Χώρα: Ολλανδία
Γλώσσα: Ολλανδικά
Πηγή: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
OMEPRAZOL MAGNESIUM 20,6 mg/stuk SAMENSTELLING overeenkomend met ; OMEPRAZOL 20 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
A02BC01
OMEPRAZOL MAGNESIUM 20,6 mg/stuk SAMENSTELLING overeenkomend met ; OMEPRAZOL 20 mg/stuk
Maagsapresistente tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; COPOVIDON (E 1208) ; CROSPOVIDON (E 1202) ; DIMETICON (E 900) ; GLUCOSE, VLOEIBAAR ; GLYCEROLMONOSTEARAAT 40-55 (E 471) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POLYSORBAAT 80 (E 433) ; POVIDON K 25 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; STEARINEZUUR (E 570) ; SUIKERMAÏSBOLLETJES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; COPOVIDON ; CROSPOVIDON (E 1202) ; DIMETICON (E 900) ; GLUCOSE, VLOEIBAAR ; GLYCEROLMONOSTEARAAT 40-55 (E 471) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POLYSORBAAT 80 (E 433) ; POVIDON K 25 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; STEARINEZUUR (E 570) ; SUIKERMAÏSBOLLETJES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; COPOVIDON ; CROSPOVIDON (E 1202) ; DIMETICON (E 900) ; GLUCOSE, VLOEIBAAR ; GLYCEROLMONOSTEARAAT 40-55 (E 471) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POLYSORBAAT 80 (E 433) ; POVIDON K 25 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551)
Oraal gebruik
Omeprazole
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); COPOVIDON; CROSPOVIDON (E 1202); DIMETICON (E 900); GLUCOSE, VLOEIBAAR; GLYCEROLMONOSTEARAAT 40-55 (E 471); HYPROMELLOSE (E 464); IJZEROXIDE ROOD (E 172); MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; POLYSORBAAT 80 (E 433); POVIDON K 25 (E 1201); PROPYLEENGLYCOL (E 1520); SACCHAROSE; SILICIUMDIOXIDE (E 551); SILICIUMDIOXIDE, GEHYDRATEERD (E 551); STEARINEZUUR (E 570); SUGAR SPHERES; TALK (E 553 B); TITAANDIOXIDE (E 171);
2010-09-03
Sandoz B.V. Page 1/8 Omeprazol (als magnesium) Sandoz OTC 20 mg RVG 105012 V13 1.3.1.3 Bijsluiter maart 2023 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OMEPRAZOL (ALS MAGNESIUM) SANDOZ ® OTC 20 MG, MAAGSAPRESISTENTE TABLETTEN Omeprazole 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 doctor or 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 [Nationally completed name] is and what it is used for 2. What you need to know before you take [Nationally completed name] 3. How to take [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [Nationally completed name] gastro-resistant tablets contain 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. [Nationally completed name] is used in adults for the short-term treatment of reflux symptoms (for example, heartburn, 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 [NATIONALLY COMPLETED NAME] DO NOT Διαβάστε το πλήρες έγγραφο
Sandoz B.V. Page 1/13 Omeprazol (als magnesium) Sandoz OTC 20 mg RVG 105012 V12 1.3.1.1 Samenvatting van de Productkenmerken maart 2023 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Omeprazol (als magnesium) Sandoz OTC 20 mg, maagsapresistente tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 20 mg omeprazole (as omeprazole magnesium). Excipients with known effect glucose, sucrose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablet Pink, oval film-coated tablet with a breaking notch on both sides. The tablet can be divided into equal doses(14.2x7.2 mm). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Nationally completed name] gastro-resistant tablets are indicated for the treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _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. Sandoz B.V. Page 2/13 Omeprazol (als magnesium) Sandoz OTC 20 mg RVG 105012 V12 1.3.1.1 Samenvatting van de Productkenmerken maart 2023 Special populations _Renal impairment _ Dose adjustment is not needed in patients with impaired renal function (see section 5.2). _Hepatic impairment _ Patients with impaired hepatic function should be advised by a doctor before taking [Nationally completed name] (see section 5.2). _Elderly _ Dose adjustment is not needed in the elderly (see section 5.2). Method of administration It is recommended to take [Nationally completed name] tablets in the morning, 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 w Διαβάστε το πλήρες έγγραφο