Striverdi respimat

Package leaflet: Information for the patient

Striverdi Respimat, 2.5 micrograms per delivered dose, solution for inhalation
olodaterol
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Striverdi Respimat is and what it is used for
2. Before you use Striverdi Respimat
3. How to use Striverdi Respimat
4. Possible side effects
5. How to store Striverdi Respimat
6. Contents of the pack and other information

1. What Striverdi Respimat is and what it is used for

Striverdi Respimat helps patients with chronic obstructive pulmonary disease (COPD) to breathe better. COPD is a chronic lung disease that causes breathlessness and cough. COPD is associated with chronic bronchitis and emphysema. COPD is a chronic condition, therefore Striverdi Respimat must be taken every day, not only when breathing problems or other COPD symptoms occur.
The active substance in Striverdi Respimat is olodaterol, a long-acting beta-2 agonist bronchodilator, which helps open the airways and allows air to move in and out of the lungs more easily. Regular use of Striverdi Respimat may also help reduce persistent breathlessness caused by the disease and help lessen the impact of the disease on daily life.

2. Important information before using Striverdi Respimat

When not to use Striverdi Respimat:

• if the patient is allergic to olodaterol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Striverdi Respimat, discuss this with your doctor or
pharmacist:

• if the patient has asthma (Striverdi Respimat should not be used for the treatment of asthma),
• if the patient has heart diseases,
• if the patient has high blood pressure,
• if the patient has epilepsy,
• if the patient has hyperthyroidism,
• in case of abnormal dilation of an artery – aneurysm,
• if the patient has diabetes,
• if the patient has severe liver disease, as Striverdi Respimat has not been studied in this patient population,
• if the patient has severe kidney disease, as experience with using Striverdi Respimat in this patient population is limited,
• if surgery is planned.

While using Striverdi Respimat

• If the patient experiences chest tightness, cough, wheezing, or shortness of breath immediately after using the medicine, the use of the medicine must be stopped and the doctor must be informed immediately. These may be symptoms of bronchospasm (see section 4).
• If breathing problems worsen or if rash, swelling, or itching occur immediately after inhalation, the use of the medicine must be stopped and the patient must contact a doctor immediately (see section 4).
• If any heart-related adverse effects occur (increased heart rate, increased blood pressure, and/or worsening of symptoms such as chest pain), the doctor must be informed immediately (see section 4).
• If muscle cramps, muscle weakness, or irregular heartbeat occur, consult a doctor, as these may be related to low potassium levels in the blood (see section 4).

Striverdi Respimat is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD). It should not be used to treat sudden attacks of breathlessness or wheezing.
Striverdi Respimat should not be used in combination with certain medicines containing long-acting beta-agonists such as salmeterol or formoterol.
If the patient regularly uses certain medicines containing long-acting beta-agonists such as salmeterol or formoterol, their use should continue only for the treatment of acute symptoms such as breathlessness.
Children and adolescents
Striverdi Respimat must not be given to children and adolescents (under 18 years of age).
Striverdi Respimat and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken.
In particular, inform the doctor about the use of:

• certain medicines used for breathing problems that are similar to Striverdi Respimat (beta-adrenergic blockers). The patient may be more susceptible to adverse effects.
• medicines belonging to the group of beta-adrenergic receptor blockers used in the treatment of hypertension or other heart conditions (such as propranolol) or medicines used in the treatment of an eye disease called glaucoma (such as timolol). These may weaken the effect of Striverdi Respimat.
• medicines that lower potassium levels in the blood. These include:
  • steroids (e.g., prednisolone),
  • diuretics (tablets that increase urine output),
• medicines used for breathing problems, such as theophylline. Taking these medicines together with Striverdi Respimat may cause symptoms such as: muscle cramps, muscle weakness, or heart rhythm disturbances.
  • tricyclic antidepressants or MAO inhibitors (e.g., selegiline or moclobemide), used in the treatment of neurological and psychiatric disorders such as Parkinson's disease or depression; using these medicines increases the likelihood of heart-related adverse effects.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Studies on the effect of the medicine on the ability to drive and operate machinery have not been conducted.
If dizziness occurs during treatment with Striverdi Respimat, the patient should not drive, use tools, or operate machinery.
Striverdi Respimat contains benzalkonium chloride
This medicine contains 0.0011 mg of benzalkonium chloride per spray.
Benzalkonium chloride may cause wheezing or respiratory disturbances (bronchospasm), especially in patients with asthma.

