Striverdi Respimat 2.5 micrograms solution for inhalation

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Striverdi Respimat 2.5 micrograms, inhalation solution

olodaterol

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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. 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 start 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 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 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 condition, you must use Striverdi Respimat every day, not only when you have breathing problems or other COPD symptoms.

Striverdi Respimat contains the active substance olodaterol, which is a long-acting bronchodilator (long-acting beta 2 agonist) that helps open your airways and makes it easier to breathe in and out. Regular use of Striverdi Respimat can also help when you have ongoing breathing difficulties due to your condition and will assist in minimizing the impact of the disease on your daily life.

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

Do not take 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

Consult your doctor or pharmacist before starting to take Striverdi Respimat

• if you have asthma (Striverdi Respimat must not be used 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 condition called thyrotoxicosis
• if you have an abnormal widening of an artery called an aneurysm
• if you have diabetes
• if you have severe liver impairment, as Striverdi Respimat has not been studied in this type of patient
• if you have severe renal impairment, as experience with Striverdi Respimat in these patients is limited
• if you are scheduled for surgery

During treatment with Striverdi Respimat

• Stop taking the medicine and consult your doctor immediately if you feel chest tightness, or develop cough, wheezing, or breathing difficulties immediately after using the medication. These may be symptoms of a condition called bronchospasm (see section 4).
• If your breathing problems worsen or you develop rashes, swelling, or itching immediately after using your inhaler, stop using it and consult your doctor immediately (see section 4).
• If you experience any heart-related side effects (increased pulse, elevated blood pressure, and/or worsening symptoms such as chest pain), consult your doctor immediately (see section 4).
• If you experience muscle cramps, muscle weakness, or an irregular heartbeat, 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. It must not be used to treat a sudden episode of breathlessness or wheezing (wheezing attacks).

Do not take Striverdi Respimat together with certain medicines containing 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 taking 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

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, 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 likely to experience side effects.

• medicines called beta-blockers used for high blood pressure or heart problems (such as propranolol) or for an eye condition known as glaucoma (such as timolol). These may reduce the effect of Striverdi Respimat.

• medicines that lower potassium levels in the blood. For example:

  • corticosteroids (e.g., prednisolone),
  • diuretics (medicines to increase urine production),
  • medicines for breathing problems such as theophylline.

  Taking these medicines together with Striverdi Respimat may cause 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 risk of heart-related side effects.

Pregnancy, breastfeeding, and fertility

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

Driving and use of machines

No studies have been conducted on the effects on driving and use of machines.

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

Striverdi Respimat contains Benzalkonium chloride

This medicine contains 0.0011 mg of benzalkonium chloride per puff.

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

3. How to take Striverdi Respimat

Follow exactly the administration instructions for this medicine as given by your doctor. If in 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; therefore, you should take Striverdi Respimat only ONCE DAILY, preferably at the same time each day. Each time you use it, inhale TWO PUFFS.

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

Make sure you know how to correctly use your reusable Respimat inhaler. Instructions for using the reusable Respimat inhaler are provided at the end of this leaflet; see “Instructions for using the reusable Respimat inhaler”.

Use in children and adolescents

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

If you take more Striverdi Respimat than you should

You may have an increased risk of experiencing an adverse effect such as chest pain, high or low blood pressure, fast or irregular pulse or palpitations, dizziness, nervousness, difficulty sleeping, anxiety, headache, tremor, dry mouth, muscle cramps, nausea, fatigue, malaise, low potassium levels in the blood (which may cause 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).

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

If you forget to take Striverdi Respimat

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

If you stop using Striverdi Respimat

Before stopping treatment with Striverdi Respimat, you should speak with your doctor or pharmacist. If you stop treatment with Striverdi Respimat, your COPD signs and symptoms may worsen.

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

4. Possible adverse effects

Like all medicines, Striverdi Respimat may cause adverse effects, although not everyone experiences them.

The adverse effects listed below have been reported by people who have taken this medicine and are listed according to their frequency as uncommon or rare.

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

• Nasopharyngitis (runny nose)
• Dizziness
• Rash

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

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

You may experience adverse effects seen with other medicines similar to Striverdi Respimat (beta-adrenergic agents) used to treat breathing problems. These may include rapid or irregular heartbeat or palpitations, 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 muscle spasms, muscle weakness, or abnormal heart rhythm), high blood sugar levels, or too much acid in your blood (which may cause symptoms such as nausea, vomiting, weakness, muscle cramps, and rapid breathing).

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

In addition, as with all inhaled medicines, some patients may experience chest tightness, cough, wheezing, or shortness of breath immediately after inhalation (bronchospasm).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Striverdi Respimat

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

Do not use this medicine after the expiry date stated on the box and on the label of the cartridge after EXP. The expiry date refers to the last day of the month indicated.

