NOTICE
ANSM - Last updated: 20/11/2014
Name of the medicinal product
VEINAMITOL 3500 mg powder for oral solution in sachet
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 your doctor.
· 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 VEINAMITOL 3500 mg, powder for oral solution in sachets AND IN WHAT CASES IS IT USED?
2. BEFORE YOU TAKE VEINAMITOL 3500 mg powder for oral solution in sachet?
3. HOW TO TAKE VEINAMITOL 3500 mg powder for oral solution in sachet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE VEINAMITOL 3500 mg powder for oral solution in sachet?
6. ADDITIONAL INFORMATION
1. WHAT VEINAMITOL 3500 mg, powder for oral solution in sachets AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
VASCULOPROTECTOR / MEDICAMENT ACTING ON CAPILLAIRES
(C05CA04: cardiovascular system)
Therapeutic indications
This drug is a veinotonic (it increases the tonicity of the venous walls) and a vasculoprotector (it increases the resistance of the small blood vessels).
This medication is indicated in venous circulation disorders (heavy legs, pain, painful sensations known as "impatience" at bedtime) and in the hemorrhoidal crisis (pain, feeling of congestion).
2. BEFORE YOU TAKE VEINAMITOL 3500 mg powder for oral solution in sachet?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take VEINAMITOL 3500 mg powder for oral solution in sachet
This medication is not recommended during breast-feeding.
Precautions for use; special warnings
Take special care with VEINAMITOL 3500 mg powder for oral solution in sachet
Warnings
Hemorrhoidal crisis : administration of this product does not provide specific treatment for other anal diseases. Treatment should be short-term. If the symptoms do not give up quickly, it is essential to consult your doctor.
Precautions for use
This treatment has all its effectiveness when combined with a healthy lifestyle: exposure to sunlight, heat, prolonged standing, overweight should be avoided, walking and possibly carrying adapted bottom areas are favorable.
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 -Alasting
This medication will only be used during pregnancy, only on the advice of your doctor.
If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
In the absence of data on passage through breast milk, treatment should be discouraged during the breastfeeding period.
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 known effect : mannitol.
3. HOW TO TAKE VEINAMITOL 3500 mg powder for oral solution in sachet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
The usual dosage is 1 sachet per day.
Method and route of administration
Oral use.
The contents of the sachet should be diluted in a glass of water.
Frequency of Administration
To be taken preferably during the meal.
IN ALL CASES CONFORM TO THE ORDER OF YOUR DOCTOR STRICTLY.
Duration of treatment
IN ALL CASES CONFORM TO THE ORDER OF YOUR DOCTOR STRICTLY.
Symptoms and Instructions for Overdose
Not applicable.
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, VEINAMITOL 3500 mg powder for oral solution in sachet is likely to have undesirable effects, although not everyone is subject to it.
· rare cases of nausea giving up when medication is taken during meals
· due to the presence of mannitol, may lead to digestive problems and diarrhea.
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 VEINAMITOL 3500 mg powder for oral solution in sachet?
Keep out of the reach and sight of children.
Expiration date
Do not exceed the expiry date clearly indicated on the packaging.
Store at room temperature.
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 contains VEINAMITOL 3500 mg powder for oral solution in sachet?
The active substance is :
Troxérutine ................................................. .................................................. .................................. 3.5000 g
For a sachet of 7.2525 g.
The other components are :
Mannitol, orange flavoring *, saccharin sodium
* Composition of the orange flavor : gum arabic, maltodextrin, concentrated orange juice, orange essential oil, butylhydroxyanisole.
Pharmaceutical form and content
What is VEINAMITOL 3500 mg powder for oral solution in sachet and contents of the pack?
This medication is in the form of a sachet. Box of 10 sachets.
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
NEGMA LABORATORIES
BUROPLUS 3
1 BIS AVENUE JEAN D'ALEMBERT
ZAC DE LA CLEF SAINT PIERRE
78990 ELANCOURT
exploiting
NEGMA LABORATORIES
BUROPLUS 3
1 BIS AVENUE JEAN D'ALEMBERT
ZAC DE LA CLEF SAINT PIERRE
78990 ELANCOURT
Maker
alkopharm
ZAC DE KERNEVEZ
11, RONTGEN STREET
29337 QUIMPER CEDEX
or
MACORS LABORATORIES
RUE DES CAILLOTTES
ZI PLAINES DES ISLES
89000 AUXERRE
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.