HEALEY PHARMA (UK) LIMITED
HEALEY PHARMA (UK) LIMITED
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OMEPRAZOLE 20 MG Capsules
COMPOSITION:
Each capsule contains omeprazole 20 mg
PHARMACOLOGICAL ACTION:
Orally administered omeprazole is well absorbed but to a variable extent. Absorption of omeprazole takes place in the small intestine and is usually completed within three to six hours. Bioavailability depends on dose and gastric pH and may reach 70% with repeated administration. Food has no influence on the bioavailability of omeprazole.
Omeprazole is more than 95% bound to plasma proteins. Clearance from the circulation is by hepatic metabolism with a plasma half-life of 30 to 90 minutes.
INDICATIONS:
OMEZ is indicated in:
Adults
| • | Treatment of duodenal ulcer, including prevention of relapse gastric ulcer and reflux oesophagitis. |
| • | Long-term management of reflux oesophagitis and Zollinger-Ellison Syndrome. |
| • | Symptomatic relief of heartburn in patients with gastro-oesophageal reflux disease (GORD) and the short-term relief of functional dyspepsia. |
| • | Helicobacter pylori-positive duodenal ulcers as part of an eradication programme with appropriate antibiotics. |
| • | Treatment of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric and/or duodenal ulcer/erosions. |
| • | Reduction of the risk to develop gastric and/or duodenal ulcer/erosions and reduction of the risk of relapse for previously healed gastric and/or duodenal ulcer/erosions in patients on NSAID treatment. |
Children
| Short-term (up to 3 months) treatment of severe ulcerative reflux oesophagitis resistant to previous medical treatment. |
CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients
Safety in pregnancy and lactation has not been established.
WARNINGS:
Symptomatic response to OMEZ therapy does not preclude the presence of gastric ulcer or malignancy or a malignant disease of the oesophagus. The administration of OMEZ in this situation may delay diagnosis .
Hepatic impairment may require a reduction in dose .
THERE IS VERY LIMITED EXPERIENCE WITH THE USE OF OMEZ IN CHILDREN.
THE LONG-TERM SAFETY OF OMEZ IN PATIENTS WITH RENAL AND/OR HEPATIC IMPAIRMENT HAS NOT BEEN ESTABLISHED.
THIS MEDICINE MAY LEAD TO DROWSINESS AND IMPAIRED CONCENTRATION THAT MAY BE AGGRAVATED BY THE SIMULTANEOUS INTAKE OF ALCOHOL OR OTHER CENTRAL NERVOUS SYSTEM DEPRESSANTS. PATIENTS SHOULD BE ADVISED, PARTICULARLY AT THE INITIATION OF THERAPY, AGAINST TAKING CHARGE OF VEHICLES OR MACHINERY OR PERFORMING POTENTIALLY HAZARDOUS TASKS WHERE LOSS OF CONCENTRATION COULD LEAD TO ACCIDENTS.
PREGNANCY AND LACTATION
Safety in pregnancy and lactation has not been established.
DOSAGE AND DIRECTIONS FOR USE:
OMEZ is recommended to be given in the morning and swallowed whole with a half glass of liquid. The capsules should not be chewed or crushed.
Adults: The usual dose is 20 mg once daily.For Zollinger-Ellison Syndrome 60 mg once daily.
Children:10 –20 kg:. 10 mg once daily..
>20 kg: 20 mg once daily.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Blood and lymphatic system disorders
Rare: Leucopenia, thrombocytopenia, agranulocytosis, pancytopenia
Endocrine disorders
Rare: Gynaecomastia
Metabolic and nutritional disorders
Rare: Hyponatraemia
Psychiatric disorders
Rare: Reversible mental confusion, agitation, aggression, depression and hallucinations
Nervous system disorders
Common: Headache (severe enough to cause discontinuation in some patients)
Uncommon: Dizziness, somnolence, insomnia, parasthaesias
Eye disorders
Rare: Blurred vision
Vascular disorders
Rare: Peripheral oedema
Respiratory, thoracic and mediastinal disorders
Rare: Bronchospasm
Gastrointestinal disorders
Common: Diarrhoea (severe enough to require discontinuation of therapy in some patients), constipation, abdominal pain or colic, nausea, vomiting, flatulence
Rare: Dry mouth, stomatitis, oesophageal candidiasis, taste disturbances
Hepato-biliary disorders
STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light and moisture.
Store the blisters in the outer carton until required for use.
Store the container well closed.
KEEP OUT OF REACH OF CHILDREN.