MENELAT 45 MG TABLETS

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

MIRTAZAPINE

Boleh didapati daripada:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

MIRTAZAPINE

Unit dalam pakej:

10tablet Tablets; 30tablet Tablets; 100tablet Tablets

Dikeluarkan oleh:

TORRENT PHARMACEUTICALS LTD

Risalah maklumat

MENELAT TABLETS
_ _
Mirtazapine (30 mg, 45 mg)
_ _
_ _
1
_ _
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is Menelat used for
2.
How Menelat works
3.
Before you use Menelat
4.
How to use Menelat
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Menelat
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT MENELAT IS USED FOR
•
Mirtazapine is one of a group of
medicines called antidepressants.
•
Menelat Tablets are used to treat
major depressive illness.
HOW MENELAT WORKS
Mirtazapine works in the brain to block
receptors
and
corrects
the
chemical
imbalance in the brain which leads to
antidepressant effects.
BEFORE YOU USE MENELAT
-
_When you must not use it _
Do not take Menelat:
•
If you are allergic (hypersensitive)
to mirtazapine or any of the other
ingredients of Menelat Tablets. If
so, you must talk to your doctor as
soon
as
you
can
before
taking
Menelat Tablets.
•
If you are taking or have recently
taken (within the last two weeks)
medicines
called
monoamine
oxidase inhibitors (MAO-Is).
_Pregnancy and lactation_
_ _
Do not take Menelat if you are pregnant
or plan to become pregnant or think you
might be pregnant.
Do not take Menelat if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
-
_Before you start use it _
Tell your doctor about these conditions
before taking Menelat Tablets:
•
Seizures (epilepsy). If you develop
seizures or your seizures become
more frequent, stop taking Menelat
Tablets
and
contact
your
doctor
immediately.
•
Liver disease, including jaundice.
If
jaundice
occurs,
stop
taking
Menelat Tablets and contact your
doctor immediately.
-
_Taking other medicines _
Tell your doctor or pharmacist if you
are taking (or plan to take) any of the
medicines in the following list.
Please
also
tell
your
doctor
or
pharmacist if you are taking or have
recently
taken
any
other
medicines,
including medicines obtained without a
prescription.
_ _
_Do _
_no

Ciri produk

Manufactured by :
TORRENT PHARMACEUTICALS LTD.
Indrad-382 721, Dist. Mehsana, INDIA.
BRAND OR PRODUCT NAME
MENELAT 30 MG TABLETS
MENELAT 45 MG TABLETS
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
MENELAT 30 MG TABLETS
Each film coated tablet contains:
Mirtazapine Ph.Eur. 30 mg
MENELAT 45 MG TABLETS
Each film coated tablet contains:
Mirtazapine Ph.Eur. 45 mg
PRODUCT DESCRIPTION
MENELAT 30 MG TABLETS
Pink colored, round, biconvex film coated tablets plain on one side
and break line on other side.
MENELAT 45 MG TABLETS
White to off white colored, round, biconvex film coated tablets plain
on both sides.
DOSAGE FORM
Film coated tablets
CLINICAL PHARMACOLOGY
PHARMACODYNAMIC
Pharmacotherapeutic group: Other antidepressants, ATC code: N06AXl l
Mirtazapine is a centrally active presynaptic
α
2-antagonist, which increases central noradrenergic and serotonergic
neurotransmission. The enhancement of serotonergic
neurotransmission is specifically mediated via 5-HT1 receptors,
because 5-HT2 and 5-HT3 receptors are blocked by mirtazapine. Both
enantiomers of mirtazapine are
presumed to 373 18A contribute to the antidepressant activity, the S
(+) enantiomer by blocking
α
2 and 5-HT2 receptors and the R (-) enantiomer by blocking 5-HT3
receptors.
The histamine H1-antagonistic activity of mirtazapine is associated
with its sedative properties. It has practically no anticholinergic
activity and, at therapeutic doses, has
practically no effect on the cardiovascular system.
PHARMACOKINETIC
After oral administration of Mirtazapine, the active substance
mirtazapine is rapidly and well absorbed (bioavailability - 50 %),
reaching peak plasma levels after approx. two
hours. Binding of mirtazapine to plasma proteins is approx. 85 %. The
mean half-life of elimination is 20·40 hours; longer half-lives, up
to 65 hours, have occasionally been
recorded and shorter half-lives have been seen in young men. The
half-life of elimination is sufficient to justify once-a-day dosing.
Steady state is reached after 3-4 days,
after which there is no further