RANITIC TABLET 150MG

Country: Malaysia

Language: English

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

Active ingredient:

RANITIDINE HYDROCHLORIDE

Available from:

IMEKS PHARMA SDN. BHD.

INN (International Name):

RANITIDINE HYDROCHLORIDE

Units in package:

100Tablet Tablets; 50Tablet Tablets; 60 Tablet Tablets

Manufactured by:

Salutas pharma GmbH

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
RANITIC
® TABLET
Ranitidine hydrochloride (150mg)
WHAT IS IN THIS LEAFLET
1.
What Ranitic
®
is used for
2.
How Ranitic
®
works
3.
Before you use Ranitic
®
4.
How to use Ranitic
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Ranitic
®
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
WHAT RANITIC
® IS USED FOR
Ranitic
®
contains the active ingredient
Ranitidine hydrochloride.
Ranitic
®
is used in:
• Prevention and management of duodenal
and stomach ulcers
• Management of Zollinger – Ellison
syndrome (a rare condition where the
stomach produces very large amounts of
acids)
• Management of reflux oesophagitis
(inflammation of oesophagus accompanied
by the regurgitating of stomach acid)
• Management of people at risk of stress –
related ulceration
HOW RANITIC
® WORKS
Ranitidine hydrochloride belongs to a group
of medicines called H
2
-receptor antagonist.
Ranitidine works by reducing the amount of
acid produced in the stomach, relieving the
pain and allows the ulcers or reflux disease
to heal.
BEFORE YOU USE RANITIC
®
_- When you must not use it_
• Have ever had any allergic reactions or
been told that you are allergic to Ranitidine
hydrochloride, the active ingredients or to
any of the other ingredients listed in this
leaflet.
_- Before you start to use it_
Tell your doctor if you:
• Have allergies to any other medicines,
food, preservatives or dyes
• Suffer from stomach cancer
• Have any kidney disease
• Suffer from acute porphyria (hereditary
disorder that affect the nervous system)
• Are pregnant, planning to become pregnant
or are breastfeeding
If you are not sure whether you should start
taking this medicine, consult your doctor.
_- Taking other medicines_
Some medicines and Ranitic
®
may
interfere with each other. It is important to
tell your doctor or pharmacist if you are
taking:
• Sucralfate, used to treat ulcers
• Procainamide or N-acetylprocainamide ,

Summary of Product characteristics

P
LEASE READ CAREFULLY!
DIRECTIONS FOR USE
Ranitic ® 150
Film‐Coated Tablets
DESCRIPTIONS
RANITIC® 150 TABLET: Yellow, round, biconvex tablet with score notch
on
one side. Each tablet contains 150mg of ranitidine
.
INDICATIONS
-
Prophylaxis and management of duodenal and gastric ulcers
-
Management of Zollinger‐Ellison syndrome
-
Management of reflux oesophagitis
-
Management of patient at risk of stress related ulceration
RECOMMENDED DOSAGES
DUODENAL ULCER AND BENIGN GASTRIC ULCERS
Take 150mg twice daily or 300mg at bedtime. Ulcer should heal within
four weeks. In cases where the ulcer is not fully healed after four
weeks,
treatment should be continued for another four weeks. The usual dosage
for long term management of duodenal ulcer and benign gastric ulcers
is
150mg at
bedtime.
ZOLLINGER‐ELLISON SYNDROME
The initial dosage regimen for Zollinger‐Ellison syndrome is 150mg
three
times a day, but this may be increased as necessary. Doses up to
6g/day
have been reported as well tolerated.
GASTRO‐OESOPHAGEAL REFLUX DISEASE
Acute reflux Gastro‐oesophageal
Take
150mg
twice
daily
or
300mg
at
bedtime.
Treatment
should
be
continued for 8 weeks, or if necessary, up to 12 weeks
MODERATE TO SEVERE GASTRO‐OESOPHAGEAL
Take
150mg
two
to
four
times
a
day
for
up
to
12
weeks.
The
recommended dosage for long term management of reflux oesophagitis is
150mg twice a day.
STRESS RELATED ULCER
Take 150mg twice a day.
RENAL IMPAIRMENT
For
patients
with
creatinine
clearance
<50ml/min,
daily
dosage
used
should be 75mg (half of 150mg) twice daily. For patient with
creatinine
clearance >50ml/min, daily dosage used should be 150mg twice daily.
Ranitidine is dialyzable. Therefore, with dialysis patient the
recommended
dose should be administered only after the dialysis.
PAEDIATRIC
In general, this patient group should not be treated with Ranitic®
150
tablet. The drug should be administered only in cases where the use of
ranitidine is absolutely indicated, and should be restricted to
short‐term
treatment only. The daily dos