Fluoxetine 20mg capsules

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Fluoxetine hydrochloride

Boleh didapati daripada:

Teva UK Ltd

Kod ATC:

N06AB03

INN (Nama Antarabangsa):

Fluoxetine hydrochloride

Dos:

20mg

Borang farmaseutikal:

Oral capsule

Laluan pentadbiran:

Oral

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 04030300; GTIN: 5017007027409

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUOXETINE 20 MG HARD CAPSULES
fluoxetine
_ _
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 illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Fluoxetine is and what it is used for
2.
What you need to know before you take Fluoxetine
3.
How to take Fluoxetine
4.
Possible side effects
5.
How to store Fluoxetine
6.
Contents of the pack and other information
IMPORTANT THINGS THAT YOU NEED TO KNOW:

Fluoxetine capsules are prescribed for different conditions, including
major depressive
episodes, obsessive-compulsive disorder and bulimia nervosa.

TAKE FLUOXETINE REGULARLY TO GET THE MAXIMUM BENEFIT. You should not
stop taking the
medicine without talking to your doctor. Sometimes stopping the
medicine can cause
problems.

Fluoxetine can cause side effects, although most people do not have
serious problems –
see section 4 for details. If you have a rash or allergic reaction
such as itching, swollen
lips/tongue or wheezing/shortness of breath; thoughts of harming or
killing yourself;
unexplained fever with faster breathing or heart rate; extreme
agitation or sleepiness;
yellowing of the skin; fits/seizures; or your skin starts to turn red
and then blister or peel,
see your doctor immediately.

Some side effects may occur early in treatment. These often disappear
after a few days as
your body gets used to the drug (for example chills, diarrhoea or
shortness of breath).

Taking other medications, including other anti-depressant drugs, may
sometimes cause
problems. Check with your do

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluoxetine 20 mg Hard Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 20 mg of fluoxetine (as hydrochloride).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard capsule
Powder blue cap with a white body.
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: 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 patients, if
after two weeks there is insufficient response to 20 mg, the dose may
be increased
gradually up to a maximum of 60 mg. If no improvement is observed
within 10