Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
rabeprazole sodium, Quantity: 20 mg
Medis Pharma Pty Ltd
Rabeprazole sodium
Tablet, enteric coated
Excipient Ingredients: iron oxide yellow; propylene glycol; povidone; sodium lauryl sulfate; magnesium stearate; titanium dioxide; methacrylic acid - ethyl acrylate copolymer (1:1); mannitol; light magnesium oxide; purified talc; hyprolose; polysorbate 80; ethylcellulose
Oral
30 tablets
(S4) Prescription Only Medicine
Rabeprazole is indicated for: ,? treatment and prevention of relapse of gastro-oesophageal reflux disease ,? symptomatic treatment of gastro-oesophageal reflux disease ,? treatment of duodenal ulcers ,? treatment of gastric ulcers. ,Patients whose gastric and duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (NSAIDs) usually require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence.,Rabeprazole is also indicated, in combination with clarithromycin and amoxycillin, for: ,? eradication of Helicobacter pylori in patients with peptic ulcer disease or chronic gastritis ,? healing of peptic ulcers in patients with Helicobacter pylori associated ulcers.
Visual Identification: Yellow, elliptical, biconvex shaped tablet with no markings; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2013-03-06
Zabep/180215/CMI-08 1 ZABEP 20 _contains the active ingredient rabeprazole sodium _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ZABEP 20. 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 benefits and risks. Your doctor has weighed the risks of you taking ZABEP 20 against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. WHAT ZABEP 20 IS USED FOR ZABEP 20 is used to: treat reflux oesophagitis or reflux disease. This can be caused by food and acid from the stomach flowing the wrong way (reflux) back up the food pipe, also known as the oesophagus. Reflux can cause a burning sensation in the chest rising up the throat, also known as heartburn. help stop reflux oesophagitis from coming back or relapsing treat peptic ulcers. Depending on the position of the ulcer it is called a gastric or duodenal ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out of the stomach. These ulcers can be caused by too much acid being made in the stomach. Most people who have a peptic ulcer also have a bacteria called Helicobacter pylori in their stomach. Your doctor may also prescribe a course of antibiotics (clarithromycin and amoxicillin) for you. When ZABEP 20 is taken with antibiotics, the combination therapy will kill the Helicobacter pylori and let your ulcer heal. The presence of the bacteria Helicobacter pylori may cause the stomach to become inflamed, resulting in pain, nausea and vomiting. When ZABEP 20 is taken with antibiotics, they will help kill Helicobacter pylori and allow the stomach to heal. ZABEP 20 belongs to a group of medicines called proton pump inhibitors (PPIs). ZABEP 20 works by decreasing the amount of acid the stomach makes, to give relief from the sympto Lesen Sie das vollständige Dokument
ZABEP 20 – Product information Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION - ZABEP 20 (RABPRAZOLE SODIUM) 1. NAME OF THE MEDICINE Rabeprazole sodium. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ZABEP 20 enteric coated tablets contain 20 mg of rabeprazole sodium. The tablets also contain povidone, hydroxypropyl cellulose, magnesium oxide, mannitol, magnesium stearate, ethylcellulose, methacrylic acid - ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, propylene glycol, iron oxide yellow, titanium dioxide and purified talc. The tablets are gluten free. 3. PHARMACEUTICAL FORM Rabeprazole sodium 20 mg enteric-coated tablet; Yellow, elliptical, biconvex shaped tablet with no markings. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ZABEP 20 is indicated for: treatment and prevention of relapse of gastro-oesophageal reflux disease symptomatic treatment of gastro-oesophageal reflux disease treatment of duodenal ulcers treatment of gastric ulcers. Patients whose gastric and duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (NSAIDs) usually require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. ZABEP 20 is also indicated, in combination with clarithromycin and amoxycillin, for: eradication of _Helicobacter pylori_ in patients with peptic ulcer disease or chronic gastritis healing of peptic ulcers in patients with _Helicobacter pylori_ associated ulcers. 4.2 DOSE AND METHOD OF ADMINISTRATION Rabeprazole sodium tablets should not be chewed or crushed, but should be swallowed whole. Rabeprazole sodium tablets should be taken at the same time each day to facilitate treatment compliance. Rabeprazole sodium was taken with or without food in the pivotal clinical trials. ADULTS Treatment of active gastro-oesophageal reflux disease (GORD) The recommended oral dose for this condition is one 20 mg tablet to be taken once daily for four to eight weeks. Prevention of rel Lesen Sie das vollständige Dokument