Attributes
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- Dosage mg
- Pack
- Description en
- Instructions for use Lucamont™ Plus film-coated tablets Lucamont™ Plus International Nonproprietary Name: Desloratadine, Montelukast Composition Each film-coated tablet contains: Active substance: Desloratadine 5 mg, Montelukast 10 mg (in the form of 10.4 mg of montelukast sodium). Excipients: Microcrystalline cellulose (PH112), Hydroxypropyl cellulose, Lactose monohydrate, Croscarmellose sodium, Magnesium stearate, Pregelatinized starch, Calcium hydrogen phosphate dihydrate, Microcrystalline cellulose (PH102), Crospovidone type A, Opadry II Pink 85F240126 (Polyvinyl alcohol, Titanium dioxide, Macrogol, Talc, FD&C Red #40/Allura Red AC Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, FD&C Blue #2/Indigotine Aluminum Lake). Description Pink, oblong, biconvex, film-coated tablets without a score line. Pharmacotherapeutic group Combination of histamine H1-receptor blockers and leukotriene receptor antagonists. ATC code: R03DC53 Pharmacological properties Pharmacodynamics Desloratadine Desloratadine is a long-acting histamine H1 receptor antagonist. It does not have a sedative effect. After oral administration, it does not affect the central nervous system. Montelukast Cysteinyl leukotrienes (LTC4, LTD4, LTE4) are potent inflammatory eicosanoids released from various cells, including mast cells and eosinophils. These eicosanoids bind to cysteinyl leukotriene receptors (CysLT) in the human airways. Airway edema, bronchospasm of the smooth muscles of the bronchi, associated with inflammatory changes in cellular activity in the pathophysiology of bronchial asthma, are caused by the binding of cysteinyl leukotrienes to leukotriene receptors. Montelukast is an active compound that binds to CysLT1 receptors with high affinity and specificity. Montelukast strongly inhibits the physiological action of LTD4 on CysLT1 receptors and does not exhibit any agonist activity. Pharmacokinetics After oral administration of Lucamont™ Plus tablets, the maximum plasma concentration (Cmax) is reached within 3 hours. The degree of absorption and bioavailability of Lucamont™ Plus is the same as when desloratadine and montelukast are administered as separate tablets. Desloratadine Absorption: Desloratadine is well absorbed, and its maximum plasma concentration is reached approximately 3 hours after administration. Water intake does not affect the bioavailability of desloratadine. Distribution: Plasma protein binding is 83-87%. Biotransformation: Desloratadine is metabolized in the liver. Elimination: The half-life is 27 hours. Approximately 87% of 14C-desloratadine is excreted in feces and urine as various metabolites. Montelukast Absorption: Montelukast is rapidly absorbed after oral administration. In adults, the maximum plasma concentration (Cmax) of 10 mg film-coated tablets is reached 3 hours after administration on an empty stomach (Tmax). The average oral bioavailability is 64%. A standard breakfast does not affect bioavailability and Cmax. Bioavailability is 73% when taken on an empty stomach and 63% after a standard breakfast. Distribution: More than 99% of montelukast is bound to plasma proteins. The steady-state volume of distribution of montelukast averages 8-11 liters. Biotransformation: Montelukast is extensively metabolized in the liver. In studies with therapeutic doses, the concentrations of montelukast metabolites in plasma of adults and children at steady state are not determined. Elimination: The clearance of montelukast averages 45 ml/min. Montelukast and its metabolites are primarily excreted with bile. Indications Relief and treatment of symptoms of allergic rhinitis and bronchial asthma. Contraindications Hypersensitivity to the active substances or any of the excipients. Special warnings Safety and efficacy in children under 15 years of age have not been established. In case of severe renal insufficiency, the drug should be administered with caution and dose adjustment. The efficacy of montelukast/desloratadine in the treatment of asthma attacks has not been established. Therefore, it is not recommended to use the drug during asthma attacks; the patient should carry appropriate medication. Although the dose of inhaled corticosteroids is gradually reduced under medical supervision when used concomitantly, it is not recommended to start taking Lucamont™ Plus immediately after discontinuing oral and inhaled corticosteroids. Patients with aspirin-sensitive asthma should not take aspirin and other non-steroidal anti-inflammatory drugs while taking Lucamont™ Plus. Pharmacological studies have shown that concomitant administration of desloratadine tablets with alcohol does not potentiate the negative effects of alcohol. In rare cases, desloratadine, one of the active components of Lucamont™ Plus, can cause drowsiness and affect the ability to drive and operate other machinery. Eosinophilia In rare cases, patients treated with montelukast may develop systemic eosinophilia with vasculitic manifestations and Churg-Strauss syndrome, which is associated with the use of systemic glucocorticosteroids. Such side reactions are usually caused by a reduction in the dose of glucocorticosteroids. The physician should consider the risk of developing eosinophilia and rash, worsening of pulmonary symptoms, cardiac complications, and/or neuropathy. During treatment with Lucamont™ Plus, it is recommended to reduce the dose of systemic glucocorticosteroids with caution and monitor the clinical condition of patients. There are reports of psychoneurological disorders in adults, adolescents, and children during the intake of montelukast/desloratadine. Post-marketing studies have reported side effects such as anxiety, aggression or hostility, depression, disorientation, unusual dreams, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thoughts and behavior (including suicide attempts), tremor. The physician can discuss these side effects with patients or their relatives and explain the need to consult a doctor if such symptoms occur. In such cases, the physician should assess the risk-benefit ratio when treating with Lucamont™ Plus tablets. Sodium Each tablet of Lucamont™ Plus contains less than 1 mmol (23 mg) of sodium, so sodium-related side effects are unlikely to develop. Lactose Lucamont™ Plus contains lactose. The drug should not be prescribed to patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. The dye Sunset Yellow, which is part of the film coating of Lucamont™ Plus tablets, may cause allergic reactions. Interactions with other medicinal products Interactions with desloratadine Clinical studies to identify interactions of desloratadine with ketoconazole, erythromycin, azithromycin, fluoxetine, and cimetidine did not reveal clinically significant changes in its plasma concentration. Food and grapefruit do not interact with desloratadine. Desloratadine does not potentiate the negative effects of alcohol. Interactions with montelukast Montelukast can be administered with other medicinal products commonly used for the prophylaxis and long-term treatment of bronchial asthma. In clinical interaction studies, the recommended dose of montelukast did not have a clinically significant effect on theophylline, prednisone, prednisolone, oral contraceptives (ethinylestradiol/norethindrone 35/1), terfenadine, digoxin, and warfarin. Phenobarbital, phenytoin, and rifampicin should be used with caution with montelukast, especially in children. Dose adjustment of montelukast is not required when administered concomitantly with gemfibrozil. Clinically significant interactions with other CYP2C8 inhibitors (e.g., trimethoprim) are not expected. Concomitant use with itraconazole does not cause a clinically significant increase in the systemic effect of montelukast. Use during pregnancy and lactation Information on the use of Lucamont™ Plus in pregnant women is insufficient. During pregnancy, Lucamont™ Plus should be taken only when strictly necessary. It is not known whether Lucamont™ Plus is excreted in breast milk. If the drug is necessary during lactation, breastfeeding should be discontinued. Effect on the ability to drive and operate other potentially dangerous machinery There is no information on the effect of the drug on the ability to drive vehicles and operate other machinery, but the possibility of side effects such as drowsiness and dizziness should be considered when taking the drug. Method of administration and dosage Lucamont™ Plus tablets are taken orally, with water, independently of food intake. The recommended dose for adults and adolescents aged 15 years and older is 1 tablet per day (desloratadine 5 mg, montelukast 10 mg). Patients taking desloratadine and montelukast tablets separately can take Lucamont™ Plus for greater convenience at the same dosages of these medicinal products. Lucamont™ Plus can be used for intermittent allergic rhinitis (i.e., when symptoms are present less than 4 days per week or less than 4 weeks per year). If symptoms disappear, treatment can be discontinued, and if they reappear, the drug can be taken again. For patients with persistent allergic rhinitis (i.e., when symptoms are present 4 days or more