CIRCULAVEEL FILM-COATED TABLETS

Introduction

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.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after two weeks.

Contents of the Package Leaflet

1. What Circulaveel Film-Coated Tablets are and what they are used for
2. What you need to know before taking Circulaveel
3. How to take Circulaveel
4. Possible side effects
5. Storage of Circulaveel

Contents of the pack and further information

1. What Circulaveel Film-Coated Tablets are and what they are used for

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.

2. What you need to know before taking Circulaveel

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.

3. How to take Circulaveel

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.

4. Possible side effects

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.

5. Storage of Circulaveel

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.

6. Contents of the pack and further information

Composition of Circulaveel

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

• 1 film-coated tablet contains 360 mg of dry extract of Vitis viniferaL. (grape leaves)

• The other ingredients 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 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

[email protected]

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/).