Valeriana Arkopharma hard capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
VALERIANA ARKOPHARMA
hard capsules
Valeriana officinalis L.
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or as directed by your pharmacist, doctor, or nurse.
- 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 adverse effects, consult your pharmacist, doctor, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 15 days.
Contents of the leaflet
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What VALERIANA ARKOPHARMA is and what it is used for
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What you need to know before taking VALERIANA ARKOPHARMA
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How to take VALERIANA ARKOPHARMA
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Possible side effects
- Storage of VALERIANA ARKOPHARMA
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Contents of the pack and other information
1. What VALERIANA ARKOPHARMA is and what it is used for
A traditional herbal medicinal product for the relief of mental stress and to help facilitate sleep.
Based solely on its traditional use.
2. Before taking VALERIANA ARKOPHARMA
Do not take VALERIANA ARKOPHARMA
If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your pharmacist or doctor before starting to take VALERIANA ARKOPHARMA.
Children
Administration of this medicine is not recommended for children under 12 years of age.
Taking VALERIANA ARKOPHARMA with other medicines
Inform your pharmacist or doctor if you are taking, have recently taken, or might need to take any other medicines. Due to the sedative effect of this medicine, the sedative effect of other drugs such as barbiturates, benzodiazepines, and H1 antihistamines may be enhanced; therefore, concomitant use is not recommended.
Taking VALERIANA ARKOPHARMA with food, beverages, and alcohol
Alcohol may enhance the sedative effect of this medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your pharmacist or doctor before using this medicine. Studies to establish the safety of using this medicine during pregnancy or breastfeeding have not been conducted; therefore, its use is not recommended under these circumstances.
Driving and using machines
This medicine may cause drowsiness. Do not drive or operate machinery if you feel sleepy or if you notice that your attention and reaction ability are reduced.
3. How to take VALERIANA ARKOPHARMA
Follow exactly the instructions for use provided in this leaflet or those indicated by your pharmacist or doctor. If in doubt, ask your pharmacist or doctor.
The recommended dose is:
Adults and adolescents over 12 years of age:
In case of mental stress: 2 capsules in the morning and 2 capsules at night. Additionally, if necessary, 2 more capsules may be taken at midday.
In case of difficulty sleeping: 2 capsules in the mid-afternoon and 2 capsules one hour before bedtime. Additionally, if necessary, 2 more capsules may be taken in the morning.
This medicine is for oral use.
The recommended treatment duration is 4 weeks. However, if you notice that your symptoms have not improved 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
Cases of overdose with VALERIANA ARKOPHARMA have not been reported.
In case of overdose or accidental ingestion, consult your pharmacist or doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the product and the amount ingested.
If you forget to take VALERIANA ARKOPHARMA
If you miss a dose, take the medicine as soon as possible and continue the treatment as prescribed. However, if it is almost time for the next dose, it is better to skip the missed dose and wait for the next scheduled dose. Do not take a double dose to make up for a missed dose.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.
After taking valerian root preparations, mild gastrointestinal discomfort (nausea and abdominal cramps) may very rarely occur. Valerian has a characteristic and unpleasant odour; this does not mean the product is spoiled.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of VALERIANA ARKOPHARMA:
Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unwanted medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of VALERIANA ARKOPHARMA:
Each capsule contains as the active substance: 350 mg of cryomilled root of Valeriana officinalis L. (Valerian).
The other components are excipients: hypromellose (capsule coating).
Appearance of the product and contents of the pack:
There are 2 presentations in bottles containing 45, 50 and 84 capsules.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization 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 most recent review of this leaflet: September 2016
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/