NOTICE
ANSM - Last updated: 27/04/2017
Name of the medicinal product
ENDOTELON 150 mg gastro-resistant coated tablet
Grape seed extract
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.
What is in this leaflet?
1. What is ENDOTELON and when is it used?
2. What information should be known before taking ENDOTELON?
3. How to take ENDOTELON?
4. What are the possible side effects?
5. How to store ENDOTELON?
6. Package contents and other information.
1. WHAT IS ENDOTELON AND IN WHAT CASES IS IT USED?
VASCULOPROTECTOR / MEDICAMENT ACTING ON CAPILLAIRES.
(C05CX: cardiovascular system).
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 ).
It is used for:
- Relieve symptoms due to venous circulation disorders (heavy legs, pain, painful sensations called "impatience" at bedtime).
- treat lymphatic edema of the arm (infiltration of lymph in the arm support tissue) to treat after a radiosurgical treatment of a breast tumor, in addition to physical treatments such as elastic restraints.
2. BEFORE YOU TAKE ENDOTELON?
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Do not take Endotelon
· if you are allergic to procyanidolic oligomers (grape seed compounds) or any of the other ingredients of this medication. You can find the list of components in section 6.
· If you are breast-feeding, unless your doctor tells you otherwise.
Take special care with ENDOTELON 150 mg, coated gastro-resistant tablet:
Special warnings
If you are taking Endotelon for venous or lymphatic circulation disorders, you should combine this treatment with a healthy lifestyle. It is important to follow the following recommendations to promote venous circulation:
· avoid exposing yourself to sunlight or heat,
· Avoid standing prolonged,
· avoid overweight
· make regular long walks,
· wear suitable stocking stockings.
Taking 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.
Pregnancy
If you are pregnant, you should use this medicine 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.
Ask your doctor or pharmacist for advice before taking any medicine.
feeding
Treatment is not advisable if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Procyanidolic oligomers have no effect on the ability to drive and use machines.
Important information about some of the ingredients of this medication
This medicine contains a sugar (sucrose).
Its use is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
3. HOW TO TAKE ENDOTELON?
Dosage
In vein-lymphatic insufficiency: 2 tablets per day, in discontinuous administration (20 days per month).
In the lymphoedema of the arm: 2 tablets per day, in continuous administration.
Administration mode
This medication is taken orally.
Frequency of Administration
Take your tablets preferably outside meals. You will distribute the daily dose: 1 tablet in the morning and 1 tablet in the evening.
Duration of treatment
IN ALL CASES, COMPLY WITH THE ORDER OF YOUR DOCTOR STRICTLY.
If you forget to take ENDOTELON:
Take your tablet as soon as possible and continue your treatment as normal.
Do not take a double dose to make up for the missed dose.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, Endotelon can cause side effects, although not everybody gets them.
· Undesirable effects rarely occur:
· Allergic symptoms: urticaria, rash with or without itching, photosensitivity (skin reaction when exposed to the sun), eczema. These effects are rare and disappear when treatment is discontinued.
· stomach upset, nausea, diarrhea.
· Undesirable effects very rarely occur:
· swelling of the face, lips, tongue and / or larynx resulting in difficulty breathing or swallowing,
· swelling of the hands and feet, severe itching of the skin.
· headache.
Declaration of side effects:
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr .
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE ENDOTELON?
Keep out of the reach and sight of children.
Do not use ENDOTELON 150 mg enteric coated tablets after the expiry date which is stated on the carton.
No special storage conditions.
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. PACKAGE CONTENTS AND OTHER INFORMATION
What ENDOTELON 150 mg contains, gastro-resistant coated tablet
The active substance is :
Grape (purified seed extract from) .......................................... ............................................... 150 mg
quantified as procyanidolic oligomers for a coated tablet.
The other components are :
Microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, methacrylic acid / ethyl acrylate copolymer, sodium hydroxide, triethyl citrate, sucrose, gelatin, gum arabic, titanium dioxide (E171), talc, yellow iron (E 172), carnauba wax.
What is ENDOTELON 150 mg Gastro-resistant coated tablets and contents of the pack
This medication is in the form of an enteric coated tablet.
Box of 20, 40 or 60 tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder
CHEPLAPHARM Arzneimittel GmbH
Bahnhofstr. 1a
17498 MESEKENHAGEN
GERMANY
Marketing Authorization Operator
Cheplapharm France
105 rue Anatole France
92300 Levallois-Perret
la France
Maker
SANOFI WINTHROP INDUSTRIE
1 RUE DE LA VIERGE
AMBARES AND LAGRAVE
33565 CARBON BLANC CEDEX
or
SANOFI SPA
SS 17 KM22,
66019 SCOPPITO
ITALY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
<{MM / YYYY}> <{YYYY month}.>
Other
Detailed information on this medicine is available on the ANSM website (France).