Ranitic 150 mg Film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

RANITIDINE HYDROCHLORIDE

Available from:

Rowex Ltd

ATC code:

A02BA; A02BA02

INN (International Name):

RANITIDINE HYDROCHLORIDE

Dosage:

150 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

H2-receptor antagonists; ranitidine

Authorization status:

Marketed

Authorization date:

1998-02-10

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
RANITIC 150 MG & 300 MG FILM-COATED TABLETS
RANITIDINE (AS 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 Ranitic is and what it is used for
2. What you need to know before you take Ranitic
3. How to take Ranitic
4. Possible side effects
5. How to store Ranitic
6. Contents of the pack and other information.
1
WHAT RANITIC IS AND WHAT IT IS USED FOR
Ranitidine belongs to a group of medicines called histamine (H2)
antagonists. These medicines
reduce the amount of acid in your stomach.
THIS MEDICINE IS USED:
For adults
- to heal ulcers in the stomach or duodenum
- to prevent the recurrence of ulcers in the stomach or duodenum (when
they are a side effect of
some medicines)
- to treat inflammation of the gullet (oesophagus) caused by reflux of
gastric acid (reflux
oesophagitis usually with heartburn)
- to treat a disease in which the stomach produces too much acid
(Zollinger-Ellison syndrome)
- to treat other conditions where reduction of acid in the stomach is
likely to be beneficial
- to treat post-operative ulcer.
For children (3 to 18 years)
- for the short term treatment of ulcers in the stomach or duodenum
- to treat inflammation of the gullet (oesophagus) caused by reflux of
gastric acid (reflux
oesophagitis usually with heartburn).
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RANITIC
DO NOT TAKE RANITIC:
• if you are allergic to ranitidine or any of the other ingredients
of this medicine (listed in section 6).
WARNINGS AND

Summary of Product characteristics

Health Products Regulatory Authority
17 December 2019
CRN0097YZ
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ranitic 150 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains ranitidine hydrochloride equivalent
to 150 mg ranitidine.
Excipients with known effect: also includes 3.1 mg lactose (as
monohydrate) and a maximum of 0.27 mg sodium per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
White to pale yellow, round, film-coated and bi-convex tablets with a
one-sided score-notch. The scoreline is only to facilitate
breaking for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of 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. Also indicated for the
treatment of reflux oesophagitis, post-operative ulcer,
Zollinger-Ellison Syndrome and other conditions where reduction of
gastric acid secretion is likely to be beneficial.
Children (3 to 18 years)

Short term treatment of peptic ulcers

Treatment of gastro-oesophageal reflux, including reflux oesophagitis
and symptomatic relief of
gastrooesophageal reflux disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of Administration: Oral.
ADULTS (INCLUDING THE ELDERLY) /ADOLESCENT (12 YEARS AND OVER):
The usual initial dosage is 150 mg twice daily or 300 mg at night.
This may be increased to ranitidine 300 mg twice daily,
without an increased incidence of unwanted effects. Subsequently a
maintenance dose of 150 mg at night may be used.
Smoking is associated with a higher rate of ulcer relapse and such
patients should be advised to stop smoking. In those who
fail to comply with such advice, a dose of 300 mg at night provides
additional ther