Erelan 400 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

MOXIFLOXACINEHYDROCHLORIDE 436,3 mg/stuk SAMENSTELLING overeenkomend met ; MOXIFLOXACINE 400 mg/stuk

Beschikbaar vanaf:

Medochemie Limited Constantinopelstreet 1-10 3011 LIMASSOL (CYPRUS)

ATC-code:

J01MA14

INN (Algemene Internationale Benaming):

MOXIFLOXACINEHYDROCHLORIDE 436,3 mg/stuk SAMENSTELLING overeenkomend met ; MOXIFLOXACINE 400 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Moxifloxacin

Autorisatie datum:

2018-12-27

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ERELAN 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 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 Erelan is and what it is used for
2.
What you need to know before you take Erelan
3.
How to take Erelan
4.
Possible side effects
5.
How to store Erelan
6.
Contents of the pack and other information
1.
WHAT ERELAN IS AND WHAT IT IS USED FOR
Erelan contains the active substance moxifloxacin, which belongs to a
group of antibiotics called
fluoroquinolones. Moxifloxacin works by killing bacteria that cause
infections.
Erelan is used in patients aged 18 years and above for treating the
following bacterial infections when
caused by bacteria against which moxifloxacin is active. Erelan 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.
Moxifloxacin tablets are not sufficient on their own for treating this
kind of infection. Therefore,
another antibiotic in addition to moxifloxacin should be prescribed by
your doctor for the treatment of
infections of the female upper genital tract (see section 2).
If the following bacterial infections hav

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Erelan 400mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400mg moxifloxacin (as
hydrochloride).
Excipient(s) with known effect: lactose monohydrate. Each film-coated
tablet contains 68 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Red, oval-shaped, biconvex film coated tablets embossed “MC” with
dimensions of nucleus
17.6mmx8mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Erelan 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).
-
Acute bacterial sinusitis (adequately diagnosed).
-
In acute bacterial sinusitis Erelan 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 exacerbation of chronic obstructive pulmonary disease including
bronchitis. In acute
exacerbation of chronic obstructive pulmonary disease Erelan should be
used only when it is
considered inappropriate to use other antibacterial agents that are
commonly recommended for the
treatment of these infections.
-
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.
Moxifloxacin is 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).
Moxifloxacin may also be used to complete a course of therapy in
patie