Valdispert Stres

Package Leaflet: Information for the User

Valdispert Stres, 200 mg + 68 mg, Chewable Tablets

Valerianae extractum hydroalcoholicum siccum + Lupuli floris extractum siccum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

The medicine should always be taken as described in the package leaflet for the patient or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed.
• If after 14 days of continuous use of Valdispert Stres there is no improvement or the patient feels worse, a doctor should be consulted.

Table of Contents of the Leaflet

• 1. What is Valdispert Stres and what is it used for
• 2. Important information before taking Valdispert Stres
• 3. How to take Valdispert Stres
• 4. Possible side effects
• 5. How to store Valdispert Stres
• 6. Contents of the pack and other information

1. What is Valdispert Stres and what is it used for

Traditional herbal medicinal product for use in specified indications, based on long-standing use. Valdispert Stres is used for mild nervous tension states. Each chewable tablet contains valerian root dry extract and hop dry extract. Valdispert Stres is intended for adults and adolescents over 12 years of age.

2. Important information before taking Valdispert Stres

When not to take Valdispert Stres:

• If the patient is allergic to the active substances, valerian, hop, or any of the other ingredients of the medicine (listed in section 6).

Warnings and precautions

Before taking Valdispert Stres, the doctor or pharmacist should be consulted.

Children

Valdispert Stres is not recommended for children under 12 years of age.

Valdispert Stres with other medicines

Valdispert Stres should not be taken with other (synthetic) sedative medicines. The doctor or pharmacist should be informed about all medicines being taken or recently taken, as well as any planned to be taken.

Valdispert Stres with food, drink, and alcohol

Valdispert Stres should not be taken with alcohol. Alcohol may enhance the effect of Valdispert Stres.

Pregnancy, breastfeeding, and fertility

Valdispert Stres should not be taken during pregnancy or breastfeeding. There is insufficient data on the safety of Valdispert Stres during pregnancy or breastfeeding. Women of childbearing age should use an appropriate contraceptive method while taking Valdispert Stres.

Driving and using machines

This medicinal product may affect the ability to drive and use machines. If symptoms such as drowsiness and reduced reaction occur, vehicles should not be driven and machines should not be operated.

Valdispert Stres contains glucose, lactose, and sucrose

If the patient has been diagnosed with intolerance to some sugars, the doctor should be informed before starting treatment with this preparation.

3. How to take Valdispert Stres

For oral use. The medicine should always be taken as described in the package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted. The recommended dose is: Adults, elderly, and adolescents over 12 years of age: 1 tablet 3 times a day. The tablet should be swallowed whole, with water or another liquid. The tablets should not be chewed. The tablets can be taken with or without food. If after 14 days of continuous use of Valdispert Stres there is no improvement or the patient feels worse, a doctor should be consulted. The total treatment period with Valdispert Stres should not exceed 6 months.

Use in children and adolescents

Valdispert Stres is not recommended for children under 12 years of age. The recommended dose for adolescents over 12 years of age is: 1 tablet 3 times a day.

Overdose of Valdispert Stres

In case of taking more than the recommended dose, a doctor or pharmacist should be consulted and this leaflet should be shown to them. Usually, there are no consequences in case of taking 1 or 2 tablets more than recommended. Symptoms of overdose include fatigue, abdominal cramps, chest tightness, dizziness, hand tremors, and pupil dilation.

Missed dose of Valdispert Stres

Tablets should be continued to be taken at the usual time. Missing one dose is not significant. A double dose should not be taken to make up for a missed dose.

Stopping Valdispert Stres

Treatment with Valdispert Stres can be stopped at any time. If there are any further questions about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. There have been reports of individual cases of liver side effects after taking high doses of valerian root. The significance of these cases for the clinical use of Valdispert Stres in the recommended doses is unknown. During treatment with Valdispert Stres, gastrointestinal symptoms such as nausea, diarrhea, or abdominal pain, as well as drowsiness, may occur. The frequency of these side effects is not known. If side effects occur, the doctor or pharmacist should be consulted. This also applies to side effects not listed in this leaflet.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to: Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Valdispert Stres

The medicine should be stored out of sight and reach of children. This medicine should not be used after the expiry date stated on the outer packaging and blister after "EXP". The expiry date refers to the last day of the month. Store below 25°C. Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Valdispert Stres contains

The active substances are: dry extract of valerian root and dry extract of hop cones. Each chewable tablet contains:

• 200 mg of hydroalcoholic dry extract (4-6.7:1) of Valeriana officinalis L. s.l. (valerian root), corresponding to 800-1340 mg of dried valerian root. Extraction solvent: ethanol 70% (V/V). 68 mg of dry extract (4-8:1) of Humulus lupulus L. (hop cones), corresponding to 272-544 mg of dried hop cones. Extraction solvent: ethanol 40% (V/V).

Other ingredients are: Excipients in the herbal extracts: spray-dried glucose liquid, anhydrous colloidal silica, lactose monohydrate. Tablet core: anhydrous colloidal silica, hydrated colloidal silica, microcrystalline cellulose, powdered cellulose, sodium carboxymethylcellulose (type A), stearic acid, magnesium stearate. Tablet coating: basic butyl methacrylate copolymer, spray-dried glucose liquid, sucrose, talc, calcium carbonate, spray-dried acacia gum, tragacanth, titanium dioxide (E 171), acetylated starch (E 1420), montan wax glycol.

What Valdispert Stres looks like and contents of the pack

Valdispert Stres is a white, round, shiny chewable tablet. The tablets are packaged in Al/PVC/PVDC blisters and are available in packs of 20, 40, 60, 80, and 100 tablets, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Vemedia Manufacturing B.V., Verrijn Stuartweg 60, 1112 AX Diemen, Netherlands

This product is registered in the EEA member states under the following names:

Poland: Valdispert Stres, Belgium, Spain: Valdispert Stress, Netherlands: Valdispert Valeriaan Hop, Italy: Valeriana e Luppolo Dispert

Date of last revision of the leaflet