Bilagis tablets 20 mg 30 pcs.

• active ingredient: bilastine;
• 1 tablet contains bilastine 20 mg;
• Excipients: microcrystalline cellulose, sodium starch glycolate (type A), colloidal anhydrous silicon dioxide, magnesium stearate.

Hypersensitivity to the active substance or to any of the excipients.

Patients receiving bilastine at a dose of 20 mg for the indication allergic rhinoconjunctivitis or chronic idiopathic urticaria most frequently reported the following adverse reactions: headache, drowsiness, dizziness and fatigue.

Adults and children (12 years of age and older): 20 mg bilastine (1 tablet) once daily for the relief of symptoms of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria.

The tablet should be taken 1 hour before or 2 hours after a meal or fruit juice.

For oral use.

The tablets should be taken with water. The daily dose is recommended to be taken in one go.

Use during pregnancy or breastfeeding

There are no or limited amount of data from the use of bilastine in pregnant women.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive function, parturition or postnatal development. For safety reasons, it is preferable to avoid taking Bilagis during pregnancy.

Studies on the excretion of bilastine into human milk have not been conducted. Available pharmacokinetic data have shown that bilastine is excreted in human milk in animals. A decision on whether to continue/discontinue breast-feeding or to discontinue/abstain from Bilagis therapy should be made taking into account the benefit of breast-feeding for the child and the benefit of bilastine therapy for the mother.

Children

The safety and effectiveness of bilastine in children under 12 years of age have not been confirmed.

Ability to influence reaction speed when driving vehicles or other mechanisms

A study of the effect of bilastine on the ability to drive showed that in adults, treatment with bilastine at a dose of 20 mg did not affect the ability to drive. However, patients should be informed that in isolated cases the drug may cause drowsiness and thus affect the ability to drive or operate machinery.

Information on acute overdose with bilastine has been obtained from clinical trials conducted during development and post-marketing surveillance. In clinical trials, after administration of bilastine to 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.

In a thorough crossover study of QT/QTc intervals in 30 healthy adult volunteers, a critical assessment of the effects of multiple doses of bilastine (100 mg × 4 days) on ventricular repolarization revealed no significant prolongation of the QTc interval.

In case of overdose, symptomatic and supportive treatment is recommended.

The specific antidote to bilastine is unknown.

Interaction with food. Food reduces the bioavailability of orally administered bilastine by 30%.

Interaction with grapefruit juice. When bilastine 20 mg was co-administered with grapefruit juice, the bioavailability of bilastine was reduced by 30%. A similar effect may also be observed with other fruit juices. The extent of the reduction in bioavailability may vary depending on the juice manufacturer and the fruit. The mechanism of this interaction is inhibition of the transporter protein OATP1A2, for which bilastine is a substrate. Medicinal products that are substrates or inhibitors of OATP1A2, such as ritonavir or rifampicin, may also reduce the plasma concentration of bilastine.

Interaction with ketoconazole or erythromycin. When bilastine was co-administered with ketoconazole or erythromycin, the AUC of bilastine was doubled and the Cmax was increased 2-3-fold. Such changes can be explained by interactions at the level of transport proteins responsible for drug efflux from intestinal cells, since bilastine is a substrate for P-glycoprotein and is not metabolized. The safety profile of bilastine, on the one hand, and ketoconazole or erythromycin, on the other hand, is probably not affected by these changes. Other drugs that are substrates or inhibitors of P-gp, such as cyclosporine, may also increase the plasma concentration of bilastine.

Store in original packaging. No special storage conditions required. Keep out of reach of children.