorpheniramine Maleate, USP2 mg
Phenylephrine Hydrochloride, USP10 mg
Guaifenesin, USP100 mg

INACTIVE INGREDIENTS


Sodium Benzoate, Citric Acid, Saccharin Sodium, Propylene Glycol, Sorbitol Solution, Glycerin, Sucralose, Cherry Flavor, D&C Red No. 33, Purified Water.



Phenylephrine Hydrochloride


C9H13NO2HCl    M.W. 203.67



Benzenemethanol, 3-hydroxy-α-[(methylamino)methyl]-, hydrochloride (R)-.



Chlorpheniramine Maleate


C16H19ClN2 • C4H4O4    M.W. 390.86



2-Pyridinepropanamine, γ-(4-chlorophenyl)-N, N-dimethyl-, (Z)-2-butenedioate (1:1)



Dextromethorphan Hydrobromide


C18H25NO • HBr • H2O    M.W. 370.32



Morphinan, 3-Methoxy-17-methyl-, (9α, 13α, 14α)-, hydrobromide, monohydrate.



Guaifenesin


C10H14O4    M.W. 198.22



1,2-Propanediol, 3-(2-methoxyphenoxy)-,(±)-.



Quartuss Syrup - Clinical Pharmacology


Dextromethorphan hydrobromide acts centrally to elevate the threshold for coughing. It has no analgesic or addictive properties. The onset of antitussive action occurs in 15 to 30 minutes after administration and is of long duration.


Chlorpheniramine maleate competitively antagonizes most of the smooth muscle stimulation actions of histamine on the H1 receptors of the GI tract, uterus, large blood vessels and bronchial muscle. It also antagonizes the action of histamine that results in increased capillary permeability and the formation of edema.


Phenylephrine hydrochloride acts predominantly by a direct action on alpha adrenergic receptors. In therapeutic doses, the drug has no significant stimulant effect on the beta adrenergic receptors of the heart. Following oral administration, constriction of blood vessels in the nasal mucosa may relieve nasal congestion. In therapeutic doses, the drug causes little, if any, central nervous system stimulation.


Guaifenesin promotes lower respiratory tract drainage by thinning bronchial secretions, lubricates irritated respiratory tract membranes through increased mucus flow, and facilitates removal of viscous, inspissated mucus. As a result, sinus and bronchial drainage is improved, and dry, nonproductive coughs become more productive and less frequent.



INDICATIONS


Cough suppressant, antihistamine, nasal decongestant, and expectorant as an aid in the management of cough and mucosal congestion or edema of the respiratory tract, or nasal passages due to the common cold, bronchitis, laryngitis, tracheitis, pharyngitis, pertussis, influenza, measles, or chronic paranasal sinusitis.



Contraindications


Hypersensitivity to any of the ingredients. Also contraindicated in patients with hypertension, hyperthyroidism, prostatic hypertrophy, and patients on MAO inhibitor therapy (or for 14 days after stopping MAOI therapy).



Warnings


Use with caution in the presence of cardiac disorders, diabetes or peripheral vascular disease.


Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.


Stimulants, such as phenylephrine, are banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).



Precautions



Pregnancy


Category C

It is not known whether Quartuss™ Syrup can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, Quartuss™ Syrup should be given to a pregnant woman only if clearly needed.



Nursing Mothers


It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Quartuss™ Syrup is administered to a nursing woman.



Pediatric Use


Safety and effectiveness in the pediatric population, under 6, have not been established.



Adverse Reactions


May include drowsiness, dizziness, nervousness, insomnia, headache, palpitation, dysuria.


Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).



Overdosage



Signs and Symptoms


Overdosage with Dextromethorphan HBr may produce CNS excitement and mental confusion.


Overdosage with sympathomimetic amines can cause hypertension, headache, convulsions, cerebral hemorrhage and vomiting. Premature ventricular beats and short paroxysms of ventricular tachycardia may also occur. Headache may be a symptom of hypertension. Bradycardia may also be seen early in phenylephrine HCl overdosage through stimulation of baroreceptors. Excessive CNS stimulation may result in excitement, tremor, restlessness, and insomnia. Other effects may include pallor, mydriasis, hyperglycemia, and urinary retention. Severe overdosage may cause tachypnea, or hypernea, hallucinations, convulsions, or delirium, but in some individuals, there may be CNS depression. Arrhythmias (including ventricular fibrillation) may lead to hypotension and circulatory collapse. Severe hypokalemia can occur, probably due to compartmental shift rather than depletion of potassium.


Should antihistamine effects predominate, central action constitutes the greatest danger. In the small child, symptoms include excitation, hallucination, ataxia, incoordination, tremors, flushed face and fever. Convulsions, fixed and dilated pupils, coma and death may occur in severe cases. In the adult, fever and flushing are uncommon; excitement leading to convulsions and postictal depression is often preceded by drowsiness and coma. Respiration is usually not seriously depressed; blood pressure is usually stable.


