Symptomatic treatment of allergic rhinitis and conjunctivitis (seasonal and perennial) and urticaria.
Composition:
1 tabl contains 20 mg of bilastine.
Action:
Antihistamine. Bilastine is a long-acting selective antagonist of peripheral H-receptors1that does not show affinity for muscarinic receptors. It does not have sedative properties. It absorbs quickly, reaches Cmax after about 1.3 hours. Food reduces its bioavailability. It binds to plasma proteins in 84-90%. 95% of the administered dose is excreted unchanged in the urine (28.3%) and faeces (66.5%). T0,5 is 14.5 hours.
Contraindications:
Hypersensitivity to the components of the preparation.
Precautions:
The efficacy and safety of bilastine in children under 12 years have not been established. In patients with moderate or severe renal impairment, bilastine should be avoided concomitantly with P-glycoprotein inhibitors (eg ketoconazole, Erythromycin, cyclosporin, ritonavir, diltiazem).
Pregnancy and lactation:
No tests, avoid using the drug during pregnancy. The decision to continue or stop breastfeeding and to continue or stop the drug therapy should be made after careful consideration of the benefit of the baby resulting from breastfeeding and the benefits for the mother resulting from bilastine treatment.
Side effects:
Common: drowsiness, headache. Uncommon: facial herpes; increased appetite; anxiety, insomnia; tinnitus, dizziness of peripheral origin; right limb block, sinus arrhythmia, QT prolongation in ECG, other ECG abnormalities; dizziness of central origin; dyspnoea; feeling of discomfort in the nose, dryness of the oral mucosa; epigastric pain, abdominal pain, nausea, abdominal discomfort, diarrhea, dry mouth, indigestion, gastritis; itching; fatigue, thirst, worsening of symptoms, increased body temperature, weakness; increased activity of GGT, ALT, AST, creatinine, triglycerides in the blood, weight gain.
Dosage:
Orally. Adults and children over 12 years: 20 mg once a day, 1 hour before or 2 h after a meal or consumption of fruit juice. The duration of treatment of allergic rhinitis should be limited to the period of exposure to allergens. In the case of seasonal rhinitis, treatment may be discontinued after symptoms have resolved and resumed after their recurrence. In all-year allergic rhinitis, treatment can be continued during periods of exposure to allergens.
(C)
