Bilastine Teva tablets 20 mg blister 10 pcs.

• active ingredient: bilastine;
• 1 tablet contains bilastine 20 mg;
• excipients: mannitol (E 421), microcrystalline cellulose, sodium starch glycolate (type A), magnesium aluminometasilicate, magnesium stearate, colloidal anhydrous silicon dioxide.

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

Nervous system disorders – drowsiness, headache, dizziness.

Gastrointestinal disorders – upper abdominal pain, abdominal pain, nausea, abdominal discomfort.

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 food or fruit juice (see section “Interaction with other medicinal products and other types of interactions”).

For oral use.

The tablets should be taken with water.

Use during pregnancy or breastfeeding

For safety reasons, it is advisable to avoid taking Bilastine-Teva during pregnancy.

A decision on whether to continue/discontinue breastfeeding or to discontinue/abstain from Bilastine therapy should be made taking into account the benefit of breastfeeding for the child and the benefit of bilastine therapy for the mother.

Children

Bilastine-Teva should be used in children over 12 years of age.

Ability to influence reaction speed when driving vehicles or other mechanisms

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 of bilastine was obtained during clinical trials conducted during the development with the participation of adults and 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 per day for 7 days), the incidence of adverse reactions was twice as high as with placebo. The most frequently 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 studies have been conducted only in adults.

Food Interaction: Food significantly reduces the oral bioavailability of bilastine, in particular when taken in the form of 20 mg tablets, the bioavailability of bilastine is reduced 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 manufacturer of the juice and the fruit. The mechanism of this interaction is inhibition of the transporter protein OATP1A2, for which bilastine is a substrate (see section 5.2). 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. In the case of simultaneous administration of 20 mg bilastine once daily and 400 mg ketoconazole once daily or 500 mg erythromycin three times daily, the AUC of bilastine increased by twofold and the Cmax by 2-3fold.

Such changes can be explained by interactions at the level of transport proteins responsible for the excretion of drugs from intestinal cells, since bilastine is a substrate for P-gp and is not metabolized (see section “Pharmacokinetics”). The safety profile of bilastine, on the one hand, and ketoconazole or erythromycin, on the other, 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.

Interaction with diltiazem. When 20 mg bilastine once daily was co-administered with 60 mg diltiazem once daily, the Cmax of bilastine increased by 50%. This effect may be explained by an interaction at the level of transport proteins responsible for the excretion of drugs from intestinal cells, but it is unlikely to affect the safety profile of bilastine.

Interaction with alcohol. After concomitant use of alcohol and 20 mg bilastine once daily, psychomotor functions were similar to those observed after alcohol and placebo.

Interaction with lorazepam. When 20 mg bilastine was administered once daily with 3 mg lorazepam once daily for 8 days, no increase in the CNS depressant effect of lorazepam was observed.

The medicine does not require any special storage conditions. Keep out of the reach of children.