Prozac 20 mg per 5 ml oral solution

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

FLUOXETINE HYDROCHLORIDE

MAH:

Eli Lilly Nederland B.V.

ATC_code:

N06AB; N06AB03

INN:

FLUOXETINE HYDROCHLORIDE

dosage:

20 mg/5ml

pharmaceutical_form:

Oral solution

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:

1994-02-23

PIL

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROZAC 20 MG PER 5 ML ORAL SOLUTION
_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 Prozac oral solution is and what it is used for
2.
What you need to know before you take Prozac oral solution
3.
How to take Prozac oral solution
4.
Possible side effects
5.
How to store Prozac oral solution
6.
Content of the pack and other information
1.
WHAT PROZAC ORAL SOLUTION IS AND WHAT IT IS USED FOR
Prozac 20 mg per 5 mL oral solution contains the active substance
fluoxetine which is one of a group of
medicines called selective serotonin re-uptake inhibitors (SSRI)
antidepressants.
This medicine is used to treat the following conditions:
_ _
_Adults_
:
•
Major depressive episodes
•
Obsessive-compulsive disorder
•
Bulimia nervosa: Prozac is used alongside psychotherapy for the
reduction of binge-eating and
purging
_Children and adolescents aged 8 years and above_
:
•
Moderate to severe major depressive disorder, if the depression does
not respond to psychological
therapy after 4-6 sessions. Prozac should be offered to a child or
young person with moderate to
severe major depressive disorder
ONLY
in combination with psychological therapy.
How Prozac works
Everyone has a substance called serotonin in their brain. People who
are depressed or have obsessive-
compulsive disorder or bulimia nervosa have lower levels of serotonin
than others. It is not fully understood
how Prozac and other SSRIs work but they may help by increasing the
level of ser

SPC

Health Products Regulatory Authority
26 March 2021
CRN00C4WS
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prozac 20 mg per 5 ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL of oral solution contains 20 mg of fluoxetine (as fluoxetine
hydrochloride).
Excipients with known effect
Contains 3 g of sucrose, 2.5 mg benzoic acid(E 210), 9.56 mg of
ethanol and traces of benzyl alcohol in each 5 mL dose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
The solution is clear, colourless, mint odoured.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults:
Major depressive episodes.
Obsessive-compulsive disorder.
Bulimia nervosa: Prozac 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 _
Health Products Regulatory Authority
26 March 2021
CRN00C4WS
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