Expiration date: 01/2025

Feature: release Form, composition

Capsules Siberry Breezhaler powder inhalations solid No. 3, with a transparent lid and body is orange, with a special marking under the black strip on the lid and the inscription "GPL50" in black ink above the black stripe. The contents of capsules: white powder or almost white.

1 caps.:

- glycopyrrolate base 50 ág, respectively. content glycopyrronium bromide 63 mcg

Excipients: lactose monohydrate 24.9 mg, magnesium stearate 0.037 mg.

The composition of the capsule: hypromellose 45.59 mg, 2.7 mg water, carrageenan 0.42 mg, sodium chloride 0.18 mg, colorant sunset yellow (E110) 0.12 mg.

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

Pharm group: bronchodilators - blocker m-holinoretseptorov.

Indications: supportive therapy of disorders of bronchial conduction in patients with chronic obstructive pulmonary disease.

Category effects on the fetus: In preclinical studies, it was shown the absence of the drug teratogenic effects after inhalation use. In the absence of clinical data on the drug Siberry Breezhaler in pregnant women, the drug can be used during pregnancy only if the expected benefit of applying for the patient outweighs the potential risk to the fetus.

It is unknown whether glycopyrrolate penetrates bromide in breast milk in humans. The use of the drug Siberry Breezhaler breastfeeding should be considered only if the benefit to the mother outweighs any potential risk to the baby.

No studies of reproductive toxicity, no other studies on animals do not give grounds to believe that the drug may affect fertility in men or women.

Contraindications:

— hypersensitivity to glycopyrrolate the bromide or any other components included in the composition of the drug,

— the age 18 years,

— concomitant use with inhaled drugs that contain other m-holinoblokatory,

— intolerance of galactose, lactase deficiency or glucose-galactose malabsorption (product contains lactose).

With caution:

Angle-closure glaucoma, diseases accompanied by urinary retention, severe renal insufficiency (GFR below 30 ml/min/1.73 m2), including end-stage renal disease requiring hemodialysis (drug Siberry Breezhaler should be used only if the expected benefit outweighs the potential risk), unstable ischemic heart disease (IHD), myocardial infarction in anamnesis, cardiac arrhythmias, prolongation of QTc interval (QT????????????????? >, 0,44).

Dosage:

Only for inhalation use!

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

Recommended dose Siberry Breezhaler is 50 mcg (contents of 1 capsule) 1 times a day. Inhalation of the drug carried out daily 1 time per day at the same time. In the case of missing 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 mcg) per day.

In the case of appointment of the drug Siberry Breezhaler patients should be instructed on the correct use of the inhaler.

Use in patients with renal insufficiency:

In patients with renal insufficiency mild to moderate severity can be applied recommended dose Siberry Breezhaler. In patients with severe renal insufficiency or end-stage renal disease requiring hemodialysis, the drug Siberry Breezhaler should be applied at the recommended dose only if the expected benefit outweighs the potential risk.

Use in patients with hepatic impairment:

Special clinical studies in patients with hepatic impairment were not conducted. The drug Siberry Breezhaler is excreted primarily by renal excretion, therefore, a significant increase of exposure in patients with hepatic insufficiency is not expected. In patients with impaired liver can be used the recommended dose Siberry Breezhaler.

Use in elderly patients:

The drug Siberry Breezhaler can be applied at the recommended dose in patients aged 75 years and older.

Directions for use:

Each package of the drug Siberry Breezhaler contains:

 One inhalation device - Breezhaler

- Blisters with capsules with powder for inhalations

Capsules with powder for inhalation can not be taken orally!

Inhalation device Breezhaler in the package, intended for use only in conjunction with capsules of the drug.

Inhalation capsules in the package, is used only inhaled device Breezhaler.

Do not use 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.

Remove the cover.

Open Breezhaler.

To open the inhaler, firmly hold the base and tilt the mouthpiece.

Prepare capsule:

Separate one blister from the blister package by tearing it along the perforation.

Take one blister and remove the protective film to release the capsule.

