Echinacea Arkopharma hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

EQUINACEA ARKOPHARMA hard capsules

Echinacea purpurea (L.) Moench

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

Follow exactly the instructions for use provided 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 further information, consult your pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 10 days.

Contents of the leaflet:

1. What EQUINACEA ARKOPHARMA is and what it is used for

2. What you need to know before taking EQUINACEA ARKOPHARMA

3. How to take EQUINACEA ARKOPHARMA

4. Possible side effects

5. How to store EQUINACEA ARKOPHARMA

6. Contents of the pack and other information

1. What EQUINÁCEA ARKOPHARMA is and what it is used for

A traditional herbal medicinal product for the supportive treatment of the common cold, based exclusively on its traditional use.

2. What you need to know before taking EQUINÁCEA ARKOPHARMA

Do not take EQUINÁCEA ARKOPHARMA

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

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

Warnings and precautions

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

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

Taking EQUINÁCEA ARKOPHARMA with other medicines

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

Taking EQUINÁCEA ARKOPHARMA with food and drink

Food and meals do not affect the medicine's action.

Pregnancy and breastfeeding

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

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

Driving and using machines

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

3. How to take ECHINACEA ARKOPHARMA

Follow exactly these instructions for administering the medicine provided in this leaflet, or those given by your pharmacist or doctor. If in doubt, ask your pharmacist or doctor.

The recommended dose is for:

Adults and adolescents over 12 years of age: take 2 capsules at breakfast, 2 capsules at lunch, and 2 capsules at dinner with a glass of water.

This medicine is for oral use.

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

Use in children

Not recommended for children under 12 years of age.

If you take more ECHINACEA ARKOPHARMA than you should

Cases of overdose with this medicine have not been reported.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91-562 04 20, indicating the medicine and the amount ingested.

If you forget to take ECHINACEA ARKOPHARMA

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.

Skin allergic reactions may occasionally occur. The 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 ECHINACEA ARKOPHARMA

Keep out of sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the container, 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 a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of EQUINACEA ARKOPHARMA

Each capsule contains as the active substance: 250 mg of cryoground roots of Echinacea purpurea (L.) Moench (Echinacea).

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

Appearance of the product and pack contents

There are 3 presentations 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 review 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/