PATIENT INFORMATION LEAFLET

Valdispert Complex 60 mg/30 mg Coated Tablets

Valerian root extract (Valeriana) and Passionflower extract (Pasiflora)

Readthe entire leaflet carefully as it contains important information for you.

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

• Keep this leaflet, as you may need to read it again.
• For advice or further information, consult your pharmacist.
• If symptoms worsen or persist after 2 weeks, consult your 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.

1. What isValdispert Complexand for what it is used

2. Before takingValdispert Complex

3. How to takeValdispert Complex

4. Possible adverse effects

5. Storage ofValdispert Complex

6. Additional information

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

It is indicated for the relief of mild nervous tension (nervousness, irritability) and sleep disorders.

Do not take Valdispert Complex

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

Special caution with Valdispert Complex

Valdispert Complex 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 Complex with food and beverages

Excessive alcohol consumption may potentiate the effect of this medication, so it should be avoided.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

As a general precaution and due to the lack of data on its use during pregnancy and breastfeeding, its use is not recommended in these situations.

IMPORTANT FOR WOMEN: If you are pregnant or believe you may be pregnant, consult your doctor before taking this medication. The consumption of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

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 is reduced.

Important information about some of the components of Valdispert Complex

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

Valdispert Complex 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 :

• Mild nervous tension relief : 1-2 tablets at any time of day, and if necessary, another dose (1-2 tablets) may be administered before bedtime.

• Sleep disorders : 1-2 tablets before bedtime.

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

The recommended treatment is 4 weeks, however, if you observe that in a period of 2 weeks your symptoms do not improve or worsen, you should consult your doctor or pharmacist.

If you take more Valdispert Complex than you should

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

Valerian root in a dose of approximately 20 g caused mild symptoms (fatigue, abdominal cramps, chest tension, dizziness, hand tremor, and mydriasis), which disappeared within 24 hours.

In case of appearance of these symptoms, follow-up should be performed and appropriate supportive measures should be used.

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 Complex

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

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

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

Adverse reactions are rare, although the most frequent are headaches and gastrointestinal symptoms, such as nausea and abdominal cramps, which may occur after ingestion of valerian root preparations. The frequency is unknown.

A case of allergy (hypersensitivity) has been reported in which vascular inflammation (vasculitis) occurred and one of nausea and tachycardia (increased heart rate) with the use of passionflower. The frequency is unknown.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

No special conservation conditions are required.

Keep out of the reach and sight of children.

Do not use Valdispert Complex after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines that you do not need at the SIGRE collection pointof the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Valdispert Complex Composition

• Each coated tablet contains as active ingredients:

60 mg of dried, granulated ethanol extract of Valeriana officinalis root (equivalent to 180-360 mg of Valeriana root). Solvent of extraction: ethanol at 70% v/v.

30 mg of dried, ethanol extract of Pasiflora incarnata (equivalent to 150-210 mg of Pasiflora).

Solvent of extraction: ethanol at 60% v/v.

• The other components are microcrystalline cellulose (E-460), anhydrous colloidal silica (E-551), magnesium stearate (E-572), talc (E-553b), shellac, vinylpyrrolidone-vinyl acetate copolymer, povidone, sodium carmellose, saccharose, titanium dioxide (E 171), kaolin, white beeswax, carnauba wax.

Product Appearance and Packaging Content

White, round, coated tablets contained in blisters, packaged in boxes of 20 or 50 tablets.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Vemedia Pharma Hispania S.A.

C/Aragon, 182 5th floor

08011 Barcelona, Spain

Responsible Manufacturer

LABORATORIOS REIG JOFRE, S.A.

Gran Capitan, 10

08970 Sant Joan Despi (Barcelona)

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/