Fluoxetine 20mg capsules

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Fluoxetine hydrochloride

זמין מ:

Bristol Laboratories Ltd

קוד ATC:

N06AB03

INN (שם בינלאומי):

Fluoxetine hydrochloride

כמות:

20mg

טופס פרצבטיות:

Oral capsule

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 04030300; GTIN: 5060013943874

עלון מידע

SAME SIZE ARTWORK
480 x 260 MM
Front
PACKAGE LEAFLET: INFORMATION FOR USER
FLUOXETINE 20MG CAPSULES
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, breastfeeding 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

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluoxetine 20 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains fluoxetine hydrochloride equivalent to 20mg
fluoxetine.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, Hard.
Green/Off-white hard gelatine self locked capsules of size ‘2’
imprinted with
’20’ and 'BL' on cap / body in black edible ink containing white
powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults:
Major depressive disorders/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 disorders/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 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 recommended dose is 20mg daily. Although
there may be
an increased potential for undesirable effects at higher doses, in
some patients, i