ZANTAC TABLET 150MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

RANITIDINE

Boleh didapati daripada:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

RANITIDINE

Unit dalam pakej:

60Tablet Tablets; 60 Tablets

Dikeluarkan oleh:

GLAXO WELLCOME S.A.

Risalah maklumat

_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
ZANTAC TABLET/SYRUP
_ _
Ranitidine (150 mg, 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 any problems with your
immu

Ciri produk

CONFIDENTIAL
ZANTAC
Ranitidine hydrochloride
QUALITATIVE 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, film-coated, biconvex tablets, engraved on one side with “GX EC2” and plain 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.
Parenteral 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.
- Post-operative ulcer.
- Reflux oesophagitis.