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PROTON 20 mg contains the active substance pantoprazole. Proton 20 mg is a selective “proton pump inhibitor”, a medicine which reduces the amount of acid produced in your stomach. It is used for treating acid-related diseases of the stomach and intestine. How to use Always take Proton 20 mg exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Method of administration Take the tablets 1 hour before a meal, without chewing or breaking them, and swallow them whole with some water. The recommended dose is: Adults and adolescents 12 years of age and above - To treat symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated to gastro-oesophageal reflux disease The usual dose is one tablet a day. This dose usually brings relief within 2 - 4 weeks – at most after another 4 weeks. Your doctor will tell you how long to continue taking the medicine. After this any recurring symptoms can be controlled by taking one tablet daily, when required. - For long-term management and for preventing the return of reflux oesophagitis The usual dose is one tablet a day. If the illness returns, your doctor can double the dose, in which case you can use Proton 40 mg tablets instead, one a day. After healing, you can reduce the dose back again to one tablet Proton 20 mg a day. Adults - To prevent duodenal and stomach ulcers in patients who need to take NSAIDs continuously The usual dose is one tablet a day. Patients with liver problems If you suffer from severe liver problems, you should not take more than one 20 mg tablet a day. Use in children and adolescents These tablets are not recommended for use in children below 12 years. If you take more Proton 20 mg than you should Tell your doctor or pharmacist. There are no known symptoms of overdose. If you forget to take Proton 20 mg Do not take a double dose to make up for a forgotten dose. Take your next normal dose at the usual time. If you stop taking Proton 20 mg Do not stop taking these tablets without first talking to your doctor or pharmacist. If you have any further questions about the use of this product, ask your doctor, pharmacist, or nurse. Warnings and precautions Do not take Proton 20 mg • If you are allergic (hypersensitive) to pantoprazole or any of the other ingredients of Proton 20 mg. • If you are allergic to medicines containing other proton pump inhibitors. Take special care with Proton 20 mg Talk to your doctor, pharmacist or nurse before taking PROTON 20 mg Side Effects Common (may affect up to 1 in 10 people) Benign polyps in the stomach. • Uncommon (may affect up to 1 in 100 people) Headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; itching; feeling weak, exhausted or generally unwell; sleep disorders, fracture of the hip, wrist or spine. Storage Information Keep out of the reach and sight of children. • Do not store above 30ºC. • Do not use this medicine after the expiry date which is stated on the carton and the bottle label after EXP. The expiry date refers to the last day of that month. Drug Interactions Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is because Proton 20 mg may influence the effectiveness of other medicines, so tell your doctor if you are taking: • Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) because PROTON 20 mg may stop these and other medicines from working properly. • Warfarin and phenprocoumon, which affect the thickening or thining of the blood. You may need further checks. • Medicines used to treat HIV-infection, such as atazanavir. • Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate your doctor may temporarily stop your Proton 20 mg treatment because pantoprazole can increase levels of methotrexate in the blood. • Fluvoxamine (used to treat depression and other psychiatric diseases) – if you are taking fluvoxamine your doctor may reduce the dose. • Rifampicin (used to treat infections). • St John’s wort (Hypericum perforatum) (used to treat mild depression). Ingredients The active substance is: pantoprazole. Specifications Proton 20 mg Beige colored, oval, shallow biconvex, enteric coated tablet, plain on both sides.
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