Overdosage with Guaifenesin is unlikely to produce toxic effects since its toxicity is low. Guaifenesin, when administered by stomach tube to test animals in doses up to 5 gm/kg, produced no signs of toxicity.



Treatment


The patient should be induced to vomit (pharmacologic vomiting is the preferred method; by the administration of ipecac syrup), unless the patient is comatose, convulsing or has lost the gag reflex, in which case gastric lavage should be performed using a large bore tube. If indicated, follow with activated charcoal and a saline cathartic. Precautions must be taken against aspiration, especially in infants, children and comatose patients.



Quartuss Syrup Dosage and Administration


Adults and Children 12 years of age or older: Two teaspoonfuls. Children 6 to 12 years of age: One teaspoonful. Dose may be repeated every 6 hours. Do not exceed four doses in a 24-hour period. This product is not indicated for use in children under 6 years of age. (see PRECAUTIONS, Pediatric Use.)



How Supplied


Quartuss™ Syrup is a cherry flavored, sugar free, alcohol free liquid supplied in 16 fl. oz. bottles, NDC 51991-513-16.



Dispense in a tight, light-resistant container, with a child-resistant closure as defined in the USP/NF.


Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from freezing.


All prescription substitutions using this product shall be pursuant to state statues as applicable. This is not an Orange Book product.



Rx Only


Manufactured by: Tri-Med Laboratories, Inc., Somerset, NJ 08873


Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487


ISS. 02/07

Rev. 4/08



PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label


Breckenridge

Pharmaceutical, Inc.


NDC 51991-513-16


Quartuss™

Syrup


Cough Suppressant/Antihistamine/

Nasal Decongestant/Expectorant


  • Sugar Free

  • Alcohol Free

Description: Each 5ml (one teaspoonful) for oral

administration contains:










Dextromethorphan Hydrobromide, USP15 mg
Chlorpheniramine Maleate, USP2 mg
Phenylephrine Hydrochloride, USP10 mg
Guaifenesin, USP100 mg

INACTIVE INGREDIENTS: Sodium Benzoate,

Citric Acid, Saccharin Sodium, Propylene Glycol,

Sorbitol Solution, Glycerin, Sucralose, Cherry

Flavor, D&C Red No. 33, Purified Water.


Rx Only


Net Contents:

16 fl oz (One Pint) 473 mL










QUARTUSS 
dextromethorphan hydrobromide, chlorpheniramine maleate, phenylephrine hydrochloride, and guaifenesin  syrup










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)51991-513
Route of AdministrationORALDEA Schedule    

















Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan)Dextromethorphan Hydrobromide15 mg  in 5 mL
Chlorpheniramine Maleate (Chlorpheniramine)Chlorpheniramine Maleate2 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine)Phenylephrine Hydrochloride10 mg  in 5 mL
Guaifenesin (Guaifenesin)Guaifenesin100 mg  in 5 mL






















Inactive Ingredients
Ingredient NameStrength
Sodium Benzoate 
Citric Acid Monohydrate 
Saccharin Sodium 
Propylene Glycol 
Sorbitol 
Sucralose 
Glycerin 
D&C Red No. 33 
Water 


















Product Characteristics
ColorPINK (Dark Pink)Score    
ShapeSize
FlavorCHERRYImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
151991-513-16473 mL In 1 BOTTLE, PLASTICNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER05/01/200711/30/2011


Labeler - Breckenridge Pharmaceutical, Inc. (150554335)









Establishment
NameAddressID/FEIOperations
Trimed182050567MANUFACTURE
Revised: 11/2010Breckenridge Pharmaceutical, Inc.

More Quartuss Syrup resources


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


Compare Quartuss Syrup with other medications


  • Cough and Nasal Congestion

Saturday, 3 March 2012

Magnesium Trisilicate Mixture BP (Boots Company plc)





1. Name Of The Medicinal Product



Boots Magnesium Trisilicate Mixture BP


2. Qualitative And Quantitative Composition













Active ingredients


 



 




Heavy magnesium trisilicate EP




0.1667 gm




Light magnesium trisilicate EP




0.0833 gm




Light magnesium carbonate EP




0.25 gm



Sodium bicarbonate EP


0.25 gm



3. Pharmaceutical Form



Oral Suspension



4. Clinical Particulars



4.1 Therapeutic Indications



For the relief of indigestion.



4.2 Posology And Method Of Administration



For oral administration.



Adults and children over 12 years



10ml (2 teaspoonfuls) 3-4 times a day in a little water, after meals or as required.



Children 5 to 12 years



5ml (1 teaspoonful) 3-4 times a day in a little water, after meals or as required.



