Nixar (bilastine) tablets 20 mg. №10

Description

Nixar composition
active substance: bilastine;
1 tablet contains bilastine 20 mg;
Excipients: microcrystalline cellulose, sodium starch glycolate (type A), colloidal anhydrous silica, magnesium stearate.

Dosage form
Tablets.

Pharmacological properties
Bilastin is a long-acting non-sedative antagonist of histamine, a highly selective peripheral H1 receptor blocker that does not bind to muscarinic receptors.
After a single application of bilastine for 24 hours inhibits the development of histamine-induced skin reactions, manifested by blisters and redness.

Indication
Symptomatic treatment of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria.

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

Children
The safety and efficacy of bilastine in children under 12 years of age have not been established.

Use during pregnancy or breastfeeding
There are no or limited 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 advisable to avoid taking Nixar during pregnancy.
Studies on the excretion of bilastine in human breast milk have not been performed. Available pharmacokinetic data have shown that in animals bilastine passes into breast milk. The decision to continue / discontinue breast-feeding or to discontinue / abstain from Nixar therapy should be made taking into account the benefit of breast-feeding to the child and the benefit of bilastine therapy to the mother.

Method of application and dosage
Adults and children (from 12 years old). 20 mg bilastine (1 tablet) once daily to relieve symptoms of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria.
Nixar should be taken 1 hour before or 2 hours after a meal or fruit juice

Overdose
Information on acute bilastine overdose was obtained during clinical trials during development and post-marketing surveillance. In clinical trials, after administering bilastine to healthy adult volunteers at doses 10–11-fold higher than the therapeutic dose (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 included dizziness, headache, and nausea. No serious adverse reactions or significant prolongation of the QTc interval were reported. The information collected during post-marketing surveillance is consistent with data obtained during clinical trials.
In a thorough cross-sectional QT / QTc interval study in 30 healthy adult volunteers, a critical evaluation of the effect of multiple doses of bilastine (100 mg × 4 days) on ventricular repolarization did not reveal a significant prolongation of the QTc interval.
In case of overdose, symptomatic and supportive treatment is recommended.
The specific antidote for bilastine is unknown.

Side effects:

• Infections and parasitic diseases: herpes of the oral cavity;
• Metabolism and nutrition disorders: increased appetite;
• Mental disorders: anxiety, insomnia;
• Nervous system disorders: drowsiness, headache, dizziness;
• Disorders of the heart: blockade of the right leg of the bundle of His, sinus arrhythmia;
• Disorders of the respiratory system, chest and mediastinum: shortness of breath, nasal discomfort;
• Disorders of the gastrointestinal tract: pain in the upper abdomen, abdominal pain, nausea;
• Disorders of the skin and subcutaneous fat: itching;
• General disorders and administration site conditions: fatigue;
• Exacerbation of existing diseases: fever.

Expiration date
5 years.
Do not use the drug after the expiration date indicated on the package.

Storage conditions
No special storage conditions are required. Keep out of reach of children.