In this manual :
1. WHAT IS ENDOTELON 150 mg, Gastro-resistant Coated Tablet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING ENDOTELON 150 mg gastro-resistant coated tablet
3. HOW DO I TAKE ENDOTELON 150 mg Gastro-resistant Coated Tablets?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE ENDOTELON 150 mg, Gastro-resistant Coated Tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS ENDOTELON 150 mg, Gastro-resistant Coated Tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
VASCULOPROTECTOR/DRUG ACTING ON THE CAPILLARIES.
(C05CX: cardiovascular system).
This medicine is a venotonic (it increases the tone of the venous walls) and a vasculoprotector (it increases the resistance of small blood vessels).
This treatment is recommended for venous circulation disorders (heavy legs, pain, painful sensations called "impatience" at bedtime).
It is also recommended in the treatment of lymphatic oedema of the arm (infiltration of lymph into the support tissue of the arm) after radiosurgical treatment of a breast tumour, in addition to physical treatments such as elastic restraints.
2. WHAT YOU SHOULD KNOW BEFORE TAKING ENDOTELON 150 mg, Gastro-resistant Coated Tablet
List of information you should know before taking this medicine
If your doctor has told you that you are intolerant to certain sugars, contact him or her before taking this medicine.
Do not take ENDOTELON 150 mg, enteric coated tablet:
This medicine should not be used in cases of known allergy to procyanidolic oligomers (compounds extracted from grape seeds) or to any of the other components of this medicine.
This medicine should not generally be used during breast-feeding.
IN ALL CASES, STRICTLY ADHERE TO YOUR DOCTOR'S PRESCRIPTION
Precautions; special warnings
Take caution with ENDOTELON 150 mg, enteric coated tablet:
Special Warnings
This treatment is most effective when combined with a healthy lifestyle: exposure to the sun, heat, prolonged standing, excess weight should be avoided, walking and possibly wearing suitable stockings are favourable.
The use of this medicine is not recommended in patients with fructose intolerance, glucose and galactose malabsorption syndrome or sucrase-isomaltase deficiency (rare hereditary diseases).
IN ALL CASES, STRICTLY COMPLY WITH YOUR DOCTOR'S PRESCRIPTION
Precautions for use
IN ALL CASES, STRICTLY FOLLOW YOUR DOCTOR'S PRESCRIPTION.
Interactions with other medicines
Taking or using other medicines
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breastfeeding
This medicine should only be used during pregnancy on the advice of your doctor.
If you discover that you are pregnant during treatment, consult your doctor, as only he or she can decide whether to continue the treatment.
The use of this medicine is not recommended while breast-feeding.
Ask your doctor or pharmacist for advice before taking any medication.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a known effect: Sucrose.
3. HOW TO TAKE ENDOTELON 150 mg, Gastro-resistant Coated Tablet
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
In veno-lymphatic insufficiency: 2 tablets per day, in discontinuous administration (20 days per month).
In lymphoedema of the arm: 2 tablets per day, continuous administration.
Method of administration
Oral administration.
Frequency of administration
The tablets should preferably be taken outside of mealtimes. The daily dosage is divided into 1 tablet in the morning and 1 tablet in the evening.
Duration of treatment
IN ALL CASES, STRICTLY ADHERE TO YOUR DOCTOR'S PRESCRIPTION.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed doses
If you forget to take ENDOTELON 150 mg, enteric coated tablet:
If you miss a dose, take it as soon as possible and continue as normal.
Never take a double dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, ENDOTELON 150 mg gastro-resistant coated tablets may have side effects, although not everyone is susceptible.
- allergic reactions: urticaria, rash with or without itching, photosensitivity (skin reaction to sunlight), eczema. These effects are rare and disappear when treatment is stopped.
Very rarely, swelling of the face, lips, tongue and/or larynx leading to difficulty in breathing or swallowing, swelling of the hands and feet, severe itching of the skin.
- Rare gastrointestinal effects: stomach ache, nausea, diarrhea.
- Exceptionally: headache.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO CONSERVE ENDOTELON 150 mg, enteric coated tablet
Keep out of the reach and sight of children.
Do not use ENDOTELON 150 mg gastro-resistant coated tablets after the expiry date stated on the carton.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What does ENDOTELON 150 mg gastro-resistant coated tablet contain?
The active substance is:
Grape (purified seed extract) ...................................................................................................... 150 mg
Quantified as procyanidolic oligomers
For one coated tablet.
The other components are:
Microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, copolymer of methacrylic acid and ethyl acrylate, sodium hydroxide, triethyl citrate, sucrose, gelatine, gum arabic, titanium dioxide (E171), talc, yellow iron oxide (E 172), carnauba wax.
Pharmaceutical form and content
What is ENDOTELON 150 mg, enteric coated tablet and what does it contain?
This medicine is presented as a gastro-resistant coated tablet.
Box of 20, 40 or 60 tablets.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
SANOFI-AVENTIS FRANCE
1-13, BOULEVARD ROMAIN ROLLAND
75014 PARIS
Operator
SANOFI-AVENTIS FRANCE
1-13, BOULEVARD ROMAIN ROLLAND
75014 PARIS
Manufacturer
SANOFI WINTHROP INDUSTRIE
1 RUE DE LA VIERGE
AMBARES ET LAGRAVE
33565 CARBON BLANC CEDEX
or
SANOFI AVENTIS S.P.A
S.S. 17 km22,
66019 SCOPPITO
ITALY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package leaflet was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
Not applicable.
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