Spiriva capsules + inhaler 18mkg №30

Indications

- as maintenance therapy in patients with COPD, including chronic bronchitis and emphysema (maintenance therapy with persistent dyspnea and to prevent exacerbations).

Dosage and administration

Assign 1 capsule / day at the same time in the form of inhalation using the inhaler HandiHaler^®.

The drug should not be swallowed. Spirivu should not be used more than 1 time per day. Spiriva Capsules should only be used with a HandiHaler inhaler.^®.

Elderly patients the drug should be taken in recommended doses.

At renal dysfunction Patients can use Spiriva in recommended doses. However, in the appointment of Spiriva in combination with other drugs that are excreted mainly by the kidneys, it is necessary to monitor the condition of the patients. Patients with moderate to severe renal failure (CK≤50 ml / min) need careful observation.

Patients with liver failure may take the drug in recommended doses.

Method of use of the inhaler HandiHaler^®

Inhaler HandiHaler^® designed specifically for use Spiriva and is not intended to receive other drugs.

The inhaler includes: a dust cap, a mouthpiece, a base, a piercing button, a central chamber.

Use of the inhaler HandiHaler^®:

one.Open the dust cap by pressing the piercing button completely and then releasing it.

2. Fully open the dust cap by lifting it up; then open the mouthpiece, lifting it up.

3. Immediately before use, take the Spiriva capsule out of the blister and put it in the central chamber (it does not matter which side the capsule is placed in the chamber).

4. Tightly close the mouthpiece until it clicks, leave the dust cap open.

5. Holding a HandiHaler^® mouthpiece up, press the piercing button once to the end and then release; thus, a hole is formed through which the drug is released from the capsule during inhalation.

6. Exhale completely; never exhale into the mouthpiece.

7. Take HandiHaler^® in the mouth and tightly squeeze the lips around the mouthpiece; keeping your head straight, inhale slowly and deeply, but at the same time with sufficient force to hear the vibration of the capsule; inhale until the lungs are completely filled; then hold your breath for as long as possible and take out the HandiHaler^® from mouth; keep breathing calmly; repeat procedures 6 and 7 to empty the capsule completely.

8. Next, re-open the mouthpiece, remove and discard the used capsule. Close the mouthpiece and dust cap.

HandiHaler inhaler cleaning^®

HandiHaler cleaning^® should be carried out 1 time per month. To do this, you need to open the mouthpiece and dust cap, then open the base of the device by lifting the piercing button. Rinse the inhaler thoroughly in warm water until the powder is completely removed. Handihaler^® wipe with a paper towel and leave the mouthpiece open, the base and dust cap leave to air dry for 24 hours. After cleaning in this way, the device is ready for subsequent use. If necessary, the outer surface of the mouthpiece can be cleaned with a damp but not wet cloth.

Blister opening

Separate the blister strip along the perforated line. Open the blister strip immediately before use so that one capsule is fully visible. The capsule contains a small amount of powder, so it is not completely filled.

If the capsule was accidentally opened and exposed to air, it should not be used. Neither the device nor the blister capsules should not be exposed to high temperatures, exposure to sunlight.

Adverse effects

From the digestive system: slight dry mouth, often disappearing with continued treatment (≥1% and <10%); oral candidiasis (≥0.1% and <1%); constipation, gastroesophageal reflux (≥0.01% and <1%); in rare cases - intestinal obstruction (including paralytic ileus), dysphagia.

Respiratory: dysphonia, bronchospasm, cough and local pharynx irritation (≥0.1% and <1%); epistaxis (≥0.01% and <1%).

Cardiovascular: tachycardia, palpitations (≥0.01% and <1%); in isolated cases - supraventricular tachycardia, atrial fibrillation.

From the side of the central nervous system: dizziness (≥0.1% and <1%).

Urogenital: difficulty urinating and urinary retention in men with predisposing factors, urinary tract infections (≥0.01% and <1%).

Allergic reactions: rash, urticaria, pruritus, hypersensitivity reactions, including immediate type reactions (≥ 0.01% and <1%); in rare cases, angioedema.

Other: in rare cases - blurred vision, increased intraocular pressure (≥0.01% and <1%); glaucoma.

Most of the above side reactions may be associated with the anticholinergic effect of Spiriva.

Contraindications

- I trimester of pregnancy;

- children's and teenage age up to 18 years;

- hypersensitivity to atropine or its derivatives (including to ipratropium and oxitropium);

- hypersensitivity to the drug.

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

Use during pregnancy and lactation

The drug is contraindicated for use in the first trimester of pregnancy.

In the II and III trimesters of pregnancy and lactation, the drug should be prescribed only in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus or infant.

Application for violations of the liver

Patients with liver failure may take the drug in recommended doses.

Application for violations of kidney function

At renal dysfunction Patients can use Spiriva in recommended doses. However, in the appointment of Spiriva in combination with other drugs that are excreted mainly by the kidneys, it is necessary to monitor the condition of the patients. Patients with moderate to severe renal failure (CK≤50 ml / min) need careful observation.

Use in children

It is contraindicated in children and adolescents under the age of 18 years.

Use in elderly patients

Elderly patients the drug should be taken in recommended doses.

Special notes

Drug Spiriva^® not intended for the relief of acute attacks of bronchospasm.

After inhalation of Spiriva powder, the development of immediate type hypersensitivity reactions is possible.

The process of inhalation of Spiriva (as well as other inhalants) can cause bronchospasm.

Patients with renal insufficiency (CC ≤ 50 ml / min) should be carefully monitored when administering Spiriva.

Patients should be familiarized with the use of the inhaler. Do not allow the powder to get into the eyes. Eye pain or discomfort, blurred vision, visual halos in combination with red eyes, conjunctival stagnation and corneal edema may indicate an acute attack of angle-closure glaucoma. With the development of any combination of these symptoms, the patient should immediately consult a doctor.Using only drugs that cause miosis is not an effective treatment in this case.

One capsule contains 5.5 mg of lactose monohydrate.

Use in pediatrics

The drug is contraindicated in children and adolescents under the age of 18.

Influence on ability to drive motor transport and control mechanisms

Studies on the effect of the drug on the ability to drive vehicles and control mechanisms have not been conducted. Cases of dizziness and blurred vision when using the drug can have a negative impact on the aforementioned ability.

Overdosage

Symptoms: with the use of high doses, manifestations of anticholinergic action are possible - dry mouth, accommodation disturbances, and an increase in heart rate.

After inhalation of a single dose of up to 282 µg in healthy volunteers, no systemic anticholinergic effects were detected. After repeated administration of a single daily dose of 141 µg in healthy volunteers, bilateral conjunctivitis was observed in combination with dry mouth, which disappeared with continued treatment. In a study that examined the effects of tiotropium with repeated use in patients with COPD who received a maximum of 36 μg of the drug for more than 4 weeks, dry mouth was the only side effect.

Acute intoxication associated with accidental ingestion of capsules is unlikely due to the low bioavailability of the drug.

Drug interaction

It is possible to assign Spiriva in combination with other drugs commonly used for the treatment of COPD: sympathomimetics, methylxanthine derivatives, oral and inhaled GCS.

Limited information on co-administration with anticholinergics was obtained from two clinical studies: a single dose of 1 dose of ipratropium bromide against the background of continuous use of Spiriva in patients with COPD (64 people) and healthy volunteers (20 people) did not lead to a decrease in adverse reactions, changes in life parameters and ECG. However, the constant combined use of anticholinergic drugs and Spiriva has not been studied and, therefore, is not recommended.

Terms and conditions of storage

The drug should be stored out of reach of children at a temperature not exceeding 25 ° C; do not freeze.