Prozac 20
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
23-10-2013
Summary of Product characteristics
(SPC)
14-10-2022
Active ingredient:
Fluoxetine hydrochloride 22.36mg equivalent to fluoxetine 20 mg
Available from:
Eli Lilly and Company (NZ) Limited
ATC code:
N06AB03
INN (International Name):
Fluoxetine hydrochloride 22.36 mg (equivalent to fluoxetine 20 mg)
Dosage:
20 mg
Pharmaceutical form:
Capsule
Composition:
Active: Fluoxetine hydrochloride 22.36mg equivalent to fluoxetine 20 mg Excipient: Dimeticone Gelatin Ink Iron oxide yellow Patent blue V Starch Titanium dioxide
Units in package:
Capsules: Each pack contains 28 capsules
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Siegfried Ltd
Therapeutic indications:
· Depression and it's associated anxiety · Bulimia nervosa · Obsessive-Compulsive disorder and Premenstrual dysphoric disorder - a severe form of PMS. Diagnosis of PMDD: The essential features of PMDD are clear and established cyclicity of symptoms (occurring during the last week of the luteal phase in most menstrual cycles) such as depressed mood, anxiety, affective lability, and physical symptoms such as breast tenderness or swelling, headaches, joint or muscle pain, bloating, and weight gain. PMDD is a severe clinical entity and is distinguished from the broader premenstrual syndrome by the intensity of its symptoms (particularly mood symptoms) and the extent to which it interferes with social and/or occupational function
Product summary:
Package - Contents - Shelf Life: Blister pack, sample pack - 7 capsules - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 28 capsules - 36 months from date of manufacture stored at or below 30°C
Authorization date:
1988-02-04
Patient Information leaflet
PROZAC
®
_fluoxetine hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PROZAC. It does not
contain all the available information
.
It
does not take the place of talking with
your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking PROZAC against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS MEDICINE.
You may need to read it again.
WHAT PROZAC IS USED
FOR
PROZAC is used to treat:
• depression
• obsessive compulsive disorder
(OCD)
• premenstrual dysphoric disorder
(PMDD)
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PROZAC HAS
BEEN PRESCRIBED FOR YOU. Your doctor
may have prescribed PROZAC for
another reason.
PROZAC belongs to a group of
medicines called selective serotonin
reuptake inhibitors (SSRIs). SSRIs are
thought to work by their action on brain
chemicals called amines which are
involved in controlling mood.
PROZAC is available only with a
doctor’s prescription.
PROZAC is not recommended for use
in children and adolescents under 18
years of age.
BEFORE YOU TAKE PROZAC
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PROZAC IF YOU ARE
ALLERGIC TO
• ANY MEDICINES CONTAINING
FLUOXETINE
• ANY OF THE INGREDIENTS LISTED AT THE
END
OF THIS LEAFLET.
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips,
tongue or other parts of the body; rash,
itching or hives on the skin.
DO NOT TAKE PROZAC IF YOU ARE
TAKING ANOTHER MEDICINE FOR
DEPRESSION CALLED A MONOAMINE
OXIDASE
Read the complete document
Summary of Product characteristics
NEW ZEALAND DATA SHEET
Prozac-ds-vA14_28Sep2022
SUPERSEDES: Prozac-ds-vA13.0_18Feb21
Page 1 of 14
1.
PROZAC
®
PROZAC 20 mg capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains fluoxetine hydrochloride equivalent to 20 mg
fluoxetine.
For the full list of excipients, see Section 6.1 List of excipients
3.
PHARMACEUTICAL FORM
PROZAC 20 capsules are presented as size 3, green/cream capsules
bearing the identicode
“Lilly 3105” printed in black ink on both the capsule cap and
base.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Depression and its associated anxiety,
Bulimia nervosa,
Obsessive-Compulsive disorder and
Premenstrual dysphoric disorder - a severe form of PMS.
Diagnosis of PMDD: The essential features of PMDD are clear and
established cyclicity of
symptoms (occurring during the last week of the luteal phase in most
menstrual cycles) such
as depressed mood, anxiety, affective lability, and physical symptoms
such as breast
tenderness or swelling, headaches, joint or muscle pain, bloating, and
weight gain. PMDD is a
severe clinical entity and is distinguished from the broader
premenstrual syndrome by the
intensity of its symptoms (particularly mood symptoms) and the extent
to which it interferes
with social and/or occupational function._ _
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
Depression - 20 mg per day is the recommended initial dose.
Bulimia Nervosa - 60 mg per day is the recommended dose.
Obsessive-Compulsive Disorder - 20 mg to 60 mg per day is the
recommended dose.
Premenstrual Dysphoric Disorder - 20 mg per day is recommended
continuously throughout
the menstrual cycle. Initial treatment should be limited to six
months, after which patients
should be reassessed regarding the benefit of continued therapy.
_All indications_ - The recommended dose may be increased or
decreased. Doses above 80
mg/day have not been systematically evaluated.
NEW ZEALAND DATA SHEET
Prozac-ds-vA14_28Sep2022
SUPERSEDES: Prozac-ds-vA13.0_18Feb21
Page 2 of 14
_Age_
There are no data to suggest tha
Read the complete document
