国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
pantoprazole sodium sesquihydrate, Quantity: 22.7 mg (Equivalent: pantoprazole, Qty 20 mg)
Arrotex Pharmaceuticals Pty Ltd
Pantoprazole sodium sesquihydrate
Tablet, enteric coated
Excipient Ingredients: sodium hydroxide; hypromellose; colloidal anhydrous silica; macrogol 6000; sodium carbonate; mannitol; crospovidone; sodium starch glycollate; calcium stearate; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate
Oral
5, 30
(S4) Prescription Only Medicine
1. For symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: i) Duodenal ulcer; ii) Gastric ulcer; iii) Gastro-oesophageal reflux disease (GORD): Symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD; Reflux oesophagitis; iv) Gastrointestinal lesions refractory H2 blockers; v) Zollinger-Ellison Syndrome. Patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (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. 3. Prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in increased risk patients with a need for continuous non-selective NSAID treatment.
Visual Identification: Yellow, oval, biconvex enteric-coated tablets, plain on both sides.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-10-15
PANTOPRAZOLE APOTEX TABLETS 1 PANTOPRAZOLE APOTEX TABLETS _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 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 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 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 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 inflammation, including arthritis (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 sensation in the chest rising up to the throat, also known as heartburn. Pantoprazole is also used to prevent reflux oesophagitis from coming back. ZOLLINGER-ELLISON SYNDROME Pantoprazole is used to treat a rare condition called Zollinger-Ellison syndr 完全なドキュメントを読む
1 AUSTRALIAN PRODUCT INFORMATION PANTOPRAZOLE APOTEX TABLETS (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 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. EXCIPIENT OF KNOWN EFFECT: soya bean products. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM PANTOPRAZOLE APOTEX Tablets 20 mg (AUST R 213715) and PANTOPRAZOLE APOTEX Tablets 40 mg (AUST R 213716) are yellow to pale yellow, oval, biconvex enteric- coated tablets, plain on both sides. 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. 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. 2 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. If a two week period of treat 完全なドキュメントを読む