VALDISPERT ORAL SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Valdispert oral solution

Liquid ethanolic extract of Valeriana officinalis L. s.l., radix (Valerian root)

Read the entire package leaflet carefully because it contains important information for you.

This medication can be obtained without a prescription. Nevertheless, to obtain the best results, it should be used properly.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or persist after 2 weeks, you should consult a doctor.
• If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the package leaflet:

1. What Valdispert solution is and what it is used for
2. Before taking Valdispert solution
3. How to take Valdispert solution
4. Possible side effects
5. Storage of Valdispert solution
6. Additional information

1. What is VALDISPERT SOLUTION and what it is used for

Valdispert solution 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 SOLUTION

Do not take Valdispert solution

If you are allergic (hypersensitive) to Valerian root extract or to any of the other components of Valdispert solution.

Be careful with Valdispert solution

It is not recommended to administer this medication to children under 12 years of age.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

This medication may enhance the effect of other sedative, tranquilizing, or sleeping medications, so if you are being treated with any of them, consult your doctor before taking it.

Taking Valdispert solution with food and drinks

Alcohol may potentiate 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, its administration is not recommended to women during pregnancy and breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

This medication may cause drowsiness. Do not drive or use machinery if you feel drowsy or if you notice that your attention or reaction capacity is reduced.

Important information about some of the components of Valdispert solution

This medication contains 25% ethanol (alcohol), which corresponds to an amount of 197.5 mg per ml of solution (approximately 20 drops), equivalent to 5 ml of beer or 2.1 ml of wine.

This medication is harmful to people suffering from alcoholism.

The alcohol content should be taken into account in the case of pregnant or breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.

3. HOW TO TAKE VALDISPERT SOLUTION

Valdispert solution is administered orally.

Follow these instructions unless your doctor or pharmacist has given you different instructions. Consult your doctor or pharmacist if you have doubts.

Adolescents over 12 years of age, adults, and elderly:

• Nervousness: 10-20 drops 1 to 3 times a day.

• Sleep disorders: 10-20 drops 30 to 60 minutes before bedtime. If necessary, 10-20 drops can be administered in the afternoon.

Pour the dose to be administered (10-20 drops) into a glass with water or infusion.

Each ml of the solution is equivalent to approximately 20 drops.

Due to the gradual appearance of the effects of Valerian root, its use is not suitable for the acute treatment of cases of nervousness and insomnia. A treatment duration of 2-4 weeks is recommended to achieve the expected effect.

If symptoms persist or worsen after 2 weeks of continuous use, you should consult a doctor.

If you take more Valdispert solution than you should

If you have taken more Valdispert solution than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, go to a medical center indicating the product and the amount ingested or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Valdispert solution

Do not take a double dose to make up for forgotten doses.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Valdispert solution can cause side effects, although not everyone will experience them.

Adverse reactions are rare, but the most frequent ones are migraines 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 package leaflet, consult your doctor or pharmacist.

Reporting of 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 Medicines and Health Products Agency's website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of VALDISPERT SOLUTION

Do not store above 30°C.

Keep out of the reach and sight of children.

Do not use Valdispert solution after the expiration date stated on the packaging. 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 medications at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Valdispert solution

• The active ingredient is liquid ethanolic extract of Valeriana officinalis L. s.l., radix (Valerian root). 1 ml of oral solution contains 942 mg of liquid ethanolic extract of Valeriana officinalis L. s.l., radix (Valerian root) (1:10) equivalent to 94.2 mg of Valerian root.
• The other components are concentrated raspberry juice, raspberry flavor, ammonium glycyrrhizinate, ethanol, and water.

Appearance of the product and packaging contents

Valdispert oral solution: oral solution in a 30 ml packaging with a drop counter.

Marketing authorization holder and manufacturer

Marketing authorization holder

Vemedia Pharma Hispania S.A.

C/ Aragón, 182 5ª Planta

08011 Barcelona

Manufacturer

Recipharm Parets S.L.

Ramón y Cajal, 2

08150 Parets del Vallés (Barcelona)

This package leaflet was approved in October 2014

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/