UMCALOR®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT UMCKALOR®

Composition:

Active substance: Dry liquid extract of Pelargonium sidoides root (EPs® 7630);

100 g of syrup (93.985 ml) contain 0.2506 g of dry liquid extract of Pelargonium sidoides root (EPs® 7630) (1:8-10), (extraction solvent – ethanol 11% (m/m));

Excipients: maltodextrin, xylitol, glycerol 85%, anhydrous citric acid, potassium sorbate, xanthan gum, purified water.

Pharmaceutical form. Syrup.

Main physicochemical characteristics: viscous syrup, ranging in color from orange to light brown.

Pharmacotherapeutic group.

Preparations used for cough and colds. ATC code R05.

Pharmacological properties.

Pharmacodynamics.

The medicinal product contains an extract from the roots of Pelargonium sidoides, which stimulates non-specific defense mechanisms of the body, has antimicrobial effects and moderate direct antibacterial and antiviral properties, as well as cytoprotective properties.

Pharmacokinetics.

There is currently no data available on the pharmacokinetics of the drug.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to the components of the drug, increased predisposition to bleeding, or use of medicinal products that impair blood coagulation. Severe liver and kidney diseases.

Interaction with other medicinal products and other forms of interaction.

No reports of interactions have been received to date.

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

Special precautions for use.

If symptoms do not resolve within a week, elevated body temperature persists for several days, or signs of impaired liver function of various origins, dyspnea, or hemoptysis occur, it is recommended to consult a physician.

Cases of impaired liver function of various origins have been reported in connection with the use of medicinal products containing extracts of Pelargonium sidoides.

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

Use during pregnancy and breastfeeding.

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

Ability to influence reaction rate when driving or operating machinery.

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

Dosage and Administration.

For adults and children aged 12 years and older: 7.5 ml of syrup three times daily.

For children aged 6 to 12 years: 5 ml of syrup three times daily.

For children aged 1 to 5 years: 2.5 ml of syrup three times daily.

Administration

The syrup should be taken orally three times a day (in the morning, at noon, and in the evening).

Duration of treatment

After symptoms disappear, it is recommended to continue treatment for several more days to prevent relapse.

The duration of treatment should not exceed 3 weeks.

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

Children

Umcalor® is not recommended for use in children under 1 year of age due to insufficient data on its safety and efficacy in this patient group.

Overdose.

No cases of overdose have been reported to date.

An overdose may lead to an increase in adverse reactions.

Side effects.

The 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 (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), 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 should be discontinued and medical advice should be sought.

Shelf life.

2 years.

After opening the bottle – 6 months.

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

Storage conditions.

No special storage conditions required.

Packaging.

Glass bottles of 100 ml or 200 ml with a measuring cap, packed in a cardboard box.

Prescription status.

Over-the-counter (without prescription).

Manufacturer.

Dr. Willmar Schwabe GmbH & Co. KG.

Address of the manufacturer and location of business operations.

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