Valenat 400 mg capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: Information for the user.
Valenat 400 mg capsules
Valeriana officinalis L
Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 14 days.
Contents of the leaflet:
- What Valenat is and what it is used for
- What you need to know before taking Valenat
- How to take Valenat
- Possible adverse effects
- Storage of Valenat
- Contents of the pack and other information
1. What Valenat is and what it is used for
Valenat belongs to a group of medicines used as sedatives of the nervous system.
It is a traditional herbal medicine for adults, adolescents, and children over 12 years of age, used for the relief of mild symptoms of mental stress and to aid sleep, based solely on traditional use.
You should consult a doctor if your condition worsens or does not improve after 14 days.
2. What you need to know before starting to take Valenat
Do not take Valenat
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 doctor or pharmacist before starting to take Valenat.
If after 14 days your symptoms worsen or persist, you should consult your doctor.
Children and adolescents
This medicine is not recommended for children under 12 years of age.
Other medicines and Valenat
Taking Valenat with other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Due to its activity, this medicine may enhance the effects of other sedative drugs, tranquilizers, or sleep medications, such as barbiturates, benzodiazepines, and H1 antihistamines. Therefore, if you are being treated with any of these, consult your doctor before taking this medicine.
Taking Valenat with food, drinks, and alcohol
Do not consume alcoholic beverages, as alcohol could enhance the sedative effect of this medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
There are no adequate and well-controlled studies in pregnant or breastfeeding women; therefore, its use is not recommended.
Driving and using machines
Valenat is a medicine that may cause drowsiness. Do not drive or operate machinery if you feel sleepy or notice that your attention and reaction ability are reduced.
3. How to take Valenat
Follow exactly the administration instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults, adolescents and children over 12 years of age:
- For relief of mild symptoms of mental stress: 1-2 capsules, 3 times a day.
- As an aid to sleep: 1-2 capsules between half an hour and one hour before bedtime. If necessary, an additional dose may be taken in the afternoon.
The recommended treatment duration is 4 weeks. However, if you notice that your symptoms have not improved or have worsened within 14 days, consult your doctor or pharmacist.
Do not use this medicine for more than 4 weeks without consulting your doctor or pharmacist.
Use in children and adolescents
Valenat is not recommended for children under 12 years of age.
If you take more Valenat than you should
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91.562.04.20, indicating the medicine and the amount ingested.
If you forget to take Valenat
Do not take a double dose to make up for missed doses.
Take Valenat as soon as possible and continue treatment as prescribed. However, if the next dose is due soon, it is better to wait until the next scheduled dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
After taking valerian root preparations, gastrointestinal symptoms (nausea, abdominal cramps) may occur. The frequency of these effects is unknown.
Other adverse effects in children and adolescents.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not mentioned in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of VALENAT
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions. Store in the original packaging.
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.
Do not use this medicine if you notice any visible signs of deterioration.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Valenat
Composition per capsule:
- The active substance is 400 mg of powdered root of Valeriana officinalis L (Valerian).
Content of sesquiterpenic acids ≥ 0.40 mg/capsule (expressed as valerenic acid).
- The other components are hypromellose and purified water (capsule shell).
Appearance of the product and pack contents
Presented in a cardboard pack containing 48 capsules of 400 mg in a PVC/PVDC/AL blister.
Marketing Authorization Holder and Manufacturer:
SORIA NATURAL S.A.
Polígono La Sacea nº 1.
Garray (42162), Soria.
Tel: 975252046
Fax: 975252267
e-mail: [email protected]
Date of the most recent revision of this leaflet: September 2019
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/