per week or more than 4 weeks per year) with allergen exposure, long-term use of the drug is recommended. The therapeutic effect of Lucamont™ Plus in the treatment of allergic rhinitis and bronchial asthma develops within the first day. It is recommended to use Lucamont™ Plus in case of allergen exposure. Additional information regarding special groups of patients Renal/hepatic insufficiency In patients with mild to moderate hepatic and renal insufficiency, it is recommended to take the initial daily dose of desloratadine 5 mg every other day. In case of severe renal insufficiency, the drug is administered with caution and dose adjustment is required. Degree of renal insufficiency Creatinine clearance (ml/min) Dosage regimen Mild 50-79 ml/min 5 mg desloratadine every other day Moderate 30-49 ml/min 5 mg desloratadine every other day Severe Less than 30 ml/min Use with caution, with a dose adjusted by a physician. There is no information regarding the use of the drug in severe hepatic insufficiency (Child-Pugh classification > 9 points). Pediatric patients Safety and efficacy of Lucamont™ Plus in children under 15 years of age are not available. Therefore, administration of the drug in this group of patients is not recommended. Elderly patients The safety and efficacy of desloratadine, one of the active components of Lucamont™ Plus, have not been established. Therefore, administration of the drug in elderly patients is not recommended. Administration of Lucamont™ Plus in combination with other drugs for the treatment of bronchial asthma is possible as an addition to the treatment of patients. Dose reduction in concomitant use Treatment with bronchodilators: Lucamont™ Plus tablets can be added to patients when adequate control of bronchial asthma symptoms is not achieved with bronchodilators alone. Upon achieving a therapeutic effect (usually after the first dose), the dose of bronchodilators is reduced to the minimum effective dose. Inhaled corticosteroids (ICS): Lucamont™ Plus provides an additional clinical effect in patients with asthma who use inhaled ICS. The dose of corticosteroids can be reduced to the minimum effective dose. The dose of ICS should be reduced gradually, under medical supervision. In some patients, the dose of inhaled ICS can be gradually and completely reduced, while in others, inhaled ICS cannot be completely replaced by Lucamont™ Plus tablets at once. Side effects Desloratadine Frequency of adverse reactions: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10000 to <1/1000); Very rare (<1/10000); Unknown frequency (cannot be estimated based on available data). General disorders and administration site reactions Very common: Fatigue, headache; Very rare: Hypersensitivity reactions (anaphylaxis, angioedema, dyspnea, pruritus, rash, edema). Nervous system disorders Very common: Dry mouth. Very rare: Dizziness, drowsiness, insomnia, psychomotor agitation, convulsions. Psychiatric disorders Very rare: Hallucinations. Cardiovascular system disorders Very rare: Tachycardia, palpitations. Gastrointestinal system disorders Very rare: Abdominal pain, nausea, vomiting, dyspepsia, diarrhea. Hepatobiliary system disorders Very rare: Increased activity of liver enzymes and bilirubin levels, hepatitis. Musculoskeletal and connective tissue disorders Very rare: Myalgia. Montelukast Montelukast is well tolerated. Mainly moderate side reactions are observed, which require discontinuation of treatment. Frequency of adverse reactions: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10000 to <1/1000); Very rare (<1/10000); Unknown frequency (cannot be estimated based on available data). Patients with asthma aged 15 years and older Nervous system disorders Common: Drowsiness, fatigue. Respiratory, thoracic and mediastinal disorders Common: Cough, nasal congestion, upper respiratory tract infections. Gastrointestinal system disorders Common: Abdominal pain, dyspepsia, toothache, gastroenteritis. Skin and subcutaneous tissue disorders Common: Rash. Musculoskeletal and connective tissue disorders Common: Muscle weakness. General disorders and administration site reactions Common: Hyperthermia, flu-like symptoms, trauma. Patients with seasonal allergic rhinitis aged 15 years and older Respiratory, thoracic and mediastinal disorders Common: Upper respiratory tract infections. General disorders and administration site reactions Common: Epistaxis. Investigations Common: Increased ALT activity. The frequency of drowsiness is comparable to placebo. Post-marketing studies: Hypersensitivity reactions (anaphylaxis, angioedema, rash, pruritus, urticaria, rarely - eosinophilic infiltration of the liver), sleep disturbances, hallucinations, behavioral disorders, drowsiness, psychomotor agitation (including nervousness, anxiety, aggression, restlessness, tremor), depression, insomnia, paresthesia/hypoesthesia, very rarely - convulsions, arthralgia, myalgia, including muscle spasms; increased bleeding tendency, palpitations, vomiting, dyspepsia, diarrhea, pancreatitis. Cholestatic hepatitis, hepatocellular and mixed liver damage are rarely observed during montelukast administration. These side reactions are mainly observed in conjunction with other factors, e.g., concomitant use with other drugs, alcoholic liver damage, and hepatitis. Very rarely, patients with asthma may develop eosinophilia with vasculitic manifestations and Churg-Strauss syndrome associated with the use of systemic glucocorticosteroids. Reporting of suspected adverse reactions Reporting of suspected adverse reactions after drug registration is important. This allows for continuous monitoring of the benefit-risk balance of the drug. Consult your doctor if adverse effects occur. Overdose There are no known cases of overdose of Lucamont™ Plus. Desloratadine: Symptoms of overdose: Drowsiness, increased heart rate, QT interval prolongation, hallucinations, lethargy. Symptomatic supportive therapy is required. Desloratadine is not removed from the body by hemodialysis. It is unknown whether the drug is removed by peritoneal dialysis. Montelukast: In case of overdose in adults and children, abdominal pain, drowsiness, thirst, headache, vomiting, psychomotor hyperactivity are most commonly observed. It is unknown whether montelukast is removed by peritoneal dialysis. Dosage form Lucamont™ Plus 5/10 mg film-coated tablets in blister packs. 3 blisters (30 film-coated tablets) are placed in a cardboard box along with the instructions for use. Storage conditions The drug should be stored at a temperature not exceeding 25°C, out of reach of children, in the original packaging. Shelf life 2 years. Do not use after the expiry date. Conditions of dispensing from pharmacies Pharmaceutical product group II, dispensed by prescription form N3. Trademark license holder Asfarma Manufacturer Pharmactive İlaç San. ve Tic. A.Ş. Karaağaç Mahallesi, Fatih Bulvarı #32 Çerkezköy Organize Sanayi Bölgesi Kapaklı/Tekirdağ/Turkey
- Active
- montelukast+desloratadine
What is it?
Instructions for use Lucamont™ Plus film-coated tablets Lucamont™ Plus International Nonproprietary Name: Desloratadine, Montelukast Composition Each film-coated tablet contains: Active substance: Desloratadine 5 mg, Montelukast 10 mg (in the form of 10.4 mg of montelukast sodium). Excipients: Microcrystalline cellulose (PH112), Hydroxypropyl cellulose, Lactose monohydrate, Croscarmellose sodium, Magnesium stearate, Pregelatinized starch, Calcium hydrogen phosphate dihydrate, Microcrystalline cellulose (PH102), Crospovidone type A, Opadry II Pink 85F240126 (Polyvinyl alcohol, Titanium dioxide, Macrogol, Talc, FD&C Red #40/Allura Red AC Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, FD&C Blue #2/Indigotine Aluminum Lake). Description Pink, oblong, biconvex, film-coated tablets without a score line. Pharmacotherapeutic group Combination of histamine H1-receptor blockers and leukotriene receptor antagonists. ATC code: R03DC53 Pharmacological properties Pharmacodynamics Desloratadine Desloratadine is a long-acting histamine H1 receptor antagonist. It does not have a sedative effect. After oral administration, it does not affect the central nervous system. Montelukast Cysteinyl leukotrienes (LTC4, LTD4, LTE4) are potent inflammatory eicosanoids released from various cells, including mast cells and eosinophils. These eicosanoids bind to cysteinyl leukotriene receptors (CysLT) in the human airways. Airway edema, bronchospasm of the smooth muscles of the bronchi, associated with inflammatory changes in cellular activity in the pathophysiology of bronchial asthma, are caused by the binding of cysteinyl leukotrienes to leukotriene receptors. Montelukast is an active compound that binds to CysLT1 receptors with high affinity and specificity. Montelukast strongly inhibits the physiological action of LTD4 on CysLT1 receptors and does not exhibit any agonist activity. Pharmacokinetics After oral administration of Lucamont™ Plus tablets, the maximum plasma concentration (Cmax) is reached within 3 hours. The degree of absorption and bioavailability of Lucamont™ Plus is the same as when desloratadine and montelukast are administered as separate tablets. Desloratadine Absorption: Desloratadine is well absorbed, and its