Cimetidine 400mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
CIMETIDINE 200 mg, 400 mg & 800 mg TABLETS (Cimetidine)
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 any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
• If any of the side effects 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 Cimetidine Tablets are and what they are used for
2. Before you take Cimetidine Tablets
3. How to take Cimetidine Tablets
4. Possible side effects
5. How to store Cimetidine Tablets
6. Further information
1. WHAT CIMETIDINE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Cimetidine Tablets. It contains the active ingredient called Cimetidine.
Cimetidine belongs to a group of medicines called H2 - antagonists.
It works by preventing your stomach from producing too much acid.
The tablets are used to:
• Treat and prevent ulcers in your stomach and the first part of your small intestine;
• Prevent acid coming up your throat;
• Prevent your stomach from producing too much acid which could cause pain and discomfort, such as heartburn, indigestion or dyspepsia;
• Prevent acid coming up from the stomach during childbirth;
• Prevent ulcers caused by stress;
• Prevent bleeding from ulcers.
• Prior to general anaesthetic in patients at risk from stomach acid being sucked into the air passages (Mendelson's Syndrome), particularly pregnant patients during labour.
• to reduce malabsorption and fluid loss in short bowel syndrome.
You should ask your doctor if you are unsure why you have been given Cimetidine Tablets.
2. BEFORE YOU TAKE CIMETIDINE TABLETS Do not take Cimetidine Tablets if you:
• have an allergy to cimetidine, or any of the other ingredients listed at the ^ end of this leaflet.
You must tell your doctor or pharmacist if you:
• have kidney disease.
• have recurrent dyspepsia (pain and discomfort in the upper part of your stomach) and have not yet seen your doctor about these symptoms.
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are taking drugs used to treat epilepsy (e.g. Phenytoin and Carbemazepine). are taking drugs to treat high blood pressure (e.g. metoprolol, propranolol and labetolol).
are taking drugs to treat anxiety (e.g. Diazepam and chlordiazepoxide). are taking drugs to prevent blood clotting.
are taking drugs used to treat respiratory disease (e.g. Theophylline or aminophylline).
are taking drugs used as sedatives (e.g. Chlormethiazole). are taking drugs used to treat heart conditions (e.g. Procainamide). are pregnant or intend to become pregnant. are breast-feeding or intend to breast-feed.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Driving and using machines
Cimetidine Tablets may cause dizziness or tiredness. If you experience these symptoms, do not drive or use any tools or machinery.
3. HOW TO TAKE CIMETIDINE TABLETS
Make sure you take the tablets as directed by your doctor. The label will tell you what to do if you cannot remember. If you are not sure of anything, ask your doctor or pharmacist.
If you are elderly, it is particularly important that you take your medicine as directed by your doctor.
The usual starting dose for adults is 400 mg twice a day with breakfast and at bedtime. However your doctor may propose a different starting dose, depending on the nature of your illness (see below). The normal duration of treatment is at least four weeks. Tablets should be taken with a little water.
Oesophageal reflux disease
The usual starting dose is 400 mg four times a day with meals and at bedtime, for four to eight weeks is recommended.
High gastric acid secretion (e.g. Zollinger-Ellison syndrome)
The usual starting dose for adults is 400 mg twice a day with breakfast and at bedtime However, it may be necessary to increase the dose to 400 mg four times a day, or in occasional cases further.
Duodenal Ulceration
The usual starting dose is 800 mg once daily at bedtime.
Other effective regimens are 200 mg three times a day with meals and 400 mg at bedtime (1.0g/day) and, if inadequate, 400 mg four times a day (1.6g/day) with meals and at bedtime. Treatment is for at least 4 weeks for Duodenal ulceration
Gastric Ulceration
Usual starting dose 400 mg twice daily with breakfast and at bedtime Acid Aspiration syndrome
Usual starting dose of 400 mg given 90 to 120 minutes before induction of general anaesthesia. For patients in labour, an initial dose of 400 mg at the start of labour may be followed by doses of 200 mg every 2 hours to a maximum of 1.6 g may be used.
