


Ask a doctor about a prescription for PASIFLORA ARKOPHARMA hard capsules
Package Leaflet: Information for the User
PASIFLORAARKOPHARMA
Hard Capsules
Passiflora incarnata L.
Read the entire package leaflet carefully before starting to take this medicine, as 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 medicine used to relieve moderate symptoms of mental stress and to help sleep.
Based exclusively on its traditional use.
Do not takePASIFLORA ARKOPHARMA
If you are allergic to the active ingredient or any of the other components of this medicine (listed in section 6).
Warnings and Precautions
Consult your doctor or pharmacist before starting to take PASIFLORA ARKOPHARMA.
Children and Adolescents
Children and adolescents under 12 years of age should not use this medicine.
TakingPASIFLORA ARKOPHARMAwith other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
TakingPASIFLORA ARKOPHARMAwith food and drinks
Food and drinks do not affect the effect of the medicine.
Pregnancy and Breastfeeding:
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your pharmacist or doctor before using this medicine. No studies have been conducted to establish the safety of this medicine 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 you notice that 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:
Sleep Disorders:
Adults and adolescents over 12 years: take 3 capsules during dinner and 3 capsules before bedtime with a glass of water.
Mental Stress Relief:
Adults and adolescents over 12 years: take 3 capsules at breakfast and 3 capsules at night with a glass of water.
This medicine is for oral use.
If you take morePASIFLORA ARKOPHARMAthan you should
No cases of overdose with PASIFLORA ARKOPHARMAhave 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 takePASIFLORA ARKOPHARMA
In case of forgetting a dose, take the medicine as soon as possible, continuing the treatment as prescribed. However, if the next dose is near, it is better not to take the missed dose and wait for the next one. Do not take a double dose to make up for the missed doses.
Like all medicines, this medicine can cause side effects, although not everyone gets them.
At the recommended doses, PASIFLORA ARKOPHARMA does not present side effects.
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 Monitoring System for Human Use: 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.
Do not store above 30°C.
Do not use this medicine after the expiration date stated on the packaging, after the abbreviation "CAD". The expiration 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 SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.
Composition ofPASIFLORA ARKOPHARMA
Each capsule contains as active ingredient: 300 mg of cryomilled aerial parts of Passiflora incarnataL.(Passiflora).
The other components are the excipients: Hypromellose (capsule coating).
Appearance of the Product and Package Contents
There are 2 presentations in bottles containing 45 and 84 capsules.
Marketing Authorization Holder and Manufacturer
Holder
Arkopharma LABORATORIOS, S.A.U.
C/ Amaltea, 9
28045 MADRID
Manufacturer
Arkopharma
LABORATOIRES PHARMACEUTIQUES
BP 28 – 06511 CARROS Cedex - FRANCE
This package leaflet was approved in: November 2015
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 PASIFLORA ARKOPHARMA hard capsules – subject to medical assessment and local rules.