maximum plasma concentration is reached approximately 3 hours after administration. Water intake does not affect the bioavailability of desloratadine. Distribution: Plasma protein binding is 83-87%. Biotransformation: Desloratadine is metabolized in the liver. Elimination: The half-life is 27 hours. Approximately 87% of 14C-desloratadine is excreted in feces and urine as various metabolites. Montelukast Absorption: Montelukast is rapidly absorbed after oral administration. In adults, the maximum plasma concentration (Cmax) of 10 mg film-coated tablets is reached 3 hours after administration on an empty stomach (Tmax). The average oral bioavailability is 64%. A standard breakfast does not affect bioavailability and Cmax. Bioavailability is 73% when taken on an empty stomach and 63% after a standard breakfast. Distribution: More than 99% of montelukast is bound to plasma proteins. The steady-state volume of distribution of montelukast averages 8-11 liters. Biotransformation: Montelukast is extensively metabolized in the liver. In studies with therapeutic doses, the concentrations of montelukast metabolites in plasma of adults and children at steady state are not determined. Elimination: The clearance of montelukast averages 45 ml/min. Montelukast and its metabolites are primarily excreted with bile. Indications Relief and treatment of symptoms of allergic rhinitis and bronchial asthma. Contraindications Hypersensitivity to the active substances or any of the excipients. Special warnings Safety and efficacy in children under 15 years of age have not been established. In case of severe renal insufficiency, the drug should be administered with caution and dose adjustment. The efficacy of montelukast/desloratadine in the treatment of asthma attacks has not been established. Therefore, it is not recommended to use the drug during asthma attacks; the patient should carry appropriate medication. Although the dose of inhaled corticosteroids is gradually reduced under medical supervision when used concomitantly, it is not recommended to start taking Lucamont™ Plus immediately after discontinuing oral and inhaled corticosteroids. Patients with aspirin-sensitive asthma should not take aspirin and other non-steroidal anti-inflammatory drugs while taking Lucamont™ Plus. Pharmacological studies have shown that concomitant administration of desloratadine tablets with alcohol does not potentiate the negative effects of alcohol. In rare cases, desloratadine, one of the active components of Lucamont™ Plus, can cause drowsiness and affect the ability to drive and operate other machinery. Eosinophilia In rare cases, patients treated with montelukast may develop systemic eosinophilia with vasculitic manifestations and Churg-Strauss syndrome, which is associated with the use of systemic glucocorticosteroids. Such side reactions are usually caused by a reduction in the dose of glucocorticosteroids. The physician should consider the risk of developing eosinophilia and rash, worsening of pulmonary symptoms, cardiac complications, and/or neuropathy. During treatment with Lucamont™ Plus, it is recommended to reduce the dose of systemic glucocorticosteroids with caution and monitor the clinical condition of patients. There are reports of psychoneurological disorders in adults, adolescents, and children during the intake of montelukast/desloratadine. Post-marketing studies have reported side effects such as anxiety, aggression or hostility, depression, disorientation, unusual dreams, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thoughts and behavior (including suicide attempts), tremor. The physician can discuss these side effects with patients or their relatives and explain the need to consult a doctor if such symptoms occur. In such cases, the physician should assess the risk-benefit ratio when treating with Lucamont™ Plus tablets. Sodium Each tablet of Lucamont™ Plus contains less than 1 mmol (23 mg) of sodium, so sodium-related side effects are unlikely to develop. Lactose Lucamont™ Plus contains lactose. The drug should not be prescribed to patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. The dye Sunset Yellow, which is part of the film coating of Lucamont™ Plus tablets, may cause allergic reactions. Interactions with other medicinal products Interactions with desloratadine Clinical studies to identify interactions of desloratadine with ketoconazole, erythromycin, azithromycin, fluoxetine, and cimetidine did not reveal clinically significant changes in its plasma concentration. Food and grapefruit do not interact with desloratadine. Desloratadine does not potentiate