NeoMercazole® Tablet 5 mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CARBIMAZOLE

Boleh didapati daripada:

A. MENARINI SINGAPORE PTE. LTD.

INN (Nama Antarabangsa):

CARBIMAZOLE

Unit dalam pakej:

100 Tablets

Dikeluarkan oleh:

CENEXI SAS

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
1
NEOMERCAZOLE®TABLET
Carbimazole (5mg)
WHAT IS IN THIS LEAFLET
:
1.
What NeoMercazole is
used for
2.
How NeoMercazole works
3.
Before
you
take
NeoMercazole
4.
How to use NeoMercazole
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Neomercazole
8.
Product description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
WHAT NEOMERCAZOLE IS USED
FOR
NeoMercazole is used to people
with
an
overactive
thyroid
gland. The condition is called
hyperthyroidism.
NeoMercazole is also used in
more serious cases as therapy
prior to and post radio-iodine
treatment.
HOW NEOMERCAZOLE WORKS
Carbimazole is thyroid reducing
agent.
NeoMercazole is used to reduce
the
formation
of
thyroid
hormones.
-
Before
you
use
NeoMercazole
_When you must not use it_
• Do not use NeoMercazole if
you had inflammation of the
pancreas
(acute
pancreatitis)
after
administration
of
carbimazole or thiamazole in
the past
• If
you
are
allergic
to
thiamazole
or
propylthiouracil.
If
you
are
allergic
(hypersensitive)
to
carbimazole
or
any
of
the
ingredients of NeoMercazole.
• If you are breast-feeding.
• If you have a serious blood
disorder.
• If you have a severe
liver disorder.
-
_Before you start use it_
• Neomercazole can cause harm
to an unborn baby. If you can
get
pregnant,
use
reliable
contraception from the time you
start
treatment
and
during
treatment.
• If you are pregnant, think you
may be pregnant or are planning
to have a baby, tell your doctor
straight
away.
Your
treatment
with Neomercazole may need to
be continued during pregnancy
if
the potential benefit
outweighs the potential risk to
you and your unborn baby.If
you have mild or moderate liver
problems.
• If you have a swelling of the
neck resulting from enlargement
of the thyroid gland. Regular
full blood count checks should be
carried out in people who may be
confused or have a poor memory.
• Tell your doctor if any of the
above applies to you.
-
_Taking other medicines_
Please
tell
you

Ciri produk

_Active ingredient:_ Carbimazole
Each NeoMercazole 5mg tablet contains carbimazole
Ph. Eur. 5mg.
_Excipients:_
Lactose, Maize Starch, Gelatin, Magnesium Stearate,
Sucrose, Acacia, Talc, Red Iron Oxide (EI72).
PHARMACEUTICAL FORM
NeoMercazole 5mg tablets are pink, circular biconvex,
imprinted with Neo 5 on the obverse and plain on the reverse.
PROPERTIES AND EFFECTS
_Pharmacodynamic properties_
ATC Code: H03B B
Pharmacotherapeutic group: Sulfur-containing
imidazole derivatives
Mechanism of action:
Carbimazole, a thionamide, is a pro-drug which
undergoes rapid and virtually completemetabolism to
the active metabolite, thiamazole, also known as
methimazole. The method of action is believed to be
inhibition of the organification of iodide and the coupling
of iodothyronine residues which in turn suppress the
synthesis of thyroid hormones.
PHARMACOKINETIC PROPERTIES
ABSORPTION
Carbimazole is rapidly metabolised to thiamazole.
After oral ingestion, peak plasma concentrations of
thiamazole, the active moiety, occur at 1 to 2 hours
DISTRIBUTION
The total volume of distribution of thiamazole is 0.5
1/kg. Thiamazole is concentrated in the thyroid gland.
This intrathyroidal concentration of thiamazole has the
effect of prolonging its activity. However, thiamazole
has a shorter half-life in hyperthyroid patients than in
normal controls and so more frequent initial doses are
required while the hyperthyroidism is active.
BIOTRANSFORMATION
Thiamazole is moderately bound to plasma proteins.
Carbimazole has a half-life of 5.3 to 5.4 hours. It is
possible that the plasma half-life may also be prolonged
by renal or hepatic disease. See section Posology and
method of administration. Thiamazole crosses the
placenta and appears in breast milk. The plasma milk
ratio approaches unity.
ELIMINATION
Over 90% of orally administered carbimazole is
excreted in the urine as thiamazole or itsmetabolites.
The remainder appears in faeces. There is 10%
enterohepatic circulation.
THERAPEUTIC INDICATIONS
NeoMercazole is an anti-thyroid agent. It is i