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Prevention of gastro-intestinal bleeding due to stress ulcers in seriously ill patients
Usual starting dose is a maximum of 2.4 g per day given as divided doses to maintain the gastric pH above 4.
Short bowel syndrome.
The usual dose of 400 mg twice daily may be used.
■ Children
The usual dose for children over one year old is 20 to 30 mg/kg daily in divided doses. However an alternative dosage form e.g. suspension may be more appropriate.
It is important to take the tablets at the right times; swallow the tablets with a little water.
Always take Cimetidine Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are still not sure.
If you take more Cimetidine Tablets than you should
Immediate medical advice should be sought in the event of taking too many tablets or an overdose, even if you feel well.
If you forget to take Cimetidine Tablets
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking it as you would normally. Do not take a double dose to make up for a missed dose.
If you have any further questions on how to take Cimetidine Tablets, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Cimetidine Tablets can cause side effects, although not everybody gets them.
You must stop taking the tablets and tell your doctor immediately, if your chest suddenly feels tight and you start to wheeze or get a skin rash or swelling of the face, lips, throat and eyelids.
Check with your doctor as soon as possible if any of these side effects are noticed:
Headache
Dizziness
Diarrhoea
Skin rashes
Tiredness
Breast enlargement
Reversible liver damage
• Muscle and joint pain
• Effects on the kidneys, pancreas, heart and on blood cell counts
• Hair loss (alopecia)
• Impotence
• Confusion, mainly in elderly or very ill patients.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CIMETIDINE TABLETS
Keep out of the reach and sight of children. Do not store above 25 °C.
Do not use Cimetidine Tablets after the expiry date which is stamped on the pack. The expiry date refers to the last day of that month.
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If you have Cimetidine Tablets left, return them to your pharmacist.
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.
6. FURTHER INFORMATION
■ What is in Cimetidine Tablets?
Each 200 mg Tablet contains 200 mg of the active ingredient cimetidine. The other ingredients are Starch, Povidone, Magnesium Stearate,
Sodium Starch Glycollate, Purified Water, Opadry Oy-8839 (E104, E132, E171, E172).
Each 400 mg Tablet contains 400 mg of the active ingredient cimetidine. The other ingredients are Starch, Povidone, Magnesium Stearate, Sodium Starch Glycollate, Purified Water, Opadry Oy-8839 (E104, E132, E171, E172).
Each 800 mg Tablet contains 800 mg of the active ingredient cimetidine. The other ingredients are Starch, Povidone, Magnesium Stearate,
Sodium Starch Glycollate, Purified Water, Opadry Oy-8839 (E104, E132, E171, E172).
Cimetidine 200 mg Tablets are green round film coated tablets coded CIM on one side and 200 on reverse. Pack sizes: 50,100, 250, 500,
120, 5000, 84 and 60 tablets. Not all pack sizes may be marketed.
Cimetidine 400 mg Tablets are green capsule shaped film coated tablets coded CIM on one side and 400 on reverse.
Pack sizes: 50, 56, 60, 100, 250, 500, 2500 and 5000 tablets.
Not all pack sizes may be marketed.
Cimetidine 800 mg Tablets are green elliptical film coated tablets coded CIM on one side and 800 on reverse. Pack sizes: 28,30, 50, 100, 250,
500 tablets. Not all pack sizes may be marketed.
Further information is available upon request.
Not all presentations are available in every country.
PLEASE KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Package insert leaflet revised May 2010
Cimetidine 200 mg Tablets PL 21880/0088 Cimetidine 400 mg Tablets PL 21880/0089 Cimetidine 800 mg Tablets PL 21880/0090
MA Holder:
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9, Royal Parade, Kew Gardens,
Surrey TW9 3QD, England.
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88091-B
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