Horse chestnut Arkopharma hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

COLA DE CABALLO ARKOPHARMA hard capsules

Equisetum arvense L.

Read this entire leaflet carefully before starting to take this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given by your pharmacist, doctor, or nurse.

• Keep this leaflet, as you may need to read it again.

• If you need advice or further information, consult your pharmacist.

• If you experience any adverse effects, consult your pharmacist, doctor, or nurse, even if they are effects not listed in this leaflet. See section 4.

• You should consult a doctor if your condition worsens or if you do not improve after 7 days.

Contents of the leaflet

1. What COLA DE CABALLO ARKOPHARMA is and what it is used for
2. What you need to know before taking COLA DE CABALLO ARKOPHARMA
3. How to take COLA DE CABALLO ARKOPHARMA
4. Possible adverse effects
5. How to store COLA DE CABALLO ARKOPHARMA
6. Contents of the pack and other information

1. What COLA DE CABALLO ARKOPHARMA is and what it is used for

Traditional herbal medicinal product used to increase urine output, thereby cleansing the urinary tract and assisting in mild urinary disorders.

Traditional herbal medicinal product used to strengthen brittle hair and nails.

Based exclusively on long-standing use.

Consult a doctor if symptoms worsen or do not improve after 7 days.

2. What you need to know before starting to take COLA DE CABALLO ARKOPHARMA

Do not take COLA DE CABALLO ARKOPHARMA

If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

If you have been advised to reduce your fluid intake (as in the case of heart or kidney diseases).

Warnings and precautions

Consult your pharmacist or doctor before starting to take COLA DE CABALLO ARKOPHARMA.

If you experience symptoms such as fever, discomfort during urination, spasms, or blood in the urine, you should consult a doctor.

Administration is not recommended in individuals under 12 years of age.

Children

Do not use in children under 12 years of age without first consulting a doctor.

Taking COLA DE CABALLO ARKOPHARMA with other medicines

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

Taking COLA DE CABALLO ARKOPHARMA with food and drink

Food and drink do not affect the action of this medicine.

Pregnancy and breastfeeding

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

There are no adequate and well-controlled studies in pregnant or breastfeeding women; therefore, its use is not recommended.

Driving and using machines

No effects on the ability to drive or operate machinery have been reported.

3. How to take COLA DE CABALLO ARKOPHARMA

Follow exactly the instructions for use provided in this leaflet or as directed by your pharmacist or doctor. In case of doubt, consult your pharmacist or doctor.

The recommended dose is:

Adults and adolescents over 12 years of age: take 3 capsules in the morning with breakfast, 3 capsules at lunchtime, and 3 capsules at dinner, with a glass of water.

This medicine is for oral use.

Use for a period of 2 to 4 weeks.

If symptoms worsen or persist after 7 days, consult a doctor.

Use in children

Do not use in children under 12 years of age without consulting a doctor.

If you take more COLA DE CABALLO ARKOPHARMA than you should

No cases of overdose with COLA DE CABALLO ARKOPHARMA have been reported. In case of overdose or accidental ingestion, contact your pharmacist or doctor immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the product and the amount ingested.

If you forget to take COLA DE CABALLO ARKOPHARMA

If you miss a dose, take the medicine as soon as possible and continue the treatment as prescribed. However, if it is almost time for the next dose, it is better to skip the missed dose and wait for the next scheduled dose. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.

Mild gastrointestinal complications and allergic reactions (rashes) have been reported. Frequency is unknown.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of COLA DE CABALLO ARKOPHARMA

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

Do not store at temperatures above 30°C.

Do not use this medicine after the expiry date stated on the packaging, following the abbreviation “CAD”. 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 medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of COLA DE CABALLO ARKOPHARMA

Each capsule contains as the active substance: 190 mg of cryomilled aerial parts of Equisetum arvense L. (Horsetail).

The other components are excipients: gelatin (capsule shell).

Appearance of the product and contents of the pack

Three pack sizes are available in bottles containing 50, 100, and 200 capsules.

Marketing Authorization Holder and Manufacturer

MARKETING AUTHORIZATION HOLDER:

Arkopharma LABORATORIOS, S.A.U.

C/ Amaltea, 9

28045 MADRID

MANUFACTURER:

ARKOPHARMA

LABORATORIES PHARMACEUTIQUES

BP 28 – 06511 CARROS Cedex – France

Date of the most recent revision of this leaflet: September 2016

Detailed and up-to-date 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/