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OMEPREX contains the active substance omeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces. OMEPREX is used to treat the following conditions: In adults: ‘Gastro-oesophageal reflux disease’ (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn. Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer). Ulcers which are infected with bacteria called ‘Helicobacter pylori’. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal. Ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). OMEPREX can also be used to stop ulcers from forming if you are taking NSAIDs. Too much acid in the stomach caused by a tumor growth in the pancreas (Zollinger-Ellison syndrome). In children: Children over 1 year of age and ≥ 10 kg ‘Gastro-oesophageal reflux disease’ (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn. In children, the symptoms of the condition can include the return of stomach contents into the mouth (regurgitation), being sick (vomiting) and poor weight gain. Children over 4 years of age and adolescents Ulcers which are infected with bacteria called ‘Helicobacter pylori’. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal. How to use Adults: To treat symptoms of GERD such as heartburn and acid regurgitation: If your doctor has found that your food pipe (gullet) has been slightly damaged, the usual dose is 20 mg once a day for 48- weeks. Your doctor may tell you to take a dose of 40 mg for a further 8 weeks if your gullet has not yet healed. The usual dose once the gullet has healed is 10 mg once a day. If your gullet has not been damaged, the usual dose is 10 mg once a day. Warnings and precautions Do not take OMEPREX If you are allergic (hypersensitive) to omeprazole or any of the other ingredients of OMEPREX. If you are allergic to medicines containing other proton pump inhibitors (eg pantoprazole, lansoprazole, rabeprazole, esomeprazole). If you are taking a medicine containing nelfinavir (used for HIV infection) Side Effects If you experience any of the following symptoms you should contact your doctor or go to the hospital straight away: Common side effects Headache. Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence). Feeling sick (nausea) or being sick (vomiting). Benign polyps in the stomach. Storage Information Store below 25°C Drug Interactions Tell your doctor or pharmacist if you are taking any of the following medicines: Ketoconazole, itraconazole, posaconazole or voriconazole (used to treat infections caused by a fungus) Digoxin (used to treat heart problems) Diazepam (used to treat anxiety, relax muscles or in epilepsy) Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking OMEPREX Medicines that are used to thin your blood, such as warfarin or other vitamin K blockers. Your doctor may need to monitor you when you start or stop taking OMEPREX Rifampicin (used to treat tuberculosis) Atazanavir (used to treat HIV infection) Tacrolimus (in cases of organ transplantation) St John’s wort (Hypericum perforatum) (used to treat mild depression) Cilostazol (used to treat intermittent claudication) Saquinavir (used to treat HIV infection) Clopidogrel (used to prevent blood clots (thrombi)) Erlotinib (used to treat cancer) Ingredients The active substance is Omeprazole. The other ingredients are Empty Gelatin Capsule, Mannitol, Lactose, Sucrose, Hydroxypropyl methyl Cellulose, Methacrylic acid copolymer and Polyethylene glycol Specifications OMEPREX 20 mg comes as a Flesh & caramel color hard gelatin capsules filled with coated pellets coded by SJ 127 on one side
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