Description
Description
Oval biconvex tablets coated with a film membrane of white or almost white color, on the one hand smooth, on the other side engraving “R 5”. In the cross section, the core is from white to almost white.
Release form
Film-coated tablets.
Indications
Allerway, film-coated tablets, 5 mg shown in adults and children 6 years and older with:
treatment of symptoms of allergic rhinitis, including year-round (persistent) and seasonal (intermittent) allergic rhinitis, and allergic conjunctivitis, like itching, sneezing, nasal congestion, rhinorrhea, lacrimation, conjunctival hyperemia
hay fever (hay fever)
urticaria
other allergic dermatoses, accompanied by itching and rashes.
Contraindications
Hypersensitivity to the active substance, cetirizine, hydroxyzine, any piperazine derivative or any excipient of the drug.
Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
End-stage renal failure (CC <10 ml / min). Children under 6 years old (due to limited safety and efficacy data). Caution For chronic renal failure (dosage adjustment necessary). In elderly patients (with age-related decrease in glomerular filtration). In patients with spinal cord injury, prostatic hyperplasia, and other predisposing factors for urinary retention, as levocetirizine may increase the risk of urinary retention. When used concomitantly with alcohol (see section “Interaction with other medicinal products”). When prescribed to pregnant women and during breastfeeding. Use during pregnancy and lactation Pregnancy Data on the use of levocetirizine during pregnancy are practically absent or limited (less than 300 pregnancy outcomes). However, the use of cetirizine, a racemate of levocetirizine, during pregnancy (more than 1000 pregnancy outcomes) was not accompanied by malformations and intrauterine and neonatal toxic effects. Animal studies have not revealed a direct or indirect adverse effect on pregnancy, embryonic and fetal development, childbirth and postnatal development. Caution is advised when prescribing levocetirizine to pregnant women. Breastfeeding period Cetirizine, a racemate of levocetirizine, is excreted in breast milk. Therefore, the allocation of levocetirizine with breast milk is also likely. In breast-fed infants, adverse reactions to levocetirizine may occur. Therefore, care must be taken when prescribing levocetirizine during breastfeeding. Fertility No clinical data on levocetirizine. Special instructions Intervals between doses Ami should be selected individually depending on renal function. Caution is advised when used concomitantly with alcohol. Caution should be exercised if patients have predisposing factors for urinary retention (for example, spinal cord injury, prostatic hyperplasia), since levocetirizine may increase the risk of urinary retention. Effect on the ability to drive vehicles and mechanisms Levocetirizine can lead to increased drowsiness, therefore, the drug may affect the ability to drive a car or operate machinery. During the treatment period, it is necessary to refrain from engaging in potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions. Composition of Each film-coated tablet contains: active ingredient: levocetirizine dihydrochloride 5.00 mg excipients: lactose monohydrate 88.00 mg cellulose microcrystalline silicon sulfide 1.6.10 mg srdlp magnesium stearate 1.30 mg film coat: Opadry white OY 58900 (hypromellose (5 cP) 62.5% titanium dioxide (E171) 31.25% macrogol-400 6.25%) 3.25 mg. Dosage and administration The tablet should be taken orally without chewing and drinking with liquid, regardless of food intake. Adults and children 6 years of age and older The daily dose is 5 mg (1 tablet) once. Duration of taking In the treatment of seasonal (intermittent) rhinitis (the presence of symptoms less than 4 days a week or their total duration less than 4 weeks), the duration of treatment depends on the duration of the symptoms, treatment can be stopped when the symptoms disappear and resumed when symptoms appear. In the treatment of perennial (persistent) allergic rhinitis (the presence of symptoms more than 4 days a week and their total duration more than 4 weeks), treatment can continue throughout the entire period of exposure to allergens. The course of treatment for hay fever is set by the doctor. There is clinical experience with the continuous use of levocetirizine in adult patients lasting up to 6 months. If you