Cimetidine 400mg Tablets
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Patient information leaflet
CIMETIDINE 200MG, 400MG & 800MG TABLETS
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Cimetidine Tablets are and what they are used for
2. What you need to know before you take Cimetidine Tablets
3. How to take Cimetidine Tablets
4. Possible side effects
5. How to store Cimetidine Tablets
6. Contents of the pack and other information
1. What Cimetidine Tablets are and what they are used for_
Cimetidine is a member of a group of medicines called “Histamine H2- receptor Antagonists.” Cimetidine reduces the amount of acid being produced by your stomach (gastric acid).
Cimetidine is used to treat and relieve the following conditions:
• ulcers in the stomach (gastric ulcer) and in upper part of the intestine (duodenum ulcer)
• recurrent stomach ulcers (ulcers that keep coming back or which have occurred following stomach surgery)
• ulcers in the stomach or duodenum which may be caused by non-steroidal anti-inflammatory drugs (NSAIDs, often used to reduce pain, fever and inflammation)
• acid from the stomach escaping into the food pipe causing pain, inflammation and heartburn (oesophageal reflux)
• persistent heartburn and stomach pain
• upper abdominal pain particularly after meals
• prevention of internal bleeding from ulcers caused by stress in seriously ill patients
• for patients at risk of acid inhalation before general anaesthesia particularly pregnant women during labour (Mendelson's syndrome)
• improve absorption of food and reduce fluid loss in short bowel syndrome
• reduce the breakdown of pancreatic enzyme supplements in patients with pancreatic problems
• excess acid in the stomach caused by a tumour in the pancreas (Zollinger- Ellison syndrome)
2. What you need to know before you take Cimetidine Tablets
♦ Do not take Cimetidine Tablets if you:
• are allergic to cimetidine or any of the other ingredients of this medicine (listed in section 6)
• are middle aged or older, with new or recently changed dyspeptic (pain and discomfort in the upper part of the stomach) symptoms
♦ Warnings and precautions
Talk to your doctor or pharmacist before taking these tablets if you:
• suffer from kidney problems or from gastric cancer
• have a history of peptic ulcers, particularly if you are taking a non steroidal anti-inflammatory drug (NSAIDs) e.g. aspirin, ibuprofen, naproxen, diclofenac
Other medicines and Cimetidine Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially if you are already taking: anticoagulants (to thin the blood, e.g. warfarin) anticonvulsants (prevent fits/seizures, e.g. phenytoin, diazepam)
bronchodilators (for breathing difficulties, e.g. theophylline)
immunosuppressants (to prevent organ rejection or rheumatism, e.g.ciclosporin) medicines that cause a fall in blood cell count (e.g. clozapine)
antifungals (used to treat fungal infections, e.g. ketoconazole, itraconazole or posaconazole) heart medicines (e.g. diltiazem, nifedipine, lidocaine, propranolol, metoprolol, procainamide or quinidine) antidiabetics (lower glucose levels in the blood, e.g. metformin or glipizide) anti-cancer drugs (treatment of cancers or tumours, e.g. carmustine, fluorouracil, epirubicin, or therapies such as radiation) strong pain killers (e.g. morphine) tricyclic antidepressants (used to treat depression, e.g. amitriptyline) antiretroviral drugs (used to treat HIV/AIDs, e.g. atazanavir) tacrolimus (for eczema)
Pregnancy and breast-feeding If you are pregnant, think you may be pregnant or planning to have a baby, ask your doctor for advice before taking this medicine. You should not take this medicine during pregnancy unless this has been agreed with your doctor.
Do not take these tablets when breast -feeding because Cimetidine is excreted in breast milk and can be harmful for your baby.
Driving and using machines
These tablets can cause some people to feel dizzy or drowsy. If you are affected do not drive or operate machinery.
Cimetidine tablets contain sodium
This medicinal product contains the following sodium content per tablet, which has to be taken into consideration by patients on a controlled sodium diet:
• 200mg tablet - 500 micrograms
• 400mg tablet - 1mg
• 800mg tablet - 1.5mg
3. How to take Cimetidine Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The maximum daily dose is 2400mg of Cimetidine. Treatment is usually for a period of 4 to 8 weeks.
♦ Adults:
• Stomach/intestinal ulcer:
The usual daily dose is 800mg, taken as either a single dose at bedtime or 400mg at breakfast and 400mg at bedtime.
For 1000mg daily dose - take 200mg three times a day with meals and 400mg at bedtime.
For 1600mg daily dose - take 400mg three times a day with meals and 400mg at bedtime. Your doctor will advise which dose is best for you.
• Prevention of stomach / intestinal ulcer:
400mg once daily at bedtime.
