Magrilan 20mg Capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FLUOXETINE

Available from:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC code:

N06AB03

INN (International Name):

FLUOXETINE 20 mg

Pharmaceutical form:

CAPSULE

Composition:

FLUOXETINE 20 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Authorised

Authorization date:

2007-03-13

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MAGRILAN 20MG CAPSULES
Fluoxetine
EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT MAGRILAN
•
MAGRILAN TREATS DEPRESSION AND ANXIETY DISORDERS.
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.
•
MAGRILAN IS NOT FOR USE IN CHILDREN AND ADOLESCENTS UNDER 18
. See section 2, Use in
children and adolescents aged 8 to 18 years.
•
MAGRILAN WON’T WORK STRAIGHT AWAY
. Some people taking antidepressants feel worse
before feeling better. Your doctor should ask to see you again a
couple of weeks after you
first start treatment. Tell your doctor if you haven’t started
feeling better. See section 3.
•
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
. See section 2.
•
DON’T STOP TAKING MAGRILAN WITHOUT TALKING TO YOUR DOCTOR
. If you stop taking Magrilan
suddenly or miss a dose, you may get withdrawal effects. See section 3
for further
information.
•
IF YOU FEEL RESTLESS AND FEEL LIKE YOU CAN’T SIT OR STAND STILL,
TELL YOUR DOCTOR
. Increasing
the dose of Magrilan may make these feelings worse. See section 4.
•
TAKING SOME OTHER MEDICINES WITH MAGRILAN CAN CAUSE PROBLEMS
. You may need to talk
to your doctor. See section 2.
•
IF YOU ARE PREGNANT OR PLANNING TO GET PREGNANT, TALK TO YOUR DOCTOR
. See section 2.
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

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Magrilan 20mg capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Magrilan 20mg capsule, contains Fluoxetine Hydrochloride
equivalent to 20mg of Fluoxetine
base.
Excipients with known effect: lactose monohydrate. Each capsule
contains 105.0 mg lactose
monohydrate.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gelatine capsules, size “4”.
4.
CLINICAL PARTICULARS 4.1
THERAPEUTIC INDICATIONS
_Adults:_
•
_Major depressive episodes_
.
•
_Obsessive-compulsive disorder_
.
•
_Bulimia nervosa:_
Fluoxetine is indicated as a complement of psychotherapy for the
reduction of binge-eating and purging activity.
_Children and adolescents aged 8 years and above: _
Moderate to severe major depressive episode, if depression is
unresponsive to psychological
therapy after 4-6 sessions. Antidepressant medication should be
offered to a child or young person
with moderate to severe depression only in combination with a
concurrent psychological therapy.
2 4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Major depressive episode_
_Adults and Elderly: _
The recommended dose is 20mg daily. 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,
in some patients, with insufficient response to 20 mg, the dose may be
increased gradually up to a
maximum of 60 mg (see section 5.1). 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.
_Obsessive-Compulsive disorder_
_Adults and Elderly: _
The recommended dose is 20mg daily. Although there may be an increased
potential for undesirable effects at higher doses, in some patients,
if after two weeks t