Esceven
Poland
Table of Contents
Package leaflet: Information for the patient
Esceven, 167 mg, coated tablets
Hippocastani seminis extractum siccum
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient information leaflet or as directed by the doctor, pharmacist, or nurse.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
- If there is no improvement after 14 days, or if you feel worse, consult your doctor.
Table of contents
- What Esceven is and what it is used for
- Important information before taking Esceven
- How to take Esceven
- Possible side effects
- How to store Esceven
- Contents of the pack and other information
1. What Esceven is and what it is used for
The active substance in Esceven tablets is dry extract of horse chestnut seed (Hippocastani seminis extractum siccum), containing escin, which increases venous vessel tone.
The medicine is traditionally used for symptoms of chronic venous insufficiency, such as: swelling, calf cramps, itching, pain, and a feeling of heaviness in the legs, varicose veins.
This product is indicated for use in adults and adolescents above 12 years of age.
If there is no improvement after 14 days, or if you feel worse, consult your doctor.
2. Important information before using Esceven
When not to use Esceven:
- if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
- if the patient has renal failure.
Warnings and precautions
Children
Esceven must not be used in children under 12 years of age due to lack of data confirming safety of use.
Esceven and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
There are no data available on interactions with other medicines.
Pregnancy and breastfeeding
Due to insufficient data, Esceven should not be used during pregnancy or breastfeeding.
Driving and operating machinery
There are no data available on the influence of the medicine on the ability to drive and operate machinery.
3. How to use Esceven
This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Use in children
Esceven medicinal product should not be used in children under 12 years of age.
Use in adults and adolescents over 12 years of age
1 tablet three times daily after meals.
Taking more Esceven than recommended
There is no data available on cases of overdose.
If you forget to take Esceven
Do not take a double dose to make up for a forgotten dose.
Stopping Esceven
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 everyone will experience them.
Esceven may rarely cause gastrointestinal disturbances; dizziness, itching, nausea, vomiting, and headache have also been reported sporadically.
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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone +48 22 4921301, fax +48 22 4921309, e-mail: [email protected]. Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Esceven
Store at a temperature not exceeding 25°C.
Keep the medicine in a place invisible and inaccessible to 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 sewage systems or household waste bins. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Contents of the pack and other information
What Esceven contains
Active substance:
One tablet contains 167 mg of dry extract from Aesculus hippocastanum L., semen (horse chestnut seeds),
Hippocastani seminis extractum siccum (5-9:1)
Extraction solvent – ethanol 80% (v/v)
Excipients: microcrystalline cellulose, sodium carboxymethyl starch type C, magnesium stearate, povidone, colloidal silicon dioxide.
Coating Opadry II 85F210063 Green: polyvinyl alcohol, macrogol 4000, talc, yellow iron oxide (E 172), titanium dioxide (E 171), quinoline yellow (E 104), aluminium lake, brilliant blue FCF (E 133), aluminium lake.
What Esceven looks like and contents of the pack
Esceven is in the form of coated tablets.
Available pack sizes:
20 tablets – 1 PVC/Al blister containing 20 tablets in a cardboard box with leaflet,
40 tablets – 2 PVC/Al blisters containing 20 tablets each in a cardboard box with leaflet,
60 tablets – 3 PVC/Al blisters containing 20 tablets each in a cardboard box with leaflet,
80 tablets – 4 PVC/Al blisters containing 20 tablets each in a cardboard box with leaflet.
For more detailed information, please contact the marketing authorisation holder.
Marketing authorisation holder and manufacturer
Poznańskie Zakłady Zielarskie Herbapol S.A.
Towarowa 47/51, 61-896 Poznań, Poland
Tel. +48 61 88 61 800, Fax +48 61 85 36 058