FLUOXETINE GENERICHEALTH fluoxetine (as hydrochloride) 20 mg capsule blister pack

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

fluoxetine hydrochloride, Quantity: 22.36 mg (Equivalent: fluoxetine, Qty 20 mg)

Saatavilla:

Generic Health Pty Ltd

INN (Kansainvälinen yleisnimi):

Fluoxetine hydrochloride

Lääkemuoto:

Capsule, hard

Koostumus:

Excipient Ingredients: pregelatinised maize starch; Gelatin; purified water; sodium lauryl sulfate; allura red AC; quinoline yellow; titanium dioxide; brilliant blue FCF

Antoreitti:

Oral

Kpl paketissa:

28 capsules

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

Major depression. Obsessive Compulsive Disorder. Premenstrual Dysphoric Disorder (PMDD) as defined by DSM-IV criteria.

Tuoteyhteenveto:

Visual Identification: Light green/off-white size 3 capsule containing white powder; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2008-10-21

Pakkausseloste

CONSUMER MEDICINE INFORMATION
FLUOXETINE GENERICHEALTH
(FLUOXETINE HYDROCHLORIDE) CAPSULES
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Fluoxetine generichealth. 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
Fluoxetine generichealth 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 FLUOXETINE
GENERICHEALTH IS USED FOR
Fluoxetine generichealth is used
to treat:
•
Depression.
•
Obsessive compulsive
disorder (OCD).
•
Premenstrual dysphoric
disorder (PMDD).
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
FLUOXETINE GENERICHEALTH HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have
prescribed Fluoxetine
generichealth for another
reason.
Fluoxetine 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.
Fluoxetine generichealth is
available only with a doctor's
prescription.
Fluoxetine generichealth is not
recommended for use in
children and adolescents under
18 years of age.
BEFORE YOU TAKE
FLUOXETINE GENERICHEALTH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE FLUOXETINE
GENERICHEALTH 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 FLUOXETINE
GENERICHEALTH IF YOU ARE TAKING
ANOTHER MEDICINE FOR
DEPRESSION CALLED A
MONOAMINE OXIDASE INHIBITOR
(MAOI) OR HAVE BEEN TAKING A
MAOI WITHIN THE LAST 14 DAYS.
CHECK WITH YOUR DOCTOR OR
P

Valmisteyhteenveto

AUSTRALIAN PRODUCT INFORMATION – FLUOXETINE GENERICHEALTH
(FLUOXETINE HYDROCHLORIDE) CAPSULES
1
NAME OF THE MEDICINE
Fluoxetine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20 mg fluoxetine (as hydrochloride).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Fluoxetine generichealth: Light green/off-white size 3 capsule
containing white powder.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fluoxetine generichealth is indicated for the treatment of:
•
Major depression;
•
Obsessive Compulsive Disorder;
•
Premenstrual Dysphoric Disorder (PMDD) as defined by DSM-IV criteria.
The essential features of PMDD, according to the Diagnostic and
Statistical Manual-4th edition (DSM-IV)
include markedly depressed mood, anxiety or tension, affective
lability and persistent anger or
irritability. Other features include decreased interest in usual
activities, difficulty concentrating, lack of
energy, change in appetite or sleep and feeling out of control.
Physical symptoms associated with PMDD
include breast tenderness, headache, joint and muscle pain, bloating
and weight gain. These symptoms
occur regularly during the luteal phase and remit within a few days
following onset of menses; the
disturbance markedly interferes with work or school or with usual
social activities and relationships with
others.
4.2 DOSE AND METHOD OF ADMINISTRATION
Fluoxetine generichealth capsules should be swallowed whole.
DEPRESSION
A dose of 20 mg/day, administered in the morning, is the usual
recommended initial dose.
If no clinical improvement is observed, a dose increase may be
considered after several weeks. Doses
above 20 mg/day should be administered on a b.i.d. schedule (i.e.
morning and noon) and should not
exceed a maximum dose of 80 mg/day (see SECTION 5.2 PHARMACOKINETIC
PROPERTIES – CLINICAL ISSUES
RELATED TO ACCUMULATION AND SLOW ELIMINATION).
Fluoxetine generichealth v4
Page 2 of 22
(fluoxetine hydrochloride) capsules
As with other antidepressants