Umcalor®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT UMCKALOR®

Composition:

Active substance: liquid extract from the root of Pelargonium sidoides (EPs® 7630), dried;

One film-coated tablet contains 20 mg of dried liquid extract from the root of Pelargonium sidoides (EPs® 7630) (1:8-10); extraction solvent: ethanol 11% (m/m);

Excipients: maltodextrin, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, colloidal anhydrous silicon dioxide, magnesium stearate, hypromellose 5 MPa, polyethylene glycol 1500, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), talc, simethicone, methylcellulose, sorbic acid.

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: round, reddish-brown film-coated tablets.

Pharmacotherapeutic group.

Agents used for cough and colds. ATC code R05.

Pharmacological properties.

Pharmacodynamics.

The medicinal product contains an extract from the roots of Pelargonium sidoides, which originates from South Africa.

In animal studies, after oral administration of the extract, the following effects were demonstrated in mice: alleviation of disease progression (non-specific disease symptoms in the context of infection) and antioxidant properties.

In in vitro tests, the following effects of Umckaloabo® have been confirmed:

Stimulation of non-specific defense mechanisms:

• stimulation of ciliary beat frequency of ciliated epithelium;
• 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/living 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 drug.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to any component of the medicinal product; increased predisposition to bleeding, concomitant use of medicinal products that impair blood coagulation. Severe liver and kidney diseases.

Interaction with other medicinal products and other forms of interaction.

Currently, there are no reports of interactions with other agents.

Due to the potential effect of Umcalor® on blood coagulation parameters, an interaction with 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 symptoms persist for more than a week, elevated body temperature continues for several days, or shortness of breath and hemoptysis occur, it is recommended to consult a physician.

There have been reports of hepatic function disorders of various origins associated with the use of medicinal products containing extracts of Pelargonium sidoides.

If symptoms of impaired liver function occur, the drug must be discontinued immediately and medical advice should be sought.

If you have known intolerance to certain sugars, consult your doctor before taking this medicinal product.

Use during pregnancy and breastfeeding.

Due to the lack of sufficient experience with the use of Umckaloabo® during pregnancy or breastfeeding, the product is not recommended for use during these periods.

There are no data available on the effect on fertility.

Ability to influence reaction rate when driving or operating machinery.

There are no studies on the effect of the drug on the ability to drive or operate machinery.

Dosage and Administration.

For adults and children aged 12 years and older: 1 tablet 3 times daily (morning, afternoon, and evening); for children aged 6 to 12 years: 1 tablet 2 times daily (morning and evening).

Umcalor® should be taken without chewing, with a small amount of liquid.

Additionally, to prevent recurrence, treatment is recommended to be continued for several more days after the symptoms have disappeared. The average duration of treatment is 7–10 days.

The treatment duration should not exceed 3 weeks.

If symptoms persist for more than 1 week without improvement during the use of the medicinal product, a doctor should be consulted.

Children.

Recommended for children aged 6 years and older.

Overdose.

There have been no reports of overdose cases to date.

Adverse Reactions

Adverse reactions reported during the use of the medicinal product are listed below by system organ classes and frequency of occurrence: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (≤ 1/10000), unknown (cannot be estimated from the available data).

Gastrointestinal disorders:

Uncommon: gastrointestinal disturbances (abdominal pain, heartburn, nausea, diarrhea);

Rare: slight bleeding of the gums.

Respiratory system:

Rare: slight nosebleeds.

Skin and subcutaneous tissue disorders / Immune system disorders:

Rare: hypersensitivity reactions (rash, urticaria, itching).

Very rare: severe allergic reactions (facial swelling, dyspnea, hypotension).

Hepatobiliary disorders:

Very rare: liver function abnormalities of various origins, including increased liver enzymes. A causal relationship between these findings and the use of the medicinal product has not been established.

If any adverse reactions occur, the use of the medicinal product must be discontinued and medical advice should be sought.

Shelf life.

5 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

No special storage conditions required.

Packaging.

15 tablets in a blister. 1 or 2 blisters per cardboard box.

Prescription status.

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.