? Solution for oral administration in the form of a clear or slightly opalescent liquid from light brown to reddish brown.
liquid extract of the roots of pelargonium sidiform EPs 7630 (1: 8-10) * 80 g
* Extractant: ethanol 11% (w / w).
Excipients: glycerol 85% - 20 g.
20 ml - bottles of dark glass with a dropper (1) - packs of cardboard.
50 ml - bottles of dark glass with a dropper (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
The preparation is of plant origin. Has antimicrobial effect, has mucolytic properties. Promotes increased nonspecific resistance of the body.
The liquid extract of the roots of pelargonium sidovid contains a large number of biologically active substances, which together determine its pharmacological activity. Therefore, the data on the pharmacokinetics of individual chemical components that make up the extract are not sufficient for extrapolation to the preparation as a whole.
- acute and chronic infectious and inflammatory diseases of the respiratory tract and ENT organs (sinusitis, rhinopharyngitis, tonsillitis, bronchitis) - as part of complex therapy.
The drug is taken orally, 30 minutes before a meal with a small amount of liquid.
Adults and children over 12 years of age 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 dispensing the drug, the bottle should be kept upright, if necessary tapping on the bottom of the bottle.
The average duration of treatment is 10 days. After the disappearance of the symptoms of the disease is recommended to continue treatment for several days to prevent relapse.
Estimates of the frequency of adverse reactions are based on the WHO classification: very often - 1/10 appointments (? 10%), often - 1/100 prescriptions (? 1%, but <10%), infrequently 1/1000 appointments (? 0.1% but <1%), rarely - 1/10 000 prescriptions (? 0.01%, but <0.1%), very rarely - less than 1/10 000 prescriptions (<0.01%).
From the respiratory system: rarely - nosebleeds.
On the part of the digestive system: infrequently - nausea, vomiting, pain in the epigastric region, diarrhea; rarely - slight bleeding gums.
From the hepatobiliary system: the frequency is unknown - signs of impaired liver function (yellowing of the skin, yellowing of the sclera of the eyes); the association of this manifestation with the use of the drug is not confirmed.
Other: rarely allergic reactions.
- predisposition to bleeding;
hepatic failure of severe degree;
- severe renal failure;
- Children's age under 1 year (due to the presence of ethyl alcohol in the preparation);
- simultaneous use of anticoagulants;
- Hypersensitivity to the components of the drug.
With caution should apply the drug with alcoholism, craniocerebral trauma, brain diseases, impaired liver and kidney function (no experience of use), in children older than 1 year.
PREGNANCY AND LACTATION
Due to the lack of sufficient research data to date, the drug is not recommended for use during pregnancy and during breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in severe renal failure.
Caution should be applied to the drug in case of impaired renal function (no experience of use).
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in severe hepatic failure.
Caution should be applied to the drug in violation of liver function (no experience of use).
APPLICATION FOR CHILDREN
Contraindicated in children under 1 year (due to the presence of ethyl alcohol in the preparation).
Caution should be used in children older than 1 year.
During storage, liquid plant extracts tend to become cloudy, however, this does not affect their pharmacological efficacy. Since Umkalor is a natural product, slight changes in color and taste of the preparation are possible.
In connection with the ethanol content (12% / vol) in the preparation, 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, the maximum daily dose for children over 12 years and adults contains 0.375 g of absolute ethyl alcohol. A single dose for children under the age of 12 years contains less than 0.1 g of absolute ethyl alcohol.
In the absence of a therapeutic effect on the background of the use of the drug for 7 days, while maintaining an elevated body temperature for several days, the appearance of dyspnea or bloody sputum, the appearance of signs of impaired liver function (such as yellowing of the skin, yellowing of the sclera of the eyes), the patient should consult a doctor .
Impact on the ability to drive vehicles and manage mechanisms
When using the drug should be careful when dealing with potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions (including vehicle management, work with moving mechanisms).
Umkalor was not reported at the time of overdose. The drug is well tolerated.
With the simultaneous use of Umkalor with anticoagulants (including coumarin derivatives), it is possible to increase their anticoagulant effect and bleeding (bleeding from the nose, bleeding gums).
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 2 years. After opening the vial, it should not be stored for more than 6 months.