Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Omeprazole
Bayer Limited
A02BC; A02BC01
Omeprazole
20 milligram(s)
Gastro-resistant tablet
Product not subject to medical prescription
Proton pump inhibitors; omeprazole
Marketed
2011-12-21
Losec Control , IE/H/0655/001/IA/008/G, BCH23019 1/6 PACKAGE LEAFLET: INFORMATION FOR THE USER LOSEC CONTROL 20 MG GASTRO-RESISTANT TABLETS Omeprazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor 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 your doctor if you do not feel better or if you feel worse after 14 days. WHAT IS IN THIS LEAFLET : 1. What Losec Control is and what it is used for 2. What you need to know before you take Losec Control 3. How to take Losec Control 4. Possible side effects 5. How to store Losec Control 6. Contents of the pack and other information 1. WHAT LOSEC CONTROL IS AND WHAT IT IS USED FOR Losec Control gastro-resistant tablets 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. Losec Control 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 burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation). It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOSEC CONTROL DO NOT TAKE LOSEC CONTROL - if you are allergic to omeprazole or any of the other ingredients of Losec Control (listed in section 6). - if you are allergic to medicines containing other proton pump inhibitors (e.g. pantopraz Belgenin tamamını okuyun
Health Products Regulatory Authority 31 March 2023 CRN00DH73 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losec Control 20 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 20.6 mg omeprazole magnesium equivalent to 20 mg omeprazole. Excipients with known effect: Each gastro-resistant tablet contains 19–20 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet. Pink, oblong, biconvex, film-coated tablets engraved with on one side and 20 mg on the other side, containing enteric coated pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Losec Control gastro-resistant tablets is indicated for the treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology in adults The recommended dose is 20 mg once daily for 14 days. It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms. The majority of patients achieve complete relief of heartburn within 7 days. Once complete relief of symptoms has occurred, treatment should be discontinued. Special populations _Impaired renal function_ Dose adjustment is not needed in patients with impaired renal function (see section 5.2). _Impaired hepatic function_ Patients with impaired hepatic function should be advised by a doctor before taking Losec Control (see section 5.2). _Elderly (> 65 years old)_ Dose adjustment is not needed in the elderly (see section 5.2). Method of administration It is recommended to take Losec Control tablets in the morning, preferably on an empty stomach, swallowed whole with half a glass of water. The tablets must not be chewed or crushed. _For patients with swallowing difficulties_ Break the tablet and disperse it in a spoonful of non-carbonated water - if so wished, mix with some fruit juices or applesauce. The dispersion should be taken immediately (or within 30 minutes). The dispersion sho Belgenin tamamını okuyun