EMILOK Global. (omeprazole) Composition: Each capsule contains 20 mg omeprazole as enteric-coated

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1 EMILOK Global (omeprazole) Composition: Each capsule contains 20 mg omeprazole as enteric-coated granules. Properties: Emilok (omeprazole) belongs to the group of proton pump inhibitors, inhibits both basal and stimulated secretion of stomach acid, and reduces the amount of pepsin. This reduction in acidity leading to relief of pain & to accelerate healing of the mucous membrane defect. omeprazole is a weak base and is concentrated and converted to the active form in the acid environment of the intracellular canaliculi within the parietal cell, where it inhibits the enzyme hydrogen-potassium adenosine triphosphatase (H+,K+-ATPase) is the proton pump : omeprazole is acid labile and is administered orally as enteric-coated granules in capsules its absorption takes place in the small intestine and is usually completed within 3-6 hours. Omeprazole is mainly metabolised in the liver through cytochrome P450. Eradication of Helicobacter pylori with omeprazole and antimicrobials is associated with rapid symptom relief, high rates of healing of any mucosal lesions. Indications: Emilok is indicated in the treatment of the following diseases: - Duodenal ulcer. - Gastric ulcer. - Reflux esophagitis.. - Gastritis which results from NSAID treatment. - Used in combination with antibiotics to treat certain types of ulcers. - Prophylaxis of acid aspiration. - Zollinger-Ellison syndrome. Dosage & Administration: Emilok capsules are recommended to be given in the morning before breakfast and swallowed whole with liquid. - Duodenal ulcer: mg once daily before meal for at least 4 weeks depending on the severity of ulcer and persistence of symptoms. - Gastric ulcer: mg once daily before meal for at least 8 weeks depending on the severity of ulcer and persistence of symptoms. - Reflux esophagitis: 20 mg once or twice daily for 8-12 weeks, depending on the severity of the lesion. - Gastritis or hyperacidity: mg once or twice daily for 1-2 weeks. - Helicobacter pylori (Hp) eradication regimens in peptic ulcer disease: Emilok is recommended at a dose of 40 mg once daily or 20 mg twice daily in association with antimicrobial agents as detailed below: Triple therapy regimens in peptic ulcer disease: Emilok and the following antimicrobial combinations: 1- amoxycillin 500 mg and metronidazole 400 mg both three times a day for one week. 2- clarithromycin 250 mg and metronidazole 400 mg (or tinidazole 500 mg) both twice a day for one week. 3- amoxycillin 1 g and clarithromycin 500 mg both twice a day for one week. If symptoms return and the patient is Hp positive, therapy may be repeated, if the patient is Hp negative then see dosage instructions for add reflux disease. - As prophylaxis for patients considered to be at risk of aspiration of the gastric contents during general anaesthesia, the recommended dosage is Emilok 40 mg on the evening before surgery followed by Emilok 40 mg 2-6 hours prior to surgery - Zollinger-Ellison syndrome: the recommended initial dosage is 60 mg Emilok once daily.

2 The dosage should be adjusted individually and treatment continued as long as clinically indicated. If patient administers dose above 80 mg daily, should be divided and given twice daily. Impaired renal function: Dose adjustment is not required in patients with impaired renal function. Impaired hepatic function: As bioavailability and half-life can increase in patients with impaired hepatic function, the dose requires adjustment with a maximum daily dose of 20 mg. Patients with swallowing difficulties: The capsules may be opened and the contents swallowed alone or suspended in a small amount of fruit juice or yogurt after gentle mixing. The dispersion should be taken immediately or within 30 minutes. The contents of the capsules should not be crushed or chewed. Contraindications: Known hypersensitivity to omeprazole. When gastric ulcer is suspected, the possibility of malignancy should be excluded before treatment with Emilok. Precautions: Should be caution, if the drug used for a long period may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter. Use in Pregnancy and lactation: Should not be given during pregnancy and lactation unless the physician considers its use is essential. Side effects: Emilok is well tolerated and adverse reactions have generally been mild and reversible, the following effects have been reported: - Central and peripheral nervous system: Headache, rarely Dizziness, Paraesthesia, Insomnia, Reversible mental confusion, Depression and hallucinations. - Gastrointestinal: Diarrhea, Constipation, Abdominal pain, Nausea, Vomiting and Flatulence, Dry mouth, Stomatitis and Gastrointestinal candidiasis. - Hepatic: Rarely increased liver enzymes. - Skin: Rash, Pruritus, Urticaria, Photosensitivity, Erythema multiforme, and Alopecia. - Endocrine: Gynaecomastia. - Haematological: Leukopenia, Thrombocytopenia. - Musculoskeletal: Arthralgia and Myalgia, and Muscular weakness. - Other: Malaise. Drug interactions: - Due to the decreased intragastric acidity the absorption of ketoconazole or itraconazole may be reduced during omeprazole treatment. - Can prolong the elimination of diazepam, phenytoin and warfarin. Monitoring of patients receiving warfarin or phenytoin is recommended and a reduction of warfarin or phenytoin dose may be necessary. - Plasma concentrations of omeprazole and clarithromycin are increased during concomitant administration. This is considered to be a useful interaction during H. pylori eradication. - The absorption of Emilok is not affected by the food. - There is no evidence of an interaction with piroxicam, diclofenac or naproxen. Overdosage: There is no a specific antidote is known for overdosage with Emilok, dosages up to 560 mg/day have been well tolerated. Treatment should be symptomatic and supportive. The clinical symptoms of Emilok overdosage include( Nausea, vomiting, dizziness, abdominal pain, diarrhoea and headache) Presentation: Emilok 20 mg capsules in a container of 14 capsules. Store below 25ºC in a dry place. Protect from light. Keep the container tightly closed. Insert code: LFT 0010 (Org.) April 2005

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