CIMETIDINE 200MG TABLETS
Active substance: CIMETIDINE
View full screen / Print PDF » Download PDF ⇩
Transcript
Patient Information Leaflet
CIMETIDINE 200mg, 400mg AND 800mg TABLETS
Please read this leaflet carefully before you start to take this medicine. If you haver further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. Keep this leaflet; you may need to read it again. IN THIS LEAFLET 1. What your medicine does and what it is used for 2. Before you take your medicine 3. How to take your medicine 4. Possible side effects 5. Storing your medicine 6. More information 1. WHAT YOUR MEDICINES DOES AND WHAT IT IS USED FOR The name of your medicine is Cimetidine Tablets. They belong to a group of medicines known as histamine H receptor agonists. They work by reducing the amount of acid produced by your stomach (gastric acid). Acid plays a part in ulcer disease and the uncomfortable condition known as heartburn. Reducing the amount of acid produced can help ulcers to heal and give relief where gastric acid is causing discomfort. Cimetidine Tablets are used to: - Treat and relieve the symptoms of stomach/intestinal ulcers - Treat and relieve Zollinger-Ellison syndrome (excessive secretion of acid by the stomach) - Treat and relieve ulceration of the oesophagus caused by reflux of gastric juices - Prevent the recurrence of stomach/intestinal ulcers Certain medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to treat conditions such as arthritis, may give rise to ulcers. If you are taking this type of medicine, your doctor may prescribe Cimetidine Tablets for you to try to keep you free of ulcers. 2. BEFORE YOU TAKE YOUR MEDICINE Do not take your medicine if you: - are pregnant or may be planning to become pregnant - are breast-feeding - have ever had an allergic reaction (for example, wheezing, runny nose, rash) after taking cimetidine or any of the ingredients of Cimetidine Tablets, see list of ingredients in section 6, more information - have a kidney or liver complaint - have a low blood cell count - are middle-aged or older with newly developed indigestion-like symptoms - have had a stomach/duodenal ulcer in the past, particularly if you are taking NSAIDs If the answer is yes to any of the above, please tell your doctor. Taking other medicines Cimetidine Tablets may interfere with other medicines that you may be taking. If you are taking any of the following medicines, make sure that your doctor is aware of this: - Medicines to thin the blood (anticoagulants) e.g. warfarin - Medicines to prevent fits (anticonvulsants) e.g. phenytoin - Theophylline, a medicine to help breathing - Lidocaine (to slow heart rate) by intravenous injection - Medicines that cause a fall in blood cell count - Non-steroidal anti-inflammatories (NSAIDs) e.g. aspirin You should also mention to your doctor or pharmacist any other medicines that you are taking, including any that you can buy without prescription. If you go into hospital or to see a doctor or dentist, tell them you are taking Cimetidine Tablets. Pregnancy and breast-feeding Unless you have recently discussed this with your doctor, please tell him or her if you are pregnant (or think you may be), planning to become pregnant or are breast-feeding. Important information about some of the ingredients of your medicine The sodium content per tablet is: - 200mg tablet - 500micrograms - 400mg tablet - 1mg - 800mg tablet - 1.5mg This is to be taken into consideration by patients on a controlled sodium diet. 3. HOW TO TAKE YOUR MEDICINE Follow your doctors instructions. The pharmacists label on your medicine should tell you how much to take and how often. If it does not or you are not sure ask your doctor or pharmacist. The dose of your medicine you need to take and length of treatment will depend on the type and severity of your illness. Treatment is usually for a period of 4 to 8 weeks. Swallow your tablets with a drink of water. Adults Stomach/intestinal ulcer: - 800mg daily taken as a single dose at bedtime or - 400mg at breakfast and at bedtime or - 200mg with each of the three meals and 400mg at bedtime (total 1000mg daily) or - 400mg with each of the three meals and 400mg at bedtime (total 1600mg daily) Prevention of stomach/intestinal ulcer: - 400mg once daily at bedtime or - 400mg at breakfast and at bedtime Zollinger-Ellison syndrome: - 400mg with each of the three meals and 400mg at bedtime (total 1600mg daily) UTN23P1
