Avelox 400mg film-coated Tablets

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktivní složka:

MOXIFLOXACIN

Dostupné s:

Bayer Public Limited Company

ATC kód:

J01MA14

INN (Mezinárodní Name):

MOXIFLOXACIN

Léková forma:

FILM-COATED TABLET

Složení:

MOXIFLOXACIN 400 milligram(s)

Druh předpisu:

POM

Terapeutické oblasti:

ANTIBACTERIALS FOR SYSTEMIC USE

Stav Autorizace:

Authorised

Datum autorizace:

2007-08-22

Informace pro uživatele

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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,

Charakteristika produktu

Page
1
of
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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