PATIENT INFORMATION LEAFLET

Valdispert 125 mg Coated Tablets

Dried ethanol extract of Valeriana officinalis root (Valeriana)

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 125 mg 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 125 mg

If you are allergic (hypersensitive) to valerian root extract or to any of the other components of Valdispert 125 mg.

Be especially careful with Valdispert 125 mg

This medication 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 sleep medications, so if you are being treated with any of these, consult your doctor before taking it.

Taking Valdispert 125 mg 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, it is not recommended for administration to 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 drowsy or if you notice that your attention or reaction time are reduced.

Important information about some of the components of Valdispert 125 mg

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with your doctor or pharmacist before taking this medication.

Valdispert 125 mg 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: 1-3 tablets 3 times a day.

-Sleep disorders: 2 tablets, 30 to 60 minutes before bedtime. If necessary, another tablet may be administered in the afternoon.

Tablets should be taken whole, not chewed, after meals and with plenty of liquid.

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 125 mg than you should

If you have taken Valdispert 125 mg 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 125 mg

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 125 mg may produce adverse effects, although not everyone will experience them.

Adverse reactions are rare, but 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 is observed that is not described in this prospectus, consult 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 that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use. Website: 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 30°C.

Keep out of the reach and sight of children.

Do not use Valdispert 125 mg after the expiration date that appears 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 packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Valdispert 125 mg

• The active ingredient is the dry ethanol extract of Valeriana officinalis root (Valeriana). Each coated tablet contains 125 mg of dry ethanol extract of Valeriana officinalis root (Valeriana) equivalent to 375-750 mg of valerian root.
• The other components are dextrin, microcrystalline cellulose (E-460), lactose monohydrate, macrogol 4.000, anhydrous colloidal silica (E-551), magnesium stearate (E-572), shellac (E-904), hypromellose (E-464), talc (E-553b), magnesium oxide (E-530), arabic gum (E-414), saccharose, povidone K25, macrogol 6.000, titanium dioxide (E 171), sodium carmelose, beeswax, and carnauba wax.

Appearance of the product and contents of the package

White coated tablets conditioned in blisters, contained in boxes of 30 or 50 tablets.

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

Vemedia Manufacturing BV.

Verrijn Stuartweg, 60. P.O Box 171 (Diemen)-110 BC

Netherlands

This leaflet was approved in April 2012

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