Sapoven T

Package Leaflet: Information for the Patient

SAPOVEN T

200 mg + 20 mg of triterpenoid glycosides in terms of anhydrous escin,

Soft capsules
Troxerutin + Dry standardized extract of horse chestnut seeds

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If after 3-4 weeks there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Sapoven T and what is it used for
• 2. Important information before taking Sapoven T
• 3. How to take Sapoven T
• 4. Possible side effects
• 5. How to store Sapoven T
• 6. Package contents and other information

1. What is Sapoven T and what is it used for

Sapoven T, soft capsules, contains troxerutin in combination with a dry standardized extract of horse chestnut seeds (containing 20% escin). The medicine affects venous tension, reduces its permeability, improves venous circulation, prevents venous stasis, and has anti-edema and anti-exudative effects.
The medicine is used for symptoms of chronic venous insufficiency of the lower limbs, such as a feeling of pain, leg swelling, nocturnal cramps, and a feeling of heaviness in the legs.
If symptoms worsen or after 3-4 weeks of use there is no improvement, or the patient feels worse, they should consult their doctor.

2. Important information before taking Sapoven T

When not to take Sapoven T

• If the patient is allergic to troxerutin, horse chestnut seed extract, or any other component of this medicine (listed in section 6).
• In case of known hypersensitivity to peanuts or soy.

Warnings and precautions

Before starting to take Sapoven T, the patient should discuss it with their doctor, pharmacist, or nurse.
In case of skin inflammation, phlebitis, subcutaneous induration, severe pain, ulcers, sudden swelling of one or both legs, heart or kidney failure, the patient should consult their doctor.
If during the use of the medicinal product the symptoms worsen or signs of skin infection appear, the patient should consult their doctor or pharmacist.
The use of this medicine is not recommended for adolescents under 18 years of age due to the lack of data on safety and efficacy.

Sapoven T and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Due to the content of escin, caution should be exercised when taking Sapoven T with nephrotoxic medicines. Escin may increase the risk of bleeding when taken with coumarin derivatives, non-steroidal anti-inflammatory drugs, and heparin.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Due to the lack of data on the safety of using escin and horse chestnut seed extract in pregnant and breastfeeding women, it is not recommended to use this medicine without consulting a doctor.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive and use machines.

Sapoven T contains purified soybean oil

Do not use in case of known hypersensitivity to peanuts or soy.

3. How to take Sapoven T

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.
The medicine is taken orally.
Adults
The recommended dose is 1 capsule 3 times a day during meals.
The recommended treatment period is 3 to 4 weeks, but the doctor may recommend continuing therapy.
Children and adolescents
There are no indications for use in children under 12 years of age. The use of this medicinal product is not recommended for adolescents under 18 years of age (see "Warnings and precautions").

Overdose of Sapoven T

In case of taking a significantly higher dose of the medicine than recommended, the patient should consult their doctor or pharmacist.
No symptoms of overdose of horse chestnut seed extract and troxerutin have been reported.

Missed dose of Sapoven T

The patient should not take a double dose to make up for a missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Sapoven T can cause side effects, although not everybody gets them.
There have been reports of gastric mucosa irritation (e.g., nausea), which subsides when the medicine is taken during meals, as well as: flushing, headaches, dizziness, allergic reactions, itching, and rash. The frequency of these side effects is not known.
Reporting side effects
If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Sapoven T

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Store in the original packaging, at a temperature not exceeding 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Sapoven T contains

• The active substances of the medicine are troxerutin ( Troxerutinum) and dry standardized extract of horse chestnut seeds ( Hippocastani seminis extractum siccum normatum). 1 capsule contains 200 mg of troxerutin and 105.3 mg of dry standardized extract of horse chestnut seeds, which corresponds to 20 mg of triterpenoid glycosides in terms of anhydrous escin (3.4-16.6:1), extractant: ethanol 80% (V/V).
• The other ingredients (excipients) are: purified soybean oil, refined palm oil, hydrogenated coconut oil, yellow wax, soy lecithin, gelatin, glycerol, titanium dioxide (E171), brown iron oxide (E172), yellow iron oxide (E172).

What Sapoven T looks like and what the package contains

Sapoven T has the form of elongated capsules of light brown color, with a smooth, shiny surface and a specific smell.
One package contains 48 capsules.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Information about the medicine

tel.: 22 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of the last update of the leaflet: