Prospecto: information for theuser

Striverdi Respimat 2.5 micrograms, inhalation solution

olodaterol

Read this prospect carefully before starting totake this medication, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed only to you, and you should not give it to other peopleeven if they have the same symptoms, as it may harm them.

-If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

1.What isStriverdi Respimatand for what it is used

2.What you need to know before starting to take Striverdi Respimat

3.Howto take Striverdi Respimat

4.Possible adverse effects

5.Storage of Striverdi Respimat

6.Contents of the package and additional information

Striverdi Respimat helps people with chronic obstructive pulmonary disease (COPD) to breathe more easily. COPD is a long-term lung disease that causes difficulty breathing and coughing. The term COPD is associated with chronic bronchitis and emphysema. Since COPD is a long-term disease, you must use Striverdi Respimat every day and not just when you have respiratory problems or other COPD symptoms.

Striverdi Respimat contains the active ingredient olodaterol, which is a long-acting bronchodilator (prolonged-action beta2 agonist) that helps to open your airways and facilitate the intake and expulsion of air from your lungs. The regular use of Striverdi Respimat may also help you when you have continuous difficulty breathing due to your disease and will help you to minimize the effects of the disease on your daily life.

Do not take Striverdi Respimat

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Striverdi Respimat

• if you have asthma (do not take Striverdi Respimat for the treatment of asthma) if you have heart problems
• if you have high blood pressure (hypertension)
• if you have epilepsy
• if you have a specific thyroid gland problem called thyrotoxicosis
• if you have an abnormal widening of an artery called an aneurysm
• if you have diabetes
• if you have severe liver failure, as Striverdi Respimat has not been studied in this type of patient
• if you have severe kidney failure, as the experience with Striverdi Respimat in these patients is limited
• if you are planning surgery

During treatment with Striverdi Respimat

• Stop taking the medicine and consult your doctor immediatelyif you feel a tightness in the chest, have cough, wheezing or difficulty breathing immediately after using the medication. These may be symptoms of a condition called bronchospasm (see section 4).
• If your breathing problems worsen or you experience hives, swelling or itching immediately after using your inhaler, stop taking it and consult your doctor immediately (see section 4).
• If you experience any heart-related side effect (increased heart rate, increased blood pressure and/or increased symptoms such as chest pain), consult your doctor immediately (see section 4).
• If you experience muscle spasms, muscle weakness or an abnormal heart rhythm, consult your doctor, as these symptoms may be related to low potassium levels in the blood (see section 4).

Striverdi Respimat is indicated for the maintenance treatment of your chronic obstructive pulmonary disease (COPD).Do not take it to treat a sudden episode of shortness of breath or wheezing.

Do not take Striverdi Respimat with certain medicines that contain long-acting beta-adrenergic agonists, such as salmeterol or formoterol.

If you regularly take certain medicines called short-acting beta-adrenergic agents, such as salbutamol, continue to take them only to relieve acute symptoms such as shortness of breath.

Children and adolescents

Do not administerStriverdi Respimatto children or adolescents (under 18 years).

Other medicines and Striverdi Respimat

Inform your doctor or pharmacist if you are taking, have taken recently or might have to take any other medicine.

Particularly, inform your doctor or pharmacist if you are taking:

• certain medicines for breathing difficulties that are similar to Striverdi Respimat (beta-adrenergic agents). You may be more prone to side effects.
• medicines called beta-blockers used for high blood pressure or heart problems (such as propranolol) or for an eye problem known as glaucoma (such as timolol). This may reduce the effect of Striverdi Respimat.
• medicines that lower potassium levels in the blood. For example:

• steroids (e.g. prednisolone),
• diuretics (urine medicines),
• medicines for breathing problems such as theophylline.

The simultaneous use of these medicines with Striverdi Respimat may cause muscle spasms, muscle weakness or abnormal heart rhythm.

• 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; the use of these medicines will increase the risk of experiencing heart-related side effects.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and operating machinery

No studies have been conducted on the effects on driving and operating machinery.

If you feel dizzy while taking Striverdi Respimat, do not drive or use tools or machinery.

Striverdi Respimat contains Benzalkonium Chloride

This medicine contains 0.0011 mg of benzalkonium chloride in each puff.

Benzalkonium chloride may cause wheezing and breathing difficulties (bronchospasm), especially in patients with asthma.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Striverdi Respimat should only be used by inhalation.

Dosage

The recommended dose is:

Striverdi Respimat has a 24-hour effect, so you should take Striverdi Respimat onlyONCE A DAY, if possible, at the same time every day. Each time you use it, inhale TWO PUFFS.

