Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
omeprazole, Quantity: 20 mg
Medis Pharma Pty Ltd
Omeprazole
Tablet, enteric coated
Excipient Ingredients: sodium stearate; Carnauba Wax; sodium stearylfumarate; hypromellose; iron oxide yellow; hypromellose acetate succinate; titanium dioxide; lactose monohydrate; triethyl citrate; purified talc; monoethanolamine; sodium lauryl sulfate; iron oxide red; propylene glycol; sodium starch glycollate
Oral
30 tablets
(S4) Prescription Only Medicine
Gastroesophageal reflux disease (GORD). Symptomatic GORD: The relief of heartburn and other symptoms associated with GORD. . Erosive oesophagitis: The treatment and prevention of relapse. . Peptic ulcers: The treatment of duodenal and gastric ulcer. . Combination therapy for the treatment of peptic ulcer disease associated with H. pylori infection. . The treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs. . 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. . Long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be H. pylori negative, or in whom eradication is inappropriate, e.g. the elderly or ineffective. . Zollinger-Ellison syndrome: The treatment of Zollinger-Ellison syndrome
Visual Identification: Brownish, capsule-shaped film coated tablets with a debossment of "20" on one side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2011-12-08
OZMEP ENTERIC-COATED TABLETS _contains the active ingredient omeprazole _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Ozmep. 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 Ozmep against the benefits expected 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 OZMEP IS USED FOR PEPTIC ULCERS Ozmep tablets are used to treat peptic ulcers and also to help prevent them from coming back. These ulcers can be caused by the stomach producing too much acid. Depending on the location of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach and a duodenal ulcer occurs in the tube leading out of the stomach, also known as the duodenum. PEPTIC ULCERS ASSOCIATED WITH HELICOBACTER PYLORI INFECTION Most people with a peptic ulcer have been found to have the bacteria Helicobacter pylori in their stomach. Ozmep taken together with two antibiotics will kill the bacteria and let your ulcer heal. It is possible that the antibiotics may not always kill Helicobacter pylori. PEPTIC ULCERS ASSOCIATED WITH NON-STEROIDAL ANTI- INFLAMMATORY DRUGS (NSAIDS) Some peptic ulcers are caused by taking medicines known as non-steroidal anti- inflammatory drugs. These medicines are commonly taken to treat arthritis and other inflammatory conditions. Ozmep can be used to heal and prevent ulcers associated with NSAIDs. REFLUX OESOPHAGITIS Ozmep is used to treat and prevent the symptoms of reflux oesophagitis. This condition is caused by the washing back, or reflux, of food and acid from the stomach into the oesophagus. Symptoms include a burning sensation in the chest rising up to the throat, also known as heartburn. ZOLLINGER-ELLISON SYNDROME Ozmep is used to treat this rare conditi Izlasiet visu dokumentu
AUSTRALIAN PRODUCT INFORMATION - OZMEP (OMEPRAZOLE) ENTERIC-COATED TABLETS 1. NAME OF THE MEDICINE Omeprazole 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ozmep enteric-coated tablets contain 20mg of omeprazole. Excipients with known effect: Contains sugars as lactose. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS 3. PHARMACEUTICAL FORM Ozmep 20mg enteric-coated tablets are brown capsule-shaped tablets debossed with “20” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) • _Symptomatic GORD: _ The relief of heartburn and other symptoms associated with GORD. • _Erosive oesophagitis: _ The treatment and prevention of relapse. PEPTIC ULCERS • The treatment of duodenal and gastric ulcer. • Combination therapy for the treatment of peptic ulcer disease associated with _H. pylori_ infection. • The treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti- inflammatory drugs. • 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. • Long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be _H. pylori_ negative, or in whom eradication is inappropriate, e.g. the elderly or ineffective. ZOLLINGER-ELLISON SYNDROME The treatment of Zollinger-Ellison syndrome. _ Ozmep 20 mg tablets _ _Product Information _ _ _ Ozmep PI Sept 21 Page 2 of 18 4.2 DOSE AND METHOD OF ADMINISTRATION Ozmep tablets must be swallowed whole (not broken, halved or chewed) with liquid. Ozmep is only available as 20 mg strength. For 10 mg dosing, other brands of omeprazole available as the 10 mg strength should be used. ADULTS _SYMPTOMATIC GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) _ Recommended dose for symptom relief is omeprazole 10 to 20mg once daily for a maximum of four weeks. In most patients symptom relief is rapid. If symptom c Izlasiet visu dokumentu