Oesophageal Reflux disease: - 400mg with each of the three meals and 400mg at bedtime (total 1600mg daily) The maximum recommended dose of Cimetidine is 2400mg a day. Children over 1 year of age The dose should be taken as instructed by your doctor. A dose of 25-30mg per kg bodyweight per day may be given in divided doses. Cimetidine 800mg Tablets are not usually prescribed for children. Overdose: If you take more of your medicine than you should If you take an unintentional dose, it is unlikely to be harmful. If a large number of tables are taken at the one time, drink plenty of water and contact your doctor or nearest hospital casualty department immediately. If you forget to take your medicine If you forget to take a dose of your medicine at the correct time, leave out that dose completely and take the next dose when it is due. If you stop taking your medicine Keep taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the medicine, your condition may re-occur or get worse. 4. POSSIBLE SIDE EFFECTS Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking this medicine. All medicines can have some unwanted effects. Sometimes, they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Stop taking your medicine and tell your doctor immediately, or go to accident and emergency if you have an allergic reaction. An allergic reaction may include: - rash - shortness of breath - low blood pressure An allergic reaction is a very rare side effect. The following more common side effects are usually mild and usually do not require stopping treatment. - dizziness - diarrhoea - tiredness If you suffer badly or these effects last for more than a few days, you should contact your doctor. The following more rare side effects should disappear when treatment is stopped: - confusion - depression - hallucination - fever - headache - breast enlargement in men - aching muscles - aching joints - heart effects - impotence - hair loss (very rare) - blood changes (symptoms may include bruising more easily, unusual tiredness) - kidney disorders (symptoms may include a change in the volume of urine passed and its colour) - liver disorders (symptoms may include yellowing of the skin and whites of eyes) - inflammation of the pancreas (symptoms may include severe stomach pain or a change in type of stomach pain) If you have these or any other unwanted effects or you are concerned about anything contact your doctor. If you still feel unwell when your course of treatment is finished, go back to see your doctor. NOTE: Patients taking this medicine on a long-term basis should be under regular supervision by their doctor. 5. STORING YOUR MEDICINE Do not use your medicine after the expiry date shown on the pack. KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. o Do not store your medicine above 25 C (room temperature). Store in a dry place and protect from light. Store in the original package. If your tablets are supplied in a plastic pot keep the lid tightly closed. If your doctor tells you to stop treatment, return any left over to the pharmacist. Only keep it if the doctor tells you to. 6. MORE INFORMATION What your medicine looks like Cimetidine 200mg Tablets are pale green, circular, biconvex, film-coated tablets, plain on one side and embossed with CIM 200 on the reverse. Cimetidine 400mg Tablets are pale green, oblong, film-coated tablets, plain on one side and embossed with CIM 400 on the reverse. Cimetidine 800mg Tablets are pale green, oval, film-coated tablets, plain on one side and embossed with CIM 800 on the reverse. Cimetidine 200mg Tablets are available in pack sizes of 120 tablets. Cimetidine 400mg Tablets are available in pack sizes of 60 tablets. Cimetidine 800mg Tablets are available in pack sizes of 30 tablets. What your medicine contains Each 200mg Cimetidine Tablet contains 200mg of the active ingredient cimetidine. Each 400mg Cimetidine Tablet contains 400mg of the active ingredient cimetidine. Each 800mg Cimetidine tablet contains 800mg of the active ingredient cimetidine. The other ingredients are microcrystalline cellulose, polyvidone, sodium starch glycollate, sodium lauryl sulphate, colloidal anhydrous silica, magnesium stearate, macrogol 400, hypromellose and the colours, titanium dioxide (E171), quinoline yellow aluminium lake (E104), indigo carmine aluminium lake (E132) and iron oxide yellow (E172). This leaflet is a summary. It does not contain the complete information about your medicine. If you have any further questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information. The holder of the product licence and company responsible for release of this medicine is: Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland. Distributor: Kent Pharmaceuticals Limited, Wotton Road, Ashford, Kent, TN23 6LL, UK. PL Numbers: Cimetidine 200mg Tablets: PL 30464/0021 Cimetidine 400mg Tablets: PL 30464/0022 Cimetidine 800mg Tablets: PL 30464/0023 This leaflet was revised in June 2008.
