VALDISPERT 125 mg FILM-COATED TABLETS

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.

Be careful with Valdispert 125 mg

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 obtained 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 125 mg 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 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 sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with your doctor or pharmacist before taking this medication.

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 instructions. Consult your doctor or pharmacist if you have any doubts.

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

• Nervousness: 1-3 tablets 3 times a day.

• Sleep disorders: 2 tablets, 30 to 60 minutes before bedtime. If necessary, 1 more tablet can be administered in the afternoon.

The tablets should be taken whole, without chewing, 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 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 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 indicating the product and the amount ingested, or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Valdispert 125 mg

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

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

4. Possible side effects

Like all medications, Valdispert 125 mg can cause side effects, although not everyone experiences them.

Adverse reactions are rare, but the most frequent ones are migraines or headaches and gastrointestinal symptoms, such as nausea and abdominal cramps, which can 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 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications. 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 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 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 medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Valdispert 125 mg

• The active ingredient is the dry ethanolic extract of Valeriana officinalis root (Valerian). Each coated tablet contains 125 mg of dry ethanolic extract of Valeriana officinalis root (Valerian), 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), arabic gum (E-414), sucrose, povidone K25, macrogol 6,000, titanium dioxide (E 171), sodium carmellose, beeswax, and carnauba wax.

Appearance of the product and packaging content

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Vemedia Pharma Hispania S.A.

C/ Aragón, 182 5ª Planta

08011 Barcelona

Manufacturer

Vemedia Manufacturing BV.

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

Netherlands

This leaflet was approved in April 2012

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/