ANTEPSIN Tablet (2013)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Antepsin 1g Tablets.
Qualitative and quantitative composition
Each tablet contains 1 gram of sucralfate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. Biconvex, oblong, white tablets with a dividing score on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Therapeutic indications
Antepsin is indicated in adults and adolescents over 14 years old for treatment of duodenal ulcer, gastric ulcer, chronic gastritis.
Posology and method of administration
For oral administration. Duodenal ulcer, gastric ulcer, chronic gastritis: Adults: The usual dose is 2 grams twice daily to be taken on rising and at bedtime, or 1 gram 4 times a day to be taken 1 hour ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
The product should only be used with caution in patients with renal dysfunction, due to the possibility of increased aluminium absorption. Sucralfate is not recommended for use in individuals on dialysis. ...
Interaction with other medicinal products and other forms of interaction
Concomitant administration of Antepsin may reduce the bioavailability of certain drugs including fluoroquinolones such as ciprofloxacin and norfloxacin, tetracycline, ketoconazole, sulpiride, digoxin, ...
Pregnancy and lactation
Pregnancy Teratogenicity studies in mice, rats and rabbits at doses up to 50 times the human dose have revealed no evidence of harm to the foetus. Safety in pregnant women has not been established and ...
Effects on ability to drive and use machines
Do not drive if you feel dizzy or drowsy.
Undesirable effects
Tabulated list of adverse reactions: Immune system disorders Not know (cannot be estimated from the available data): Anaphylactic reaction including pruritus, urticaria, oedema, dyspnoea Nervous system ...
Overdose
In a clinical trial on healthy men of overdose with sucralfate, most cases remained asymptomatic, but symptoms of abdominal pain, nausea, and vomiting were reported in a few cases. Acute oral toxicity ...
Pharmacodynamic properties
Pharmacotherapeutic group: Alimentary tract and metabolism ATC code: A02BX02 Mechanism of action The action of Antepsin is non-systemic as the drug is only minimally absorbed from the gastro-intestinal ...
Pharmacokinetic properties
Absorption Sucralfate is only minimally absorbed from the gastro-intestinal tract. The small amounts that are absorbed are excreted primarily in the urine. Absorption of aluminium from sucralfate may be ...
Preclinical safety data
There was no evidence of carcinogenesis in mice and rats receiving oral sucralfate in dosages of up to 1 g/kg daily (12 times the usual human dosage) for 2 years. In animal studies there was no effect ...
List of excipients
Macrogol 6000 Microcrystalline cellulose Calcium carmellose Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Store below 25°C.
Nature and contents of container
Blister packs (pack size 50 tablets).
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Chugai Pharma UK Ltd., Mulliner House, Flanders Road, Turnham Green, London, W4 1NN, U.K.
Marketing authorization number(s)
PL 12185/0008
Date of first authorization / renewal of the authorization
Date of first authorisation: 1 December 1998 Date of latest renewal: 27 April 2001
Date of revision of the text
September 2013
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