Sibri Brizhaler, 50 mcg blisters 30 pcs

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

The results of studies show that glycopyrronium bromide effectively improves lung function, reduces the severity of COPD symptoms and reduces the frequency of exacerbations.

Glycopyrronium bromide starts working within 5 minutes after intake, is well tolerated, and provides a bronchodilator effect lasting 24 hours.

Indications

Bronchospasm, Low learning capacity

Supportive therapy for bronchial conduction abnormalities in patients with chronic obstructive pulmonary disease.

Active ingredient

Glycopyrronium bromide

Composition

1 capsule of powder for inhalation contains:

the active ingredients:

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

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, sunset yellow dye (E110) – 0.12 mg.

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

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How to take, the dosage

For inhalation use only!

The product Cibri Brizhaler is an inhalation powder capsule which should only be used for oral inhalation with the Brizhaler inhalation device included in the package. The drug may not be taken orally. The capsules containing the inhalation powder must be stored in the blister and removed just before use.

The recommended dose of Cibri Brizhaler is 50 mcg (1 capsule contents) once daily. Inhalation of the drug is performed daily once 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.

Patients should be instructed to use the inhaler correctly if Cibri Breezehaler is prescribed.

The use in patients with renal impairment

In patients with mild to moderate renal impairment, the recommended dose of Cibri Brizhaler may be used. In patients with severe renal impairment or end-stage renal disease requiring hemodialysis, Cibri Brizhaler should be used in the recommended dose only if the anticipated benefit exceeds the potential risk.

The use in patients with hepatic impairment

There have been no specific clinical studies in patients with hepatic impairment. Cibri Brizhaler is excreted primarily by renal excretion; therefore, no significant increase in exposure in patients with hepatic impairment is anticipated. In patients with impaired hepatic function, the recommended dose of Cibri Brizhaler may be used.

The use in elderly patients

The drug Cibri Brizhaler may be used in the recommended dose in patients aged 75 years and older.

Precautionary information

Each pack of Cibri Brizhaler contains:
– One inhalation device – Brizhaler
– Blister capsules with inhalation powder
Capsules with inhalation powder must not be taken orally!

The Brizhaler inhalation device in the pack is for use with the product capsules only.
Only the Brizhaler inhalation device is used to inhale the capsules in the pack.

Do not use the product capsules with any other inhalation device and do not use the Brizhaler to inhale other medications.

The Brizhaler should be discarded after 30 days of use.
How to use the inhaler.

Lift off the lid.
Open the Breezehaler.
To open the inhaler, grip the base firmly and tilt the mouthpiece.

Prepare the capsule:
Separate one blister from the blister pack by tearing it along the perforations.
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 the blister and removed only just before use. Wipe your hands dry and remove the capsule from the blister.

Do not swallow the capsule.
Insert the capsule into the Breezehaler:
Put the capsule in the capsule chamber.
Never put the capsule directly into the mouthpiece.

Close the Breezehaler:
Close the inhaler tightly. You should hear a “click” when it closes all the way.

Pierce the capsule:
Hold the Brizhaler upright with the mouthpiece pointing upwards.
Simultaneously press both buttons all the way down. You should hear a “click” when the capsule is pierced.
Do not press the buttons to pierce the capsule more than once.

Please completely release the buttons on both sides of the Breezehaler.
Breathe out:
Before inserting the mouthpiece into your mouth, exhale completely.
Never blow into the mouthpiece.

Inhale the medicine:
– Hold the Brizhaler in your hand so that the buttons are left and right (not top and bottom) as shown.
– Put the Brizhaler mouthpiece in your mouth and squeeze your lips tightly around it.
– Take a quick, even, deepest breath possible. Do not press the buttons of the piercing device.

Please note:
When you inhale through the inhaler, you should hear a distinctive rattling sound created by the rotation of the capsule in the chamber and the atomization of the powder. You may feel the sweet taste of the medicine in your mouth.

