SPIRIVA RESPIMAT 2.5 micrograms INHALATION SOLUTION

Introduction

Package Leaflet: Information for the User

Spiriva Respimat 2.5 micrograms, inhalation solution

tiotropium

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Spiriva Respimat and what is it used for
2. What you need to know before you take Spiriva Respimat
3. How to take Spiriva Respimat
4. Possible side effects
5. Storing Spiriva Respimat
6. Contents of the pack and other information

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

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 should take Spiriva Respimat every day and not just when you have breathing problems or other symptoms. When used to treat asthma, you should take Spiriva Respimat in addition to the so-called inhaled corticosteroids and long-acting beta2 agonists.

Spiriva Respimat is a long-acting bronchodilator that helps to open up your airways and makes it easier to take and expel air from your lungs. Regular use of Spiriva Respimat can also help you when you have persistent difficulty breathing due to your disease, and it 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 may last for several days.

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

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

Do not take Spiriva Respimat

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Spiriva Respimat.

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

If you have kidney problems, please talk to your doctor.

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

If your breathing worsens or a rash, inflammation, or itching occurs immediately after using your inhaler, stop using it and contact your doctor immediately.

The dry mouth 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 purpose. Follow the instructions your doctor has given you.

If you have been prescribed Spiriva Respimat for asthma, it should be taken 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.

In case you have had a heart attack in the last 6 months or unstable, life-threatening irregular heartbeats, or severe heart failure in the last year, inform your doctor. This is important to decide if Spiriva is the right medicine for you.

Do not take Spiriva Respimat more than once a day.

Also, contact your doctor if you feel that your breathing is getting worse.

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

Children and adolescents

Spiriva Respimat is not recommended for children under 6 years of age.

Other medicines and Spiriva Respimat

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

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

No adverse reaction 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), and/or oral or inhaled steroids (e.g., budesonide, prednisolone).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

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

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. The occurrence of dizziness or blurred vision may affect the ability to drive and use machines.

Spiriva 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.

3. How to take Spiriva Respimat

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

Spiriva Respimat should only be used by inhalation.

The recommended dose for patients over 6 years is:

Spiriva Respimat is effective for 24 hours, so you will need to take Spiriva Respimat only ONCE A DAY, if possible at the same time each day .Each time you use it, perform TWO PUFFS.

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

Make sure you know how to use your Respimat inhaler correctly. The instructions for use of the Respimat inhaler are at the end of this leaflet, see "Instructions on how to use the Respimat inhaler".

Use in children and adolescents

Spiriva Respimat is not recommended for use in children under 6 years of age 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 puffs of Spiriva Respimat in a day, talk to 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, talk to your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount administered.

If you forget to take Spiriva Respimat

If you forget to take a dose (TWO PUFFS 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 stop taking Spiriva Respimat

Before you stop taking Spiriva Respimat, you should talk to your doctor or pharmacist. If you stop taking Spiriva Respimat, the signs and symptoms of your COPD and asthma may worsen.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

The side effects listed below are based on experience with people who have taken this medicine and are listed according to their frequency as frequent, uncommon, rare, or not known.

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 throat (angioedema), or sudden difficulty breathing may occur.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Spiriva 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 cartridge. The expiry date is the last day of the month stated.

Do not freeze.

Shelf life after first opening:

Replace the cartridge after a maximum of 3 months after insertion.

Do not use the Respimat inhaler for more than 1 year.

Recommended use: 6 cartridges per inhaler.

Note: The functioning of the Respimat inhaler has been demonstrated in tests for 540 puffs (corresponding 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. These measures will help protect the environment.

6. Container Contents and Additional Information

Composition of Spiriva Respimat

The active ingredient is tiotropium. The delivered dose is 2.5 micrograms of tiotropium per actuation (2 actuations are a dose) and is equivalent to 3.124 micrograms of tiotropium bromide monohydrate.

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 3.6% hydrochloric acid to adjust the pH.

Appearance of the Product and Container Contents

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

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

Tripack: 1 Respimat inhaler and 3 cartridges, each providing 60 actuations (30 doses).

Single refill pack: 1 cartridge providing 60 actuations (30 doses).

Tripack refill: 3 cartridges, each providing 60 actuations (30 doses).

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

The marketing authorization holder for 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) 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: Spiriva Respimat

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

Date of Last Revision of this Leaflet:December 2024

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

Instructions on How to Use the Respimat Reusable Inhaler

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

Children should 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 ACTUATIONS.

• If Spiriva Respimat has not been used for more than 7 days, perform one actuation towards the ground.
• If Spiriva Respimat has not been used for more than 21 days, repeat the steps from 4 to 6, described in “Preparation for Use” until you see a cloud. Then repeat the steps from 4 to 6 three more times.

How to Maintain Your Respimat Reusable Inhaler

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

Any slight discoloration of the mouthpiece does not affect the functioning of your Respimat reusable inhaler.

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

When to Replace the Inhaler

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

Preparation for Use

Daily Use

When to Replace the Spiriva Respimat Cartridge

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

60 actuations are left.

Less than 10 actuations are left. Get 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 more than the first cartridge (continue with step 3). Remember to replace the transparent base to unlock the inhaler.

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 replacing the cartridge?The new cartridge will protrude more than the first cartridge. 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 Respimat reusable 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 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 turn the cartridge at the same time.

I cannot turn or replace the transparent base.

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 “ACTUATE” described in “Daily Use” to use your medication.

My Spiriva Respimat has run out too soon.

Have you used Spiriva Respimat as directed (two actuations/once a day)?Each cartridge will last 30 days if two actuations are performed once a day.

Have you sprayed into the air frequently 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 it is 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 changing the cartridge, the dose counter registers an actuation and the remaining doses are reduced.

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 steps TURN, OPEN, ACTUATE less than three times after inserting the cartridge?Repeat the steps TURN, OPEN, ACTUATE three times after inserting the cartridge as described in steps 4 to 6 in “Preparation 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 Spiriva Respimat is spraying 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 movement 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 replaced the cartridge?Close the cap, then replace the cartridge.

Other Sources of Information

You can access detailed and up-to-date information on how to administer this medicinal product by scanning the QR code included in the “Instructions on How to Use the Respimat Reusable Inhaler” section of this leaflet and on the packaging with your smartphone. You can also access this information on the following internet address: https://cima.aemps.es/info/69589.