ZANTAC Ranitidine 300mg (as hydrochloride) effervescent tablet (New formulation)

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ranitidine hydrochloride, Quantity: 336 mg (Equivalent: ranitidine, Qty 300 mg)

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Tablet, effervescent

Composition:

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

Administration route:

Oral

Units in package:

4 in foil strips sample pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

1. Short-term treatment of provenduodenal ulcer and gastric ulcer, including intravenous use for prophylaxis against recurrent haemorrhage. 2. Maintenance treatment to reduce the risk of relapse in duodenal ucler. 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 MJG" on one side and flat on the other; Container Type: Strip Pack; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1993-12-21

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