LUVOX 100MG FILM COATED TABLET

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

FLUVOXAMINE MALEATE

Available from:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (International Name):

FLUVOXAMINE MALEATE

Units in package:

30Tablet Tablets; 30 Tablets

Manufactured by:

Mylan Laboratories SAS

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
LUVOX® FILM-COATED TABLET
_ _
Fluvoxamine maleate (50mg, 100mg)
1
WHAT IS IN THIS LEAFLET
1. What Luvox® is used for
2. How Luvox® works
3. Before you use Luvox®
4. How to use Luvox®
5. While you are using it
6. Side effects
7. Storage and disposal of Luvox®
8. Product description
9. Manufacturer and product
registration holder
10. Date of revision
WHAT LUVOX®
IS USED FOR
It is used to treat depression.
Luvox® can also treat people who
have obsessive compulsive disorder
(OCD).
HOW LUVOX® WORKS
Luvox® belongs to a group of
medicines called selective serotonin
re-uptake inhibitors (SSRI).
It contains a substance called
fluvoxamine that works to correct the
chemical imbalance in the brain that
are thought to cause depression and
OCD, helping to relieve symptoms.
BEFORE YOU USE LUVOX®
_- When you must not use it _
•
If you are allergic to
fluvoxamine maleate or any
of the ingredients listed at
the end of this leaflet
•
You are taking medicines
called monoamine oxidase
inhibitors (MAOI) or have
taken them in the last two
weeks. Your doctor will
advise you how you should
begin taking Luvox® once
you have stopped taking the
MAOI. This medicine is
sometimes prescribed to
treat depression
•
You are breast feeding
Do not take this medicine if you
are taking the following medicines:
• pimozide, used for mental problems
• tizanidine, used as a muscle
relaxant.
• ramelteon, used to help you sleep
Do not take Luvox® if any of the
above apply to you. If you are not
sure, talk to your doctor or
pharmacist before taking Luvox®.
_- Before you start to use it _
Take special care with Luvox® and
tell your doctor if:
•
you are pregnant, or could
be pregnant
•
you have epilepsy
•
you have a history of
bleeding problems or if you
regularly use medicines
which increase the risk of
bleeding, such as common
pain killers
•
you have diabetes
•
you are having treatment
with electroconvulsive
therapy (ECT)
•
you ever had mania (a
feeling of elation or

Summary of Product characteristics

Luvox ® 50mg
film -coated tablets
Luvox ® 100mg
film -coated tablets
50 or 100 mg fluvoxamine maleate
Read this entire leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again. If you have questions not answered by this pamphlet,
please ask your doctor or pharmacist. This medicine has been prescribed to you personally and you
should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
Luvox 50 mg film -coated tablets are: round, biconvex, scored, white to off -white film coated
tablets for oral administration (to be taken by mouth). Each tablet contains 50 mg of
fluvoxamine maleate. The tablet can be divided into equal halves.
Luvox 100 mg film -coated tablets are: oval, biconvex, scored, white to off -white film coated
tablets for oral administration (to be taken by mouth). Each tablet contains 100 mg of
fluvoxamine maleate. The tablet can be divided into equal halves.
Excipients (non -medicinal ingredients): Tablet core: Mannitol (E421), maize starch,
pregelatinised starch, sodium stearyl fumarate, colloidal anhydrous silica
Film -coating: Hypromellose, polyethylene glycol 6000, talc, tit aniumdioxyde (E171).
Indications
• Treatment of depressive illness and the symptoms of depressive disorder.
• Treatment of symptoms of obsessive compulsive disorder (OCD)
Dosage and administration
Depression
The recommended starting dose is 50 or 100 mg, given as a single dose in the evening. It is recommended
to increase the dose gradually until an effective dose is reached. The usual effective dose is 100 mg per
day and should be adjusted on individual patie nt response. Doses of up to 300 mg per day have been
given. Dosages above 150 mg should be given in divided doses.
In agreement with the consensus statement of the WHO, antidepressant medication should be continued
for at least 6 months after recovery f rom a depressive episode.
Fluvoxamine at a fixed single daily dose of 100 mg is the recommended dose for the prevention of
recurr