Leaflet: information for the user

ARKOPHARMA Horse Tail hard capsules

Equisetum arvense L.

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

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

• 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 pharmacist, doctor or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 7 days.

1. What isARKOPHARMA Horse Tailand what it is used for

2. What you need to know before starting to takeARKOPHARMA Horse Tail

3. How to takeARKOPHARMA Horse Tail

4. Possible side effects

5. Storage ofARKOPHARMA Horse Tail

6. Contents of the pack and additional information

Traditional plant-based medication to increase urine production, thereby cleaning the urinary tract and helping with mild urinary disorders.

Traditional plant-based medication used to strengthen brittle hair and nails.

Based exclusively on its traditional use.

You should consult a doctor if it worsens or does not improve after 7 days.

Do not takeCOLA DE CABALLO ARKOPHARMA

If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).

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

Warnings and precautions

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

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

It is not recommended for use in children under 12 years old.

Children

Do not use in children under 12 years old, without consulting a doctor.

TakingCOLA DE CABALLO ARKOPHARMAwith other medications

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

TakingCOLA DE CABALLO ARKOPHARMAwith food and drinks

Foods and drinks have no influence on the effect of the medication.

Pregnancy and breastfeeding

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.

There are no adequate and well-controlled studies in pregnant women or breastfeeding women, so it is not recommended for use.

Driving and operating machinery

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

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

The recommended dose is:

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

This medication is taken orally.

Use for a period of 2 to 4 weeks.

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

Use in children

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

If you take moreCOLA DE CABALLO ARKOPHARMAthan you should

No cases of overdose withCOLA DE CABALLO ARKOPHARMAhave been described. In case of overdose or accidental ingestion, consult your pharmacist or doctor immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the product and the amount ingested.

If you forgot to takeCOLA DE CABALLO ARKOPHARMA

In case of forgotten dose, take the medication as soon as possible and continue treatment as prescribed. However, if the next dose is near, it is better not to take the missed dose and wait for the next one. Do not take a double dose to compensate for the missed doses.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Moderate gastrointestinal complications and allergic reactions (rashes) have been described. Frequency is unknown.

Reporting Adverse Effects

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

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

Do not store at a temperature above 30°C.

Do not usethis medicationafter the expiration date that appears on the packaging, after the abbreviation “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications that you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition ofCOLA DE CABALLO ARKOPHARMA

Each capsule contains as active ingredient: 190 mg of cryomilled aerial parts ofEquisetum arvense L.(Mare's tail).

The other components are the excipients: gelatina (capsule coating).

Appearance of the product and contents of the packaging

There are 3 presentations in bottles containing 50, 100 and 200 capsules.

Holder of the marketing authorization and responsible for manufacturing

HOLDER:

Arkopharma LABORATORIES, S.A.U.

C/ Amaltea, 9

28045 MADRID

RESPONSIBLE FOR MANUFACTURING:

ARKOPHARMA

Laboratories Pharmaceutiques

BP 28 – 06511 CARROS Cedex – France

Date of the last review of this leaflet: September 2016

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)http://www.aemps.gob.es/