Sapoven t
Poland
Table of Contents
Package leaflet: Information for the patient
SAPOVEN T, (20 mg + 10 mg)/g, gel
Troxerutinum + Hippocastani semen extractum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
doctor, pharmacist, or nurse.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
- If there is no improvement after two weeks, or if you feel worse, you should contact your doctor.
Contents of the leaflet
- What Sapoven T gel is and what it is used for
- Important information before using Sapoven T gel
- How to use Sapoven T gel
- Possible side effects
- How to store Sapoven T gel
- Contents of the pack and other information
1. What Sapoven T gel is and what it is used for
Sapoven T gel contains troxerutin and a pharmacodynamically irrelevant addition of a plant substance – a concentrated extract from horse chestnut seeds. It exerts anti-edematous, vessel-sealing, and venotonic effects, improving the condition of capillary endothelia by reducing their permeability and fragility.
This medicine is indicated for chronic venous insufficiency, including:
- treatment of venous circulation disorders in the lower limbs (with symptoms such as swelling and itching),
- conditions associated with varicose veins and pre-varicose states,
- adjunctive treatment of 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 to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting to use Sapoven T gel, consult your doctor, pharmacist, or nurse.
If during treatment symptoms worsen or signs of skin infection appear, consult a doctor or pharmacist.
Do not apply the medicinal product on open, extensive wounds or damaged skin, and avoid contact with eyes and mucous membranes.
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In case of skin inflammation, phlebitis, subcutaneous sclerosis, severe pain, ulcers, sudden swelling of one or both legs, or cardiac or renal insufficiency, consult a doctor.
Children and adolescents
Not recommended for use in individuals under 18 years of age due to lack of safety and efficacy data in this age group.
Sapoven T gel and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
Currently, no interactions with other medicines or other types of interactions are known following topical application of troxerutin and horse chestnut seed extract.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Due to lack of safety data regarding escin and horse chestnut seed extract in pregnant and breastfeeding women, self-administration of this medicine is not recommended during pregnancy or breastfeeding.
Driving and operating machinery
This medicine is considered safe and does not affect the ability to drive or operate machinery.
Sapoven T gel contains propylene glycol
This 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
These may cause allergic reactions (including delayed-type reactions).
Sapoven T gel contains citral (a component of lemon fragrance)
Citral may cause allergic reactions.
3. How to use Sapoven T gel
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
The medicine is for topical application to the skin.
Adults: Apply a thin layer of gel and gently rub it into the affected area 2 to 3 times daily.
If symptoms persist for longer than 2 weeks despite treatment, consult a doctor.
Concurrent use of oral medications containing the same active substances as Sapoven T gel should be discussed with a 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 (see section "Warnings and precautions").
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Overdose of Sapoven T gel
There are no known cases of overdose following topical application of troxerutin and horse chestnut seed extract.
Missed dose of Sapoven T gel
If a dose is missed, resume treatment as soon as possible.
If there are any further doubts concerning the use of this medicine, consult a doctor, pharmacist, or nurse.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Cases of skin hypersensitivity reactions (itching and redness) and transient sensation of warmth have been reported; urticaria may occur in hypersensitive individuals. The frequency of these adverse reactions is not known.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Sapoven T, gel
Store in a closed, original package at a temperature below 25°C.
Keep the medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.
6. Contents of the packaging and other information
What Sapoven T, gel contains
- The active substances in the medicine are troxerutin and triterpene glycosides expressed as anhydrous aescin, derived from the concentrated extract of horse chestnut seeds Aesculus hippocastanum L. One gram of gel contains:
- 20 mg of troxerutin (Troxerutinum),
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- 100 mg of concentrated extract from horse chestnut seeds (Aesculus hippocastanum L.), containing 10 mg of triterpene glycosides expressed as anhydrous aescin (DER 4:1); extraction solvent: ethanol 80% V/V.
- 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 contents of the pack
Sapoven T is a yellow gel with a lemon scent.
The medicine comes in an aluminium tube containing 30 g of gel, packed in a cardboard box.
Marketing Authorisation 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: [email protected]
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