Do not freeze.

Period of use after first opening:

Replace the cartridge no later than three months after insertion.

Do not use the Respimat reusable inhaler for longer than one year.

Recommended use: 6 cartridges per inhaler.

Note: The performance of the reusable RESPIMAT inhaler has been demonstrated in testing up to 540 actuations (equivalent to 9 cartridges).

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE point in your usual pharmacy. Ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Striverdi Respimat

The active substance is olodaterol. The delivered dose is 2.5 micrograms of olodaterol (as hydrochloride) per puff.

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

The other components are:

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

Appearance of the product and contents of the pack

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

Single pack: 1 reusable Respimat inhaler and 1 cartridge providing 60 puffs (30 doses).

Triple pack: 1 reusable Respimat inhaler and 3 cartridges, each providing 60 puffs (30 doses).

Single replacement pack: 1 cartridge providing 60 puffs (30 doses).

Triple replacement pack: 3 cartridges, each providing 60 puffs (30 doses).

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

The Marketing Authorization Holder of 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 medicinal product is authorized in the European Economic Area countries 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: ????????? ????????

Date of the most recent review of this leaflet: December 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.

Instructions on how to use the reusable Respimat inhaler

Respimat is an inhalation device that generates an aerosol for inhalation. Respimat is for your personal use only. One cartridge provides multiple doses. The reusable Respimat inhaler allows cartridge replacement and can be used with up to 6 cartridges.

Read these instructions before starting to use Striverdi Respimat.

You will need to use this inhaler ONCE DAILY. Each time you use it, administer TWO PUFFS.

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

How to maintain your reusable Respimat inhaler

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

Any minor discoloration of the mouthpiece does not affect the performance of your reusable Respimat inhaler.

If necessary, clean the outer part of your reusable Respimat inhaler with a damp cloth.

When to replace the inhaler

When you have used 6 cartridges with the same inhaler, obtain a new pack of Striverdi Respimat containing a new inhaler. Do not use the reusable Respimat inhaler for longer than one year after inserting the first cartridge.

Preparation for use

Daily use

When to replace the Striverdi Respimat cartridge

The dose indicator shows how many actuations remain in the cartridge.

60 actuations remain.

Fewer than 10 actuations remain. Obtain a new cartridge.

Your cartridge is empty. Turn the transparent base to loosen it. Your inhaler is now locked. Remove the cartridge from the inhaler. Insert a new cartridge until it clicks (see step 2). The new cartridge will protrude further than the previous one (continue with step 3). Remember to replace the transparent base 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, then insert the cartridge.

Are you replacing the cartridge? The new cartridge will protrude further than the previous one. Insert the cartridge until it clicks, then replace the transparent base.

I cannot press the dose release button.

Have you replaced the transparent base? If not, replace the transparent base to unlock the inhaler. The reusable Respimat inhaler only works when the transparent base is in place.

Have you turned the transparent base? If not, turn the transparent base with a continuous motion until it clicks (half a turn). Does the dose indicator on your cartridge show 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 once it is empty.

Pull and twist the cartridge at the same time.

I cannot turn or replace the transparent base.

Is the transparent base loose and does the dose indicator on your cartridge show 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 "OPEN" and "PUSH" steps described in "Daily use" to use your medication.

My Striverdi Respimat ran out too soon.

Have you used Striverdi Respimat as directed (two actuations/once daily)? Each cartridge will last 30 days if two actuations are taken once daily.

Have you frequently sprayed into the air to check if Striverdi Respimat is working? Once Striverdi Respimat has been prepared for use, it is not necessary to test its function by spraying the solution if used daily.

Have you removed and replaced the transparent base several times? Do not remove the transparent base before the cartridge is empty. Each time you remove the transparent base without replacing the cartridge, the dose counter records an actuation and the remaining doses are reduced.

My Striverdi Respimat does not spray.

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

Have you repeated the TURN, OPEN, PUSH steps fewer than three times after inserting the cartridge? Repeat the TURN, OPEN, PUSH steps three times after inserting the cartridge, as described in steps 4 to 6 under "Preparing for use".

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

My reusable Striverdi Respimat sprays automatically.

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

Did you press 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.

Did you stop turning the transparent base before it clicked? Turn the transparent base with a continuous motion until it clicks (half a turn). The dose counter will count each incomplete turn and the number of remaining doses will be reduced.

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 up-to-date information on how to administer this medicine by scanning with your mobile phone (smartphone) the QR code included in the section "Instructions on how to use the reusable Respimat inhaler" of this leaflet and on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/info/78253