Umckalor^® (Solution) Instructions for Use

Marketing Authorization Holder

Dr. Willmar Schwabe GmbH & Co. KG (Germany)

Contact Information

Dr. Willmar Schwabe GmbH & Co. KG (Germany)

ATC Code

V30 (Not assigned)

Active Substance

Pelargonium root (Ph.Eur. European Pharmacopoeia)

Dosage Form

Umckalor®

Oral solution 80 g/100 g: 20 ml or 50 ml bottle with dropper.

Dosage Form, Packaging, and Composition

Oral solution in the form of a clear or slightly opalescent liquid ranging from light brown to reddish-brown in color.

* Extraction solvent ethanol 11% (mass/mass).

Excipients: glycerol 85% – 20 g.

20 ml – dark glass bottles with a dropper (1) – cardboard boxes.
50 ml – dark glass bottles with a dropper (1) – cardboard boxes.

Clinical-Pharmacological Group

Herbal preparation, used for infectious diseases of the respiratory tract and ENT organs

Pharmacotherapeutic Group

Antimicrobial agent of plant origin

Pharmacological Action

A herbal preparation. It has an antimicrobial effect and possesses mucolytic properties. It helps to increase the body’s non-specific resistance.

Pharmacokinetics

The liquid extract of Pelargonium sidoides roots contains a large number of biologically active substances, which collectively determine its pharmacological activity.

Therefore, data on the pharmacokinetics of individual chemical components included in the extract are insufficient for extrapolation to the drug as a whole.

Indications

• Acute and chronic infectious and inflammatory diseases of the respiratory tract and ENT organs (sinusitis, rhinopharyngitis, tonsillitis, bronchitis) – as part of complex therapy.

ICD codes

Dosage Regimen

The drug is taken orally, 30 minutes before meals with a small amount of liquid.

Adults and children over 12 years are prescribed 20-30 drops 3 times/day, children aged 6 to 12 years – 10-20 drops 3 times/day, children from 1 year to 6 years – 5-10 drops 3 times/day.

When dosing the drug, the bottle should be held vertically, tapping the bottom of the bottle if necessary.

The average duration of the treatment course is 10 days. After the symptoms of the disease disappear, it is recommended to continue treatment for several more days to prevent relapse.

Adverse Reactions

The assessment of the frequency of adverse reactions is based on the WHO classification: very common – 1/10 prescriptions (≥10%), common – 1/100 prescriptions (≥1%, but <10%), uncommon – 1/1000 prescriptions (≥0.1%, but <1%), rare – 1/10,000 prescriptions (≥0.01%, but <0.1%), very rare – less than 1/10,000 prescriptions (<0.01%).

Respiratory system disorders rare – nosebleeds.

Gastrointestinal system disorders uncommon – nausea, vomiting, epigastric pain, diarrhea; rare – slight gum bleeding.

Hepatobiliary system disorders frequency unknown – signs of impaired liver function (yellowing of the skin, yellowing of the sclera of the eyes); the connection of this manifestation with the use of the drug has not been confirmed.

Other rare – allergic reactions.

Contraindications

• Predisposition to bleeding;
• Severe hepatic insufficiency;
• Severe renal insufficiency;
• Children under 1 year of age (due to the presence of ethyl alcohol in the drug);
• Concomitant use of anticoagulants;
• Hypersensitivity to the components of the drug.

With caution, the drug should be used in cases of alcoholism, traumatic brain injury, brain diseases, impaired liver and kidney function (no experience of use), and in children over 1 year of age.

Use in Pregnancy and Lactation

Due to the lack of sufficient research data to date, the drug is not recommended for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated in severe hepatic insufficiency.

With caution, the drug should be used in cases of impaired liver function (no experience of use).

Use in Renal Impairment

Contraindicated in severe renal insufficiency.

With caution, the drug should be used in cases of impaired kidney function (no experience of use).

Pediatric Use

Contraindicated in children under 1 year of age (due to the presence of ethyl alcohol in the drug).

With caution, the drug should be used in children over 1 year of age.

Special Precautions

During storage, liquid herbal extracts tend to become cloudy; however, this does not affect their pharmacological efficacy.

Since Umckalor^® is a natural product, minor changes in the color and taste of the drug are possible.

Due to the ethanol content (12% vol.) in the drug, it should be taken into account that the maximum single dose for children over 12 years and adults contains 0.125 g of absolute ethyl alcohol, and the maximum daily dose for children over 12 years and adults contains 0.375 g of absolute ethyl alcohol.

The single dose for children under 12 years of age contains less than 0.1 g of absolute ethyl alcohol.

If there is no therapeutic effect while using the drug for 7 days, if elevated body temperature persists for several days, if shortness of breath or bloody sputum appears, or if signs of impaired liver function (such as yellowing of the skin, yellowing of the sclera of the eyes) appear, the patient should consult a doctor.

Effect on the ability to drive vehicles and operate machinery

Caution should be exercised when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions (including driving vehicles, working with moving machinery) while using the drug.

Overdose

To date, no cases of overdose with Umckalor^® have been reported. The drug is well tolerated.

Drug Interactions

With the simultaneous use of Umckalor^® with anticoagulants (including coumarin derivatives), an enhancement of their anticoagulant effect and the occurrence of bleeding (nosebleeds, gum bleeding) are possible.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 2 years. After opening the bottle, store for no more than 6 months.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.