Sibri Brizhaler caps 50mcg #30

Sibri Brizhaler instruction for use

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Composition

    1 capsule with powder for inhalation contains:
    active substances: 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.
    the composition of the capsule: hypromellose - 45.59 mg, water - 2.7 mg, carrageenan - 0.42 mg, sodium chloride - 0.18 mg, dye sunset yellow (E110) - 0.12 mg.
    Ink composition: shellac, iron oxide, black oxide, propylene glycol, sodium hydroxide.

Packaging

30 capsules complete with device for inhalation (Brizhaler)

pharmachologic effect

Sibri Brizhaler (glycopyrronium bromide) is an anticholinergic long-acting bronchodilator designed to treat COPD.
According to the results of the research, glycopyrronium bromide effectively improves lung function, reduces the severity of COPD symptoms and reduces the frequency of exacerbations.
Glycopyrronium bromide begins to act for 5 minutes after ingestion, is well tolerated and provides a bronchodilation effect lasting 24 hours.

Sibri Brizhaler, indications for use

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

Contraindications

    hypersensitivity to glycopyrronium bromide or any other components included in the preparation of Sibri Brizhaler;
    age to 18 years;
    simultaneous administration with inhaled drugs containing other m-holinoblokatory;
    intolerance to galactose, deficiency of lactase or glucose-galactose malabsorption (the preparation contains lactose).

Carefully

Closed-angle glaucoma, diseases accompanied by urinary retention, severe renal failure (GFR below 30 mL / min / 1.73 m2), including the terminal stage of renal failure requiring hemodialysis (Sibri Brizhaler drug should only be used if the expected benefit exceeds the potential risk); unstable ischemic heart disease (CHD), a history of myocardial infarction, cardiac rhythm disturbances, QTc interval prolongation (QT-adjusted> 0.44 s).

Dosing and Administration

Only for inhalation use!
Sibri Brizhaler is a capsule with powder for inhalation, which should be used only for inhalations through the mouth with the help of a special device for inhalation Brizhaler, 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 Brizhaler is 50 μg (1 capsule) once a day. Inhalation of the drug is carried out daily once a day at the same time. In case of missed inhalation, 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 micrograms) per day.
In the case of the prescription of Sibri Brizhaler, patients should be instructed about the proper use of the inhaler. Use in patients with renal insufficiency
In patients with mild to moderate renal failure, the recommended dose of Sibri Brizhaler can be used. In patients with severe renal failure or terminal stage of kidney disease requiring hemodialysis, Sibri Brizhaler should be used at the recommended dose only if the intended benefit exceeds the potential risk.

Use in patients with hepatic impairment

Special clinical studies in patients with hepatic insufficiency was not carried out. The preparation of Sibri Brizhaler is excreted primarily 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 Brizhaler can be used.

Use in elderly patients

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

Instructions for use

Each package of the drug Sibri Brizhaler contains:
- One inhalation device - Brizhaler
- Blisters with capsules with powder for inhalation
Capsules with powder for inhalation can not be taken inside!
The inhalation device Brizhaler, contained in the package, is intended for use only with the capsules of the preparation.
For the inhalation of capsules contained in the package, only the inhalation device Brizhaler is used.
Do not use the drug capsules with any other inhalation device and, in turn, do not use Brizhaler for inhalation of other medications.
After 30 days of use, Brizhaler should be discarded.

How to use an inhaler.

Remove the cover.
Open Brizhaler.
To open the inhaler, firmly grasp the base and tilt the mouthpiece.

Prepare the capsule:

Separate one blister from the blister pack, tearing it off 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 Brizhaler:

Place the capsule in the capsule chamber.
Never put the capsule directly on the mouthpiece.

Close Brizhaler:

Close the inhaler tightly. When it closes to the end, there should be a "click".

Pierce the capsule:

Hold the Brizhaler in an upright position, so that the mouthpiece is pointing upwards.
Simultaneously press the end button on both buttons. When puncturing the capsule, a "click" should be heard.
Do not press the buttons to puncture the capsule more than once.
Completely release the Brizhaler inhaler buttons on both sides.

Exhale:

Before inserting the mouthpiece into your mouth, make a full exhalation.
Never blow into the mouthpiece.

