Zantac 300mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Ranitidine hydrochloride

Dostupné z:

GlaxoSmithKline UK Ltd

ATC kód:

A02BA02

INN (Medzinárodný Name):

Ranitidine hydrochloride

Dávkovanie:

300mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 01030100; GTIN: 5000123105571

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZANTAC TABLETS 150 MG AND 300 MG
RANITIDINE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours.
•
If you get any side effects talk to your doctor, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1
What Zantac is and what it is used for
2
What you need to know before you take Zantac
3
How to take Zantac Tablets
4
Possible side effects
5
How to store Zantac
6
Contents of the pack and other information
1
WHAT ZANTAC IS AND WHAT IT IS USED FOR
Zantac contains a medicine called ranitidine. This belongs to a group
of medicines
called H
2
-receptor antagonists. It lowers the amount of acid in your stomach.
For adults (including the elderly) Zantac is used to:
•
heal and stop ulcers in the stomach, or the part of the gut it empties
into (the
duodenum)
•
help clear up infection in your stomach, when taken with antibiotic
medicines
(medicines taken to treat germs)
•
stop stomach ulcers when they are a side effect of some medicines
•
stop ulcers from bleeding
•
improve problems caused by acid in the food pipe (oesophagus) or too
much acid
in the stomach. Both of these can cause pain or discomfort sometimes
known as
‘indigestion’, ‘dyspepsia’ or ‘heartburn’
•
stop acid coming up from the stomach while under anaesthetic during an
operation.
For children (3 to 18 years) Zantac is used to:
•
heal ulcers in the stomach, or the part of the gut it empties into
(the duodenum)
•
heal and stop problems caused by acid in the food pipe (oesophagus) or
too
much acid in the stomach. Both of these can cause pain or discomfort

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zantac Tablets 300 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains ranitidine 300 mg (as the hydrochloride).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults
Zantac Tablets are indicated for:
•
treatment of duodenal ulcer and benign gastric ulcer, including that
associated with non-
steroidal anti-inflammatory agents.
•
treatment of duodenal ulcers associated with _Helicobacter pylori
_infection.
•
treatment of post-operative ulcer
•
Zollinger-Ellison syndrome
•
oesophageal reflux disease
•
chronic episodic dyspepsia, characterised by pain (epigastric or
retrosternal) which is
related to meals or disturbs sleep but is not associated with the
preceding conditions may
benefit from ranitidine treatment.
Zantac Tablets are indicated for the following conditions where
reduction of gastric
secretion and acid output is desirable:
•
prophylaxis of gastrointestinal haemorrhage from stress ulceration in
seriously ill patients
•
prophylaxis of recurrent haemorrhage in patients with bleeding peptic
ulcers
•
before general anaesthesia in patients considered to be at risk of
acid aspiration
(Mendelson's syndrome), particularly obstetric patients during labour.
For appropriate cases Zantac Injection is also available (see separate
SPC).
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
Posology
Adults (including the elderly)
The usual dosage is 150 mg twice daily, taken in the morning and
evening.
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 time the dose in relation to meals.
Duodenal ulcer, benign gastric ulcer and post operative ulcer:
In mo