Valdispert 125 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Valdispert 125 mg coated tablets
Dry ethanolic extract of root of Valeriana officinalis (Valeriana)
Read the entire leaflet carefully because it contains important information for you.
This medicine is available without a prescription. However, to achieve the best results, it must be used correctly.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If symptoms worsen or persist beyond 2 weeks, you should consult a doctor.
- If you consider any of the side effects you experience to be severe, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What Valdispert 125 mg is and what it is used for
- Before taking Valdispert 125 mg
- How to take Valdispert 125 mg
- Possible side effects
- How to store Valdispert 125 mg
- Further information
1. What VALDISPERT 125 mg is and what it is used for
Valdispert 125 mg is a herbal medicine belonging to a group of medicines called hypnotics and sedatives (to help you fall asleep and relax).
It is indicated for the relief of mild nervous tension and sleep disorders.
2. BEFORE TAKING VALDISPERT 125 mg
Do not take Valdispert 125 mg
If you are allergic (hypersensitive) to valerian root extract or to any of the other components of Valdispert 125 mg.
Take special care with Valdispert 125 mg
Administration of this medicine is not recommended for children under 12 years of age.
Use of other medicines
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
This medicine may enhance the effect of other sedatives, tranquilizers, or sleeping medications; therefore, if you are undergoing treatment with any of these, consult your doctor before taking it.
Taking Valdispert 125 mg with food and drinks
Alcohol may enhance its sedative effect, so excessive consumption should be avoided.
Pregnancy and breastfeeding
Safety during pregnancy and breastfeeding has not been established. As a precautionary measure, administration of this medicine is not recommended for women who are pregnant or breastfeeding.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines
This medicine may cause drowsiness. Do not drive or operate machinery if you feel sleepy or if your attention or reaction ability is reduced.
Important information about some of the components of Valdispert 125 mg
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor or pharmacist before taking this medicine.
3. HOW TO TAKE VALDISPERT 125 mg
Valdispert 125 mg is administered orally.
Follow these instructions unless your doctor or pharmacist has given you different advice. Consult your doctor or pharmacist if you have any doubts.
Adolescents over 12 years of age, adults, elderly:
-
Nervousness: 1–3 tablets three times daily.
-
Sleep disorders: 2 tablets, 30 to 60 minutes before bedtime. If necessary, an additional tablet may be taken in the afternoon.
The tablets should be swallowed whole, without chewing, after meals and with plenty of liquid.
Due to the gradual onset of effects of valerian root, this product is not suitable for the acute treatment of nervousness or insomnia. To achieve the desired effect, a treatment duration of 2–4 weeks is recommended.
If symptoms persist or worsen after 2 weeks of continuous use, consult your doctor.
If you take more Valdispert 125 mg than you should
If you have taken more Valdispert 125 mg than you should, consult your doctor or pharmacist immediately.
In case of overdose or accidental ingestion, go to a medical center and indicate the product and amount ingested, or call the Toxicology Information Service at telephone number 91 562 04 20.
If you forget to take Valdispert 125 mg
Do not take a double dose to make up for missed doses.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Valdispert 125 mg may produce adverse effects, although not everyone experiences them.
Adverse reactions are rare; however, the most frequent ones are migraine or headaches and gastrointestinal symptoms such as nausea and abdominal cramps, which may occur after ingestion of valerian root preparations. The frequency is unknown.
If you notice any other adverse reaction not described in this leaflet, consult your doctor or pharmacist.
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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaRAM.es By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of VALDISPERT 125 mg
Do not store above 30°C.
Keep out of the reach and sight of children.
Do not use Valdispert 125 mg after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This way, you will help protect the environment.
6. ADDITIONAL INFORMATION
Composition of Valdispert 125 mg
- The active substance is dried ethanolic extract of the root of Valeriana officinalis (Valerian). Each coated tablet contains 125 mg of dried ethanolic extract of Valeriana officinalis (Valerian) root, equivalent to 375–750 mg of valerian root.
- The other components are dextrin, microcrystalline cellulose (E-460), lactose monohydrate, macrogol 4,000, colloidal anhydrous silica (E-551), magnesium stearate (E-572), shellac (E-904), hypromellose (E-464), talc (E-553b), magnesium oxide (E-530), gum arabic (E-414), sucrose, povidone K25, macrogol 6,000, titanium dioxide (E 171), sodium carmellose, beeswax, and carnauba wax.
Appearance of the medicinal product and contents of the package
White coated tablets presented in blisters, packed in boxes containing 30 or 50 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Vemedia Pharma Hispania S.A.
C/ Aragón, 182, 5th Floor
08011 Barcelona, Spain
Manufacturer
Vemedia Manufacturing BV
Verrijn Stuartweg, 60, P.O. Box 171 (Diemen)-110 BC
The Netherlands
This leaflet was last approved in April 2012
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/