Sibri Breezhaler capsules 50mg, No. 30

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

Inhalation

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 BreezhalerЃ, which is included in the package. The drug should not be taken orally. Powder capsules for inhalation should be stored in and removed from the blister immediately before use.

The recommended dose of SibriЃ BreezhalerЃ is 50 ?g (contents of 1 capsule) 1 time per day. Inhalation of the drug is carried out daily 1 time per day at the same time. If 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.

Before using the drug SibriЃ BreezhalerЃ, patients should be instructed on the correct use of the inhaler.

If there is no improvement in respiratory function, you should make sure that the patient is using the drug correctly. The drug should be inhaled, not swallowed.

Special patient groups

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

Liver failure. Special clinical studies in patients with impaired liver function have not been conducted. The drug SibriЃ BreezhalerЃ is excreted mainly by renal excretion, therefore, a significant increase in exposure in patients with impaired liver function is not expected. In patients with impaired liver function, the recommended dose of SibriЃ BreezhalerЃ may be used.

Elderly patients. The drug SibriЃ BreezhalerЃ can be used at the recommended dose in patients aged 75 years and older.

Directions for use of the BreezhalerЃ inhalation device

Each package of SibriЃ BreezhalerЃ contains:

- 1 inhalation device BreezhalerЃ;

- blisters with capsules with powder for inhalation.

Powder inhalation capsules should not be taken orally.

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

For inhalation of capsules contained in the package, only the BreezhalerЃ inhalation device is used.

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

Throw away BreezhalerЃ after 30 days of use.

Using an inhaler

1. Remove the cover.

2. Open BreezhalerЃ: To open the inhaler, grasp the base firmly and tilt the mouthpiece.

3. Prepare a capsule: separate 1 bl. from the blister package 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. Take out the capsule: the 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 BreezhalerЃ: put the capsule in the capsule chamber; never put a capsule directly into the mouthpiece.

6. Close BreezhalerЃ: close the inhaler tightly; when it is fully closed, a click should be heard.

7. Pierce the capsule: hold BreezhalerЃ in an upright position with the mouthpiece pointing up; simultaneously press both buttons fully; when the capsule is pierced, a click should be heard; do not press the buttons to pierce the capsule more than once.

8. Fully release the buttons on both sides of the BreezhalerЃ inhaler.

9. Exhale; exhale completely before inserting the mouthpiece into your mouth; never blow into the mouthpiece.

10. Inhale the drug: hold BreezhalerЃ in your hand so that the buttons are on the left and right (and not above and below); put the mouthpiece of the BreezhalerЃ inhaler into your mouth and press your lips tightly around it; take a quick, even, deepest breath; do not press the buttons on the lancing device.

11. Pay attention. When inhaled through the inhaler, a characteristic rattling sound should be heard, created by rotating the capsule in the chamber and spraying the powder. The patient may feel a sweetish taste of the drug in the mouth. If no rattling sound is heard, 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 capsule piercing buttons. Repeat steps 9 and 10 if necessary.

12. Hold your breath: if a characteristic sound is heard during inhalation, hold your breath as long as possible (so as not to experience discomfort), and at the same time remove the mouthpiece from your mouth; then exhale. Open BreezhalerЃ and see if any powder remains in the capsule. If powder remains in the capsule, close BreezhalerЃ and repeat steps 9-12. Most people can empty a capsule in 1 or 2 inhalations. Some people have a cough for a short time after inhaling the drug, but you 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 capsule: after taking the daily dose of SibriЃ BreezhalerЃ, tilt the mouthpiece, remove the empty capsule by tapping on the inhaler and discard it. Close the mouthpiece of the BreezhalerЃ inhaler and close the BreezhalerЃ lid. Do not store capsules in the BreezhalerЃ inhaler.

Remember the following:

Do not swallow capsules with powder for inhalation.

Use only BreezhalerЃ included in the package.

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

Never insert a capsule into the mouthpiece of a BreezhalerЃ inhaler.

Do not press down on the lancing device more than once.

Never blow into the mouthpiece of the BreezhalerЃ inhaler.

Always pierce the capsule prior to inhalation.

Do not wash BreezhalerЃ. Keep it dry (see How to Clean BreezhalerЃ).

Do not disassemble BreezhalerЃ.

When starting a new package of the drug, always use the new BreezhalerЃ provided in the package for inhalation of capsules.

Do not store capsules in the BreezhalerЃ inhaler.

Always store capsule blisters and BreezhalerЃ in a dry place.

Additional Information

In very rare cases, a small amount of the contents of the capsules may enter the mouth.

Do not worry when inhaling or swallowing the drug.

If the capsule is pierced more than once, the risk of breaking it increases.

How to clean BreezhalerЃ

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

hypersensitivity to glycopyrronium bromide or any other components that make up the drug;

simultaneous reception with inhalation drugs containing other m-anticholinergics;

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

age up to 18 years.

With care: angle-closure glaucoma; diseases accompanied by urinary retention; severe renal failure (GFR below 30 ml / min / 1.73 m2), including end-stage renal failure requiring hemodialysis (SibriЃ BreezhalerЃ should be used only if the expected benefit outweighs the potential risk); unstable coronary heart disease; a history of myocardial infarction; heart rhythm disturbances; lengthening of the QTc interval (QT corrected> 0.44 s).