Famotidine 40mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Famotidine

Tilgjengelig fra:

Tillomed Laboratories Ltd

ATC-kode:

A02BA03

INN (International Name):

Famotidine

Dosering :

40mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 01030100; GTIN: 5024655001705

Informasjon til brukeren

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Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Famotidine 40mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains famotidine 40 mg.
Excipient with known effect: Each tablet contains 3.19mg of lactose
(as lactose
monohydrate).
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet
White, oblong, biconvex tablet, scored on one side
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Duodenal ulcers and prevention of relapses of duodenal ulceration.
Benign gastric ulcers.
Zollinger-Ellison syndrome.
Symptomatic treatment of mild to moderate reflux oesophagitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults _
Duodenal ulcers - The initial recommended dose is 40 mg of famotidine
to be
taken at night. Healing generally occurs in most patients within 4
weeks. This
period, however, may be shortened if an endoscopic examination reveals
that
the ulcer has healed. However, in those patients whose ulcers have not
healed
within this 4 week period, treatment should continue for a further 4
weeks.
Prevention of relapses of duodenal ulceration - To prevent ulcers from
reoccurring the recommended dose is 20 mg of famotidine to be taken at
night.
Benign gastric ulcers - The recommended dose of 40 mg of famotidine to
be
taken at night. Treatment should continue for between 4-8 weeks unless
earlier
healing is revealed by endoscopy.
Zollinger-Ellison syndrome - Patients who are not receiving any
antisecretory
therapy should be started on a dose of 20 mg of famotidine every 6
hours. The
dosage should then be adjusted to individual response. Doses up to 800
mg
daily have been used up to one year without the development of
significant
adverse effects or tachyphylaxis.
If the desired inhibition of acid secretion cannot be attained with a
daily
dosage of 800 mg, alternative treatment should be considered to
regulate acid
secretion, since no long ter