UTN23P1
CIMETIDINE 200mg, 400mg AND 800mg TABLETS
Please read this leaflet carefully before you start to take this medicine. If you haver further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. Keep this leaflet; you may need to read it again. IN THIS LEAFLET 1. What your medicine does and what it is used for 2. Before you take your medicine 3. How to take your medicine 4. Possible side effects 5. Storing your medicine 6. More information 1. WHAT YOUR MEDICINES DOES AND WHAT IT IS USED FOR The name of your medicine is Cimetidine Tablets. They belong to a group of medicines known as histamine H receptor agonists. They work by reducing the amount of acid produced by your stomach (gastric acid). Acid plays a part in ulcer disease and the uncomfortable condition known as heartburn. Reducing the amount of acid produced can help ulcers to heal and give relief where gastric acid is causing discomfort. Cimetidine Tablets are used to: - Treat and relieve the symptoms of stomach/intestinal ulcers - Treat and relieve Zollinger-Ellison syndrome (excessive secretion of acid by the stomach) - Treat and relieve ulceration of the oesophagus caused by reflux of gastric juices - Prevent the recurrence of stomach/intestinal ulcers Certain medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to treat conditions such as arthritis, may give rise to ulcers. If you are taking this type of medicine, your doctor may prescribe Cimetidine Tablets for you to try to keep you free of ulcers. 2. BEFORE YOU TAKE YOUR MEDICINE Do not take your medicine if you: - are pregnant or may be planning to become pregnant - are breast-feeding - have ever had an allergic reaction (for example, wheezing, runny nose, rash) after taking cimetidine or any of the ingredients of Cimetidine Tablets, see list of ingredients in section 6, more information - have a kidney or liver complaint - have a low blood cell count - are middle-aged or older with newly developed indigestion-like symptoms - have had a stomach/duodenal ulcer in the past, particularly if you are taking NSAIDs If the answer is yes to any of the above, please tell your doctor. Taking other medicines Cimetidine Tablets may interfere with other medicines that you may be taking. If you are taking any of the following medicines, make sure that your doctor is aware of this: - Medicines to thin the blood (anticoagulants) e.g. warfarin - Medicines to prevent fits (anticonvulsants) e.g. phenytoin - Theophylline, a medicine to help breathing - Lidocaine (to slow heart rate) by intravenous injection - Medicines that cause a fall in blood cell count - Non-steroidal anti-inflammatories (NSAIDs) e.g. aspirin You should also mention to your doctor or pharmacist any other medicines that you are taking, including any that you can buy without prescription. If you go into hospital or to see a doctor or dentist, tell them you are taking Cimetidine Tablets. Pregnancy and breast-feeding Unless you have recently discussed this with your doctor, please tell him or her if you are pregnant (or think you may be), planning to become pregnant or are breast-feeding. Important information about some of the ingredients of your medicine The sodium content per tablet is: - 200mg tablet - 500micrograms - 400mg tablet - 1mg - 800mg tablet - 1.5mg This is to be taken into consideration by patients on a controlled sodium diet. 3. HOW TO TAKE YOUR MEDICINE Follow your doctors instructions. The pharmacists label on your medicine should tell you how much to take and how often. If it does not or you are not sure ask your doctor or pharmacist. The dose of your medicine you need to take and length of treatment will depend on the type and severity of your illness. Treatment is usually for a period of 4 to 8 weeks. Swallow your tablets with a drink of water. Adults Stomach/intestinal ulcer: - 800mg daily taken as a single dose at bedtime or - 400mg at breakfast and at bedtime or - 200mg with each of the three meals and 400mg at bedtime (total 1000mg daily) or - 400mg with each of the three meals and 400mg at bedtime (total 1600mg daily) Prevention of stomach/intestinal ulcer: - 400mg once daily at bedtime or - 400mg at breakfast and at bedtime Zollinger-Ellison syndrome: - 400mg with each of the three meals and 400mg at bedtime (total 1600mg daily) UTN23P1
