PATIENT INFORMATION LEAFLET.

Valenat 400 mg capsules

Valeriana officinalisL

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse, or if you do not improve after 14 days.

Valenat belongs to a group of medications used as central nervous system sedatives.

It is a traditional plant-based medication for adults, adolescents, and children over 12 years old, for the relief of mild symptoms of mental stress and to help sleep, based exclusively on traditional use.

Consult a doctor if symptoms worsen or do not improve after 14 days.

Do not take Valenat

If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valenat.

If after 14 days the symptoms worsen or persist, you must consult your doctor.

Children and adolescents

This medication is not recommended for children under 12 years old.

Other medications and Valenat

Taking Valenat with other medications. Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Due to its activity, it is possible that this medication may enhance the effects of other sedative, tranquilizing, or sleeping medications, such as barbiturates, benzodiazepines, H1 antihistamines, so if you are being treated with any of them, consult your doctor before taking this medication.

Taking Valenat with food, drinks, and alcohol

You should not take alcoholic beverages as alcohol may potentiate the sedative effect of this medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

There are no adequate and well-controlled studies in pregnant women, or in breastfeeding women, so its administration is not recommended.

Driving and operating machinery

Valenat is a medication that can cause drowsiness. Do not drive or operate machinery if you feel drowsy or if you notice that your attention and reaction time are reduced.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults, adolescents, and children over 12 years:

The recommended treatment duration is 4 weeks. However, if you notice that within 14 days your symptoms do not improve or worsen, consult your doctor or pharmacist.

Do not use this medication for more than 4 weeks without consulting your doctor or pharmacist.

Use in children and adolescents

It is not recommended to administer to children under 12 years.

If you take more Valenat than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist immediately, or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

If you forgot to take Valenat

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

Take Valenat as soon as possible, continuing treatment as prescribed. However, if the next dose is near, it is better to wait for the next scheduled dose.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

After taking valerian root preparations, gastrointestinal symptoms (nausea, abdominal cramps) may appear. The frequency of these effects is unknown.

Other adverse effects in children and adolescents.

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is apossibleadverse effect not listed in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions. Store in the original packaging.

Do not use this medication after the expiration date that appears on the packaging after "Cad." The expiration date is the last day of the month indicated.

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Valenat

Composition per capsule:

• The active principle is 400 mg of valerian root powder fromValeriana officinalisL (Valeriana)

Content of sesquiterpene acids ≥ 0.40 mg/capsule (expressed as valerenic acid).

• The other components are hypromellose and purified water. (capsule coating).

Appearance of the product and contents of the packaging

It is presented in a cardboard container containing 48 capsules of 400 mg in a PVC/PVDC/AL blister.

Holder of the marketing authorization and responsible for manufacturing:

SORIA NATURAL S.A.

Polígono La Sacea nº 1.

Garray. (42162). Soria.

Tel: 975252046

Fax: 975252267

e-mail: [email protected]

Date of the last review of this leaflet:September 2019

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