


Ask a doctor about a prescription for CIRCULAVEEL FILM-COATED TABLETS
PACKAGE LEAFLET
Package Leaflet: Information for the Patient
Circulaveel Film-Coated Tablets
Dry extract of Vitis viniferaL. (dry extract of red grape leaves)
Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.
Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.
Contents of the Package Leaflet
Contents of the pack and further information
Circulaveel Film-Coated Tablets are a herbal medicinal product for the treatment of adults with symptoms of chronic venous insufficiency, such as swollen legs, feeling of heaviness, pain, fatigue, itching, tension, and cramps in the back of the legs.
Do not takeCirculaveel:
If you are allergic to red grape leaf extract (Vitis viniferaL) or to any of the other components of this medication (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Circulaveel.
Consult your doctor immediately if skin inflammation or ulcers, thrombophlebitis, or subcutaneous induration (hardening of tissues under the skin), severe pain, ulcers, sudden swelling of one or both legs, heart or kidney failure appear.
Other non-invasive actions recommended by the doctor, such as compressive bandaging of the legs, wearing compression stockings, or taking cold water baths, should be strictly followed.
In the case of an inadequate or unsatisfactory symptomatic response within 2 weeks, a doctor should be consulted, as edema or other symptoms may have other causes.
If your symptoms worsen, consult your doctor or pharmacist.
Children and adolescents
The use of Circulaveel is not recommended in children and adolescents under 18 years of age.
Taking Circulaveel with other medications
Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.
Taking Circulaveel with food and drinks
No interactions are expected.
Pregnancy and breast-feeding
Pregnancy
Circulaveel should not be used during pregnancy. There are no sufficient data on the use of grape leaf extract in pregnant women.
Breast-feeding
Circulaveel should not be used during breast-feeding, as there is not enough information on the excretion of grape leaf extract in breast milk.
If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.
Driving and using machines
No studies have been conducted on the effect on the ability to drive and use machines. However, it is unlikely to affect driving ability or machine operation.
Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, ask your doctor or pharmacist.
The recommended dose is:
Adults and elderly: 1-2 tablets per day, with water, before breakfast.
The score line is only for breaking the tablet if you find it difficult to swallow it whole.
The recommended duration of treatment with Circulaveel is 12 weeks. It may take 2-3 weeks of treatment before beneficial effects are observed.
Long-term treatments can be performed after consulting a doctor.
Use in children and adolescents
The use of Circulaveel is not recommended in children and adolescents under 18 years of age.
If you take more Circulaveel than you should
If you have taken more than the recommended dose, consult your doctor or pharmacist and bring this package leaflet with you. You can also call the Toxicology Information Service, phone 915 620 420.
If you forget to take Circulaveel
Do not take a double dose to make up for forgotten doses, but continue taking your usual dose at the usual time.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
Like all medications, this medication can cause side effects, although not everyone experiences them.
Skin hypersensitivity reactions (itching, erythema, urticaria) of unknown frequency may occur after taking Circulaveel.
Additionally, nausea, gastrointestinal discomfort, and headache may occur. The frequency is unknown.
If you experience side effects, consult your doctor or pharmacist. This includes any side effects not listed in this package leaflet.
Reporting of side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.
Keep this medication out of the sight and reach of children.
This medication should not be stored above 30°C, and the tablets should be kept in the original packaging (in the blister pack).
Do not use this medication after the expiration date shown on the carton and blister pack after "EXP". The expiration date is the last day of the month indicated.
Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.
Composition of Circulaveel
Appearance of the product and pack contents
Circulaveel are oblong film-coated tablets with a reddish-brown color and a score line on both sides.
They are available in blister packs of 30, 60, and 90 film-coated tablets.
Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer
Marketing authorization holder
Laboratorios Heel España, S.A.U.
Calle Madroño, s/n 28770
Colmenar Viejo (Madrid)
Phone: 918473910
Fax: 918463614
Manufacturer:
Wiewelhove GmbH
Dörnebrink 19
49479 Ibbenbüren
Germany
Date of the last revision of this package leaflet:December 2019
Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for CIRCULAVEEL FILM-COATED TABLETS – subject to medical assessment and local rules.