VEINOSMIN Film Coated Tablets

Ország: Malajzia

Nyelv: angol

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

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Betegtájékoztató Betegtájékoztató (PIL)
03-10-2022
Termékjellemzők Termékjellemzők (SPC)
27-12-2023

Aktív összetevők:

Diosmin; Hesperidin

Beszerezhető a:

PERNIAGAAN NORMAHAS SDN. BHD.

INN (nemzetközi neve):

Diosmin; Hesperidin

db csomag:

30 Tablets

Gyártó:

Saga Lifesciences Limited

Betegtájékoztató

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
1
VEINOSMIN FILM COATED TABLETS
Diosmin/Hesperidin (450mg/50mg)
WHAT IS IN THIS LEAFLET
1.
What Veinosmin is used for
2. How Veinosmin works
3. Before you use Veinosmin
4. How to use Veinosmin
5. While you are using it
6. Side effects
7. Storage and disposal of
Veinosmin
8. Product description
9.
Manufacturer
and
product
registration holder
10. Date of revision
WHAT VEINOSMIN IS USED FOR
It is recommended for the treatment
for
venous
circulation
disorders
(heavy
legs,
pain,
early
morning
restless legs)
and
the
treatment of
symptoms
related
to
hemorrhoids
(acute hemorrhoidal attack).
HOW VEINOSMIN WORKS
This medicine strengthens veins by
increasing venous tone, and protects
small blood vessels.
BEFORE YOU USE VEINOSMIN
_When you must not use it_
DO NOT TAKE VEINOSMIN
FILM-COATED TABLET:
If you are allergic (hypersensitive) to
diosmin,
hesperidin,
micronized
purified flavonoid fraction or any of
the other ingredients of this medicine
(see Ingredients section).
Do not use in children below 18 years
old unless advised by your doctor.
_Before you start to use it_
Ask your doctor or pharmacist for
advice before taking this medicine.
PREGNANCY AND BREAST-FEEDING:
If you are pregnant, think you may be
pregnant, planning to have a baby, or
breast-feeding,
ask
your
doctor
or
pharmacist for advice before taking
this medicine.
_Taking other medicines_
Please tell your doctor or pharmacist
if you are taking, have recently taken
or might take any other medicines,
including
medicines
obtained
without a prescription.
HOW TO USE VEINOSMIN
Always take this medicine exactly as
your doctor or pharmacist has told
you. Check with your doctor or
pharmacist if you are not sure.
_How much to use & When to use it_
_VENOUS CIRCULATION DISORDERS_
The recommended dose is 2 tablets
daily; i.e. one at midday and one in
the evening at mealtimes.
_ACUTE HEMORRHOIDAL ATTACK_
The recommended dose is 6 tablets
daily for 4 days, then 4 tablets daily
for the next 3 days at mealtimes.
_How long to use 
                                
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Termékjellemzők

                                1.
PRODUCT NAME:
VEINOSMIN Film Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains:
Diosmin 450mg and Hesperidin 50mg
Excipients:
Microcrystalline cellulose powder, maize starch, colloidal anhydrous
silica, povidone K 30,
sodium lauryl sulphate, citric acid, purified water, magnesium
stearate, purified talc,
croscarmellose sodium, titanium dioxide, yellow iron oxide, red iron
oxide
3.
DOSAGE FORM:
Film-coated tablet
4.
PRODUCT DESCRIPTION:
Peach colored oval shaped film coated tablet having break line on one
side.
5.
PHARMACODYNAMICS:
In pharmacology:
VEINOSMIN exerts an action on the vascular return system:
-
at the venous level, it reduces venous distensibility and reduces
venous stasis;
-
at the microcirculatory level, it normalises capillary permeability
and reinforces capillary
resistance.
In clinical pharmacology:
Controlled, double-blind studies using methods that allow
demonstrating and quantifying
the activity on venous haemodynamics have confirmed the
pharmacological properties of
this medicinal product in humans.
-
dose/effect relationship:
Statistically-significant dose-effect relationships have been
demonstrated for the following
venous plethysmography parameters: capacitance, distensibility and
emptying time. The
best dose/effect ratio is obtained with 2 tablets.
-
venotonic activity:
It increases venous tone: venous occlusion plethysmography with a
mercury strain gauge
revealed a reduction in venous emptying time.
-
microcirculatory activity:
Controlled, double-blind studies have demonstrated a
statistically-significant difference
between this medicinal product and placebo. In patients with signs of
capillary fragility, it
increases capillary resistance as measured by angiosterrometry.
6.
PHARMACOKINETICS:
In humans, following oral administration of the medicinal product with
carbon 14-labelled
diosmin:
-
Excretion is essentially faecal and urinary excretion is on average
14% of the administered
quantity,
-
The elimination half-life is 11 hours,
-
The produ
                                
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