miss a dose, do not take a double dose, take the next dose at the usual time. Special patient groups Patients with impaired renal function Since levocetirizine is excreted from the body by the kidneys, when using the drug, the dose should be adjusted depending on the degree of renal failure. With a CC value of 50-79 ml / min, dose adjustment is not required, with a CC of 30 to 49 ml / min, the recommended dose is 5 mg (1 tablet) every other day (1 time in 2 days), in patients with severe renal failure (CC less than 30 ml / min) recommended dose of 5 mg (1 tablet) once every 3 days. In patients with end-stage renal failure (CC less than 10 ml / min), the drug is contraindicated. Patients with renal and hepatic insufficiency Dosing is carried out according to the above scheme. Patients with impaired liver function Dose adjustment is not required for isolated impaired liver function. Elderly patients without impaired renal function Dose adjustment is not required. Side effects Clinical trials During clinical trials in men and women 12-71 years old with a frequency of 1% or more (often? 1/100, <1/10), the following side effects were observed: headache, drowsiness, dryness in the mouth, fatigue, infrequently (? 1/1000, < 1/100) there was asthenia and abdominal pain. During clinical trials in children aged 6 years to 12 years with a frequency of 1% or more (often? 1/100, <1/10), headache and drowsiness occurred. Post-registration studies The incidence of side effects is not known (cannot be estimated from the available data). Immune system disorders Hypersensitivity reactions, including anaphylaxis. Metabolic and nutritional disorders Increased appetite. Mental disorders Anxiety, aggression, agitation, depression, hallucinations, insomnia, suicidal thoughts. Violations of the nervous system Seizures, thrombosis of the sinuses of the dura mater, paresthesia, dizziness, fainting, tremor, dysgeusia. Hearing disorders and labyrinth disorders Vertigo Visual disturbances Impaired vision, blurred visual perception, inflammatory manifestations. Disorders of the cardiovascular system Angina pectoris, tachycardia, palpitations, jugular vein thrombosis. Disorders of the respiratory system Dyspnea, increased symptoms of rhinitis. Disorders of the gastrointestinal tract Nausea, vomiting, diarrhea. Disorders of the liver and biliary tract Hepatitis, a change in functional liver samples. Disorders of the kidneys and urinary system Dysuria, urinary retention. Disorders of the skin and subcutaneous tissues Angioedema, persistent drug erythema, rash, itching, urticaria, hypotrichosis, cracks, photosensitivity. Disorders of the musculoskeletal and connective tissue Muscle pain, arthralgia. General disorders Peripheral edema, weight gain. Miscellaneous Cross-reactivity. If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor. Drug Interactions There has been no study of the interaction of levocetirizine with other drugs. When studying the drug interaction of cetirizine racemate with antipyrine, azithromycin, cimetidine, diazepam, erythromycin, glipizide, ketoconazole, pseudoephedrine and phenazone, no clinically significant adverse interactions were detected. With simultaneous administration with theophylline (400 mg / day), the total clearance of cetirizine decreases by 16% (the kinetics of theophylline does not change). In a study with the simultaneous administration of ritanovir (600 mg 2 times a day) and cetirizine (10 mg per day) it was shown that the exposure of cetirizine increased by 40%, and the exposure of ritonavir slightly changed (-11%). In some cases, with the simultaneous use of levocetirizine with alcohol or drugs that have an overwhelming effect on the central nervous system (CNS), it can cause lethargy and poor performance. Overdose Symptoms: drowsiness (in adults), agitation and anxiety, alternating with drowsiness (in children). Treatment: It is necessary to wash the stomach or take activated charcoal if little time has passed after taking the drug. Symptomatic and supportive therapy is recommended. There is no specific antidote. Hemodialysis is not effective. Storage conditions Do not store above 25 ° C. Keep out of the reach and sight of children! Shelf life 2 years. Deystvuyushtee substance Levocetirizine Conditions of release from drugstores Without prescription tablet dosage form of tablets Appointment Appointment Children older than 6 years, Adult
