Olmac 5 (Olanzapine Film-Coated Tablets USP 5 mg)

País: Malàisia

Idioma: anglès

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

ingredients actius:

OLANZAPINE

Disponible des:

Macleods Pharmaceuticals Sdn. Bhd.

Designació comuna internacional (DCI):

OLANZAPINE

Unidades en paquete:

3 x 10 Tablets

Fabricat per:

Macleods Pharmaceuticals Limited

Informació per a l'usuari

_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
OLMAC TABLET
Olanzapine Film-Coated Tablets USP (5mg & 10mg)
__________________________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET?
1. What Olmac are used for
2. How Olmac works
3. Before you use Olmac
4. How to use Olmac
5. While you are using Olmac
6. Side effects
7.Storage and Disposal of Olmac
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
11. Serial Number
1. WHAT OLMAC ARE USED
FOR:
Olmac is indicated for the treatment
and maintenance of schizophrenia, a
disease with symptoms such as
hearing, seeing or sensing things
which are not there, mistaken beliefs,
unusual suspiciousness, and
becoming withdrawn.
Olmac is also indicated for the
treatment of moderate to severe
manic episodes, a condition with
symptoms of excitement or euphoria.
2. HOW OLMAC WORKS:
Olmac is in a class of medications
called antipsychotics. It works by
changing the activity of certain
natural substances in the brain.
3. BEFORE YOU USE OLMAC
_When you must not use it _
If you are allergic (hypersensitive) to
olanzapine or any of the other
ingredients of this medicine.
Certain medical conditions do not
allow the use of Olmac, such as
narrow-angle glaucoma, Parkinson’s
disease, dementia-related psychosis
and/or behavioural disturbances.
Discuss with your healthcare
provider before you start to take this
medication.
_Pregnancy and lactation _
Do not take Olmac if you are
pregnant, trying to get pregnant or
think you may be pregnant.
Do not take Olmac if you are
breastfeeding.
Ask your doctor or pharmacist for
advice before taking any medicine.
_Before you start to use it _
Your doctor need to know if you have
any other medication condition,which
includes:
• Any medical condition mentioned in
the sub-header
_ _
_When you must not use it. _
• Any known liver, heart problems
• All other medical condition.
This medication may also affect your
body temperature. Let your doctor
kn

Fitxa tècnica

1
FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR
A
LABORATORY
BRAND OR PRODUCT NAME:
OLMAC 5
(Olanzapine Film-Coated Tablets USP 5 mg)
OLMAC 10
(Olanzapine Film-Coated Tablets USP 10 mg)
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S):
Olanazapine 5mg
Olanazapine 10mg
PRODUCT DESCRIPTION
OLMAC 5:
White to off white coloured, round shaped, biconvex, film coated
tablets having ‘CL 40’ debossed on one side and plain on other
side.
OLMAC 10:
White to off white coloured, round shaped, biconvex, film coated
tablets having ‘CL 42’ debossed on one side and plain on other
side.
PHARMACODYNAMIC PROPERTIES
Olanzapine,
a
thienobenzodiazepine,
is
an
antipsychotic
agent
that
demonstrates a broad pharmacologic profile across a number of receptor
systems.
Olanzapine
displays
high
receptor
affinity
binding
in
vitro
at
dopamine D1, D3, D4 (Ki = 11-31 nM), 5-HT2A/C (Ki = 4 and 11 nM,
respectively),
5-HT3,
5-HT6,
muscarinic
M1-M5
(Ki
=
1.9-2.5
nM),
adrenergic α1 (Ki = 19 nM), and histamine H1 (Ki = 7 nM) receptor
subtypes,
while displaying a lower affinity at dopamine D1 and D5 receptors (Ki
= 51 –
119 nM).
Olanzapine also increases extracellular levels of dopamine in a
regionally
specific manner in the prefrontal cortex, similar to mood stabilizers,
lithium
and valproate.
PHARMACOKINETICS
_Oral administration: _
Absorption: Olanzapine is well absorbed after oral administration,
reaching
peak plasma concentrations within 5 to 8 hours. The absorption is not
affected
by food.
Distribution: Plasma concentrations of orally administered olanzapine
were
linear and dose proportional. The maximum plasma concentrations (Cmax)
of
olanzapine after single oral doses of 5, 10 and 15 mg averaged 7, 14,
and 21
ng/mL, respectively (20 ng/mL = 0.064 μM). In young healthy adult,
after
once-a-day repeated dosing, steady-state Cmax was approximately twice
that
achieved after a single dose (e.g. 23ng/mL versus 12ng/mL for a 10-mg
dose).
In the elderly, the steady state plasma concentration was
approximately 3-fold
higher tha