Instructions Umkalor film-coated tablets 20 mg blister No. 15
Composition
active ingredients: 1 film-coated tablet contains 20 mg of liquid extract from the roots of Pelargonium sidoides (EPs® 7630) (1:8-10), dried (extractant: ethanol 11% (m/m));
excipients: maltodextrin, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, hypromellose 5MPa, macrogol 1500, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), talc, simethicone, methylcellulose, sorbic acid.
Dosage form
Film-coated tablets.
Main physicochemical properties: round, red-brown tablets, film-coated.
Pharmacotherapeutic group
Medicines used for coughs and colds. ATX code R05.
Pharmacological properties
Pharmacodynamics
The drug contains an extract from the roots of stonecrop pelargonium (Pelargonium sidoides), native to South Africa.
In animal studies, after internal administration of the extract, mice were shown to have: relief of the course of the disease (nonspecific symptoms of the disease in the context of infection) and antioxidant properties.
In vitro tests have confirmed the following effects of Umcalor®:
stimulation of nonspecific defense mechanisms:
- stimulation of the frequency of contraction of the ciliated epithelium;
- modulation of the synthesis of interferon and pro-inflammatory cytokines;
- stimulation of NK cell activity;
- stimulation of phagocytes, expression of adhesion molecules, chemotaxis;
antimicrobial effects:
- moderate direct antibacterial and antiviral properties;
- growth/inhibition of adhesion of group A streptococci to desquamative/living epithelial cells;
- inhibition of beta-lactamase;
cytoprotective properties:
- inhibition of human leukocyte elastase;
- antioxidant properties.
Pharmacokinetics
The drug is a complex mixture of many components, which as a whole is considered as an active substance. There is no data on the pharmacokinetics of the drug yet.
Indication
Acute and chronic infections of the respiratory tract and ENT organs (bronchitis, sinusitis, tonsillitis, rhinopharyngitis).
Contraindication
Hypersensitivity to one of its ingredients, with an increased tendency to bleeding and in case of taking medications that slow down the blood clotting process. Umkalor® cannot be used in severe liver and kidney diseases (due to the lack of sufficient experience of using this drug in such cases).
Interaction with other medicinal products and other types of interactions
To date, there are no reports of interactions with other drugs.
Due to the possible effect of Umcalor® on blood coagulation parameters, it cannot be excluded that, when used simultaneously, it may affect the effect of indirect anticoagulants such as warfarin. In a placebo-controlled, double-blind clinical study involving healthy volunteers, no interactions of Umcalor® with penicillin V were found.
Application features
If symptoms persist for a week, fever persists for several days, or shortness of breath and bloody sputum are observed, it is recommended to consult a doctor.
Use during pregnancy and breastfeeding
Due to the lack of sufficient experience with the use of Umcalor®, it is not recommended for use during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are no studies on the effect of the drug on the ability to drive or operate other mechanisms.
Method of administration and doses
Adults and children over 12 years of age: 1 tablet 3 times a day (morning, afternoon and evening); children aged 6 to 12 years: 1 tablet 2 times a day (morning and evening).
It is recommended to take Umcalor® without chewing, with a small amount of liquid.
In addition, in order to prevent relapse, it is recommended to continue treatment for a few more days after the symptoms of the disease disappear. The average duration of the treatment course is 7-10 days.
The duration of treatment should not exceed 3 weeks.
If, despite following the prescribed dosage, there is no improvement in the condition, the patient should inform the doctor.
Children
Prescribed for children aged 6 years and over.
Overdose
To date, there have been no reports of overdose.
Adverse reactions
Gastrointestinal disorders:
uncommon: gastrointestinal disorders;
Rare: slight bleeding of the gums.
Respiratory, thoracic and mediastinal disorders:
Rare: mild nosebleeds.
Skin and subcutaneous tissue disorders/immune system disorders:
Rare: hypersensitivity reactions.
Hepatobiliary system disorders:
Very rare: increased liver function tests. A causal relationship between the increase in these tests and the use of the drug has not been demonstrated.
Expiration date
5 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Does not require special storage conditions.
Packaging
15 tablets in a blister. 1 or 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Dr. Wilmar Schwabe GmbH & Co. KG.
Location of the manufacturer and address of its place of business
Wilmar-Schwabe-Strasse, 4,
76227 Karlsruhe, Germany.
