NORZAC 20 Milligram Capsules Hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUOXETINE HYDROCHLORIDE

Available from:

Norton Healthcare Limited T/A IVAX Pharmaceuticals UK

INN (International Name):

FLUOXETINE HYDROCHLORIDE

Dosage:

20 Milligram

Pharmaceutical form:

Capsules Hard

Prescription type:

Product subject to prescription which may not be renewed (A)

Authorization status:

Withdrawn

Authorization date:

2014-06-11

Patient Information leaflet

PRODUCT:
AMENDS:
APPROVAL:
• SUBJECT TO REG. AGENCY APPROVAL
• APPROVED BY REG. DEPT. FOR PRINT 
DESIGN DEPARTMENT 
Harlow
Signed
Signed
29931
NORZAC (FLUOXETINE) 20MG HARD 
CAPS ALL (FOR PUT) TEI V2
12-8-13
160x560mm
5
19-12-13
YS
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CUTTER GUIDE
PMS PROCESS BLACK
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PAGE 1: FRONT FACE (INSIDE OF REEL)
NORZAC™ 
20 MG HARD CAPSULES 
FL UOXETINE (AS HYDROCHLORIDE) 
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START 
USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT 
INFORMATION FOR YOU.
•  Keep this leafl et. 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 leafl et. See section 4.
WHAT IS IN THIS LEAFLET
1.  WHAT NORZAC HARD CAPSULES ARE AND WHAT THEY 
ARE USED FOR 
2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORZAC 
HARD CAPSULES
3. HOW TO TAKE NORZAC HARD CAPSULES
4. POSSIBLE SIDE EFFECTS 
5. HOW TO STORE NORZAC HARD CAPSULES
6. CONTENTS OF THE PACK AND OTHER INFORMATION 
  WHAT NORZAC HARD CAPSULES 
ARE AND WHAT THEY ARE USED 
FOR
Norzac Hard Capsules contain fl uoxetine which 
belongs to a group of medicines ca

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Norzac 20 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 22.4 mg of fluoxetine hydrochloride equivalent to 20.0 mg fluoxetine base.
Excipients - Contains Lactose Monohydrate 146.6mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules, hard.
Light green, opaque capsules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Adults:_
Major depressive episodes.
Obsessive-compulsive disorder.
Bulimia nervosa: Norzac 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
For oral administration to adults only.
_Major depressive episodes_
Adults and the elderly: 20 mg/day to 60 mg/day. A dose of 20 mg/day is recommended as the initial dose. Although
there may be an increased potential for undesirable effects at higher doses, a dose increase may be considered after
three weeks if there is no response.
In agreement with the consensus statement of the WHO, antidepressant medication should be continued for at least 6
months.
_Obsessive-compulsive disorder _- Adults and the elderly: 20 mg/day to 60 mg/day. A dose of 20mg/day is
recommended as the initial dose. Although there may be an increased potential for side effects at higher doses, a dose
increase may be considered after two weeks if there is no response. If no improvement is observed with