Land: Neuseeland
Sprache: Englisch
Quelle: Medsafe (Medicines Safety Authority)
Omeprazole 20mg;
Dr Reddy's New Zealand Limited
Omeprazole 20 mg
20 mg
Modified release capsule
Active: Omeprazole 20mg Excipient: Crospovidone Gelatin Hypromellose Isopropyl alcohol Magnesium stearate Mannitol Meglumine Methacrylic acid - ethyl acrylate copolymer Opacode black S-1-27794 Poloxamer Povidone Purified water Triethyl citrate
Blister pack, Alu/Alu blisters, 7 capsules
Pharmacy only
Pharmacy only
Dr Reddy's Laboratories Limited
Package - Contents - Shelf Life: Blister pack, Alu/Alu blisters - 7 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, Alu/Alu blisters - 14 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, Alu/Alu blisters - 28 capsules - 36 months from date of manufacture stored at or below 25°C
2010-02-25
NEW ZEALAND DATASHEET 1 PRODUCT NAME Dr Reddy’s Omeprazole 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Omeprazole 20 mg capsules 3 PHARMACEUTICAL FORM Omeprazole capsules 20 mg: hard gelatine size 2 capsules with a light grey opaque body printed with "R158" in black ink, and a purple opaque cap printed with "Omeprazole 20 mg" in black ink. Each capsule contains omeprazole 20 mg as enteric coated pellets. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Dr Reddy’s Omeprazole capsules are for the short-term relief of gastric reflux-like symptoms in sufferers aged 18 years and over. 4.2 Dose and method of administration Dr Reddy’s Omeprazole capsules are recommended to be given in the morning and swallowed whole with half a glass of water. The contents of the capsule should not be chewed or crushed. For patients with swallowing difficulties the capsule can be opened and the contents swallowed directly with half a glass of liquid or after mixing the contents in a slightly acidic fluid e.g. fruit juice, yoghurt or in non carbonated water. The dispersion should be taken immediately or within 30 minutes. Alternatively patients can suck the capsule and swallow the pellets with liquid. The pellets must not be chewed or crushed. REFLUX OESOPHAGITIS The recommended dosage is one Dr Reddy’s Omeprazole capsule 20 mg once daily. Symptom resolution is rapid and in most patients healing occurs within 4 weeks. The maximum daily dose should not exceed 20 milligrams. IMPAIRED RENAL FUNCTION Dose adjustment is not needed in patients with impaired renal function. IMPAIRED HEPATIC FUNCTION As bioavailability and plasma half-life of omeprazole are increased in patients with impaired hepatic function a daily dose of 10 - 20 mg may be sufficient. ELDERLY Dose adjustment is not needed in the elderly. 4.3 Contraindications Known hypersensitivity to omeprazole. 4.4 Special warnings and precautions for use Dr Reddy’s Omeprazole 20 mg capsules are for short-term use only, except on medical advice. Do not use the medicine for any pu Lesen Sie das vollständige Dokument