APO-RANITIDNE ranitidine 300mg (as hydrochloride) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ranitidine hydrochloride, Quantity: 335.8 mg (Equivalent: ranitidine, Qty 300 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Ranitidine hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: polydextrose; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; vanillin; Carnauba Wax; titanium dioxide; hypromellose

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

DUODENAL ULCER: Short-term treatment of proven duodenal ulcer, maintenance treatment to reduce the risk of relapse in duodenal ulcer. GASTRIC ULCER: Short-term treatment of proven gastric ulcer, maintenance treatment for periods up to one year to reduce the risk of relapse in patients with documented healing of benign gastric ulcer. REFLUX OESOPHAGITIS: Short-term symptomatic treatment of reflux oesophagitis unresponsive to conservative antireflux measures and simple drug therapies such as antacids. Maintenance treatment to reduce risk of relapse of reflux oesophagitis. SCLERODERMA OESOPHAGITIS: Treatment of scleroderma oesophagitis. ZOLLINGER-ELLISON SYNDROME: Treatment of gastrinoma (Zollinger-Ellison syndrome).

Product summary:

Visual Identification: White to off white, capsule-shaped, biconvex film-coated tablets. Scored on one side and engraved "RAN 300" on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2006-11-01

Patient Information leaflet

APO-RANITIDINE
_Ranitidine (as hydrochloride)_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about ranitidine. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Ranitidine tablets. It contains the
active ingredient ranitidine (as
hydrochloride).
It is used to treat:
•
Duodenal ulcer
•
Gastric ulcer
•
Reflux oesophagitis
•
Scleroderma oesophagitis
•
Zollinger-Ellison syndrome
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
Ranitidine belongs to a group of
medicines called H2 antagonists or
H2 blockers.
Ranitidine works by decreasing the
amount of acid made by the stomach.
This helps reduce pain and also
allows an ulcer and/or reflux disease
to heal in most people.
There is no evidence that this
medicine is addictive.
_USE IN CHILDREN_
Experience with ranitidine
preparations in children is limited
and such use has not been fully
evaluated in clinical studies. It has,
however, been used successfully in
children aged 8 to 18 years in doses
up to 150 mg twice daily.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
Do not take this medicine if:
•
You are hypersensitive to, or
have had an allergic reaction to,
ranitidine or any of the
ingredients listed at the end of
this leaflet.
•
The expiry date (EXP) printed on
t

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO- RANITIDINE (RANITIDINE HYDROCHLORIDE)
TABLETS
1
NAME OF THE MEDICINE
Ranitidine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains ranitidine 150 mg or 300 mg.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Ranitidine 150 mg tablets
White to off-white, round, biconvex tablets. Scored on one side and
engraved “RAN” over “150”
on the other side.
Ranitidine 300 mg tablets
White to off-white, capsule-shaped, biconvex tablets. Scored on one
side and engraved “RAN
300” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DUODENAL ULCER
Short-term treatment of proven duodenal ulcer.
Maintenance treatment to reduce the risk of relapse in duodenal ulcer.
GASTRIC ULCER
Short-term treatment of proven gastric ulcer.
Maintenance treatment for periods up to one year to reduce the risk of
relapse in patients with
documented healing of benign gastric ulcer.
REFLUX OESOPHAGITIS
Short-term symptomatic treatment of reflux oesophagitis unresponsive
to conservative antireflux
measures and simple drug therapies such as antacids.
Maintenance treatment to reduce the risk of relapse of reflux
oesophagitis.
SCLERODERMA OESOPHAGITIS
Treatment of scleroderma oesophagitis.
ZOLLINGER-ELLISON SYNDROME
Treatment of gastrinoma (Zollinger-Ellison syndrome).
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO- Ranitidine tablets are intended for oral administration.
DOSAGE
It is not necessary to time the ranitidine dose in relation to meals.
ACUTE DUODENAL ULCERATION
Acute Treatment
300 mg taken orally as a single dose at bedtime, or 150 mg taken
orally twice a day, in the
morning and at bedtime. In most cases healing will occur in four weeks
although a small
number of patients may require an additional two to four weeks of
therapy.
Maintenance Treatment
150 mg taken at night.
As smoking is associated with a higher rate of relapse of duodenal
ulcer, patients should be
advised to stop smoking. In patients unable to stop