Striverdi Respimat

Leaflet accompanying the packaging: patient information

Striverdi Respimat, 2.5 micrograms/delivered dose, inhalation solution

olodaterol

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 specifically for you. 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.

Table of contents of the leaflet:

• 1. What is Striverdi Respimat and what is it used for
• 2. Important information before using 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 is Striverdi Respimat and what is it used for

Striverdi Respimat makes it easier for patients with chronic obstructive pulmonary disease (COPD) to breathe. COPD is a chronic lung disease that causes shortness of breath and coughing. COPD is associated with chronic bronchitis and emphysema. Since COPD is a chronic disease, Striverdi Respimat should be taken every day, not just when breathing problems or other COPD symptoms occur.
The active substance of Striverdi Respimat is olodaterol, a long-acting bronchodilator (long-acting beta-2 agonist) that helps open the airways and makes it easier for air to enter and leave the lungs. Regular use of Striverdi Respimat can also help reduce persistent shortness of breath associated with the disease and help reduce the impact of the disease on daily life.

2. Important information before using Striverdi Respimat

When not to use Striverdi Respimat:

• if you are 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 with your doctor or pharmacist:

• if you have asthma (Striverdi Respimat should not be used to treat asthma),
• if you have heart disease,
• if you have high blood pressure,
• if you have epilepsy,
• if you have hyperthyroidism,
• in case of abnormal enlargement of the artery - aneurysm,
• if you have diabetes,
• if you have severe liver disease, as Striverdi Respimat has not been studied in this patient population,
• if you have severe kidney disease, as experience with the use of Striverdi Respimat in this patient population is limited,
• if surgery is planned.

During use of Striverdi Respimat

• If you experience chest tightness, cough, wheezing, and shortness of breath immediately after using the medicine, stop taking the medicine and inform your doctor immediately. These may be symptoms of bronchospasm (see section 4).
• If breathing problems worsen or a rash, swelling, or itching occur immediately after inhalation, stop taking the medicine and see a doctor immediately (see section 4).
• If you experience any side effects related to the heart (increased heart rate, increased blood pressure, and/or worsening of symptoms such as chest pain), inform your doctor immediately (see section 4).
• If you experience muscle spasms, muscle weakness, or irregular heartbeat, consult your doctor, as this 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. It should not be used to treat sudden attacks of shortness of breath or wheezing.
Do not take Striverdi Respimat in combination with certain medicines containing long-acting beta-mimetics, such as salmeterol or formoterol.
If you regularly take certain medicines containing long-acting beta-mimetics, such as salmeterol or formoterol, their use should be continued only for the treatment of acute symptoms such as shortness of breath.

Children and adolescents

Do not give Striverdi Respimat to children and adolescents (under 18 years of age).

Striverdi Respimat and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken.
In particular, inform your doctor about taking:

• certain medicines used for breathing problems that are similar to Striverdi Respimat (beta-adrenergic medicines). You may be more likely to experience side effects.
• medicines belonging to the group of medicines blocking beta-adrenergic receptors used to treat high blood pressure or other heart diseases (such as propranolol) or medicines used to treat eye disease called glaucoma (such as timolol). This may weaken the effect of Striverdi Respimat.
• medicines that lower potassium levels in the blood. These include:
• corticosteroids (e.g., prednisolone),
• diuretics (pills that increase urine production),
• medicines taken for breathing problems, such as theophylline. Taking these medicines with Striverdi Respimat may cause symptoms such as muscle spasms, muscle weakness, or irregular heartbeat.
• medicines from the group of tricyclic antidepressants or MAO inhibitors (e.g., selegiline or moclobemide), which are used to treat neurological and psychiatric disorders, such as Parkinson's disease or depression; taking these medicines with Striverdi Respimat increases the likelihood of side effects affecting the heart.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines.
If you experience dizziness while using Striverdi Respimat, do not drive, use tools, or operate machines.

Striverdi Respimat contains benzalkonium chloride

This medicine contains 0.0011 mg of benzalkonium chloride in each spray.
Benzalkonium chloride may cause wheezing or breathing difficulties (bronchospasm), especially in patients with asthma.

3. How to use Striverdi Respimat

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Striverdi Respimat is for inhalation use only.

