ZANTAC SYRUP 150MG/10ML

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

RANITIDINE HYDROCHLORIDE

Available from:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (International Name):

RANITIDINE HYDROCHLORIDE

Units in package:

200ml mL

Manufactured by:

Aspen Bad Oldesloe GmbH

Patient Information leaflet

_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
ZANTAC TABLET
_ _
Ranitidine (150 mg, 300 mg)
ZANTAC SYRUP
Ranitidine (150mg/10ml)
1
WHAT IS IN THIS LEAFLET
1.
What ZANTAC is used for
2.
How ZANTAC works
3.
Before you use ZANTAC
4.
How to use ZANTAC
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of ZANTAC
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT ZANTAC IS USED FOR
_Adults/Adolescents (12 years and _
_over) _
ZANTAC is used for:

Stomach and small bowel ulcer that
is associated with non-steroidal anti-
inflammatory agents (painkillers)

Small bowel ulcer with Helicobacter
pylori (bacteria) infection in the
stomach

Post-operative ulcer

Symptom relief in reflux disease
including esophagus inflammation

Zollinger-Ellison Syndrome (excess
acid production in the stomach
caused by growth in the pancreas)

Chronic impaired digestion,
characterised by heartburn or
epigastric pain which is related to
meals or disturbs sleep but not
associated with the above conditions

Prevention of stress ulceration in
seriously ill people

Prevention of recurrent bleeding
from stomach ulcer

Prevention of Mendelson’s
syndrome (aspiration of gastric
contents in pregnant women)
HOW ZANTAC WORKS
ZANTAC belongs to a group of
medicines called H
2
-receptor blockers.
It works by reducing the amount of
acid produced in your stomach.
BEFORE YOU USE ZANTAC
-
_When you must not use it _
Don’t take ZANTAC if you are
allergic (_hypersensitive_) to ranitidine
or any other ingredients of ZANTAC.
If you think this applies to you, don’t
take ZANTAC until you have checked
with your doctor.
-
_Before you start to use it _
Before you take ZANTAC, your
doctor needs to know:

If you have stomach cancer

If you have kidney disease, your
doctor may lower your dose of
ZANTAC

If you have a rare condition called
acute porphyria

If you are over 50 years old

If you have lung disease

If you are diabetic

If you have an

Summary of Product characteristics

CONFIDENTIAL
ZANTAC ®
Ranitidine hydrochloride
QUALITATI VE AND QUANTITATIVE COMPOSITION
For all presentations, ranitidine is present as the hydrochloride salt .
Syrup:
Peppermint flavoured, sugar free syrup, free from artificial colouring. Each 10ml contains
ranitidine 150mg .
Tablets:
150 mg : White, round, film -coated tablet engraved ‘ZANTAC 150’ on one face and
‘GLAXO’ on the other. Each tablet contains ranitidine 150mg .
Injection:
A clear, colourless to pale yellow liquid. Each 2ml contains ranitidine 50mg .
PHARMACEUTICAL FORM
Oral Formulations
Syrup.
Tablets: film -coated .
Parent eral Formulation
Injection.
CLINICAL PARTICULARS
Indications
 Adults/Adolescents (12 years and over)
Oral formulations:
­ 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.
­ Duodenal ulcer associated with Helicobacter pylori infection.