Venoruton 2% gel

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

O, BETA, HYDROXYETHYL, RUTOSIDES

Tilgængelig fra:

Novartis Consumer Health UK Limited Park View, Riverside Way, Watchmoor Park, Camberley, Surrey GU15 3YL, United Kingdom

ATC-kode:

C05CA54

INN (International Name):

O-(BETA-HYDROXYETHYL)-RUTOSIDES 2 g

Lægemiddelform:

GEL

Sammensætning:

O-(BETA-HYDROXYETHYL)-RUTOSIDES 2 g

Recept type:

OTC

Terapeutisk område:

VASOPROTECTIVES

Autorisation status:

Withdrawn

Autorisation dato:

2007-04-20

Indlægsseddel

VENORUTON Gel

®

DOSE/METHOD OF USE

HOW SHOULD VENORUTON GEL BE USED? Apply the gel morning and 
evening to the areas to be treated. Rub gently to help the gel
penetrate, until the skin is dry.

If necessary, Venoruton gel many be applied under bandages or
elastic stockings.

Keep to the dose given in this leaflet or prescribed by your doctor.
If you feel that the medicine is not effective enough, or indeed
that 
it is too strong, see your doctor, pharmacist or chemist.
_LOCAL TREATMENT FOR VENOUS_
_DISORDERS OR TRAUMA_
_ _
PROPERTIES/THERAPEUTIC USE 
WHAT IS VENORUTON GEL AND WHEN IS IT USED? Venoruton gel
contains O-(ß-hydroxyethyl)-rutosides which helps to restore
normal function to the smallest blood vessels, the capillaries.
This 
reduces swelling of the ankles and other symptoms (pain,
heaviness) related to varices or of traumatic origin (sprains and
twists, bruised muscles).

Venoruton gel is alcohol-free, odourless and non-greasy. It is very 
suitable for repeated application to the skin. It is pleasant to
apply 
and feels fresh.

UNDESIRABLE SIDE EFFECTS

WHAT UNDESIRABLE SIDE EFFECTS CAN VENORUTON GEL HAVE?
Medicines that are effective may cause certain side effects.

Venoruton gel is generally well tolerated. Rare cases of
sensitivity 
with skin reactions have been reported; these symptoms quickly 
disappear once you stop applying the gel. 
This medicinal product contains Benzalkonium chloride which is
irritant and may cause skin irritation.

SPECIAL COMMENTS
WHAT ELSE SHOULD I KNOW ABOUT? Medicines should be kept out of 
the reach of children.

The medicine should not be used after the date ‹EXP› printed on
the pack.

If you have any medicines which have passed their expiry date,
take them back to your pharmacist or chemist.

If you need any more information, see your doctor, pharmacist
or 
chemist who have detailed information which is produced for
people in the medical profession.

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS 
1. 
NAME OF THE MEDICINAL PRODUCT 
Venoruton
®
 2% gel 
2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
100g Venoruton
®
 2% gel contains 2 g O-( ß-hydroxyethyl)-rutosides (abbreviated to
HR) 

British Approved Name : Oxerutins 
For excipients, see 6.1. 
3. PHARMACEUTICAL 
FORM 
Topical gel 
4. CLINICAL 
PARTICULARS 
4.1. THERAPEUTIC 
INDICATIONS 
Relief of oedema and related symptoms of Chronic Venous
Insufficiency (CVI) such as 
pain and heavy legs, pain after sclerotherapy or during long
flights. 
Relief of pain and oedema of traumatic origin such as sprain and
muscular contusion. 
4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 
- 2 applications daily with gentle massage to penetrate until the
skin is dry 
-  If necessary Venoruton
®
 2% gel may be applied under occlusive or elastic bandages 
4.3. CONTRA-INDICATIONS 
Known hypersensitivity to any ingredient of the product 
4.4. 
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 

The gel should only be used on intact skin; do not use it on the
mucosa.  Do not rub it in if 
you have venous disorders that were caused by a blood clot (called
thromboembolism).  If 
your symptoms persist or become worse, see a doctor.  Before using
Venoruton gel, tell 
your doctor, your pharmacist or your chemist if  
-  you have any other illness, 
-  you are allergic, particularly to other medicines, 
-  you are already taking or using other medicines (including self-
medication!) 

Page 2 of 3 
4.5. 
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION 
No drug interactions have been reported. 
4.6. 
PREGNANCY AND LACTATION 
No controlled studies have been performed in pregnant or
breast-feeding women with 
topical forms of HR. Only studies with oral forms of HR are
available. In consequence, 
according to generally accepted safety recommendation, Venoruton
®
 2% gel is not be used 
during the 1
st
 three months of pregnancy unless, in the opinion of