Nixar 10 mg orodispersible tablets 10 mg 30 pcs.

• symptomatic treatment of allergic rhinoconjunctivitis and urticaria.

• 1 orodispersible tablet contains bilastine 10 mg;
• excipients: mannitol, croscarmellose sodium, sodium stearyl fumarate, sucralose (E 955), red grape flavoring (main components: gum arabic, ethyl butyrate, triacetin, methyl anthranilate, ethanol, D-limonene, linalool).

Hypersensitivity to the active substance or to any of the excipients listed in the “Composition” section.

Oral use.

The orodispersible tablet should be placed in the mouth where it will disperse rapidly in saliva and be easily swallowed. Alternatively, the orodispersible tablet may be dispersed in water before use. Grapefruit juice or any other fruit juice should not be used for dispersion.

Dosage.

Pediatric population.

Children aged 6 to 11 years with a body weight of at least 20 kg. 10 mg bilastine (1 orodispersible tablet) once daily for the relief of symptoms of allergic rhinoconjunctivitis (seasonal allergic rhinitis and perennial allergic rhinitis) and urticaria. The orodispersible tablet should be taken 1 hour before or 2 hours after a meal or fruit juice.

Children under 6 years of age with a body weight of up to 20 kg: Bilastine should not be used in this age group.

Adults and adolescents (aged 12 years and over) can use bilastine 20 mg tablets.

Paediatric population: Since the efficacy and safety of bilastine in children under 2 years of age have not been established and there is limited clinical experience in children aged 2 to 5 years, bilastine should not be administered to these age groups.

In patients with moderate or severe renal impairment, concomitant use of bilastine with P-glycoprotein inhibitors, such as ketoconazole, erythromycin, cyclosporine, ritonavir or diltiazem, may lead to increased plasma levels of bilastine and therefore an increased risk of adverse reactions. Therefore, concomitant use of bilastine and P-glycoprotein inhibitors should be avoided in patients with moderate or severe renal impairment.

Pregnant women

For safety reasons, it is advisable to avoid taking Nixar® 10 mg during pregnancy.

Children

Since the efficacy and safety of bilastine in children under 2 years of age have not been established, and clinical experience in children aged 2 to 5 years is limited, bilastine should not be administered to these age groups.

Drivers

A study conducted in adults to assess the effects of bilastine on driving ability demonstrated that treatment with bilastine 20 mg did not affect driving ability. However, as individual response to the drug may vary, patients should be advised to refrain from driving or operating machinery until their own response to bilastine is known.

There are no data on overdose in children.

Information on acute overdose with bilastine was obtained from clinical trials conducted during the development in adults and from post-marketing surveillance. In clinical trials, after administration of bilastine to 26 healthy adult volunteers at doses exceeding the therapeutic dose by 10-11 times (220 mg as a single dose or 200 mg daily for 7 days), the incidence of adverse reactions was twice as high as with placebo. The most commonly reported adverse reactions were dizziness, headache and nausea. There were no reports of serious adverse reactions and no significant prolongation of the QTc interval. The information collected during post-marketing surveillance is consistent with the data obtained during clinical trials.

Infectious and parasitic diseases – rhinitis.

Nervous system disorders – headache, dizziness, loss of consciousness.

Disorders of the organs of vision – allergic conjunctivitis, eye irritation.

Gastrointestinal disorders – abdominal pain/upper abdominal pain, diarrhea, nausea.

Skin and subcutaneous tissue disorders – eczema, urticaria, lip swelling.

No special storage conditions are required.