Prospect: information for the user

PASIFLORAARKOPHARMA

Hard capsules

Passiflora incarnata L.

Read this prospect 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 prospect or those indicated by yourdoctor or pharmacist.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult yourdoctor or pharmacist,even if they are not listed in this prospect. See section 4.
• You should consult a doctor if it worsens or does not improve after 15 days.

1.What isPASIFLORA ARKOPHARMAand for what it is used

2.What you need to knowbefore starting to takePASIFLORA ARKOPHARMA

3.How to takePASIFLORA ARKOPHARMA

4.Possible adverse effects

1. Storage ofPASIFLORA ARKOPHARMA

6.Contents of the package and additional information.

Traditional medication based on plants used to relieve moderate symptoms of mental stress and to help sleep.

Based exclusively on its traditional use.

Do not takePASIFLORA ARKOPHARMA

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

Warnings and precautions

Consult yourdoctor or pharmacistbefore starting to takePASIFLORA ARKOPHARMA.

Children and adolescents

This medication should not be used by children and adolescents under 12 years old.

TakingPASIFLORA ARKOPHARMAwith other medications

Inform yourdoctor or pharmacistif you are taking, have taken recently ormayhave to take any other medication

TakingPASIFLORA 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 pharmacist or doctor before using this medication. No studies have been conducted to establish the safety of using this medication during pregnancy or breastfeeding, so its administration is not recommended.

Driving and operating machines

This medication may cause drowsiness. Do not drive or operate machines if you feel drowsy or if you notice that your attention and reaction time are reduced.

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

The recommended dose is for:

Sleep disorders:

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

Relief of mental stress:

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

This medication is taken orally.

If you take morePASIFLORA ARKOPHARMAthan you should

No cases of overdose withPASIFLORA 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 takePASIFLORA 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 forgotten 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.

At the recommended dosesPASIFLORA ARKOPHARMAdoes not present adverse effects.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this leaflet. 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 this medication out of the sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medication 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 medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofPASIFLORA ARKOPHARMA

Each capsule contains as active ingredient: 300 mg of cryomilled aerial parts ofPassiflora incarnataL.(Pasiflora).

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

Appearance of the product and contents of the packaging

There are 2 presentations in bottles containing 45 and 84 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder

Arkopharma LABORATORIOS, S.A.U.

C/ Amaltea, 9

28045 MADRID

Responsible for manufacturing

Arkopharma

Laboratoires Pharmaceutiques

BP 28 – 06511 CARROS Cedex - FRANCE

This leaflet was approved in: November 2015

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/