Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
RANITIDINE AS HYDROCHLORIDE
GLAXO SMITH KLINE (ISRAEL) LTD
A02BA02
SYRUP
RANITIDINE AS HYDROCHLORIDE 150 MG / 10 ML
PER OS
Required
ASPEN BAD OLDESLOE GMBH, GERMANY
RANITIDINE
RANITIDINE
Adults:Zantac syrup is indicated for the treatment of duodenal ulcer and benign gastric ulcer, including that associated with non-steroidal anti-inflammatory agents. Zantac syrup is also indicated for the treatment of post-operative ulcer, Zollinger-Ellison Syndrome and oesophageal reflux disease including long term management of healed oesophagitis. Zantac syrup is indicated for the following conditions where reduction of gastric secretion and acid output is desirable; the prophylaxis of gastro-intestinal haemorrhage from stress ulceration in seriously ill patients and before general anaesthesia in patients considered to be at risk of acid aspiration (Mendelson's Syndrome), particularly obstetric patients during labour. Children (3 to 18 years):Short term treatment of peptic ulcer. Treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease.
2013-03-31
Patient leaflet in accordance with the Pharmacists' Regulations (Preparations) – 1986 The medicine is dispensed according to a physician’s prescription only Zantac Syrup Each 10 ml of syrup contains 150 mg Ranitidine (as Hydrochloride) For the list of inactive and allergenic ingredients, see section 2 - “Important information about some of the ingredients of the medicine” and section 6 - “Additional information”. Read the entire leaflet carefully before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the physician or the pharmacist. This medicine has been prescribed for you or for your child. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. What is the medicine intended for? Adults: Zantac Syrup is indicated for the treatment of duodenal ulcer and benign gastric ulcer, including ulcer that is caused by treatment with non-steroidal anti-inflammatory agents. Zantac Syrup is also indicated for the treatment of post-operative ulcer, Zollinger-Ellison Syndrome and oesophageal reflux disease including long-term management of healed oesophagitis. Zantac Syrup is indicated for conditions where reduction of gastric secretion is desirable; the prophylaxis of gastro-intestinal haemorrhage from stress ulceration in seriously ill patients and before general anaesthesia in patients considered to be at risk of acid aspiration (Mendelson’s Syndrome), particularly in obstetric patients during labour. Children (3 to 18 years): Short term treatment of peptic ulcer. Treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease. Therapeutic group Zantac Syrup contains a medicine called ranitidine. This belongs to a group of medicines called H 2 -receptor antagonists. 2. Before using the medicine Do not use the medicine if: ∙ you or your child is sensitive (allergic) to ranitidine or to any of the other ingredients Lesen Sie das vollständige Dokument
_Page 1 of 11 _ _ _ ZANTAC SYRUP 1. NAME OF THE MEDICINAL PRODUCT Zantac Syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 ml of syrup contains Ranitidine Hydrochloride 168.0 mg (Equivalent to Ranitidine 150.0 mg) Each 10 ml of syrup also contains the following excipients: - 800 mg ethanol - 1.5 mg propyl Parahydroxybenzoate - 0.75 mg butyl Parahydroxybenzoate - 1000 mg Sorbitil Liquid (Non-crystallising) For the full list of excipients, see section 6.1 The preparation contains: Ethanol (96%) The amount of ethanol per bottle (300 ml): 24 grams The amount of ethanol in every 10 ml:800 mg The concentration of ethanol in the preparation: approximately 7.5% w/v 3. PHARMACEUTICAL FORM Syrup 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults: Zantac syrup is indicated for the treatment of duodenal ulcer and benign gastric ulcer, including that associated with non-steroidal anti-inflammatory agents. Zantac syrup is also indicated for the treatment of post-operative ulcer, Zollinger-Ellison Syndrome and oesophageal reflux disease including long term management of healed oesophagitis. Zantac syrup is indicated for the following conditions where reduction of gastric secretion and acid output is desirable; the prophylaxis of gastro-intestinal haemorrhage from stress ulceration in seriously ill patients and before general anaesthesia in patients considered to be at risk of acid aspiration (Mendelson's Syndrome), particularly obstetric patients during labour. For appropriate cases Zantac injection is also available (see separate Physician Leaflet). _Page 2 of 11 _ _ _ Children (3 to 18 years): Short term treatment of peptic ulcer. Treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease. See section 4.4 Special warnings and precautions for use. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults (including the elderly) The usual dosage is 150 mg twice daily, taken in the morning and evening. Alternatively, patients with duodenal ulc Lesen Sie das vollständige Dokument