the negative effects of alcohol. Interactions with montelukast Montelukast can be administered with other medicinal products commonly used for the prophylaxis and long-term treatment of bronchial asthma. In clinical interaction studies, the recommended dose of montelukast did not have a clinically significant effect on theophylline, prednisone, prednisolone, oral contraceptives (ethinylestradiol/norethindrone 35/1), terfenadine, digoxin, and warfarin. Phenobarbital, phenytoin, and rifampicin should be used with caution with montelukast, especially in children. Dose adjustment of montelukast is not required when administered concomitantly with gemfibrozil. Clinically significant interactions with other CYP2C8 inhibitors (e.g., trimethoprim) are not expected. Concomitant use with itraconazole does not cause a clinically significant increase in the systemic effect of montelukast. Use during pregnancy and lactation Information on the use of Lucamont™ Plus in pregnant women is insufficient. During pregnancy, Lucamont™ Plus should be taken only when strictly necessary. It is not known whether Lucamont™ Plus is excreted in breast milk. If the drug is necessary during lactation, breastfeeding should be discontinued. Effect on the ability to drive and operate other potentially dangerous machinery There is no information on the effect of the drug on the ability to drive vehicles and operate other machinery, but the possibility of side effects such as drowsiness and dizziness should be considered when taking the drug. Method of administration and dosage Lucamont™ Plus tablets are taken orally, with water, independently of food intake. The recommended dose for adults and adolescents aged 15 years and older is 1 tablet per day (desloratadine 5 mg, montelukast 10 mg). Patients taking desloratadine and montelukast tablets separately can take Lucamont™ Plus for greater convenience at the same dosages of these medicinal products. Lucamont™ Plus can be used for intermittent allergic rhinitis (i.e., when symptoms are present less than 4 days per week or less than 4 weeks per year). If symptoms disappear, treatment can be discontinued, and if they reappear, the drug can be taken again. For patients with persistent allergic rhinitis (i.e., when symptoms are present 4 days or more per week or more than 4 weeks per year) with allergen exposure, long-term use of the drug is recommended. The therapeutic effect of Lucamont™ Plus in the treatment of allergic rhinitis and bronchial asthma develops within the first day. It is recommended to use Lucamont™ Plus in case of allergen exposure. Additional information regarding special groups of patients Renal/hepatic insufficiency In patients with mild to moderate hepatic and renal insufficiency, it is recommended to take the initial daily dose of desloratadine 5 mg every other day. In case of severe renal insufficiency, the drug is administered with caution and dose adjustment is required. Degree of renal insufficiency Creatinine clearance (ml/min) Dosage regimen Mild 50-79 ml/min 5 mg desloratadine every other day Moderate 30-49 ml/min 5 mg desloratadine every other day Severe Less than 30 ml/min Use with caution, with a dose adjusted by a physician. There is no information regarding the use of the drug in severe hepatic insufficiency (Child-Pugh classification > 9 points). Pediatric patients Safety and efficacy of Lucamont™ Plus in children under 15 years of age are not available. Therefore, administration of the drug in this group of patients is not recommended. Elderly patients The safety and efficacy of desloratadine, one of the active components of Lucamont™ Plus, have not been established. Therefore, administration of the drug in elderly patients is not recommended. Administration of Lucamont™ Plus in combination with other drugs for the treatment of bronchial asthma is possible as an addition to the treatment of patients. Dose reduction in concomitant use Treatment with bronchodilators: Lucamont™ Plus tablets can be added to patients when adequate control of bronchial asthma symptoms is not achieved with bronchodilators alone. Upon achieving a therapeutic effect (usually after the first dose), the dose of bronchodilators is reduced to the minimum effective dose. Inhaled corticosteroids (ICS): Lucamont™ Plus provides an additional clinical effect in patients with asthma who use inhaled ICS. The dose of corticosteroids can be reduced to the minimum effective dose. The dose of ICS should be reduced gradually, under medical supervision. In some patients, the dose of inhaled ICS can be gradually and completely reduced, while in others, inhaled