Children under 5 years



Not recommended except on the advice of a doctor.



Elderly



There is no need for dosage reduction in the elderly.



4.3 Contraindications



Hypersensitivity to any of the ingredients.



4.4 Special Warnings And Precautions For Use



If symptoms persist for more than 5 days, talk to your doctor.



Because of the sodium content, Magnesium Trisilicate Mixture should be used with caution in patients with renal impairment, heart failure, hypertension and in those on a low sodium diet.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Magnesium Trisilicate Mixture may interfere with the absorption of the tetracyclines when these are taken concurrently. The renal excretion of lithium appears to be increased by sodium bicarbonate and this could lead to reduced plasma levels of lithium and impairment of the therapeutic response.



4.6 Pregnancy And Lactation



The safety of Magnesium Trisilicate Mixture during pregnancy and lactation has not been established but use during these periods is not considered to constitute a hazard.



4.7 Effects On Ability To Drive And Use Machines



No adverse effects known.



4.8 Undesirable Effects



Magnesium Trisilicate Mixture may cause diarrhoea and flatulence.



4.9 Overdose



Symptoms of overdosage include diarrhoea, flatulence and gastrointestinal irritation.



Treatment need only be symptomatic.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Magnesium trisilicate, magnesium carbonate and sodium bicarbonate have antacid properties.



5.2 Pharmacokinetic Properties



Magnesium trisilicate is converted to magnesium chloride and silicon dioxide during neutralisation of gastric acid. Some magnesium is absorbed and traces of the silicon dioxide may be absorbed and excreted in the urine.



Magnesium carbonate reacts with gastric acid to form magnesium chloride and carbon dioxide in the stomach. Some magnesium is absorbed, but is usually excreted rapidly in the urine.



Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide. Any bicarbonate not involved in that reaction is absorbed and in the absence of a deficit of bicarbonate in the plasma, bicarbonate ions are excreted in the urine that is rendered alkaline and there is an accompanying diruresis.



5.3 Preclinical Safety Data



There are no preclinical data of relevance to the prescriber which are additional to that already included.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Sodium methyldroxybenzoate



Sodium propylhydroxybenzoate



Peppermint oil



Tween 20



Chloroform



Purified water



6.2 Incompatibilities



None stated.



6.3 Shelf Life



18 months.



6.4 Special Precautions For Storage



Store below 25°C.



6.5 Nature And Contents Of Container



An amber medical glass bottle fitted with a rolled on pilfer proof cap with a flowed in liner or a triseal (LDPE/EPE/LDPE) liner, alternative cap: a wadless polypropylene screw cap.



Pack size: 200 ml.



6.6 Special Precautions For Disposal And Other Handling



None stated.



7. Marketing Authorisation Holder



The Boots Company PLC



1 Thane Road West



Nottingham NG2 3AA



8. Marketing Authorisation Number(S)



PL 00014/0310



9. Date Of First Authorisation/Renewal Of The Authorisation



Date of First Authorisation: 31 May 1984



Last Renewal: 27 January 1995



10. Date Of Revision Of The Text



September 1999.




Thursday, 1 March 2012

Adcal-D3 Dissolve 1500mg / 400IU Effervescent Tablets






Adcal-D3
Dissolve 1500mg/400IU Effervescent Tablets



Calcium carbonate and Colecalciferol



Read all of this leaflet carefully before you start taking this medicine


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

  • If you have further questions, please 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.



In this leaflet:


  • 1. What these tablets do

  • 2. Check before you take…

  • 3. How to take these tablets

  • 4. Possible side effects

  • 5. Storing your medicine

  • 6. Further information




What these tablets do


Adcal-D3 Dissolve contains calcium and vitamin D3 which are both essential for healthy bones and teeth. Adcal-D3 Dissolve provides extra calcium and vitamin D3 to your diet. It is therefore used in conditions where your body’s calcium and vitamin D levels need to be increased.


Adcal-D3 Dissolve can be prescribed by doctors for certain bone conditions, for example, osteoporosis.


Studies show that taking calcium and vitamin D3 over a long time can prevent hip and other non vertebral bone fractures in later life.




Check before you take




Do not take if you:


  • Are allergic (hypersensitive) to calcium carbonate, vitamin D3 or any of the other ingredients in Adcal-D3 Dissolve (see Section 6 Further Information)

  • Are allergic to peanut or soya. Adcal-D3 Dissolve contains soya oil.




Take special care:


Tell your doctor or pharmacist if you:


  • Have high levels of calcium in your blood (hypercalcaemia) or high levels of calcium in your urine (hypercalciuria). If you are unsure your doctor will advise you

  • Have problems with your kidneys, for example kidney stones

  • Have sarcoidosis (inflammation that produces lumps of cells in various organs in the body). If you are unsure your doctor will advise you

  • Have previously been told by your doctor that you have an intolerance to some sugars

  • Are taking any other medication, even those you may have bought for yourself without prescription.

