Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
pantoprazole sodium sesquihydrate
Amneal Pharma Australia Pty Ltd
Pantoprazole sodium sesquihydrate
Registered
_Pantoprazole AN tablets – Consumer Medicine Information _ _ _ Pantoprazole AN CMI v1.0 _ _ _ _ _ _ Page 1_ _ PANTOPRAZOLE AN TABLETS _Pantoprazole (as sodium sesquihydrate) enteric coated tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PANTOPRAZOLE AN. 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 PANTOPRAZOLE AN 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 PANTOPRAZOLE AN IS USED FOR The name of your medicine is PANTOPRAZOLE AN. It contains the active ingredient called pantoprazole. It belongs to a group of medicines called proton pump inhibitors (PPIs). PANTOPRAZOLE AN works by decreasing the amount of acid the stomach makes to give relief from the symptoms and allow healing to take place. ULCERS PANTOPRAZOLE AN 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. PANTOPRAZOLE AN 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 AN is also 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 AN is also used to prevent reflux oesophagitis from Soma hati kamili
_ _ _ _ _ _ _Pantoprazole AN tablets Product Information _ _ _ _ Amneal Pharma Australia Pty Ltd _ Pantoprazole AN PI v3.0 Page 1 of 13 PANTOPRAZOLE AN _ _ _(PANTOPRAZOLE SODIUM SESQUIHYDRATE ENTERIC-COATED TABLETS) _ _ _ PRODUCT INFORMATION NAME OF THE MEDICINE The name of the medicine is Pantoprazole sodium (as pantoprazole sodium sesquihydrate). Chemical name: Sodium 5-(difluoromethoxy)-2-[(RS)-[(3,4-dimethoxypyridin- 2-yl)methyl]sulphinyl]benzimidazol-1-ide sesquihydrate CAS No: 164579-32-2 Molecular formula: C 16 H 14 F 2 N 3 NaO 4 S,1.5H 2 0 MW (sodium salt x 1.5 H 2 O):432.4 DESCRIPTION Each Pantoprazole AN 40mg enteric coated tablet contains 45.10mg of pantoprazole sodium sesquihydrate equivalent to 40mg of pantoprazole. Each Pantoprazole AN 20mg enteric coated tablet contains 22.55mg pantoprazole sodium sesquihydrate equivalent to 20mg of pantoprazole. Pantoprazole is a substituted benzimidazole which inhibits basal and stimulated gastric secretion. It is a white to off white crystalline powder. Freely soluble in water and in ethanol (96 per cent), practically insoluble in hexane. Solubility is low at neutral pH and increases with increasing pH. In addition to pantoprazole sodium sesquihydrate, these tablets also contain mannitol, sodium carbonate, sodium starch glycollate, crospovidone, colloidal anhydrous silica, calcium stearate, hypromellose, macrogol 6000, sodium hydroxide, EUDRAGIT L30-D55 and OPADRY AMB Aqueous Moisture Barrier Coating System 80W52172 Yellow. Pantoprazole AN tablets are gluten free. PHARMACOLOGY PHARMACODYNAMICS: Pantoprazole is a proton pump inhibitor. It inhibits specifically and dose-proportionately H + /K + - ATPase, the enzyme which is responsible for gastric acid secretion in the parietal cells of the stomach. _ _ _ _ _ _ _Pantoprazole AN tablets Product Information _ _ _ _ Amneal Pharma Australia Pty Ltd _ Pantoprazole AN PI v3.0 Page 2 of 13 The substance is a substituted benzimidazole which accumulates in the acidic environment of the parietal cells after absorption. Ther Soma hati kamili