Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Azithromycin
Mawdsley-Brooks & Company Ltd
J01FA10
Azithromycin
500mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010500
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 Azithromycin Tablets are and what they are used for 2. What you need to know before you take Azithromycin Tablets 3. How to take Azithromycin Tablets 4. Possible side effects 5. How to store Azithromycin Tablets 6. Contents of the pack and other information Azithromycin Tablets is an antibiotic. It belongs to a group of antibiotics called macrolides. It is used to treat infections caused by bacteria. This medicine is usually prescribed to treat: • chest infections such as chronic bronchitis, pneumonia • infections of the tonsils, throat (pharyngitis) and sinuses • ear infections (acute otitis media) • skin and soft tissue infections, with exception of infected burn wounds • urethra and cervix infections caused by chlamydia. DO NOT TAKE THIS MEDICINE IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO: • azithromycin • erythromycin • any other macrolide or ketolide antibiotic • any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Azithromycin Tablets: • Liver problems: your doctor may need to monitor your liver function or stop the treatment. • Kidney problems: if you have severe kidney problems, the dose may have to be adjusted. • Nervous (neurological) or mental (psychiatric) problems. • A certain type of muscle weakness called myasthenia gravis. Since azithromycin may increase the risk of abn Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Azithromycin 500mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: 500 mg of azithromycin (as monohydrate) Excipient(s) with known effect: Each tablet contains 0.36 mg soya lecithin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White to off-white, oblong, film-coated tablet, deep break line on one side and score line on other side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Azithromycin tablets can be applied for the treatment of the following infections, when caused by microorganisms sensitive to azithromycin (see sections 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 − skin and soft tissue infections − uncomplicated _Chlamydia trachomatis_ urethritis and cervicitis Considerations should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Adults _ In uncomplicated _Chlamydia trachomatis_ urethritis and cervicitis the dose is 1000 mg as a single oral dose. For all other indications the dose is 1500 mg, to be administered as 500 mg per day for three consecutive days. As an alternative the same total dose (1500 mg) can also be administered over a period of five days with 500 mg on the first day and 250 mg on the second to the fifth day. _Elderly people _ The same dose as in adult patients is used for older people. Since elderly people can be patients with ongoing proarrhythmic conditions a particular caution is recommended due to the risk of developing cardiac arrhythmia and torsades de pointes (see section 4.4). _Paediatric population _ Azithromycin tablets should only be administered to children weighi Прочитайте повний документ