국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
ranitidine hydrochloride, Quantity: 168 mg
Aspen Pharmacare Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; triacetin
Oral
90 tablets (E), 2 tablets (starter pack), 60 tablets, 6 tablets
Not scheduled. Not considered by committee, (S4) Prescription Only Medicine
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 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
Visual Identification: White, film-coated biconvex tablets, engraved on one side with "RAN 150" and plain on the other; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
1995-11-20
ZANTAC ® TABLETS 1 ZANTAC ® TABLETS _Ranitidine hydrochloride _ CONSUMER MEDICINE INFORMATION ABOUT YOUR ZANTAC 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 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 cancer, • you have kidney disease, • you have had stomach u 전체 문서 읽기
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 전체 문서 읽기