Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Azithromycin dihydrate
McDermott Laboratories Ltd., T/A Gerard Laboratories
J01FA; J01FA10
Azithromycin dihydrate
250 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Macrolides; azithromycin
Marketed
2010-06-04
PAGE 1 OF 8 PACKAGE LEAFLET PAGE 2 OF 8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AZROMAX 250MG FILM-COATED TABLETS azithromycin 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 Azromax is and what it is used for 2. What you need to know before you take Azromax 3. How to take Azromax 4. Possible side effects 5. How to store Azromax 6. Contents of the pack and other information 1. WHAT AZROMAX IS AND WHAT IT IS USED FOR Azromax is one of a group of antibiotics known as macrolides. It is used to treat bacterial infections caused by microorganisms such as bacteria. These infections include: • Chest infections such as bronchitis and pneumonia • Infections in your sinuses, throat, tonsils or ears • Mild to moderate skin and soft tissue infections, _e.g._ infection of the hair follicles (folliculitis), bacterial infection of the skin and its deeper layers (cellulitis), skin infection with shiny red swelling (erysipelas) • Infections caused by a bacterium called _Chlamydia trachomatis_ . They can cause inflammation of the tube that carries urine from your bladder (urethra) or where your womb joins your vagina (cervix). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AZROMAX DO NOT TAKE AZROMAX: • if you are allergic to azithromycin, any other macrolide (such as erythromycin or clarithromycin) or ketolide antibiotic or any of the ingredients of this medicine (listed in section 6). An allergic reaction may cause skin rash or wheezing. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist Przeczytaj cały dokument
Health Products Regulatory Authority 27 May 2022 CRN00CVQS Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Azromax 250 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg azithromycin (as azithromycin dihydrate). Excipient with known effect: Each film-coated tablet contains 3.08 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Azithromycin 250 mg Film-coated Tablets are white to off-white, oblong film-coated tablets and plain on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Azithromycin is indicated for the treatment of the following infections, when caused by microorganisms sensitive to azithromycin (see section 4.4 and 5.1): • Acute bacterial sinusitis (adequately diagnosed) • Acute bacterial otitis media (adequately diagnosed) • Pharyngitis, tonsillitis • Acute exacerbation of chronic bronchitis (adequately diagnosed) • Mild to moderately severe community acquired pneumonia • Infections of the skin and soft tissues of mild to moderate severity e.g. folliculitis, cellulitis, erysipelas • Uncomplicated Chlamydia trachomatis urethritis and cervicitis Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Azithromycin tablets should be given as a single daily dose. The duration of treatment in each of the infectious diseases is given below. _Adults, elderly, children and adolescents over 45 kg body weight_ The total dosage of azithromycin is 1500 mg which is spread over three days (500 mg once daily). Alternatively, the dosage can be spread over five days (500 mg as a single dose on the first day and thereafter 250 mg once daily). In uncomplicated _Chlamydia trachomatis_ urethritis and cervicitis the dosage is 1000 mg as a single oral dose. _For sinusitis_, treatment is indicated for adults and adolescents 16 years of age and over. _Ch Przeczytaj cały dokument