Valused Noc

Leaflet included in the packaging: patient information

Valused NOC

200 mg, coated tablets

Valerianae extractum hydroalcoholicum siccum
Read the leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or according to
the doctor's or pharmacist's instructions.

• Keep this leafletto be able to read it again if necessary.
• If advice or additional information is needed, consult a pharmacist.
• If the patient experiences any undesirable effects, including any possible undesirable effects not listed in the leaflet, inform the doctor or pharmacist. See section 4.
• If after 2 weeks there is no improvement or the patient feels worse, contact a doctor.

Table of contents of the leaflet

• 1. What is Valused NOC and what is it used for
• 2. Important information before taking Valused NOC
• 3. How to take Valused NOC
• 4. Possible undesirable effects
• 5. How to store Valused NOC
• 6. Package contents and other information

1. What is Valused NOC and what is it used for

Valused NOC contains valerian root extract. It has a calming effect and facilitates falling asleep.
It is used for difficulties in falling asleep, in mild states of nervous tension.

2. Important information before taking Valused NOC

When not to take Valused NOC

• if the patient is allergic to the active substance (valerian root extract) or any of the other ingredients of this medicine (listed in section 6).

Children

The medicine is not recommended for use in children under 12 years of age (see section "Warnings and precautions").

Warnings and precautions

Before starting to take Valused NOC, discuss it with a doctor or pharmacist.
Taking Valused NOC in children under 12 years of age is not recommended due to the lack of data on safety and efficacy in this age group.
If symptoms worsen during treatment, consult a doctor or pharmacist.

Valused NOC and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
Do not take Valused NOC with other medicines with a calming effect, as this may increase the effect of this medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
It is not recommended to take Valused NOC during pregnancy and breastfeeding due to the lack of data on the safety of using valerian root extract.

Driving and operating machinery

The medicine may impair psychomotor performance, so do not drive vehicles or operate machinery while taking the medicine.

3. How to take Valused NOC

Take this medicine always exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions. In case of doubt, consult a doctor or pharmacist.
The medicine is taken orally.
Adults and adolescents over 12 years of age
In difficulties in falling asleep: 3 tablets half an hour to one hour before bedtime. If necessary, the dose before bedtime should be preceded by a single dose (3 tablets) in the early evening hours.
In mild states of nervous tension: 3 tablets once, 3 times a day.
The maximum daily dose is 4 single doses.
Duration of treatment
Due to the gradual effect of valerian root, it is not indicated for short-term treatment of acute states of nervous tension. To achieve the best therapeutic effect, it is recommended to continue treatment for 2 to 4 weeks.
If there is no improvement after 2 weeks of treatment or symptoms worsen, consult a doctor.

Taking a higher dose of Valused NOC than recommended

In case of overdose (25-40 tablets), symptoms of overdose may occur, such as fatigue, abdominal cramps, difficulty breathing, and heart rhythm disturbances, dizziness, hand tremors, and pupil dilation. These symptoms usually resolve within 24 hours. If symptoms do not resolve, consult a doctor.

Missing a dose of Valused NOC

Do not take a double dose to make up for a missed dose.
In case of any further doubts related to the use of this medicine, consult a doctor or pharmacist.

4. Possible undesirable effects

Like all medicines, this medicine can cause undesirable effects, although not everybody gets them.
Valused NOC is generally well-tolerated in recommended doses. During treatment with valerian root extract, gastrointestinal disorders (nausea, abdominal pain) have been observed.

Reporting undesirable effects

If any undesirable effects occur, including any possible undesirable effects not listed in the leaflet, inform the doctor or pharmacist. Undesirable effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Undesirable effects can also be reported to the marketing authorization holder.
Reporting undesirable effects can help gather more information on the safety of the medicine.

5. How to store Valused NOC

Store in the original packaging, at a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Valused NOC contains

• The active substance of the medicine is dry hydroalcoholic extract from valerian root (Valerianae extractum hydroalcoholicum siccum). One tablet contains 200 mg of extract from Valeriana officinalis L., radix (valerian root), which corresponds to 462-1000 mg of valerian root. Extraction solvent: ethanol 60% V/V.
• Other ingredients (excipients) are: maltodextrin, colloidal anhydrous silica, siliconized microcrystalline cellulose (composition: microcrystalline cellulose, colloidal anhydrous silica), calcium hydrogen phosphate dihydrate, crospovidone type A, croscarmellose sodium, magnesium stearate, and Opadry II 57U210006 Green coating (composition: hypromellose, polydextrose (E 1200), yellow iron oxide (E 172), talc, black iron oxide (E 172), maltodextrin, triglycerides of saturated fatty acids with an average chain length, titanium dioxide).

What Valused NOC looks like and what the package contains

One package of the medicine contains 10 or 30 coated tablets in blisters in a cardboard box.
The tablets are round, biconvex, with a smooth surface, dark green in color.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Information about the medicine

tel.: 22 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of last update of the leaflet: