Package leaflet: Information for the patient

Persen Noc, 445 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 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, 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 after 14 days of treatment, or if you feel worse, consult your doctor.

Table of contents

What Persen Noc is and what it is used for
What you need to know before taking Persen Noc
How to take Persen Noc
Possible side effects
How to store Persen Noc
Contents of the pack and other information

1. What Persen Noc is and what it is used for

Persen Noc is a herbal medicinal product used to relieve sleep disturbances (such as feeling unrested and difficulty falling asleep) and mild states of nervous tension (e.g. fatigue, nervousness, and irritability).
If you do not feel better or experience worsening symptoms after 14 consecutive days of taking Persen Noc, you should consult your doctor.

2. Important information before using Persen Noc

When not to use Persen Noc

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

Warnings and precautions
Before starting to use Persen Noc, please consult your doctor or pharmacist.
Children and adolescents
Use of Persen Noc is not recommended in children under 12 years of age due to limited experience with use in this age group.
Persen 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 the patient plans to take, including those available without a prescription.
Concomitant use of Persen Noc with other medicines used for sedation or relief of nervousness requires a doctor's approval and should be supervised by a physician.
Pregnancy, breastfeeding and fertility
If a woman 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.
It is not known whether compounds contained in valerian pass into breast milk. Due to insufficient data, use of Persen Noc is not recommended during pregnancy and breastfeeding.
Driving and operating machinery
Persen Noc may affect the ability to drive safely and operate machinery. Patients who experience impaired ability to perform these activities while taking this medicine should not drive or operate machinery.
Persen Noc contains sucrose
If the patient has been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

3. How to use Persen Noc

This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Adolescents over 12 years of age, adults and elderly patients
Recommended dose:

Mild states of nervous tension: 1 tablet up to 3 times daily
Sleep disturbances: 1 tablet half an hour to one hour before bedtime. If necessary, an additional dose may be taken earlier in the evening.

The maximum daily dose is 4 tablets.

Method of administration
Tablets should be swallowed with an adequate amount of liquid (preferably a glass of cool water).
The tablets are enteric-coated and must be swallowed whole (i.e. without breaking or chewing) due to the unpleasant odour and taste of the valerian extract.

Duration of treatment
The effect of the medicine develops gradually; therefore, it should not be used to achieve immediate relief in mild nervous tension or sleep disturbances. The best treatment results are achieved by taking the tablets continuously for 2 to 4 weeks.

Use in children
This medicine is not recommended for children under 12 years of age due to lack of data.

Accidental overdose of Persen Noc
In case of taking more than the recommended dose, consult your doctor or pharmacist.
Taking too many tablets (10 tablets or more) may cause fatigue, abdominal cramps, chest tightness, dizziness, hand tremors or pupil dilation. These symptoms usually resolve within 24 hours.

Missed dose of Persen Noc
Missing a dose is not significant. If you miss a dose, take the next one at the usual time.
Do not take a double dose to make up for the missed dose.

Stopping Persen Noc
The medicine may be discontinued at any time.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions have been reported, although their frequency cannot be determined from the available data:

nausea, abdominal cramps

If adverse reactions occur and are troublesome, the medicine should be discontinued.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. 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:
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Persen Noc

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
blister pack following EXP. The expiry date refers to the last day of the specified month.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the packaging and other information

What Persen Noc contains
The active substance in this medicine is dry extract of valerian root (3-6:1).
Each coated tablet contains 445 mg of dry extract from valerian root
( Valeriana officinalis L. s.l., radix ) (3-6:1). Extraction solvent: 70% ethanol (V/V).
Other ingredients: maltodextrin, anhydrous colloidal silicon dioxide.
Tablet core: microcrystalline cellulose, magnesium stearate, hydrated colloidal silicon dioxide.
Coating: talc, sucrose, calcium carbonate (E 170), spray-dried gum arabic, titanium dioxide
(E 171), shellac, heavy kaolin, purified castor oil, macrogol 6000.

What Persen Noc looks like and contents of the pack
Persen Noc tablets are round, white, convex, with a diameter of 12 mm.
They are packed in Al/PVC/PVDC blisters, placed in a cardboard box.
Pack sizes: 15, 30, 45 and 60 coated tablets.
Not all pack sizes may be available on the market.

Marketing Authorisation Holder:
Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer:
Wiewelhove GmbH
Dörnebrink 19
D-49479 Ibbenbüren, Germany

For further information, contact:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 22 375 92 00

Date of preparation of the text: January 2025
(Logo of the Marketing Authorisation Holder)