Kalms Noc

PATIENT INFORMATION LEAFLET

Leaflet enclosed with the packaging: information for the patient

Kalms Noc, 385 mg, coated tablets

Valerianae extractum hydroalcoholicum siccum

Read the contents of 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 this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 14 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

Kalms Noc is a herbal medicine used for the short-term relief of sleep disturbances and difficulty falling asleep.
If after 14 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking Kalms Noc

When not to take Kalms Noc

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

Warnings and precautions

Before taking Kalms Noc, the patient should discuss it with their doctor or pharmacist. The recommended dose should not be exceeded. If after 2 weeks of taking the medicine sleep disturbances persist or worsen, the patient should consult their doctor or pharmacist.
The effect of the medicine may be enhanced by alcohol, so excessive alcohol consumption should be avoided.

Children

This medicine should not be taken by children under 12 years of age due to the lack of sufficient data on its use in this age group.

Kalms Noc and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Interactions with other medicines are not known.
Concomitant use of this medicine with synthetic sedatives requires medical supervision.

Pregnancy and breastfeeding

Due to the lack of data, the use of this medicine during pregnancy and breastfeeding is not recommended. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.

Driving and operating machinery

The medicine may affect the ability to drive and operate machinery. It is not recommended to take the medicine before driving or operating machinery.

3. How to take Kalms Noc

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Adults, elderly, and adolescents over 12 years
The recommended dose is 1-2 tablets 30-60 minutes before bedtime. If necessary, an additional tablet can be taken. The recommended dose should not be exceeded, with a maximum of 3 tablets per day.
This medicine can be taken for 2-4 weeks in case of recurring difficulty falling asleep. If after 2 weeks of taking the medicine sleep disturbances persist or worsen, the patient should consult their doctor.
It is not recommended to take this medicine with other products containing valerian root extracts.

Use in children

This medicine should not be taken by children under 12 years of age.

Overdose of Kalms Noc

In case of taking a higher dose of Kalms Noc than recommended and experiencing any side effects, the patient should contact their doctor.

Missed dose of Kalms Noc

A double dose should not be taken to make up for a missed dose.

Stopping Kalms Noc

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Kalms Noc can cause side effects, although not everybody gets them.
After taking the medicine, stomach and intestinal disorders (e.g., nausea, abdominal cramps) may occur.
There is no data on the frequency of these side effects. If other side effects not listed above occur, the patient should consult their doctor or pharmacist.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Kalms Noc

The medicine should be stored 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 month.
Do not use if the blister is damaged.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Kalms Noc contains

The active substance of the medicine is a hydroalcoholic extract (in the form of a dry extract) of valerian root ( Valerianaeextractum hydroalcoholicum siccum).

• One coated tablet contains 385 mg of hydroalcoholic extract (in the form of a dry extract) of Valeriana officinalisL., radix, (valerian root) which corresponds 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, silicon dioxide, Prosolv SMCC50microcrystalline cellulose; the ingredients of the tablet coating are: Opadry 07F28588 White (hypromellose, talc, titanium dioxide (E171), polyethylene glycol, sodium saccharin).

What Kalms Noc looks like and contents of the packaging

White, oval, coated tablets.
The packaging contains 14, 21, 28, 42, or 56 coated tablets in PVC/PCTFE/Aluminum blisters and an information leaflet.
Not all pack sizes may be marketed.

Marketing authorization holder

LanesHealth (Ireland) Limited,
Suite 7, The Courtyard, Carmanhall Road, Sandyford, Dublin 18,
D18 NW62, Ireland.
Tel.: +44 (0)1452 524012,
e-mail: info@laneshealth.com

Importer responsible for batch release

Elara Pharmaservices Europe Limited,
239 Blanchardstown, Corporate Park, Ballycoolin,
Dublin, D15 KV21, Ireland.

For further information about this medicine, please contact

Orkla Care S.A.,ul. Fabryczna 5a, 00-446 Warsaw, tel. +48 22 358 13 00, e-mail:
office@orklacare.pl

Date of last revision of the leaflet: