Fluoxetine 60mg capsules

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Fluoxetine hydrochloride

Prieinama:

DE Pharmaceuticals

ATC kodas:

N06AB03

INN (Tarptautinis Pavadinimas):

Fluoxetine hydrochloride

Dozė:

60mg

Vaisto forma:

Oral capsule

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 04030300

Pakuotės lapelis

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE.
•
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. Do not pass it on to others. It may
harm them, even if their symptoms are the
same as yours.
•
If any of the side effects gets serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. What Fluoxetine Capsules are and what
they are used for.
2. Before you take Fluoxetine Capsules
3. How to take Fluoxetine Capsules
4. Possible side effects
5. How to store Fluoxetine Capsules
6. Further Information
1. WHAT FLUOXETINE CAPSULES ARE
AND WHAT THEY ARE USED FOR?
The name of your medicine is Fluoxetine
60mg Capsules (called fluoxetine throughout
this leaflet). Fluoxetine belongs to a group of
medicines called 'selective serotonin
reuptake inhibitor (SSRI) antidepressants'.
They are used to treat the following
conditions IN ADULTS: -
-
the symptoms of depression and any
feelings of anxiety.
-
the symptoms of obsessive-compulsive
disorder (OCD).
-
Bulimia nervosa: for the reduction of
binge-eating and purging activity
2. BEFORE YOU TAKE FLUOXETINE
CAPSULES
You should not take fluoxetine until you are
sure it is safe for you to do so.
DO NOT TAKE FLUOXETINE AND TELL YOUR DOCTOR IF:
-
You are allergic (hypersensitive) to
fluoxetine hydrochloride or any of the other
ingredients of fluoxetine capsules (listed in
Section 6 below). If you develop a rash or
other allergic reactions (like itching,
swollen lips or face or shortness of breath),
stop taking the capsules straight away and
contact your doctor immediately.
-
taking other medicines used to treat
depression, known as non-selective
monoamine oxidase inhibitors or reversible
monoamine oxidase inhibitors type A
(MAOIs), since serious or even fatal
reactions can occur. Examples of MAOIs
include nialamide, iproniazide, selegeline,
moclobemide, phenelzine, tranylcyp

Prekės savybės

1
NAME OF THE MEDICINAL PRODUCT
Fluoxetine 60 mg Capsules, Hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains fluoxetine hydrochloride equivalent to 60mg of
fluoxetine.
Excipient with known effect:
Each capsule contains 256.92 mg lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
Capsule size 1 with a light yellow opaque body and cap, printed
“FL60” on the body and
“G” on the cap in black ink.
4.1
THERAPEUTIC INDICATIONS
Fluoxetine 60 mg capsules are indicated for:
_ _
_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
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.
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
patient