If you do not hear a rattling sound, it could mean that the capsule is stuck in the chamber of the inhaler.

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 to pierce the capsule. Repeat steps 9 and 10 if necessary.

Hold your breath:
If you hear a distinctive sound when you inhale, hold your breath as long as possible (to avoid discomfort), and at the same time remove the mouthpiece from your mouth. After that, exhale.

open the Breezehaler and see if there is any powder left in the capsule. If there is powder left in the capsule, close the Breezehaler and repeat steps 9-12. Most people can empty the capsule in one or two inhalations.

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

Eject the capsule:
After you have taken your daily dose of Cibri Breezehaler, tilt the mouthpiece away, remove the empty capsule by tapping on the inhaler and throw it away. Close the mouthpiece of the Brizhaler inhaler and close the Brizhaler with the lid.

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

Please only use the Brizhaler in the package.
Capsules should be stored in the blister and removed just before use

Never insert the capsule into the mouthpiece of your Brizhaler inhaler. Do not press the piercing device more than once.
Never blow into the mouthpiece of your Breezehaler inhaler.

Always roll the capsule before inhalation.
Do not wash the Breezehaler. Keep it dry. See “How to Clean the Breezehaler”. Do not disassemble the Brizhaler.

When starting a new pack, always use the new Breechhaler in the pack to inhale the capsules.

Do not store capsules in the Brizhaler inhaler.
Always keep the capsule blisters and Brizhaler in a dry place

Additional information
On very rare occasions, a small amount of capsule contents may enter your mouth. Don’t worry if you inhale it or swallow it.
Please note, if you puncture the capsule more than once, there is an increased risk of it breaking.

How to clean the Breezehaler
Clean the Breezehaler once a week. Wipe the mouthpiece inside and out with a clean, dry cloth. Never use water to clean your Brizhaler inhaler. Keep it dry.

Interaction

The concomitant use of glycopyrronium bromide and inhaled indacaterol, a beta2-adrenoceptor agonist, does not affect the pharmacokinetics of either drug.

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 indications, no clinically significant interaction is expected when Cibri Brizhaler is used concomitantly with cimetidiol or other cation transporter inhibitors. In vitro studies have shown that Cibri Brizhaler probably does not affect the metabolism of other drugs.

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

Special Instructions

Cibri Brizhaler is not recommended for the management of acute episodes of bronchospasm.

Paradoxic bronchospasm
As with other inhalation therapies, use of Cibri Brizhaler may result in paradoxic bronchospasm, which may be life-threatening. If paradoxical bronchospasm occurs, the use of Cibri Brizhaler should be discontinued immediately and alternative therapy should be prescribed.

M-cholinoblocking effect
Like other m-cholinoblocking medications, Cibri Brizhaler should be used with caution in patients with closed-angle glaucoma or urinary retention.

Patients should be informed of the signs and symptoms of an acute attack of closed-angle glaucoma and the need to discontinue use of Cibri Brizhaler, and should inform their physician immediately if any of these signs or symptoms develop.

Severe renal impairment

Patients with severe renal impairment (GFR less than 30 mL/min/1.73 m2), including terminally ill patients requiring hemodialysis, should be closely monitored for possible adverse drug reactions.
Cibri Brizhaler is for maintenance treatment of COPD patients.

Due to the fact that the general COPD population is significantly dominated by patients over 40 years of age, spirometric confirmation of the diagnosis of COPD is required when prescribing the drug in patients under 40 years of age.

The effect on the ability to perform potentially hazardous activities requiring particular attention and quick reactions (driving, operating moving machinery, etc.)

The Cibri Brizhaler has no adverse effect on the ability to drive vehicles and perform potentially hazardous activities requiring greater concentration and quick psychomotor reactions.

Contraindications

• high sensitivity to glycopyrronium bromide or any of the other components that make up Cibri Brizhaler;
• Age under 18 years of age;
• concurrent use of inhaled drugs containing other m-cholinoblockersconcomitant use with inhaled drugs containing other m-cholinoblockers;
• Galactose intolerance, lactase deficiency or glucose-galactose malabsorption (the drug contains lactose).