3. How to use Striverdi Respimat

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Striverdi Respimat is intended for inhalation use only.
Dosage
Recommended dose:
Striverdi Respimat works for 24 hours, therefore it should be taken ONCE DAILY, preferably at the
same time each day. Two actuations should be administered with each use.
Since COPD is a chronic condition, Striverdi Respimat should be used every day, not only when
breathing problems occur. Do not exceed the recommended dose.
Ensure that you are using the Respimat reusable inhaler correctly.
Instructions for preparing the Respimat reusable inhaler are provided at the end of this leaflet; see
section “Instructions for use of the Respimat reusable inhaler”.
Use in children and adolescents
Striverdi Respimat is not recommended for use in children and adolescents (under 18 years of age).
Use of a higher than recommended dose of Striverdi Respimat
The risk of adverse effects may increase in the patient, such as: chest pain, high or low blood
pressure, faster heartbeat or sensation of irregular heartbeat or palpitations, dizziness, nervousness,
sleep disturbances, anxiety, headache, tremor, dry mouth, muscle cramps, nausea, fatigue,
malaise, low blood potassium levels (which may cause muscle cramps, muscle weakness, and
heart rhythm disturbances), high blood glucose levels, or excess acid in the blood (which may cause
symptoms such as: nausea, vomiting, weakness, muscle cramps, and faster breathing).
Missed dose of Striverdi Respimat
If a dose is missed, take only one dose the next day at the usual time.
Do not use a double dose to make up for a missed dose.
Stopping Striverdi Respimat
Before stopping treatment with Striverdi Respimat, consult your doctor or pharmacist. Symptoms of
COPD may worsen after discontinuation of Striverdi Respimat.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been reported in patients taking this medicine and are listed
according to their frequency of occurrence, as either uncommon or rare.

Uncommon (may occur in fewer than 1 in 100 people):

• Nasal and throat inflammation (common cold)
• Dizziness
• Rash

Rare (may occur in fewer than 1 in 1,000 people):

• Joint pain
• Hypertension

Patients may also experience adverse reactions that occur with other medicines similar to Striverdi Respimat (beta-adrenergic agents) used for breathing problems. These may include faster or irregular heartbeat, palpitations, chest pain, high or low blood pressure, muscle tremors, headache, nervousness, sleep disturbances, dizziness, dry mouth, nausea, muscle cramps, fatigue, malaise, low potassium levels in the blood (which may cause muscle cramps, muscle weakness, and heart rhythm disturbances), high blood glucose levels, or excess acid in the blood (which may cause symptoms such as nausea, vomiting, weakness, muscle cramps, and rapid breathing).

Immediate allergic reactions may occur after administration of Striverdi Respimat, such as rash, urticaria, swelling of the mouth or face, or sudden breathing difficulties (angioedema), or other hypersensitivity reactions. If any of these symptoms occur, treatment with Striverdi Respimat should be stopped immediately and medical advice should be sought without delay.

As with other inhaled medicines, some patients may experience sudden chest tightness, cough, wheezing, or shortness of breath immediately after inhalation of Striverdi Respimat.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301; fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl.

