VALENAT 400 mg CAPSULES

Introduction

PACKAGE LEAFLET: Information for the user.

Valenat 400 mg capsules

Valeriana officinalisL

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

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

Contents of the package leaflet:

1. What is Valenat and what is it used for
2. What you need to know before taking Valenat
3. How to take Valenat
4. Possible side effects
5. Storage of Valenat
6. Package contents and additional information

1. What is Valenat and what is it used for

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

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

You should consult a doctor if your symptoms worsen or do not improve after 14 days.

2. What you need to know before taking Valenat

Do not take Valenat

If you are allergic to the active ingredient or 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 your symptoms worsen or persist, you should 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 recently taken, 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 sleep-inducing medications, such as barbiturates, benzodiazepines, antihistamines H1, so if you are being treated with any of these, consult your doctor before taking this medication.

Taking Valenat with food, beverages, and alcohol

Do not consume 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and using machines

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

3. How to take Valenat

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults, adolescents, and children over 12 years old:

• For the relief of mild symptoms of mental stress: 1-2 capsules, 3 times a day.
• As a sleep aid: 1-2 capsules between half an hour and one hour before bedtime. If necessary, you can take an additional dose in the afternoon.

The recommended treatment duration is 4 weeks; however, if you observe that your symptoms do not improve or worsen within 14 days, 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

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

If you take more Valenat than you should

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

If you forget to take Valenat

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

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

Other side effects in children and adolescents

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet.

Reporting 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 package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Valenat

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

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

Do not use this medication after the expiration date shown on the package after "EXP". The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Valenat

Composition per capsule:

• The active ingredient is 400 mg of Valeriana officinalisL (Valerian) root powder.

Content in 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 package contents

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

Marketing authorization holder and manufacturer:

SORIA NATURAL S.A.

Polígono La Sacea nº 1.

Garray. (42162). Soria.

Tel: 975252046

Fax: 975252267

e-mail: [email protected]

Date of the last revision of this package leaflet:September 2019

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