Inhale the drug:

- Hold the Brizhaler in your hand so that the buttons are on the left and right (rather than on top and bottom).
- Insert the mouthpiece of the Brizhaler inhaler into your mouth and squeeze your lips tightly around it.
- Take a quick, uniform, maximum deep breath. Do not press the buttons of the lancing device.

Note:

When you inhale through an inhaler, you should hear a characteristic rattling sound created by rotating the capsule in the chamber and spraying the powder. You can feel the sweet taste of the drug in your mouth.
If you do not hear a rattling sound, it may mean that the capsule is stuck in the inhaler chamber.
In this case, open the nebulizer and gently release the capsule by tapping on the base of the device. To release the capsule, do not press the buttons to puncture the capsule. If necessary, repeat steps 9 and 10.

Hold your breath:

If by inhalation you have heard a characteristic sound, hold your breath as long as possible (so as not to experience unpleasant sensations), and at the same time remove the mouthpiece from the mouth. After that, exhale.
Open Brizhaler and see if the powder remained in the capsule. If the powder remains in the capsule, close Brizhaler and repeat steps 9-12. Most people can empty the capsule for one or two inhalations.
Some people notice coughing for a short time after inhalation of the drug. If you cough, do not worry. If there is no powder in the capsule, then you have received the full dose of the drug.

Remove the capsule:

After you take a daily dose of the drug Sibri Brizhaler, by deflecting the mouthpiece, remove the empty capsule by tapping on the inhaler and discard it. Close the mouthpiece of the Brizhaler inhaler and close the Brizhaler lid.
Do not store capsules in a Brizhaler inhaler.
Do not swallow capsules with powder for inhalation.
Use only Brizhaler, which is in the package.
Capsules should be stored in a blister and extracted immediately before use.
Never put the capsule in the mouthpiece of the Bryshaler inhaler. Do not press the piercing device more than once.
Never blow into the inhaler mouthpiece Brizhaler.
Always roll the capsule before inhalation.
Do not wash Brizhaler. Keep it dry. See the section "How to clean Brizhaler". Do not disassemble Brizhaler.
When starting a new package of the drug, always use a new Brizhaler in the package to inhale the capsules.
Do not store capsules in a Brizhaler inhaler.
Always store blisters with capsules and Brizhaler in a dry place

Additional Information

In very rare cases, a small amount of the contents of the capsules can enter the mouth. Do not worry if you inhaled it or swallowed it.
Note, if you punctured the capsule more than once, the risk of breaking it up increases.

How to clean Brizhaler

Clean Brizhaler once a week. Wipe the mouthpiece from the outside and inside with a clean dry cloth. Never use water to clean the Brizhaler inhaler. Keep it dry.

Application in pregnancy and lactation

In preclinical studies, the drug was shown to have no teratogenic effect after inhalation. Due to the lack of clinical data on the use of the drug Sibri Brizhaler in pregnant women, the drug can be used during pregnancy only if the intended use of the drug for the patient exceeds the potential risk to the fetus.
It is not known whether glycopyrronium bromide penetrates human breast milk. The use of Sibri Brizhaler in breastfeeding should be considered only if the benefit to the mother exceeds any potential risk to the infant.
Neither reproductive toxicity studies nor other animal studies suggest that the drug may affect fertility in men or women.

