Страна: Австралія
мова: англійська
Джерело: 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
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
2015-08-24
APO-OMEPRAZOLE 1 APO-OMEPRAZOLE _Contains the active ingredient omeprazole _ CONSUMER MEDICINE INFORMATION For a copy of a large print leaflet, Ph: 1800 195 055 WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about omeprazole. 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 last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Omeprazole. It contains the active ingredient omeprazole. It is used to treat: • REFLUX OESOPHAGITIS Omeprazole 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. Omeprazole is also used to help stop reflux oesophagitis coming back or relapsing. • PEPTIC ULCERS Omeprazole 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 is a Прочитайте повний документ
1 AUSTRALIAN PRODUCT INFORMATION APO-OMEPRAZOLE (OMEPRAZOLE) ENTERIC COATED TABLETS 1 NAME OF THE MEDICINE Omeprazole. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each enteric-coated tablet contains 20 mg omeprazole as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT 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 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 _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, e.g. the elderly or ineffective. ZOLLINGER-ELLISON SYNDROME The treatment of Zollinger-Ellison syndrome. 2 4.2 DOSE AND METHOD OF ADMINISTRATION APO-Omeprazole enteric-coated tablets are intended for oral administration. They must be swallowed whole (not broken or chewed) with liquid. DOSAGE APO-Omeprazole is only available as 20 mg enteric coated tablet which must not be broken. For 10 mg dosing, another brand of omeprazole with a 10 mg dose strength should be used. SYMPTOMATIC GORD Recommended dose for symptom relief: omeprazole 10–20 mg once daily for a maximum of 4 weeks. In most patients symptom relief is rapid. If symptom control has not been achieved after 4 weeks treatment Прочитайте повний документ