Dosage

The recommended dose is:
Striverdi Respimat works for 24 hours, so it should be taken ONCE A DAY,
if possible at the same time every day. Each time, perform TWO SPRAYS.
Since COPD is a chronic disease, Striverdi Respimat should be used every day, not just when breathing problems occur. Do not exceed the recommended dose.
Make sure to use the Respimat multi-dose inhaler (re-usable) correctly. The instructions for preparing the Respimat multi-dose inhaler (re-usable) are at the end of the leaflet, see the section "Instructions for using the Respimat multi-dose inhaler (re-usable)".

Use in children and adolescents

There are no indications for the use of Striverdi Respimat in children and adolescents (under 18 years of age).

Using a higher dose of Striverdi Respimat than recommended

This may increase the risk of side effects, such as: chest pain, high or low blood pressure, faster or irregular heartbeat, dizziness, nervousness, sleep disturbances, anxiety, headache, tremors, dry mouth, muscle spasms, nausea, fatigue, malaise, low potassium levels in the blood (which may cause muscle spasms, muscle weakness, and irregular heartbeat), high glucose levels in the blood or too much acid in the blood (which may cause symptoms such as nausea, vomiting, weakness, muscle spasms, and rapid breathing).

Missing a dose of Striverdi Respimat

If you miss an inhalation, take only one dose the next day at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping use of Striverdi Respimat

Before stopping the use of Striverdi Respimat, consult your doctor or pharmacist. After stopping the use of Striverdi Respimat, COPD symptoms may worsen.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported in patients taking this medicine and are listed according to their frequency, as uncommon or rare.
Uncommon (may affect up to 1 in 100 people):

• nasopharyngitis (common cold)
• dizziness
• rash

Rare (may affect up to 1 in 1,000 people):

• joint pain
• high blood pressure

You may also experience side effects that occur when using other medicines similar to Striverdi Respimat (beta-adrenergic medicines), which are used for breathing problems. This may include faster or irregular heartbeat, chest pain, high or low blood pressure, tremors, headaches, nervousness, sleep disturbances, dizziness, dry mouth, nausea, muscle spasms, fatigue, malaise, low potassium levels in the blood (which may cause muscle spasms, muscle weakness, and irregular heartbeat), high glucose levels in the blood or too much acid in the blood (which may cause symptoms such as nausea, vomiting, weakness, muscle spasms, and rapid breathing).
After using Striverdi Respimat, immediate allergic reactions, such as rash, hives, swelling of the mouth and face, or sudden breathing difficulties (angioedema) or other hypersensitivity reactions may occur. If you experience any of these symptoms, stop taking Striverdi Respimat and contact your doctor immediately.
As with other inhaled medicines, after inhaling Striverdi Respimat, some patients may experience sudden chest tightness, cough, wheezing, or shortness of breath.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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.
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Striverdi Respimat

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the cartridge after: EXP. The expiry date refers to the last day of the month.
Do not freeze.
Shelf life after first use
The cartridge should be replaced no later than three months after it has been inserted into the inhaler.
The Respimat multi-dose inhaler (re-usable) should not be used for more than one year.
Recommended use: 6 cartridges per inhaler.
Note: The Respimat multi-dose inhaler (re-usable) has been tested for 540 sprays (equivalent to 9 cartridges).
Medicines should 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.
Delivered dose is the dose that is available to the patient after passing through the mouthpiece of the inhaler.
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 an inhalation solution and one Respimat inhaler. Before first use, insert the cartridge into the inhaler.
Single pack: 1 Respimat multi-dose inhaler (re-usable) and 1 cartridge delivering 60 sprays (30 medicinal doses).
Triple pack: 1 Respimat multi-dose inhaler (re-usable) and 3 cartridges, each delivering 60 sprays (30 medicinal doses).
Single refill pack: 1 cartridge delivering 60 sprays (30 medicinal doses).
Triple refill pack: 3 cartridges, each delivering 60 sprays (30 medicinal doses).
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Boehringer Ingelheim International GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Manufacturer:
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
To obtain more detailed information, contact the representative of the marketing authorization holder:
Poland
Boehringer Ingelheim Sp. z o.o.
Tel: +48 22 699 0 699

This medicine is authorized in the Member States of 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

Date of last revision of the leaflet: 12/2024

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Instructions for using the Respimat multi-dose inhaler (re-usable)

Respimat is an inhaler that produces an aerosol for inhalation. Respimat is intended for use by one patient only. One cartridge contains multiple doses. The Respimat multi-dose inhaler (re-usable) allows the cartridge to be replaced and can be used with up to 6 cartridges.
Read the following instructions before starting to use Striverdi Respimat.
This inhaler should be used only ONCE A DAY. Each time, inhale the medicine released during TWO SPRAYS.