  • Have diabetes mellitus or require a low-sugar diet, each tablet contains 1.672mg of sucrose.




Taking other medicines with Adcal-D3 Dissolve


Tell your doctor if you are taking calcium supplements or antacids for indigestion, digitalis drugs (eg. Lanoxin), diuretics or corticosteroids.


If you are taking thyroxine, bisphosphonates, iron or fluoride medicines, tetracycline or quinolone antibiotics make sure your doctor knows this. When taking these medicines leave a period of about 4 hours before taking your Adcal-D3 Dissolve tablets. Do not take them at the same time.


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines taken without a prescription.




Pregnancy and breast-feeding


In pregnancy or when breast feeding, Adcal-D3 Dissolve should only be used under medical supervision. Ask your doctor or pharmacist for advice before taking any medicine.




Important information about some of the ingredients of Adcal-D3 Dissolve


  • The tablets contains a small amount of sugar and may be harmful to the teeth if used for a prolonged period

  • If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine

  • Adcal-D3 Dissolve contains soya oil. If you are allergic to peanut or soya, do not use this medicine.

  • This medicine contains 52 mg of sodium per tablet. To be taken into consideration by patients on a controlled sodium diet.




How to take your tablets


Always take Adcal-D3 Dissolve exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.



Adults, elderly and children over 12 years of age - 2 tablets daily, ideally one taken in the morning and one tablet in the evening. Dissolve one tablet in a glass of water (approximately 200ml) and drink immediately, do not chew or swallow the tablets whole.




Children under 12 – Adcal-D3 Dissolve must not be given to children under 12 years.



If you take more Adcal-D3 Dissolve than you should - You should only take what your doctor recommends. If you take too many Adcal-D3 Dissolve tablets contact your doctor or pharmacist if you can do so. If not, go to the nearest hospital casualty department immediately, taking the Adcal-D3 Dissolve pack and remaining tablets with you.



If you forget to take Adcal-D3 Dissolve - If you forget to take your tablet, take it as soon as possible and continue to take the tablets as normal. Do not take a double dose to make up for a forgotten tablet.



If you stop taking Adcal-D3 Dissolve - Always talk to your doctor or pharmacist before stopping Adcal-D3 Dissolve.



If you have any further questions on the use of this product, ask your doctor or pharmacist.





Possible side effects


Like all medicines, Adcal-D3 Dissolve can have side effects, although not everybody gets them.



Rare side effects (affecting fewer than 1 in 1,000 people)


  • Constipation, wind, feeling sick, stomach ache, diarrhoea

  • Skin rash

  • Hypercalcaemia (too much calcium in your blood) and hypercalciuria (too much calcium in your urine).

If you are on long term treatment your doctor may, from time to time wish to check the level of calcium in your blood and take urine samples to monitor kidney function.


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




Storing your medicine


  • Keep out of the sight and reach of children

  • Do not store above 25°C

  • Keep the container tightly closed

  • Do not use Adcal-D3 Dissolve after the expiry date (Exp) which is stated on the tube/label. The expiry date refers to the last day of that month.

  • 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


  • Each tablet contains 1500 mg calcium carbonate (equivalent to 600 mg calcium) and 400 iu vitamin D3 (equivalent to 10 µg of colecalciferol). It also contains citric acid anhydrous, malic acid, sodium hydrogen carbonate (E500), sodium cyclamate (E953), lemon flavour (BSL Code 119: containing lemon oil, lime flavouring, sorbitol (E420), mannitol (E421), gluconolactone, maltodextrin, and acacia), sodium carbonate anhydrous (E500), maltodextrin, and saccharin sodium (E954). The dry vitamin D3 type 100 CWS contains α-tocopherol, hydrogenated soyabean oil, gelatin, sucrose and maize starch.

  • The tablets are white, round and lemon flavoured

  • Adcal-D3 Dissolve is provided in tubes containing 14 effervescent tablets, and is supplied in cartons of 4 tubes (total of 56 effervescent tablets).


Marketing Authorisation Holder:



ProStrakan Limited

Galabank Business Park

Galashiels

Scotland

TD1 1QH




Manufacturer:



Hermes Arzneimittel GmbH

82049 Grosshesselohe

Germany




Additional information


If you have been prescribed Adcal-D3 Dissolve effervescent tablets for the treatment or prevention of osteoporosis and would like further information you should speak to your doctor or contact the National Osteoporosis Society on 0845 1303076. The National Osteoporosis Society is a national charity dedicated to offering advice, information and support to all osteoporosis sufferers and those at risk of the disease.





This leaflet was last approved in 12/2007


PG0479