Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
pantoprazole sodium sesquihydrate, Quantity: 22.56 mg (Equivalent: pantoprazole, Qty 20 mg)
Alphapharm Pty Ltd
Pantoprazole sodium sesquihydrate
Tablet, enteric coated
Excipient Ingredients: mannitol; crospovidone; hypromellose; macrogol 6000; sodium carbonate; sodium starch glycollate; colloidal anhydrous silica; sodium hydroxide; calcium stearate; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin; purified water; polysorbate 80; methacrylic acid copolymer; sodium lauryl sulfate
Oral
5, 100, 50, 28, 15, 30, 140, 56, 60, 14
(S4) Prescription Only Medicine
1. 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. For eradication of Helicobacter pylori, treatment with pantoprazole and one of the following combinations of antibiotics:,i) Clarithromycin and amoxicillin or ii) Clarithromycin and metronidazole or iii) Amoxicillin and metronidazole,is recommended in cases
Visual Identification: Yellow to light 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 30 degrees Celsius
Registered
2010-02-17
PANTOPRAZOLE MYL _pantoprazole_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PANTOPRAZOLE MYL. 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 PANTOPRAZOLE MYL 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 THE MEDICINE. You may need to read it again. WHAT PANTOPRAZOLE MYL IS USED FOR The name of your medicine is PANTOPRAZOLE MYL. It contains the active ingredient pantoprazole. ULCERS PANTOPRAZOLE MYL 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 MYL is taken with antibiotics, the combination therapy will kill the Helicobacter pylori and let your ulcer heal. PANTOPRAZOLE MYL may 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 MYL 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 MYL is also used to prevent reflux oesophagitis from coming back. ZOLLINGER-ELLISON SYNDROME PANTOPRAZOLE MYL is used to treat a rare condition called read_full_document
AUSTRALIAN PRODUCT INFORMATION PANTOPRAZOLE MYL _pantoprazole (as sodium sesquihydrate) _ 1 NAME OF THE MEDICINE Pantoprazole (as sodium sesquihydrate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each PANTOPRAZOLE MYL 20mg enteric coated tablet contains 22.56 mg pantoprazole sodium sesquihydrate equivalent to 20mg of pantoprazole. Each PANTOPRAZOLE MYL 40mg enteric coated tablet contains 45.12 mg of pantoprazole sodium sesquihydrate equivalent to 40mg of pantoprazole. EXCIPIENTS WITH KNOWN EFFECT PANTOPRAZOLE MYL also contains traces of soya bean products. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM PANTOPRAZOLE MYL 20 mg enteric-coated tablets are yellow to light yellow, _oval _ shaped, biconvex enteric coated tablets plain on both sides. PANTOPRAZOLE MYL 40 mg enteric-coated tablets are yellow to light yellow, _oval _ shaped, biconvex enteric coated tablets plain on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS 1. Symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: • duodenal ulcer • gastric ulcer • gastro-oesophageal reflux disease (GORD): i. symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD ii. reflux oesophagitis • gastrointestinal lesions refractory to H 2 blockers • 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. For eradication of _Helicobacter pylori_ , treatment with pantoprazole and one of the following combinations of antibiotics: PANTOPRAZOLE MYL – PRODUCT INFORMATION 2 • clarithromycin and amoxicillin or • clarithromycin and metronidazole or • amoxicillin and metronidazo read_full_document