Valdispert Complex is a herbal medicine, belonging to a group of medicines called hypnotics and sedatives in combination excluding barbiturates (to help you fall asleep and relax).

It is indicated for the relief of mild nervous tension (situations of 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 ingredients of Valdispert Complex .

Take special care with Valdispert Complex

This medicine is not recommended for children under 12 years of age.

Use of other medications

Please inform your doctor or pharmacist if you are using or have recently used any other medicines , even those obtained without a prescription.

This medicine can reinforce the effect of other sedative, tranquilizer or sleep drugs, so if you are in treatment with any of them consult your doctor before taking it.

Taking Valdispert Complex with food and drink

Alcohol can enhance the effect of this medicine, so excessive consumption should be avoided.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

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

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

Driving and using machines

This medicine may make you sleepy. Do not drive or use machinery if you feel drowsy or if you notice that your attention or ability to react is reduced .

Important information about some of the ingredients of Valdispert Complex

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Valdispert Complex is administered orally.

Follow these instructions unless your doctor or pharmacist has given you different directions. Ask your doctor or pharmacist if you have doubts.

Adolescents over 12 years old, adults, the 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 going to bed.

• Sleep disorders : 1-2 tablets before going to bed.

Due to the gradual onset of the effects of valerian root, its use is not suitable for the acute phase 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 notice that your symptoms do not improve or worsen within 2 weeks, 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 benign symptoms (fatigue, abdominal cramps, chest tightness, dizziness, hand tremor, and mydriasis), which disappeared within 24 hours.

If these symptoms appear, follow-up should be carried out and adequate support 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, telephone 91 562 04 20.

If you forget to take Valdispert Complex

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

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

Like all medicines, Valdispert Complex can cause side effects, although not everyone gets them.

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

One case of allergy (hypersensitivity) in which inflammation of the blood vessels (vasculitis) and one of nausea and tachycardia (increased number of heart beats) occurred with the use of passionflower. The frequency is unknown.

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

It does not require any special storage conditions.

Keep out of the reach and sight of children.

Do not use Valdispert Complex after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Deposit the containers and medicines that you do not need at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.

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: 70% v / v ethanol.

30 mg of dry ethanolic extract of Passionflower incarnata (equivalent to 150-210 mg of Passionflower).

Extraction solvent: 60% v / v ethanol.

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

What the product looks like and contents of the pack

Round white coated tablets packed in blisters, contained in boxes of 20 or 50 tablets.

Holder of the marketing authorization and responsible for manufacturing

Marketing authorization holder

Vemedia Pharma Hispania SA

C / Aragon, 182 5th floor

08011 Barcelona, Spain

Responsible for manufacturing

LABORATORIES REIG JOFRE , SA

Grand Captain, 10

08970 Sant Joan Despi (Barcelona)

This leaflet was approved in April 2012

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