CALIFORNIA POPPY ARKOPHARMA hard capsules

Introduction

Package Leaflet: Information for the User

CALIFORNIA POPPY ARKOPHARMA

Hard Capsules

Eschscholtzia californicaCham.

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

• 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 doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 28 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 nervousness and irritability, and as an aid to improve sleep, based solely on its traditional use.

You should consult a doctor if your condition worsens or does not improve after 28 days.

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

Do not take CALIFORNIA POPPY ARKOPHARMA

If you are allergic to any component of this medication or any of the other components of this medication (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 CALIFORNIA POPPY ARKOPHARMA.

Children and Adolescents

Administration of this medication to children and adolescents under 18 years of age is not recommended without consulting a pharmacist or doctor.

Taking CALIFORNIA POPPY ARKOPHARMA with other medications

Inform your pharmacist or doctor if you are using, have recently used, or may need to use any other medication.

Taking CALIFORNIA POPPY ARKOPHARMA with food and drinks

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

Pregnancy and Breastfeeding

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

Adequate clinical studies have not been conducted in pregnant or breastfeeding women; therefore, its administration is not recommended.

Driving and Using Machines

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

3. How to take CALIFORNIA POPPY ARKOPHARMA

Follow these instructions unless your doctor has given you different instructions. Consult your pharmacist or doctor if you have doubts.

The recommended dose is:

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 6 capsules per day if necessary.

This medication is for oral use.

Use for a period of 4 weeks, as needed.

Use in Children

Administration of this medication to children and adolescents under 18 years of age is not recommended without consulting a pharmacist or doctor.

If you take more CALIFORNIA POPPY ARKOPHARMA than you should

There have been no reported cases of overdose with CALIFORNIA POPPY ARKOPHARMA. 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 medication as soon as possible, continuing the treatment as prescribed. However, if the next dose is near, it is best not to take the missed dose and wait for the next one. Do not take a double dose to make up for missed doses.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

At the recommended doses, CALIFORNIA POPPY ARKOPHARMA does not present

side effects.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of CALIFORNIA POPPY ARKOPHARMA

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

Do not store above 30°C.

Do not use CALIFORNIA POPPY ARKOPHARMA after the expiration date stated on the packaging, after the abbreviation "CAD". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of CALIFORNIA POPPY ARKOPHARMA

Each capsule contains as the active ingredient: 240 mg of cryomilled flowering aerial parts of Eschscholtzia californicaCham. (California Poppy)

The other components are the excipients: gelatin (capsule shell).

Appearance of the Product and Package Contents

There are 2 presentations in bottles containing 50 and 100 capsules.

Marketing Authorization Holder and Manufacturer

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: September 2016

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