Pajjiż: Olanda
Lingwa: Olandiż
Sors: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
OMEPRAZOL
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
A02BC01
OMEPRAZOLE
Maagsapresistente capsule, hard
AMMONIA (E 527) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; GELATINE (E 441) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505) ; ZWARTE INKT,
Oraal gebruik
Omeprazole
Hulpstoffen: AMMONIA (E 527); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); GELATINE (E 441); HYPROMELLOSE (E 464); IJZEROXIDE ZWART (E 172); KALIUMHYDROXIDE (E 525); MAÏSZETMEEL; NATRIUMLAURILSULFAAT (E 487); POLYSORBAAT 80 (E 433); PROPYLEENGLYCOL (E 1520); SACCHAROSE; SCHELLAK (E 904); TALK (E 553 B); TITAANDIOXIDE (E 171); TRIETHYLCITRAAT (E 1505); ZWARTE INKT;
2002-06-04
Sandoz B.V. Pagina 1/10 Omeprazol ® capsule 10/20/40 1313-V20 RVG 27932-3-4 1.3.1.3 Bijsluiter Februari 2020 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OMEPRAZOL ® CAPSULE 10, MAAGSAPRESISTENTE CAPSULES, HARD, 10 MG OMEPRAZOL ® CAPSULE 20, MAAGSAPRESISTENTE CAPSULES, HARD, 20 MG OMEPRAZOL ® CAPSULE 40, MAAGSAPRESISTENTE CAPSULES, HARD, 40 MG omeprazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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. 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] 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. [Nationally completed name] is used to treat the following conditions: Adults ‘Gastro-oesophageal reflux disease’ (GORD). 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 a Aqra d-dokument sħiħ
Sandoz B.V. Pagina 1/17 Omeprazol capsule 10/20/40 1311-V22 RVG 27932-3-4 1.3.1.1 Samenvatting van de productkenmerken Februari 2020 1 NAME OF THE MEDICINAL PRODUCT Omeprazol capsule 10, maagsapresistente capsules, hard, 10 mg Omeprazol capsule 20, maagsapresistente capsules, hard, 20 mg Omeprazol capsule 40, maagsapresistente capsules, hard, 40 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant capsule, hard contains 10 mg of omeprazole. Excipients with known effect Each gastro-resistant capsule, hard contains up to 61.63 mg of sucrose. Each gastro-resistant capsule, hard contains 20 mg of omeprazole. Excipients with known effect Each gastro-resistant capsule, hard contains up to 123.26 mg of sucrose. Each gastro-resistant capsule, hard contains 40 mg of omeprazole. Excipients with known effect Each gastro-resistant capsule, hard contains up to 246.52 mg of sucrose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard. Opaque white capsule, with imprint “OM 10” Opaque white capsule, with imprint “OM 20” Opaque white capsule, with imprint “OM 40” 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Nationally completed name] capsules are indicated in: Sandoz B.V. Pagina 2/17 Omeprazol capsule 10/20/40 1311-V22 RVG 27932-3-4 1.3.1.1 Samenvatting van de productkenmerken Februari 2020 Adults • Treatment of duodenal ulcers • Prevention of relapse of duodenal ulcers • Treatment of gastric ulcers • Prevention of relapse of gastric ulcers • In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease • Treatment of NSAID-associated gastric and duodenal ulcers • Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk • Treatment of reflux oesophagitis • Long-term management of patients with healed reflux oesophagitis • Treatment of symptomatic gastro-oesophageal reflux disease • Treatment of Zollinger-Ellison syndrome Paediatric population _Children Aqra d-dokument sħiħ