Leaflet: information for the user

Valdispertstress, coated tablets

Valerian root extract/Lupulin hop extract

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

This medicine can be obtained without a prescription. However, for the best results, it should be used properly.

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

• Keep this leaflet, as you may need to refer to it again.
• If you have any doubts, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.
• You should consult your doctor if your symptoms worsen or do not improve after 2 weeks.

Valdispertstress is a traditional herbal medicine, belonging to a group of medications known as hypnotics and sedatives.

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

Valdispertstress is indicated for adults and adolescents over 12 years old.

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

Do not take Valdispertstress:

• if you are allergic to valerian or hops 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 takeValdispertstress.

Children

Valdispertstress is not indicated for children under 12 years of age, because there is not enough information about its efficacy and safety in this age group.

Taking Valdispertstress with other medications

Inform your doctor or pharmacist if you are taking or have taken recently or might have 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 not enough information about the safety of Valdispertstress during pregnancy or breastfeeding. Women of childbearing age should use an appropriate contraceptive method during the use of Valdispertstress.

Driving and operating machines

Valdispertstress is a medication that may cause drowsiness. Do not drive or use machines if you feel drowsiness or if you notice that your attention and reaction time 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 him before taking this medication.

For oral use.

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, elderly people, and adolescents over 12 years old: 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 2 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 old.

The recommended dose in adolescents over 12 years old 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 leaflet with you. In general, there are no consequences if you take one or two tablets more than recommended. Symptoms of overdose include fatigue, abdominal cramps, chest tightness, dizziness, hand tremors, and dilated pupils (mydriasis).

If you forgot to take Valdispertstress

Continue taking the tablets at the usual time. It is not important if you forgot to take a tablet. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Valdispertstress

You can stop taking Valdispertstress at any time you want.

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.

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

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use. Website:www.notificaRAM.esBy 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.

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

Store below 25 °C in the original packaging.

Medicines should not be thrown down the drains or in the trash.Dispose of the containers and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Valdispertstress

The active principles are:

• Dry extract of valerian root. Each coated tablet contains 200 mg of extract (as dry extract) of root ofValeriana officinalis L. s.l. (valerian root) (4-6,7:1). Solvent for extraction: 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 flower ofHumulus lupulus L. (hop cones) (4-8:1). Solvent for extraction: ethanol 40% v/v.

Equivalent to 272-544 mg of dry hop cone.

The other components are:

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

Tablet core: anhydrous colloidal silica, hydrated colloidal silica, microcrystalline cellulose, powder cellulose, sodium carboxymethyl starch type A (potato), stearic acid, magnesium stearate.

Coating of the tablet: basic copolymer of butyl methacrylate, liquid glucose (dried with atomizer), sucrose, talc, calcium carbonate, acacia (dried with atomizer), tragacanth gum, titanium dioxide, acetylated potato starch (E 1420), glycolated montan wax.

Appearance of the product and contents of the package

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 blisters, available in packs of 20, 40, 60, 80, or 100 coated tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Vemedia Manufacturing B.V.

Verrijn Stuartweg 60

1112 AX Diemen

Netherlands

For more information about this medication, please contact the local representative of the marketing authorization holder:

Vemedia Pharma Hispania S.A.

c/ Aragón, 182 5th floor

08011 Barcelona

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:May 2013

For detailed and updated information about this medication, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/