Pajjiż: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
ranitidine hydrochloride
Sandoz Pty Ltd
Registered
RANITIDINE SANDOZ ® 1 RANITIDINE SANDOZ ® _ranitidine hydrochloride film-coated tablets _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Ranitidine Sandoz. 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 risk of you taking 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 THE MEDICINE. You may need to read it again. WHAT RANITIDINE SANDOZ IS USED FOR This medicine is used to treat: • Treat stomach and duodenal ulcer disease (also known as peptic ulcers). Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out of the stomach. These can be caused in part by too much acid being produced in the stomach. Ranitidine Sandoz is also used to help stop these ulcers from coming back. • Stop these ulcers from coming back • Treat reflux oesophagitis or reflux disease. This can be caused by "washing back" (reflux) of food and acid from the stomach into the food pipe, also known as the oesophagus. Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn. • Treat Zollinger-Ellison syndrome, a rare condition where the stomach produces very large amounts of acid, much more than in ulcers and reflux disease. • Treat Scleroderma oesophagitis. Scleroderma is a rare condition, and in scleroderma oesophagitis the food pipe is abnormal and reflux occurs. It contains the active ingredient ranitidine hydrochloride. Ranitidine hydrochloride belongs to a group of medicines called H2 antagonists or H2 blockers. It works by decreasing the amount of acid made by the stomach. This helps to reduce the pain and also allows the ulcer and/or re Aqra d-dokument sħiħ
181220-Ranitidine Sandoz-pi Page 1 of 9 AUSTRALIAN PRODUCT INFORMATION RANITIDINE SANDOZ (RANITIDINE HYDROCHLORIDE) TABLETS 1. NAME OF THE MEDICINE Ranitidine hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Ranitidine Sandoz 150 mg tablets contains 150 mg ranitidine hydrochloride. Each Ranitidine Sandoz 300 mg tablets contains 300 mg ranitidine hydrochloride. List of excipients with known effect: lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Ranitidine Sandoz 150 mg Tablets: yellow, round, film-coated tablets, scored on one side. Ranitidine Sandoz 300 mg Tablets: yellow, oblong, film-coated tablets, scored on one side. 4. CLINICAL PARTICULARS T HERAPEUTIC INDICATIONS • Short-term treatment of proven duodenal ulcer 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. • Maintenance treatment to reduce the risk of relapse of reflux oesophagitis. • Treatment of scleroderma oesophagitis. D OSE AND METHOD OF ADMINISTRATION DOSAGE _Duodenal or gastric ulceration _ _Acute treatment._ 300 mg taken as a single dose at bedtime, or 150 mg taken twice daily, in the morning and at bedtime. It is not necessary to time the dose in relation to meals. 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_ . Duodenal ulcer: 150 mg taken at night. As smoking is associated with a higher rate of ulcer relapse, patients should be advised to stop smoking. In patients unable to stop smoking, a dose of 300 mg at night provides additional therapeutic benefit. Aqra d-dokument sħiħ