Land: Holland
Sprog: hollandsk
Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CLARITROMYCINE 500 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
J01FA09
CLARITROMYCINE 500 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CHINOLINEGEEL (E 104) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SILICIUMDIOXIDE (E 551) ; SORBITANMONOOLEAAT (E 494) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; VANILLINE, CELLULOSE, MICROKRISTALLIJN (E 460) ; CHINOLINEGEEL (E 104) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SILICIUMDIOXIDE (E 551) ; SORBITANMONOOLEAAT (E 494) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; VANILLINE,
Oraal gebruik
Clarithromycin
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CHINOLINEGEEL (E 104); CROSCARMELLOSE NATRIUM (E 468); HYPROLOSE (E 463); HYPROMELLOSE (E 464); MAGNESIUMSTEARAAT (E 470b); POVIDON K 30 (E 1201); PROPYLEENGLYCOL (E 1520); SILICIUMDIOXIDE (E 551); SORBITANMONOOLEAAT (E 494); TALK (E 553 B); TITAANDIOXIDE (E 171); VANILLINE;
2011-09-23
Sandoz B.V. Page 1/9 Claritromycine Sandoz ® 250/500 mg, filmomhulde tabletten RVG 107886-902 1311-V4 1.3.1.3 Bijsluiter Maart 2021 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CLARITROMYCINE SANDOZ ® 250 MG, FILMOMHULDE TABLETTEN CLARITROMYCINE SANDOZ ® 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 [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 Clarithromycin is an antibiotic which belongs to the group of macrolide antibiotics. It stops the growth of certain bacteria. [Nationally completed name] is used in adults and adolescents (12 years and older)to treat infections caused by bacteria which are sensitive to clarithromycin, for example: • THROAT and SINUS infections • CHEST infections, such as bronchitis and pneumonia • SKIN and SOFT-TISSUE infections • GASTRIC ULCERS caused by the bacterium _Helicobacter pylori_ . 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME] DO NOT TAKE [NATIONALLY COMPLETED NAME] • if you are ALLERGIC to clarithromycin, other macrolide antibiotics or any of the other ingredients of this medicine (listed in section 6), Sandoz B.V. Page 2/9 Claritromycine Sandoz ® 250/500 mg, filmomhulde tabletten RVG Læs hele dokumentet
Sandoz B.V. Page 1/23 Claritromycine Sandoz 250/500 mg, filmomhulde tabletten RVG 107886-902 1311-V5 1.3.1.1 Samenvatting van de Productkenmerken Maart 2021 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Claritromycine Sandoz 250 mg, filmomhulde tabletten Claritromycine Sandoz 500 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg of clarithromycin. Excipient with known effect Each film-coated tablet contains 0.13 mmol (3.06 mg) sodium. Each film-coated tablet contains 500 mg of clarithromycin. Excipient with known effect Each film-coated tablet contains 0.13 mmol (3.06 mg) sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. _ _ _250 mg film-coated tablets: _ Dark yellow, film-coated, capsule shaped tablets (15.6 x 7.9 mm). _500 mg film-coated tablets: _ Light yellow, film-coated, oval shaped tablets (18.8 x 8.8 mm). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clarithromycin 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 Sandoz B.V. Page 2/23 Claritromycine Sandoz 250/500 mg, filmomhulde tabletten RVG 107886-902 1311-V5 1.3.1.1 Samenvatting van de Productkenmerken Maart 2021 • Skin infections and soft tissue infections of mild to moderate severity, for example folliculitis, cellulitis and erysipelas. [Nationally completed name] 250 mg/ 500 mg film-coated tablets 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). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 P Læs hele dokumentet