Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
pantoprazole sodium sesquihydrate, Quantity: 22.57 mg (Equivalent: pantoprazole, Qty 20 mg)
Takeda Pharmaceuticals Australia Pty Ltd
Tablet, enteric coated
Excipient Ingredients: triethyl citrate; povidone; sodium lauryl sulfate; purified water; crospovidone; methacrylic acid copolymer; mannitol; polysorbate 80; propylene glycol; calcium stearate; iron oxide yellow; sodium carbonate; titanium dioxide; hypromellose; butan-1-ol; isopropyl alcohol; iron oxide red; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid
Oral
28 tablets, 5 tablets, 50 tablets, 60 tablets, 15 tablets, 14 tablets, 140 tablets, 100 tablets, 56 tablets, 30 tablets
(S4) Prescription Only Medicine
Adults: 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 to 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: - Clarithromycin and amoxicillin or - Clarithromycin and metronidazole, or - Amoxicillin 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 Dosage & Administration). 4. Pantoprazole in combination with bismuth, metronidazole and tetracycline is indicated for the eradication of Helicobacter pylori associated with peptic ulcer disease with the objective of reducing the recurrence of peptic ulcers caused by this organism. 5. 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. Children aged from 5 to 17 years: Gastro-oesophageal reflux disease (GORD) - Symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD. - Reflux oesophagitis. The treatment duration should not exceed 8 weeks.
Visual Identification: Yellow, oval, biconvex enteric-coated tablets with white to off-white cores. 'P20' printed on one side in brown ink.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2000-04-07
SOMAC ® TABLETS AND GRANULES _pantoprazole sodium sesquihydrate_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Somac. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on this medicine. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Somac 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 SOMAC IS USED FOR ULCERS Somac 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 Somac is taken with antibiotics the combination therapy will kill the Helicobacter pylori and let your ulcer heal. Somac 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 Somac 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. Somac is also us Read the complete document
SOMAC TABLETS AND GRANULES V14.0 (CCDS V9.0) _ _ _ _ _ _ _Page 1 _ AUSTRALIAN PRODUCT INFORMATION SOMAC ® (PANTOPRAZOLE SODIUM SESQUIHYDRATE) TABLETS AND GRANULES 1 NAME OF THE MEDICINE Pantoprazole (as sodium sesquihydrate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SOMAC 20 mg enteric coated tablets, each tablet contains 22.6 mg pantoprazole sodium sesquihydrate equivalent to 20 mg pantoprazole. SOMAC 40 mg enteric coated tablets, each tablet contains 45.1 mg pantoprazole sodium sesquihydrate equivalent to 40 mg pantoprazole. SOMAC 40 mg enteric coated granules, each sachet contains 45.1 mg pantoprazole sodium sesquihydrate equivalent to 40 mg pantoprazole. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM 20 mg enteric coated tablets are yellow and oval shaped, marked with the letter "P20" on one side. 40 mg enteric coated tablets are yellow and oval shaped, marked with the letter "P40" on one side. 40 mg granules are pale yellowish to dark brownish in colour 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) o Symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD o 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 SOMAC TABLETS AND GRANULES V14.0 (CCDS V9.0) _ _ _ _ _ _ _Page 2 _ 3. For eradication of _ Helicobacter pylori_, treatment with pantoprazole and one of the following combinations of antibiotics: • Clarit Read the complete document