Cimetidine 400mg Tablets
PATIENT INFORMATION LEAFLET
CIMETIDINE 200mg, 400mg AND 800mg TABLETS
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 your 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 side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET
1. What Cimetidine is and what it is used for
2. Before you take Cimetidine.
3. How to take Cimetidine
4. Possible side effects
5. How to store Cimetidine
6. Further information
1. WHAT CIMETIDINE IS AND WHAT IT IS USED FOR
The name of your medicine is Cimetidine Tablets. Cimetidine belongs to a group of medicines known as histamine H 2 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/duodenal ulcers
• Treat and relieve Zollinger-Ellison syndrome (excessive secretion of acid by the stomach)
• Treat and relieve ulceration of the oesophagus (gullet) caused by reflux of gastric juices
• Prevent the recurrence of stomach/duodenal ulcers.
• Treat or prevent ulcers caused by medicines such as non-steroidal antiinflammatory drugs (NSAIDs), which are used to treat conditions such as arthritis. If you are taking this type of medicine, your doctor may prescribe Cimetidine Tablets for you to try to keep you free of ulcers.
• Improve absorption of food and reduce fluid loss in short bowel syndrome
• Prevent acid coming up the oesophagus (gullet) before an anaesthetic
2. BEFORE YOU TAKE CIMETIDINE
DO NOT TAKE Cimetidine 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, further information.
Take special care with cimetidine
Before you take cimetidine tablets tell your doctor if:
• You have a kidney or liver complaint
• You have a low blood cell count
• You have lost weight recently and also have stomach ache or pain or indigestion at the same time, particularly if you are over 40 years
• Have had a stomach/duodenal ulcer in the past, particularly if you are regularly taking anti-inflammatories (NSAIDs) to treat arthritis. You should see your doctor regularly if this is the case.
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
• Procainamide, to treat irregular heart beats
Medicines that cause a fall in blood cell count
• Non-steroidal anti-inflammatories (NSAIDs) e.g. Aspirin, indometacin
• Medicines to help treat anxiety, e.g. Diazepam
• Medicines to treat high blood pressure- e.g. Propranolol, Metoprolol, Diltiazem &
Nifedipine
• Antidepressants such as amitriptyline
• Anti-diabetic medicines such as Glipizide, Metformin
• Medicines used to prevent rejection of an organ following a transplant, e.g.
ciclosporin and tacrolimus.
• Medicines used to treat fungal infections, e.g. Ketoconazole, itraconazole or
posaconazole.
• Atazanavir- used in the treatment of HIV
• Medicines used in the treatment of cancer, e.g. carmustine, flourouracil, epirubicin
or radiation therapy
• Morphine - a powerful painkiller used to treat severe pain
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 breastfeeding.
Driving and using machines
Cimetidine tablets are unlikely to affect your ability to operate machinery or to drive. When you first start taking cimetidine, make sure your abilities are not affected before you drive or operate machinery
Important information about some of the ingredients of your medicines
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.
Follow your doctor’s instructions. The pharmacist’s 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 and older people 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) 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.
People with severe kidney problems:
The dose may be lowered if you have severe kidney problems as you may be more sensitive to the medicine.
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 tablets 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.
Like all medicines, Cimetidine can have side effects although not everybody gets them.
Some side effects are more likely to occur than others. The possible side effects of Cimetidine are listed below and can be divided as follows;
Very common Common Uncommon Rare
Very rare
affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000
STOP taking your medicine and tell your doctor immediately, or go to accident and emergency if you experience any of the following side effects:
An allergic reaction; signs of an allergic reaction are swelling of the lips, face and tongue; difficulty breathing; skin rash, itching, feeling faint
• Inflammation of the pancreas (symptoms may include severe stomach pain or a change in type of stomach pain)
• Skin and / or whites of the eyes start turning yellow, this may suggest a liver problem (Hepatitis)
• Kidney disorders (symptoms may include a change in the volume of urine passed and its colour)
• Unusual bleeding or bruising; or fever, sore throat, mouth ulcers, repeated infections or infections that will not go away. This may be due to changes in your blood
The following are side effects you may wish to discuss with you doctor or pharmacist if they become troublesome or they worry you.
Common
Tiredness
Headaches
o Dizziness o Muscle pain o Diarrhoea
Uncommon
o Fast heart beats, palpitations. Mild skin rash
o Depression, confusional states and hallucinations. Impotence in men
o Breast enlargement in men.
Rare
o Slowing of heart beat
Very Rare
o Fever Hair loss
o Joint pains
o Production of breast milk, in people not breast feeding or pregnant
If any of the side effects get serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
NOTE: Patients taking this medicine on a long-term basis should be under regular supervision by their doctor
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
5. HOW TO STORE CIMETIDINE
Do not use your medicine after the expiry date shown on the pack.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
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. FURTHER INFORMATION
What your medicine looks like
Cimetidine 200 mg 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 “CIM400” 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.
Marketing Authorisation Holder and company responsible for release of this medicine.
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units Polhampton lane, Overton, Hampshire, RG25 3ED UK.
PL Numbers:
Cimetidine 200mg Tablets: PL 20416/0415 Cimetidine 400mg Tablets: PL 20416/0416 Cimetidine 800mg Tablets: PL 20416/0417
This leaflet was revised in June 20, 2016