Kalms

Leaflet attached to the packaging: information for the user

Kalms

45 mg + 33.75 mg + 22.5 mg, sugar-coated tablets

Please 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 the patient leaflet or according to
the doctor's or pharmacist's instructions.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the 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 after 4 weeks there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is Kalms and what is it used for

Kalms is a herbal medicine intended for use in mild symptoms of nervous tension and as a sleep aid.
The traditional herbal medicinal product is used for the mentioned indications and its efficacy is based
solely on long-standing use and experience.

2. Important information before taking Kalms

When not to take Kalms

It should not be taken if there is hypersensitivity to the active substances or any of the
excipients of this medicine (listed in section 6).

Warnings and precautions

• The recommended dose should not be exceeded
• In case of more serious disorders or if the condition worsens, the doctor should be consulted
• It should not be given to children under 12 years of age.

Information for diabetics:

The medicine can be taken by diabetics. 1 tablet contains 248 mg of sucrose (0.02 bread units).

Kalms and other medicines

Interactions with other medicines are not known.
The doctor or pharmacist should be informed about all medicines currently being taken or recently
taken, including those available without a prescription.
Combination with synthetic sedatives is not recommended.

Pregnancy and breastfeeding

It is not recommended to take during pregnancy and breastfeeding.

Driving and operating machinery

If the patient feels drowsy, they should not drive a car or operate machinery.
Kalms contains sucrose (sugar). In case of intolerance to some sugars, the doctor should be consulted before taking the medicine.

3. How to take Kalms

Adults and adolescents over 12 years old:
In mild symptoms of nervous tension: take a single dose of 3 tablets, up to 3 times a day. Maximum 4 times a day.
As a sleep aid: take a single dose of 3 tablets 30 minutes before planned sleep. If necessary, another dose can be taken in the evening.
Duration of treatment
If after 4 weeks of taking Kalms the symptoms do not subside or the patient feels worse, they should contact their doctor.

Taking a higher dose of Kalms than recommended

In case of taking a higher dose of Kalms than recommended and experiencing any side effects, the doctor should be consulted.

Missing a dose of Kalms

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

4. Possible side effects

Like all medicines, this medicine 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.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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 the medicine.

5. How to store Kalms

The medicine should be stored out of sight and reach of children.
Store in a temperature below 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 specified month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Kalms contains

1 tablet contains the active substances:
Lupuli flos pulvis (hop cones powder) 45.00 mg
Valerianae extractum hydroalcoholicum sicccum (4:1)
(valerian root extract)
33.75 mg
extractant: ethanol 45-80% (V/V)
Gentianae extractum siccum (4:1) (gentian root extract) 22.50 mg
extractant: ethanol 50% (V/V)
and excipients: maltodextrin, colloidal silicon dioxide, corn starch, arabic gum, sucrose, stearic acid, sodium starch glycolate, magnesium stearate, colloidal silicon dioxide, shellac varnish (shellac, pharmaceutical alcohol), sucrose, calcium carbonate, talc, titanium dioxide, Mastercote white SP0950 G (titanium dioxide, sucrose, purified water, pharmaceutical alcohol), beeswax, carnauba wax.

What Kalms looks like and what the package contains

White, round, sugar-coated tablets. Kalms is packaged in aluminum/PVC blisters in a cardboard box. The package contains 40 or 100 tablets.

Marketing authorization holder

LanesHealth (Ireland) Limited
Suite 7, The Courtyard, Carmanhall Road, Sandyford, Dublin 18
D18 NW62, Ireland
Tel.: +44 (0)1452 524012
Fax: +44 (0)1452 507930
e-mail: info@laneshealth.com

Importer, responsible for batch release

Elara Pharmaservices Europe Limited,
239 Blanchardstown Corporate Park, Ballycoolin, Dublin
D15 KV21, Ireland
To obtain more detailed information, 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 update of the leaflet:04/2021