• Zollinger - Ellison syndrome:
400mg three times a day with meals and 400mg at bedtime (total 1600mg daily).
• Ulceration of the oesophagus from the reflux of gastric juices:
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400mg three times a day with meals and 400mg at bedtime (total 1600mg daily).
♦ The elderly
As per adults dosage, unless you have serious kidney problems. Your doctor will advise if your dose needs to be reduced.
♦ Children over 1 year
Your doctor will decide the right dose, depending on your child’s weight.
♦ How to take
• Swallow the tablets with water.
• Continue taking your tablets until the prescribed course has been completed. If you stop your treatment early your symptoms may return.
♦ Long term usage
Patients taking this medicine on a long- term basis should be checked regularly by their doctor.
♦ If you take more Cimetidine than you should
If you or anyone else has taken too many tablets, drink plenty of water and contact your nearest hospital casualty department or doctor immediately. Take any remaining tablets with you to show the doctor.
♦ If you forget to take Cimetidine
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose and just carry on as before. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
♦ If you experience any of the following side effects you should STOP taking the tablets and contact your doctor immediately:
Rare (may affect up to 1 in 1,000 people):
• allergic reactions that include rash, itching or hives on the skin, swelling of the face or other parts of the body, shortness of breath, wheezing or difficulty breathing
• kidney problems (symptoms may include changes in the amount of urine passed and its colour, nausea, vomiting, confusion, fever and rash)
• a rare type of anaemia in which the red and white blood cells and platelets are all reduced in number (symptoms might include tiredness, being short of breath, looking pale, frequent infections, bruising more easily or nose bleeds)
• liver inflammation, which might cause any of the following: nausea (feeling sick), vomiting (being sick), loss of appetite, feeling generally unwell, fever, itching, dark coloured urine and yellowing of the skin and eyes
• slowing of heartbeat, irregular heartbeat or fainting
• inflammation of the pancreas (sudden onset of abdominal pain, nausea and vomiting)
♦ Tell your doctor if you get any of the following side effects
Common (may affect up to 1 in 10 people), these are usually mild and do not last long:
• diarrhoea, headache, dizziness
• tiredness, muscle pain, joint pain Rare (may affect up to 1 in 1,000 people):
• hair loss
• mouth ulcers, infections of the throat
• confusion (usually in the elderly or ill patients)
• feelings of sadness, depression
• trouble getting or keeping an erection (impotence)
• hallucinations - seeing/feeling/hearing things that are not there
Very rare (may affect up to 1 in 10,000 people):
• breast swelling or sexual problems in men
• unexpected secretion of breast milk in female and male patients
All these side effects should disappear when treatment is stopped.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Cimetidine Tablets
Keep this medicine out of the sight and reach of
children.
• Do not us this medicine after the expiry date stated after abbreviation ‘EXP’ on the pack.
• Do not store above 25°C. Store in the original package.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Cimetidine tablets contain:
The active substance is cimetidine. Each tablet contains 200mg or 400mg or 800mg of cimetidine.
The other ingredients are:
microcrystalline cellulose, povidone, sodium starch glycollate, sodium lauryl sulphate, colloidal silicon dioxide, magnesium stearate, polyethylene glycol 400, hypromellose, titanium dioxide (E171), quinoline yellow aluminium lake (E104), indigo carmine aluminium lake (E132), iron oxide yellow (E172). See end of section 2 for further information on sodium. What Cimetidine tablets look like, and contents of packs:
Cimetidine 200mg tablets: pale green circular, film coated tablets embossed with ‘’PV’’ on one face and ‘’CIM 200’’ on reverse.
Pack sizes of Cimetidine 200mg tablets are “60 and 120 tablets in blister packs”.
Cimetidine 400mg tablets: pale green oblong, film coated tablets embossed with ‘’PV’’ on one face and ‘’ CIM 400’’ on reverse.
Pack sizes of Cimetidine 400mg tablets are “60 tablets in blister pack”.
Cimetidine 800mg tablets: pale green, oval, film coated tablets embossed with ‘’PV’’ on one face and ‘’CIM 800’’ on reverse.
Pack sizes of Cimetidine 800mg tablets are “30 tablets in blister pack”.
Not all pack sizes may be marketed.
Marketing Authorisation holder and Manufacturer
Pharmvit Ltd, 177 Bilton Road, Perivale,
Greenford, Middlesex UB6 7HQ.
Telephone: 02089975444 Fax: 02089975433
To request a copy of this leaflet in large print or audio format, please contact the licence holder at the address (or telephone, fax) above
PL 4556/0035, PL 4556/0036, PL 4556/0037
Reference: 003536370414/02
This leaflet was last revised: April 2014