Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AZITHROMYCIN DIHYDRATE
STADPHARM SDN. BHD.
AZITHROMYCIN DIHYDRATE
6capsule Capsules
STELLAPHARM J.V. Co., LTD. - BRANCH 1
_ Consumer Medication Information Leaflet (RiMUP) _ AZICINE 250MG HARD CAPSULE Azithromycin dihydrate 262mg EQ to 250mg of azithromycin 1 WHAT IS IN THIS LEAFLET 1. What Azicine is used for 2. How Azicine works 3. Before you use Azicine 4. How to use Azicine 5. While you are using it 6. Side effects 7. Storage and disposal of Azicine 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT AZICINE IS USED FOR Azithromycin is used to treat many different types of infections caused by bacteria, such as respiratory infections, skin infections, ear infections and sexually transmitted diseases. HOW AZICINE WORKS It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other viral infections. BEFORE YOU USE AZICINE _- When you must not use it _ If you are allergic to Azicine or any other macrolide antibiotic such as erythromycin or any of the ingredients listed at the end of this leaflet. _If you think any of these apply to you, or if _ _you are in any doubt at all, consult your _ _doctor before taking this drug. _ _ _ _- Before you start use it _ _If any of the situations mentioned below _ _apply to you, you should tell your _ _doctor before taking this drug: _ Inform your doctor if you suffer from heart, liver or kidney disease. Let your doctor know if you are pregnant or breastfeeding. _- Taking other medicines _ _Please tell your doctor or pharmacist if _ _you are taking or have recently taken _ _any other medicines, including _ _medicines obtained without a _ _prescription. _ - Antacids (for indigestion) - Digoxin (used to treat heart failure) - Zidovudine (used to treat HIV). - Ergot or ergotamine (used to treat migraine). - Ciclosporin (used to suppress the immune system to prevent and treat rejection of a transplanted organ or bone marrow). - Terfenadine (for hay fever or a skin allergy). HOW TO USE AZICINE _- How much to use _ _Always take this drug exactly as your _ _doctor has told you. You should check _ _with yo Lees het volledige document
_RX PRESCRIPTION ONLY _ 1. NAME OF THE MEDICINAL PRODUCT AZICINE 2. SPECIAL NOTICE AND RECOMMENDATION Keep out of reach of children Read the package insert carefully before use 3. COMPOSITION Each hard gelatin capsule contains azithromycin 250 mg (as azithromycin dihydrate 262 mg). 4. PHARMACEUTICAL FORM Hard gelatin capsule. Hard gelatin capsule size No.0, white cap and white body, imprinted logo “ ” on cap and “Azicine” on the body with edible black ink, containing white powder. 5. INDICATIONS Azithromycin is indicated for infections caused by susceptible organisms; in lower respiratory tract infections including bronchitis and pneumonia, in skin and soft tissue infections, in acute otitis media and in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis. (Penicillin is the usual drug of choice in the treatment of _Streptococcus pyogenes_ pharyngitis, including the prophylaxis of rheumatic fever. Azithromycin is generally effective in the eradication of streptococci from the oropharynx, however, data establishing the efficacy of azithromycin and the subsequent prevention of rheumatic fever are not available at present). In sexually transmitted diseases in men and women, azithromycin is indicated in the treatment of uncomplicated genital infections due to _Chlamydia trachomatis_ . It is also indicated in the treatment of chancroid due to _Haemophilus ducreyi_ ; and uncomplicated genital infection due to non-multiresistant _Neisseria gonorrhoea_ ; concurrent infection with _Treponema pallidum_ should be excluded. Azithromycin is indicated, either alone or in combination with rifabutin, for prophylaxis against _Mycobacterium avium-intracellulare complex_ (MAC) infection, an opportunistic infection prevalent in patients with advanced human immunodeficiency virus (HIV). Azithromycin is indicated in combination with ethambutol for the treatment of disseminated MAC (DMAC) infection in patients with advanced HIV infection. 6. ADMINISTRATION AND DOSAGE ADMINISTRATION Azicine is admi Lees het volledige document