California poppy Arkopharma hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

AMAPOLA DE CALIFORNIA ARKOPHARMA hard capsules

Eschscholtzia californica Cham.

Read all of this 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 given 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 pharmacist, doctor, or nurse, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor or pharmacist if your condition worsens or if you do not improve after 15 days.

Contents of this leaflet

1. What AMAPOLA DE CALIFORNIA ARKOPHARMA is and what it is used for
2. What you need to know before taking AMAPOLA DE CALIFORNIA ARKOPHARMA
3. How to take AMAPOLA DE CALIFORNIA ARKOPHARMA
4. Possible side effects
5. How to store AMAPOLA DE CALIFORNIA ARKOPHARMA
6. Contents of the pack and other information

1. What AMAPOLA DE CALIFORNIA ARKOPHARMA is and what it is used for

A traditional herbal medicinal product used for the relief of mental stress (nervousness and irritability), and as an aid to help improve sleep, based solely on its traditional use.

Consult a doctor if symptoms worsen or do not improve after 15 days.

2. What you need to know before starting AMAPOLA DE CALIFORNIA ARKOPHARMA

Do not take AMAPOLA DE CALIFORNIA ARKOPHARMA

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

If you are pregnant or breastfeeding.

If you are under 18 years of age.

Warnings and precautions

Consult your pharmacist, doctor, or nurse before starting to take AMAPOLA DE CALIFORNIA ARKOPHARMA.

Children and adolescents

Administration of this medicine is not recommended in children or adolescents under 18 years of age.

Taking AMAPOLA DE CALIFORNIA ARKOPHARMA with other medicines

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

Taking AMAPOLA DE CALIFORNIA ARKOPHARMA with food and drinks

Alcoholic beverages should not be consumed during treatment with this medicine.

Pregnancy and breastfeeding

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

There is insufficient clinical information available regarding use during pregnancy or breastfeeding; therefore, administration is not recommended.

Driving and using machines

This medicine may cause drowsiness. Do not drive or operate machinery if you feel sleepy or if your attention and reaction capacity are impaired.

3. How to take AMAPOLA DE CALIFORNIA ARKOPHARMA

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

The recommended dose is as follows:

Adults:

Nervousness and irritability: take 2 capsules at breakfast and 2 capsules at dinner with a glass of water.

Sleep aid: take 2 capsules during dinner and 2 capsules before bedtime with a glass of water.

The dose may be increased to 5 capsules per day if necessary.

This medicine is for oral use.

If symptoms persist after four weeks of treatment, consult your doctor or pharmacist regarding the appropriateness of continuing the treatment.

Use in children

Administration of this medicine is not recommended for children or adolescents under 18 years of age due to insufficient clinical data.

If you take more AMAPOLA DE CALIFORNIA ARKOPHARMA than you should

Cases of overdose with AMAPOLA DE CALIFORNIA ARKOPHARMA have not been reported. In case of overdose or accidental ingestion, immediately consult your pharmacist or doctor 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 AMAPOLA DE CALIFORNIA 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 to skip the missed dose and wait for the next scheduled dose. Do not take a double dose to make up for missed doses.

4. Possible adverse effects

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

No serious adverse effects have been reported with this medicine.

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 CALIFORNIA POPPY ARKOPHARMA

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

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 drains or household waste. Dispose of unused containers and medicines at the Sigre Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This way, you will help protect the environment.

6. Contents of the package and other information

Composition of AMAPOLA DE CALIFORNIA ARKOPHARMA

Each capsule contains as the active substance: 300 mg of cryo-ground powder of the flowering aerial parts of Eschscholtzia californica Cham. (California Poppy).

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

Appearance of the product and contents of the package

There are 2 presentations in PVC bottles containing 45 and 84 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: March 2019

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/)