Prospecto: information for the user

Spiriva Respimat 2.5 micrograms, inhalation solution

tiotropio

Read this prospect carefully before starting to take this medicine, as 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 medicine has been prescribed only for you, and you must not give it to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3.How to take Spiriva Respimat

4.Possible adverse effects

5.Storage of Spiriva Respimat

6. Contents of the package and additional information

Spiriva Respimat helps patients with chronic obstructive pulmonary disease (COPD) or asthma 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. Asthma is a long-term disease characterized by inflammation and narrowing of the airways.

Since COPD and asthma are long-term diseases, you must take Spiriva Respimat every day and not just when you have respiratory problems or other symptoms. When used to treat asthma, you should take Spiriva Respimat in addition to inhaled corticosteroids and long-acting beta2 agonists.

Spiriva Respimat is a long-acting bronchodilator that helps open your airways and allows you to take and expel air from your lungs more easily. Regular use of Spiriva Respimat can also help when you have persistent difficulty breathing due to your disease, and will help minimize the effects of the disease on your daily life. Daily use of Spiriva Respimat will also help prevent any sudden and short-term worsening of your COPD symptoms that can last for several days.

For proper dosing of Spiriva Respimat, see section 3. How to take Spiriva Respimat and the instructions on how to use the Respimat rechargeable inhaler included at the end of this leaflet.

Do not take Spiriva Respimat

• if you are allergic (hypersensitive) to tiotropium or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic (hypersensitive) to atropine or related substances, for example ipratropium or oxitropium.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Spiriva Respimat.

Consult your doctor if you have narrow-angle glaucoma, prostate problems or difficulty urinating.

If you have kidney problems, please consult your doctor.

When using Spiriva Respimat, be careful not to get the product in your eyes. This may cause eye pain or discomfort, blurred vision, halos, or colored images associated with eye redness (i.e., narrow-angle glaucoma). The ocular symptoms may be accompanied by headache, nausea, or vomiting. Rinse your eyes with warm water, discontinue the use of tiotropium bromide, and consult your doctor immediately for further information.

If your breathing worsens or you experience an eruption, inflammation, or itching shortly after using your inhaler, stop using it and contact your doctor immediately.

The dry mouth that has been observed with anticholinergic treatment may be associated with dental caries in the long term. Therefore, remember to take care of your oral hygiene.

Spiriva Respimat is indicated for the maintenance treatment of your chronic obstructive pulmonary disease or asthma. Do not take this medicine to treat a sudden episode of shortness of breath or wheezing. Your doctor should have given you another inhaler (“rescue medication”) for this. Follow the instructions given by your doctor.

If you have been prescribed Spiriva Respimat for asthma, you should take it in addition to your treatment that includes inhaled corticosteroids and long-acting beta2 agonists. Continue taking inhaled corticosteroids as prescribed by your doctor, even if you feel better.

If you have had a myocardial infarction in the last 6 months or unstable irregular heartbeats that have put your life at risk, or severe heart failure in the past year, inform your doctor. This is important for deciding whether Spiriva is the right medicine for you.

Do not take Spiriva Respimat more than once a day.

Contact your doctor if you feel that your breathing is worsening.

If you have cystic fibrosis, inform your doctor, as Spiriva Respimat may worsen your cystic fibrosis symptoms.

Children and adolescents

Spiriva Respimat is not recommended for children under 6 years.

Other medicines and Spiriva Respimat

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

Especially inform your doctor or pharmacist if you are taking or have taken anticholinergic medicines such as ipratropium or oxitropium.

No interactions have been reported when Spiriva Respimat has been taken with other medicines commonly used to treat COPD and asthma, such as rescue inhalers (e.g., salbutamol), methylxanthines (e.g., theophylline), antihistamines, mucolytics (e.g., ambroxol), leukotriene modifiers (e.g., montelukast), anti-IgE treatment (e.g., omalizumab), or oral or inhaled corticosteroids (e.g., budesonide, prednisolone).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

You should not take this medicine unless your doctor recommends it specifically.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery. The occurrence of dizziness or blurred vision may affect the ability to drive and operate machinery.

Spiriva Respimat contains Benzalkonium chloride

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Spiriva Respimat should only be used by inhalation.

The recommended dose for patients over 6 years old is:

Spiriva Respimat is effective for 24 hours, so you will need to take Spiriva Respimat onlyONCE A DAY, if possible at the same time of day.Each time you use it, performTWO ACTIVATIONS.

Since COPD and asthma are long-term diseases, take Spiriva Respimat every day and not just when you have respiratory problems. Do not take more than the recommended dose.

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

Use in children and adolescents

Spiriva Respimat is not recommended for use in children under 6 years old due to the lack of data on safety and efficacy.

If you take more Spiriva Respimat than you should

If you take more than two activations of Spiriva Respimat in a day, consult your doctor immediately. You may have a higher risk of experiencing an adverse effect such as dry mouth, constipation, difficulty urinating, increased heart rate, or blurred vision.

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

If you forget to takeSpiriva Respimat

If you forget to take a dose (TWO ACTIVATIONS A DAY) take it as soon as you remember but do not take two doses at the same time or on the same day. Then take your next dose as usual.

If you interrupt treatment with Spiriva Respimat

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The evaluation of side effects is based on the following frequencies:

The side effects listed below are based on the experience of people who have taken this medicine and are listed in order of frequency as frequent, infrequent, rare, or unknown.

After administration of Spiriva Respimat, individual or as part of a severe allergic reaction (anaphylactic reaction), immediate allergic reactions such as rash, irritant rash (urticaria), swelling of the mouth and face or sudden difficulty breathing (angioneurotic edema) or other hypersensitivity reactions (such as sudden decrease in blood pressure or dizziness) may occur.

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

If you experience any of these reactions, please consult your doctor immediately.

Reporting of side effects

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

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

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

Do not freeze.

Shelf life in use:

Replace the cartridge no more than 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 disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of your usual pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Spiriva Respimat

The active ingredient is tiotropium. The released dose is 2.5 micrograms of tiotropium per pulse (2 pulses are a dose) and corresponds to 3.124 micrograms of tiotropium bromide monohydrate.

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 3.6% hydrochloric acid to adjust the pH.

Appearance of the product and contents of the package

Spiriva Respimat 2.5 micrograms consists of a cartridge with the inhalation solution and a Respimat inhaler. The cartridge must be inserted into the inhaler before the first use.

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

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

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

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

The marketing authorization holder of Spiriva Respimat is:

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

The manufacturer of Spiriva Respimat is:

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Boehringer Ingelheim España, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallès (Barcelona)

Spain

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 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: Spiriva Respimat

Bulgaria: ??????? ????????

Last review date of this leaflet:December 2024

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)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.

Children must use Spiriva Respimat with the help of an adult.

Read these instructions before starting to use Spiriva Respimat.

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

• If Spiriva Respimat has not been used for more than 7 days, perform one puff towards the floor.
• If Spiriva 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 slight 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 Spiriva 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 Spiriva 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).
Is the dose indicator on your cartridge showing 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.

Try to pull and turn the cartridge at the same time.

I cannot turn or put the transparent base back.

Is the transparent base loose and the dose indicator on your cartridge showing 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 medication.

My Spiriva Respimat has run out too soon.

Have you used SpirivaRespimat 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 Spiriva Respimat is working?Once you have prepared Spiriva 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 Spiriva Respimat is not spraying.

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

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

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

My Spiriva Respimat is spraying 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 medication by scanning the QR code included in the section “Instructions for using the rechargeable Respimat inhaler” of this leaflet and on the packaging. You can also access this information on the following internet address:https://cima.aemps.es/info/69589.