Striverdi Respimat

Package leaflet: Information for the user

Striverdi Respimat 2.5 micrograms, inhalation solution

olodaterol
This medicinal product is subject to additional monitoring. This will allow for the rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Striverdi Respimat is and what it is used for
2. What you need to know 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 people with chronic obstructive pulmonary disease (COPD) to breathe more easily. COPD is a chronic lung disease that causes shortness of breath and cough. The term COPD refers to chronic conditions of bronchitis and emphysema. Since COPD is a chronic disease, Striverdi Respimat must be taken every day, not only when breathing difficulties or other COPD symptoms occur.
Striverdi Respimat contains the active substance olodaterol, which is a long-acting bronchodilator (long-acting beta 2 agonist) that opens the airways and makes breathing easier. Regular use of Striverdi Respimat may also help when shortness of breath associated with the disease develops, and may minimize the impact of the disease on daily life.

2. What you should know before using Striverdi Respimat

Do not use Striverdi Respimat

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

Warnings and precautions
Talk to your doctor or pharmacist before using Striverdi Respimat

• if you suffer from asthma (you must not use Striverdi Respimat for the treatment of asthma).
• if you suffer from heart diseases.
• if you have high blood pressure.
• if you suffer from epilepsy.
• if you suffer from a specific thyroid gland disorder called thyrotoxicosis.
• if you suffer from an abnormal dilation of an artery called aneurysm.
• if you suffer from diabetes.
• if you have severe hepatic impairment, as Striverdi Respimat has not been studied in this patient population.
• if you have severe renal impairment, as experience with Striverdi Respimat in this patient population is limited.
• if you are scheduled for surgery.

During treatment with Striverdi Respimat

• Stop using the medicine and inform your doctor immediately if you experience chest tightness, cough, wheezing, or shortness of breath immediately after using the medicine. These may be signs of a condition called bronchospasm (see section 4).
• If your breathing worsens or if you develop a skin rash, swelling, or itching immediately after using the inhaler, stop using it and inform your doctor immediately (see section 4).
• If you experience any side effects affecting your 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 cramps, muscle weakness, or an irregular heartbeat, consult your 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. It must not be used to treat sudden attacks of breathlessness or shortness of breath.
Do not use Striverdi Respimat together with certain medicines containing long-acting β-adrenergic agonists, such as salmeterol or formoterol.
If you regularly take certain medicines called short-acting β-adrenergic agents, such as salbutamol, continue to use them only for relief of acute symptoms such as breathlessness.

Children and adolescents
Striverdi Respimat must not be administered to children or adolescents (under 18 years of age).

Other medicines and Striverdi Respimat
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• certain medicines for breathing problems that are similar to Striverdi Respimat (β-adrenergic agents). You may be more likely to experience side effects.
• medicines called beta-blockers, used for high blood pressure or other heart conditions (such as propranolol), or for the eye disorder called glaucoma (such as timolol). These may counteract the effect of Striverdi Respimat.
• medicines that lower potassium levels in the blood. These include:
  • corticosteroids (e.g., prednisolone),
  • diuretics,
  • medicines for breathing problems such as theophylline. If you use these medicines together with Striverdi Respimat, you may experience symptoms such as muscle cramps, muscle weakness, or irregular heartbeat.
• medicines called tricyclic antidepressants or MAO inhibitors (such as selegiline or moclobemide), used to treat neurological or psychiatric disorders such as Parkinson’s disease or depression; using these medicines increases the likelihood of experiencing side effects affecting the heart.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
No studies on the effects on the ability to drive or use machines have been conducted.
If you feel dizzy while taking Striverdi Respimat, do not drive or operate tools or machinery.

For athletes
Using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Striverdi Respimat contains benzalkonium chloride
This medicine contains 0.0011 mg of benzalkonium chloride per dose.
Benzalkonium chloride may cause wheezing and breathing difficulties (bronchospasm), especially if you suffer from asthma.

3. How to take Striverdi Respimat

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
Striverdi Respimat is for inhalation use only.
Dosage
The recommended dose is:
Striverdi Respimat is effective for 24 hours; therefore, Striverdi Respimat should be taken only
ONCE DAILY , preferably at the same time each day. Each time, you must take TWO
PUFFS.
Since COPD is a chronic disease, take Striverdi Respimat every day, not only when breathing problems occur. Do not take more than the recommended dose.
Use in children and adolescents
There is no indication for specific use of Striverdi Respimat in the paediatric population (under 18 years of age).
Make sure you know how to use Striverdi Respimat properly. Instructions for using the Striverdi Respimat inhaler are provided on the other side of this leaflet.
If you take more Striverdi Respimat than you should
You may be at increased risk of experiencing side effects such as chest pain, high or low blood pressure, rapid or irregular heartbeat or awareness of your heartbeat, dizziness, nervousness, difficulty sleeping, anxiety, headache, tremor, dry mouth, muscle cramps, nausea, tiredness, malaise, low levels of potassium in the blood (which may cause symptoms such as muscle spasms, muscle weakness, or abnormal heart rhythm), high blood sugar levels, or excess acid in the blood (which may cause symptoms such as nausea, vomiting, weakness, muscle cramps, and rapid breathing).
If you forget to take Striverdi Respimat
If you forget to inhale a dose, inhale only one dose at your usual time the next day.
Do not take a double dose to make up for the forgotten dose.
If you stop taking Striverdi Respimat
Before stopping treatment with Striverdi Respimat, speak to your doctor or pharmacist. If you stop treatment with Striverdi Respimat, the signs and symptoms of COPD may worsen.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The side effects described below have occurred in people taking this medicine and are listed according to frequency as uncommon or rare.

Uncommon (may affect up to 1 in 100 people):

• Nasopharyngitis (nasal discharge)
• Dizziness
• Skin rash

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

• Arthralgia (joint pain)
• Hypertension

You may also experience side effects that are known to occur with some medicines used for respiratory problems similar to Striverdi Respimat (beta-adrenergic agents). These may include increased or irregular heartbeat or awareness of your heartbeat, chest pain, high or low blood pressure, tremor, headache, nervousness, difficulty sleeping, dizziness, dry mouth, nausea, muscle cramps, fatigue, malaise, low levels of potassium in the blood (which may cause symptoms such as muscle spasms, muscle weakness, or abnormal heart rhythm), high blood sugar levels, or excess acid in the blood (which may cause symptoms such as nausea, vomiting, weakness, muscle cramps, and rapid breathing).

Immediately after administration of Striverdi Respimat, immediate allergic reactions such as skin rash, hives, swelling of the mouth and face, or sudden breathing difficulty (angioedema) or other hypersensitivity reactions may occur. If this happens, stop treatment with Striverdi Respimat and contact your doctor immediately.

Additionally, as with all inhaled medicines, some patients may experience chest tightness, cough, shortness of breath, or unexpected breathing difficulties immediately after inhalation (bronchospasm).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Striverdi Respimat

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the label of the
Respimat inhaler after Exp. The expiry date refers to the last day of that month.
Do not freeze.
Period of validity in use
Replace the cartridge no later than 3 months after insertion.
Do not use the reusable Respimat inhaler for longer than one year.
Recommended use: 6 cartridges per inhaler
Note: The performance of the reusable Respimat inhaler has been tested for 540 actuations (corresponding to 9 cartridges).
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

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

Description of the appearance of Striverdi Respimat and contents of the pack
Striverdi Respimat 2.5 micrograms consists of a cartridge containing the inhalation solution and a Respimat inhaler. The cartridge must be inserted into the inhaler before first use.
Single pack: 1 reusable Respimat inhaler and 1 cartridge providing 60 actuations (30 doses of medicine)
Triple pack: 1 reusable Respimat inhaler and 3 cartridges, each providing 60 actuations (30 doses of medicine)
Single refill pack: 1 cartridge providing 60 actuations (30 doses of medicine)
Triple refill pack: 3 cartridges, each providing 60 actuations (30 doses of medicine)
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
The Marketing Authorization Holder for Striverdi Respimat is:
Boehringer Ingelheim International GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany

The manufacturer of Striverdi Respimat is:
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria, Liechtenstein: Striverdi Respimat 2,5 Mikrogramm - Lösung zur Inhalation
Belgium, Luxembourg: Striverdi Respimat 2,5 microgrammes, solution à inhaler
Bulgaria: Стриверди Респимат 2,5 микрограма разтвор за инхалация
Cyprus, Greece: Striverdi Respimat
Czech Republic: Striverdi Respimat 2,5 mikrogramů
Denmark: Striverdi Respimat
Estonia: Striverdi Respimat
Finland: Striverdi Respimat 2.5 mikrog per suihke, inhalaationeste, liuos
France: Striverdi Respimat 2,5 microgrammes/dose, solution à inhaler
Germany: Striverdi Respimat 2,5 Mikrogramm/Hub Lösung zur Inhalation
Hungary: Striverdi Respimat 2,5 mikrogram inhalációs oldat
Iceland: Striverdi Respimat
Ireland, Malta,
United Kingdom: Striverdi Respimat
Italy: Striverdi Respimat 2,5 microgrammi, soluzione per inalazione
Latvia: Striverdi Respimat 2,5 mikrogrami inhalācijas šķīdums
Lithuania: Striverdi Respimat 2,5 mikrogramo/išpurškime įkvepiamasis tirpalas
Netherlands: Striverdi Respimat 2,5 microgram, inhalatieoplossing
Norway: Striverdi Respimat
Poland: Striverdi Respimat
Portugal: Striverdi Respimat
Romania: Striverdi Respimat 2,5 micrograme soluţie de inhalat
Slovakia: Striverdi Respimat
Slovenia: Striverdi Respimat 2,5 mikrogramov/vdih raztopina za inhaliranje
Spain: Striverdi Respimat 2,5 microgramos solución para inhalación
Sweden: Striverdi Respimat 2,5 mikrogram per puff, inhalationsvätska, lösning

STRIVERDI RESPIMAT

Instructions for use

Introduction
Read these instructions for use before starting to use the reusable Striverdi Respimat inhaler.
You must use this inhaler only ONCE DAILY. Each time, take TWO
ACTUATIONS.

