VALDISPERTSTRESS COATED TABLETS

Introduction

Package Leaflet: Information for the User

Valdispertstress, Coated Tablets

Valerian Root Extract/Hop Cones Extract

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

This medication can be obtained without a prescription. Nevertheless, to achieve the best results, it should be used properly.

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 have any doubts, consult your doctor or pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet.
• You should consult your doctor if your condition worsens or does not improve after 2 weeks.

Contents of the Package Leaflet

1. What is Valdispertstress and what is it used for
2. What you need to know before taking Valdispertstress
3. How to take Valdispertstress
4. Possible side effects
5. Storage of Valdispertstress
6. Package Contents and Additional Information

1. What is Valdispertstress and what is it used for

Valdispertstress is a traditional herbal medicinal product, belonging to a group of medications called hypnotics and sedatives.

Valdispertstress is used to relieve mild symptoms of mental stress. This product is a traditional herbal medicinal product for use in the specified indications, based exclusively on long-standing use.

Valdispertstress is indicated for adults and adolescents over 12 years of age.

Each coated tablet contains valerian root extract and hop cones extract.

2. What you need to know before taking Valdispertstress

Do not take Valdispertstress:

• if you are allergic to valerian or hop 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 Valdispertstress.

Children

Valdispertstress is not indicated for children under 12 years of age, as there is insufficient information on its efficacy and safety in this age group.

Taking Valdispertstress with other medications

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

Do not take Valdispertstress with other sedatives (synthetic).

Taking Valdispertstress with food, drinks, and alcohol

Do not take Valdispertstress with alcohol. Alcohol may increase the effect of Valdispertstress.

Pregnancy, Breastfeeding, and Fertility

Do not take Valdispertstress during pregnancy or breastfeeding. There is insufficient information on the safety of Valdispertstress during pregnancy or breastfeeding. Women of childbearing age should use an adequate contraceptive method during the use of Valdispertstress.

Driving and Using Machines

Valdispertstress 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.

Valdispert Stress contains glucose, sucrose, and lactose

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 Valdispertstress

For oral use.

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, elderly, and adolescents over 12 years: 1 tablet 3 times a day.

Swallow the tablets whole with a little water or other liquid. Do not chew the tablets.

You can take the tablets with or without food.

You should consult your doctor if you do not feel better or if you feel worse after 2 weeks of continuous treatment with Valdispertstress.

After two months of treatment, consult your doctor about the convenience of continuing with the same.

Use in Children and Adolescents

Valdispertstress is not recommended for children under 12 years of age.

The recommended dose in adolescents over 12 years is: 1 tablet 3 times a day.

If you take more Valdispertstress than you should

Consult your doctor or pharmacist if you have taken a dose higher than recommended and bring this package leaflet with you. In general, there are no consequences if you take one or two tablets more than recommended. The symptoms of overdose include fatigue, abdominal cramps, chest tightness, dizziness, hand tremors, and pupil dilation (mydriasis).

If you forget to take Valdispertstress

Continue taking the tablets at the usual schedule. It is not important if you forget to take a tablet. Do not take a double dose to make up for forgotten doses.

If you stop taking Valdispertstress

You can stop taking Valdispertstress at any time you wish.

If you have any other doubts 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 experiences them.

Cases have been published in the literature on adverse effects of valerian (high doses) on the liver. The relevance of these cases to the clinical use of Valdispertstress at the recommended dose levels is unknown.

During treatment with Valdispertstress, gastrointestinal symptoms such as nausea, diarrhea, or abdominal pain and drowsiness may occur. The frequency of these side effects is unknown.

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 Pharmacovigilance System for Human Use Medications. Website: www.notificaRAM.es By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Valdispertstress

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the carton and blister pack after CAD. The expiration date is the last day of the month indicated.

Store below 25°C in the original packaging.

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 the 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. Package Contents and Additional Information

Composition of Valdispertstress

The active ingredients are:

• Dry extract of valerian root. Each coated tablet contains 200 mg of extract (as dry extract) of valerian root (Valeriana officinalis L. s.l. (valerian root) (4-6.7:1). Extraction solvent: ethanol 70% v/v.

Equivalent to 800-1340 mg of dry valerian root.

• Dry extract of hop cones. Each coated tablet contains 68 mg of extract (as dry extract) of hop flowers (Humulus lupulus L. (hop cones) (4-8:1). Extraction solvent: ethanol 40% v/v.

Equivalent to 272-544 mg of dry hop cones.

The other components are:

Other components used in plant extracts: liquid glucose (spray-dried), colloidal anhydrous silica, lactose monohydrate.

Core of the tablet: colloidal anhydrous silica, colloidal hydrated silica, microcrystalline cellulose, powdered cellulose, sodium carboxymethyl starch type A (potato), stearic acid, magnesium stearate.

Coating of the tablet: basic butyl methacrylate copolymer, liquid glucose (spray-dried), sucrose, talc, calcium carbonate, acacia (spray-dried), tragacanth gum, titanium dioxide, potato starch acetate (E 1420), glycolized montan wax.

Appearance of the Product and Package Contents

Valdispertstress is a white, round, and shiny coated tablet. The tablets are packaged in PVC/PVDC-Aluminum blisters, available in packs of 20, 40, 60, 80, or 100 tablets.

Valdispertstress is packaged in PVC/PVDC-Aluminum blister packs, available in packs of 20, 40, 60, 80, or 100 coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Vemedia Manufacturing B.V.

Verrijn Stuartweg 60

1112 AX Diemen

Netherlands

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Vemedia Pharma Hispania S.A.

c/ Aragón, 182 5ª planta

08011 Barcelona

This medication is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this package leaflet:May 2013

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/