Bilazin 20

Rx

Indications

Symptomatic treatment of allergic rhino-conjunctivitis (seasonal or perennial) and urticaria.

Dosage

• Adults and adolescents (12 years of age and over): 20 mg (1 tablet) once daily.
• Elderly: No dosage adjustments are required. There is little experience in patients above the age of 65.
• Pediatrics (< 12 years of age): The safety and efficacy have not yet been established.
• Patients with hepatic/renal impairment: No dosage adjustments are required.
• Duration of treatment:
  + Seasonal allergic rhinitis: It could be discontinued after the symptoms have resolved and reinitiated upon their reappearance.
  + Perennial allergic rhinitis: Continued treatment may be proposed to the patients during the allergen exposure periods.
  + Urticaria: The duration of treatment depends on the type, duration and course of the complaints.

Usage

Oral use. The tablet should be taken one hour before or two hours after meal. It is recommended to take the daily dose in one single intake.

Hypersensitivity to bilastine or to any of the excipients.

Common:

• Somnolence, headache.

Uncommon:

• Oral herpes;
• Increased appetite;
• Anxiety, insomnia; tinnitus, vertigo;
• Right bundle branch block, sinus arrhythmia, electrocardiogram QT prolonged, other ECG abnormalities;
• Dizziness; dyspnoea, nasal discomfort, nasal dryness;
• Upper abdominal pain, abdominal pain, nausea, stomach discomfort, diarrhoea, dry mouth, dyspepsia, gastritis;
• Pruritus;
• Fatigue, thirst, improved pre-existing condition, pyrexia, asthenia;
• Increased gamma-glutanyltransferase, alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine increased, blood triglyceride increased, increased weight.

• Efficacy and safety of bilastine in children under 12 years of age have not been established.
• Coadministration of bilastine and P-glycoprotein inhibitors such as ketoconazole, erythromycin, cyclosporine, ritonavir or diltiazem should be avoided in patients with moderate or severe renal impairment since increase in plasmatic levels of bilastine and therefore increase the risk of adverse effects of bilastine.
• Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• As a precautionary measure, it is preferable to avoid the use of bilastine during pregnancy.
• It is unknown whether bilastine is excreted in human breast milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue from bilastine therapy must be made taking into account the benefit of breastfeeding for the child and the benefit of bilastine therapy for the mother.
• Dose of 20 mg did not affect the driving performance. However, there is very rarely some people experience drowsiness, which may affect their ability to drive or use machines.