Faverin 50mg Film-coated Tablets

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

FLUVOXAMINE MALEATE

متاح من:

Mylan Products Limited

ATC رمز:

N06AB08

INN (الاسم الدولي):

FLUVOXAMINE MALEATE

الشكل الصيدلاني:

FILM-COATED TABLET

تركيب:

FLUVOXAMINE MALEATE 50 mg

نوع الوصفة الطبية :

POM

المجال العلاجي:

PSYCHOANALEPTICS

الوضع إذن:

Authorised

نشرة المعلومات

1503128_d2
P. Process Black U - Cutting Die (not printed)
pharmacode > > >
pharmacode > > >
folding
folding
50
50
1503128 CL 3280
FRONT
50 mg and 100 mg film-coated tablets
fluvoxamine maleate
•
Faverin treats depression and Obsessive
Compulsive
Disorder
(OCD).
Like
all
medicines it can have unwanted effects. It is
therefore important that you and your doctor
weigh up the benefits of treatment against the
possible unwanted effects, before starting
treatment.
•
Faverin should not be used to treat
depression in children and adolescents
under 18. See section 2, Use in Children and
adolescents under 18.
•
Faverin won’t work straight away. Some
people taking antidepressants feel worse
before feeling better. Your doctor should see
you regularly during your course of treatment.
Tell your doctor if you haven’t started feeling
better.
•
Some people who are depressed or anxious
think of harming or killing themselves. If you
start to feel worse, or think of harming or killing
yourself, see your doctor or go to a hospital
straight away.
•
Don’t stop taking Faverin without talking to
your doctor. If you stop taking Faverin
suddenly or miss a dose, you may get
withdrawal effects. See Section 3, How to take
Faverin.
•
If you feel restless and feel like you can’t
sit or stand still, tell your doctor. Increasing
the dose of Faverin may make these feelings
worse.
•
Taking some other medicines with Faverin
can cause problems. You may need to talk
to your doctor. See section 2, Are you taking
any other medicines.
•
If you are pregnant or planning to get
pregnant, talk to your doctor. See section 2,
Pregnancy and breastfeeding.
Read all of this leaflet carefully before you start
taking this medicine.
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. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
If any of the side effects become serious, or if you
notice any

خصائص المنتج

Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Faverin 50 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg fluvoxamine maleate.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet
Round, biconvex, scored, white to off-white film coated tablets
imprinted '291' on both
sides of the score.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Major depressive episode
-
Obsessive Compulsive Disorder (OCD)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Depression _
_ _
_Adults_
The recommended dose is 100 mg daily. Patients should start on 50 or
100 mg, given
as a single dose in the evening. Dosage should be reviewed and
adjusted if necessary
within 3 to 4 weeks of initiation of therapy and thereafter as judged
clinically
appropriate. Although there may be an increased potential for
undesirable effects at
higher doses, if after some weeks on the recommended dose insufficient
response is
seen some patients may benefit from having their dose increased
gradually up to a
maximum of 300 mg a day (see section 5.1). Doses up to 150 mg can be
given as a
single dose, preferably in the evening. It is advisable that a total
daily dose of more
than 150 mg is given in 2 or 3 divided doses. Dosage adjustments
should be made
carefully on an individual patient basis, to maintain the patients at
the lowest effective
dose.
Patients with depression should be treated for a sufficient period of
at least 6 months
to ensure that they are free from symptoms.
Page 2 of 15
_Children/adolescents_
Faverin should not be used in children and adolescents under the age
of 18 years for the
treatment of major depressive episode. The efficacy and safety of
Faverin have not been
established in the treatment of paediatric major depressive episode
(see section 4.4).
_Obsessive Compulsive Disorder_
_ _
_Adults_
The recommended dose is between 100-300 mg daily. Patients should
start at 50 mg
per day. Al