Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
omeprazole, Quantity: 20 mg
Arrotex Pharmaceuticals Pty Ltd
Omeprazole
Tablet, enteric coated
Excipient Ingredients: iron oxide black; microcrystalline cellulose; povidone; iron oxide red; crospovidone; purified talc; lactose monohydrate; hypromellose phthalate; magnesium stearate; triacetin; ascorbyl palmitate
Oral
5 tablets, 30 tablets, 10 tablets
(S4) Prescription Only Medicine
Omeprazole Tablets are indicated for: A. Gastro-Oesophageal Reflux Disease (GORD): 1. Symptomatic GORD: The relief of heartburn and other symptoms associated with GORD. 2. Erosive Oesophagitis: The treatment and prevention of relapse. B. Peptic Ulcers: 1. The treatment of duodenal and gastric ulcer. 2. Combination therapy for the treatment of peptic ulcer disease associated with Heliobacter pylori infection. 3. The treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs. 4. The prevention of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer. 5. Long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be Heliobacter pylori negative, or in whom eradication is inappropriate, e.g. the elderly, or ineffective. C. Zollinger-Ellison Syndrome: The treatment of Zollinger-Ellison Syndrome.
Visual Identification: Red brown, oblong, enteric coated tablets.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2009-05-12
_Omeprazole AN tablets – Consumer Medicine Information _ _ _ _Doc ID: 83.AN.M.1.0 _ _ _ _ _ _Page 1 _ OMEPRAZOLE AN TABLETS _Omeprazole _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Omeprazole 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 Omeprazole 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 OMEPRAZOLE AN IS USED FOR _Peptic Ulcers _ Omeprazole AN is used to treat peptic 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 from the stomach. These ulcers can be caused by too much acid being made in the stomach. Omeprazole AN is also used to help stop peptic or duodenal ulcers coming back. _Peptic _ _Ulcers _ _Associated _ _with _ _Helicobacter pylori Infection _ Most peptic ulcers are caused by an infection with the bacterium Helicobacter pylori in the stomach. _H. _ _pylorus_ weakens the protective mucous coating of the stomach and duodenum, which allows acid to get through to the sensitive lining beneath. Both the acid and the bacteria irritate the lining and cause a sore, or ulcer. When Omeprazole AN is taken together with an antibiotic, the combination will kill _H. pylori_ and let your peptic ulcer heal. _Peptic _ _Ulcers _ _Associated _ _with _ _Non-Steroidal _ _Anti-Inflammatory _ _Drugs (NSAID’s) _ Some peptic ulcers are caused by medicines called non- steroidal anti- inflammatory drugs. These medicines are commonly taken to treat joint disease or arthritis. Omeprazole AN is also used to heal and prevent ulcers associated with NSAIDs. _Reflux Oesophagitis _ Omepraz Lugege kogu dokumenti
_Omeprazole AN tablets Product Information _ _ _ _ _ _ Scentia Pharmaceuticals Pty Ltd _ Doc ID: 83.AN.P.1.2 Page 1 of 12 OMEPRAZOLE AN _ _ _(OMEPRAZOLE TABLETS) _ _ _ PRODUCT INFORMATION _ _ NAME OF THE MEDICINE The name of the medicine is omeprazole. CHEMICAL NAME: 5-methoxy-2-[(_RS_)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]- sulphinyl]-1_H_- benzimidazole MOLECULAR FORMULA: C 17 H 19 N 3 O 3 S MOLECULAR WEIGHT: 345.4 CAS REGISTRY NUMBER: _[73590-58-6] _ DESCRIPTION Omeprazole is a white or almost white powder, very slightly soluble in water, soluble in methylene chloride, sparingly soluble in alcohol and in methanol. It dissolves in dilute solutions of alkali hydroxides. Each tablet contains 20 mg of omeprazole and the following excipients: ascorbyl palmitate, - microcrystalline cellulose, crospovidone, magnesium stearate, povidone, lactose, purified talc, hypromellose phthalate, glycerol triacetate, iron oxide red, iron oxide black. PHARMACOLOGY Omeprazole reversibly reduces gastric acid secretion by specifically inhibiting the gastric enzyme H+, K+-ATPase, the proton pump, in the acid environment of the intracellular canaliculi within the parietal cell. This effect of omeprazole on the final step of the gastric acid formation process is dose dependent and effectively inhibits both basal acid secretion and stimulated acid secretion, irrespective of the stimulus to acid production. Omeprazole has no effect on acetylcholine or histamine receptors. No clinically significant pharmacodynamic effects, other than those explained by the effect on acid secretion, have been observed. _EFFECT ON GASTRIC ACID SECRETION: _Oral dosing with omeprazole 20 mg once daily provides rapid and effective reduction of gastric acid secretion. After a single dose the onset of _Omeprazole AN tablets Product Information _ _ _ _ _ _ Scentia Pharmaceuticals Pty Ltd _ Doc ID: 83.AN.P.1.2 Page 2 of 12 antisecretory effect occurs within one hour and is maximal within two hours. With repeated once daily dosing the maximum effect is usuall Lugege kogu dokumenti