Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
MOXIFLOXACIN
Bayer Public Limited Company
J01MA14
MOXIFLOXACIN
FILM-COATED TABLET
MOXIFLOXACIN 400 milligram(s)
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2007-08-22
v028_0 Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AVELOX 400MG 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 more 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 aged 18 years and above 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 on their own for treating this kind of infection. 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 TAKE AVELOX, Baca dokumen lengkapnya
Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 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 68mg 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). 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: - Acute bacterial sinusitis (adequately diagnosed) - Acute exacerbations of chronic bronchitis (adequately diagnosed) - 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). Avelox 400 mg film-coated tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous moxifloxacin for the following indications Baca dokumen lengkapnya