Ultibro Brizhaler, 50 mcg+110 mcg 30 pcs

Chronic Obstructive Pulmonary Disease, Bronchospasm, Bronchial Asthma

– Maintenance therapy of bronchial conduction disorders in patients with chronic obstructive pulmonary disease.

Indications

– maintenance therapy for bronchial conduction disorders in patients with chronic obstructive pulmonary disease.

Pharmacological effect

Bronchodilator – m-cholinergic receptor blocker

Special instructions

The drug Sibri® Breezhaler® is not recommended for the relief of acute episodes of bronchospasm.

Hypersensitivity reactions

Cases of immediate hypersensitivity reactions have been reported after the use of Sibri® Breezhaler®. If there are signs indicating the development of an allergic reaction, incl. angioedema (including difficulty breathing or swallowing, swelling of the tongue, lips and face), urticaria or skin rash, the drug should be discontinued and alternative therapy should be selected.

Paradoxical bronchospasm

As with other inhaled therapy, the use of Sibri®Brizhaler® can lead to paradoxical bronchospasm, which can be life-threatening. If paradoxical bronchospasm occurs, use of Sibri® Breezhaler® should be immediately discontinued and alternative therapy applied.

M-anticholinergic effect

Like other m-anticholinergic drugs, Sibri®Brizhaler® should be used with caution in patients with angle-closure glaucoma or urinary retention.

Patients should be informed of the signs and symptoms of an acute attack of angle-closure glaucoma and the need to stop using Sibri® Breezhaler®, and to immediately notify their doctor if any of these signs or symptoms develop.

Severe renal failure

Patients with impaired renal function (GFR less than 30 ml/min/1.73 m2), including patients with end-stage disease requiring hemodialysis, require careful monitoring for the development of possible adverse drug reactions.

Sibri® Breezhaler® is intended for the maintenance treatment of patients with COPD.

Due to the fact that in the general COPD population there is a significant predominance of patients over the age of 40 years, when using the drug in patients under 40 years of age, spirometric confirmation of the diagnosis of COPD is required.

Impact on the ability to drive vehicles and operate machinery

The drug Sibri® Breezhaler® does not have a negative effect on the ability to drive vehicles or machinery.

Active ingredient

Glycopyrronium bromide, Indacaterol

Composition

Excipients:

lactose monohydrate – 24.9 mg,

magnesium stearate – 0.037 mg.

Capsule composition:

hypromellose – 45.59 mg,

water – 2.7 mg,

carrageenan – 0.42 mg,

sodium chloride – 0.18 mg,

Sunset yellow dye (E110) – 0.12 mg.

Ink composition:

shellac, black iron oxide dye, propylene glycol, sodium hydroxide.

Contraindications

– hypersensitivity to glycopyrronium bromide or any other components included in the drug;

– children and adolescents up to 18 years of age;

– simultaneous use with inhaled drugs containing other m-anticholinergic agents;

– galactose intolerance, lactase deficiency or glucose-galactose malabsorption (the drug contains lactose).

With caution

Closed-angle glaucoma, diseases accompanied by urinary retention, severe renal failure (GFR below 30 ml/min/1.73 m2), including end-stage renal failure requiring hemodialysis (Sibri® Breezhaler® should be used only if the expected benefit outweighs the potential risk); unstable ischemic heart disease, history of myocardial infarction, heart rhythm disturbances, prolongation of the QTc interval (corrected QT > 0.44 s).

Side Effects

The safety profile of Sibri® Breezhaler® is characterized by symptoms associated with m-anticholinergic effects, including dry mouth (2.2%), while other gastrointestinal effects and signs of urinary retention were infrequent.

Adverse drug reactions associated with local tolerability of the drug included pharyngeal irritation, nasopharyngitis, rhinitis and sinusitis. At recommended doses, Sibri® Breezhaler® has no effect on blood pressure and heart rate.

The safety and tolerability of Sibri® Breezhaler® was studied in 1353 patients with COPD at the recommended dose of 50 mcg once a day. Of these, 842 patients were treated for at least 26 weeks and 351 for at least 52 weeks.

Determination of the frequency of adverse drug reactions: very often (≥1/10); often (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, 1/1000); very rare (<1/10,000).

Infectious and parasitic diseases: often – nasopharyngitis; infrequently – rhinitis, cystitis.

From the side of metabolism: infrequently – hyperglycemia.

From the mental side: often – insomnia.

From the nervous system: often – headache; infrequently – hypoesthesia.

From the cardiovascular system: infrequently – atrial fibrillation, palpitations.

From the respiratory system, chest and mediastinal organs: uncommon – congestion in the sinuses, productive cough, pharyngeal irritation, nosebleeds.

From the digestive system: often – dry mouth, gastroenteritis; infrequently – dyspepsia, dental caries.

From the skin and subcutaneous tissues: rarely – skin rash.

From the musculoskeletal system: infrequently – pain in the extremities, pain in the skeletal muscles of the chest.

From the urinary system: often – urinary tract infection; infrequently – dysuria, urinary retention.

General disorders: infrequently – fatigue, asthenia.

In a clinical study lasting 12 months, the following additional adverse events were identified that occurred more frequently with Sibri® Breezhaler® compared to placebo: nasopharyngitis (9.0% versus 5.6%), vomiting (1.3% versus 0.7%), muscle pain (1.1% versus 0.7%), neck pain (1.3% versus 0.7%), diabetes mellitus (0.8% versus 0%).

Adverse drug reactions obtained during post-marketing studies and according to the literature: since the data are reported voluntarily from a population of unknown size, it is not possible to determine their frequency (frequency unknown) – angioedema.

In elderly patients over 75 years of age, the incidence of urinary tract infections and headaches with Sibri®Brizhaler® was higher than in the placebo group (3.0% versus 1.5% and 2.3% versus 0%, respectively).

If any of the above side effects worsen or any other side effects occur, the patient should inform the doctor.

Interaction

The simultaneous use of glycopyrronium bromide and inhaled indacaterol, a beta2-adrenergic receptor agonist, does not affect the pharmacokinetics of both drugs.

In clinical studies in healthy volunteers, cimetidine, an inhibitor of organic cation transporters affecting the renal clearance of glycopyrronium bromide, increased the total exposure (AUC) of glycopyrronium bromide by 22% and decreased renal clearance by 23%.

Based on these indicators, no clinically significant interaction is expected when Sibri® Breezhaler® is used concomitantly with cimetidine or other cation transporter inhibitors.

In vitro studies have shown that Sibri® Breezhaler® does not likely affect the metabolism of other drugs.

Inhibition or induction of glycopyrronium bromide metabolism does not lead to significant changes in the systemic exposure of the drug.

Overdose

There is no data on an overdose of Sibri® Breezhaler®.

In patients with COPD, regular inhaled administration of Sibri®Brizhaler® in a total dose of 100 and 200 mcg once a day for 28 days was well tolerated. Acute intoxication due to accidental ingestion of Sibri® Breezhaler® capsules is unlikely due to the low bioavailability of glycopyrronium bromide when administered orally (about 5%).

Cmax in blood plasma and total systemic exposure after intravenous administration of 150 mcg of glycopyrronium bromide (equivalent to 120 mcg of glycopyrronium) in healthy volunteers were approximately 50 and 6 times higher, respectively, than Cmax in plasma and total systemic exposure at steady state, achieved when using the drug Sibri® Breezhaler® inhaled at recommended doses (50 mcg 1 time / day). There were no signs of overdose.

Manufacturer

Novartis Pharma GmbH, Germany