Daflon 1000mg Film-Coated Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Diosmin; Hesperidin

Boleh didapati daripada:

SERVIER MALAYSIA SDN BHD

INN (Nama Antarabangsa):

Diosmin; Hesperidin

Unit dalam pakej:

10 Tablets; 30 Tablets

Dikeluarkan oleh:

LES LABORATOIRES SERVIER INDUSTRIE

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
DAFLON 1000 MG FILM-COATED TABLETS_ _
_micronised purified flavonoid fraction _
WHAT IS IN THIS LEAFLET
1.
What
DAFLON
1000MG
is
used for
2.
How DAFLON 1000MG works
3.
Before
you
use
DAFLON
1000MG
4.
How to use DAFLON 1000MG
5.
While you are using it
6.
Side effects
7.
Storage
and
disposal
of
DAFLON 1000MG
8.
Product description
9.
Manufacturer
and
product
registration holder
10. Date of revision
WHAT DAFLON 1000MG IS USED
FOR
It is recommended for:
- treating symptoms such as heavy
legs, pain, early morning restless legs
due to chronic venous insufficiency
-
treating
symptoms
due
to
acute
haemorrhoidal
attack.
If
haemorrhoidal
problems
persists
more than 15 days, it is essential that
you consult your doctor.
HOW DAFLON 1000MG WORKS
PHARMACOTHERAPEUTIC
GROUP:
VASOPROTECTIVES/
CAPILLARY
STABILIZING
AGENTS/
BIOFLAVONOIDS
(C05CA53:
CARDIOVASCULAR
SYSTEM)
This
medicine
is
a
venotonic
(it
increases
venous
tone)
and
a
vasculoprotector
(it
increases
resistance in small blood vessels).
BEFORE YOU USE DAFLON 1000MG
_When you must not use it_
DO NOT TAKE DAFLON 1000MG,
FILM-COATED TABLET:
If you are allergic (hypersensitive) to
micronised
purified
flavonoid
fraction,
or
any
of
the
other
ingredients of this medicine (listed in
_Ingredients_
).
_Before you start to use it _
_WARNING AND PRECAUTIONS: _
Do not hesitate to ask your doctor of
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.
_PREGNANCY _
_AND _
_BREAST-FEEDING_
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor
or
pharmacist
for
advice
before taking this medicine.
_PREGNANCY _
As
a
precautionary
measure,
it
is
preferable
to
avoid
the
use
of
DAFLON during pregnancy.
_ _
_BREAST FEEDING _
Breast-feeding is not recommended
for the duration of the treatment, due
to

Ciri produk

Final PI_Daflon 1000mg_17.05.2022
1.
NAME OF THE MEDICINAL PRODUCT
DAFLON 1000 MG, FILM-COATED TABLET
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Micronized purified flavonoid fraction
......................................................................................................
1000 mg
Corresponding to:
Diosmin: 90 percent
....................................................................................................................................
900 mg
Flavonoids expressed as hesperidin: 10 percent
.......................................................................................
100 mg
Mean
moisture……………………………………………………………………………………………...............40
mg
For one film-coated tablet
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Salmon coloured, oblong shaped film-coated tablet, scored on both
faces.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
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
POSOLOGY
- Venolymphatic insufficiency: 1 tablet daily, in the morning at
breakfast.
- Acute hemorrhoidal attack: 3 tablets daily (in 3 divided doses) for
the first 4 days, then 2 tablets per day (in 2
divided doses) for the next 3 days.
_ _
_Paediatric population _
The safety and efficacy of Daflon 1000mg in children and adolescents
under 18 years of age have not been
established.
METHOD OF ADMINISTRATION
Oral route.
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Hemorrhoidal attack:
The administration of this product does not preclude treatment for
other anal conditions. The treatment must be
short-term. If sympt