Ultibro Breezhaler capsules with powder for inhalation 50mcg +110mcg in an inhaler set 30pcs

Composition

Auxiliary substances:

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,

dye sunny sunset yellow (E 110) – 0.12 mg. Ink composition:

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

Pharmacological action

Bronchodilator – blocker of m-cholinergic receptors

Indications

-maintenance therapy of bronchial conduction disorders in patients with chronic obstructive pulmonary disease.

Contraindications

-hypersensitivity to glycopyrronium bromide or any other components that are part of the drug;

– children and adolescents under 18 years of age;

— simultaneous use with inhaled medications containing other m-holinoblokatorov;

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

With caution

Angle-closure glaucoma, diseases associated with urinary retention, severe renal failure (GFR below 30 ml / min/1.73 m2), including end-stage renal failure requiring hemodialysis (Sibri® Breezhaler® should only be used if the expected benefit exceeds the potential risk); unstable coronary heart disease, a history of myocardial infarction, cardiac arrhythmias, prolongation of the QTc interval (QT corrected > 0.44 s).

Side effects

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

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

Safety and tolerability of Sibri® Breezhaler® was studied in 1,353 patients with COPD at the recommended dose of 50 mcg 1 time / 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 common (≥1/10); common (≥1/100, <1/10); infrequent (≥1/1000, <1/100); rare (≥1/10 000,1/1000); very rare (

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

From the side of metabolism: infrequently – hyperglycemia.

From the side of the psyche: often – insomnia.

Nervous system disorders: often-headache; infrequently-hypesthesia.

From the cardiovascular system: infrequently – atrial fibrillation, palpitation sensation.

Respiratory, thoracic and mediastinal disorders: infrequently-sinus congestion, productive cough, pharyngeal irritation, nosebleeds.

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

Skin and subcutaneous tissue disorders: infrequently – skin rash.

Musculoskeletal disorders: infrequently-pain in the extremities, pain of the skeletal muscles of the chest.

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

General violations: infrequently – fatigue, asthenia.

In a clinical trial lasting 12 months, the following additional adverse events were identified, which were more common with the use of Sibri® Compared to placebo: nasopharyngitis (9.0% vs. 5.6%), vomiting (1.3% vs. 0.7%), muscle pain (1.1% vs. 0.7%), neck pain (1.3% vs. 0.7%), diabetes mellitus (0.8% vs. 0%).

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

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

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

Interaction

Concomitant use of glycopyrronium bromide and inhaled indacaterol, a beta-2-adrenergic agonist, does not affect the pharmacokinetics of both drugs.

In clinical studies in healthy volunteers, cimetidine, an inhibitor of organic cation transporters that affect 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 with the simultaneous use of Sibri®. Breezhaler ® with cimetidine or other cation transporter inhibitors.

In vitro studies have shown that Sibri® Breezhaler® probably does not 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.

How to take, course of use and dosage

Each package of Sibri® Breezhaler® contains:

– one inhalation device-Breezhaler®;

– blisters with capsules with powder for inhalation.

Capsules with powder for inhalation should not be taken orally!

The Breezhaler® inhalation device included in the package is intended for use only with capsules of the drug.

Only the Breezhaler®inhalation device is used to inhale the capsules in the package.

Do not use the capsules of the drug with any other inhalation device and, in turn, do not use Breezhaler® for inhalation of other drugs.

After 30 days of use, Breezhaler® should be discarded.

How to use the inhaler

1. Remove the cover.

2. Open Breezhaler®. To open the inhaler, take it firmly by the base and tilt the mouthpiece.

3. Prepare the capsule: separate one blister from the blister pack by tearing it off along the perforation; take one blister and remove the protective film from it to release the capsule; do not squeeze the capsule through the protective film.

4. Remove the capsule: capsules should be stored in a blister and removed only immediately before use; wipe your hands dry and remove the capsule from the blister. Do not swallow the capsule.

5. Insert the capsule into the Breezhaler®: place the capsule in the capsule chamber; never place the capsule directly into the mouthpiece.

6. Close Breezhaler®: Close the inhaler tightly; when it is fully closed, there is a “click”sound.

7. Pierce the capsule: hold the Breezhaler® in an upright position with the mouthpiece pointing up; press both buttons all the way down at the same time; there is a “click” when the capsule is pierced; do not press the buttons to pierce the capsule more than once.

8. Release the Breezhaler ® inhaler buttons completely on both sides.

9. Exhale: Before you put the mouthpiece in your mouth, you should exhale completely; never blow into the mouthpiece.

10. Inhale the medicine: hold the Breezhaler® in your hand so that the buttons are on the left and right (and not on the top and bottom); put the mouthpiece of the Breezhaler® inhaler in your mouth and press your lips tightly around it; take a quick, even, as deep as possible breath. Do not press the buttons of the piercing device.

