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TAGAMET is a brand name for Cimetidine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Cimetidine is a histamine H2-receptor antagonist which rapidly inhibits both basal and stimulated gastric secretion of acid and reduces pepsin output. Cimetidine is indicated in the treatment of duodenal and benign gastric ulceration, including that associated with non-steroidal anti-inflammatory agents, recurrent and…
Verbatim from this product's MHRA label. Tap a section to expand.
4 g. 4).
Posology Adults:
For patients with duodenal or benign gastric ulceration, a single daily dose of 800mg at bedtime is recommended. Otherwise the usual dosage is 400mg twice a day with breakfast and at bedtime. 6 g/day) also with meals and at bedtime. Symptomatic relief is usually rapid.
Treatment should be given initially for at least four weeks (six weeks in benign ulcer, eight weeks in ulcer associated with continued non-steroidal anti-inflammatory agents). Most ulcers will have healed by that stage, but those which have not will usually do so after a further course of treatment.
Treatment may be continued for longer periods in those patients who may benefit from reduction of gastric secretion and the dosage may be reduced as appropriate to 400mg at bedtime or 400mg in the morning and at bedtime. In patients with benign peptic ulcer disease, relapse may be prevented by continued treatment, usually with 400mg at bedtime; 400mg in the morning and at bedtime has also been used.
In oesophageal reflux disease, 400mg four times a day, with meals and at bedtime, for four to eight weeks is recommended to heal oesophagitis and relieve associated symptoms. g. Zollinger-Ellison syndrome) it may be necessary to increase the dose to 400mg four times a day, or in occasional cases further.
Antacids can be made available to all patients until symptoms disappear. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients, doses of 200-400mg can be given every four to six hours, by oral or nasogastric routes.
In patients thought to be at risk of acid aspiration syndrome an oral dose of 400mg can be given 90-120minutes before induction of general anaesthesia or, in obstetric practice prior to the start of labour. 4g. Cimetidine Syrup should not be used.
The usual precautions to avoid acid aspiration should be taken. g. following substantial resection for Crohn’s disease, the usual dosage range (see above) can be used according to individual response. To reduce degradation of pancreatic enzyme supplements, 800 – 1600mg a day may be given according to response in four divided doses, one to one and a half hours before meals.
4).
Adverse experiences with cimetidine are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Blood and lymphatic system disorders Uncommon:
Leukopenia Rare: Thrombocytopenia, aplastic anaemia Very rare: Pancytopenia, agranulocytosis Immune system disorders Very rare: Anaphylaxis. Anaphylaxis is usually cleared on withdrawal of the drug.
Psychiatric disorders Uncommon:
Depression, confusional states, hallucinations. Confusional states, reversible within a few days of withdrawing cimetidine, have been reported, usually in elderly or ill patients.
Nervous system disorders Common:
Headache, dizziness Cardiac disorders Uncommon: Tachycardia Rare: Sinus bradycardia Very rare: Heart block Gastrointestinal disorders Common: Diarrhoea Very rare: Pancreatitis. Pancreatitis cleared on withdrawal of the drug.
Hepatobiliary disorders Uncommon:
Hepatitis Rare: Increased serum transaminase levels. Hepatitis and increased serum transaminase levels cleared on withdrawal of the drug.
Skin and subcutaneous tissue disorders Common:
Skin rashes Very rare: Reversible alopecia and hypersensitivity vasculitis. Hypersensitivity vasculitis usually cleared on withdrawal of the drug.
Musculoskeletal and connective tissue disorders Common:
Myalgia Very rare: Arthralgia Renal and urinary disorders Uncommon: Increases in plasma creatinine Rare: Interstitial nephritis. Interstitial nephritis cleared on withdrawal of the drug. Small increases in plasma creatinine have been reported, unassociated with changes in glomerular filtration rate.
Dosage should be reduced in patients with impaired renal function according to creatinine clearance. The following dosages are suggested: creatinine clearance of 0 to 15ml per minute, 200mg twice a day; 15 to 30ml per minute, 200mg three times a day; 30 to 50ml per minute, 200mg four times a day; over 50ml per minute, normal dosage.
Cimetidine is removed by haemodialysis, but not to any significant extent by peritoneal dialysis. Clinical trials of over six years’ continuous treatment and more than 15 years’ widespread use have not revealed unexpected adverse reactions related to long-term therapy.
The safety of prolonged use is not, however, fully established and care should be taken to observe periodically patients given prolonged treatment. Cimetidine treatment can mask the symptoms and allow transient healing of gastric cancer.
The potential delay in diagnosis should particularly be borne in mind in patients of middle age and over with new or recently changed dyspeptic symptoms. Care should be taken that patients with a history of peptic ulcer, particularly the elderly, being treated with Cimetidine and a non-steroidal anti- inflammatory agent are observed regularly.
Due to possible interaction with coumarins, close monitoring of prothrombin time is recommended when cimetidine is concurrently used. 5). Excipients This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reaction (possibly delayed).
This medicine contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Sucrose may be harmful to the teeth. This medicine contains 350 mg sorbitol per 5 ml, equivalent to 70 mg per ml.
Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. Sorbitol may cause gastrointestinal discomfort and mild laxative effect. This medicine contains Sunset Yellow which may cause allergic reactions.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Cimetidine in United Kingdom.
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Paediatric population:
Experience in children is less than that in adults. In children more than one year old, Cimetidine 25 – 30 mg/kg body weight per day in divided doses may be administered. The use of Cimetidine in infants under one year old is not fully evaluated; 20 mg/kg body weight per day in divided doses has been used.
Method of administration:
For oral use
The increases do not progress with continued therapy and disappear at the end of therapy.
Reproductive system and breast disorders Uncommon:
Gynaecomastia and reversible impotence. Gynaecomastia is usually reversible upon discontinuation of cimetidine therapy. g. in Zollinger-Ellison Syndrome). However, at regular dosage, the incidence is similar to that in the general population.
Very rare:
Galactorrhoea General disorders and administration site conditions Common: Tiredness Very rare: Fever. Fever cleared on withdrawal of the drug. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
e. 42 g per maximum daily dose (60 ml), equivalent to 36 ml beer, 15 ml wine per 60 ml. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
This medicine contains 500 mg propylene glycol in each 5 ml which is equivalent to 100 mg/ml. - Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce adverse effects in children less than 5 years old.
- While propylene glycol has not been shown to cause reproductive or developmental toxicity in animals or humans, it may reach the foetus and was found in milk. As a consequence, administration of propylene glycol to pregnant or lactating patients should be considered on a case by case basis.
- Medical monitoring is required in patients with impaired renal or hepatic functions because various adverse events attributed to propylene glycol have been reported such as renal dysfunction (acute tubular necrosis), acute renal failure and liver dysfunction.
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