Persen Noc

Package Leaflet: Information for the Patient

Persen Noc, 445 mg, Effervescent Tablets

Valerianae extractum hydroalcoholicum siccum

Read the Leaflet Carefully Before Taking the Medication, as it Contains

Important Information for the Patient.
This medication should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 14 days, they should contact their doctor.

Table of Contents of the Leaflet

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

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

Persen Noc is a herbal medicine used to relieve sleep disorders (such as feeling unrefreshed and having difficulty falling asleep) and mild nervous tension (such as fatigue, nervousness, and irritability).
If the patient does not feel better or worsens after taking Persen Noc continuously for 14 days, they should consult their doctor.

2. Important information before taking Persen Noc

When not to take 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 take Persen Noc, the patient should discuss it with their doctor or pharmacist.

Children and adolescents

Persen Noc is not recommended for children under 12 years of age due to limited experience with its use in this age group.

Persen Noc and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take, including those available without a prescription.
Concomitant use of Persen Noc with other medicines used to calm or relieve nervousness requires the doctor's consent and should be supervised by them.

Pregnancy, breastfeeding, and fertility

If a woman is pregnant, breastfeeding, thinks she may be pregnant, or plans to have a baby, she should consult her doctor or pharmacist before taking this medicine.
It is not known whether the compounds in valerian pass into breast milk. Due to the lack of sufficient data, the use of Persen Noc is not recommended during pregnancy and breastfeeding.

Driving and using machines

Persen Noc may affect the ability to drive and use machines safely. Patients who experience impaired ability to perform these activities should not drive or operate machinery.

Persen Noc contains sucrose

If the patient has been told they have an intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Persen Noc

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

Adolescents over 12 years, adults, and the elderly

Recommended dose:

• mild nervous tension: 1 tablet up to 3 times a day
• sleep disorders: 1 tablet half an hour to one hour before bedtime. If necessary, an additional dose can be taken earlier in the evening.

No more than 4 tablets should be taken in 24 hours.

Method of administration

Tablets should be swallowed with a sufficient amount of liquid (preferably a glass of cold water).
The tablets are effervescent and should be swallowed whole (i.e., without breaking or chewing) due to the unpleasant smell and taste of the valerian extract.

Duration of treatment

The effect of the medicine is gradual, so it should not be taken to achieve immediate relief from mild nervous tension or sleep disorders. The best treatment effects are achieved by taking the tablets continuously for 2 to 4 weeks.

Use in children

Persen Noc is not recommended for children under 12 years of age due to a lack of data.

Overdose of Persen Noc

In case of an overdose, the patient should consult their doctor or pharmacist.
Taking more than the recommended dose (10 tablets or more) may cause drowsiness, 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 a dose is missed, the next one should be taken at the usual time.
A double dose should not be taken to make up for a missed dose.

Stopping Persen Noc

The use of Persen Noc can be stopped at any time.
If there are any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Persen Noc can cause side effects, although not everybody gets them.
The following side effects have been reported, although their frequency cannot be estimated from the available data:

• nausea, abdominal cramps

If the side effects are troublesome, the patient should stop taking the medicine.
Reporting side effects
If any side effects occur, including any possible side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Persen Noc

The medicine should be stored out of sight and reach of children.
This medicine should not be taken after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Persen Noc contains

The active substance is dry valerian root extract (3-6:1).
Each effervescent tablet contains 445 mg of dry valerian root extract (Valeriana officinalis L. s.l., radix) (3-6:1). Extraction solvent: ethanol 70% (V/V).
The other ingredients are: maltodextrin, colloidal anhydrous silica.
Core: microcrystalline cellulose, magnesium stearate, colloidal hydrated silica.
Coating: talc, sucrose, calcium carbonate (E 170), spray-dried acacia gum, 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, and convex, with a diameter of 12 mm.
They are packaged in Al/PVC/PVDC foil blisters in a carton.
The packs contain 15, 30, 45, and 60 effervescent tablets.
Not all pack sizes may be marketed.

Marketing authorization 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, please contact:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 22 375 92 00
Date of revision of the leaflet:January 2025
(Logo of the marketing authorization holder)