Seebri Breezhaler, inhalation powder 50mcg, 30pcs + breezehaler

Composition

1 capsule with powder for inhalation contains:

active ingredients:

glycopyrronium base 50 mcg, which corresponds to the content of glycopyrronium bromide 63 mcg,

excipients:

lactose monohydrate – 24.9 mg,

magnesium stearate-0.037 mg.

:

hypromellose-45.59 mg, water-2.7 mg, carrageenan-0.42 mg, sodium chloride-0.18 mg, dye sunset yellow (E 110) – 0.12 mg

. ink composition: shellac, iron oxide black dye, propylene glycol, sodium hydroxide

Pharmacological action

Sibri Breezhaler (glycopyrronium bromide) is a long-acting anticholinergic bronchodilator intended for the treatment of COPD.

Studies have shown that glycopyrronium bromide effectively improves lung function, reduces the severity of COPD symptoms, and reduces the frequency of exacerbations.

Glycopyrronium bromide begins to act within 5 minutes after use, is well tolerated and provides a bronchodilatory effect lasting 24 hours.

Indications

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

Use during pregnancy and lactation

Preclinical studies have shown that the drug does not have a teratogenic effect after inhalation. Due to the lack of clinical data on the use of Sibri Breezhaler in pregnant women, the drug can be used during pregnancy only if the intended benefit of use for the patient exceeds the potential risk to the fetus.

It is not known whether glycopyrronium bromide is excreted in human breast milk. The use of Sibri Breezhaler during breastfeeding should only be considered if the benefit to the mother outweighs any potential risk to the infant.

Neither reproductive toxicity studies nor other animal studies suggest that the drug can affect fertility in men or women.

Contraindications

• hypersensitivity to glycopyrronium bromide or any other components that are part of the Sibri Breezhaler preparation;
• age up to 18 years;
• concomitant use with inhaled medications containing other m-holinoblockers;
• 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 (CHD), a history of myocardial infarction, cardiac arrhythmias, prolongation of the QTc interval (QT adjusted > 0.44 s).

Side effects

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

Adverse drug reactions (NLR) associated with local drug tolerance included pharyngeal irritation, nasopharyngitis, rhinitis, and sinusitis. At the recommended doses, Sibri Breezhaler has no effect on blood pressure (BP) and heart rate.

The safety and tolerability of Sibri Breezhaler was studied in 1,353 patients with COPD at the recommended dose of 50 mcg once daily. Of these,842 patients were treated for at least 26 weeks and 351-for at least 52 weeks.

To assess the frequency of NLR, the following criteria were used: very often (>1/10); often (>>1/100, >><1/10); infrequently (>1/1000, <1/10); infrequently (><1/100); rarely (>1/10000,1/1000); very rarely (<1/100); rarely (>

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

Metabolic and nutritional disorders: infrequently-hyperglycemia.

Mental disorders: often-insomnia.

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

Cardiac disorders: infrequently – atrial fibrillation, palpitation sensation.

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

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

Skin and subcutaneous tissue disorders: infrequently-skin rash.

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

Kidney and urinary tract disorders: often-urinary tract infection; infrequently-dysuria, urinary retention.

General disorders and disorders at the injection site: infrequently-fatigue, asthenia.

In a 12-month clinical trial, the following additional adverse events were identified that were more common with Sibri Breezhaler 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%).

Special patient groups

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

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your 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 when Sibri Breezhaler is co-administered with cimetidiom 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

For inhalation use only!

Sibri Breezhaler is a capsule containing powder for inhalation, which should only be used for oral inhalation using a special Breezhaler inhalation device, which is included in the package. The drug should not be taken orally. Capsules with powder for inhalation should be stored in a blister and removed from it immediately before use.

The recommended dose of Sibri Breezhaler is 50 mcg (contents of 1 capsule) once a day. Inhalation of the drug is carried out daily 1 time a day at the same time. If the inhalation is missed, the next dose should be taken as soon as possible. Patients should be instructed not to take more than 1 dose of the drug (50 mcg) per day.

If Sibri Breezhaler is prescribed, patients should be instructed about the correct use of the inhaler.

Use in patients with renal insufficiency

In patients with mild to moderate renal insufficiency, the recommended dose of Sibri Breezhaler may be used. In patients with severe renal insufficiency or end-stage renal disease requiring hemodialysis, Sibri Breezhaler should only be used at the recommended dose if the intended benefit outweighs the potential risk.

Use in patients with hepatic insufficiency

No specific clinical studies have been conducted in patients with hepatic insufficiency. Sibri Breezhaler is mainly excreted by renal excretion, so a significant increase in exposure in patients with hepatic insufficiency is not expected. In patients with impaired liver function, the recommended dose of Sibri Breezhaler may be used.

Use in elderly patients

Sibri Breezhaler can be used at the recommended dose in patients aged 75 years and older.

