Circulaveel film-coated tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
PACKAGE LEAFLET
Package leaflet: Information for the patient
Circulaveel Film-coated Tablets
Vitis vinifera L. dry extract (dry extract of red vine leaves)
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow the instructions for use of this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet, as you may need to refer to it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve after two weeks.
Contents of the leaflet
- What Circulaveel Film-coated Tablets are and what they are used for
- What you need to know before taking Circulaveel
- How to take Circulaveel
- Possible side effects
- How to store Circulaveel
Pack contents and additional information
1. What Circulaveel Film-coated Tablets are and what they are used for
Circulaveel Film-coated Tablets is a herbal medicinal product used in adults to treat symptoms of chronic venous insufficiency, such as swollen legs, sensation of heaviness, pain, fatigue, pruritus, tension, and cramps in the lower legs.
2. What you need to know before starting to take Circulaveel
Do not take Circulaveel:
If you are allergic to red vine leaf extract (Vitis vinifera L) or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Circulaveel.
Seek immediate medical advice if you experience skin inflammation or ulcers, thrombophlebitis, subcutaneous induration (hardening of tissues beneath the skin), severe pain, ulcers, sudden swelling of one or both legs, or heart or kidney failure.
Other non-invasive measures recommended by your doctor should be strictly followed, such as compression bandaging of the legs, wearing compression stockings, or cold water baths.
If there is an inadequate or unsatisfactory symptomatic response within 2 weeks, consult a doctor, as edema or other symptoms may have other underlying causes.
If your symptoms worsen, consult your doctor or pharmacist.
Children and adolescents
Use in children and adolescents under 18 years of age is not recommended.
Taking Circulaveel with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking Circulaveel with food and drinks
No interactions are expected.
Pregnancy and breastfeeding
Pregnancy
Circulaveel must not be used during pregnancy. There is insufficient data on the use of vine leaf extract in pregnant women.
Breastfeeding
Circulaveel must not be used during breastfeeding, as there is insufficient information regarding the excretion of vine leaf extract in breast milk.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
No studies have been conducted on the effects on the ability to drive and use machines. However, it is unlikely to affect your ability to drive or operate machinery.
3. How to take Circulaveel
Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults and elderly: 1 - 2 tablets daily, with water, before breakfast.
The score line is intended solely to facilitate breaking the tablet if you have difficulty swallowing it whole.
The recommended duration of treatment with Circulaveel is 12 weeks. It may take two to three weeks of treatment before beneficial effects are observed.
Long-term treatments may be carried out after consulting with your doctor.
Use in children and adolescents
Use in children and adolescents under 18 years of age is not recommended.
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 leaflet with you. You may also contact the Toxicology Information Service at telephone number 915 620 420.
If you forget to take Circulaveel
Do not take a double dose to make up for missed doses. Continue taking your usual dose at the usual time.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Skin hypersensitivity reactions (itching, erythema, urticaria) of unknown frequency may occur after taking Circulaveel.
In addition, nausea, gastrointestinal discomfort, and headache may occur. The frequency is unknown.
If you experience any side effects, consult your doctor or pharmacist. This includes any side effect not listed in this leaflet.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not mentioned in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Circulaveel
Keep this medicine out of the sight and reach of children.
This medicine must not be stored above 30°C, and the tablets should be kept in the original packaging (in the blister).
Do not use this medicine after the expiry date stated on the carton and on the blister after "EXP". The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Circulaveel
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The active substance is dried extract of Vitis vinifera L., folium (grape leaves) (4-6:1), extraction solvent: water.
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One film-coated tablet contains 360 mg of dried grape leaf extract (Vitis vinifera L.).
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The other components are: Microcrystalline cellulose, Maltodextrin, Hypromellose, Sodium croscarmellose, Anhydrous colloidal silica, Crospovidone, Vegetable magnesium stearate, Talc, Titanium dioxide E171, Macrogol 6000 (polyethylene glycol), Iron oxide red E172.
Appearance of the medicinal product and contents of the pack
Circulaveel are oblong, film-coated tablets in reddish-brown colour, with a groove on both sides.
They are available in blister packs containing 30, 60 and 90 film-coated tablets.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorios Heel España, S.A.U.
Calle Madroño, s/n 28770
Colmenar Viejo (Madrid)
Telephone: 918473910
Fax: 918463614
[email protected]
Manufacturer:
Wiewelhove GmbH
Dörnebrink 19
49479 Ibbenbüren
Germany
Date of the most recent revision of this leaflet: December 2019
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).