Tagamet 200mg Tablets (2009)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Chemidex Pharma Ltd |
|---|---|
| Διεύθυνση | Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB |
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Name of the medicinal product
Tagamet 200 mg Tablets.
Qualitative and quantitative composition
Each tablet contains Cimetidine 200 mg. For excipients, see 6.1.
Pharmaceutical form
Film-coated tablet. Pale green, circular, biconvex, film-coated tablet embossed with Tagamet on one side and 200 on the reverse.
Therapeutic indications
Tagamet is a histamine H2-receptor antagonist which rapidly inhibits both basal and stimulated gastric secretion of acid and reduces pepsin output. Tagamet is indicated in the treatment of duodenal and ...
Posology and method of administration
The total daily dose should not normally exceed 2.4g. Dosage should be reduced in patients with impaired renal function (see Section 4.4). Adults The usual dosage is 400mg twice a day with breakfast and ...
Contraindications
Hypersensitivity to cimetidine.
Special warnings and precautions for use
Dosage should be reduced in patients with impaired renal function according to creatinine clearance. The following dosages are suggested: creatinine clearance of 0-15ml per minute, 200mg twice a day; 15 ...
Interaction with other medicinal products and other forms of interaction
Cimetidine can prolong the elimination of drugs metabolised by oxidation in the liver. Although pharmacological interactions between cimetidine and a number of drugs have been demonstrated e.g. diazepam ...
Pregnancy and lactation
Although tests in animals and clinical evidence have not revealed any hazards from the administration of Tagamet during pregnancy or lactation, both animal and human studies have shown that it does cross ...
Effects on ability to drive and use machines
None known.
Undesirable effects
Adverse experiences with cimetidine are listed below by system organ class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10000, ...
Overdose
Acute overdosage of up to 20g has been reported several times with no significant ill-effects. Induction of vomiting and/or gastric lavage may be employed together with symptomatic and supportive therapy. ...
Pharmacodynamic properties
Cimetidine, one of the H2 blockers is a reversible, competitive antagonist of the actions of histamine on H2 receptors. It is highly selective in its action and is virtually without effect on H1 receptors ...
Pharmacokinetic properties
Cimetidine is rapidly and virtually completely absorbed. Absorption is little impaired by food or by antacids. Peak concentrations in plasma are attained in about 1 to 2 hours. Hepatic first-pass metabolism ...
Preclinical safety data
Not available.
List of excipients
Microcrystalline cellulose Povidone 30 Sodium starch glycollate Sodium lauryl sulphate Colloidal anhydrous silica Magnesium stearate Hypromellose (E464) Titanium dioxide (E171) Macrogol 400 Indigo carmine ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Blister: Do not store above 25°C. Store in the original package. Keep blister in the outer carton. Tablet container (polypropylene tube): Do not store above 25°C. Keep the container tightly closed. Store ...
Nature and contents of container
1. Blister packs consisting of 250µm clear PVC and 20µm hard temper aluminium foil contained in a carton. Pack sizes: 60 & 120 tablets. 2. Polypropylene tubes with low density polyethylene caps. High density ...
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Chemidex Pharma Limited Chemidex House Egham Business Village Crabtree Road Egham Surrey TW20 8RB United Kingdom
Marketing authorization number(s)
PL 17736/0020
Date of first authorization / renewal of the authorization
23 December 2002
Date of revision of the text
February 2009