Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
omeprazole, Quantity: 20 mg
Southern Cross Pharma 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
10 Tablets, 5 Tablets, 30 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
2015-03-24
CONSUMER MEDICINE INFORMATION OMEPRAZOLE GENERICHEALTH (OMEPRAZOLE) ENTERIC-COATED TABLET WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Omeprazole generichealth. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Omeprazole generichealth 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 OMEPRAZOLE GENERICHEALTH IS USED FOR _PEPTIC ULCERS _ Omeprazole generichealth is 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. Omeprazole generichealth 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 nonsteroidal anti-inflammatory drugs. These medicines are commonly taken to treat arthritis and other inflammatory conditions. Omeprazole generichealth can be used to heal and prevent ulcers associated with NSAIDs. _REFLUX OESOPHAGITIS _ Omeprazole generichealth 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 burnin Baca dokumen lengkap
AUSTRALIAN PRODUCT INFORMATION – OMEPRAZOLE GENERICHEALTH (OMEPRAZOLE) ENTERIC-COATED TABLETS 1 NAME OF THE MEDICINE Omeprazole. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient in Omeprazole generichealth 20 mg enteric-coated tablets is omeprazole. Each tablet contains 20 mg of omeprazole. List of excipients with known effects: sugars as lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Red brown, oblong, enteric -coated tablet. 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 _Helicobacter 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 _Helicobacter pylori _negative, or in whom eradication is inappropriate, eg. the elderly or ineffective. ZOLLINGER-ELLISON SYNDROME The treatment of Zollinger-Ellison syndrome. Omeprazole generichealth v2.2 Page 2 of 18 (omeprazole) enteric-coated tablets 4.2 DOSE AND METHOD OF ADMINISTRATION _Omeprazole generichealth tablets must be swallowed whole (not broken, halved or chewed) with liquid. _ _Omeprazole generichealth 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 om Baca dokumen lengkap