PATIENT INFORMATION LEAFLET

Valdispert oral solution

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

Read this leaflet carefully because it contains important information for you.

This medicine can be purchased without a prescription. However, for the best results, it should be used properly.

• Keep this 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 any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Valdispert solution is a plant-based medication, belonging to a group of medications known as hypnotics and sedatives (to help you fall asleep and relax).

It is indicated for the relief of mild nervous tension and sleep disorders.

Do not take Valdispert solution

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

Special precautions with Valdispert solution

Valdispert solution is not recommended for children under 12 years old.

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 sedatives, tranquilizers, or sleeping medications, so if you are being treated with any of these, consult your doctor before taking it.

Taking Valdispert solution with food and beverages

Excessive alcohol consumption may potentiate its sedative effect, so it should be avoided.

Pregnancy and breastfeeding

The safety during pregnancy and breastfeeding has not been established. As a precaution, its administration is not recommended for women during pregnancy and breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Important information about some of the components of Valdispert solution

This medication contains 25% ethanol (alcohol), which corresponds to 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 individuals with alcoholism.

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

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 any doubts.

Adolescents over 12 years, adults, elderly:

- Anxiety: 10-20 drops one to three times a day.

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

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

Each ml of the solution is approximately equivalent to 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 anxiety and insomnia. To achieve the expected 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 solution than you should

If you have taken Valdispert solution more 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 Toxicological Information Service, phone 91 562 04 20.

If you forgot to take Valdispert solution

Do not take a double dose to compensate for the missed doses.

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

Like all medications, Valdispert solution may produce adverse effects, although not all people will experience them.

Adverse reactions are rare, although the most frequent 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 any other adverse reaction not described in this prospectus is observed, consult with your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects not appearing in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Do not store at a temperature above 86°F (30°C).

Keep out of the reach and sight of children.

Do not use Valdispert solution after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Valdispert solution

- The active ingredient is liquid ethanol extract ofValeriana officinalis L. s.l., radix (Valeriana root). 1 ml of oral solution contains 942 mg of liquid ethanol extract ofValeriana officinalis L. s.l., radix (Valeriana root) (1:10) which are equivalent to 94.2 mg of Valeriana root.

- The other components are concentrated raspberry juice, raspberry aroma, ammonium glycyrrhizinate, ethanol, and water.

Appearance of the product and contents of the packaging

Valdispert oral solution: oral solution in a 30 ml container provided with a dropper.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Vemedia Pharma Hispania S.A.

C/ Aragón, 182 5th Floor

08011 Barcelona

Responsible for manufacturing

Recipharm Parets S.L.

Ramón y Cajal, 2

08150 Parets del Vallés (Barcelona)

This leaflet was approved in October 2014

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/