Zantac 150mg effervescent tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ranitidine hydrochloride

Available from:

GlaxoSmithKline UK Ltd

ATC code:

A02BA02

INN (International Name):

Ranitidine hydrochloride

Dosage:

150mg

Pharmaceutical form:

Effervescent tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030100; GTIN: 5000123105403

Patient Information leaflet

Reason for Update: Type II to update in line with PSUSA -erlotinib and
Minor amendments
Market: UK
Agency Approval Date:
Text Date: 16/10/2019
Text Issue and Draft No.: Issue 09 Draft 01
LOGO GSK
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZANTAC EFFERVESCENT 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 Effervescent 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 u

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zantac Effervescent Tablets 150 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains ranitidine 150 mg (as the hydrochloride).
Excipients with known effect:
Contains 327 mg of sodium.
Contains aspartame (E951)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Effervescent Tablet.
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 (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.
Symptom relief in gastro-oesophageal 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 stress ulceration in seriously ill patients.
Prophylaxis of recurrent haemorrhage from peptic ulcer.
Prophylaxis of Mendelson's syndrome.
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)
Duodenal ulcer and benign gastric ulcer:
Acute treatment:
The standard dosage regimen for duodenal or benign gastric ulcer is
150 mg
twice daily or 300 mg nocte. In most cases of duodenal ulcer or benign
gastric
ulcer healing occurs within 4 weeks. Healing usually occurs after a
further 4
weeks in those not fully healed after the initial 4 weeks.
Long-term management:
For the long-term management of duodenal or benign gastric ulcer the
usual
dosage regimen is 150 mg nocte.
In duodenal ulcer 300 mg twice daily for 4 wee