Spiriva respimat cartridges with inhalation solution 2.5 mg/dose 4 ml

Indications

- for maintenance treatment of patients with COPD, chronic bronchitis, pulmonary emphysema, for maintenance therapy with persistent dyspnea, to improve the quality of life, impaired by COPD, to reduce the frequency of exacerbations;

- for additional maintenance therapy in patients with bronchial asthma with persistent symptoms of the disease while taking inhaled GCS, to reduce the symptoms of bronchial asthma, improve the quality of life and reduce the frequency of exacerbations.

Dosing regimen

The recommended therapeutic dose is 2 inhalation doses of spray from Respimat inhaler^® (5 mcg / dose) 1 time / day, at the same time of day.

In the treatment of asthma, the full therapeutic effect occurs in a few days.

Have elderly patients, patients with impaired liver function and patients with minor impaired renal function (CC 50-80 ml / min) you can use the drug Spiriva ^® Respimat^® at the recommended dose.

However, the use of the drug in patients with moderate or significant renal impairment (CC <50 ml / min) should be monitored carefully.

COPD does not usually occur in children. Safety and efficacy of the drug Spiriva^® Respimat^® at children not studied.

Rules for use of the Spiriva inhaler^® Respimat^®

Cartridge insertion and preparation for use

Before the first use of the inhaler, it is necessary to carry out the steps listed below with numbers 1-6.

1. With the green cap closed, press the locking button and at the same time remove the transparent sleeve by pulling it down.

2. Remove the cartridge from its packaging. Insert it with a narrow end into the inhaler before fixation. To make sure that the cartridge is fully inserted, you need to push the cartridge firmly onto a hard surface. In this case, the bottom of the cartridge should not be flush with the bottom edge of the inhaler, the lower part of the cartridge of silver color should be visible. Once the cartridge is inserted into the inhaler, do not remove it.

3. Put on the transparent sleeve again. After that the sleeve should not be removed anymore.

Preparation for the first use of the Spiriv inhaler^® Respimat^®

4. It is necessary to keep an inhaler of Spiriva^® Respimat^® upright with a clad green cap. Turn the transparent sleeve in the direction of the red arrows indicated on the label until it clicks (half a turn).

5. Remove the green cap.

6. Aim the Spiriva inhaler^® Respimat^® way down. Press the dose button. Close the green cap.

Repeat steps 4, 5 and 6 until an aerosol cloud appears.

Then repeat steps 4, 5 and 6 another 3 times to ensure the preparation of the inhaler for use.

Now inhaler Spiriva^® Respimat^® ready to use.

The implementation of these stages does not reduce the number of doses of the drug. After preparing the inhaler Spiriva^® Respimat^® allows you to release 30 doses (60 inhalations).

Use of the inhaler Spiriva^® Respimat^®

Should use this inhaler only 1 time / day. Every time you need to do 2 inhalations.

I. Hold the spiriva inhaler^® Respimat^® vertically with a green cap on to prevent accidental release of medication. Turn the transparent sleeve in the direction of the red arrows indicated on the label until it clicks (half a turn).

Ii. Remove the green cap. Exhale slowly and deeply. Cover your mouth tightly with your lips. The air inlet of the inhaler should be free. Direct the inhaler to the back of the pharynx.

During a slow and deep breath through the mouth, press the dose button and continue to inhale as long as possible. Hold your breath for 10 seconds or as long as convenient.

III. Repeat steps I-II to get the full dose. You should use this inhaler only 1 time / day. Each time it is necessary to do 2 inhalations.

Close the green cap of the inhaler until its next use.

If the inhaler is spiriva^® Respimat^® it has not been used for more than 7 days, you should direct it down before application and press the dose button once. If the inhaler has not been used for more than 21 days, repeat steps 4-6 until the aerosol cloud is obtained. Then repeat steps 4-6 three more times.

Determining the moment when you need to start using a new inhaler

Spiriva Inhaler^® Respimat^® contains 30 doses (60 inhalations). The dose index indicates how much approximately the drug is still left. When the inhaler pointer shows on the red area of ​​the scale, it means that the medication is left for about 7 days (14 inhalations). During this period, you need to get a prescription for the new inhaler Spiriva^® Respimat^®.

When the inhaler pointer reaches the end of the red area of ​​the scale (i.e. when 30 doses have been used), this means that the inhaler^® Respimat^® is empty. The inhaler will be automatically blocked. From this point on, rotation of the transparent sleeve will not be possible.

After first use of the inhaler, Spiriva^® Respimat^® should be disposed of no later than 3 months, even if not the entire amount of the medicine has been applied.

Inhaler Care

The mouthpiece and the metal part of the dispenser must be cleaned with a damp, soft cloth with a cloth at least once a week.

A slight discoloration of the mouthpiece does not affect the functioning of the inhaler. If necessary, wipe the inhaler also outside with a damp cloth.

Adverse Effects

Many of the adverse reactions listed below may be due to the m-anticholinergic properties of the drug.

Adverse reactions were identified based on data obtained during clinical trials and individual reports during post-registration use of the drug.

Metabolism: dehydration*.

From the nervous system: infrequently (≥0.1% and <1%) - dizziness; insomnia*.

On the part of the organ of vision: rarely (≥0.01% and <0.1%) —increased intraocular pressure, glaucoma, blurred vision.

Since the cardiovascular system: infrequently (> 0.1% and <1%) - atrial fibrillation, tachycardia (including supraventricular tachycardia), palpitations.

On the part of the respiratory system: infrequently (≥0.1% and <1%) - cough, nosebleeds, pharyngitis, dysphonia; rarely (≥0.01% and <0.1%) - paradoxical bronchospasm, laryngitis; sinusitis*.

