Fluoxetine 20mg Hard Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fluoxetine

Available from:

Bristol Laboratories Limited

ATC code:

N06AB; N06AB03

INN (International Name):

Fluoxetine

Dosage:

20 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Selective serotonin reuptake inhibitors; fluoxetine

Authorization status:

Not marketed

Authorization date:

2012-07-13

Patient Information leaflet

SAME SIZE ARTWORK
480 x 240 MM
Front
Ir
PACKAGE LEAFLET: INFORMATION FOR USER
FLUOXETINE 20 MG HARD CAPSULES
FLUOXETINE 60 MG HARD CAPSULES
(FLUOXETINE)
EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT FLUOXETINE
FLUOXETINE 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.
FLUOXETINE IS NOT FOR USE IN CHILDREN AND ADOLESCENTS UNDER 18. See
section 2, _ Use_
_in children and adolescents aged 8 to 18 years._
FLUOXETINE 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 Fluoxetine 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 FLUOXETINE WITHOUT TALKING TO YOUR DOCTOR. If you
stop taking
Fluoxetine 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 Fluoxetine may make these feelings worse. See
section 4, _Possible_
_side-effects._
TAKING SOME OTHER MEDICINES WITH FLUOXETINE CAN CAUSE PROBLEMS. You
may need
to talk to your doctor. See section 2, _Other medicines and Fluoxetine
capsules._
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

Summary of Product characteristics

Health Products Regulatory Authority
02 October 2019
CRN00980R
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fluoxetine 20mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Fluoxetine 20mg capsule contains 20mg of fluoxetine as fluoxetine
hydrochloride.
Excipient with known effect: Sunset Yellow (E110) 0.0014 mg per
capsule
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule Hard (capsules)
Hard gelatin capsules, size '4', having green coloured cap and cream
coloured body filled with white to off-white powder.
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
_Major depressive episodes_
_Adults and the elderly_: A dose of 20 mg/day is recommended. 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 20mg, the dose may be increased
gradually up to a maximum of 3 capsules (60mg) (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 the elderly: The recom