Ranitidine 300mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ranitidine hydrochloride

Available from:

Arrow Generics Ltd

ATC code:

A02BA02

INN (International Name):

Ranitidine hydrochloride

Dosage:

300mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030100

Patient Information leaflet

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PAGE 1 OF 2
Received Date:
21/06/2018
CDL JOB No. :
65455
Required By :
25/06/2018
PRODUCT NAME:
Ranitidine 150 mg
& 300 mg
Effervescent Tablets
PIP CODE:
GB 674-6051-APIL
COMPONENT:
Leaflet
SIZE:
165x300 mm
MARKET:
Great Britain
PRODUCT SITE:
TBC
SCALE:
100%
COLOURS:
Black
Cutter
DATE:
25/06/2018
FONT SIZE:
9 pt
VERSION NO:
2
AMENDED BY:
VK
PROJECT:
Sovereign Medical
RANITIDINE 150 mg and 300 mg Effervescent Tablets
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, please ask your doctor or
pharmacist.
•
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 or pharmacist.
This includes any possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ranitidine Effervescent Tablets are and what they are
used for
2.
What you need to know before you take Ranitidine
Effervescent Tablets
3.
How to take Ranitidine Effervescent Tablets
4.
Possible side effects
5.
How to store Ranitidine Effervescent Tablets
6.
Contents of the pack and other information
1. WHAT RANITIDINE EFFERVESCENT TABLETS ARE A

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ranitidine 300mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
300 mg ranitidine (as hydrochloride).
3
PHARMACEUTICAL FORM
Coated tablet.
White to off-white, oblong.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults
Ranitidine Tablets are indicated for:
•
treatment of duodenal ulcer and benign gastric ulcer, including that
associated with nonsteroidal 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.
Ranitidine 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 Ranitidine 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 most cases of duodenal ulcer,