Sapoven

Leaflet included in the packaging: patient information

SAPOVEN, 10 mg triterpenoid glycosides in terms of escin / g, ointment

You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by
your doctor, pharmacist, or nurse.

• You should keep this leafletso that you can read it again if you need to.
• If you need advice or additional information, you should 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 14 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is SAPOVEN and what is it used for
• 2. Important information before using SAPOVEN
• 3. How to use SAPOVEN
• 4. Possible side effects
• 5. How to store SAPOVEN
• 6. Package contents and other information

1. What is SAPOVEN and what is it used for

SAPOVEN contains a standardized extract of horse chestnut seeds with a defined content of 1.0%
active compounds. The medicine is traditionally used for symptoms of heavy legs and swelling of the legs
and a feeling of tired legs caused by minor venous circulation disorders.
SAPOVEN is intended for traditional use in the indications listed and its efficacy is based on long-term use and experience in treatment.

2. Important information before using SAPOVEN

When not to use SAPOVEN:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• on open, extensive wounds and damaged skin.

Warnings and precautions

Before starting to use SAPOVEN, you should discuss it with your doctor or pharmacist.
In case of skin inflammation, phlebitis, or subcutaneous induration, severe pain, ulcers, or sudden swelling, the use of the medicine should be consulted with a doctor.
You should consult a doctor, even if the above warnings concern situations that have occurred in the past.

Children and adolescents

The medicine is not intended for children and adolescents under 18 years of age.
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SAPOVEN and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No interactions with other medicines have been reported so far.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Due to the lack of sufficient data on safety, use during pregnancy and breastfeeding is not recommended.

Driving and using machines

SAPOVEN does not affect the ability to drive vehicles or operate machines.

SAPOVEN contains cetostearyl alcohol and sorbic acid

The medicine may cause local skin reactions (e.g., contact dermatitis).

SAPOVEN contains propylene glycol

The medicine may cause skin irritation.

SAPOVEN contains methyl parahydroxybenzoate and propyl parahydroxybenzoate

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

3. How to use SAPOVEN

This medicine should always be used exactly as described in the patient leaflet or as directed by
your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
The medicine is applied locally to the skin.
Apply to the skin such an amount of ointment that, after spreading, it forms a thin layer. Rub in until the medicine is absorbed. The ointment should be used up to 3 times a day for a period of up to 2 weeks.
If symptoms persist for longer than 2 weeks, you should consult your doctor about further use of the medicine.

Use in children and adolescents

The medicine is not intended for children and adolescents under 18 years of age.

Use of a higher dose of SAPOVEN than recommended

No cases of overdose have been reported after topical use of horse chestnut seed extract.

Missed dose of SAPOVEN

In case of a missed dose of SAPOVEN, you should resume treatment as soon as possible.
You should not use a double dose to make up for the missed dose.

Stopping use of SAPOVEN

In case of any further doubts related to the use of this medicine, you should consult your doctor or pharmacist.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During use, transient warmth and skin irritation may occur, and in sensitive individuals, hives may occur.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor, pharmacist, or nurse. 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309,
e-mail: ndl@urpl.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

Store in a closed, original packaging, at a temperature below 25°C.
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. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 contains

• The active substance of the medicine is Hippocastani seminis extractum(DER 4:1), extractant: ethanol 80% (V/V) with a content of 10% triterpenoid glycosides in terms of escin.
• The other ingredients (excipients) are: light liquid paraffin, white petrolatum, self-emulsifying glycerol monostearate, cetostearyl alcohol, polysorbate 40, triglycerides of saturated fatty acids with an average chain length, propylene glycol, anhydrous colloidal silica, sorbic acid, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

What SAPOVEN looks like and what the packaging contains

The medicine is a cream-colored to light beige ointment with a characteristic odor.
The packaging consists of an aluminum tube with a polyethylene cap, in a cardboard box.
1 tube of 30 g
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Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine information
tel.: 22 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of last update of the leaflet:

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