Do not squeeze the capsule through the protective film.

Remove the capsule:

Capsules should be stored in the blister and only removed immediately before use. Wipe the hands dry and remove the capsule from the blister. Do not swallow the capsule.

Insert the capsule in Breezhaler:

Put the capsule into the chamber for a capsule.

Never place a capsule directly into the mouthpiece.

Close Breezhaler:

Close the inhaler. When it will be closed until the end to hear a "click".

Pierce the capsule:

Hold Breezhaler in a vertical position so that the mouthpiece is facing upwards.

Press to end both buttons. When perforation of the capsule should hear a "click".

Do not click on the buttons to pierce the capsule more than once.

Fully release button of the inhaler Breezhaler on both sides.

Exhale:

Before inserting the mouthpiece in your mouth, take a full breath.

Never blow into the mouthpiece.

Breathe drug:

- Hold Breezhaler in the hand so that the buttons were on the left and right (not top and bottom), as shown in the picture.

- Insert the mouthpiece of the inhaler Breezhaler in your mouth and tighten your lips around it.

- Make a quick, uniform, maximum a deep breath. Do not press the piercing buttons on the device.

Please note:

When You inhale through the inhaler, You should hear a distinctive rattling sound that is created by the rotation of the capsule in the chamber and the spraying of the powder. You can feel the sweet taste of the drug in the mouth.

If You do not hear a rattling sound, it may mean that the capsule was stuck in the chamber of the inhaler.

In this case, open the inhaler and carefully loosen the capsule by tapping the base of the device. To release the capsule, do not click on the buttons to pierce the capsule. If necessary, repeat steps 9 and 10.

Hold your breath:

If, when inhaled, you heard a distinctive sound, hold your breath as long as possible (in order not to experience unpleasant feelings), and at the same time remove the mouthpiece from the mouth. After that, breathe out.

Open Breezhaler and see if there are any in the capsule powder. If the capsule remained in the powder, close Breezhaler and repeat steps 9-12. Most people can empty the capsule in one or two inhalations.

Some people for a short time after inhalation of the drug noted a cough. If you are coughing, don't worry. If powder in the capsule left, so You got a full dose of the drug.

Remove the capsule:

After You take the daily dose Siberry Breezhaler, rejecting the mouthpiece, remove the empty capsule by tapping on the inhaler, and discard it. Close the mouthpiece of the inhaler Breezhaler breezhaler and close the lid.

Do not store capsules in the inhaler Breezhaler.

Do not swallow capsules with powder for inhalation.

Use only Breezhaler in the package.

Capsules should be stored in the blister and removed immediately before use

You should never put a capsule in the mouthpiece of the inhaler Breezhaler. Do not press the lancing device more than once.

Never blow into the mouthpiece of the inhaler Breezhaler.

Always prokatyvaja capsule before inhalation.

Do not wash Breezhaler. Keep it dry. Cm. the section "How to clean Breezhaler". Do not disassemble Breezhaler.

Starting a new pack of drug, the inhalation capsules always use new Breezhaler in the package.

Do not store capsules in the inhaler Breezhaler.

Always keep the blisters with capsules and Breezhaler in a dry place

Additional information:

In very rare cases, a small amount of the contents of the capsules may get into the mouth. Don't worry if You inhaled it or swallowed it.

Please note, if You pierce the capsule more than once, increasing the risk of breakage.

How to clean Breezhaler:

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

Side effects: the safety Profile of the drug Siberry Breezhaler is symptoms associated with m-holinoblokirutuyu effects, including dry mouth (2,2%), while other effects from the gastrointestinal tract and signs of urinary retention were infrequent.

Adverse drug reaction (NLR) is related to local tolerability included throat irritation, nasopharyngitis, rhinitis and sinusitis. In recommended doses, the drug Siberry Breezhaler has no effect on blood pressure (BP) and heart rate.

Safety and tolerability of the drug Siberry Breezhaler were investigated in the application of the 1353 patients with COPD the recommended dose is 50 mg 1 time a day. Of these, 842 patients were treated for at least 26 weeks and 351 and not less than 52 weeks.

