Dr Reddy's Omeprazole

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Omeprazole 20mg;  

Available from:

Dr Reddy's New Zealand Limited

INN (International Name):

Omeprazole 20 mg

Dosage:

20 mg

Pharmaceutical form:

Modified release capsule

Composition:

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

Units in package:

Blister pack, Alu/Alu blisters, 7 capsules

Class:

Pharmacy only

Prescription type:

Pharmacy only

Manufactured by:

Dr Reddy's Laboratories Limited

Product summary:

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

Authorization date:

2010-02-25

Summary of Product characteristics

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