CALIFORNIA POPPY ARKOPHARMA HARD CAPSULES

Introduction

Package Leaflet: Information for the User

CALIFORNIA POPPY ARKOPHARMAhard capsules

Eschscholtzia californicaCham.

Read the package leaflet carefully before starting to take this medicine because it contains important information for you.

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

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

Contents of the Package Leaflet

1. What CALIFORNIA POPPY ARKOPHARMA is and what it is used for
2. What you need to know before taking CALIFORNIA POPPY ARKOPHARMA
3. How to take CALIFORNIA POPPY ARKOPHARMA
4. Possible side effects
5. Storage of CALIFORNIA POPPY ARKOPHARMA
6. Package Contents and Additional Information

1. What CALIFORNIA POPPY ARKOPHARMA is and what it is used for

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

You should consult a doctor if it worsens or does not improve after 15 days.

2. What you need to know before taking CALIFORNIA POPPY ARKOPHARMA

Do not take CALIFORNIA POPPY ARKOPHARMA

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

If you are pregnant or breastfeeding.

If you are under 18 years old.

Warnings and Precautions

Consult your pharmacist, doctor, or nurse before taking CALIFORNIA POPPY ARKOPHARMA.

Children and Adolescents

This medicine is not recommended for children and adolescents under 18 years old.

Taking CALIFORNIA POPPY ARKOPHARMA with other medicines

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

Taking CALIFORNIA POPPY ARKOPHARMA with food and drinks

Do not drink alcoholic beverages 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 no adequate clinical information during pregnancy or breastfeeding, so its administration is not recommended.

Driving and Using Machines

This medicine may cause drowsiness. Do not drive or use machines if you feel drowsy or if your attention and reaction are reduced.

3. How to take CALIFORNIA POPPY ARKOPHARMA

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your pharmacist or doctor. If in doubt, ask your pharmacist or doctor.

The recommended dose is for:

Adults:

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

Aid to improve sleep: take 2 capsules at dinner and 2 capsules before bedtime with a glass of water.

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

This medicine is for oral use.

If symptoms persist after four weeks of using the medicine, consult your doctor or pharmacist about the convenience of continuing treatment.

Use in Children

This medicine is not recommended for children and adolescents under 18 years old due to the lack of sufficient clinical information.

If you take more CALIFORNIA POPPY ARKOPHARMA than you should

No cases of overdose with CALIFORNIA POPPY ARKOPHARMA have been reported. In case of overdose or accidental ingestion, consult your pharmacist or doctor immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the product and the amount ingested.

If you forget to take CALIFORNIA POPPY ARKOPHARMA

In case of forgetting a dose, take the medicine as soon as possible, continuing 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 make up for the forgotten doses.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

No serious side effects have been reported with this medicine.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side 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 special storage conditions.

Do not use this medicine after the expiry date stated on the packaging, after the abbreviation "CAD". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of CALIFORNIA POPPY ARKOPHARMA

Each capsule contains as active ingredient: 300 mg of cryomilled powder of flowering aerial parts of Eschscholtzia californicaCham. (California Poppy).

The other ingredients are the excipients: hypromellose (capsule coating).

Appearance of the Product and Package Contents

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 Last Revision of this Package Leaflet:March2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)