Product Information for the User

VALERIANA ARKOPHARMA

Hard Capsules

Valeriana officinalisL.

Read this leaflet carefully before you start taking this medicine because 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 15 days.

1.What isVALERIANA ARKOPHARMAand what is it used for

2.What you need to know before takingVALERIANA ARKOPHARMA

3.How to takeVALERIANA ARKOPHARMA

4.Possible side effects

1. Storage ofVALERIANA ARKOPHARMA

6.Contents of the pack and additional information

Traditional medication based on plants for relief of mental stress and to facilitate sleep.

Based exclusively on its traditional use.

Do not take VALERIANA ARKOPHARMA

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

Warnings and precautions

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

Children

This medication is not recommended for children under 12 years old.

Taking VALERIANA ARKOPHARMA with other medications

Inform your pharmacist or doctor if you are taking, have taken recently, or may need to take any other medication. Due to the sedative action of this specialty, the sedative effect of other drugs such as barbiturates, benzodiazepines, H1 antihistamines may be potentiated, so it is not recommended to take them together.

Taking VALERIANA ARKOPHARMA with food, drinks, and alcohol

Alcohol may potentiate the sedative effect of this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 it is not recommended to administer it in these circumstances.

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:

Adults and adolescents over 12 years old:

For mental stress: 2 capsules in the morning and 2 capsules at night. Additionally, if necessary, you can take another 2 capsules in the middle of the day.

For difficulty sleeping: 2 capsules in the middle of the day and 2 capsules one hour before bedtime. Additionally, if necessary, you can take another 2 capsules in the morning.

This medication is taken orally.

The recommended treatment is 4 weeks, however, if you observe that within 15 days your symptoms do not improve or worsen, you should consult with your pharmacist or doctor.

Use in children:

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

If you take more VALERIANA ARKOPHARMA than you should

No cases of overdose with VALERIANA ARKOPHARMA have 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 take VALERIANA ARKOPHARMA

In case of forgotten dose, take the medication as soon as possible and continue the 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 forgotten doses.

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

After ingestion of valerian root preparations, mild gastrointestinal discomfort (nausea and abdominal cramps) may rarely occur. Valerian has a characteristic and unpleasant odor, which does not mean it is spoiled.

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.Reporting adverse effects can help provide 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 above25°C.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or inthe trash. Disposeof the packaging and medicines you no longer need at the SIGREcollection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of VALERIANA ARKOPHARMA:

Each capsule contains as active ingredient: 350 mg of cryomilled roots ofValeriana officinalisL. (Valeriana).

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, 50, and 84 capsules.

Holder of the marketing authorization and responsible for manufacturing:

Holder

Arkopharma LABORATORIOS, S.A.U.

C/ Amaltea, Nº9,

28045 MADRID

Responsible for manufacturing

ARKOPHARMA S.A.

LID de Carros le Broc

Zone Industrielle lère Avenue2709 m

06511 CARROS (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/