Country: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
pantoprazole sodium sesquihydrate
Apotex Pty Ltd
Pantoprazole sodium sesquihydrate
Registered
APOTEX-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 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 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 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. Most people who have a peptic ulcer also have bacteria called Helicobacter pylori in their stomach. When pantoprazole is taken with antibiotics, the combination therapy will kill the Helicobacter pylori and let your ulcer heal. 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 সম্পূর্ণ নথি পড়ুন
1 AUSTRALIAN PRODUCT INFORMATION APOTEX-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. For eradication of _ Helicobacter pylori_, treatment with pantoprazole and one of the following combinations of antibiotics: • clarithromycin and amoxycillin or • clarithromycin and metronidazole or • amoxycillin and metronidazole is recommended in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism (see section 4.2 DOSE AND METHOD OF ADMINISTRATION). 4. Pantoprazole in combination with bismuth, metronidazole and tetracycline is indicated for the era সম্পূর্ণ নথি পড়ুন