Oesophageal Reflux disease: - 400mg with each of the three meals and 400mg at bedtime (total 1600mg daily) The maximum recommended dose of Cimetidine is 2400mg a day. Children over 1 year of age The dose should be taken as instructed by your doctor. A dose of 25-30mg per kg bodyweight per day may be given in divided doses. Cimetidine 800mg Tablets are not usually prescribed for children. Overdose: If you take more of your medicine than you should If you take an unintentional dose, it is unlikely to be harmful. If a large number of tables are taken at the one time, drink plenty of water and contact your doctor or nearest hospital casualty department immediately. If you forget to take your medicine If you forget to take a dose of your medicine at the correct time, leave out that dose completely and take the next dose when it is due. If you stop taking your medicine Keep taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the medicine, your condition may re-occur or get worse. 4. POSSIBLE SIDE EFFECTS Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking this medicine. All medicines can have some unwanted effects. Sometimes, they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Stop taking your medicine and tell your doctor immediately, or go to accident and emergency if you have an allergic reaction. An allergic reaction may include: - rash - shortness of breath - low blood pressure An allergic reaction is a very rare side effect. The following more common side effects are usually mild and usually do not require stopping treatment. - dizziness - diarrhoea - tiredness If you suffer badly or these effects last for more than a few days, you should contact your doctor. The following more rare side effects should disappear when treatment is stopped: - confusion - depression - hallucination - fever - headache - breast enlargement in men - aching muscles - aching joints - heart effects - impotence - hair loss (very rare) - blood changes (symptoms may include bruising more easily, unusual tiredness) - kidney disorders (symptoms may include a change in the volume of urine passed and its colour) - liver disorders (symptoms may include yellowing of the skin and whites of eyes) - inflammation of the pancreas (symptoms may include severe stomach pain or a change in type of stomach pain) If you have these or any other unwanted effects or you are concerned about anything contact your doctor. If you still feel unwell when your course of treatment is finished, go back to see your doctor. NOTE: Patients taking this medicine on a long-term basis should be under regular supervision by their doctor. 5. STORING YOUR MEDICINE Do not use your medicine after the expiry date shown on the pack. KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. o Do not store your medicine above 25 C (room temperature). Store in a dry place and protect from light. Store in the original package. If your tablets are supplied in a plastic pot keep the lid tightly closed. If your doctor tells you to stop treatment, return any left over to the pharmacist. Only keep it if the doctor tells you to. 6. MORE INFORMATION What your medicine looks like Cimetidine 200mg Tablets are pale green, circular, biconvex, film-coated tablets, plain on one side and embossed with CIM 200 on the reverse. Cimetidine 400mg Tablets are pale green, oblong, film-coated tablets, plain on one side and embossed with CIM 400 on the reverse. Cimetidine 800mg Tablets are pale green, oval, film-coated tablets, plain on one side and embossed with CIM 800 on the reverse. Cimetidine 200mg Tablets are available in pack sizes of 120 tablets. Cimetidine 400mg Tablets are available in pack sizes of 60 tablets. Cimetidine 800mg Tablets are available in pack sizes of 30 tablets. What your medicine contains Each 200mg Cimetidine Tablet contains 200mg of the active ingredient cimetidine. Each 400mg Cimetidine Tablet contains 400mg of the active ingredient cimetidine. Each 800mg Cimetidine tablet contains 800mg of the active ingredient cimetidine. The other ingredients are microcrystalline cellulose, polyvidone, sodium starch glycollate, sodium lauryl sulphate, colloidal anhydrous silica, magnesium stearate, macrogol 400, hypromellose and the colours, titanium dioxide (E171), quinoline yellow aluminium lake (E104), indigo carmine aluminium lake (E132) and iron oxide yellow (E172). This leaflet is a summary. It does not contain the complete information about your medicine. If you have any further questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information. The holder of the product licence and company responsible for release of this medicine is: Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland. Distributor: Kent Pharmaceuticals Limited, Wotton Road, Ashford, Kent, TN23 6LL, UK. PL Numbers: Cimetidine 200mg Tablets: PL 30464/0021 Cimetidine 400mg Tablets: PL 30464/0022 Cimetidine 800mg Tablets: PL 30464/0023 This leaflet was revised in June 2008.
UTN23P1
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
