Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CLARITROMYCINE 250 mg/stuk
Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)
J01FA09
CLARITROMYCINE 250 mg/stuk
Filmomhulde tablet
ALLURAROOD AC ALUMINIUM LAK (E 129) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MACROGOL 400 ; MAGNESIUMHYDROXIDE (E 528) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TARTRAZINE ALUMINIUMLAK (E 102) ; TITAANDIOXIDE (E 171) ; VANILLINE, ALLURAROOD AC ALUMINIUM LAK (E 129) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MACROGOL 400 ; MAGNESIUMHYDROXIDE (E 528) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TARTRAZINE ALUMINIUMLAK (E 102) ; TITAANDIOXIDE (E 171) ; VANILLINE, ALLURAROOD AC ALUMINIUM LAK (E 129) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MACROGOL 400 ; MAGNESIUMHYDROXIDE (E 528) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TARTRAZINE ALUMINIUMLAK (E 102) ; TITAANDIOXIDE (E 171) ; VANILLINE,
Oraal gebruik
Clarithromycin
Hulpstoffen: ALLURAROOD AC ALUMINIUM LAK (E 129); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); INDIGOKARMIJN ALUMINIUMLAK (E 132); MACROGOL 400; MAGNESIUMHYDROXIDE (E 528); MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); STEARINEZUUR (E 570); TARTRAZINE ALUMINIUMLAK (E 102); TITAANDIOXIDE (E 171); VANILLINE;
1900-01-01
Clarithromycin, NL/H/2597/001-002, 25.01.24 Rvg 111801-2 EU PIL IA/027 met NL info-clean PACKAGE LEAFLET: INFORMATION FOR THE USER CLARITROMYCINE RATIOPHARM 250 MG, FILMOMHULDE T ABLETTEN CLARITROMYCINE RATIOPHARM 500 MG, FILMOMHULDE TABLETTEN clarithromycin 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 {Product name} is and what it is used for 2. What you need to know before you take {Product name} 3. How to take {Product name} 4. Possible side effects 5. How to store {Product name} 6. Contents of the pack and other information 1. WHAT {PRODUCT NAME} IS AND WHAT IT IS USED FOR {Product name} belongs to a group of drugs called macrolide antibiotics. It stops the growth of certain bacteria. {Product name} is used to treat: • Chest infections, such as bronchitis and pneumonia • throat and sinus infections • skin and soft tissue infections • gastric ulcers caused by the bacterium_ Helicobacter pylori_ infection associated with duodenal ulcer. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE {PRODUCT NAME} DO NOT TAKE {PRODUCT NAME} • if you are allergic to clarithromycin, to other macrolide antibiotics (e.g. erythromycin, azithromycin) or to any of the other ingredients of this medicine (listed in section 6). • if you are taking any of the following medicines: - astemizole or terfenadine (for hay fever or allergies), cisapride or domperidone (for stomach disorders) or pimozide (to treat certain psychiatric diseases) as taking theses medicines with {Product name} can cause serious disturbances Lees het volledige document
Clarithromycin, NL/H/2597/001-002, 25.01.24 Rvg 111801-2 EU SPC IA/027 met NL info-clean SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Claritromycine ratiopharm 250 mg, filmomhulde tabletten Claritromycine ratiopharm 500 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION {Product name} 250 mg Each film-coated tablet contains 250 mg clarithromycin. {Product name} 500 mg Each film-coated tablet contains 500 mg clarithromycin. Excipients with known effect: {Product name} 250 mg contains 0.30 mg tartrazine aluminium lake (E102) and 0.008 mg allura red aluminium lake (E129). {Product name} 500 mg contains 0.14 mg tartrazine aluminium lake (E102) and 0.001 mg allura red aluminium lake (E129). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. {Product name} 250 mg Yellow, film-coated oval shaped tablet, debossed with “93” on one side and “7157” on the other. Length: 17 mm Width: 8 mm Thickness: 5-6 mm {Product name} 500 mg Light yellow, film-coated oval shaped tablet, debossed with “93” on one side and “7158” on the other. Length: 22 mm Width: 11 mm Thickness: 6.7-7.7 mm 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS {Product name} is indicated in adults and adolescents 12 years and older for the treatment of the following infections, when caused by clarithromycin-susceptible bacteria (see sections 4.4 and 5.1): - Bacterial pharyngitis - Acute bacterial sinusitis - Acute bacterial exacerbation of chronic bronchitis - Mild to moderate community acquired pneumonia - Skin infections and soft tissue infections of mild to moderate severity, for example folliculitis, cellulites and erysipelas. {Product name} can also be used in appropriate combination with antibacterial therapeutic regimens and an appropriate ulcer healing agent for the eradication of _H. pylori_ in patients with _H. pylori_ associated ulcers (see section 4.2). Clarithromycin, NL/H/2597/001-002, 25.01.24 Rvg 111801-2 EU SPC IA/027 met NL info-clean Conside Lees het volledige document