DAFLON 500mg, film-coated tablet

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HESPERIDIN, DIOSMIN

Available from:

Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France

ATC code:

C05CA03

INN (International Name):

HESPERIDIN 50 mg DIOSMIN 450 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

HESPERIDIN 50 mg DIOSMIN 450 mg

Prescription type:

OTC

Therapeutic area:

VASOPROTECTIVES

Authorization status:

Authorised

Authorization date:

2005-10-26

Patient Information leaflet

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PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
DAFLON 500 MG, FILM-COATED TABLET
Micronized purified flavonoid fraction
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after
WHAT IS IN THIS LEAFLET
:
1.
What DAFLON 500 mg is and what it is used for
2.
What you need to know before you take DAFLON 500 mg
3.
How to take DAFLON 500 mg
4.
Possible side effects
5.
How to store DAFLON 500 mg
6.
Contents of the pack and other information
1.
WHAT DAFLON 500 MG IS AND WHAT IT IS USED FOR
DAFLON 500 mg is a venotonic (it increases venous tone) and a
vasculoprotector (it increases resistance in
small blood vessels).
It is recommended for treating venous circulation disorders (swollen
legs, pain, restless legs) and for treating
symptoms due to acute hemorrhoidal attack.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DAFLON 500 MG
DO NOT TAKE DAFLON 500 MG
If you are hypersensitive (allergic) to micronised purified flavonoic
fraction or any of the other ingredients of
this medicine.
TAKE SPECIAL CARE WITH DAFLON 500 MG
_Acute hemorrhoidal attack: _
If the hemorrhoid symptoms do not disappear within 15 days, you should
ask your doctor for advice.
_Venous circulation disorders: _
The most effective way of taking this treatment is in combination with
a healthy lifestyle.
Avoid exposure to the sun, heat, excessive standing and being
overweight. Walking and wearing special
support stockings stimulate blood circulation.
If you are in any doubt, do not hesitate to ask your doctor or your
pharmacist for advice.
T

Summary of Product characteristics

1
1. NAME OF THE MEDICINAL PRODUCT
DAFLON 500 MG
, film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
For a film-coated tablet:
Micronized purified flavonoid fraction .......................... 500
mg
Corresponding to:
.
Diosmin (90 %)
......................................................... 450 mg
.
Flavonoids expressed as hesperidin (10 %) ............... 50 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
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 symtomatic 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. No clinically relevant
drug interaction has been
reported to date from post marketing experience on the product.
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4.6. FERTILITY, PREGNANCY AND LACTATION
Pregnancy:
There are no or limited amount of data from the use of Micronised
Purified Flavonoid
Fraction in pregnant women.
Animal studies do not indicate reproductive toxicity (see section
5.3).
As a precautionary measure, it is preferable to avoid the use of
Daflon during pregnancy.
Breast-feeding:
It is unknown whether the active substance/metabolites are excreted in
human milk.
A risk to t