


Ask a doctor about a prescription for VALERIANA ARKOPHARMA hard capsules
Package Leaflet: Information for the User
VALERIANA ARKOPHARMA
Hard Capsules
Valeriana officinalisL.
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 pharmacist, doctor, or nurse.
Contents of the Package Leaflet
Traditional herbal medicinal product for the relief of mental stress and to facilitate sleep.
Based exclusively on its traditional use.
Do not take VALERIANA ARKOPHARMA
If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
Warnings and Precautions
Consult your pharmacist or doctor before starting to take VALERIANA ARKOPHARMA.
Children
This medication is not recommended for children under 12 years of age.
Taking VALERIANA ARKOPHARMA with other medications
Inform your pharmacist or doctor if you are taking, have recently taken, or may need to take any other medication. Due to the sedative action of the specialty, the sedative effect of other drugs such as barbiturates, benzodiazepines, antihistamines H1 may be enhanced, so it is not recommended to take them together.
Taking VALERIANA ARKOPHARMA with food, drinks, and alcohol
Alcohol may enhance the sedative effect of this medication.
Pregnancy and Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your pharmacist or doctor before using this medication. No studies have been conducted to establish the safety of using this medication during pregnancy or breastfeeding, so its administration is not recommended in these circumstances.
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.
Follow the administration instructions for the medication contained in this package leaflet or as indicated by your pharmacist or doctor. In case of doubt, ask your pharmacist or doctor.
The recommended dose is:
Adults and adolescents over 12 years:
In case of mental stress: 2 capsules in the morning and 2 capsules at night. Additionally, if necessary, 2 more capsules can be taken at noon.
In case of difficulty sleeping: 2 capsules in the late afternoon and 2 capsules 1 hour before bedtime. Additionally, if necessary, 2 more capsules can be taken in the morning.
This medication is for oral use.
The recommended treatment is 4 weeks; however, if you observe that your symptoms do not improve or worsen within 15 days, you should consult your pharmacist or doctor.
Use in Children:
Do not use in children under 12 years of age without consulting a doctor.
If you take more VALERIANA ARKOPHARMA than you should
No cases of overdose with VALERIANA 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 VALERIANA 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 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 medications, this medication may cause side effects, although not everyone experiences them.
After ingestion of valerian root preparations, mild gastrointestinal discomfort (nausea and abdominal cramps) may rarely appear. Valerian has a characteristic and unpleasant odor, which does not mean it is in poor condition.
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 Medication Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
Keep this medication out of the sight and reach of children.
Do not store above 25°C.
Do not use this medication after the expiration date shown on the packaging after "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 any unused medication in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.
Composition of VALERIANA ARKOPHARMA:
Each capsule contains as an active ingredient: 350 mg of cryomilled roots of Valeriana officinalisL. (Valerian).
The other components are the excipients: hypromellose (capsule coating).
Appearance of the Product and Package Contents:
There are 2 presentations in bottles containing 45, 50, and 84 capsules.
Marketing Authorization Holder and Manufacturer:
Holder
Arkopharma LABORATORIOS, S.A.U.
C/ Amaltea, Nº9,
28045 MADRID
Manufacturer
ARKOPHARMA S.A.
LID de Carros le Broc
Zone Industrielle lère Avenue 2709 m
06511 CARROS (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 Health Products (AEMPS) http://www.aemps.gob.es/
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for VALERIANA ARKOPHARMA hard capsules – subject to medical assessment and local rules.