Sapoven T

Package Leaflet: Information for the Patient

SAPOVEN T, (20 mg + 10 mg)/g, Gel

Troxerutin + Hippocastani semen extractum

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in this package leaflet for the patient or as advised by
the doctor, pharmacist, or nurse.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should inform the doctor, pharmacist, or nurse. See section 4.
• If after two weeks there is no improvement or the patient feels worse, they should contact the doctor.

Table of Contents of the Package Leaflet

• 1. What is Sapoven T gel and what is it used for
• 2. Important information before using Sapoven T gel
• 3. How to use Sapoven T gel
• 4. Possible side effects
• 5. How to store Sapoven T gel
• 6. Contents of the package and other information

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

Sapoven T gel contains troxerutin and a non-essential pharmacodynamic additive of plant substance - a concentrated extract of horse chestnut seeds. It has anti-edematous, sealing, and toning effects on veins, improving the condition of the microvessel endothelium by reducing its permeability and fragility.
The medicine is used in chronic venous insufficiency, including:

• treatment of circulatory disorders in the lower limbs (with symptoms of edema, itching),
• complaints related to varicose veins and pre-varicose conditions,
• auxiliary treatment of post-traumatic and post-surgical edema.

2. Important information before using Sapoven T gel

When not to use Sapoven T gel:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Sapoven T gel, the patient should discuss it with their doctor, pharmacist, or
nurse.
If the symptoms worsen or signs of skin infection appear during the use of the medicinal product, the patient should consult a doctor or pharmacist.
The medicinal product should not be used on open, extensive wounds and damaged skin, as well as near the eyes and on mucous membranes.
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 a doctor.

Children and adolescents

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 in this age group.

Sapoven T gel 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.
No interactions with other medicines and other types of interactions are known after topical use of troxerutin and horse chestnut seed extract.

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 using this medicine.
Due to the lack of data on the safety of using escin and horse chestnut seed extract in pregnant and breastfeeding women, self-administration of the medicine is not recommended in these cases.

Driving and using machines

The medicine is considered safe and does not affect the ability to drive and use machines.

Sapoven T gel contains propylene glycol

The medicine contains 100 mg of propylene glycol in 1 g of gel. Propylene glycol may cause skin irritation.

Sapoven T gel contains methyl parahydroxybenzoate and propyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late-type reactions).

Sapoven T gel contains citral (a component of lemon flavor)

Citral may cause allergic reactions.

3. How to use Sapoven T gel

This medicine should always be used exactly as described in this package leaflet for the patient or as advised by
the doctor, pharmacist, or nurse. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.
The medicine is used topically on the skin.
Adults: Apply a thin layer of gel and rub it into the affected area 2 to 3 times a day.
If the symptoms persist for more than 2 weeks despite using the medicine, the patient should consult their doctor.
Concomitant use of oral medicines containing the same active substances as Sapoven T gel should be discussed with the doctor.

Children and adolescents

There are no indications for use in children under 12 years of age. The use of this medicine is not recommended for adolescents under 18 years of age (see "Warnings and precautions").

Using more than the recommended dose of Sapoven T gel

No cases of overdose are known after topical use of troxerutin and horse chestnut seed extract.

Missing a dose of Sapoven T gel

In case of a missed dose, the patient should resume treatment as soon as possible.
In case of any further doubts about using this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
There have been reports of skin hypersensitivity reactions (itching and erythema) and transient warmth, and hives may occur in sensitive individuals. The frequency of these side effects is not known.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this package leaflet, they should inform their doctor or pharmacist. 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.: +48 22 49 21 301, fax: +48 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 gather more information on the safety of this medicine.

5. How to store Sapoven T gel

Store in the original package, at a temperature below 25°C.
The medicine should be kept out of sight and reach of children.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Sapoven T gel contains

• The active substances of the medicine are troxerutin and triterpenoid glycosides in terms of anhydrous escin, obtained from a concentrated extract of horse chestnut seeds Aesculus hippocastanumL. One gram of gel contains:
• 20 mg of troxerutin (Troxerutinum),

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• 100 mg of concentrated extract of horse chestnut seeds Aesculus hippocastanumL., containing 10 mg of triterpenoid glycosides in terms of anhydrous escin (DER 4:1); extraction solvent: ethanol 80% V/V.
• The other ingredients (excipients) are: propylene glycol (E 1520), tromethamine, carbomer, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate, disodium edetate, lemon flavor (contains citral), purified water.

What Sapoven T gel looks like and what the package contains

Sapoven T is a yellow gel with a lemon scent.
The package is an aluminum tube containing 30 g of gel, in a cardboard box.

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: [email protected]

Date of the last update of the package leaflet:

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