Veinofitil

1. What is Veinofytil and what is it used for

Veinofytil is a herbal medicinal product containing dry extract of horse chestnut seeds.
Veinofytil is used to treat chronic venous insufficiency, which is characterized by swelling of the legs, varicose veins, feeling of heaviness in the legs, painful symptoms, fatigue, itching, tension, and cramps in the calves.

2. Important information before taking Veinofytil

When not to take Veinofytil

• If the patient is allergic to the active substance (dry extract of horse chestnut seeds) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Veinofytil, the doctor or pharmacist should be consulted.
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• In case of skin inflammation, phlebitis, or subcutaneous induration, severe pain, ulcers, sudden swelling of one or both legs, heart or kidney failure, the doctor should be consulted. If symptoms worsen or signs of infection (inflammation) of the skin appear during the use of this medicine, the doctor or pharmacist should be contacted.

Taking Veinofytil does not replace other preventive measures, such as taking cold showers or wearing compression stockings, if prescribed by the doctor.
If the treatment of chronic venous disease requires the use of Veinofytil for more than 8 weeks, the doctor should be consulted.

Children and adolescents

There are no indications for the use of Veinofytil in children under 12 years of age.
The use of Veinofytil is not recommended in adolescents under 18 years of age due to the lack of data on safety and efficacy.

Veinofytil and other medicines

There are no reports. No drug interaction studies have been conducted.
The doctor or pharmacist should be informed about all medicines currently or recently taken by the patient, as well as any medicines planned to be taken.

Veinofytil with food and drink

Not applicable.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Due to the lack of sufficient data on the use of Veinofytil during pregnancy and breastfeeding, the use of this medicine is not recommended during this time. There are no data on the effect of the medicine on fertility.

Patients with renal and/or hepatic impairment

There are no data on dosing in patients with hepatic and/or renal impairment.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines.

Veinofytil contains the colorant Allura Red AC, aluminum lake (E 129)

This medicine contains the colorant Allura Red AC, aluminum lake (E 129), which may cause allergic reactions.

Veinofytil contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means 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 the patient leaflet or
according to the doctor's or pharmacist's instructions. In case of doubts, the doctor or pharmacist should be consulted.
Adults
The recommended dose of Veinofytil for adults is 1 tablet twice a day.
The tablets should be swallowed with a full glass of water.
The first signs of the beneficial effect of the medicine may only be visible after 4 weeks of use.
If symptoms worsen or do not improve after 8 weeks, the doctor should be consulted.
In case of long-term use, the treatment should be periodically evaluated by the doctor.

Taking a higher dose of Veinofytil than recommended

The doctor or pharmacist should be contacted immediately, or the Poison Control Center.

Missing a dose of Veinofytil

A double dose should not be taken to make up for a missed tablet.
Any further questions about the use of this medicine should be directed to the doctor or pharmacist.

4. Possible side effects

Like all medicines, Veinofytil can cause side effects, although not everybody gets them.
There are reports of gastrointestinal disorders, headaches, dizziness, itching (pruritus), and allergic reactions.
The frequency of occurrence is not known.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
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Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Veinofytil

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date (EXP) stated on the blister pack and carton. The expiration date refers to the last day of the specified month.
Store in the original packaging.
This medicinal product does not require special storage temperature recommendations.
Medicines should not be disposed of via wastewater or household waste containers.
The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Veinofytil contains

The active substance is dry extract of horse chestnut seeds, which corresponds to 21 mg of triterpenoid glycosides calculated as protoescigenin.
One tablet contains 192-258 mg of extract (as dry extract) from Aesculus hippocastanumL., semen(horse chestnut seeds) (DER 5-8:1), which corresponds to 21 mg of triterpenoid glycosides calculated as protoescigenin.
Extraction solvent: ethanol 50% V/V.
Other ingredients:
Core:maltodextrin, microcrystalline cellulose, calcium hydrogen phosphate, pregelatinized starch, talc, colloidal anhydrous silica, magnesium stearate.
Coating:methacrylic acid and ethyl acrylate copolymer (1:1), talc, titanium dioxide (E 171), Allura Red AC, aluminum lake (E 129), colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate, triethyl citrate. Auxiliary substances used in the extract: maltodextrin, colloidal anhydrous silica.

• Auxiliary substances used in the extract: maltodextrin, colloidal anhydrous silica.

What Veinofytil looks like and what the pack contains

Veinofytil is a red, oblong, biconvex tablet with dimensions of 18 × 8 mm.
The medicine is available in blisters, in cardboard boxes of 42 tablets or 98 tablets, or in single-dose blisters in cardboard boxes of 100 × 1 tablet.
Not all pack sizes may be marketed.
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Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet:

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