VENAFIX (Diosmin and Hesperidin Tablet)

Страна: Малайзия

Език: английски

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

Активна съставка:

Diosmin; Hesperidin

Предлага се от:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Международно Name):

Diosmin; Hesperidin

Броя в опаковка:

3 X 10 Tablets; 10 X 10 Tablets

Произведено от:

XL Laboratories Pvt. Ltd.

Листовка

VENAFIX
_Consumer Medication Information Leaflet (RiMUP)_
Diosmin 450mg and Hesperidin 50mg Tablet
1
WHAT IS IN THIS LEAFLET
1.
What
_VENAFIX_
is used for
2.
How
_VENAFIX_
works
_3._
_ _
Before you use
_VENAFIX _
_4._
_ _
How to use
_VENAFIX _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_VENAFIX_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS _VENAFIX_ USED FOR
_VENAFIX_
is used for the treatment of
symptoms related to venolymphatic
insufficiency (heavy legs, pain, early
morning restless legs).
_VENAFIX _
also used for the treatment of
functional symptoms related to acute
hemorrhoidal attack.
HOW _VENAFIX_ WORKS
Diosmin and hesperidin are
bioflavonoids found in may citrus
fruits. The bioflavonoids strengthen
the blood vessels, thus reduces its
weakness. The bioflavonoids also
reduces inflammation of the blood
vessels and maintains circulation of
the small blood vessels.
BEFORE YOU USE _VENAFIX_
-
_When you must not use it _
•
If you are allergic to the
diosmin, hesperidin or any other
ingredients of this product.
•
If you are breast-feeding.
-
_Before you start to use it _
Ask your doctor or pharmacist for
advice before taking any medicine.
Please make sure you have
understood the explanation given by
your doctor or pharmacist before
taking this medicine. Speak to your
doctor /pharmacist if you have any
other health related problems.
_Pregnancy and Lactation _
_Pregnancy: _
No teratogenic effects
have been shown in several studies
and no adverse effect have been
reported in human.
_Lactation:_
In the absence of data on
excretion in milk, treatment should
be avoided during breast-feeding.
-
_Taking other medications _
Tell your doctor if you are taking any
other medicines, including any that
you buy without a prescription from
a pharmacy, supermarket or health
food shop.
HOW TO USE _VENAFIX _
-
_How much to use _
The usual dosage is 2 tablets daily in
two divided doses, midday and
evening at meal times.
The recommen

Данни за продукта

Size : 165x120mm
COMPOSITION:
Each film coated tablet contains:
Diosmin BP 450mg
Hesperidin 50mg
PRODUCT DESCRIPTION:
Light brown coloured, oblong shaped, biconvex, film-coated
tablets plain on both sides.
PHARMACODYNAMICS/ PHARMACOKINETICS:
PHARMACOTHERAPEUTIC
GROUP:
VENOTONIC
AND
VASCULAR
PROTECTOR.
ATC code: C05CA53.
PHARMACOLOGY
It is active upon the return vascular system in the following
way:
-
it reduces venous distensibility and stasis,
-
in the microcirculation, it normalises capillary permeability
and increases capillary resistance.
PHARMACOKINETICS
Absorption
Following oral administration, diosmin is rapidly hydrolyzed in
the intestine by intestinal flora and absorbed as its aglycone
derivative, diosmetin. Oral bioavailability is approximately
57.9%.
Distribution
Diosmetin has a volume of distribution of 62.1 L indicating a
broad distribution into tissues.
Biotransformation
Diosmetin is extensively metabolized to phenolic acids or to its
glucuronide derivatives of aglycone that are eliminated in urine.
The major metabolite found in urine is m-hydroxyphenylpropionic
acid
which
is
mainly
eliminated
in
its
conjugated
form.
Metabolites found in small quantities include phenolic acids
corresponding to 3-hydroxy-4 methoxybenzoic acid, 3-metoxy-4-
hydroxyphenylacetic acid and 3,4-dihydroxybenzoic acid.
Elimination
The elimination half-life of diosmetin showed a mean value of
31.5 hours, ranging between 26 and 43 hours.
INDICATION
-
Treatment
of
symptoms
related
to
venolymphatic
insufficiency (heavy legs, pain, early morning restless legs).
-
Treatment
of
functional
symptoms
related
to
acute
hemorrhoidal attack.
RECOMMENDED DOSAGE:
-
Usual dosage: 2 tablets daily in two divided doses, midday
and evening at meal times.
-
Acute hemorrhoidal attack: 6 tablets per day for the first 4
days, then 4 tablets per day for 3 days.
ROUTE OF ADMINISTRATION: Oral use
CONTRAINDICATIONS:
Hypersensitivity
to
the
active
substance
or
to
any
of
the
excipients.
WARNINGS AND PRECAUTIONS:
JAUHKAN DARIPADA CAPAIAN KANAK-KANAK.
KEEP O