Land: Holland
Sprog: hollandsk
Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LANSOPRAZOL
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
A02BC03
LANSOPRAZOLE
Maagsapresistente capsule, hard
CARRAGEENAN (E 407) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; HYPROMELLOSE (E 464) ; KALIUMCHLORIDE ; MACROGOL 400 ; MAGNESIUMCARBONAAT, LICHT (E 504 (II)) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; SUGAR SPHERES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Lansoprazole
Hulpstoffen: CARRAGEENAN (E 407); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); HYPROMELLOSE (E 464); KALIUMCHLORIDE; MACROGOL 400; MAGNESIUMCARBONAAT, LICHT (E 504 (II)); MAÏSZETMEEL; NATRIUMLAURILSULFAAT (E 487); POLYSORBAAT 80 (E 433); SACCHAROSE; SILICIUMDIOXIDE (E 551); SUGAR SPHERES; TALK (E 553 B); TITAANDIOXIDE (E 171);
2005-08-15
Sandoz B.V. Page 1/8 Lansoprazol 15, 30 mg, maagsapresistente capsules RVG 32983-4 v18 1.3.1.3 Package Leaflet Juli 2020 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LANSOPRAZOL 15 MG, MAAGSAPRESISTENTE CAPSULES LANSOPRAZOL 30 MG, MAAGSAPRESISTENTE CAPSULES lansoprazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINSIMPORTANT 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. 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 The active substance in [Nationally completed name] is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach makes. Your doctor may prescribe [Nationally completed name] for the following indications: - Treatment of duodenal and stomach ulcer - Treatment of inflammation in your oesophagus (reflux oesophagitis) - Prevention of reflux oesophagitis - Treatment of heartburn and acid regurgitation - Treatment of infections caused by the bacteria _Helicobacter pylori_ when given in combination with antibiotic therapy - Treatment or prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment (NSAID treatment is used against pain or inflammation) - Treatment of Zollinger-Ellison syndrome. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME] DO NOT TAKE [NATIONALLY Læs hele dokumentet
Sandoz B.V. Page 1 / 12 Lansoprazol 15. 30 mg, maagsapresistente capsules RVG 32983 en 32984 v19 1.3.1.1 Summary of Product Characteristics Juli 2020 1 NAAM VAN HET GENEESMIDDEL Lansoprazol 15 mg, maagsapresistente capsule Lansoprazol 30 mg, maagsapresistente capsule 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ [Nationally completed name] 15 mg: Each hard gastro-resistant capsule contains 15 mg of lansoprazole Excipient(s) with known effect Each 15 mg capsule contains 65.6 mg sucrose [Nationally completed name] 30 mg: Each hard gastro-resistant capsule contains 30 mg of lansoprazole Excipient(s) with known effect Each 30 mg capsule contains 131.2 mg sucrose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard gastro-resistant capsule. [Nationally completed name] 15 mg: White / white opaque capsules containing white to off-white pellets. [Nationally completed name] 30 mg: White / white opaque capsules containing white to off-white pellets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Nationally completed name] 15 mg/30 mg gastro-resistant capsules are indicated for: - Treatment of duodenal and gastric ulcer - Treatment of reflux oesophagitis - Prophylaxis of reflux oesophagitis - Eradication of _Helicobacter pylori _ ( _H. pylori_ ) concurrently given with appropriate antibiotic therapy for treatment of _H. pylori_ -associated ulcers - Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment - Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in patients at risk (see section 4.2) requiring continued therapy - Symptomatic gastro-esophageal reflux disease - Zollinger-Ellison syndrome. Sandoz B.V. Page 2 / 12 Lansoprazol 15. 30 mg, maagsapresistente capsules RVG 32983 en 32984 v19 1.3.1.1 Summary of Product Characteristics Juli 2020 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology TREATMENT OF DUODENAL ULCER The recommended dose is 30 mg once daily for 2 weeks. In patients not fully healed within this time, the Læs hele dokumentet