Leaflet: information for the user

AMAPOLA DE CALIFORNIA ARKOPHARMAhard capsules

Eschscholtzia californicaCham.

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated 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 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 or pharmacist if it worsens or does not improve after 15 days

1. What isAMAPOLA DE CALIFORNIA ARKOPHARMAand for what it is used

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

3. How to takeAMAPOLA DE CALIFORNIA ARKOPHARMA

4. Possible side effects

5. Storage ofAMAPOLA DE CALIFORNIA ARKOPHARMA

6. Contents of the pack and additional information

Traditional medication based on plants used for relief of mental stress (nervousness and irritability), and as an aid to improve sleep, based exclusively on its traditional use.

Consult a doctor if it worsens or does not improve after 15 days.

Do not take AMAPOLA DE CALIFORNIA ARKOPHARMA

If you are allergic to the active ingredient 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 old.

Warnings and precautions

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

Children and adolescents

This medication is not recommended for children or adolescents under 18 years old.

Taking AMAPOLA DE CALIFORNIA ARKOPHARMA with other medications

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

Taking AMAPOLA DE CALIFORNIA ARKOPHARMA with food and drinks

Do not consume alcoholic beverages during treatment with this medication.

Pregnancy and breastfeeding

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

No clinical information is available for use during pregnancy, or lactation, so administration is not recommended.

Driving and operating machines

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

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

The recommended dose is for:

Adults:

Nervousness and irritability: take 2 capsules in the morning and 2 capsules in the evening with a glass of water.

Help to improve sleep: take 2 capsules in the evening and 2 capsules before bedtime with a glass of water.

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

This medication is taken orally.

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

Use in children

This medication is not recommended for children, or adolescents under 18 years, due to the lack of sufficient clinical information.

If you take more AMAPOLA DE CALIFORNIA ARKOPHARMA than you should

No cases of overdose with AMAPOLA DE CALIFORNIA 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 AMAPOLA DE CALIFORNIA ARKOPHARMA

In case of forgotten dose, take the medication as soon as possible continuing 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 will experience them.

No serious adverse effects have been reported with the medication.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance for Human Use Medications: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.

This medication does not require special storage conditions.

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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of AMAPOLA DE CALIFORNIA ARKOPHARMA

Eachcapsule contains as active ingredient: 300 mg of cryomilled powder of aerial flowered parts ofEschscholtzia californicaCham.(California Poppy).

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

Appearance of the product and content of the container

There are 2 presentations in PVC 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

Laboratories Pharmaceutiques

BP 28 – 06511 CARROS Cedex – France

Date of the last review of this leaflet:March2019

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/)