JUBREXA ODT (Olanzapine Orodispersible Tablets 5 mg)

国家: 马来西亚

语言: 英文

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

有效成分:

OLANZAPINE

可用日期:

SYNERRV SDN BHD

INN（国际名称）:

OLANZAPINE

每包单位数:

28tablet Tablets

厂商:

Jubilant Generics Limited

资料单张

Consumer Medication Information Leaflet (RiMUP)
JUBREXA ODT
Olanzapine Ph. Eur. 5mg Orodispersable Tablet;
Olanzapine Ph. Eur, 10mg Orodispersable Tablet
1
WHAT IS IN THIS LEAFLET
1.
What Jubrexa ODT Tablet is
used for
2.
How Jubrexa ODT Tablet
works
3.
Before you take Jubrexa
ODT Tablet
4.
How to take Jubrexa ODT
Tablet
5.
While you are using Jubrexa
ODT Tablet
6.
Side Effects
7.
Storage and Disposal of
Jubrexa ODT Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
1.
WHAT JUBREXA ODT
TABLET IS USED FOR
Jubrexa ODT is used for acute
and maintenance treatment for
schizophrenia, a mental illness
with symptoms such as hearing,
seeing, or sensing things which
are not there, mistaken beliefs,
unusual suspiciousness and
becoming withdrawn.
2.
HOW JUBREXA ODT TABLET
WORKS
Jubrexa ODT is an
antipsychotic, antimanic, and
mood stabilising agent which
helps to correct chemical
imbalances in the brain which
may cause mental illness.
3.
BEFORE YOU TAKE JUBREXA
ODT TABLETS
_WHEN YOU MUST NOT USE IT _
-
if you are allergic
(hypersensitive) to olanzapine or
any of the other ingredients of
Jubrexa ODT.
An allergic reaction may be
recognized as a rash, itching, a
swollen face, swollen lips or
shortness of breath. If this has
happened to you, tell your doctor.
-
if you have been previously
diagnosed with eye problems such
as certain kinds of glaucoma
(increased pressure in the eye).
_BEFORE YOU START TO TAKE IT _
Tell your doctor if you have or
have had any medical conditions
or illnesses especially as
following:
•
Prostate problem ( which
cause difficulty in urination)
•
Diabetes mellitus
•
Hyperglycaemia( excess
glucose in bloodstream, often
associated with diabetes
mellitus)
•
Liver or kidney disease
•
Blocked intestine (paralytic
ileus)
•
Blood disorder
•
Seizures
•
Parkinson’s disease
•
Stroke or mini stroke
(temporary symptoms of
stroke)
•
Heart disease
•
Dementia
Pregnancy and breastfeeding
•
Tell your doctor if you are
pregnant or breastfeeding,
thin

产品特点

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Last modified: 2. September 2020, 5:21 PM
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FOR THE USE OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR A
LABORATORY ONLY
JUBREXA ODT
(Olanzapine Orodispersible tablets 5 mg)
JUBREXA ODT
(Olanzapine Orodispersible tablets 10 mg)
PRODUCT NAME:
JUBREXA ODT (Olanzapine Orodispersible tablets 5 mg)
JUBREXA ODT (Olanzapine Orodispersible tablets 10 mg)
NAME AND STRENGTH OF ACTIVE INGREDIENT:
EACH ORODISPERSIBLE TABLET CONTAINS
Olanzapine Ph.Eur. 5 mg
Olanzapine Ph.Eur. 10 mg
PRODUCT DESCRIPTION
FOR 5 MG
Yellow coloured, round, flat face beveled edge tablets with
characteristic flavour, debossed with “D5” on one side
and “CO” on other side
FOR 10 MG
Yellow coloured, round, flat face beveled edge tablets with
characteristic flavour, debossed with “D10” on one side
and “CO” on other side
PHARMACODYNAMICS / PHARMACOKINETICS
PHARMACODYNAMICS:
_Pharmacotherapeutic group: _Diazepines, oxazepines and thiazepines.
_ATCcode: _N05A H03.
Olanzapine is an antipsychotic, antimanic, and mood stabilising agent
that demonstrates a broad pharmacologic
profile across a number of receptor systems.
PHARMACOKINETICS
Olanzapine is well absorbed from the gastrointestinal tract after oral
doses but undergoes considerable firstpass
metabolism. Peak plasma concentrations are achieved about 5 to 8 hours
after oral doses and about 15 to 45 minutes
after an intramuscular dose. Olanzapine is about 93% bound to plasma
proteins. It is extensively metabolised in
the liver, primarily by direct glucuronidation and by oxidation
mediated through the cytochrome P450 isoenzymes
CYP1A2, and, to a lesser extent, CYP2D6. The 2 major metabolites
10-N-glucuronide and 4′-N-desmethyl olanzapine
appear to be inactive. About 57% of a dose is excreted in the urine,
mainly as metabolites, and a