


Ask a doctor about a prescription for CALIFORNIA POPPY ARKOPHARMA HARD CAPSULES
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.
Contents of the Package Leaflet
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.
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.
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.
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.
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.
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/)
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for CALIFORNIA POPPY ARKOPHARMA HARD CAPSULES – subject to medical assessment and local rules.