Sapoven t
Poland
Table of Contents
Patient Information Leaflet
SAPOVEN T
200 mg + 20 mg triterpene glycosides calculated as anhydrous escin,
soft capsules
Troxerutinum + Hippocastani seminis extractum siccum normatum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has advised.
- 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 3-4 weeks of treatment, or if you feel worse, contact your doctor.
Contents of the leaflet
- What Sapoven T is and what it is used for
- What you need to know before taking Sapoven T
- How to take Sapoven T
- Possible side effects
- How to store Sapoven T
- Contents of the pack and other information
1. What Sapoven T is and what it is used for
Sapoven T soft capsules contain troxerutin in combination with a standardized dry extract of horse chestnut seeds (containing 20% escin). The medicine affects venous tone, reduces vascular permeability, improves venous circulation, prevents venous stasis, and exerts anti-edematous and anti-exudative effects.
Sapoven T is indicated for symptoms of chronic venous insufficiency of the lower limbs, such as leg pain, leg swelling, nocturnal calf cramps, and sensation of heavy legs.
If symptoms worsen or if there is no improvement after 3-4 weeks of treatment, or if you feel worse, consult your doctor.
2. Important information before using Sapoven T
When not to use Sapoven T
- If the patient is allergic to troxerutin, horse chestnut seed extract, or any of the other ingredients of this medicine (listed in section 6).
- In case of known hypersensitivity to peanuts or soy.
Warnings and precautions
Before starting treatment with Sapoven T, please consult your doctor, pharmacist, or nurse.
If you have skin inflammation, phlebitis, subcutaneous sclerosis, severe pain, ulcers, sudden swelling of one or both legs, heart or kidney failure, you should consult your doctor.
If during treatment symptoms worsen or signs of skin infection appear, consult your doctor or pharmacist.
Use in individuals under 18 years of age is not recommended due to lack of data on safety and efficacy.
Sapoven T and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for use.
Due to the presence of escin, caution is advised when using Sapoven T concomitantly with nephrotoxic drugs. Escin may increase the risk of bleeding when used together with coumarin derivatives, non-steroidal anti-inflammatory drugs, and heparin.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Due to lack of safety data regarding the use of escin and horse chestnut seed extract in pregnant or breastfeeding women, self-administration of this medicine is not recommended in these populations.
Driving and operating machinery
There is no data available on the influence of this medicine on the ability to drive or operate machinery.
Sapoven T contains purified soybean oil
Do not use if hypersensitivity to peanuts or soy has been diagnosed.
3. How to use Sapoven T
This medicine should always be taken exactly as described in the patient information leaflet, or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
This medicine is for oral use.
Adults
The recommended dose is 1 capsule three times daily during meals.
The recommended duration of treatment is 3 to 4 weeks, although the doctor may recommend continuing therapy.
Children and adolescents
There is no indication for use in children under 12 years of age. The use of this medicinal product is not recommended in adolescents under 18 years of age (see "Warnings and precautions").
Taking more Sapoven T than recommended
If a significantly higher than recommended dose is taken, consult a doctor or pharmacist.
No symptoms of overdose have been reported with dry extract of horse chestnut and troxerutin.
If you miss a dose of Sapoven T
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your 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 gastric mucosa irritation (manifesting, for example, as nausea) have been reported; these subside when the medicine is taken during meals. Other reported reactions include: transient facial flushing, headache and dizziness, allergic reactions, as well as itching and rash. The frequency of these reactions is unknown.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 .
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safe use of the medicine.
5. How to store Sapoven T
Keep the medicine 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 must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the packaging and other information
What Sapoven T contains
- The active substances in the medicinal product are troxerutin (Troxerutinum) and dry standardized extract from horse chestnut seeds (Hippocastani seminis extractum siccum normatum). One capsule contains 200 mg of troxerutin and 105.3 mg of dry standardized extract from horse chestnut seeds, equivalent to 20 mg of triterpene glycosides calculated as anhydrous escin (3,4-16,6:1); extraction solvent: ethanol 80% (V/V).
- Other components (excipients) are: purified soybean oil, refined palm oil, hydrogenated coconut oil, yellow wax, soy lecithin, gelatin, glycerol, titanium dioxide (E171), iron oxide brown (E172), iron oxide yellow (E172).
What Sapoven T looks like and contents of the pack
Sapoven T is in the form of elongated, light brown capsules with a smooth, glossy surface and characteristic odour.
One pack contains 48 capsules.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal Product Information
tel.: 22 742 00 22
e-mail: [email protected]