PROZAC

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FLUOXETINE AS HYDROCHLORIDE

Available from:

ELI LILLY ISRAEL LTD, ISRAEL

ATC code:

N06AB03

Pharmaceutical form:

CAPSULES

Composition:

FLUOXETINE AS HYDROCHLORIDE 20 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

PATHEON FRANCE S.A.S.,FRANCE

Therapeutic area:

FLUOXETINE

Therapeutic indications:

Adults:Major depressive episodes.Obsessive-compulsive disorder (OCD).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.

Authorization date:

2015-02-28

Patient Information leaflet

I PROZCP P 13
Page 1 of 11
PATIENT PACKAGE LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a physician’s prescription only
Prozac
Capsules
Active ingredient:
Each capsule contains fluoxetine (as hydrochloride) 20 mg
Inactive ingredients and allergens: see section 6 “Additional
Information”.
Read this entire leaflet carefully before you start using this
medicine. This leaflet
contains concise information about this medicine. If you have any
further questions,
ask your doctor or pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on
to others. It may harm them, even if you think that their illness is
the same as yours.
Antidepressants and antianxiety medicines increase the risk of
suicidal behavior
and thoughts among children, adolescents and young adults up to 25
years of age.
When beginning treatment with this medicine, patients of all ages and
their
relatives, must monitor behavioral changes such as: worsening of
depression,
suicidal thoughts, aggressiveness etc.
If changes such as these occur, contact the doctor immediately.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Prozac is indicated for the treatment of:
Adults:

Major depressive episodes

Obsessive-compulsive disorder (OCD)

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.
Therapeutic group:
Prozac belongs to a group of medicines called Selective Serotonin
Reuptake
Inhibitor (SSRI) antidepressants.
How Prozac works
Everyone has a substance called serotonin in their brain. People who
are depressed
or have obsessive-compulsive d

Summary of Product characteristics

X PROZCP P 13
Page 1 of 18
1.
NAME OF THE MEDICINAL PRODUCT
Prozac
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20 mg of fluoxetine (as fluoxetine
hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsules.
The capsules are green and yellow, printed ‘Lilly 3105’.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS:
Major depressive episodes.
Obsessive-compulsive disorder (OCD).
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.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior
in children,
adolescents, and young adults in short-term studies. These studies did
not show an
increase in the risk of suicidal thoughts and behavior with
antidepressant use in
patients over age 25; there was a reduction in risk with
antidepressant use in patients
aged 65 and older [see Special warnings and precautions for use
(section 4.4)].
In patients of all ages who are started on antidepressant therapy
monitor closely for
clinical worsening and emergence of suicidal thoughts and behaviors.
Advise families
and caregivers of the need for close observation and communication
with the
prescriber [see Special warnings and precautions for use (section
4.4)].
X PROZCP P 13
Page 2 of 18
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
_Major Depressive Disorder _
Adults and the elderly: The recommended dose is 20 mg 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 a