Ranitidine 150mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Ranitidine hydrochloride

Prieinama:

Boston Healthcare Ltd

ATC kodas:

A02BA02

INN (Tarptautinis Pavadinimas):

Ranitidine hydrochloride

Dozė:

150mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 01030100

Pakuotės lapelis

FRONT
BACK
430 mm
25 mm
5 mm
5 mm
5 mm
5 mm
430 mm
160 mm
5 mm
5 mm
5 mm
160 mm
5 mm
5 mm
5 mm
5 mm
5 mm
5 mm
5 mm
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Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ranitidine 150 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ranitidine Hydrochloride equivalent to 150 mg
ranitidine.
For excipients see 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Appearance: White to yellowish, circular, convex, film-coated tablets,
diameter 10 mm marked with letters “R” and “I” either side of
the scoreline on
one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults
Duodenal ulcer and benign gastric ulcer, including that associated
with non-
steroidal anti-inflammatory agents.
Prevention
of
non-steroidal
anti-inflammatory
drug
(NSAID)
(including
aspirin) associated duodenal ulcers, especially in patients with a
history of
peptic ulcer disease.
Treatment of duodenal ulcers associated with _Helicobacter pylori
_infection.
Post-operative ulcer.
Oesophageal
reflux
disease
including
long
term
management
of
healed
oesophagitis.
Symptomatic relief in gastrooesophageal reflux disease.
Zollinger-Ellison Syndrome.
Chronic episodic dyspepsia, characterised by pain (epigastric or
retrosternal)
which is related to meals or disturbs sleep but not associated with
the above
conditions.
Prophylaxis
of
gastrointestinal
haemorrhage
from
stress
ulceration
in
seriously ill patients.
Prophylaxis of recurrent haemorrhage with bleeding peptic ulcers.
Before general anaesthesia in patients at risk of acid aspiration
(Mendelson's
syndrome), particularly obstetric patients during labour.
Children (3 to 18 years)
-
Short term treatment of peptic ulcer
-
Treatment of gastro-oesophageal reflux, including reflux oesophagitis
and symptomatic relief of gastro-oesophageal reflux disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
_Adults: _The usual dosage is 150 mg twice daily, taken in the morning
and evening.
Alternatively, patients with duodenal ulceration, gastric ulceration
or oesophageal reflux
disease may be treated with a single bedtime dose of 300 mg. It is not
necessary to