From the digestive system: often (≥1% and <10%) - slight transient dryness of the pharyngeal mucosa; infrequently (> 0.1% and <1%) - constipation, oral candidiasis, dysphagia; rarely (≥0.01% and <0.1%) - gastroesophageal reflux, gingivitis, glossitis, stomatitis; intestinal obstruction, including paralytic intestinal obstruction *.

From the skin: rarely (≥0.01% and <0.1%) - skin infections and skin ulcers, dry skin.

Allergic reactions: infrequently (> 0.1% and <1%) - rash, itching; rarely (≥0.01% and <0.1%) - angioedema, urticaria; hypersensitivity, including immediate type of reaction *.

From the musculoskeletal system and connective tissue: swelling of joints *.

From the urinary system: infrequently (> 0.1% and <1%) - dysuria, urinary retention (more often in men with the presence of predisposing factors); rarely (≥0.01% and <0.1%) - urinary tract infection.

* in the joint database of clinical studies, these adverse reactions were not identified; only isolated reports of these adverse reactions were noted with widespread use of the drug, but the relationship with the m-holinoblokiruyuschim action of the drug has not been proven; the frequency of these rare events is difficult to estimate.

Contraindications

- children and adolescents under 18 years of age (due to the lack of data on efficacy and safety);

- hypersensitivity to atropine or its derivatives, for example, ipratropium bromide, oxitropium bromide or to any component of the drug.

Carefully the drug should be used for angle-closure glaucoma, prostatic hyperplasia, bladder neck obstruction.

Use during pregnancy and lactation

Data on the effect of the drug Spiriva^® Respimat^® for pregnancy are limited. In the study of reproductive toxicity in animals, no indications of direct or indirect adverse effects of the drug were obtained. As a precautionary measure, it is preferable to refrain from using the drug Spiriva.^® Respimat^® during pregnancy.

There are no clinical data on the effect of tiotropium bromide during breastfeeding.

The drug should not be used in pregnant or lactating women, unless the expected benefit to the mother outweighs the potential risk to the fetus and child. For the period of use of the drug it is necessary to stop breastfeeding.

Application for violations of the liver

Have patients with impaired liver function you can use the drug Spiriva^® Respimat^® at the recommended dose.

Application for violations of kidney function

Have patients with minor impaired renal function (CC 50-80 ml / min) you can use the drug Spiriva^® Respimat^® at the recommended dose.

However, the use of the drug in patients with moderate or significant renal impairment (CC <50 ml / min) should be monitored carefully.

Use in children

Contraindicated purpose children and adolescents under the age of 18 (due to the lack of data on efficacy and safety).

Use in elderly patients

Have elderly patients you can use the drug Spiriva^® Respimat^® at the recommended dose.

special instructions

Drug Spiriva^® Respimat^®as a bronchodilator, used 1 time / day for maintenance treatment, should not be used as an initial treatment for acute attacks of bronchospasm or to eliminate acute symptoms. In the case of an acute attack, high-speed β are used.₂agonists.

Drug Spiriva^® Respimat^® should not be used for the treatment of bronchial asthma as a first-line therapy. Patients should be recommended while taking the drug Spiriva^® Respimat^® continue anti-inflammatory therapy (for example, inhaled GCS), even if the symptoms diminish.

Following the use of the drug may develop immediate hypersensitivity reactions.

Inhalation of the drug may cause bronchospasm.

In moderate or severe renal failure (QC ≤ 50 ml / min), the drug should be taken under close supervision, as with all medications excreted primarily by the kidneys.

Before use, patients should be familiar with the instructions for use.

Do not allow the solution or aerosol in the eyes. Pain or discomfort in the eyes, blurred vision, visual halos combined with red eyes, swelling of the conjunctiva and cornea can be symptoms of acute angle-closure glaucoma. With the development of any combination of these symptoms should immediately consult a specialist. Eye drops with a miotic effect are not considered an effective treatment.

Spiriva^® Respimat^® should not be used more often than 1 time / day.

Spiriva Cartridges^® should only be used with Respimat inhaler^®.

Influence on ability to drive motor transport and control mechanisms

Studies on the effect on the ability to drive vehicles and mechanisms have not been conducted. Care should be taken when performing these activities, because may develop dizziness or blurred vision.

Overdose

When using the drug in high doses, manifestations of m-anticholinergic blocking action are possible. After a 14-day inhalation use of tiotropium bromide in doses up to 40 μg, no significant adverse events were observed in healthy individuals, except for a feeling of dryness of the mucous membranes of the nose and oropharynx, the frequency of which depended on the dose (10-40 μg / day). The exception was a clear decrease in salivation, starting from day 7 of the drug.In six long-term studies in patients with COPD with inhalation use of a solution of tiotropium bromide in a daily dose of 10 μg for 4-48 weeks, no significant adverse events were observed.

Due to the low oral bioavailability, the occurrence of acute intoxication in case of unintentional ingestion of a solution of tiotropium bromide for inhalation from the cartridge is unlikely.

Drug interaction

Although there have been no specific drug interaction studies, tiotropium bromide has been used in conjunction with other drugs used to treat COPD, including sympathomimetic bronchodilators, methylxanthines, GCS for oral and inhalation use, antihistamines, mucolytics, leukotriene modifiers, cromones, anti-IgE drugs; there were no clinical signs of drug interaction.

Long-term combined use of tiotropium bromide with other m-anticholinergic drugs has not been studied. Therefore, long-term joint use of the drug Spiriva^® Respimat^® with other m-holinoblokiruyuschimi drugs is not recommended.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not higher than 25 ° C.