Adverse reactions can also be reported to the Marketing Authorisation Holder. Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Striverdi Respimat

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the medicine cartridge: EXP. The expiry date refers to the last day of the stated month.
Do not freeze.
Period of use after first use
The medicine cartridge should be replaced no later than three months after inserting it into the inhaler.
Do not use the Respimat reusable inhaler for longer than one year.
Recommended usage: 6 medicine cartridges per inhaler.
Note: The performance of the Respimat reusable inhaler has been demonstrated in studies for 540 actuations (equivalent to 9 medicine cartridges).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Striverdi Respimat contains
The active substance is olodaterol. One delivered dose contains 2.5 micrograms of olodaterol
(as hydrochloride) per spray.
The delivered dose is the amount of drug available to the patient after passing through the inhaler mouthpiece.
The other ingredients are: benzalkonium chloride, disodium edetate, purified water, anhydrous citric acid.

What Striverdi Respimat looks like and contents of the pack
Striverdi Respimat 2.5 micrograms/delivered dose consists of one cartridge containing a solution for inhalation and one Respimat inhaler. Before first use, the provided cartridge must be inserted into the inhaler.
Single pack: 1 reusable Respimat inhaler and 1 medicine cartridge providing 60 sprays (30 therapeutic doses).
Triple pack: 1 reusable Respimat inhaler and 3 medicine cartridges, each providing 60 sprays (30 therapeutic doses).
Single refill pack: 1 medicine cartridge providing 60 sprays (30 therapeutic doses).
Triple refill pack: 3 medicine cartridges, each providing 60 sprays (30 therapeutic doses).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Boehringer Ingelheim International GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Manufacturers:
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Boehringer Ingelheim France
100-104 Avenue de France
75013 Paris
France

For further information, contact the local representative of the Marketing Authorisation Holder:
Poland
Boehringer Ingelheim Sp. z o.o.
Tel: +48 22 699 0 699

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria, Liechtenstein, Belgium, Luxembourg, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Malta, United Kingdom (Northern Ireland), Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden: Striverdi Respimat
Bulgaria: Стриверди Респимат

Instructions for use of the reusable Respimat inhaler
Respimat is an inhaler that generates an aerosol for inhalation. Respimat is intended for use by a single patient only. One medicine cartridge delivers multiple doses. The reusable Respimat inhaler allows cartridge replacement and can be used with up to 6 cartridges. Please read the following instructions carefully before starting to use Striverdi Respimat.
This inhaler must be used ONCE DAILY. Each time, inhale the medication released during TWO SPRAYS.

• If Striverdi Respimat has not been used for more than 7 days, release one spray with the inhaler pointed away from the eyes.
• If Striverdi Respimat has not been used for more than 21 days, repeat the steps described in points 4–6 in the section "Getting started" until a mist appears. Then repeat steps 4 to 6 three more times.

How to care for the reusable Respimat inhaler
Clean the mouthpiece, including the metal part inside, at least once a week using only a damp cloth or wipe.
Slight discolouration of the mouthpiece does not affect the performance of the reusable Respimat inhaler.
If necessary, wipe the outer surface of the reusable Respimat inhaler with a damp cloth.

When to replace the inhalator
After using the inhaler with 6 cartridges, purchase a new Striverdi Respimat pack containing a new inhaler. Do not use the reusable Respimat inhaler for longer than one year from the date the first cartridge was inserted.

Getting started

1. Remove the transparent base Keep the cap closed. Press the safety button while removing the transparent base with the other hand.
2. Insert the medicine cartridge Insert the medicine cartridge into the inhaler. Place the inhaler on a hard surface and press down firmly until the cartridge clicks into place.
3. Monitor the number of used medicine cartridges and reinsert the transparent base Mark the box on the inhaler label to track the number of used cartridges. Reinsert the transparent base until you hear a click.
4. Turn Keep the cap closed. Turn the transparent base in the direction indicated by the arrows until you hear a click (half a turn).
5. Open Open the cap fully by lifting it up.
6. Press Point the inhaler downward toward the ground. Press the dose release button. Close the cap. Repeat the steps described in points 4–6 until a visible mist appears. Once the mist appears, repeat the steps in points 4–6 three more times. The inhaler is now ready for use and will deliver 60 sprays (30 doses).

