RANI 2 ranitidine 150mg (as hydrochloride) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ranitidine hydrochloride, Quantity: 168 mg (Equivalent: ranitidine, Qty 150 mg)

Available from:

Alphapharm Pty Ltd

INN (International Name):

Ranitidine hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; hypromellose; Castor Oil; iron oxide yellow; titanium dioxide; purified talc

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Indicated for short-term treatment of proven duodenal ulcer and gastric ulcer; Maintenance treatment to reduce the risk of relapse in duodenal ulcer; Maintenance treatment for periods up to one year to reduce the risk of relapse in patients with documented healing of benign gastric ulcer; Treatment of gastrinoma (Zollinger-Ellison Syndrome); Short-term symptomatic treatment of reflux oesophagitis unresponsive to conservative anti-reflux measures and simple drug therapies such as antacids; Maintenance treatment to reduce the risk of relapse of reflux oesophagitis; Treatment of scleroderma oesophagitis.

Product summary:

Visual Identification: Creamish yellow, biconvex, round, film-coated tablets with "G" on one side and "00" over "30" on the reverse; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-06-29

Patient Information leaflet

RANI 2
_contains the active ingredient ranitidine hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Rani 2.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Rani 2 against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT RANI 2 IS USED
FOR
Rani 2 is used to:
•
treat stomach and duodenal ulcers
(duodenal ulcers occur in the tube
leading out of the stomach).
•
prevent stomach and duodenal
ulcers from coming back.
•
treat and prevent reflux
oesophagitis (also known as
reflux), which is the washing
back of food and acid from the
stomach up into the food pipe.
Reflux can cause heartburn, a
painful burning sensation which
occurs in the chest and rises up to
the throat.
•
treat Zollinger-Ellison syndrome,
a rare disorder where the stomach
produces very large amounts of
acid, much more than in ulcers
and reflux disease.
•
treat scleroderma oesophagitis, a
rare condition in which the food
pipe becomes thick and hardened,
allowing acid to reflux.
Rani 2 belongs to a group of
medicines called histamine2 (H2)
antagonists or histamine2 (H2)
blockers. These medicines work by
reducing the amount of acid
produced by the stomach. This helps
to heal the ulcer and/or reflux
disease.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY RANI 2 HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Rani 2 for another reason.
Rani 2 is not recommended for use in
children under the age of 8, as there
have been limited studies of its
effects in children of this age group.
There is no evidence that Rani 2 is
addictive.
BEFORE YOU TAKE RANI 2
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE RANI 2 IF YOU ARE
ALLERGIC TO MEDICINES CONTAINING
RANITIDINE OR A

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
RANI 2
_Ranitidine hydrochloride _
1
NAME OF THE MEDICINE
Ranitidine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Rani 2 tablet contains ranitidine hydrochloride as the active
ingredient equivalent to 150 mg or 300 mg
of ranitidine. For the full list of excipients, see Section 6.1 LIST
OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Rani 2 150 mg: Creamish yellow, biconvex, round, film-coated tablets
with ”G” on one side and “00” over
“30” on the reverse.
Rani 2 300 mg: Creamish yellow, biconvex, capsule shaped, film-coated
tablets with “G” on one side and
“0031” on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short-term treatment of proven duodenal ulcer and gastric ulcer.
Maintenance treatment to reduce the risk of relapse in duodenal ulcer.
Maintenance treatment for periods up to one year to reduce the risk of
relapse in patients with documented
healing of benign gastric ulcer.
Treatment of gastrinoma (Zollinger-Ellison syndrome).
Short-term symptomatic treatment of reflux oesophagitis unresponsive
to conservative anti-reflux measures
and simple drug therapies such as antacids.
Maintenance treatment to reduce the risk of relapse of reflux
oesophagitis.
Treatment of scleroderma oesophagitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
ACUTE DUODENAL OR GASTRIC ULCERATION
_ACUTE TREATMENT _
300 mg taken as a single dose at bedtime, or 150 mg taken twice daily,
in the morning and at bedtime.
It is not necessary to time the dose in relation to meals. In most
cases healing will occur in four weeks although
a small number of patients may require an additional two to four weeks
therapy.
_MAINTENANCE TREATMENT OF DUODENAL ULCER _
150 mg taken at night. As smoking is associated with a higher rate of
ulcer relapse, patients should be advised
to stop smoking. In patients unable to stop smoking, a dose of 300 mg
at night provides additional therapeutic
benefit.
RANI 2 – PRODUCT INFORMATION
2
_MAINTENANCE TREATMENT OF GASTRIC ULCER _
150 mg taken at ni