ENDOTHELON for venous and lymphatic insufficiency 150 mg x 20

ENDOTHELON tablets 150 mg x 20
PACKAGE LEAFLET: INFORMATION FOR THE USER ENDOTELON 150 mg gastro-resistant tablets ENDOTELON 150 mg gastro-resistant tablets PROCYANIDOLIDOL OLYGOMERS PROCYANIDOLIDOL OLYGOMERS Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. This medicine is available without a prescription. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Keep this leaflet. You may need to read it again. If you need further information or advice, ask your pharmacist. If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. If you do not feel better or your condition gets worse, you should seek medical advice.
What this leaflet contains: 1. What Endotelon is and what it is used for 2. What you need to know before you take Endotelon 3. How to take Endotelon 4. Possible side effects 5. How to store Endotelon 6. Contents of the pack and other information
1. What is Endotelon and what is it used for? This medicinal product is a venotonic (it increases the tone of the venous walls) and protects the vessels (it increases the resistance of small blood vessels).
What is Endotelon used for? Endotelon is intended for:
Improvement of symptoms related to venous and lymphatic insufficiency, associated with complaints such as: fatigue, heaviness, swelling and pain in the legs, cramps (muscle cramps), "restless legs", initial decubitus ulcers.
2. What you need to know before you take Endotelon Do not take Endotelon if:
you are allergic (hypersensitive) to: procyanidol oligomers; any of the other ingredients of Endotelon (described in section 6 "Contents of the pack and further information"). This medicinal product should not be used during breast-feeding.
If you think any of these conditions apply to you, or you have any doubts, consult your pharmacist or doctor before treatment with Endotelon 150 mg.
Take special care with Endotelon treatment. This treatment can be fully effective when combined with a healthy lifestyle. If symptoms do not respond or worsen, and are likely related to the underlying vascular pathology (hemorrhages, purpura, etc.), the treatment should be re-evaluated.
Additional advice for patients with CVI (chronic venous insufficiency): Avoid:
Prolonged standing or sitting, shoes with very low or high heels, exposure to the sun or heat sources, excessive weight gain and avoiding foods considered to increase blood flow in the veins (alcohol, spices, coffee, tea, tobacco). Tips:
Elevate your legs whenever possible, especially in bed at night. Practice regular physical activity (brisk walking, swimming, gymnastics, cycling), wash your feet with a cold shower and massage them as often as possible, wear appropriate elastic stockings. Warning signs that require a doctor's consultation: Do not try to take your treatment if:
your symptoms are localized to only one lower limb; your pain appears suddenly; your symptoms are accompanied by other signs of seriousness such as redness, local induration, unilateral edema (swelling). These signs may indicate a more serious condition, so a medical opinion is required.
Important information about some of the ingredients of Endotelon Due to the sucrose content, this medicine should not be used in cases of fructose intolerance, glucose or galactose malabsorption syndrome or cases of sucrose-isomaltase deficiency - rare metabolic diseases.
If you are not sure if this medicine is suitable for you, consult your pharmacist or doctor.
Taking other medicines To avoid any possibility of unwanted interactions between different medicinal products, including those obtained without a prescription, you should inform your pharmacist about all medicinal products you are taking or have recently taken.
Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. It is not recommended to use procyanidol oligomers during pregnancy; It is not recommended to take this medicine during breast-feeding.
Always consult your pharmacist or doctor before starting to take any other medicine.
Driving and using machines Endotelon 150 mg has no known effects on the ability to drive or use tools or machines.
3. How to take Endotelon Always take Endotelon exactly as instructed in this leaflet. If you are not sure, ask your pharmacist or doctor.
How to take this medicine
Take the medicine by mouth; It is recommended to take the tablets in the morning and evening before meals. The usual dosage is: For venous-lymphatic insufficiency:
1 tablet morning and evening for 20 days a month (intermittent courses). Do not exceed 3 months of treatment without medical advice.
If you forget to take Endotelon Always take Endotelon according to the instructions in this leaflet. If you forget to take a dose, take it as soon as you remember. However, when it is almost time for your next dose, you should take only a single dose as usual. Do not take more than the recommended dose of Endotelon. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, please ask your pharmacist or doctor.
4. Possible side effects Like all medicines, Endothelon can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below has been determined using the following convention:
very common (affects more than 1 user in 10); common (affects 1 to 10 users in 100); uncommon (affects 1 to 10 users in 1,000); rare (affects 1 to 10 users in 10,000); very rare (affects less than 1 user in 10,000); not known (frequency cannot be estimated from the available data). Some patients have experienced the following side effects during treatment with Endotelon: Rare (affects 1 to 10 users in 10,000):
Allergic manifestations: urticaria, rash with or without itching, photosensitivity (skin reactions to sun exposure), eczema. These reactions are reversible (i.e. they stop after discontinuation of treatment).
Rare (affects 1 to 10 users in 10,000):
Gastrointestinal disorders: stomach pain, nausea, diarrhea. Very rare (affects less than 1 user in 10,000):
Swelling of the face, lips and/or larynx, difficulty breathing or swallowing, swelling of the hands and feet, requiring immediate medical attention; Headache. If any of the side effects become serious or you notice any other side effects not listed in this leaflet, please tell your pharmacist or doctor.
5. How to store Endotelon Store below 25°C. Keep out of the reach of children. Do not use after the expiry date which is stated on the packaging. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help to protect the environment.
6. Contents of the pack and additional information What Endotelon contains The active substance of Endotelon is: procyanidolic oligomers 150 mg. The other ingredients are: microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, methacrylic acid/ethyl acrylate copolymer (1:1), sodium hydroxide, triethyl citrate, sucrose, gelatin, gum arabic, titanium dioxide, talc, yellow iron oxide, carnauba wax.
What Endotelon looks like and what the package contains Endotelon tablets are round, yellow in color. Endotelon is available in a cardboard box of 20 tablets (2 blisters x 10 tablets) or 60 tablets (6 blisters x 10 tablets) in PVC/aluminum blisters. Not all types of packaging may be marketed.
Marketing Authorisation Holder: CHEPLAPHARM Arzneimittel GmbH, Germany.
Manufacturers: Sanofi Winthrop Industrie, France; Sanofi SpA, Italy.