Package leaflet: Information for the user

Valdispert Stres, 200 mg + 68 mg, coated tablets
Valerianae extractum hydroalcoholicum siccum + Lupuli floris extractum siccum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
You should always take the medicine exactly as described in this patient information leaflet or as directed by your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
If there is no improvement or if you feel worse after 14 days, you should contact your doctor.

Table of contents

What Valdispert Stres is and what it is used for
Important information before taking Valdispert Stres
How to take Valdispert Stres
Possible side effects
How to store Valdispert Stres
Contents of the pack and other information

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

Traditional herbal medicinal product used based on solely long-standing use for specified indications.
Valdispert Stres is used in mild states of nervous tension.
Each coated tablet contains a dry hydroalcoholic extract of valerian root and a dry extract of hop flowers.
Valdispert Stres is intended for adults and adolescents above the age of 12.

2. Important information before taking Valdispert Stres

When not to take Valdispert Stres:

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

Warnings and precautions
Before starting to take Valdispert Stres, consult your doctor or pharmacist.
Children
Valdispert Stres is not recommended for children under 12 years of age.
Valdispert Stres and other medicines
Do not use Valdispert Stres together with other (synthetic) sedative medicines.
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken,
including medicines you plan to use.
Valdispert Stres with food, drink and alcohol
Do not take Valdispert Stres with alcohol. Alcohol may enhance the effect of Valdispert Stres.
Pregnancy, breastfeeding and fertility
Do not use Valdispert Stres during pregnancy or breastfeeding. There is insufficient data on the safety of Valdispert Stres during pregnancy or breastfeeding. Women of childbearing potential should use an appropriate method of contraception during treatment with Valdispert Stres.
Driving and operating machinery
This medicinal product may affect the ability to drive and operate machinery. If symptoms such as drowsiness or reduced reaction ability occur, do not drive or operate machinery.
Valdispert Stres contains glucose, lactose and sucrose
If the patient has been diagnosed with an intolerance to certain sugars, inform the doctor before starting treatment with this medicine.

3. How to use Valdispert Stres

For oral use.
This medicine should always be taken according to the instructions in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

The recommended dose is:
Adults, elderly patients, and adolescents over 12 years of age: 1 tablet three times daily.
The tablet should be swallowed whole with water or another liquid. Do not chew the tablets.
Tablets may be taken with or without food.

If there is no improvement or if the patient feels worse after 14 days of continuous treatment with Valdispert Stres, consult a doctor.
The total duration of treatment 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 three times daily.

Taking more Valdispert Stres than recommended
If more tablets have been taken than recommended, consult a doctor or pharmacist and show them this leaflet. Usually, no consequences occur after taking 1 or 2 extra tablets. Symptoms of overdose may include fatigue, cramping abdominal pain, chest tightness, dizziness, hand tremor, and pupil dilation.

Missing a dose of Valdispert Stres
Continue taking the tablets at your usual times. Missing one dose is not significant. Do not take a double dose to make up for a missed dose.

Stopping Valdispert Stres
Treatment with Valdispert Stres can be stopped at any time.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Isolated cases of liver-related adverse effects have been reported in the literature following the use of
high doses of valerian root. The significance of these cases for the clinical use of Valdispert Stres at recommended doses is unknown.
When using Valdispert Stres, gastrointestinal symptoms such as nausea, diarrhoea or abdominal pain, as well as drowsiness, may occur. The frequency of these adverse effects is not known.
If any adverse effects occur, consult a doctor or pharmacist. This also applies to any adverse effects not listed in this leaflet.
Reporting of adverse effects
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to:
Department of Monitoring of Adverse Drug Reactions, 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: [email protected]
Adverse effects may also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Valdispert Stres

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and
blister after "EXP". The expiry date refers to the last day of the specified month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Valdispert Stres contains
The active substances in this medicinal product are: dry extract of valerian root and dry extract of hop cones.
Each coated tablet contains:

200 mg of aqueous-alcoholic dry extract (4-6.7:1) from 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) from Humulus lupulus L. (hop cones), corresponding to 272–544 mg of dried hop cones. Extraction solvent: ethanol 40% (V/V).

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

What Valdispert Stres looks like and contents of the pack
Valdispert Stres is a white, round, shiny coated tablet. The tablets are packed in Al./PVC/PVDC blisters and are available in packs of 20, 40, 60, 80, and 100 tablets, contained in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Vemedia Manufacturing B.V.
Verrijn Stuartweg 60
1112 AX Diemen
The Netherlands

This product is registered in the EEA Member States under the following names:
Poland: Valdispert Stres
Belgium, Spain: Valdispert Stress
The Netherlands: Valdispert Valeriaan Hop
Italy: Valeriana e Luppolo Dispert