Nixar^® (Tablets) Instructions for Use

Marketing Authorization Holder

Menarini International Operations Luxembourg, S.A. (Luxembourg)

Manufactured By

A.Menarini Manufacturing Logistics and Services, S.r.l. (Italy)

Primary Packaging

A.Menarini Manufacturing Logistics and Services, S.r.L. (Italy)

Or

MENARINI-VON HEYDEN, GmbH (Germany)

Secondary Packaging

A.Menarini Manufacturing Logistics and Services, S.r.L. (Italy)

Or

MENARINI-VON HEYDEN, GmbH (Germany)

Quality Control Release

A.Menarini Manufacturing Logistics and Services, S.r.L. (Italy)

ATC Code

R06AX29 (Bilastine)

Active Substance

Bilastine (Rec.INN registered by WHO)

Dosage Form

Nixar®

Tablets 20 mg: 10, 20, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets are white, oval, biconvex, with a score on one side for dividing.

Excipients: microcrystalline cellulose (type PH-102), sodium carboxymethyl starch (type A), colloidal silicon dioxide, magnesium stearate.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.

Clinical-Pharmacological Group

Histamine H₁-receptor blocker. Antiallergic drug

Pharmacotherapeutic Group

Systemic antihistamines; other systemic antihistamines

Pharmacological Action

Long-acting antihistamine, selectively blocks peripheral H₁ receptors.

A significant therapeutic effect is observed one hour after administration, and the antihistamine effect lasts for 24 hours. Minimal penetration through the blood-brain barrier is possible. It does not have an anticholinergic effect. No QT interval prolongation on ECG is observed.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract. The time to reach C_max is 1.3 hours. Oral bioavailability is 61%. Concurrent food intake reduces bioavailability by 30%. Plasma protein binding is 84-90%.

After a single dose, up to 95% of the administered dose is excreted unchanged by the kidneys (28.3%) and in the bile (66.5%). T1/2 is 14.5 hours.

Indications

Allergic (seasonal and perennial) rhinoconjunctivitis, urticaria.

ICD codes

Dosage Regimen

Administer orally as a single daily dose of 20 mg (one tablet).

Take the tablet one hour before or two hours after a meal to ensure optimal absorption.

Swallow the tablet whole with a glass of water; the tablet may be divided at the score line for ease of administration.

The standard dosage for adults and adolescents 12 years of age and older is 20 mg once daily.

Do not exceed the recommended daily dose.

For patients with moderate to severe renal impairment (creatinine clearance less than 30 mL/min), avoid use.

Exercise caution when co-administering with potent P-glycoprotein inhibitors (e.g., ketoconazole, erythromycin, cyclosporine, ritonavir, diltiazem).

Adjust dosing interval in renal impairment only if used concomitantly with a P-gp inhibitor; specific guidance should be sought from a healthcare professional.

Treatment duration depends on the nature of the allergic condition; use for as long as the allergen exposure persists.

Discontinue use if symptoms worsen or do not improve after an appropriate treatment period.

Adverse Reactions

Gastrointestinal disorders: dry mouth, diarrhea, dyspepsia, gastritis, pain in the upper abdomen, stomach discomfort, nausea.

Skin and subcutaneous tissue disorders: skin itching.

Nervous system disorders: drowsiness, headache, dizziness, anxiety, insomnia.

Metabolism and nutrition disorders: increased appetite, weight gain.

Ear and labyrinth disorders: tinnitus, vertigo.

Cardiac disorders: right bundle branch block, sinus arrhythmia, QT interval prolongation on ECG, other ECG changes.

General disorders and administration site conditions: oral herpes, thirst, increased fatigue, asthenia, fever, increased plasma triglycerides, increased plasma creatinine, increased activity of “liver enzymes” (AST, ALT, GGT).

Contraindications

Age under 12 years, pregnancy and breastfeeding period.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and breastfeeding.

Pediatric Use

Use is contraindicated in children under 12 years of age.

Special Precautions

Caution is required in patients with moderate and severe renal insufficiency when used concomitantly with P-glycoprotein inhibitors (ketoconazole, erythromycin, cyclosporine, ritonavir, diltiazem, etc.).

Effect on ability to drive vehicles and operate machinery

Dizziness and drowsiness may occur.

Drug Interactions

Concomitant use with ketoconazole or erythromycin increased the area under the concentration-time curve by 2 times, and C_max by 2-3 times. Diltiazem increases C_max by 50%. Grapefruit and other fruit juices reduce bioavailability by 30%. Medicinal products that are substrates or inhibitors of OATP1A2 (e.g., ritonavir or rifampicin) may reduce the plasma concentration of the medicinal product.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.