• If Striverdi Respimat has not been used for more than 7 days, perform one spray with the inhaler pointing downwards.
• If Striverdi Respimat has not been used for more than 21 days, repeat the actions described in points 4-6 in the "Preparing for use" section until a mist is visible. Then repeat the actions described in points 4-6 three more times.

How to care for the Respimat inhaler (re-usable)

Clean the mouthpiece, including the metal part inside, with a damp cloth or tissue at least once a week.
A slight change in the color of the mouthpiece does not affect the function of the Respimat multi-dose inhaler (re-usable).
If necessary, wipe the outer surface of the Respimat multi-dose inhaler (re-usable) with a damp cloth.

When to replace the inhaler

After using the inhaler with 6 cartridges, purchase a new Striverdi Respimat pack containing an inhaler. Do not use the Respimat multi-dose inhaler (re-usable) for more than one year from the first insertion of the cartridge.

Preparing for use

1. Remove the transparent base Keep the cap closed. Press the protective cap while pulling the transparent base with the other hand.
2. Insert the cartridge Insert the cartridge into the inhaler. Place the inhaler on a hard surface and press down until the cartridge clicks into place.
3. Monitor the number of cartridges used and replace the transparent base Mark the box on the inhaler label to monitor the number of cartridges used. Replace the transparent base until you hear a click.

4. Turn Keep the cap closed. Turn the transparent base in the direction of the arrows until you hear a click (half a turn).
5. Open Open the cap fully.
6. Press Point the inhaler downwards. Press the dose release button. Close the cap. Repeat the steps "Turn", "Open", "Press" to take a total of 2 sprays. Close the cap for further use.

Daily use

OPEN Open the cap fully.

PRESS Take a slow and complete exhalation. Seal your lips around the mouthpiece, without covering the air vent. Point the inhaler towards the back of the throat. While taking a slow and deep breath in through your mouth, PRESS the dose release button and continue breathing in slowly for as long as is comfortable. Hold your breath for 10 seconds or for as long as is comfortable. Repeat the steps "TURN", "OPEN", "PRESS" to take a total of 2 sprays. Close the cap for further use.

When to replace the Striverdi Respimat cartridge

The dose indicator shows the number of sprays left in the cartridge.

60 sprays remaining

Less than 10 sprays remaining. Purchase a new cartridge.

The cartridge is empty. Turn the transparent base to release it.
The inhaler is now locked. Remove the cartridge from the Respimat multi-dose inhaler.
Insert a new cartridge into the inhaler until you hear a click (see step 2).
A newly inserted cartridge will protrude more than the first cartridge (continue from step 3). Remember to replace the transparent base to unlock the inhaler.

Answers to frequently asked questions

Difficulty inserting the cartridge into the inhaler

Did you accidentally turn 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?A new cartridge will protrude more than the first cartridge. Insert it until you hear a click, and then replace the transparent base.

Unable to press the dose release button

Is the transparent base in place?If not, replace the transparent base. The Respimat multi-dose inhaler (re-usable) only works with the transparent base in place.
Did you turn the transparent base?If not, turn the transparent base until you hear a click (half a turn).

Does the dose indicator on the cartridge show a white arrow on a red background?

Your cartridge is empty. Insert a new cartridge and replace the transparent base.

Difficulty removing the cartridge

Pull and turn the cartridge at the same time.

Unable to turn or replace the transparent base

Is the transparent base loose and does the dose indicator on the cartridge show a white arrow on a red background?

Your cartridge is empty. Insert a new cartridge.

Did you already turn the transparent base?

If the transparent base has already been turned, to take the medicine, perform the actions described in the "OPEN" and "PRESS" steps in the "Daily use" section.

The Striverdi Respimat inhaler is emptying too quickly

Are you using Striverdi Respimat as directed (two sprays once a day)?Each cartridge contains enough medicine for 30 days when used as directed.

The Striverdi Respimat inhaler is not working

Did you insert the cartridge?If not, insert the cartridge. After assembling the Striverdi Respimat inhaler, do not remove the transparent base or remove the cartridge until it is empty.
Did you repeat the steps in points 4-6 in the "Preparing for use" section less than three times after inserting the cartridge?Repeat the steps in points 4-6 three times after inserting the cartridge, as shown in the "Preparing for use" section.
Does the dose indicator on the cartridge show a white arrow on a red background?Your cartridge is empty. Insert a new cartridge.