Spiriva Respimat 2.5 micrograms solution for inhalation

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Spiriva Respimat 2.5 micrograms, inhalation solution

tiotropio

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

• Keep this leaflet, as 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 others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Spiriva Respimat is and what it is 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.

Because COPD and asthma are long-term conditions, you must take Spiriva Respimat every day, not only when you have breathing problems or other symptoms. When used to treat asthma, Spiriva Respimat must be taken 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 inhale and exhale air from the lungs more easily. Regular use of Spiriva Respimat can also help when you have ongoing difficulty breathing due to your disease, and will help minimize the impact of the disease on your daily life. Daily use of Spiriva Respimat will also help prevent sudden, short-term worsening of your COPD symptoms, which may last for several days.

For correct dosing of Spiriva Respimat, see section 3. How to take Spiriva Respimat and the instructions for using the reusable Respimat inhaler included at the end of this leaflet.

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

Do not take Spiriva Respimat

• if you are allergic (hypersensitive) to tiotropium or to any of the other components 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 starting to use 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, take care not to get the medicine in your eyes. This may cause eye pain or discomfort, blurred vision, visual halos, or colored images associated with eye redness (i.e., narrow-angle glaucoma). Eye symptoms may be accompanied by headache, nausea, or vomiting. Rinse your eyes with lukewarm water, stop using tiotropium bromide, and contact your doctor immediately for further advice.

If your breathing worsens or you develop a rash, swelling, or itching immediately after using your inhaler, stop using it and contact your doctor immediately.

Dry mouth, which has been observed during anticholinergic treatment, may over time be associated with dental caries. Therefore, remember to maintain good oral hygiene.

Spiriva Respimat is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) or asthma. Do not take this medicine to treat a sudden episode of breathing difficulty or wheezing (sibilance). Your doctor should have prescribed another inhaler ("rescue medication") for this purpose. Always follow your doctor's instructions.

If Spiriva Respimat has been prescribed for your asthma, it should be used in addition to your current treatment, which 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 (heart attack) within the last 6 months, or if you have unstable or life-threatening irregular heartbeats, or severe heart failure within the past year, inform your doctor. This is important in determining whether Spiriva is the appropriate medicine for you.

Do not take Spiriva Respimat more than once a day.

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

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 of age.

Other medicines and Spiriva Respimat

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

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

No adverse interactions have been reported when Spiriva Respimat has been taken together 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., budesonida, prednisolone).

Pregnancy and breastfeeding

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

You should not take this medicine unless specifically recommended by your doctor.

Driving and using machines

No studies have been conducted on the effects on the ability to drive or use machinery. Dizziness or blurred vision may affect your ability to drive or use machinery.

Spiriva 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 Spiriva Respimat

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Spiriva Respimat must only be used by inhalation.

The recommended dose for patients over 6 years of age is:

Spiriva Respimat is effective for 24 hours, so you will need to take Spiriva Respimat only ONCE DAILY, preferably at the same time each day. Each time you use it, deliver TWO PUFFS.

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

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

Use in children and adolescents

Spiriva Respimat is not recommended for use in children under 6 years of age due to 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 one day, consult your doctor immediately. You may have an increased 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, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Spiriva Respimat

If you forget to take a dose (TWO PUFFS PER 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 using Spiriva Respimat

Before stopping treatment with Spiriva Respimat, you should speak with your doctor or pharmacist. If you stop treatment with Spiriva Respimat, your COPD or asthma 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, this medicine may cause adverse effects, although not everyone experiences them.

The assessment of adverse effects is based on the following frequencies:

Common: may affect up to 1 in 10 people Uncommon: may affect up to 1 in 100 people Rare: may affect up to 1 in 1,000 people Frequency not known: frequency cannot be estimated from the available data

The adverse effects listed below are based on the experience of people who have taken this medication and are listed according to their frequency as frequent, uncommon, rare, or not known.

