Valused noc

Package leaflet: Information for the patient

Valused NOC
200 mg, coated tablets
Valerianae extractum hydroalcoholicum siccum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 2 weeks, you should consult your doctor.

Contents of the leaflet

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

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

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

2. Important information before using Valused NOC

When not to use Valused NOC

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

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

Warnings and precautions
Before starting treatment with Valused NOC, consult your doctor or pharmacist.
The use of Valused NOC in children under 12 years of age is not recommended due to lack of safety and efficacy data in this age group.
If symptoms worsen during treatment, consult your doctor or pharmacist.

Valused NOC and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
Do not use Valused NOC together with other sedative medicines, due to the possibility of enhanced sedative effect.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Valused NOC is not recommended during pregnancy and breastfeeding due to lack of safety data regarding the use of valerian root extract.

Driving and operating machinery
This medicine may impair psychomotor performance; therefore, driving vehicles or operating machinery should be avoided during treatment.

3. How to use Valused NOC

This medicine should always be taken exactly as described in the patient information leaflet or according to the instructions of a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is taken orally.
Adults and adolescents over 12 years of age
For difficulty in falling asleep: 3 tablets half to one hour before bedtime. If necessary, this bedtime dose may be preceded by a single dose (3 tablets) in the early evening hours.
For mild states of nervous tension: 3 tablets as a single dose, 3 times daily.
The maximum daily dose is 4 single doses.
Duration of use
Due to the gradual action of valerian root, this medicine is not indicated for immediate relief of acute nervous tension. To achieve the best therapeutic effect, it is recommended to continue treatment for a period of 2 to 4 weeks.
If there is no improvement after 2 weeks of using the medicine, or if symptoms worsen, consult your doctor.
Use of a higher than recommended dose of Valused NOC
In case of overdose (25–40 tablets), symptoms of overdose may occur, such as fatigue, abdominal cramps, breathing difficulties, heart rhythm disturbances, dizziness, hand tremors, and pupil dilation. These symptoms usually resolve within 24 hours. If symptoms persist, consult your doctor.
Missed dose of Valused NOC
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not in everyone.
Valused NOC is generally well tolerated at recommended doses.
Gastrointestinal disturbances (nausea, abdominal pain) have been observed during the use of valerian root.
Reporting adverse reactions
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting of adverse reactions enables further collection of information on the safety of the medicinal product.

5. How to store Valused Noc

Store in the original packaging at a temperature below 25°C.
Keep the medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Valused NOC contains

• The active substance is a dry hydroalcoholic extract from the root of valerian (Valerianae extractum hydroalcoholicum siccum). One tablet contains 200 mg of extract from Valeriana officinalis L., radix (valerian root), corresponding to 462–1000 mg of valerian root. The extraction solvent is ethanol 60% V/V.
• Other ingredients (excipients) are: maltodextrin, anhydrous colloidal silicon dioxide, silicified microcrystalline cellulose (composition: microcrystalline cellulose, anhydrous colloidal silicon dioxide), calcium hydrogen phosphate dihydrate, crospovidone type A, sodium carboxymethyl starch, magnesium stearate, and Opadry II 57U210006 Green coating (composition: hypromellose, polydextrose (E 1200), iron oxide yellow (E 172), talc, iron oxide black (E 172), maltodextrin, medium-chain triglycerides, titanium dioxide).

What Valused NOC looks like and contents of the pack
One pack contains 10 or 30 film-coated tablets in blisters within a cardboard box.
The tablets are round, biconvex discs with a uniform smooth surface, dark green in colour.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicinal Product Information
tel.: 22 742 00 22
e-mail: [email protected]