Phlebodia 600mg film coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DIOSMIN

Available from:

Laboratoires Innothera 22 Avenue Aristide Briand, Arcueil 94110, France

ATC code:

C05CA03

INN (International Name):

DIOSMIN 600 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

DIOSMIN 600 mg

Prescription type:

OTC

Therapeutic area:

VASOPROTECTIVES

Authorization status:

Authorised

Authorization date:

2006-08-11

Patient Information leaflet

_Phlebodia 600 mg, film-coated tablet - PIL _
_ _
_1_
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ANNEX IIIB
PACKAGE LEAFLET: INFORMATION FOR THE USER
NAME OF THE MEDICINAL PRODUCT
PHLEBODIA 600 MG, FILM-COATED TABLET
DIOSMIN
TEXT BOX
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.
WHAT IS IN THIS LEAFLET?
1. What PHLEBODIA 600 mg, film-coated tablet is and what it is used
for?
2. What you need to know before you take PHLEBODIA 600 mg, film-coated
tablet?
3. How to take PHLEBODIA 600 mg, film-coated tablet?
4. Possible side effects
5. How to store PHLEBODIA 600 mg, film-coated tablet?
6. Contents of the pack and other information
1.
WHAT PHLEBODIA 600 MG, FILM-COATED TABLET IS AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: VASOPROTECTIVES/CAPILLARY STABILIZING
AGENTS, ATC code:
C05CA03 (cardiovascular system)
.
This medicine is a venotonic _ (it increases the tonus of the venous
walls)_ and a vasoprotective _ (it _
_increases the resistance of small blood vessels)_.
It is recommended for:
•
venous circulation disorders _(heavy legs, pain, restlessness when
lying down),_
•
haemorrhoidal crisis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHLEBODIA 600 MG, FILM-COATED
TABLET?
DO NOT TAKE PHLEBODIA 600 MG, FILM-COATED TABLET:
•
if you are allergic to diosmin or any of the other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking PHLEBODIA 600 mg,
film-coated tablet.
SPECIAL WARNINGS
If the discomfort and fragility of the vessels do not decrease within
15

Summary of Product characteristics

_Phlebodia 600 mg, film-coated tablet - SmPC _
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ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PHLEBODIA 600 MG, FILM-COATED TABLET
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Diosmin (expressed in anhydrous and pure diosmin)
...................................................................
600 mg
For one film-coated tablet.
Excipient with known effect: cochineal red A.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
•
Improvement of symptoms associated with venolymphatic insufficiency:
heavy legs, pain, primo-
decubitus restlessness,
•
Supportive treatment for capillary fragility functional disorders,
•
Treatment of functional signs associated with haemorrhoidal crisis.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
•
Venous insufficiency: 1 tablet per day during a meal.
•
Haemorrhoidal crisis: 2 to 3 tablets per day during meals.
_Paediatric population _
The safety and efficacy of PHLEBODIA in children and adolescents aged
less than 18 years have not
yet 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
This medicinal product contains an azo colouring agent (cochineal Red
A) and may cause allergic
reactions.
Haemorrhoidal crisis:
The administration of this product does not dispense patients from
following specific treatments for
other anal diseases.
The treatment must be short-term only.
If symptoms do not show signs of improvement rapidly, a proctological
examination should be
performed and the treatment should be revised.
_Phlebodia 600 mg, film-coated tablet - SmPC _
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4.5.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No clinically relevant drug interaction has been reported to date with
diosmin.
4.6.
FERTILITY, PREGNANCY AND LACTATION
PREGNANCY
There are