Fluoxetine 60mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluoxetine hydrochloride

Available from:

Viatris UK Healthcare Ltd

ATC code:

N06AB03

INN (International Name):

Fluoxetine hydrochloride

Dosage:

60mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030300; GTIN: 5016695320427

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUOXETINE 60 MG
CAPSULES, HARD
(fluoxetine)
EIGHT IMPORTANT THINGS YOU NEED TO KNOW
ABOUT FLUOXETINE.
Please read all of this leaflet. It includes a lot
of additional important information about
this medicine.
• 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. See section 4
‘Possible side effects’, inside this leaflet.
• FLUOXETINE IS NOT FOR USE IN CHILDREN UNDER
8 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 have
started feeling better. See section 3, ‘How to
take Fluoxetine’.
• 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 ‘What you need to
know before you take Fluoxetine’.
• 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, ‘If you stop
taking Fluoxetine’.
• 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’.
• IF YOU ARE PREGNANT OR PLANNING TO BECOME
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

Summary of Product characteristics

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