Country: ইউরোপীয় ইউনিয়ন
ভাষা: ইংরেজি
সূত্র: EMA (European Medicines Agency)
esomeprazole
GlaxoSmithKline Dungarvan Limited
A02BC05
esomeprazole
Proton pump inhibitors
Gastroesophageal Reflux
Nexium Control is indicated for the short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults.
Revision: 17
Authorised
2013-08-26
40 B. PACKAGE LEAFLET 41 PACKAGE LEAFLET: INFORMATION FOR THE USER NEXIUM CONTROL_ _20 MG GASTRO-RESISTANT TABLETS esomeprazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 14 days WHAT IS IN THIS LEAFLET 1. What Nexium Control is and what it is used for 2. What you need to know before you take Nexium Control 3. How to take Nexium Control 4. Possible side effects 5. How to store Nexium Control 6. Contents of the pack and other information - Further helpful information 1. WHAT NEXIUM CONTROL_ _IS AND WHAT IT IS USED FOR Nexium Control _ _ contains the active substance esomeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces. This medicine is used in adults for the short-term treatment of reflux symptoms (for example, heartburn and acid regurgitation). Reflux is the backflow of acid from the stomach into the gullet (“foodpipe”) which may become inflamed and painful. This may cause you symptoms such as a painful sensation in the chest rising up to your throat (heartburn) and a sour taste in the mouth (acid regurgitation). Nexium Control is not meant to bring immediate relief. You may need to take the tablets for 2-3 days in a row before you feel better. You must talk to a doctor if you do not feel better or if you feel worse after 14 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEXIUM CONTROL_ _ _ _ DO NOT TAKE NEXIUM CONTROL_ _ - If you are allergic to esomeprazole or any of the other ingredients of th সম্পূর্ণ নথি পড়ুন
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Nexium Control _ _ 20 mg gastro-resistant tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 20 mg esomeprazole (as magnesium trihydrate) Excipient(s) with known effect Each gastro-resistant tablet contains 28 mg sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablet. A light pink, oblong, biconvex, film-coated, gastro-resistant tablet of 14 mm x 7 mm engraved with ‘20 mG’ on one side and ‘A/EH’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nexium Control is indicated for the short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ The recommended dose is 20 mg esomeprazole (one tablet) per day. It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms. The duration of treatment is up to 2 weeks. Once complete relief of symptoms has occurred, treatment should be discontinued. If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor. _Special populations _ _Patients with renal impairment _ Dose adjustment is not required in patients with impaired renal function. Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution (see section 5.2). _Patients with hepatic impairment _ Dose adjustment is not required in patients with mild to moderate liver impairment. However, patients with severe liver impairment should be advised by a doctor before taking Nexium Control (see sections 4.4 and 5.2). _Elderly patients (≥65 years old) _ Dose adjustment is not required in elderly patients. 3 _Paediatric population _ There is no relevant use of Nexium Control in the paediatric population below 18 years of age for the indication of “short-term treatment of reflux sympto সম্পূর্ণ নথি পড়ুন