Label: information for the user

EQUINÁCEA ARKOPHARMA hard capsules

Echinacea purpurea(L.) Moench

Read this label carefully before starting to take this medicine, as it contains important information for you.

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

• Keep this label, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
• You should consult a doctor if you worsen or do not improve after 10 days.

1.What isEQUINÁCEA ARKOPHARMAand for what it is used

2.What you need to know before starting to takeEQUINÁCEA ARKOPHARMA

3.How to takeEQUINÁCEA ARKOPHARMA

4.Possible adverse effects

5.Conservation ofEQUINÁCEA ARKOPHARMA

6.Content of the package and additional information

Traditional plant-based medication for the supportive treatment of the common cold, basedexclusively on its traditional use.

Do not take EQUINÁCEA ARKOPHARMA

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

It is contraindicated in cases of progressive systemic diseases such as tuberculosis, immune system diseases, collagenosis, multiple sclerosis, AIDS, HIV infections, and other immune disorders.

Warnings and precautions

If symptoms worsen or high fever appears during treatment, consult your doctor.

Consult your doctor or pharmacist before starting to take EQUINÁCEA ARKOPHARMA.

Taking EQUINÁCEA ARKOPHARMA with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Taking EQUINÁCEA ARKOPHARMA with food and beverages

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

Pregnancy and breastfeeding

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

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

Driving and operating machines

No effects have been registered on the ability to drive and operate machines.

Follow these medication administration instructions exactly as stated in this leaflet or as directed by your pharmacist or doctor. If you are unsure, ask your pharmacist or doctor.

The recommended dose is for:

Adults and adolescents over 12 years: take 2 capsules in the morning, 2 capsules at lunchtime, and 2 capsules in the evening with a glass of water.

This medication is taken orally.

If symptoms persist after 10 days of treatment, consult your doctor or a healthcare professional.

Use in children

It is not recommended for children under 12 years.

If you take more EQUINÁCEA ARKOPHARMA than you should

No cases of overdose have been described with this medication.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91-562 04 20, indicating the medication and the amount ingested.

If you forgot to take EQUINÁCEA ARKOPHARMA

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

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

Skin allergic reactions may rarely occur. Frequency is unknown.

Reporting 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 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 about the safety of this medication.

Keep out of sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medicine after 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 medicines that you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition of EQUINÁCEA ARKOPHARMA

Each capsule contains as active ingredient: 250 mg of cryomolded roots ofEchinacea purpurea(L.) Moench (Echinacea).

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

Appearance of the product and content 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 Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/