To assess the frequency of NLR used the following criteria: very often (>,1/10), often (>,1/100, <,1 10="">,1/1000, <,1 100="">,1/10000, 1/1000), very rare (<,1 10000="" span="">,

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

Violations of the metabolic and nutritional: rarely - hyperglycemia.

Mental disorders: often - insomnia.

Violations of the nervous system: often - headache, rarely - hypoesthesia.

Disorders of the heart: rare - atrial fibrillation, palpitations.

Violations of the respiratory system, chest and mediastinum disorders: infrequent - congestion in the sinuses, productive cough, throat irritation, nasal bleeding.

Disorders of the digestive system: often - dry mouth, gastroenteritis, rarely - indigestion, tooth decay.

Violations of the skin and subcutaneous tissue: rare - skin rash.

Violations by musculoskeletal and connective tissue: rare - pain in the limbs, pain, skeletal muscles of the chest.

Violations of the kidney and urinary tract: often - urinary tract infection, rarely - dysuria, urinary retention.

General disorders injection site: often - fatigue, asthenia.

In a clinical study lasting 12 months identified the following additional adverse events, which occurred more frequently with use of the drug Siberry Breezhaler compared to placebo: nasopharyngitis (9.0 percent vs. 5.6%), vomiting (1.3% versus 0.7 percent), muscle pain (1.1% vs 0,7%), pain in the neck (1.3% versus 0.7%), diabetes (0.8% vs. 0%).

Special patient groups:

In elderly patients aged over 75 years the incidence of urinary tract infections and headaches when using the drug Siberry, Brighter was higher than in the placebo group (3.0% versus 1.5% and 2.3% vs 0%, respectively).

If any of the instructions side effects worsen, or You notice any side effects not mentioned in the instructions, inform your doctor.

Overdose: there is No data on overdose drug Siberry Breezhaler.

In patients with COPD on a regular inhaled drug Siberry Breezhaler a total dose of 100 and 200 mg 1 time daily for 28 days was well tolerated. Acute intoxication if swallowed capsules of the drug Siberry Breezhaler unlikely due to the low bioavailability glycopyrronium bromide when administered orally (approximately 5%).

The maximum concentration in plasma and total systemic exposure after intravenous administration of 150 micrograms glycopyrronium bromide (equivalent to 120 mcg glycopyrronium) in healthy volunteers was approximately 50 and 6 times higher, respectively, than the maximum concentration in plasma and total systemic exposure at steady state, achieved when using the drug Siberry Breezhaler inhalation of recommended doses (50 mcg, 1 time per day). Signs of overdose were not detected.

Special instructions: Siberry Breezhaler not recommended for relief of acute episodes of bronchospasm.

Paradoxical bronchospasm:

As in the cases of other inhalation therapy, the drug Siberry Breezhaler may result in paradoxical bronchospasm that may be life-threatening. In case of paradoxical bronchospasm, the drug Siberry Breezhaler should be terminated immediately and assigned to alternative therapy.

M-holinoblokirutmi effect:

Like other m-holinoblokirutuyu drug drug Siberry Breezhaler should care be exercised in patients with angle-closure glaucoma or urinary retention.

Patients should be informed about the signs and symptoms of an acute attack zakratougolna glaucoma and the need to stop using the product ARIS Breezhaler, as well as to notify your doctor if any of these signs or symptoms.

Severe renal insufficiency:

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 observed for the development of possible adverse drug reactions.

The drug Siberry Breezhaler intended for maintenance treatment of patients with COPD.

In connection with the fact that in the General population is significantly dominated by COPD patients aged over 40 years, in appointing the drug to patients under 40 years of age must have spirometric confirmation of COPD diagnosis.

The impact on the ability to perform potentially hazardous activities that require special attention and fast reactions (driving vehicles, work with moving machinery, etc.):

Siberry Breezhaler does not adversely impact the PA's ability to operate vehicles and performing potentially hazardous activities, require high concentration and psychomotor speed reactions.