Composition: One tablet contains: Active ingredients: montelukast sodium (equivalent to montelukast) — 10.0 mg; levocetirizine hydrochloride — 5.0 mg. Excipients: lactose, maize starch, microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, povidone K-30, purified talc, crospovidone, magnesium stearate, colloidal anhydrous silicon. Film coating: Super Coat film (hydroxypropyl methylcellulose, PEG-400, titanium dioxide, purified talc), purified talc, titanium dioxide, isopropyl alcohol, dichloromethane.
Form: Film-coated tablets.
Indications: • Seasonal (intermittent) and perennial (persistent) allergic rhinitis. • Relief of symptoms associated with allergic rhinitis in patients with bronchial asthma: sneezing, nasal discharge, itching, swelling, nasal congestion, itchy eyes, tearing and red eyes, palatal itching and cough. • Allergic conjunctivitis with characteristic symptoms of itching, nasal congestion and sneezing, rhinorrhoea, conjunctival hyperaemia and tearing. • Allergic dermatoses accompanied by itching and rash. • Urticaria, including chronic idiopathic urticaria.
Contraindications: • Hypersensitivity to the active ingredient, other piperazine derivatives or other excipients. • Severe renal impairment with creatinine clearance below 10 ml/min. • Galactose intolerance, Lapp lactase deficiency, glucose and galactose malabsorption syndrome. • Children under 18 years of age. • Pregnancy and breastfeeding.
Dosage: Take 1 tablet orally once daily in the evening. Swallow whole without chewing, during or after meals. The course of treatment is 14 days. Renal impairment: no dose adjustment is required for patients with moderate renal impairment (creatinine clearance >79 ml/min). In patients with moderate and severe renal impairment (creatinine clearance <79 ml/min to >10 ml/min), use with caution and under close medical supervision. Hepatic impairment: no dose adjustment is required.
Side effects: Drowsiness, dry mouth, headache, nausea, abdominal pain, mood changes.
Interactions: Alcohol potentiates sedative effects. Caution with theophylline, phenytoin, rifampicin, NSAIDs.
Warnings: Use with caution in chronic renal impairment (dose-regimen adjustment is required) and in older people (glomerular filtration may be reduced). Caution is required with concomitant alcohol use. This combination of montelukast and levocetirizine is not recommended for treating acute asthma attacks. Appropriate emergency medicines should always be available. During an attack, seek medical attention immediately. The complete special warnings section is available in the attached instruction.
Age restrictions: Contraindicated in children under 18 years of age.
Pregnancy: Contraindicated during pregnancy and breastfeeding.
Country of origin: India
Manufacturer: Synokem Pharmaceuticals
Storage conditions: Store in a dry place protected from light at a temperature below 30°C, away from children.