ICS cannot be completely replaced by Lucamont™ Plus tablets at once. Side effects Desloratadine Frequency of adverse reactions: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10000 to <1/1000); Very rare (<1/10000); Unknown frequency (cannot be estimated based on available data). General disorders and administration site reactions Very common: Fatigue, headache; Very rare: Hypersensitivity reactions (anaphylaxis, angioedema, dyspnea, pruritus, rash, edema). Nervous system disorders Very common: Dry mouth. Very rare: Dizziness, drowsiness, insomnia, psychomotor agitation, convulsions. Psychiatric disorders Very rare: Hallucinations. Cardiovascular system disorders Very rare: Tachycardia, palpitations. Gastrointestinal system disorders Very rare: Abdominal pain, nausea, vomiting, dyspepsia, diarrhea. Hepatobiliary system disorders Very rare: Increased activity of liver enzymes and bilirubin levels, hepatitis. Musculoskeletal and connective tissue disorders Very rare: Myalgia. Montelukast Montelukast is well tolerated. Mainly moderate side reactions are observed, which require discontinuation of treatment. Frequency of adverse reactions: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10000 to <1/1000); Very rare (<1/10000); Unknown frequency (cannot be estimated based on available data). Patients with asthma aged 15 years and older Nervous system disorders Common: Drowsiness, fatigue. Respiratory, thoracic and mediastinal disorders Common: Cough, nasal congestion, upper respiratory tract infections. Gastrointestinal system disorders Common: Abdominal pain, dyspepsia, toothache, gastroenteritis. Skin and subcutaneous tissue disorders Common: Rash. Musculoskeletal and connective tissue disorders Common: Muscle weakness. General disorders and administration site reactions Common: Hyperthermia, flu-like symptoms, trauma. Patients with seasonal allergic rhinitis aged 15 years and older Respiratory, thoracic and mediastinal disorders Common: Upper respiratory tract infections. General disorders and administration site reactions Common: Epistaxis. Investigations Common: Increased ALT activity. The frequency of drowsiness is comparable to placebo. Post-marketing studies: Hypersensitivity reactions (anaphylaxis, angioedema, rash, pruritus, urticaria, rarely - eosinophilic infiltration of the liver), sleep disturbances, hallucinations, behavioral disorders, drowsiness, psychomotor agitation (including nervousness, anxiety, aggression, restlessness, tremor), depression, insomnia, paresthesia/hypoesthesia, very rarely - convulsions, arthralgia, myalgia, including muscle spasms; increased bleeding tendency, palpitations, vomiting, dyspepsia, diarrhea, pancreatitis. Cholestatic hepatitis, hepatocellular and mixed liver damage are rarely observed during montelukast administration. These side reactions are mainly observed in conjunction with other factors, e.g., concomitant use with other drugs, alcoholic liver damage, and hepatitis. Very rarely, patients with asthma may develop eosinophilia with vasculitic manifestations and Churg-Strauss syndrome associated with the use of systemic glucocorticosteroids. Reporting of suspected adverse reactions Reporting of suspected adverse reactions after drug registration is important. This allows for continuous monitoring of the benefit-risk balance of the drug. Consult your doctor if adverse effects occur. Overdose There are no known cases of overdose of Lucamont™ Plus. Desloratadine: Symptoms of overdose: Drowsiness, increased heart rate, QT interval prolongation, hallucinations, lethargy. Symptomatic supportive therapy is required. Desloratadine is not removed from the body by hemodialysis. It is unknown whether the drug is removed by peritoneal dialysis. Montelukast: In case of overdose in adults and children, abdominal pain, drowsiness, thirst, headache, vomiting, psychomotor hyperactivity are most commonly observed. It is unknown whether montelukast is removed by peritoneal dialysis. Dosage form Lucamont™ Plus 5/10 mg film-coated tablets in blister packs. 3 blisters (30 film-coated tablets) are placed in a cardboard box along with the instructions for use. Storage conditions The drug should be stored at a temperature not exceeding 25°C, out of reach of children, in the original packaging. Shelf life 2 years. Do not use after the expiry date. Conditions of dispensing from pharmacies Pharmaceutical product group II, dispensed by prescription form N3. Trademark license holder Asfarma Manufacturer Pharmactive İlaç San. ve Tic. A.Ş. Karaağaç Mahallesi, Fatih Bulvarı #32 Çerkezköy Organize Sanayi Bölgesi Kapaklı/Tekirdağ/Turkey