Daily use

ROTATE Keep the cap closed. ROTATE the transparent base in the direction indicated by the arrows until you hear a click (half a turn).
OPEN OPEN the cap fully.
PRESS Breathe out slowly and fully. Place your mouth tightly around the mouthpiece, without covering the air inlet. Point the inhaler toward the back of your throat. While breathing in slowly and deeply through your mouth, PRESS the dose release button and continue inhaling slowly, as long as comfortable. Hold your breath for 10 seconds, or as long as comfortable. Repeat the ROTATE, OPEN, PRESS steps to take a total of 2 sprays. Close the cap for future use of the inhaler.

When to replace the Striverdi Respimat cartridge
The dose indicator shows the number of sprays remaining in the cartridge.

60 sprays remaining

Fewer than 10 sprays remaining. Please purchase a new cartridge.

The cartridge is empty. Rotate the transparent base to release it.
The inhaler is now locked. Remove the cartridge from the reusable inhaler.
Insert a new cartridge into the reusable inhaler until you hear a click (see step 2).
The newly inserted cartridge will protrude further than the first one inserted (continue
from step 3). Remember to replace the transparent base to unlock the inhaler.

Answers to frequently asked questions

I am having difficulty inserting the cartridge deep enough.
Have you accidentally rotated the transparent base before inserting the cartridge?
Open the cap, press the dose release button, and then insert the cartridge.

Are you replacing the cartridge? The next, new cartridge will protrude more than the first cartridge. Insert it until you hear a click, then replace the transparent base.

I cannot press the dose release button.
Have you replaced the transparent base? If not, replace the transparent base. The Respimat reusable inhaler only works when the transparent base is correctly in place.

Have you rotated the transparent base? If not, rotate the transparent base continuously until you hear a click (half a turn).

Does the dose indicator on the cartridge display a white arrow on a red background?
Your cartridge is empty. Insert a new cartridge and replace the transparent base.

It is difficult to remove the cartridge after it has been used.
Pull and simultaneously rotate the cartridge.

I cannot rotate or replace the transparent base.
Is the transparent base loose and does the dose indicator on the cartridge display a white arrow on a red background?
Your cartridge is empty. Insert a new cartridge.

Have you already rotated the transparent base?
If the transparent base has already been rotated, to administer the medication, perform the steps described under “OPEN” and “PRESS” in the section “Daily use”.

My Striverdi Respimat inhaler ran out too quickly.
Have you used Striverdi Respimat as directed (two sprays once daily)? Each cartridge contains 30 days’ supply of medication when two sprays are used once daily.

Have you frequently activated the Striverdi Respimat inhaler to check if it is working properly? After preparing the Striverdi Respimat inhaler for use, there is no need to check its function if it is used daily.

Have you repeatedly removed and replaced the transparent base? Do not remove the transparent base before the cartridge is used up. Each time the transparent base is removed without replacing the cartridge, the dose counter records one spray, reducing the number of doses remaining.

My Striverdi Respimat inhaler does not activate.
Have you inserted the cartridge? If not, insert the cartridge. After assembling the Striverdi Respimat set, do not remove the transparent base or the cartridge until the cartridge is used up.

After inserting the cartridge, did you repeat the steps “Rotate”, “Open”, “Press” fewer than three times? After inserting the cartridge, repeat the steps “Rotate”, “Open”, “Press” three times, as shown in steps 4–6 in the section “Preparing for use”.

Does the dose indicator on the cartridge display a white arrow on a red background?
Your cartridge is empty. Insert a new cartridge.

My Striverdi Respimat inhaler activates on its own.
Was the cap open while rotating the transparent base? Close the cap, then rotate the transparent base.

Did you press the dose release button while rotating the transparent base? Close the cap so that the dose release button is covered, then rotate the transparent base.

Did you stop rotating the transparent base before hearing the click? Rotate the transparent base continuously until you hear a click (half a turn). The dose counter registers each incomplete rotation, reducing the number of doses remaining.

Was the cap open when replacing the cartridge? Close the cap, then replace the cartridge.