Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
MOXIFLOXACIN
Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland
J01MA14
MOXIFLOXACIN 400 mg
FILM-COATED TABLET
MOXIFLOXACIN 400 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2007-08-22
BP22036_REC30610 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AVELOX 400 MG FILM-COATED TABLETS For use in adults. Moxifloxacin 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 Avelox is and what it is used for 2. What you need to know before you take Avelox 3. How to take Avelox 4. Possible side effects 5. How to store Avelox 6. Contents of the pack and other information 1. WHAT AVELOX IS AND WHAT IT IS USED FOR Avelox contains the active substance moxifloxacin which belongs to a group of antibiotics called fluoroquinolones. Avelox works by killing bacteria that cause infections. Avelox is used in patients of 18 years and older for treating the following bacterial infections when caused by bacteria against which moxifloxacin is active. Avelox should only be used to treat these infections when usual antibiotics cannot be used or have not worked: Infection of the sinuses, sudden worsening of long term inflammation of the airways or infection of the lungs (pneumonia) acquired outside the hospital (except severe cases). Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including infections of the fallopian tubes and infections of the uterus mucous membrane. Avelox tablets are not sufficient for sole therapy of this kind of infections and therefore another antibiotic in addition to Avelox tablets should be prescribed by your doctor for the treatment of infections of the female upper genital tract (see section _2._ _What you need to know before you Citiți documentul complet
Page 1 of 17 BP22036_REC30610 1. NAME OF THE MEDICINAL PRODUCT Avelox 400 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 film-coated tablet contains 400 mg moxifloxacin (as hydrochloride). Excipient with known effect: The film-coated tablet contains 68 mg lactose monohydrate (= 66.56 mg lactose) (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Dull red film-coated tablet with an oblong, convex shape with facet, a dimension of 17 x 7 mm, and marked with “M400” on one side and “BAYER” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Avelox 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections in patients of 18 years and older caused by bacteria susceptible to moxifloxacin (see sections 4.4, 4.8 and 5.1). In the following indications, Moxifloxacin should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections: - Acute bacterial sinusitis - Acute exacerbation of chronic obstructive pulmonary disease including bronchitis In the following indications, Moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed: - Community acquired pneumonia, except severe cases - Mild to moderate pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess. Avelox 400 mg film-coated tablets are not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease but should be given in combination with another appropriate antibacterial agent (e.g. a cephalosporin) due to increasing moxifloxacin resistance of _Neisseria gonorrhoeae_ unless moxifloxacin-resistant _Neisseria gonorrhoeae_ can be excluded (see sections 4.4 and 5.1). Citiți documentul complet