Magrilan capsules

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

fluoxetine (fluoxetine hydrochloride)

Available from:

Medochemie Ltd (Factory AZ)

ATC code:

N06AB03

INN (International Name):

fluoxetine (fluoxetine hydrochloride)

Dosage:

20mg

Pharmaceutical form:

capsules

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-12-23

Patient Information leaflet

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Package leaflet: Information for the patient
Magrilan 20mg capsules
Fluoxetine hydrochloride
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

Summary of Product characteristics

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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 20 mg capsule contains 105.0 mg lactose monohydrate.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Blue-white hard gelatine capsules, size “4”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults:_
•
_Major depressive episodes_
.
•
_Obsessive-compulsive disorder_
.
•
_Bulimia nervosa:_
Magrilan 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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Posology
MAJOR DEPRESSIVE EPISODES
_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
effe