Prozac 20mg hard capsules

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Wirkstoff:

FLUOXETINE

Verfügbar ab:

Eli Lilly & Co. Limited

ATC-Code:

N06AB03

INN (Internationale Bezeichnung):

FLUOXETINE

Darreichungsform:

HARD CAPSULE

Zusammensetzung:

FLUOXETINE 20 mg

Verschreibungstyp:

POM

Therapiebereich:

PSYCHOANALEPTICS

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2007-01-29

Gebrauchsinformation

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROZAC 20 MG HARD CAPSULES
_fluoxetine _
EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT PROZAC
PROZAC 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.
PROZAC IS NOT FOR USE IN CHILDREN AND ADOLESCENTS UNDER 18. See
section 2, _Children and adolescents aged _
_8 to 18 years. _
PROZAC 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, _How to take
Prozac hard capsules. _
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 PROZAC WITHOUT TALKING TO YOUR DOCTOR. If you stop
taking Prozac 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 Prozac
may make these feelings worse. See section 4, _Possible side-effects.
_
TAKING SOME OTHER MEDICINES WITH PROZAC CAN CAUSE PROBLEMS. You may
need to talk to your doctor. See
section 2, _Taking other medicines. _
IF YOU ARE PREGNANT OR PLANNING TO GET PREGNANT, talk to your doctor.
See section 2, _Pregnancy, breast-_
_feeding and fertility._
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 il

Fachinformation

Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 16
1.
NAME OF THE MEDICINAL PRODUCT
Prozac 20 mg hard capsules
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.
Bulimia nervosa: Prozac 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
Posology
_Adults _
_Major depressive episodes _
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 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.
Page 3 of 16
_Obsessive-compulsive disorder _
Adults and the elderly: The recommended dose is 20 mg daily. Although
there may be an increased potential
for undesirable effects at higher doses, in some patients, if after
two weeks there is insufficient response to
20 mg, the dose may be increased