NOTICE
ANSM - Last updated: 21/11/2013
Name of the medicinal product
VELITEN, film-coated tablet
Alpha-tocopherol acetate / rutin / ascorbic acid
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS VELITEN film-coated tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE VELITEN, film-coated tablet?
3. HOW TO TAKE VELITEN, film-coated tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE VELITEN, film-coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS VELITEN film-coated tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
Not applicable.
Therapeutic indications
This drug is a veinotonic (it increases the tone of the veins), a vasculoprotector (it increases the resistance of the small blood vessels).
This medication is recommended in venous circulation disorders, haemorrhoids, fragility of small blood vessels, visual disturbances of circulatory origin.
2. BEFORE YOU TAKE VELITEN, film-coated tablet?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take VELITEN film-coated tablets in the following cases:
If you are allergic (hypersensitive) to any of the components contained in VELITEN, film-coated tablet.
IN CASE OF DOUBT YOU MUST ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with VELITEN, film-coated tablet:
Precautions for use
· hemorrhoidal crisis :
If the hemorrhoidal disorders do not give up in 15 days, it is essential to consult your doctor.
· Venous circulation disorder :
This treatment is effective when combined with a healthy lifestyle.
· avoid exposure to sunlight, heat, prolonged standing, overweight,
· walking and possibly wearing appropriate stockings promote blood circulation.
· If the discomfort and fragility of the vessels increase (blues and bruises spread), consult your doctor immediately.
· Notify doctor in case of pregnancy.
This medication contains an azo coloring agent (E110, orange-yellow S) and may cause allergic reactions.
IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Interaction with other medicines
Taking or using other medicines:
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Notify doctor in case of pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with a well-known effect : yellow orange S (E110).
3. HOW TO TAKE VELITEN, film-coated tablet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Usual dosage: 1 tablet 3 times daily
Hemorrhoid crisis: 2 tablets 3 times a day for 7 days. If there is no rapid improvement, consult your doctor.
IN ALL CASES CONFORM TO THE ORDER OF YOUR DOCTOR STRICTLY.
Symptoms and Instructions for Overdose
If you take more VELITEN, film-coated tablets than you should:
At high doses (greater than 1 g / day of ascorbic acid) possibility of:
· digestive disorders (gastric burns, diarrhea),
· urinary disorders (oxalic, cystinic and uric lithiasis),
· hemolysis in G6PD-deficient subjects.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, VELITEN film-coated tablets may have side effects, although not everybody gets them:
· exceptionally skin reactions (itching, urticaria).
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE VELITEN, film-coated tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use VELITEN film-coated tablets after the expiry date which is stated on the outer packaging.
Storage conditions
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does VELITEN contain in film-coated tablets?
The active substances are :
Ascorbic acid, amount required for a titre of ......................................... 200 mg
Alpha-tocopherol acetate .............................................. .................................................. .............. 50.00 mg
Rutine ................................................. .................................................. ...................................... 200.00 mg
For a film-coated tablet.
The other components are :
Gelatin, corn starch, talc, methylhydroxypropylcellulose, glycerol, titanium dioxide, sun-yellow lacquer (1) , shellac.
(1)Yellow lacquer composition : yellow orange S, aluminum hydroxide.
Pharmaceutical form and content
What is VELITEN film-coated tablets and contents of the pack?
This drug is in the form of film-coated tablet. Box of 20, 30, 40, 60, 90 or 100 film-coated tablets.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
ZAMBON FRANCE
13 RUE RENE JACQUES
92138 ISSY-LES-MOULINEAUX CEDEX
exploiting
ZAMBON FRANCE SA
13 RUE RENE JACQUES
92138 ISSY LES MOULINEAUX CEDEX
Maker
LAPHAL INDUSTRIES
248 avenue de la Victoire
13106 ROUSSET
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.