Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
pantoprazole sodium sesquihydrate, Quantity: 45.2 mg (Equivalent: pantoprazole, Qty 40 mg)
Arrotex Pharmaceuticals Pty Ltd
Pantoprazole sodium sesquihydrate
Tablet, enteric coated
Excipient Ingredients: crospovidone; methacrylic acid copolymer; sodium carbonate; titanium dioxide; macrogol 8000; magnesium stearate; iron oxide yellow; lactose; triethyl citrate; purified talc; hypromellose; microcrystalline cellulose
Oral
30, 500, 100
(S4) Prescription Only Medicine
Symptomatic improvement and healing of the following gastrointestinal diseases which require a reduction in acid secretion. - Duodenal ulcer. - Gastric ulcer. - Gastroesophageal reflux disease (GORD). Symptomatic GORD: the treatment of heartburn and other symptoms associated with GORD. - Reflux oesophagitis. - Gastrointestinal lesions refractory to H 2-blockers. - Zollinger-Ellison syndrome.. Patients whose gastric or duodenal ulceration is not associated with ingestion of NSAIDs require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence.. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis.. Prevention of gastroduodenal lesions and dyspeptic symptoms associated with nonselective NSAIDs in increased risk patients with a need for continuous nonselective NSAID treatment.
Visual Identification: Yellow, oval, biconvex, enteric-coated tablets engraved "APO" on one side and "40" on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2009-12-09
APO-PANTOPRAZOLE TABLETS 1 APO-PANTOPRAZOLE TABLETS _Contains the active ingredient, pantoprazole (as sodium sesquihydrate)_ _ _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ _ _ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about pantoprazole. 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 using this medicine 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 made in the stomach. Pantoprazole may also be used to prevent ulcers associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs). These are medicines used to relieve pain, swelling and other symptoms of This medicine is available only with a doctor's prescription. This medicine is not addictive. There is not enough information to recommend the use of this medicine in children. BEFORE YOU TAKE THIS MEDICINE against the benefits they expect it inflammation, including arthritis will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may want to read it again. WHAT THIS MEDICINE IS USED FOR Pantoprazole belongs to a group of medicines called proton pump inhibitors (PPIs). PPIs work by decreasing the amount of acid the stomach makes, to give relief from the symptoms and allow healing to take place. ULCERS Pantoprazole is used to treat and help heal duodenal and gastric 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 (inflammation of the joints). REFLUX DISEASE Pantoprazole is used to 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 se Прочетете целия документ
1 AUSTRALIAN PRODUCT INFORMATION APO-PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) TABLETS 1 NAME OF THE MEDICINE Pantoprazole (as sodium sesquihydrate). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each enteric coated tablet contains 20 mg or 40 mg pantoprazole (as sodium sesquihydrate) as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Lactose For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 20 MG TABLETS Yellow, oval, biconvex, enteric-coated tablets engraved “APO” on one side, “20” on the other side. 40 MG TABLETS Yellow, oval, biconvex, enteric-coated tablets engraved “APO” on one side, “40” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: • Duodenal ulcer • Gastric ulcer • Gastro-oesophageal reflux disease (GORD) – Symptomatic GORD: the treatment of heartburn and other symptoms associated with GORD – Reflux oesophagitis • Gastrointestinal lesions refractory to H 2 -blockers • Zollinger-Ellison syndrome _Patients whose gastric or duodenal ulceration is not associated with ingestion of NSAIDs _ _require treatment with antimicrobial agents in addition to antisecretory drugs whether on first _ _presentation or on recurrence. _ 2. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 2 3. Prevention of gastroduodenal lesions and dyspeptic symptoms associated with nonselective NSAIDs in increased risk patients with a need for continuous nonselective NSAID treatment. 4.2 DOSE AND METHOD OF ADMINISTRATION The enteric coated tablets are intended for oral administration. Pantoprazole tablets should not be chewed or crushed, but swallowed whole with a little water. DOSAGE DUODENAL ULCER Pantoprazole 40 mg (one tablet) should be given once a day. In most patients, freedom from symptoms is achieved rapidly and healing generally occurs within two weeks. Прочетете целия документ