With caution

Closed-angle glaucoma, diseases accompanied by urinary retention, severe renal insufficiency (FFR below 30 ml/min/1.73 m²), including end-stage renal failure requiring hemodialysis (Cibri Brizhaler should only be used if the expected benefit exceeds the potential risk); unstable coronary heart disease (CHD), history of myocardial infarction, heart rhythm disorders, QTc interval prolongation (QTc-corrected > 0.44 s).

Side effects

The safety profile of Cibri Brizhaler was characterized by symptoms associated with m-holyoblocating effects, including dry mouth (2.2%), while other GI effects and signs of urinary retention were infrequent.

Unwanted drug reactions (ADRs) associated with local tolerance of the drug included pharyngeal irritation, nasopharyngitis, rhinitis, and sinusitis. At the recommended doses, Cibri Brizhaler has no effect on blood pressure (BP) or HR.

The safety and tolerability of Cibri Brizhaler was studied when used 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.

The following criteria were used to assess the incidence of NLD: very frequent (>1/10); frequent (>1/100, <1/10); infrequent (>1/1000, <1/100); rare (>1/10000, 1/1000); very rare (<1/10000).

Infectious and parasitic diseases: frequent – nasopharyngitis; infrequent – rhinitis, cystitis.

Metabolic and nutrition disorders: infrequent – hyperglycemia.

Mental disorders: often – insomnia.

Nervous system disorders: often – headache; infrequent – hypoesthesia.

Chronic disorders: infrequent – atrial fibrillation, palpitations.

Respiratory system, chest and mediastinum disorders: infrequent – sinus congestion, productive cough, pharyngeal irritation, nasal bleeding.

Digestive system disorders: frequently – dry mouth, gastroenteritis; infrequently – dyspepsia, dental caries.

Skin and subcutaneous tissue disorders: infrequent – skin rash.

Muscular and connective tissue disorders: infrequent – pain in the extremities, pain in the skeletal muscles of the chest.

River and urinary tract disorders: frequently – urinary tract infection; infrequently – dysuria, urinary retention.

General disorders and disorders at the site of administration: infrequent – fatigue, asthenia.

In a 12-month clinical trial, the following additional adverse events were found to occur more frequently with Cibri Brizhaler 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.7%), and diabetes mellitus (0.8% vs. 0%).

Particular patient groups

The incidence of urinary tract infections and headache was higher in elderly patients over 75 years of age 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 worsen, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

There are no data on overdose with Cibri Brizhaler.

In patients with COPD, regular inhalation administration of Cibri Brizhaler at a total dose of 100 and 200 mcg once daily for 28 days was well tolerated. Acute intoxication from accidentally swallowing a capsule of Cibri Brizhaler is unlikely due to the low bioavailability of glycopyrronium bromide when administered orally (approximately 5%).

. Maximum plasma concentration and total systemic exposure after intravenous administration of 150 μg glycopyrronium bromide (equivalent to 120 μg glycopyrronium) in healthy volunteers were approximately 50 and 6 times higher, respectively, than the maximum plasma concentration and total systemic exposure in equilibrium achieved when using Cibri Breazehaler inhaled at the recommended dose (50 μg once daily). There were no signs of overdose.

Pregnancy use

In preclinical studies it was shown that the drug has no teratogenic effect after inhalation use. Due to the lack of clinical data on the use of Cibri Brizhaler in pregnant women, the drug may be used during pregnancy only if the estimated benefit to the patient exceeds the potential risk to the fetus.

It is not known whether glycopyrronium bromide passes into human breast milk. Use of Cibri Brizhaler in breastfeeding should be considered only if the benefit to the mother outweighs any potential risk to the infant.

No reproductive toxicity studies or other animal studies suggest that the drug may affect fertility in men or women.