Since COPD is a long-term disease, you must take Striverdi Respimat every day and not only when you have difficulty breathing. Do not take more than the recommended dose.

Make sure you know how to use your Respimat rechargeable inhaler correctly. The usage instructions for the Respimat rechargeable inhaler can be found at the end of this leaflet, see “Instructions on using the Respimat rechargeable inhaler”.

Use in children and adolescents

There is no specific recommendation for the use of Striverdi Respimat in the pediatric population (under 18 years old).

If you take more Striverdi Respimat than you should

You may have a higher risk of experiencing an adverse effect such as chest pain, high or low blood pressure, rapid or irregular heartbeat, dizziness, nervousness, difficulty sleeping, anxiety, headache, tremors, dry mouth, muscle cramps, nausea, fatigue, discomfort, low potassium levels in the blood (which can cause muscle spasms, muscle weakness, or abnormal heart rhythm), high blood sugar levels, or excessive acid in the blood (which can cause symptoms such as nausea, vomiting, weakness, muscle cramps, and rapid breathing).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Striverdi Respimat

If you have forgotten to inhale a dose, inhale a single dose the next day at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Striverdi Respimat

Before interrupting treatment with Striverdi Respimat, you should talk to your doctor or pharmacist. If you interrupt treatment with Striverdi Respimat, the signs and symptoms of COPD may worsen.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Striverdi Respimat may cause adverse effects, although not everyone will experience them.

The adverse effects listed below have been experienced by people who have taken this medication and are listed in order of frequency as uncommon or rare.

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

• Nasopharyngitis (nasal discharge)
• Dizziness
• Rash

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

• Arthralgia (joint pain)
• High blood pressure (hypertension)

You may experience adverse effects that appear with other medications similar to Striverdi Respimat (beta-adrenergic agents) for treating respiratory problems. These may be rapid or irregular pulse or palpitations, chest pain, high or low blood pressure, tremors, headache, nervousness, difficulty sleeping, dizziness, dry mouth, nausea, muscle cramps, fatigue, discomfort, low levels of potassium in the blood (which may cause muscle spasms, muscle weakness, or abnormal heart rhythm), high levels of blood sugar, or excessive acid in the blood (which may cause symptoms such as nausea, vomiting, weakness, muscle cramps, and rapid breathing).

After administration of Striverdi Respimat, immediate allergic reactions such as rash, urticaria, swelling in the mouth and face, or sudden difficulty breathing (angioneurotic edema) or other hypersensitivity reactions may occur. If this happens, stop taking Striverdi Respimat and consult your doctor immediately.

Additionally, as occurs with all inhaled medications, some patients may experience chest tightness, cough, wheezing, or immediate lack of breathing after inhalation (bronchospasm).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the cartridge label after CAD. The expiration date is the last day of the month indicated.

Do not freeze.

Shelf life in use:

Replace the cartridge at most three months after its insertion.

Do not use the rechargeable Respimat inhaler for more than one year.

Recommended use: 6 cartridges per inhaler.

Nota: the functioning of the rechargeable RESPIMAT inhaler has been demonstrated in tests for 540 pulses (corresponding to 9 cartridges).

Medicines should not be thrown down the drains or in the trash. Deposit the containers and medicines that you no longer need at the SIGRE collection point of your usual pharmacy. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Striverdi Respimat

The active ingredient is olodaterol. The released dose is 2.5 micrograms of olodaterol (as chloride) per puff.

The released dose is the dose available to the patient after passing through the mouthpiece.

The other components are:

Benzalkonium chloride, disodium edetate, purified water, and anhydrous citric acid.

Appearance of the product and contents of the package

Striverdi Respimat 2.5 micrograms consists of a cartridge with an inhalation solution and a Respimat inhaler. Before the first use, you must insert the cartridge into the inhaler.

Individual package: 1 rechargeable Respimat inhaler and 1 cartridge that provides 60 puffs (30 doses).

Triple package: 1 rechargeable Respimat inhaler and 3 cartridges that provide 60 puffs (30 doses) each.

Replacement individual package: 1 cartridge that provides 60 puffs (30 doses).

Replacement triple package: 3 cartridges that provide 60 puffs (30 doses) each.

Only some sizes of the packages may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

The holder of the marketing authorization for Striverdi Respimat is:

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

The manufacturer of Striverdi Respimat is:

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

Local representative:

Boehringer Ingelheim España, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallès (Barcelona)

Spain

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with 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: ????????? ????????

Last review date of this leaflet: December 2024

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) at http://www.aemps.gob.es.

Instructions for using the rechargeable Respimat inhaler

Respimat is an inhaler device that generates an aerosol for inhalation.Respimat is only for you. A cartridge provides several doses. The rechargeable Respimat inhaler allows you to replace the cartridge and can be used up to 6 cartridges.

