Circulaveel comprimidos recubiertos con pelicula

PATIENT INFORMATION LEAFLET

Patient Information Leaflet: Information for the Patient

Circulaveel Coated Tablets

Dried extract ofVitis viniferaL. (dried extract of red grape leaves)

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side 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 pack and additional information

Circulaveel Tablets Coated with Film is a plant-based medication for the treatment in adults of 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 takeCirculaveel.

Consult your doctorimmediately if you experience skin inflammation or ulcers, thrombophlebitis or subcutaneous induration (hardening of tissues beneath the skin), intense pain, ulcers, sudden swelling of one or both legs, heart or renal insufficiency.

Strictly follow other non-invasive actions recommended by your doctor, such as compressive bandaging of the legs, wearing compression stockings or cold water baths.

In the case of inadequate or unsatisfactory symptomatic response within 2 weeks, consult a doctor as edema or other symptoms may have other causes.

If symptoms worsen, consult your doctor or pharmacist.

Children and adolescents

Use is not recommended in children and adolescents under 18 years.

Taking Circulaveel with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

Taking Circulaveel with foodanddrinks

No interactions are expected.

Pregnancy andbreastfeeding

Pregnancy

Circulaveel should not be used during pregnancy. There is insufficient data on the use of grape leaf extract in pregnant women.

Breastfeeding

Circulaveel should not be used during breastfeeding, as there is insufficient information on the excretion of grape leaf extract in breast milk.

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

No studies have been conducted on the effect on the ability to drive and operate machinery. However, it is unlikely to affect driving ability or machine operation.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and elderly: 1 - 2 tablets per day, with water, before breakfast.

The groove is only for breaking the tablet if it is difficult to swallow whole.

The recommended treatment duration with Circulaveel is 12 weeks. It may take two to three weeks of treatment before beneficial effects are observed.

Long-term treatments can be carried out after consulting with the doctor.

Use in children and adolescents

Use is not recommended in children and adolescents under 18 years old.

If you take more Circulaveel with coating than you should

If you have taken more than the recommended dose, consult your doctor or pharmacist and bring this leaflet with you. You can also call the Toxicological Information Service, phone 915 620 420.

If you forgot to takeCirculaveel

Do not take a double dose to compensate for the missed 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 may cause side effects, although not everyone will experience them.

Reactions of skin hypersensitivity (itching, erythema, urticaria) of unknown frequency may occur after taking Circulaveel.

Nausea, gastrointestinal discomfort, and headache may also occur. The frequency is unknown.

If you experience side effects, consult your doctor or pharmacist. This includes any side effect not included in this prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist.orpharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

This medication should not be stored at a temperature above 30°C and the tablets should be kept in their original packaging (in the blister).

Do not use this medication after the expiration date that appears on the box and in the blister after "CAD". The expiration date is the last day of the month indicated.

Do not dispose of medications through the drains, or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Circulaveel

• The active principle is dry extract ofVitis viniferaL., folium (grape leaves) (4-6: 1), extraction solvent: water.

• 1 coated tablet contains 360 mg of dry extract of grape leafVitis viniferaL.

• 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 product and contents of the packaging

Circulaveel are oblong coated tablets with a reddish-brown film coating and a groove on both sides.

They are available in blister packs of 30, 60, and 90 coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Heel España, S.A.U.

Calle Madroño, s/n 28770

Colmenar Viejo (Madrid)

Phone: 918473910

Fax: 918463614

[email protected]

Responsible manufacturer:

Wiewelhove GmbH

Dörnebrink 19

49479 Ibbenbüren

Germany

Last review date of this leaflet:December 2019

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).