Passiflora Arkopharma hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

PASIFLORA ARKOPHARMA

hard capsules

Passiflora incarnata L.

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 as directed by your doctor or pharmacist.

• 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 15 days.

Contents of the leaflet

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

2. What you need to know before taking PASIFLORA ARKOPHARMA

3. How to take PASIFLORA ARKOPHARMA

4. Possible adverse effects

   1. Storage of PASIFLORA ARKOPHARMA

5. Contents of the pack and other information.

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

A traditional herbal medicinal product used to relieve mild symptoms of mental stress and to aid sleep.

Based exclusively on traditional use.

2. What you need to know before starting to take PASIFLORA ARKOPHARMA

Do not take PASIFLORA ARKOPHARMA

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

Warnings and precautions

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

Children and adolescents

This medicine must not be used in children and adolescents under 12 years of age.

Taking PASIFLORA 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 PASIFLORA ARKOPHARMA with food and drinks

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

Pregnancy and breastfeeding

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. Studies to determine the safety of this medicine during pregnancy or breastfeeding have not been conducted; therefore, its use is not recommended.

Driving and using machines

This medicine may cause drowsiness. Do not drive or operate machinery if you feel sleepy or notice that your attention or reaction ability is impaired.

3. How to take PASIFLORA ARKOPHARMA

Follow exactly the instructions for use provided in this leaflet or those indicated by your pharmacist or doctor. If in doubt, consult your pharmacist or doctor.

Recommended dosage is as follows:

Sleep disorders:

Adults and adolescents over 12 years of age: take 3 capsules during dinner and another 3 capsules before bedtime with a glass of water.

Relief of mental stress:

Adults and adolescents over 12 years of age: take 3 capsules at breakfast and 3 capsules at night with a glass of water.

This medicine is for oral use.

If you take more PASIFLORA ARKOPHARMA than you should

Cases of overdose with PASIFLORA ARKOPHARMA have not been reported.

In case of overdose or accidental ingestion, consult 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 PASIFLORA ARKOPHARMA

If you miss a dose, take the medicine as soon as possible and continue the treatment as prescribed. However, if the next dose is due soon, it is better not to take the missed dose and wait until 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 produce adverse effects, although not everyone will experience them.

At the recommended doses, PASIFLORA ARKOPHARMA has no adverse effects.

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 PASIFLORA ARKOPHARMA

Keep this medicine out of 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 “EXP”. 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 packaging at a SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the package and other information

Composition of PASIFLORA ARKOPHARMA

Each capsule contains as the active ingredient: 300 mg of cryomilled aerial parts of Passiflora incarnata L. (Passiflora).

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

Appearance of the product and contents of the package

There are 2 pack sizes available in bottles containing 45 and 84 capsules.

Marketing Authorization Holder and Manufacturing Responsible

Marketing Authorization Holder

Arkopharma LABORATORIOS, S.A.U.

C/ Amaltea, 9

28045 MADRID

Manufacturing Responsible

Arkopharma

LABORATOIRES PHARMACEUTIQUES

BP 28 – 06511 CARROS Cedex - FRANCE

This summary has been approved in: November 2015

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/