Treatment of reflux oesophagitis disease. In reflux oesophagitis the majority of patients are healed after 4 weeks. Symptoms relief is rapid. Treatment of duodenal and benign gastric ulcers including complicating NSAID therapy. Relief of reflux-like symptoms ( e.g. heartburn ) and/or ulcer-like symptoms ( e.g. epigastric pain ) associated with acid-related dyspepsia. Treatment and prophylaxis of NSAID-associated benigen gastric ulcers, duodenal ulcers and gastroduodenal erosions in patients with a previous history of gastroduodenal lesions who require continued NSAID treatment. Relief of associated dyspeptic symptoms. Helicobacter pylori eradication: When used with in combination with antibiotics, Omeprazole proves effective in the eradication of Helicobacter pylori ( Hp) in peptic ulcer disease. Prophylaxis of acid aspiration. Zollinger-Ellison syndrome. For 10 and 20 mg capsules only: Relief of reflux-like symptoms (e.g heartburn) and/or ulcer-like symptoms (e.g. epigastric pain) associated with acid-related dyspepsia. Treatment and prophylaxis of NSAID-associated bengin gastric ulcers, duodenal ulcers and gastroduodenal erosions in patients with a previous history of gastroduodenal lesions who require continued NSAID treatment. Children over 1 year of age and ≥ 10 kg; Reflux oesophagitis. Symptomatic treatment of heartburn and acid regurgitation in gastroesophageal reflux disease.

DOSAGE OF OMEZ 20MG CAP

Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet

Ask your pharmacist or doctor for help if you do not understand the instructions on the box .

The recommended dose is : –

OMEZ capsules are recommended to be given in the morning and swallowed whole with half of a glass of water. The capsules should not be chewed or crushed. For patients with swallowing difficulties: The capsule can be opened & contents swallowed directly with half a glass of water or after mixing the contents in a slightly acidic fluid e.g. fruit juice or in a non-carbonated water. The dispersion should be taken immediately ( or within 30 minutes). Always stir just before drinking. Rinse it down with glass of water. Alternatively patients can suck the capsule and swallow the pellets with half a glss of water. Ingest without chewing the enteric-coated pellets. Duodenal ulcer: The recommended oral dose is OMEZ 20 mg given once daily. Symptom resolution is rapid and in most patients healing occurs within 2 weeks. For those patients who may not fully healed after the initial course, Healing usually occurs during a further 2 week treatment period. In patients with poorly responsive duodenal ulcer OMEZ 40 mg once daily is recommended and Healing is usually achieved within four weeks. For prevention of relapse in patients with Duodenal ulcer: The recommended dose is OMEZ 10 mg once daily, increased to OMEZ 20-40 mg once daily. Gastric ulcer: The recommended adult dose is OMEZ 20 mg given once daily. Symptom resolution is rapid and in most patients healing occurs within 4 weeks. For those patients who may not fully healed after the initial course, Healing usually occurs during a further 4 week treatment period. In patients with poorly responsive gastric ulcer Omez 40 mg once daily is recommended and healing is usually achieved within 8 weeks. For prevention of relapse in patients with poorly responsive gastric ulcers: The recommended dose is OMEZ 20 mg once daily, If needed the dose can be increased to OMEZ 40 mg once daily. NSAID-Associated Gastric or Duodenal ulcers or gastroduodenal erosions in patients with or without continued NSAID treatment :The recommended adult dos age of OMEZ is 20 mg given once daily. Symptom resolution is rapid and healing usually occurs within four weeks. For those patients not healed after this initial course of therapy, an additional four weeks of treatment is recommended. For the prevention of NSAID associated gastric ulcers, duodenal ulcers, gastroduodenal erosions & dyspeptic symptoms the recommended dosage of OMEZ is 20 mg given once daily. Helicobacter pylori-Associated peptic ulcer disease. Triple therapy regimen: OMEZ 20 mg , amoxicillin 1 g and clarithromycin 500 mg, all twice daily ONE WEEK. Or OMEZ 20 mg , metronidazole 500 mg and clarithromycin 250 mg, all twice daily for one week . Or 40 mg OMEZ once daily with amoxicillin 500 mg & metronidazole 400 mg both three times a day for one week. Dual therapy regimes: OMEZ 40-80 mg daily with amoxicillin 1.5 g daily in divided doses for two weeks. In clinical studies daily doses of 1.5-3 g of amoxicillin have been used. Or OMEZ 40 mg once daily and clarithromycin 500 mg three times a day for two weeks. In each regimen if the patient is still Hp positive, therapy must be repeated. Reflux Esophagitis: The recommended doagse is OMEZ 20 mg given once daily . Symptoms resolution is rapid & in most patients , healing occurs within four weeks. For patients not healed after this initial course of therapy, healing usually occurs during a further four weeks treatment period. In patients with severe reflux esophagitis OMEZ 40 mg given once daily. Healing is usually achieved within eight weeks. For the long-term management patients with healed reflux esophagitis, the recommended dose is Losec 10 mg once daily, if needed the dose can be increased to 20-40 mg OMEZ once daily. Symptomatic Gastroesophageal reflux disease: The recommended adult dose is OMEZ 20 mg given once daily. Symptoms relief should be rapid. Patients may respond adequately to 10 mg daily, and therefore individual dose adjustment should be considered. If symptom control is not achieved after four weeks, further investigation is recommended. Acid related dyspepsia: In the relief of symptoms in patients with epigastric pain/discomfort with or without heartburn the recommended dosage is Omez 20 mg once daily. Patients may respond adequately to 10 mg daily and therefore this dose could be considered as a starting dose, If symptoms control has not been achieved after 4 weeks treatment with Omez 20 mg daily, further investigation is recommended. Zollinger-Ellison Syndrome: In patients with Zollinger-Ellison syndrome the dosage should be individually adjusted and treatment continued as long as is clinically indicated.In patients with Zollinger-Ellison syndrome the dosage should be individually adjusted and treatment continued as long as is clinically indicated. The recommended initial dose is OMEZ 60 mg , given daily. All patients with severe disease and inadequate response to other therapies have been effectively controlled and More than 90% of the patients with the severe form of the disease and inadequate response to other therapies have been adequaltely controlled with doses of 20 mg to 120 mg daily. When doses exceed OMEZ 80 mg, the dose should be divided and given twice daily. Impaired renal function: Dose adjustment is not needed in patients with impaired renal function. Impaired hepatic function: In patients with impaired hepatic function a daily dose of 10-20 mg may be sufficient. Elderly (> 65 years old): Dose adjustment is not needed in the elderly. Children: There is only limited experience of treatment in children.

OVER-DOSAGE OF OMEZ 20MG CAP

Probably low acute toxicity, 320-800 mg to adults resulted in low intoxication, 560 mg to adults resulted in moderate intoxication. Symptoms: Dizziness, apathy, headache, confusion, blood vessel dilation, tachycardia. Nausea, vomiting, flatulence, diarrhoes. Treatment: If necessary, gastric lavage, charcoal. Symptomatic therapy.

CONTRA-INDICATION OF OMEZ 20MG CAP

Known hypersensitivity to omeprazole. Omeprazole like other PPIs should not be administered with atazanavir.

STORAGE OF OMEZ 20MG CAP

Keep at a temperature not exceeding 30 °C, in dry place.
PACK OF OMEZ 20MG CAP
A carton box containing 2 strips (PVDC/Aluminium) each of 7 capsules.
OMEZ 20MG CAP MANUFACTURED BY
PHARAONIA PHARMACEUTICALS PHARO PHARMA NEW BORG EL-ARAB CITY – ALEXANDRIA – A.R.E.

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