Ranitidine 150mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

RANITIDINE

Available from:

Accord Healthcare Limited

ATC code:

A02BA02

INN (International Name):

RANITIDINE

Pharmaceutical form:

FILM-COATED TABLET

Composition:

RANITIDINE 150 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Authorization status:

Authorised

Authorization date:

2013-03-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
RANITIDINE 150 MG FILMCOATED TABLETS
RANITIDINE 300 MG FILM-COATED TABLETS
RANITIDINE
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 Ranitidine is and what it is used for
2.
What you need to know before you take Ranitidine
3.
How to take Ranitidine
4.
Possible side effects
5.
How to store Ranitidine
6.
Contents of the pack and other information
1.
WHAT RANITIDINE IS AND WHAT IT IS USED FOR
Ranitidine
film-coated
tablets
are
a
gastrointestinal
medicine
(a
medicine
to
treat
gastrointestinal diseases) containing ranitidine. It belongs to the
group known as histamine H2
antagonists, which inhibit the production of stomach acid.
Ranitidine film-coated tablets are used to treat diseases of the
stomach and duodenum in which
a reduction in the production of gastric acid is required:
-
Duodenal ulcer.
-
Benign gastric ulcer.
-
Long term treatment of duodenal ulcers (150 mg only).
-
Reflux oesophagitis (inflammation of the oesophagus as a result of
regurgitation of
stomach contents).
-
Zollinger-Ellison Syndrome (a disease in which the stomach produces
too much acid).
Ranitidine film-coated tablets are used in Children from 3 to 18 years
• Short-term treatment of peptic ulcer
• Treatment of gastroesophageal reflux, including reflux
oesophagitis, and relief of the
symptoms of gastroesophageal reflux disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RANITIDINE
DO NOT TAKE RANITIDINE TABLETS
-
If you are allergic (hypersensitive) to ranitidi

Summary of Product characteristics

Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ranitidine 150 mg film-coated tablets.
Ranitidine 300 mg film-coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Ranitidine 150 mg film-coated tablets.
Each tablet contains 167,5 mg ranitidine hydrochloride equivalent to
150 mg ranitidine.
Excipient with known effect: Each film-coated tablet contains 1.520 mg
castor oil
Ranitidine 300 mg film-coated tablets.
Each tablet contains 335,0 mg ranitidine hydrochloride, equivalent to
300 mg ranitidine.
Excipient with known effect: Each film-coated tablet contains 3.040 mg
castor oil
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Ranitidine 150 mg film-coated tablets.
Creamish yellow, round, biconvex, film-coated tablets having
approximately 10 mm diameter
with the inscription "IL" on one side and plain on the other side.
Ranitidine 300 mg film-coated tablets.
Creamish yellow, round, biconvex, film-coated tablets having
approximately 12.5 mm
diameter with the inscription "II" on one side and plain on the other
side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
RANITIDINE 150 MG TABLETS
Page 2 of 11
- Duodenal ulcer
- Benign gastric ulcer
- Long-term treatment of duodenal ulcers
- Reflux oesophagitis
- Zollinger-Ellison syndrome.
Children from 3 to 18 years
• Short-term treatment of peptic ulcer
• Treatment of gastroesophageal reflux, including reflux
oesophagitis and symptomatic relief
of gastroesophageal reflux disease.
RANITIDINE 300 MG TABLETS
- Duodenal ulcer
- Benign gastric ulcer
- Reflux oesophagitis
- Zollinger-Ellison syndrome
Children from 3 to 18 years
• Short-term treatment of peptic ulcer
• Treatment of gastroesophageal reflux, including reflux
oesophagitis and symptomatic relief
of gastroesophageal reflux disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
RANITIDINE 150 MG TABLETS
The tablets with some liquid to swallow. It is not necessary to take
tablets with meals.
ADULTS (INCLUDING THE ELDERLY)/ADOLESCENT