Adverse Effects	Frequency COPD	Frequency Asthma
Dry mouth	Frequent	Uncommon
Dizziness	Uncommon	Uncommon
Headache (cephalalgia)	Uncommon	Uncommon
Difficulty sleeping (insomnia)	Rare	Uncommon
Irregular heartbeat (atrial fibrillation, supraventricular tachycardia)	Rare	Not known
Feeling your heartbeat (palpitations)	Rare	Uncommon
Faster heartbeat (tachycardia)	Rare	Not known
Cough	Uncommon	Uncommon
Nosebleed (epistaxis)	Rare	Rare
Throat inflammation (pharyngitis)	Uncommon	Uncommon
Hoarseness (dysphonia)	Uncommon	Uncommon
Chest tightness, associated with cough, wheezing, or shortness of breath immediately after inhalation (bronchospasm)	Rare	Uncommon
Constipation	Uncommon	Rare
Fungal infections in mouth and throat (oropharyngeal candidiasis)	Uncommon	Uncommon
Difficulty swallowing (dysphagia)	Rare	Not known
Rash	Uncommon	Uncommon
Itching (pruritus)	Uncommon	Rare
Difficulty urinating (urinary retention)	Uncommon	Not known
Pain when urinating (dysuria)	Uncommon	Not known
Visual halos (diffuse lights) or colored images associated with eye redness (glaucoma)	Rare	Not known
Increased eye pressure	Rare	Not known
Blurred vision	Rare	Not known
Inflammation of the larynx (laryngitis)	Rare	Not known
Heartburn (gastroesophageal reflux)	Rare	Not known
Dental caries	Rare	Not known
Inflammation of the gums (gingivitis)	Rare	Rare
Inflammation of the tongue (glossitis)	Rare	Not known
Inflammation of the mouth (stomatitis)	Not known	Rare
Severe allergic reaction which may cause swelling of the mouth, face, or throat (angioedema)	Rare	Rare
Itchy rash (urticaria)	Rare	Rare
Skin infection or ulceration	Rare	Not known
Dry skin	Rare	Not known
Hypersensitivity, including immediate reactions	Not known	Rare
Urinary tract infection	Rare	Rare
Loss of body water (dehydration)	Not known	Not known
Sinusitis	Not known	Not known
Intestinal obstruction or absence of movement in the large intestine (intestinal obstruction including paralytic ileus)	Not known	Not known
Nausea	Not known	Not known
Severe allergic reaction (anaphylactic reaction)	Not known	Not known
Inflammation of the joints	Not known	Not known

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

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

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

Reporting of adverse reactions

If you experience any type of adverse reaction, talk to your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Spiriva Respimat

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

Do not use this medicine after the expiry date stated on the outer carton and on the label of the cartridge. 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 reusable Respimat 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 (corresponding to 9 cartridges).

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Spiriva Respimat

The active substance is tiotropium. The delivered dose is 2.5 micrograms of tiotropium per puff (2 puffs constitute a dose) and corresponds 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 hydrochloric acid 3.6% to adjust the pH.

Appearance of the product and contents of the pack

Spiriva Respimat 2.5 micrograms consists of a cartridge containing the solution for inhalation 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 puffs (30 doses).

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

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and 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 European Economic Area (EEA) Member States 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 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 intended solely for your personal use. One cartridge provides multiple doses. The reusable Respimat inhaler allows cartridge replacement and can be used with up to 6 cartridges.

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

Please read these instructions before starting to use Spiriva Respimat.

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

• If Spiriva Respimat has not been used for more than 7 days, release one puff towards the ground.
• If Spiriva 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 discolouration 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 Spiriva 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

Remove the transparent base Keep the cap closed. Press the safety lock while removing the transparent base with your other hand.
Insert the cartridge Insert the cartridge into the inhaler. Place the inhaler on a firm surface and press down firmly until it clicks.
Register the cartridge and replace the transparent base Check the box on the inhaler label to track the number of cartridges used. Replace the transparent base into position until it clicks.
Turn Keep the cap closed. Turn the transparent base in the direction of the arrows on the label until it clicks (half a turn).
Open Open the cap fully.
Press Point the inhaler downward toward the floor. Press the dose release button. Close the cap. Repeat steps 4 to 6 until you see a cloud. After observing a cloud, repeat steps 4 to 6 three more times. Your inhaler is now ready to use and will deliver 60 actuations (30 doses).

Daily use

TURN Keep the cap closed. TURN the transparent base in the direction of the arrows on the label until it clicks (half a turn).
OPEN OPEN the cap fully.
PRESS Breathe out slowly and fully. Close your lips around the mouthpiece without covering the air vents. Point the inhaler toward the back of your throat. While breathing in slowly and deeply through your mouth, PRESS the dose release button and continue inhaling slowly as comfortably as possible. Hold your breath for 10 seconds or as long as comfortable. Repeat the steps TURN, OPEN, PRESS to complete a total of 2 actuations. Close the cap until you use the inhaler again.

When to replace the Spiriva 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 first cartridge (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 deeply enough.

Did you accidentally turn 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 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 reusable Respimat inhaler only functions with the transparent base 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 Spiriva Respimat ran out too soon.

Have you used Spiriva 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 Spiriva Respimat is working? Once you have prepared Spiriva Respimat 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 Spiriva Respimat does not spray.

Have you inserted a cartridge? If not, insert a cartridge. Once your Spiriva 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 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 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/69589.