FLUOXETINE MLABS 20mg fluoxetine (as hydrochloride) 20 mg capsules blister pack

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

fluoxetine hydrochloride, Quantity: 22.35 mg (Equivalent: fluoxetine, Qty 20 mg)

Tersedia dari:

Micro Labs Pty Ltd

INN (Nama Internasional):

Fluoxetine hydrochloride

Bentuk farmasi:

Capsule, hard

Komposisi:

Excipient Ingredients: pregelatinised maize starch; Shellac; ethanol absolute; iron oxide black; butan-1-ol; isopropyl alcohol; propylene glycol; purified water; titanium dioxide; brilliant blue FCF; iron oxide yellow; Gelatin; sodium lauryl sulfate

Rute administrasi :

Oral

Unit dalam paket:

PVC/PVdC/Aluminium blister pack of 28 (14'sx2) capsules in carton

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

FLUOXETINE MLABS 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.

Ringkasan produk:

Visual Identification: Green/Off-white hard gelatin self locked capsules of size '2' imprinted with 'FLX' and 'MIL' on cap/body in black edible ink containing white powder.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 42 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status otorisasi:

Registered

Tanggal Otorisasi:

2017-02-23

Selebaran informasi

FLUOXETINE MLABS
1
FLUOXETINE MLABS
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or
pharmacist.
1.
WHY AM I USING FLUOXETINE MLABS?
FLUOXETINE MLabs contains the active ingredient fluoxetine
hydrochloride. FLUOXETINE MLabs is used to treat
depression, obsessive compulsive disorder (OCD) and premenstrual
dysphoric disorder (PMDD).
For more information, see Section 1. Why am I using FLUOXETINE MLabs?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE FLUOXETINE MLABS?
Do not use if you have ever had an allergic reaction to fluoxetine or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO
BECOME PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
FLUOXETINE MLabs? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with FLUOXETINE MLabs and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE FLUOXETINE MLABS?

Your doctor will tell you how much FLUOXETINE MLabs you need to take
each day.
More instructions can be found in Section 4. How do I use FLUOXETINE
MLabs? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING FLUOXETINE MLABS?
THINGS YOU
SHOULD DO

Remind any doctor, dentist or pharmacist you visit that you are taking
FLUOXETINE MLabs.

Tell your doctor immediately if you become pregnant while taking
FLUOXETINE MLabs.

Tell your doctor immediately if you have thoughts about harming or
killing yourself
THINGS YOU
SHOULD NOT
DO


Do not stop using this medicine suddenly or lower the dosage without
checking with your doctor.

Do not take the herbal remedy St. John’s Wort while you are being
treated with FLUOXETINE
MLabs.

Do not give FLUOXETINE MLabs to anyone else, even if they have the
same condition

Karakteristik produk

FLUOXETINE MLABS
1
AUSTRALIAN PRODUCT INFORMATION
FLUOXETINE MLABS 20 MG (FLUOXETINE HYDROCHLORIDE) CAPSULES
1.
NAME OF THE MEDICINE
Fluoxetine Hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
FLUOXETINE
MLABS
capsules
contains
fluoxetine
hydrochloride
equivalent
to
20
mg
of
fluoxetine.
For a full list of excipients, See section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
20 mg fluoxetine (present as the hydrochloride) green/off-white hard
gelatin self locked capsules
of size '2' imprinted with 'FLX' and 'MIL' on cap/body in black edible
ink containing white
powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FLUOXETINE MLabs is indicated for
Treatment of Major depression.
Treatment of Obsessive Compulsive Disorder.
Treatment of 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 MLabs is only available as a 20 mg capsule and therefore
only appropriate for use _
_in patients prescribed ≥ 20 mg of fluoxetine. For patients
requiring treatment with lower _
_strengths of fluoxetine, fluoxetine dispersible tablets are available
from other brands. _
Fluoxetine MLabs capsules should be swallowed whole.
FLUOXETINE MLABS
2
DEPRESSION:
A dose of 20 mg/day, administered in the morning, is the usual
recommended initial d