Ranitidine 150mg effervescent tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Ranitidine hydrochloride

Beschikbaar vanaf:

Sovereign Medical Ltd

ATC-code:

A02BA02

INN (Algemene Internationale Benaming):

Ranitidine hydrochloride

Dosering:

150mg

farmaceutische vorm:

Effervescent tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 01030100; GTIN: 05021730003760

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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

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ranitidine 150mg Effervescent Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 mg ranitidine (as hydrochloride).
Excipients with known effect:
Each tablet contains 119.7 mg sodium and 438 mg lactose monohydrate
(see
section 4.4).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Effervescent Tablets.
Yellow white to light yellow cylindrical, biplanar tablets with
bevel-edges on both
sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ranitidine Effervescent Tablets are indicated for:
Adults
Treatment of duodenal ulcer including that associated with
non-steroidal anti-
inflammatory drugs (NSAIDs)
Prevention of NSAID associated duodenal ulcers
Treatment of duodenal ulcers associated with Helicobacter pylori
infection
Treatment of post-operative ulcer
Zollinger-Ellison syndrome
Oesophageal reflux disease including the long-term management of
healed
oesophagitis as well as the symptomatic relief of gastro-oesophageal
reflux
disease.
Patients with 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 Effervescent tablets are also indicated for the following
conditions
where reduction of gastric secretion and acid output is desirable:
The prophylaxis of gastrointestinal haemorrhage from stress ulceration
in
seriously ill patients; the prophylaxis of recurrent haemorrhage in
patients with
bleeding peptic ulcers and before general anaesthesia in patients
considered to
be 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
Posology
ADULTS (INCLUDING TH