Country: Netherlands
Language: Dutch
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
AMLODIPINEBESILAAT 13,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 10 mg/stuk ; OLMESARTANMEDOXOMIL 40 mg/stuk
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
C09DB02
AMLODIPINEBESILAAT 13,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 10 mg/stuk ; OLMESARTANMEDOXOMIL 40 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; ERWTENZETMEEL, HYDROXYPROPYL (GEMODIFICEERD) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; SORBITOL (D-)(E 420) ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; ERWTZETMEEL, HYDROXYPROPYL (GEMODIFICEERD) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; SORBITOL (D-)(E 420) ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Olmesartan Medoxomil And Amlodipine
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); ERWTZETMEEL, HYDROXYPROPYL (GEMODIFICEERD); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); SORBITOL (D-)(E 420); STEARINEZUUR (E 570); TITAANDIOXIDE (E 171);
2018-02-20
PIL-NL-OlmeAmlo-3868-Var017 2022-07-05 Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER OLMESARTANMEDOXOMIL/AMLODIPINE STADA 20 MG/5 MG FILMOMHULDE TABLETTEN OLMESARTANMEDOXOMIL/AMLODIPINE STADA 40 MG/5 MG FILMOMHULDE TABLETTEN OLMESARTANMEDOXOMIL/AMLODIPINE STADA 40 MG/10 MG FILMOMHULDE TABLETTEN Olmesartan medoxomil l/ Amlodipine besilate 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 Olmesartanmedoxomil/Amlodipine STADA is and what it is used for 2. What you need to know before you take Olmesartanmedoxomil/Amlodipine STADA 3. How to take Olmesartanmedoxomil/Amlodipine STADA 4. Possible side effects 5. How to store Olmesartanmedoxomil/Amlodipine STADA 6. Contents of the pack and other information 1. WHAT OLMESARTANMEDOXOMIL/AMLODIPINE STADA IS AND WHAT IT IS USED FOR Olmesartanmedoxomil/Amlodipine STADA contains two substances called olmesartan medoxomil and amlodipine (as amlodipine besilate). Both of these substances help to control high blood pressure. • _olmesartan medoxomil_ belongs to a group of medicines called “angiotensin-II receptor antagonists” which lower blood pressure by relaxing the blood vessels • _amlodipine_ belongs to a group of substances called “calcium channel blockers”. Amlodipine stops calcium from moving into the blood vessel wall which stops them from tightening thereby also reducing blood pressure The actions of both these substances contribute to stopping the tightening of blood vessels, so that they relax and blood pressure decreases. Olmesartan Read the complete document
SPC-NL-OlmAmlo3868-Var0017 2022-07-05 Page 1 of 22 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Olmesartanmedoxomil/Amlodipine STADA 20 mg/5 mg filmomhulde tabletten Olmesartanmedoxomil/Amlodipine STADA 40 mg/5 mg filmomhulde tabletten Olmesartanmedoxomil/Amlodipine STADA 40 mg/10 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Olmesartanmedoxomil/Amlodipine STADA 20 mg/5 mg filmomhulde tabletten: Each film-coated tablet of Olmesartanmedoxomil/Amlodipine STADA contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besilate). Olmesartanmedoxomil/Amlodipine STADA 40 mg/5 mg filmomhulde tabletten: Each film-coated tablet of Olmesartanmedoxomil/Amlodipine STADA contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besilate). Olmesartanmedoxomil/Amlodipine STADA 40 mg/10 mg filmomhulde tabletten: Each film-coated tablet of Olmesartanmedoxomil/Amlodipine STADA contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as amlodipine besilate). Excipient(s) with known effect One film-coated tablet of Olmesartanmedoxomil/Amlodipine STADA 20 mg/5 mg contains 29.96 mg lactose monohydrate and 0.45 mg sorbitol One film-coated tablet of Olmesartanmedoxomil/Amlodipine STADA 40 mg/5 mg contains 66.85 mg lactose monohydrate and 0.90 mg sorbitol One film-coated tablet of Olmesartanmedoxomil/Amlodipine STADA 40 mg/10 mg> contains 59.91 mg lactose monohydrate and 0.90 mg sorbitol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Olmesartanmedoxomil/Amlodipine STADA 20 mg/5 mg filmomhulde tabletten: White, round biconvex filmomhulde tabletten. Olmesartanmedoxomil/Amlodipine STADA 40 mg/5 mg filmomhulde tabletten: Yellowish-white, round, biconvex filmomhulde tabletten. Olmesartanmedoxomil/Amlodipine STADA 40 mg/10 mg filmomhulde tabletten: Brownish-red, round, biconvex filmomhulde tabletten. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Olmesartanmedoxomil/A Read the complete document