Umcalor

INSTRUCTIONS for medical use of the medicinal product UMKAOLOR®

Composition:

Active substances: extract of Pelargonium sidoides (Pelargonii sidoides) roots (1:8-10), extraction solvent: ethanol 11% (m/m);

1 g of solution contains 800 mg of extract of Pelargonium sidoides (Pelargonii sidoides) roots (1:8-10), extraction solvent: ethanol 11% (m/m);

Excipient: glycerol 85%.

Pharmaceutical form. Oral solution.

Main physicochemical characteristics: liquid of light brown to red-brown color.

Pharmacotherapeutic group. Agents acting on the respiratory system.

ATC code R05.

Pharmacological Properties

Pharmacodynamics

The medicinal product contains an extract from the roots of Pelargonium sidoides.

In animal studies, following oral administration of the extract, inhibition of disease progression (non-specific disease symptoms in the context of infection) and antioxidant properties were observed.

The following effects of Umckaloabo® have been confirmed in in vitro tests:

Stimulation of non-specific defense mechanisms:

• stimulation of ciliary beat frequency;
• modulation of interferon and pro-inflammatory cytokine synthesis;
• stimulation of NK-cell activity;
• stimulation of phagocytes, expression of adhesion molecules, chemotaxis;

Antimicrobial effects:

• moderate direct antibacterial and antiviral properties;
• increased/inhibited adhesion of A-streptococci to desquamated/viable epithelial cells;
• inhibition of beta-lactamase;

Cytoprotective properties:

• inhibition of human leukocyte elastase;
• antioxidant properties.

Pharmacokinetics

Currently, there are no data available on the pharmacokinetics of the medicinal product.

Clinical characteristics.

Indications.

Acute and chronic infections of the respiratory tract and ENT organs (bronchitis, sinusitis, tonsillar angina, rhinopharyngitis).

Contraindications.

Hypersensitivity to the components of the drug; increased predisposition to bleeding, concomitant use of medicinal products that impair blood coagulation; severe liver and kidney diseases (due to lack of sufficient experience with the use of this medicinal product in such cases).

Interaction with other medicinal products and other forms of interaction.

No reports have been received to date.

Due to the potential effect of Umcalor® on blood coagulation parameters, the possibility that it may influence the action of indirect anticoagulants such as warfarin cannot be excluded when used concomitantly. In a placebo-controlled, double-blind clinical study involving healthy volunteers, no interactions between Umcalor® and penicillin V were observed.

Special precautions for use.

If disease symptoms do not disappear within 1 week, elevated body temperature persists for more than 3 days, or general condition worsens, as well as in case of impaired liver function of any origin, dyspnea, or bloody sputum, medical advice is recommended.

Use during pregnancy or breastfeeding.

The drug is not recommended during pregnancy or breastfeeding due to insufficient clinical experience with its use in these patient groups.

Ability to affect reaction speed when driving or operating machinery.

The effect has not been studied during driving or operating machinery; however, it should be taken into account that the preparation contains 12% v/v ethanol.

Dosage and Administration.

The solution should be taken with a small amount of liquid, 30 minutes before meals, in the morning, afternoon, and evening.

In the acute stage of the disease, the usual dosage is as follows: adults and children aged 12 years and older – 30 drops three times daily; children aged 6 to 12 years – 20 drops three times daily; children aged 1 to 6 years – 10 drops three times daily.

For prevention of relapses and ongoing treatment of chronic conditions, adults and children aged 12 years and older should take 10–20 drops three times daily.

The average duration of treatment for acute conditions and prevention of relapses is 7–10 days. The total treatment duration should not exceed 3 weeks.

Hold the bottle vertically and, if necessary, gently tap the bottom.

Children.

There is no experience with the use of the drug in children under 1 year of age; therefore, Umcalor® can be administered to children from the age of 1 year.

The use of Umcalor® for the treatment of younger children (aged 1 to 6 years) is recommended under medical supervision.

Overdose.

There have been no reports of overdose cases to date. However, adverse reactions may be intensified.

Side effects.

Gastrointestinal tract: gastrointestinal disorders (including stomach pain, heartburn, nausea, diarrhea), slight bleeding of the gums.

Respiratory system: mild nosebleeds.

Skin/immune system: hypersensitivity reactions (including skin rash, urticaria, itching of the skin and mucous membranes). In extremely rare cases, severe hypersensitivity reactions with facial swelling, shortness of breath, and decreased blood pressure may occur.

Hepatobiliary system: increased liver function parameters. A causal relationship between these increases and the use of the drug has not been demonstrated.

Shelf life. 2 years.

The shelf life of the solution after opening the bottle is 6 months.

Note. With plant extracts in the form of solutions, slight cloudiness may occur over time, which does not affect the efficacy of the drug. Since Umckalo® is a herbal medicinal product, minor changes in its color and taste are possible.

Storage conditions.

Store at a temperature not exceeding 30 °C, in a place inaccessible to children.

Packaging.

20 ml, 50 ml of solution in a bottle; 1 bottle per cardboard box.

Availability category. Over-the-counter.

Manufacturer.

Dr. Willmar Schwabe GmbH & Co. KG.

Manufacturer's address and location of business operations:

Willmar-Schwabe-Strasse 4, 76227 Karlsruhe, Germany.