Patient Information Leaflet

Kalms
45 mg + 33.75 mg + 22.5 mg, film-coated tablets
Please read the entire leaflet carefully before taking this 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
your doctor or pharmacist.

Keep this leaflet for future reference.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 4 weeks, or if you feel worse, you should contact your doctor.

Table of Contents:

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

1. What Kalms is and what it is used for

Kalms is a herbal medicinal product used for the relief of mild symptoms of nervous tension and as an aid to sleep.
This medicinal product is traditionally used for the indications listed above, and its effectiveness is based solely on long-standing use and experience.

2. Important information before using Kalms

When not to use Kalms
Do not use if there is hypersensitivity to the active substances or any of the
excipients listed in section 6.
Warnings and precautions

Do not exceed the recommended dose.
In case of more serious disorders or if the condition worsens, consult a doctor.
Do not give 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 carbohydrate exchange unit).

Kalms and other medicines
Interactions with other medicines are not known.
Inform your doctor or pharmacist about all medicines currently taken or recently taken, including those obtained without a prescription.
Combination with synthetic sedatives is not recommended.
Pregnancy and breastfeeding
Use during pregnancy and breastfeeding is not recommended.
Driving and operating machinery
If the patient experiences drowsiness, they should not drive or operate machinery.
Kalms contains sucrose (sugar). In case of intolerance to certain sugars, consult a doctor before taking the medicine.

3. How to take Kalms

Adults and adolescents over 12 years of age:
For mild symptoms of nervous tension: take a single dose of 3 tablets, up to 3 times a day. Maximum of 4 times a day.
As an aid to sleep: take a single dose of 3 tablets half an hour before intended bedtime. If necessary, another dose may be taken in the evening.

Duration of treatment
If symptoms have not improved or worsen after 4 weeks of taking Kalms, consult a doctor.

Taking more Kalms than recommended
If you take more Kalms than recommended and experience any adverse effects, contact your doctor.

If you forget to take Kalms
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Gastrointestinal disorders (e.g. nausea, abdominal cramps) may occur after taking the medicine.
There is no data available regarding the frequency of these adverse reactions.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring of Adverse Reactions of 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather further information on the safety of using this medicine.

5. How to store Kalms

Keep the medicine out of the sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Kalms contains
Each tablet contains the following active substances:
Lupuli flos pulvis (powdered hop cones) 45.00 mg
Valerianae extractum hydroalcoholicum sicccum (4:1)
(hydroalcoholic extract of valerian root) 33.75 mg
extraction solvent: ethanol 45–80% (V/V)
Gentianae extractum siccum (4:1) (extract of gentian root) 22.50 mg
extraction solvent: ethanol 50% (V/V)

and excipients: maltodextrin, colloidal anhydrous silicon dioxide, maize starch,
arabic gum, sucrose, stearic acid, sodium starch glycolate, magnesium stearate,
colloidal silicon dioxide, shellac varnish (shellac, pharmaceutical alcohols),
sucrose, calcium carbonate, talc, titanium dioxide, Mastercote white SP0950 G (titanium dioxide,
sucrose, purified water, pharmaceutical alcohols), beeswax, carnauba wax.

What Kalms looks like and contents of the pack
White, round coated tablets. Kalms is packed in aluminium/PVC blisters in a cardboard box.
The pack contains 40 or 100 tablets.

Marketing Authorisation 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: [email protected]

Importer responsible for batch release
Elara Pharmaservices Europe Limited,
239 Blanchardstown Corporate Park, Ballycoolin, Dublin
D15 KV21, Ireland

For further information, please contact:
Orkla Care S.A., ul. Fabryczna 5a, 00-446 Warsaw, Poland
Tel.: +48 22 358 13 00
e-mail: [email protected]