PACKAGE LEAFLET: INFORMATION FOR THE USER Cimetidine Tablets 200mg, 400mg and 800mg [Cimetidine] Read all of this leaflet carefully before you start ! Are taking other medicines (see Section 'Other taking this medicine because it contains medicines and Cimetidine Tablets '). important information for you. ! Keep this leaflet. You may need to read it again. Other medicines and Cimetidine Tablets ! If you have any further questions, ask your doctor or pharmacist or nurse. Tell your doctor or pharmacist if you are taking, have ! This medicine has been prescribed for you only. recently taken or might take any other medicines. Do not pass it on to others. It may harm them, In particular tell your doctor if you are taking any of even if their signs of illness are the same as the following: yours. ! Anticoagulants to thin your blood e.g. warfarin ! If you get any side effects, talk to your doctor, or ! Anticonvulsants to prevent fits e.g. phenytoin pharmacist or nurse. This includes any possible ! Bronchodilators for breathing difficulties e.g. side effects not listed in this leaflet. See section 4. theophylline ! Anti-arrhythmics to slow heart rate e.g. lidocaine, What is in this leaflet: propranolol 1. What Cimetidine Tablets are and what they ! Antidepressants to treat anxiety e.g. diazepam are used for ! Immunosuppresants to prevent organ rejection 2. What you need to know before you take or rheumatism (e.g. ciclosporin) Cimetidine Tablets ! Medicines that cause a fall in blood cell count 3. How to take Cimetidine Tablets ! Antifungals used to treat fungal infections (e.g. 4. Possible side effects ketoconazole, itraconazole or 5. How to store Cimetidine Tablets posaconazole) 6. Contents of the pack and other information ! Antidiabetics to lower glucose levels in the blood (e.g. metformin 1. WHAT CIMETIDINE TABLETS ARE AND or glipizide) WHAT THEY ARE USED FOR ! Anti-cancer drugs for the treatment of cancer or tumors (e.g. carmustine, Cimetidine Tablets belong to a group of medicines fluorouracil, epirubicin, or therapies called H2-receptor antagonists which act to such as radiation) decrease the natural production of acid in the ! Strong pain killers (e.g. morphine) stomach. ! Antiretroviral drugs used to treat Cimetidine Tablets have been prescribed to treat any HIV/AIDS (e.g. atazanavir) of the following: ! Tacrolimus used to treat eczema ! Ulcers in the stomach (gastric ulcer) or in the ! Medicines to treat heart problems e.g. upper part of the intestine (duodenum ulcer) diltiazem, procainamide, metoprolol. ! Acid from the stomach escaping into the food pipe causing pain, inflammation and heartburn Pregnancy and breast-feeding (oesophageal reflux disease) ! Ask your doctor or pharmacist for advice if you are Excess acid in the stomach caused by a tumor in pregnant, planning on becoming pregnant or are the pancreas (Zollinger-Ellison syndrome) ! breast- feeding. The use of Cimetidine during Ulcers in the stomach or duodenum which may pregnancy and breast-feeding should be avoided be caused by non-steroidal anti-inflammatory unless considered essential by your doctor. drugs (NSAIDs), often used to reduce pain, fever and inflammation ! Various conditions where reduction of gastric Driving and using machines acid by cimetidine has been shown to be These tablets can cause some people to feel dizzy or beneficial e.g. drowsy. If you are affected do not drive or operate , Indigestion symptoms (e.g. stomach pain or machinery. discomfort, heartburn) , Meal-related upper abdominal pain 3. HOW TO TAKE CIMETIDINE TABLETS , To prevent stress ulcers from bleeding , To be given before general anaesthesia to prevent damage to the lungs caused by Always take Cimetidine Tablets exactly as your breathing in stomach fluids (acid aspiration) doctor has instructed you. You should check with , To improve absorption of food and reduce your doctor or pharmacist if you are unsure. fluid loss in short bowel syndrome , Reduction of breakdown of pancreatic The usual dosage is 400mg to 1600mg cimetidine enzyme supplements. per day. Take twice a day with breakfast and at bedtime or as directed by your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU Do not take more then 2400mg cimetidine per day. TAKE CIMETIDINE TABLETS Do not take Cimetidine Tablets: Elderly: ! If you are hypersensitive (allergic) to cimetidine The normal adult dosage may be used unless you or any of the other ingredients of Cimetidine have kidney problems. Tablets (listed in section 6). Patients with duodenal or gastric ulceration: Warnings and precautions A single dose of 800mg at bedtime is recommended. Talk to your doctor, pharmacist or nurse before taking Although your doctor may recommend 200mg three Cimetidine Tablets if you: times a day with meals and 400mg at bedtime. ! Suffer or have suffered in the past from kidney disease ! Have a history of peptic ulcer, particularly if you Patients with oesophageal reflux disease: are taking a non-steroidal anti-inflammatory drug 400mg four times a day with meals and at bedtime is (NSAID) e.g. aspirin, ibuprofen, naproxen, recommended. diclofenac ! Are taking drugs or you have an illness that could Patients with Zollinger-Ellison syndrome: cause a fall in blood cell count ! Are middle aged or over, with new or recently 400mg four times a day with meals and at bedtime is changed indigestion symptoms (e.g stomach recommended. Higher doses may be given. pain or discomfort, heartburn), then other causes of your symptoms such as stomach cancer, should be excluded PENC 1520 Patients with acid aspiration: Very rare side effects (affects less than 1 user in A dose of 400mg can be given 90-120 minutes 10,000): before having a general anaesthetic or, in obstetric ! Pancytopenia - blood disorder with low number practice, at the start of labour. While there is still a of red and white blood cells and platelets risk of acid aspiration, a dose of up to 400mg may be ! Agranulocytosis - blood disorders with very low repeated at 4 hourly intervals, as required, up to the numbers of white blood cells usual daily maximum of 2.4g. ! Heart block - symptoms may include irregular heartbeats Prevention of bleeding from stress ulcers in seriously ! Inflammation of the pancreas - symptoms ill patients: include stomach and back pain, nausea and 200-400mg can be given every 4-6 hours. vomiting ! Hair loss -reversible after treatment has stopped Patients with kidney problems: ! Arthralgia - aching muscles and joints Doses may be reduced but your doctor will advise ! Galactorrhoea - leakage of a milky substance you on the amount to take. from the breasts ! Fever. If you take more Cimetidine Tablets than you should Reporting of side effects This medicine is to be taken at regular intervals, as If you get any side effects, talk to your doctor, determined by the physician. If you take too many pharmacist or nurse. This includes any possible side tablets by mistake contact your nearest hospital effects not listed in this leaflet. You can also report casualty department or tell your doctor immediately. side effects directly via the Yellow Card Scheme at: Take your tablet pack with you. www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more If you stop taking Cimetidine Tablets information on the safety of this medicine. You may feel better after a few days, but you should keep taking your tablets until the prescribed course is 5. HOW TO STORE CIMETIDINE TABLETS finished. Your symptoms may come back if you stop your treatment too soon. Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the If you forget to take Cimetidine Tablets label. If you have forgotten to take a dose, leave out that Do not store above 25°C. Store in the original dose completely. Take your next dose at the normal package. time. If you have trouble remembering to take the In case of any visible signs of deterioration, you tablets, tell your doctor or pharmacist. should discard the package. Medicines should not be disposed of via waste water 4. POSSIBLE SIDE EFFECTS or household waste. Ask your pharmacist how to dispose of medicines no longer required. These Like all medicines, this medicine can cause side measures help to protect the environment. effects, although not everyone gets them. Keep out of the sight and reach of children Allergic reactions may occur rarely, with symptoms such as rash, itching, swelling of the face, 6. CONTENTS OF THE PACK AND OTHER wheeziness, shortness of breath, tightness in the INFORMATION chest, fever, low blood pressure and feeling dizzy particularly when standing up. If any of these occur What Cimetidine Tablets contain: STOP taking the medicine and contact a doctor Cimetidine Tablets 200, 400 and 800mg contain immediately. the active substance cimetidine 200mg, 400mg or 800mg in each film-coated tablet respectively. Common side effects (affects 1 to 10 users in 100): The other ingredients are: Microcrystalline cellulose ! Headache (E460), povidone 30, sodium starch glycollate, ! Dizziness sodium lauryl sulphate, colloidal silicon dioxide, ! Diarrhoea magnesium stearate, hydroxypropyl methylcellulose ! Skin rashes (E464), polyethylene glycol, quinoline yellow ! Myalgia (muscle aches) aluminium lake (E104), indigo carmine aluminium ! Tiredness. lake (E132), titanium dioxide (E171) and iron oxide yellow (E172). Uncommon side effects (affects 1 to 10 users in 1,000): What Cimetidine Tablets look like and contents ! Leukopenia - decrease in the number of white of the pack blood cells Cimetidine Tablets 200mg are pale green, circular, ! Depression biconvex, film coated tablets, embossed with C1 on ! Confusion (usually in the elderly or seriously ill) one side. ! Hallucinations (hearing and seeing things that Cimetidine Tablets 400mg are pale green, oblong, are not there) film coated tablets, embossed with C2 on one side. ! Tachycardia (fast heartbeat) Cimetidine Tablets 800mg are pale green, oval, film ! Liver disorder (hepatitis) stomach and abdomen coated tablets, embossed with C3 on one side. tenderness, loss of appetite, with or without jaundice (yellowing of the whites of the eyes and Cimetidine 200mg Tablets are packed in cartons skin) containing 12, 24, 48, 60 or 120 tablets in foil blister ! Breast enlargement in men (gynaecomastia) - strips and in polypropylene tubes with pack sizes of this is usually reversible when the medicine is 100, 250, 500 and 1000 tablets. stopped ! Problems getting and maintaining an erection Cimetidine 400mg Tablets are packed in cartons (impotence). containing 60 tablets in foil blister strips and in polypropylene tubes with pack sizes of 100, 250, 500 Rare side effects (affects 1 to 10 users in 10,000): and 1000 tablets. ! Thrombocytopenia - abnormally low number of platelets in the blood Cimetidine 800mg Tablets are packed in cartons ! Aplastic anaemia - bone marrow disorder containing 30 tablets in foil blister strips and in ! Sinus bradycardia - slow heartbeat polypropylene tubes with pack sizes of 60, 100, 150, ! Increased serum transaminase levels which is and 250 tablets. reversible when the medicine is stopped ! Kidney disorders (Interstitial nephritis with Not all pack sizes may be marketed. symptoms such as blood in urine, increased or decreased urine output, nausea and vomiting) Manufacturer and Marketing Authorisation ! Small increases in plasma creatinine have been Holder: reported. Ennogen Pharma Limited, Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS, UK. This leaflet was last revised in June 2014.