Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
rabeprazole sodium, Quantity: 20 mg
Arrotex Pharmaceuticals Pty Ltd
Rabeprazole sodium
Tablet, enteric coated
Excipient Ingredients: ethylcellulose; iron oxide yellow; mannitol; diethyl phthalate; hypromellose phthalate; sodium starch glycollate type A; light magnesium oxide; magnesium stearate; titanium dioxide; purified talc; povidone
Oral
30
(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 coloured, round, biconvex, delayed release tablet, plain on both sides.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2012-07-09
_PARBEZOL tablets – Consumer Medicine Information _ _ _ _ _ _ _ _Page 1 _ PARBEZOL TABLETS _Rabeprazole sodium _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PARBEZOL tablets. 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 risks of you taking PARBEZOL against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING PARBEZOL ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT PARBEZOL IS USED FOR The name of your medicine is PARBEZOL. It contains the active ingredient rabeprazole sodium. PARBEZOL belongs to a group of medicines called proton pump inhibitors (PPIs). PARBEZOL works by decreasing the amount of acid the stomach makes, to give relief from the symptoms and allow healing to take place. Your food will still be digested in the same way. GASTRO-OESOPHAGEAL REFLUX DISEASE: PARBEZOL is used to treat gastro- oesophageal reflux disease (GORD), commonly known as 'reflux'. 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 to the throat, also known as heartburn. PARBEZOL is also used to help stop gastro- oesophageal reflux disease from coming back or relapsing. PEPTIC ULCERS: PARBEZOL is used to treat 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 ulcers can be caused by too much acid being made in the stomach. Most people who have a peptic ulcer also have bacteria called Helicobacter pylori in their stomach. Your doctor may also prescribe a course of antibiotics (clarithromycin and amoxycillin) for you. When Prečítajte si celý dokument
1 AUSTRALIAN PI – PARBEZOL (RABEPRAZOLE SODIUM) TABLETS 1 NAME OF THE MEDICINE Rabeprazole sodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PARBEZOL tablets are enteric coated tablets containing 10 mg rabeprazole sodium (equivalent to 9.42 mg rabeprazole) or 20 mg rabeprazole sodium (equivalent to 18.85 mg rabeprazole). Rabeprazole sodium is a substituted benzimidazole and belongs to the class of proton pump inhibitors. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM PARBEZOL 10 mg are pink, biconvex tablets blank on both sides. PARBEZOL 20 mg are light yellow, biconvex tablets, blank on both sides. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS PARBEZOL 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. PARBEZOL is also indicated, in combination with clarithromycin and amoxycillin, for: • Eradication of _Helicobacter pylori _in patients with peptic ulcer disease or chronic gastritis 2 • Healing of peptic ulcers in patients with _Helicobacter pylori _associated ulcers. 4.2 D OSE AND METHOD OF ADMINISTRATION PARBEZOL tablets should not be chewed or crushed, but should be swallowed whole. PARBEZOL tablets should be taken at the same time each day to facilitate treatment compliance. Rabeprazole 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 Relapse of Gastro-Oesophageal Reflux Disease (GORD): _The recommended oral dose fo Prečítajte si celý dokument