Instructions for use

Each package of Sibri Breezhaler contains: – One inhalation device-Breezhaler-Blisters with powder capsules for inhalationcapsules with powder for inhalation can not be taken inside!

The Breezhaler inhalation device 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 the Breezhaler to inhale other drugs.

After 30 days of use, the Breezhaler should be discarded. How to use the inhaler.

Remove the cover. Open the Breezhaler. To open the inhaler, hold it firmly by the base and tilt the mouthpiece.

Prepare the capsule: Separate one blister from the blister pack by ripping 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. 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. Insert the capsule into the Breezhaler:Put the capsule in the capsule chamber. Never place the capsule directly in the mouthpiece.

Close the Breezhaler:Close the inhaler tightly. When it closes to the end, there should be a “click”.

Pierce the capsule:Hold the Breezhaler in an upright position with the mouthpiece pointing up. Press both buttons all the way to the end at the same time. When the capsule is punctured, a “click”should be heard. Do not push the buttons to pierce the capsule more than once.

Fully release the Breezhaler inhaler buttons on both sides. Exhale:Before inserting the mouthpiece into your mouth, exhale completely. Never blow into the mouthpiece.

Inhale the medication:- Hold the Breezhaler in your hand so that the buttons are on the left and right (and not on the top and bottom), as shown in the picture. – Place the mouthpiece of the Breezhaler inhaler in your mouth and press your lips tightly around it. – Take a quick, even, deep breath as possible. Do not press the buttons of the piercing device.

Pay attention:When you inhale through the inhaler, you should hear a distinctive rattling sound created by rotating the capsule in the chamber and spraying the powder. You may feel a sweet taste of the drug in your mouth.

If you don’t hear a 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.

Hold your breath:If you hear a distinctive sound when inhaling, 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 the Breezhaler and see if there is any powder left in the capsule. If there is any powder left in the capsule, close the Breezhaler and repeat steps 9-12. Most people can empty a capsule in one or two inhalations.

Some people have a cough for a short time after inhaling the drug. If you cough, don’t worry. If there is no powder left in the capsule, then you have received the full dose of the drug.

Remove the capsule:After you have taken your daily dose of Sibri Breezhaler, tilt the mouthpiece, remove the empty capsule by tapping the inhaler, and discard it. Close the mouthpiece of the Breezhaler inhaler and cover the Breezhaler with the lid.

Do not store capsules in the Breezhaler inhaler. Do not swallow capsules with powder for inhalation.

Use only the Breezhaler that is in the package. Capsules should be stored in a blister and removed immediately before use. Never insert the capsule into the mouthpiece of the Breezhaler inhaler. Do not press the piercing device more than once. Never blow into the mouthpiece of a Breezhaler inhaler.

Always roll the capsule before inhaling. Do not wash the Breezhaler. Keep it dry. See “How to clean the Breezhaler”. Do not disassemble the Breezhaler.

When starting a new package, 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

Additional INFORMATIONIN very rare cases, a small amount of capsule contents may enter the mouth. Don’t worry if you inhaled it or swallowed it. Please note that if you have punctured the capsule more than once, the risk of breaking it increases.

How to clean the Breezhaler Clean the Breezhaler 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 with Sibri Breezhaler.

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

The maximum plasma concentration 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 maximum plasma concentration and total systemic exposure at steady state achieved with the use of Sibri Breezhaler inhaled at the recommended doses (50 mcg 1 time per day). There were no signs of overdose.

Special instructions

Sibri Breezhaler is not recommended for the management of acute episodes of bronchospasm.

Paradoxical bronchospas Mas with other inhaled therapies, the use of Sibri Breezhaler can lead to paradoxical bronchospasm, which can be life-threatening. In case of paradoxical bronchospasm, the use of Sibri Breezhaler should be stopped immediately and alternative therapy should be prescribed.

M-holinoblocking effectas with other m-holinoblocking medications, Sibri 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 Breezhaler, and immediately inform their doctor if any of these signs or symptoms develop.

Severe renal failure

Patients with severe renal insufficiency (GFR less than 30 ml/min/1.73 m2), including patients with end-stage disease requiring hemodialysis, should be carefully monitored for possible adverse drug reactions. Sibri 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 prescribing the drug to patients under 40 years of age, spirometric confirmation of the diagnosis of COPD is required.

Influence on the ability to perform potentially dangerous activities that require special attention and quick reactions (driving vehicles, working with moving mechanisms, etc. )

Sibri Breezhaler does not adversely affect the ability to drive vehicles and perform potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Capsules with powder for inhalation

Storage conditions

In a dry place, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Glycopyrronium bromide

Conditions of release from pharmacies

By prescription

Dosage form

powder for inhalation

Purpose

Adults as prescribed by a doctor

Indications

Bronchospasm, Low learning rate