País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
ranitidine hydrochloride, Quantity: 16.8 mg/mL (Equivalent: ranitidine, Qty 15 mg/mL)
Aspen Pharmacare Australia Pty Ltd
Oral Liquid
Excipient Ingredients: hypromellose; ethanol; sorbitol solution (70 per cent) (non-crystallising); butyl hydroxybenzoate; saccharin sodium; propyl hydroxybenzoate; sodium chloride; dibasic sodium phosphate; monobasic potassium phosphate; purified water; Flavour
Oral
300mL
(S4) Prescription Only Medicine
Short-term treatment of proven duodenal ulcer and gastric ulcer, including intravenous use for prophylaxis against recurrent haemorrhage: 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 treatment of severe reflux oesophagitis: treatment of scleroderma oesophagitis. The intravenous injection is indicated where oral treatment is inappropriate. 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 syndrom
Visual Identification: Clear pale yellow liquid in the above container.; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1994-03-08
Zantac oral liquid - CMI 1 ZANTAC ORAL LIQUID _ranitidine (as hydrochloride) oral solution _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Zantac oral liquid. It does not contain all of 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 taking Zantac Oral liquid against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ZANTAC ORAL LIQUID IS USED FOR Zantac oral liquid belongs to a group of medicines called H2-antagonists. It 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 or heartburn). Zantac oral liquid is also used to treat: • Zollinger-Ellison disease, • scleroderma oesophagitis. These problems are improved by reducing the amount of acid in the stomach. Zantac oral liquid reduces stomach acid to decrease pain and allow the ulcer and reflux to heal. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ZANTAC ORAL LIQUID HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is not addictive. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE _ _ZANTAC ORAL LIQUID _ DO NOT TAKE ZANTAC ORAL LIQUID IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO RANITIDINE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction may be mild or severe. They usually include some or all of the following: wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash ("hives") or fainting. DO NOT TAKE ZANTAC ORAL LIQUID IF YOU ARE PREGNANT, TRYING TO BECOME PREGNANT OR BREASTFEEDING, UNLESS YOUR DOCTOR SAYS YOU SHOULD. Your doctor will discuss the risks a Leer el documento completo
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 Leer el documento completo