RUVENTIN film coated Tablet (Diosmin & Hesperidin)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Diosmin; Hesperidin

Boleh didapati daripada:

NVS REGULATORY SERVICES SDN BHD

INN (Nama Antarabangsa):

Diosmin; Hesperidin

Unit dalam pakej:

3 x 10 Tablets

Dikeluarkan oleh:

XL Laboratories Pvt. Ltd.

Risalah maklumat

RUVENTIN FILM COATED TABLET (DIOSMIN & HESPERIDIN)
Diosmin 450mg and Hesperidin 50mg
_Consumer Medication Information Leaflet (RiMUP) _
1
WHAT IS IN THIS LEAFLET
1.
What
_RUVENTIN _
is used for
2.
How
_RUVENTIN _
works
_3._
_ _
Before you use
_RUVENTIN _
_4._
_ _
How to use
_RUVENTIN _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_RUVENTIN _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS _RUVENTIN _USED FOR
_RUVENTIN _
is used for the treatment
of symptoms related to
venolymphatic insufficiency (heavy
legs, pain, early morning restless
legs).
_RUVENTIN _
also used for the
treatment of functional symptoms
related to acute hemorrhoidal attack.
HOW _RUVENTIN _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 _RUVENTIN _
-
_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 _RUVENTIN _
-
_How much to use _
The usual dosage is 2 tablets daily in
two divided

Ciri produk

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PACK INSERT
1.
NAME OF THE MEDICINAL PRODUCT
RUVENTIN FILM COATED TABLET (DIOSMIN & HESPERIDIN)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains:
Diosmin BP 450mg
Hesperidin 50mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Light brown coloured, oblong shaped, biconvex, film-coated tablets
plain on both sides.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
-
Treatment of symptoms related to venolymphatic insufficiency (heavy
legs, pain, early
morning restless legs).
-
Treatment of functional symptoms related to acute hemorrhoidal attack.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
-
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.
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
The administration of this product for the symptomatic treatment of
acute hemorrhoids does
not preclude treatment for other anal conditions. If symptoms do not
subside promptly, a
proctological examination should be performed and the treatment should
be reviewed.
4.5.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No interaction studies have been performed. However and taking into
consideration the huge
post marketing experience on the product, no drug interaction has been
reported to date.
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4
4.6.
FERTILITY, PREGNANCY AND LACTATION
Pregnancy:
No teratogenic effects have been shown in several studies and no
adverse effect have been
reported in human.
Breast-feeding:
In the absence of data on excretion in milk, treatment should be
avoided during breast-feeding.
Fertility:
Reproductive toxicity studies showed no effect on fertility in male
and female rats.
4.7.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
No studies on the effects of flavonoid fraction on the a