Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
pantoprazole sodium, Quantity: 22.557 mg
Sun Pharma ANZ Pty Ltd
Pantoprazole sodium
Tablet, enteric coated
Excipient Ingredients: purified talc; microcrystalline cellulose; sodium carbonate; sodium lauryl sulfate; iron oxide yellow; titanium dioxide; triethyl citrate; mannitol; crospovidone; hyprolose; methacrylic acid - ethyl acrylate copolymer (1:1); calcium stearate; hypromellose; propylene glycol; povidone; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid
Oral
30 tablets
(S4) Prescription Only Medicine
1. For symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion i.e for duodenal ulcer, gastric ulcer, gastro-oesophageal reflux disease (GORD) including - symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD; - reflux oesophagitis; gastrointestinal lesions refractory to H2 blockers, and Zollinger-Ellison Syndrome. Patients whose gastric or duodenal ulceration is not associated with ingestion of nonsteroidal 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 coloured, enteric coated, oval shaped, biconvex tablet printed with 'II' on one side and plain on other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2009-07-13
Ozpan CMI V3 Sep 2019 Page 1 of 9 OZPAN PANTOPRAZOLE ENTERIC-COATED TABLETS CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about OZPAN (PANTOPRAZOLE ENTERIC-COATED TABLETS 20/40 MG). It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from https://www.ebs.tga.gov.au/ and may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you taking pantoprazole against the benefits it is expected to 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 OZPAN IS USED FOR The name of your medicine is OZPAN. It contains the active ingredient pantoprazole. ULCERS OZPAN 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 OZPAN is taken with antibiotics the combination therapy will kill the Helicobacter pylori and let your ulcer heal. Ozpan CMI V3 Sep 2019 Page 2 of 9 OZPAN 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 OZPAN is also used to treat reflux oesophagitis or reflux disease. This can be caused by “washing back” (refl Belgenin tamamını okuyun
Ozpan PI V6 Aug 2022 Page 1 of 26 AUSTRALIAN PRODUCT INFORMATION OZPAN (PANTOPRAZOLE ENTERIC-COATED TABLETS) 1. NAME OF MEDICINE Pantoprazole sodium sesquihydrate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of OZPAN contains Pantoprazole sodium sesquihydrate equivalent to 20mg or 40mg of Pantoprazole. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS . 3. PHARMACEUTICAL FORM OZPAN 20 mg tablets are available as yellow-coloured, enteric-coated oval-shaped, biconvex tablets imprinted with ‘ II ’ in black ink on one side and plain on other side. OZPAN 40 mg tablets are available as yellow coloured, enteric-coated oval shaped, biconvex tablets imprinted with ‘ IV ’ in black ink on one side and plain on other side. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS OZPAN is indicated for: 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 Ozpan PI V6 Aug 2022 Page 2 of 26 Gastrointestinal lesions refractory to H2 blockers Zollinger-Ellison Syndrome Patients whose gastric or duodenal ulceration is not associated with ingestion of nonsteroidal 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. 4.2. DOSE AND METHOD OF ADMINISTRATION OZPAN tablets should not be chewed or crushed but swallowed whole with a little water. In _H. pylori_ negative patients, the following dosage guid Belgenin tamamını okuyun