Patient information leaflet

What active substances and auxiliary materials does the preparation contain?

Active substances:

• 187.5 mg valerianae radicis extractum siccum (5-8:1) (dry extract of valerian)
• 42 mg lupuli strobuli extractum siccum (7-10:1) (dry extract of hop flower) per film-coated tablet.

Auxiliary materials:

Core: maltodextrin, microcrystalline cellulose, soy polysaccharide, hydrogenated castor oil, macrogol, magnesium stearate, water-free colloid silicon dioxide.
Coating: macrogol 400 and 20000, propylene glycol, vanilla aroma, hypromellose, titanium dioxide E171, indigotine E132.

Marketing authorisation holder: Béres Házipatika Kft., 1037 Budapest, Mikoviny u. 2-4.
Manufacturer: Béres Gyógyszergyár Zrt., 5005 Szolnok, Nagysándor József u. 39.

1. What diseases is Béres ReDormin© film-coated tablet for and how it takes effect
Béres ReDormin© contains valerian and hop extracts gained with a standard procedure. Standard procedure ensures the permanent quality of the herb preparation. The two medicinal herbs (the effects of which have long been verified), namely valerian and hop complete each other. They help falling asleep and owing to their mild tranquillizing effect, they ensure a calm sleep. So, Béres ReDormin© film-coated tablet can be applied for the following complaints: difficulties in falling asleep, as well as fragmented sleep and restless sleep.

What to pay attention to?
If you have sleeping disorders, avoid consuming stimulating drinks (coffee, black tea) nicotine and abundant meals. Accustom yourself to a regular sleep rhythm. A short walk in the fresh air, a relaxing bath or reading in a calm environment helps you get sleepy. Please remember that the demand on the time of sleep decreases, as we grow older. If the problem persists for longer than a month, see a doctor.

2. Important notes before taking Béres ReDormin© film-coated tablet

Béres ReDormin© film-coated tablet cannot be applied or can be applied with caution
If you are allergic to any of the components of the preparation.

Pregnancy, lactation
According to present experiences, the medicine is not harmful to children. No targeted clinical trials have been conducted about it. Avoid every medicine during pregnancy and lactation, or contact your doctor for advice. You can take it exclusively based on the doctor’s judgement during pregnancy and lactation.

The effects of the preparation on driving capabilities and capabilities of the operation of machines
The quantity taken in accordance with the specifications does not influence capabilities necessary for driving and the operation of machines. However, do not take the film-coated tablet immediately before driving or operating dangerous machines.

Taking other medicines
No interactions with other medicines are known.

3. How to apply Béres ReDormin© film-coated tablet?
Its usual dose is 2 tablets for adults taken with little liquid 1 hour before going to bed. Children aged 6 or older can take half a dose, i.e. 1 tablet. Always keep to the dose recommended in the patient information leaflet or prescribed by the doctor. If you feel that the dose is too mild or strong, contact your doctor or pharmacist.

4. Possible side effects
The auxiliary substances used may cause (skin-related) side effects very rarely.

5. Storage
Store it below 25 ^oC.
Do not take the medicine after its expiry date printed on the packaging. The medicine is to be stored out of reach of children!

OGYI-T-9087/02

For risks and side effects, please read the patient information leaflet or consult your doctor, pharmacist!