VALDISPERT COMPLEX

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Valdispert Complex 60 mg/30 mg coated tablets

Extract of Valeriana officinalis root (Valerian) and Extract of Pasiflora incarnata (Passionflower)

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

1. What is Valdispert Complex and what is it used for

Valdispert Complex is a plant-based medication, belonging to a group of medications called hypnotics and sedatives in combination excluding barbiturics (to help you fall asleep and relax).

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

2. Before taking Valdispert Complex

Do not take Valdispert Complex

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

Be careful with Valdispert Complex

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 sleep-inducing medications, so if you are being treated with any of them, consult your doctor before taking it.

Taking Valdispert Complex with food and beverages

Alcohol may potentiate the effect of this medication, so excessive consumption should be avoided.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

As a general precaution and since there is no data on its use during pregnancy and breastfeeding, its use is not recommended in these situations.

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

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 Complex

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

3. How to take Valdispert Complex

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 doubts.

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

• Relief of mild nervous tension: 1-2 tablets at any time of the day, and if necessary, a new dose (1-2 tablets) can be administered before bedtime.

• Sleep disorders: 1-2 tablets before bedtime.

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. 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 within 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 more Valdispert Complex than you should, consult your doctor or pharmacist immediately.

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

In case of appearance of these symptoms, follow-up and adequate support measures should be employed.

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 Complex

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 Complex can cause side effects, although not everyone experiences them.

Adverse reactions are rare, and the most frequent ones 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 vasculitis (inflammation of blood vessels) occurred, and one case of nausea and tachycardia (increased heart rate) with the use of passionflower. The frequency is unknown.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of Valdispert Complex

No special storage conditions are required.

Keep out of the reach and sight of children.

Do not use Valdispert Complex after the expiration date stated on the packaging after CAD. 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 collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of Valdispert Complex

• Each coated tablet contains as active ingredients:

60 mg of dry granulated ethanolic extract of Valeriana officinalis root (equivalent to 180-360 mg of valerian root). Extraction solvent: ethanol 70% v/v.

30 mg of dry ethanolic extract of Pasiflora incarnata (equivalent to 150-210 mg of passionflower). Extraction solvent: ethanol 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, sucrose, titanium dioxide (E 171), kaolin, white beeswax, carnauba wax.

Appearance of the product and packaging content

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Vemedia Pharma Hispania S.A.

C/Aragon, 182 5th floor

08011 Barcelona, Spain

Manufacturer

LABORATORIOS REIG JOFRE, S.A.

Gran Capitan, 10

08970 Sant Joan Despi (Barcelona)

This package leaflet was approved in April 2012

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/