Side effects

The safety profile of the Sibri Brizhaler preparation is characterized by symptoms associated with m-holin blocking action, including dry mouth (2.2%), while other effects on the gastrointestinal tract and urinary retention symptoms were infrequent.
Undesirable drug reactions (NLR) associated with local drug tolerance included irritation of the pharynx, nasopharyngitis, rhinitis and sinusitis. In the recommended doses, the drug Sibri Brizhaler does not affect blood pressure (BP) and heart rate.
The safety and tolerability of the Sibri Brizhaler drug was investigated when used in 1353 patients with COPD at a recommended dose of 50 μg 1 time per day. Of these, 842 patients were treated for at least 26 weeks and 351 for at least 52 weeks.
The following criteria were used to estimate the frequency of NLR: very often (> 1/10); often (> 1 / 100.1 / 1000.1 / 10000, 1/1000); rarely (
Infectious and parasitic diseases: often - nasopharyngitis; infrequently - rhinitis, cystitis.
Disorders from the metabolism and nutrition: infrequently - hyperglycemia.
Disorders of the psyche: often - insomnia.
Disturbances from the nervous system: often - headache; infrequently - hypoesthesia.
Disturbances from the heart: infrequent - atrial fibrillation, palpitation.
Disturbances from the respiratory system, chest and mediastinal organs: infrequent - stagnant phenomena in the sinuses, productive cough, irritation of the pharynx, nosebleed.
Disturbances from the digestive system: often - dry mouth, gastroenteritis; infrequently - dyspepsia, dental caries.
Disturbances from the skin and subcutaneous tissues: infrequent - skin rash.
Disorders from the musculoskeletal and connective tissue: infrequently - pain in the limbs, pain of the skeletal muscles of the chest.
Disorders from the kidneys and urinary tract: often - infection of the urinary tract; 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 occurred more frequently with the use of the Sibri Brizhaler drug compared with placebo: nasopharyngitis (9.0% versus 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 the age of 75 years, the incidence of urinary tract infections and headache with Sibri Bischter 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 manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

special instructions

Sibri Brizhaler is not recommended for relief of acute episodes of bronchospasm.

Paradoxical bronchospasm

As with other inhalation therapies, the use of Sibri Brizhaler can lead to paradoxical bronchospasm, which can be life threatening. In the event of a paradoxical bronchospasm, the use of the Sibri Brizhaler drug should be immediately discontinued and alternative therapy should be prescribed.

M-anticholinergic effect

Like other m-holinoblokiruyuschie drugs preparation Sibri Brizhaler should be used with caution in patients with zakratougolnoy 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 discontinue use of the drug Sibri Brizhaler, and to report promptly to your doctor if any of these signs or symptoms develop.

Severe renal insufficiency

Patients with severe renal insufficiency (GFR <30 ml / min / 1.73 m2), including patients with terminal stage of the disease requiring hemodialysis, should be carefully observed for the development of possible unwanted drug reactions.
The drug Sibri Brizhaler is designed to support the treatment of patients with COPD.
Due to the fact that patients in the general population of COPD are significantly older than 40, the prescription of a drug for patients under 40 years of age requires spirometric confirmation of the diagnosis of COPD.
Impact on the ability to carry out potentially hazardous activities requiring special attention and quick reactions (vehicle management, working with moving mechanisms, etc.)
Sibri Brizhaler does not adversely affect the ability to drive vehicles and carry out potentially dangerous activities requiring increased concentration and speed of psychomotor reactions.

Drug Interactions

Simultaneous use of glycopyrronium bromide and inhaled indacaterol, a beta2-adrenoreceptor 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 reduced renal clearance by 23%. Based on these indicators, no clinically significant interaction is contemplated with the simultaneous use of the Sibri Brizhaler preparation with cimetidium or other inhibitors of cation transporters. In vitro studies have shown that the drug Sibri Brizhaler probably does not affect the metabolism of other drugs.
Inhibition or induction of glycopyrronium bromide metabolism does not lead to significant changes in the system exposure of the drug.

Overdose

There is no evidence of an overdose of Sibri Brizhaler.
In patients with COPD, regular inhalation of Sibri Brizhaler in a total dose of 100 and 200 μg once a day for 28 days was well tolerated. Acute intoxication with accidental ingestion of the capsule of the drug Sibri Brizhaler is unlikely due to low bioavailability of glycopyrronium bromide in oral use (about 5%).
The maximum plasma concentration and total systemic exposure after intravenous administration of 150 μg of glycopyrronium bromide (equivalent to 120 μg of glycopyrronium) in healthy volunteers was approximately 50 and 6 times higher than the maximum plasma concentration and total systemic exposure in the equilibrium state, Sibri Brizhaler inhalation in recommended doses (50 mcg once a day). Signs of an overdose were not detected.

Storage conditions

In a dry place at a temperature of no higher than 25 ° C. Keep out of the reach of children.
Shelf life - 2 years.

Terms of sell

To buy Sibri Brizhaler the prescription is not required.