Read these instructions before starting to use Striverdi Respimat.

You will need to use this inhaler ONCE A DAY.Each time you use it, perform TWO PUFFS.

• If Striverdi Respimat has not been used for more than 7 days, perform a puff towards the floor.
• If Striverdi Respimat has not been used for more than 21 days, repeat steps 4 to 6 described in “Preparation for use” until you observe a cloud. Then repeat steps 4 to 6 three more times.

How to maintain your rechargeable Respimat inhaler

Clean the mouthpiece, including the metal part inside, only with a damp cloth or a handkerchief, at least once a week.

Any small discoloration of the mouthpiece does not affect the functioning of your rechargeable Respimat inhaler.

If necessary, clean the outside of your rechargeable Respimat inhaler with a damp cloth.

When to change the inhaler

When you have used 6 cartridges with the same inhaler, get a new package of Striverdi Respimat containing a new inhaler.Do not use the rechargeable Respimat inhaler for more than one year after inserting the first cartridge.

Preparation for use

Daily use

When to change the cartridge of Striverdi Respimat

The dose indicator shows how many puffs are left in the cartridge.

There are 60 puffs left.

There are less than 10 puffs left. Get a new cartridge.

Your cartridge is empty.Turn the transparent base to loosen it. Your inhaler is now blocked. Remove the cartridge from the inhaler. Insert a new cartridge until it clicks (see step 2).The new cartridge will protrude more than the first cartridge (continue with step 3). Remember to put the transparent base back to unlock the inhaler.

Answers to frequently asked questions

It is difficult to insert the cartridge deep enough.

Have you accidentally turned the transparent base before inserting the cartridge?Open the cap, press the dose release button, and then insert the cartridge.

Are you changing the cartridge?The new cartridge will protrude more than the first cartridge. Insert the cartridge until it clicks, then put the transparent base back.

I cannot press the dose release button.

Have you put the transparent base back?If not, put the transparent base back to unlock the inhaler. The Respimat inhaler only works with the transparent base in place.

Have you turned the transparent base?If not, turn the transparent base with a continuous movement until it clicks (half turn). The dose counter will count each incomplete turn and the remaining doses will decrease.

The dose indicator of your cartridge shows a white arrow on a red background.Your cartridge is empty. Insert a new cartridge and put the transparent base back.

It is difficult to remove the cartridge once it is empty.

Push and turn the cartridge at the same time.

I cannot turnor put the transparent base back.

The transparent base is loose and the dose indicator of your cartridge shows a white arrow on a red background.Your cartridge is empty. Insert a new cartridge.

Have you already turned the transparent base?
If you have already turned the transparent base, follow the steps “OPEN” and “BREATHE” described in “Daily use” to use your medicine.

My Striverdi Respimat has run out too soon.

Have you used Striverdi Respimat as indicated (2 puffs/once a day)?Each cartridge will last 30 days if you perform 2 puffs once a day.

Have you sprayed the air often to check if Striverdi Respimat is working?Once you have prepared Striverdi Respimat for use, it is not necessary to test its functioning by spraying the solution if you use it daily.

Have you removed and put the transparent base back several times?Do not remove the transparent base before the cartridge is empty. Each time you remove the transparent base without changing the cartridge, the dose counter will register a puff and the remaining doses will decrease.

My Striverdi Respimat does not spray.

Have you inserted a cartridge?If not, insert a cartridge.Once your Respimat inhaler is assembled, do not remove the transparent base or the cartridge until the cartridge is empty.

Have you repeated the steps TURN, OPEN,BREATHEless than three times after inserting the cartridge?Repeat the steps TURN, OPEN, BREATHE three times after inserting the cartridge as described in steps 4 to 6 in “Preparation for use”.

The dose indicator of your cartridge shows a white arrow on a red background.Your cartridge is empty. Insert a new cartridge.

My Striverdi Respimat recargable sprays automatically.

Was the cap open when you turned the transparent base?Close the cap, then turn the transparent base.

Have you pressed the dose release button while turning the transparent base?Close the cap so that the dose release button is covered, then turn the transparent base.

Have you stopped turning the transparent base before it clicked?Turn the transparent base with a continuous movement until it clicks (half turn). The dose counter will count each incomplete turn and the remaining doses will decrease.

Was the cap open when you changed the cartridge?Close the cap, then change the cartridge.

Other sources of information

You can access detailed and updated information on how to administer this medicine by scanning the QR code included in the section “Instructions for using the rechargeable Respimat inhaler” of this leaflet and in the packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/info/78253