Glencet Advance tablets are used (fixed combination of montelukast and levocetirizine) to reduce symptoms associated with seasonal and perennial allergic rhinitis, as well as rhinitis in patients with bronchial asthma.
One film-coated tablet contains (active ingredients):
montelukast sodium is equivalent to montelukast - 10 mg;
levocetirizine dihydrochloride - 5 mg.
Excipients: lactose monohydrate, microcrystalline cellulose, dibasic calcium phosphate anhydrous, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, yellow opadri 13B52204 (hypromellose, titanium dioxide (E 171), macrogol, yellow iron oxide (E 171), iron oxide red (E 172)).
Hypersensitivity to montelukast sodium, levocetirizine or cetirizine, as well as other components of the preparation. The preparation is also contraindicated in severe renal failure (creatinine clearance <10 ml / minute); with severe hereditary galactose intolerance, lactose enzyme deficiency or impaired absorption of glucose and galactose.
For adults and children over 15 years of age, the recommended dose is one tablet per day, in the evening, regardless of the meal. The tablets are swallowed whole without chewing. The course of treatment is 14 days.
Pregnant
There have been no reliable and well-controlled clinical studies of the use of this medicinal product in pregnant women. Use during pregnancy is contraindicated.
Given that many preparations are excreted in breast milk in women who are breastfeeding, breastfeeding should be discontinued if necessary.
Children
The preparation is used in children over 15 years of age.
Drivers
No studies have been conducted on the effect of a fixed dose combination of montelukast and levocetirizine on the ability to drive or operate machinery. Some patients may feel drowsiness, increased fatigue, and weakness with levocetirizine therapy. Patients should refrain from driving and working with potentially dangerous machinery during treatment with Glencet Advance.
Montelukast
Currently, there are no specific recommendations for the treatment of an overdose of montelukast. Cases of acute overdose with montelukast have been reported during post-marketing surveillance and during clinical trials. These reports include reports of overdose cases in adults and children after using doses as high as 1000 mg. Clinical and laboratory data were consistent with the safety profile for adults and children. In most of the reported cases of overdose, no serious adverse reactions were observed. The most common adverse reactions were consistent with the safety profile of montelukast and included abdominal pain, drowsiness, thirst, headache, vomiting, and psychomotor hyperactivity. It is not known whether montelukast is excreted by peritoneal dialysis or hemodialysis.
Treatment is symptomatic.
Levocetirizine
Cases of overdose with levocetirizine have been reported. Overdose symptoms may include drowsiness in adults, and in children - initially a state of agitation and anxiety, followed by the development of drowsiness. There is no known specific antidote to levocetirizine. In case of overdose, symptomatic or supportive therapy is recommended. Levocetirizine is not excreted during dialysis.
Montelukast
Below are the most common adverse reactions reported in post-marketing surveillance.
Infections and parasitic diseases: very often (≥ 1/10) - upper respiratory tract infection.
From the gastrointestinal tract: often (from ≥ 1/100 to <1/10) - diarrhea, nausea, vomiting.
Hepatobiliary system: often (from ≥ 1/100 to <1/10) - increased serum levels of transaminases (ALT, AST).
On the part of the skin and subcutaneous tissue: often (from ≥ 1/100 to <1/10) - skin rashes.
Levocetirizine
The following adverse reactions have been reported that have been observed in clinical trials:
often (from> 1/100 to <1/10) - headache, drowsiness, dry mouth, increased fatigue;
infrequently (from ≥ 1/1000 to <1/100) - general weakness, abdominal pain.
Store at a temperature not exceeding 30 ° C, in a dry, dark place and out of reach of children.
Shelf life is 2 years.
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