• If not used for more than 7 days, release one actuation towards the ground.
• If not used for more than 21 days, repeat steps 4 to 6 of the section "Preparation for use" until a spray becomes visible. Then repeat steps 4 to 6 three more times.

Maintenance of the reusable Striverdi Respimat inhaler
Clean the mouthpiece, including the metal part inside, only with a damp cloth or tissue, at least once a week.
Any slight discolouration of the mouthpiece does not affect the performance of the reusable Striverdi Respimat inhaler.
If necessary, clean the outside of the reusable Striverdi Respimat inhaler with a damp cloth.
When to replace the inhaler
When you have used an inhaler with 6 cartridges, you must obtain a new pack of the reusable Striverdi Respimat inhaler containing a new inhaler.

Preparation for use

1. Remove the transparent base  Keep the cap closed.  Press the safety lock and slide off the transparent base with the other hand.
2. Insert the cartridge  Insert the cartridge into the inhaler.  Place the inhaler on a solid surface and press firmly until the cartridge is fully inserted.
3. Keep track of the cartridge  Mark the check box on the inhaler label to keep track of the number of cartridges used.  Reattach the transparent base until you hear a click.
4. Rotate  Keep the cap closed.  Rotate the transparent base in the direction of the arrows shown
on the label until you hear a click (half a turn).
5. Open  Flip open the cap and open fully.
6. Press  Point the inhaler towards the ground.  Press the dose release button.  Close the cap.  Repeat steps 4–6 until a cloud becomes visible.  After a cloud becomes visible, repeat steps 4–6 three more times. The inhaler is now ready for use and will deliver 60 actuations (30 doses).

Daily use

ROTATE  Keep the cap closed.  ROTATE the transparent base in the direction of the arrows shown on the label until you hear a click (half a turn).
OPEN  Snap the cap open and OPEN fully.
PRESS  Breathe out slowly and completely.  Close lips around the mouthpiece without covering the air holes. Point the inhaler towards the back of the throat.  While inhaling slowly and deeply through the mouth, PRESS the dose button and continue inhaling slowly for as long as possible.  Hold breath for 10 seconds or as long as possible.  Repeat the ROTATE, OPEN, PRESS steps for a total of 2 actuations.  Close the cap until next use of the inhaler.

When to replace the Striverdi Respimat cartridge
The dose indicator shows how many sprays remain in the cartridge.

60 sprays remaining

Fewer than 10 sprays remaining. Obtain a new cartridge.

The cartridge is empty. Rotate the transparent base to loosen it. The inhaler is now
in a locked position. Remove the cartridge from the inhaler. Insert a new cartridge
(continue from step 2).

Answers to common questions

It is difficult to fully insert the cartridge.
Was the transparent base accidentally rotated before inserting the cartridge?
Open the cap, press the dose delivery button, then insert the cartridge.

Are you replacing the cartridge?
The new cartridge will protrude further than the initial cartridge. Insert it until you hear a
click, then reposition the transparent base.

The dose delivery button cannot be pressed.
Has the transparent base been rotated?
If it has not been rotated, rotate the transparent base with a continuous movement until you hear a
click (half a turn).

The dose indicator on the cartridge shows a white arrow on a red background?
The cartridge is empty. Insert a new cartridge.

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

The transparent base cannot be rotated or repositioned.
Has the transparent base already been rotated?
If the transparent base has already been rotated, follow the “OPEN” and “PUSH” steps in the
“Daily use” section to take your medicine.

Is the transparent base loose and does the dose indicator on the cartridge show a white arrow
on a red background?
The cartridge is empty. Insert a new cartridge.

The reusable Respimat has run out too quickly.
Has the reusable Respimat been used as directed (two sprays/once daily)?
The Respimat is sufficient for 30 days if used with two sprays once daily.

Have you frequently performed test sprays into the air to check the function of the reusable Respimat?
After preparing the reusable Respimat, there is no need to perform test sprays into the air if
the inhaler is used daily.

The reusable Respimat does not deliver the dose.
Has the cartridge been inserted?
If not, insert the cartridge. After the reusable Respimat has been assembled, do not remove the transparent base or the cartridge until the cartridge is empty.

Were the ROTATE, OPEN, PUSH steps repeated fewer than three times after
inserting the cartridge?
Repeat the ROTATE, OPEN, PUSH steps three times after inserting the cartridge as
shown in steps 4 to 6 of the “Preparing for use” section.

The dose indicator on the cartridge shows a white arrow on a red background?
The cartridge is empty. Insert a new cartridge.

The reusable Respimat automatically delivers the dose.
Was the cap open when the transparent base was rotated?
Close the cap, then rotate the transparent base.

Was the dose delivery button pressed when the transparent base was rotated?
Close the cap so that the dose delivery button is covered, then rotate the transparent base.

Was the rotation of the transparent base interrupted before hearing a click?
Rotate the transparent base with a continuous movement until you hear a click (half a turn).

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