Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
Tilman SA ZI Sud 15, Baillonville, 5377, , Belgium
C05CX03
Horse Chestnut seed 21 mg
GASTRO-RESISTANT TABLET
Horse Chestnut seed 21 mg
OTC
VASOPROTECTIVES
Authorised
2023-11-24
LEAFLET PIL 1/4 PACKAGE LEAFLET: INFORMATION FOR THE USER VEINOFYTOL GASTRO-RESISTANT TABLETS Horse chestnut dry extract corresponding to 21 mg triterpene glycosides, calculated as protoaescigenin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse, or if Veinofytol gastro- resistant tablets is required for more than 8 weeks. WHAT IS IN THIS LEAFLET : 1. What Veinofytol gastro-resistant tablets is and what it is used for 2. What you need to know before you take Veinofytol gastro-resistant tablets 3. How to take Veinofytol gastro-resistant tablets 4. Possible side effects 5. How to store Veinofytol gastro-resistant tablets 6. Contents of the pack and other information 1. WHAT VEINOFYTOL GASTRO-RESISTANT TABLETS IS AND WHAT IT IS USED FOR Veinofytol gastro-resistant tablets is a herbal medicinal product containing Horse chestnut dry extract. Veinofytol gastro-resistant tablets is used for treatment of chronic venous insufficiency, which is characterised by swollen legs, varicose veins, a feeling of heaviness, pain, tiredness, itching, tension and cramps in the calves. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VEINOFYTOL GASTRO-RESISTANT TABLETS DO NOT TAKE VEINOFYTOL GASTRO-RESISTANT TABLETS - if you are allergic to Horse chestnut or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Veinofytol gastro-resistant tablets. - If there is inflammation of the skin, thrombophlebitis or subcutaneous induration, severe pain, Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS SmPC 1/5 1. NAME OF THE MEDICINAL PRODUCT Veinofytol gastro-resistant tablets Horse chestnut dry extract, corresponding to 21 mg triterpene glycosides, calculated as protoaescigenin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 192 mg - 258 mg of extract (as dry extract) from _Aesculus hippocastanum_ L., semen (Horse chestnut seed) corresponding to 21 mg triterpene glycosides, calculated as protoaescigenin. Extraction solvent: Ethanol 50 % V/V. Excipient(s) with known effect Each tablet contains 5.261 mg of Allura Red AC (E129). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablet. Red, oblong, biconvex tablets of 18 x 8 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Veinofytol gastro-resistant tablets is indicated in adults. Herbal medicinal product for treatment of chronic venous insufficiency, which is characterised by swollen legs, varicose veins, a feeling of heaviness, pain, tiredness, itching, tension and cramps in the calves. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adult and elderly _ 1 tablet two times daily. _Paediatric population _ There is no relevant indication in children under 12 years of age. The use is not recommended in adolescents under 18 years of age due to a lack of data on safety and efficacy. Duration of use At least 4 weeks of treatment may be required before any beneficial effect is observed. Long-term use is possible in consultation with a doctor. SUMMARY OF PRODUCT CHARACTERISTICS SmPC 2/5 Method of administration Oral use. Swallow the tablets with a large glass of water. Patients with impaired renal/liver function: No data are available for a dosing instruction in case of impaired hepatic and/or renal function. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If there is inflammation of the skin, thrombophlebitis or subcutaneous induration, severe pain, ulcers Διαβάστε το πλήρες έγγραφο