Avelox 400mg film-coated Tablets

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktivní složka:

MOXIFLOXACIN

Dostupné s:

Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland

ATC kód:

J01MA14

INN (Mezinárodní Name):

MOXIFLOXACIN 400 mg

Léková forma:

FILM-COATED TABLET

Složení:

MOXIFLOXACIN 400 mg

Druh předpisu:

POM

Terapeutické oblasti:

ANTIBACTERIALS FOR SYSTEMIC USE

Stav Autorizace:

Withdrawn

Datum autorizace:

2007-08-22

Informace pro uživatele

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

Charakteristika produktu

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).