País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
omeprazole, Quantity: 20 mg
Pharmacor Pty Ltd
Omeprazole
Capsule
Excipient Ingredients: purified water; titanium dioxide; quinoline yellow; Gelatin; sodium lauryl sulfate; dibasic sodium phosphate; mannitol; hypromellose; macrogol 6000; purified talc; polysorbate 80; methacrylic acid copolymer; maize starch; sucrose
Oral
7,14,15,28,30,50,56,60,90,98,100,140,280,&500
(S4) Prescription Only Medicine
The relief of heartburn and other symptoms associated with GORD. The treatment and prevention of relapse in erosive oesophagitis. 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. The treatment of Zollinger-Ellison syndrome.
Visual Identification: Opaque yellow cap an body, No 2 hard gelatin capsules, containing off-white (ivory) to cream-white spherical microgranules; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2009-07-07
October 2019 OMEPRO-GA CAPSULES OMEPRAZOLE CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about Omepro-GA. It does not contain all the information that is known about Omepro-GA. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking Omepro-GA 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 OMEPRO-GA IS USED FOR REFLUX OESOPHAGITIS Omepro-GA is used to treat the symptoms of reflux oesophagitis or reflux disease. This can be caused by "washing back" (reflux) of food and acid from the stomach into the food pipe (oesophagus). Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn. Omepro-GA is also taken to help stop reflux oesophagitis coming back or relapsing. PEPTIC ULCERS Omepro-GA 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. Omepro-GA is also used to help stop gastric or duodenal ulcers coming back. PEPTIC ULCERS ASSOCIATED WITH _HELICOBACTER PYLORI_ INFECTION Most people who have a peptic ulcer also have a bacterium called _Helicobacter pylori_ in their stomach. When Omepro-GA is taken with antibiotics, they work to kill the bacterium and let your ulcer heal. You may need further treatment with antibiotics. PEPTIC ULCERS ASSOCIATED WITH NON- STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) Some peptic ulcers are caused by taking medicines called non-steroidal anti-inflammatory drugs (NSAIDs), a type of medicine used to treat pain or inflammation. Omepro-GA is also used to heal and Leia o documento completo
1 AUSTRALIAN PRODUCT INFORMATION – OMEPRO-GA (OMEPRAZOLE) CAPSULE 1 NAME OF THE MEDICINE Omeprazole 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains omeprazole 20mg Excipients with known effect Gelatin, sucrose For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Opaque yellow cap and body No 2 hard gelatin capsules containing enteric coated off-white (ivory) to cream-white spherical microgranules. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS OMEPRO-GA is indicated for: 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. Peptic Ulcers 1. The treatment of duodenal and gastric ulcer. 2. Combination therapy for the treatment of peptic ulcer disease associated with Helicobacter pylori infection. 3. The treatment of gastric and duodenal ulcers and erosions associated with non-steroidal antiinflammatory drugs. 4. The prevention of gastric and duodenal ulcers and erosions associated with non-steroidal antiinflammatory drugs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer. 2 5. Long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be Helicobacter pylori negative, or in whom eradication is inappropriate, e.g. the elderly or ineffective. Zollinger-Ellison Syndrome The treatment of Zollinger-Ellison Syndrome. 4.2 D OSE AND METHOD OF ADMINISTRATION Dosage OMEPRO-GA should be swallowed whole (not broken or chewed) with liquid. It should be noted that OMEPRO-GA is only available in 20 mg. Symptomatic GORD Recommended dose for symptom relief: Omeprazole 10 mg to 20 mg once daily for a maximum of four weeks. In most patients, symptom relief is rapid. If symptom control has not been achieved after four weeks treatment with OMEPRO-GA 20 mg daily, further investigation is recommended. Erosive oesophagitis Recommended healing dosage: Omepra Leia o documento completo