Package leaflet: Information for the user

Kalms Noc, 385 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 used 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, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 14 days, or if you feel worse, you should consult your doctor.

Contents of the leaflet

What Kalms Noc is and what it is used for
Important information before taking Kalms Noc
How to take Kalms Noc
Possible side effects
How to store Kalms Noc
Contents of the pack and other information

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

Kalms Noc is a herbal medicine intended for the temporary relief of sleep disturbances and difficulty falling asleep.
If there is no improvement after 14 days, or if you feel worse, you should consult your doctor.

2. Important information before taking Kalms Noc

When not to take Kalms Noc

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

Warnings and precautions
Before starting to take Kalms Noc, discuss this with your doctor or pharmacist. Do not exceed the recommended dose. If sleep disturbances persist or worsen after 2 weeks of use, seek advice from a doctor or pharmacist.
The effect of the medicine may be intensified by alcohol; therefore, excessive alcohol consumption should be avoided.

Children
Do not use this medicine in children under 12 years of age due to insufficient data on use in this age group.

Kalms Noc and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Interactions with other medicines are not known.
Concomitant use of this medicine with synthetic sleeping medicines requires medical supervision.

Pregnancy and breastfeeding
Due to lack of data, use during pregnancy and breastfeeding is not recommended. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.

Driving and operating machinery
This medicine may affect the ability to drive or operate machinery. Its use is not recommended before driving or operating machinery.

3. How to use Kalms Night

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults, elderly and adolescents over 12 years of age
The recommended dose is 1–2 tablets, taken 30 to 60 minutes before bedtime. If necessary, an additional tablet may be taken. Do not exceed the recommended dose of 3 tablets per day.
This medicine may be used for 2–4 weeks in cases of recurring difficulty in falling asleep. If sleep disturbances persist or worsen after 2 weeks of treatment, medical advice should be sought.
Concomitant use with other products containing valerian root extracts is not recommended.
Use in children
This medicine should not be used in children under 12 years of age.
Taking more Kalms Night than recommended
If more Kalms Night has been taken than recommended and any adverse effects occur, consult a doctor immediately.
Missed dose of Kalms Night
Do not take a double dose to make up for a missed dose.
Stopping Kalms Night
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
After taking the medicine, gastrointestinal disturbances (e.g. nausea, abdominal cramps) may occur.
There is no data available on the frequency of occurrence of these adverse effects. If any other adverse effects not mentioned above occur, consult your doctor or pharmacist.
Reporting of adverse effects
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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.: 22 49-21-301, fax: 22 49-21-309
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
By reporting adverse effects, more information on the safety of this medicine can be collected.

5. How to store Kalms Night

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month. Do not use if the blister is damaged.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Kalms Night contains
The active substance is a hydroalcoholic extract (in the form of dry extract) from the root of
valerian (Valerianae extractum hydroalcoholicum siccum).

Each coated tablet contains 385 mg of hydroalcoholic extract (in the form of dry extract) from Valeriana officinalis L., radix (valerian root), corresponding to 1540 mg - 1925 mg of valerian root, DER 4-5:1, extraction solvent: ethanol 60% (V/V).
The other ingredients (excipients) are: maltodextrin, sodium croscarmellose, magnesium stearate, microcrystalline cellulose silicified Prosolv SMCC50, talc, colloidal anhydrous silica; ingredients of the tablet coating: Opadry 07F28588 White (hypromellose, talc, titanium dioxide (E171), polyethylene glycol, sodium saccharin).

What Kalms Night looks like and contents of the pack
White, oval coated tablets.
The pack contains 14, 21, 28, 42 or 56 coated tablets in PVC/PCTFE/Aluminium blisters
and a patient information leaflet.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
LanesHealth (Ireland) Limited,
Suite 7, The Courtyard, Carmanhall Road, Sandyford, Dublin 18,
D18 NW62, Ireland.
Tel.: +44 (0)1452 524012,
e-mail: [email protected]
Importer responsible for batch release
Elara Pharmaservices Europe Limited,
239 Blanchardstown, Corporate Park, Ballycoolin,
Dublin, D15 KV21, Ireland.
For further information about this medicinal product, please contact:
Orkla Care S.A., ul. Fabryczna 5a, 00-446 Warsaw, Poland, tel. +48 22 358 13 00, e-mail:
[email protected]