Package leaflet: Information for the user

Veinofytil, enteric tablets
Hippocastani seminis extractum siccum,
corresponding to 21 mg of triterpene glycosides calculated as aescin
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or
as directed by the doctor or pharmacist.

Keep this leaflet, so that you can reread it when necessary.
If you have any doubts, consult your doctor or pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement, if your health condition worsens, or if Veinofytil needs to be used for longer than 8 weeks, consult your doctor.

Contents of the leaflet

What Veinofytil is and what it is used for
Important information before taking Veinofytil
How to take Veinofytil
Possible side effects
How to store Veinofytil
Contents of the pack and other information

1. What Veinofytil is and what it is used for
Veinofytil is a herbal medicinal product containing dry extract of horse chestnut seed.
Veinofytil is used in the treatment of chronic venous insufficiency, which is characterized by leg swelling, varicose veins, sensation of leg heaviness, pain, fatigue, itching, tension, and calf cramps.

2. Important information before taking Veinofytil

When not to take Veinofytil

If you are allergic to the active substance (dry extract of horse chestnut seed) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting Veinofytil, consult your doctor or pharmacist.
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If you experience skin inflammation, phlebitis, thrombophlebitis, induration, severe pain, ulcers, sudden swelling of one or both legs, or heart or kidney failure, consult your doctor. If symptoms worsen during treatment or signs of skin infection (inflammation) occur, contact your doctor or pharmacist.

Taking Veinofytil does not replace other preventive measures such as cold showers or wearing compression stockings, if prescribed by your doctor.
If treatment of chronic venous disease requires using Veinofytil for longer than 8 weeks, consult your doctor.
Children and adolescents
There is no indication for use in children under 12 years of age.
Use in adolescents under 18 years of age is not recommended due to lack of data on safety and efficacy.
Veinofytil with other medicines
No reports available. No studies have been conducted on drug interactions.
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Veinofytil with food and drink
Not applicable.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Due to insufficient data on Veinofytil and the use of dry horse chestnut extract during pregnancy and breastfeeding, the use of this medicine is not recommended during these periods. There are no data on the effect of the medicine on fertility.
Patients with kidney and/or liver function disorders
There are no data on dosing in case of liver and/or kidney impairment.
Driving and operating machinery
No studies have been conducted on the effect of this medicine on the ability to drive or operate machinery.
Veinofytil contains the colour Allura Red AC, aluminium lake (E 129)
This medicine contains the colour Allura Red AC, aluminium lake (E 129), which may cause allergic reactions.
Veinofytil contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
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3. How to take Veinofytil
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults
The recommended dose for adults is 1 tablet twice daily.
Tablets should be swallowed with a full glass of water.
First signs of beneficial effect may become apparent only after 4 weeks of treatment.
If symptoms worsen or do not improve after 8 weeks, consult your doctor.
In case of long-term use, treatment should be periodically reviewed by a doctor.
Taking more than the recommended dose of Veinofytil
Contact your doctor, pharmacist, or Poison Control Centre immediately.
If you miss a dose of Veinofytil
Do not take a double dose to make up for the missed tablet.
For any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
There have been reports of gastrointestinal disorders, headache, dizziness, itching (pruritus), and allergic reactions.
Frequency of occurrence is not known.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
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Adverse effects can also be reported to the marketing authorisation holder or its representative.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Veinofytil

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the blister and carton. The expiry date refers to the last day of the stated month.
Store in the original packaging.
This medicinal product does not require any special temperature storage conditions.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Veinofytil contains
The active substance is dry extract of horse chestnut seed, corresponding to 21 mg of
triterpene glycosides expressed as escin.
Each tablet contains 192–258 mg of extract (as dry extract) from Aesculus hippocastanum L.,
semen (horse chestnut seed) (DER 5-8:1), equivalent to 21 mg of triterpene glycosides
expressed as escin.
Extraction solvent: ethanol 50% V/V.
Other ingredients:
Tablet core: maltodextrin, microcrystalline cellulose, calcium hydrogen phosphate,
pregelatinized starch, talc, colloidal anhydrous silica, magnesium stearate.
Coating: copolymer of methacrylic acid and ethyl acrylate (1:1), talc, titanium dioxide (E
171), allura red AC, aluminium lake (E 129), colloidal anhydrous silica, sodium hydrogen
carbonate, sodium lauryl sulfate, triethyl citrate.
Excipients used in the extract: maltodextrin, colloidal anhydrous silica.

What Veinofytil looks like and contents of the pack
Veinofytil is red, elongated, biconvex tablets, 18 × 8 mm in size.
The medicine is available in blisters, in cardboard boxes containing 42 tablets or 98 tablets, or
in unit-dose blisters in cardboard boxes containing 100 × 1 tablet.
Not all pack sizes may be marketed.

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Marketing Authorisation Holder and Manufacturer
Tilman S.A.
Zone d'Activités Sud 15
5377 Somme-Leuze
Belgium
+32 (0) 84 320 360
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