Methyldopa Remedica 250 mg film-coated tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

METHYLDOPA

Boleh didapati daripada:

EUCOGEN SDN BHD

INN (Nama Antarabangsa):

METHYLDOPA

Unit dalam pakej:

3 x10 Tablets; 10 x 10 Tablets

Dikeluarkan oleh:

Remedica Ltd.

Risalah maklumat

METHYLDOPA REMEDICA 250 MG FILM-COATED TABLETS
Methyldopa anhydrous (250 mg)
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
WHAT IS IN THIS LEAFLET
1.
What Methyldopa Remedica is used
for
2.
How Methyldopa Remedica works
3.
Before
you
use
Methyldopa
Remedica
4.
How to use Methyldopa Remedica
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Methyldopa
Remedica
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT METHYLDOPA REMEDICA IS USED FOR
Methyldopa Remedica is indicated for the
treatment
of
moderate
to
severe
hypertension.
HOW METHYLDOPA REMEDICA WORKS
Methyldopa,
the
active
ingredient
of
Methyldopa Remedica tablets, belongs to
the
general
class
of
medicines
called
antihypertensives.
Methyldopa
is
converted
to
a
natural
chemical in the body which acts to lower
blood pressure.
BEFORE YOU USE METHYLDOPA REMEDICA
-
_When you must not use it _
_ _
Do not take Methyldopa Remedica:
• If
you
have
had
an
allergy
(hypersensitive) to methyldopa or to
any of the other ingredients of this
medicine
• If you ever had liver disease
• If you ever had depression
• If you are taking MAOIs (monoamine
oxidase inhibitors) for depression
• If you have high blood pressure due to
a
tumour
near
your
kidney
called
‘phaeochromocytoma’
or
‘paraganglioma’
• Porphyria
(a
rare,
inherited
blood
disorder)
If you think any of these apply to you,
do
not
take
Methyldopa
Remedica.
Inform you doctor.
-
_Before you start to use it _
_ _
Talk to your doctor or pharmacist before
taking Methyldopa Remedica:
• If you have a blood disorder called
haemolytic anaemia
• If
you
have
leucopenia
(decreased
number of white blood cells)
• If you have liver problems
• If you have jaundice (yellowing of the
skin and eyes)
• If you have fever
• If you have dialysis
• If you have laboratory test
• If you have an operation
_Pregnancy and lactation _
Please consult your doctor or pharmacist
if
you
are
pregnant,
planning
for
pregnancy or breast-feeding befo

Ciri produk

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PACKAGE INSERT
1. NAME OF THE PRODUCT
Methyldopa Remedica 250 mg film-coated tablets
2. NAME AND STRENGTH OF ACTIVE INGREDIENT
Each film-coated tablet contains methyldopa equivalent to 250 mg
anhydrous methyldopa.
3. DOSAGE FORM
Film-coated tablet.
Yellow, round, film-coated, with Remedica’s logo on one side and
embossed with
“MD250” on the other side.
4. PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMICS
Pharmacotherapeutic group: antiadrenergic agents; ATC code: C02AB
Mechanism of action
It appears that several mechanisms of action account for the
clinically useful effects of
methyldopa and the current generally accepted view is that its
principal action is on the
central nervous system. The antihypertensive effect of methyldopa is
probably due to its
metabolism to alpha-methyl noradrenaline, which lowers arterial
pressure by stimulation
of central inhibitory alpha-adrenergic receptors, false
neurotransmission, and/or reduction
of plasma renin activity. Methyldopa has been shown to cause a net
reduction in the tissue
concentration
of
serotonin,
dopamine,
epinephrine
(adrenaline)
and
norepinephrine
(noradrenaline).
PHARMACOKINETICS
_Absorption _
Absorption of oral methyldopa is variable and incomplete.
_Distribution _
Bioavailability after oral administration averages 25%.
_ _
_Biotransformation _
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Peak concentrations in plasma occur at two to three hours, and
elimination of the drug is
biphasic regardless of the route of administration. Plasma half-life
is 1.8 ± 0.2 hours.
_ _
_Elimination _
Renal excretion accounts for about two thirds of drug clearance from
plasma.
5. CLINICAL PARTICULARS
INDICATIONS
For treatment of moderate to severe hypertension.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
The recommended dose is:

Adults: Initial - Oral, 250 mg two or three times a day for two days,
the dosage then
being adjusted as directed.

Maintenance: Oral, 500 mg to 2 g a day, divided into two to