ZANTAC Ranitidine 150mg (as hydrochloride) effervescent tablet

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:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Tablet, effervescent

Composition:

Excipient Ingredients: sodium benzoate; povidone; sodium bicarbonate; monosodium dihydrogen citrate; aspartame; Flavour

Administration route:

Oral

Units in package:

10, 30, 60 in polypropylene tubes

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Short term treatment of proven duodenal 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. Treatment of scleroderma oesophagitis. NEW INDICATIONS AS AT 2 NOVEMBER 1993: 1. Short-term treatment of proven duodenal ulcer and gastric ulcer, including intravenous use for prophylaxis against recurrent haemorrhage. 2. Maintenance treatment to reduce the risk of relapse in duodenal ulcer. 3. Maintenance treatment for periods up to one year to reduce the risk of relapse in patients with documented healing of benign gastric ulcer. 4. Treatment of gastrinoma (Zollinger-Ellison syndrome). 5. Short- term symptomatic treatment of reflux oesophagitis unresponsive to conservative anti-reflux measures and siomple drug therapies such as antacids. 6. Treatment of scleroderma oesophagitis. The intravenous injection is indicated where oral treatment is inappropriate. INDICATIONS AS AT 31 OCTOBER 1995: Short-term treatment of proven duodenal ulcer and gastric ulcer, including intravenous use for prophylaxis against recurrent haemorrhage. 2. Maintenance treatment to reduce the risk of relapse in duodenal ulcer. 3. Maintenance treatment for periods up to one year to reduce the risk of relapse in patients with documented healing of benign gastric ulcer. 4. Treatment of gastrinoma (Zollinger-Ellison syndrome). 5. Short-term symptomatic treatment of reflux oesophagitis unresponsive to conservative anti-reflux measures and simple drug therapies such as antacids. 6. Maintenance treatment to reduce the risk of relapse of reflux oesophagitis. 7. Treatment of scleroderma oesophagitis. The intravenous injection is indicated where oral treatment is inappropriate.

Product summary:

Visual Identification: White to pale yellow, round, bevelled tablets marked "GS LHK" on one side and flat on the other.; Container Type: Tube; Container Material: PP; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1993-09-23

Patient Information leaflet

ZANTAC
®
EFFERVESCENT TABLETS
1
ZANTAC
® EFFERVESCENT
TABLETS
_ranitidine (as hydrochloride) _
CONSUMER MEDICINE INFORMATION
ABOUT YOUR ZANTAC
EFFERVESCENT TABLETS
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU TAKE YOUR MEDICINE.
This leaflet does not have the
complete information available about
your medicine. If you have any
questions about your medicine, you
should ask your doctor or pharmacist
(also known as chemist).
All medicines have some risks.
Sometimes new risks are found even
when a medicine has been used for
many years.
If there is anything you do not
understand, ask your doctor or
pharmacist. If you want more
information, ask your doctor or
pharmacist.
WHAT IS IN MY ZANTAC?
The medicine in your Zantac
effervescent tablets is called
ranitidine (as hydrochloride). This
belongs to a group of medicines
called H2-antagonists.
WHAT DOES MY ZANTAC
DO?
Zantac is mostly used to:
•
treat stomach and duodenal ulcer
disease (also known as peptic
ulcer),
•
stop these ulcers from coming
back,
•
treat reflux oesophagitis (also
known as reflux).
These problems are caused, in part,
by too much acid in the stomach.
This can lead to pain such as
heartburn. Zantac works by reducing
the amount of acid in the stomach.
This reduces the pain and also allows
the ulcer and reflux to heal.
Zantac is also used to treat:
•
Zollinger-Ellison disease,
•
scleroderma oesophagitis.
BEFORE YOU TAKE IT
_DO NOT TAKE IF: _
You must not take Zantac if:
•
you have ever had an allergic
(hypersensitive) reaction to
ranitidine or any of the
ingredients listed towards the end
of this leaflet.
•
the expiry date (EXP) printed on
the pack has passed.
•
the packaging is torn or shows
signs of tampering.
_TELL YOUR DOCTOR IF: _
You must tell your doctor if:
•
you are allergic to foods, dyes,
preservatives or any other
medicines.
•
you have ever had an allergic
(hypersensitive) reaction to
ranitidine or any of the
ingredients listed towards the end
of this leaflet.
•
you are allergic to any medicine,
•
you have stomach canc

Summary of Product characteristics

Zantac ranitidine (as hydrochloride) PI
Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION
ZANTAC
RANITIDINE (AS HYDROCHLORIDE)
TABLETS, DISPERSIBLE TABLETS, EFFERVESCENT TABLETS, ORAL LIQUID AND
INJECTION
1.
NAME OF THE MEDICINE:
Ranitidine hydrochloride.
2. AND 3. QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL
FORM
Zantac 150 mg tablets are white film-coated tablets engraved “RAN
150” on one face and plain on the other.
The tablets contain 150 mg ranitidine (as hydrochloride).
Zantac 300 mg tablets are white capsule-shaped, film-coated tablets
engraved “RAN 300” on one face and
plain on the other. The tablets contain 300 mg ranitidine (as
hydrochloride).
Zantac 150 mg dispersible tablets are white, capsule-shaped,
film-coated tablets with a breakline on one
face. The tablets contain 150 mg ranitidine (as hydrochloride). These
tablets also contain saccharin sodium
as an excipient.
Zantac 150 mg effervescent tablets are white to pale yellow, round,
bevelled tablets debossed “GS LHK” on
one side and flat on the other. The tablets contain 150 mg of
ranitidine (as hydrochloride). Each 150 mg
tablet contains 328 mg (14.3 mEq) sodium, as well as aspartame and
sodium benzoate as excipients.
Zantac 300 mg effervescent tablets are white to pale yellow, round,
bevelled tablets debossed “GS MJG” on
one side and flat on the other. The tablets contain 300 mg of
ranitidine (as hydrochloride). Each 300 mg
tablet contains 479 mg (20.8 mEq) sodium, as well as aspartame and
sodium benzoate as excipients.
Zantac oral liquid is a clear pale yellow liquid containing 150 mg
ranitidine (as hydrochloride) in each 10 mL.
It
also
contains
butyl
hydrozybenzoate,
propyl
hydroxybenzoate,
ethanol
and
saccharin
sodium
as
excipients.
Zantac injection is a clear colourless to pale yellow liquid,
practically free from visible particles containing
50 mg ranitidine (as hydrochloride) in 2 mL ampoules.
For the full list of excipients, see Section 6.1 List of excipients.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
Sh