11. When inhaled through an inhaler, the patient should hear a characteristic rattling sound created by rotating the capsule in the chamber and spraying the powder. In this case, a sweet taste of the drug may appear in the mouth.

If there is no rattling sound, it may mean that the capsule is stuck in the inhaler chamber. In this case, open the inhaler and gently release the capsule by tapping on the base of the device. To release the capsule, do not press the buttons for puncturing the capsule. If necessary, repeat steps 9 and 10.12

. Hold your breath: if a characteristic sound appears when inhaling, then hold your breath as long as possible (so as not to experience unpleasant sensations), and at the same time remove the mouthpiece from your mouth. Then exhale. Open Breezhaler® and see if there is any powder left in the capsule. If there is any powder left in the capsule, close Breezhaler® and repeat steps 9-12. In most cases, the capsule is emptied in 1 or 2 inhalations. Some patients have a cough for a short time after inhalation. If there is no cough, then the patient should not worry. If there is no powder left in the capsule, then the patient has received the full dose of the drug.

13. Remove the empty capsule: after the daily dose of Sibri®has been administered. Breezhaler ® is accepted, you should tilt the mouthpiece, remove the empty capsule by tapping on the inhaler, and throw it away. Close the mouthpiece of the Breezhaler ® inhaler and close the Breezhaler® lid. Do not store capsules in the Breezhaler®inhaler.

Do not swallow capsules with powder for inhalation.

Use only the Breezhaler® contained in the package.

Capsules should be stored in a blister and removed immediately before use.

Never place the capsule in the mouthpiece of a Breezhaler®inhaler. Do not press the piercing device more than once.

Never blow into the mouthpiece of the Breezhaler®inhaler.

Always pierce the capsule before inhalation.

Do not wash Breezhaler®. Keep it dry. Do not disassemble Breezhaler®.

When starting a new package of the drug, you should always use the new Breezhaler® in the package to inhale the capsules.

Do not store capsules in the Breezhaler®inhaler.

Always store blisters with capsules and Breezhaler® in a dry place.

In very rare cases, a small amount of the capsule contents may enter the mouth when inhaled or swallowed; this is irrelevant.

If the capsule has been punctured more than once, the risk of breaking increases.

How to clean Breezhaler®

Breezhaler® should be cleaned once a week. Wipe the mouthpiece inside and out with a clean, dry cloth. Never use water to clean the Breezhaler ® inhaler. Keep it dry.

Overdose

There are no data on overdose of Sibri® Breezhaler®.

In patients with COPD, regular inhalation of Sibri®is recommended. Breezhaler® at a total dose of 100 and 200 mcg once daily for 28 days was well tolerated. Acute intoxication caused by accidental ingestion of Sibri®capsules Breezhaler® is unlikely due to the low bioavailability of glycopyrronium bromide with oral use (about 5%).

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

Special instructions

Sibri ® preparation Breezhaler® it is not recommended for 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 that indicate the development of an allergic reaction, including 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 inhalation therapy, the use of Sibri®should be considered as appropriate. Breezhaler® can lead to paradoxical bronchospasm, which can be life-threatening. In case of paradoxical bronchospasm, the use of Sibri®is recommended. Breezhaler® should be discontinued immediately and alternative therapy should be used.

M-holinoblokiruyushchy effect

Like other m-holinoblocking medicinal products, Sibri®is also used Breezhaler® should be used with caution in patients with angle-closure glaucoma or urinary retention.

Patients should be informed about the signs and symptoms of an acute attack of angle-closure glaucoma and the need to stop using Sibri®. If any of these signs or symptoms occur, contact your healthcare professional immediately.

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, should be closely monitored for possible adverse drug reactions.

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

Due to the fact that the general population of COPD is significantly dominated by 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.

Influence on the ability to drive motor vehicles and manage mechanisms

Sibri ® preparation Breezhaler® it does not negatively affect the ability to drive vehicles and mechanisms.

Form of production

Capsules with powder for inhalation are solid, size #3, with a transparent lid and body in orange color, with a special marking “Novartis logo” under the black stripe on the lid and the inscription “GPL50” in black ink above the black stripe on the body; the contents of the capsules are white or almost white powder.

Active ingredient

Glycopyrronium bromide, Indacaterol

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Purpose

For adults as directed by your doctor

Indications

Bronchospasm, Bronchial asthma, Chronic Obstructive pulmonary Disease