SPIRIVA 2.5 mcg/measured dose Solution

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Spiriva Respimat, 2.5 micrograms/dose, inhalation solution
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Spiriva Respimat and what is it used for
4. Important information before taking Spiriva Respimat
   1. When not to take Spiriva Respimat:
   2. Warnings and precautions
   3. Children and adolescents
   4. Spiriva Respimat and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Spiriva Respimat contains benzalkonium chloride
5. How to take Spiriva Respimat
   1. Use in children and adolescents
   2. Taking a higher dose of Spiriva Respimat than recommended
   3. Missing a dose of Spiriva Respimat
   4. Stopping Spiriva Respimat
6. Possible side effects
   1. Reporting side effects
7. How to store Spiriva Respimat
8. Package contents and other information
   1. What Spiriva Respimat contains
   2. What Spiriva Respimat looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
   5. Date of last revision of the leaflet: 12/2024
   6. Instructions for using the reusable Respimat inhaler
   7. How to care for the reusable Respimat inhaler
   8. When to replace the reusable Respimat inhaler
   9. Preparing for use
   10. Daily use
   11. When to replace the Spiriva Respimat cartridge
   12. Answers to frequently asked questions
   13. Difficulty inserting the cartridge into the inhaler.
   14. Was the transparent base turned before inserting the cartridge?
   15. Are you replacing the cartridge?
   16. Cannot press the dose release button.
   17. Is the dose indicator on the cartridge showing a white arrow on a red background?
   18. Difficulty removing the empty cartridge from the inhaler.
   19. Cannot turn or replace the transparent base.
   20. Is the transparent base loose and is the dose indicator on the cartridge showing a white arrow on a red background?
   21. Has the transparent base already been turned?
   22. The Spiriva Respimat inhaler is emptying too quickly.
   23. The Spiriva Respimat inhaler is not activating.
   24. The Spiriva Respimat inhaler is activating by itself.

Leaflet accompanying the packaging: patient information

Spiriva Respimat, 2.5 micrograms/dose, inhalation solution

Tiotropium

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Spiriva Respimat and what is it used for
• 2. Important information before taking Spiriva Respimat
• 3. How to take Spiriva Respimat
• 4. Possible side effects
• 5. How to store Spiriva Respimat
• 6. Package contents and other information

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

Spiriva Respimat makes it easier for patients with chronic obstructive pulmonary disease (COPD) or asthma to breathe. COPD is a chronic lung disease that causes shortness of breath and coughing. COPD is associated with chronic bronchitis and emphysema. Asthma is a chronic disease characterized by inflammation of the airways and their constriction.
COPD and asthma are chronic diseases, so Spiriva Respimat should be taken every day, not just when breathing problems or other symptoms occur. In the treatment of asthma, Spiriva Respimat should be taken as an additional medicine along with inhaled corticosteroids and long-acting beta-2 agonists.
Spiriva Respimat is a long-acting bronchodilator that helps open the airways and makes it easier for air to enter and leave the lungs. Regular use of Spiriva Respimat can also help reduce persistent shortness of breath associated with the disease and help reduce the impact of the disease on daily life. Daily use of Spiriva Respimat will also help prevent sudden, short-term worsening of COPD symptoms, which can last for several days.
To use Spiriva Respimat correctly and take the right dose, see section 3. How to take Spiriva Respimat and the instructions for using the reusable Respimat inhaler at the end of the leaflet.

2. Important information before taking Spiriva Respimat

When not to take Spiriva Respimat:

• if the patient is allergic (hypersensitive) to tiotropium or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic (hypersensitive) to atropine or its derivatives, such as ipratropium or oxytropium.

Warnings and precautions

Before taking Spiriva Respimat, consult a doctor or pharmacist.
Consult a doctor if the patient has: narrow-angle glaucoma, prostate problems or difficulty urinating.
If the patient has kidney problems, they should consult a doctor.
When inhaling Spiriva Respimat, be careful not to get the medicine in the eyes, as this may cause: eye pain or discomfort, blurred vision, seeing a rainbow around a light source, or changes in color vision with accompanying eye redness (i.e., narrow-angle glaucoma). Eye symptoms may be accompanied by headache, nausea, or vomiting. If the medicine gets in the eyes, rinse them with warm water, stop using tiotropium bromide, and consult a doctor immediately for further instructions.
If breathing problems worsen or a rash, swelling, or itching occur immediately after inhalation, stop taking the medicine and consult a doctor immediately.
Dryness of the oral mucosa occurring during the use of a medicine with anticholinergic action may, after a longer period, cause tooth decay, so it is essential to maintain oral hygiene.
Spiriva Respimat is indicated for the maintenance treatment of chronic obstructive pulmonary disease or asthma. Do not take this medicine to treat sudden attacks of shortness of breath or wheezing. In this case, the doctor will prescribe another inhaler (a "rescue medicine"). Follow the doctor's instructions.
If the patient has been prescribed Spiriva Respimat for the treatment of asthma, they should take it as an additional medicine to the treatment that includes an inhaled corticosteroid and long-acting beta-2 agonists. Continue taking the inhaled corticosteroid as directed by the doctor, even if the patient feels better.
If the patient has had a heart attack, experienced heart rhythm disturbances, or life-threatening irregular heartbeat in the last 6 months, or severe heart failure in the last year, they should inform their doctor. This will help decide whether Spiriva Respimat is still suitable for use.
Do not take Spiriva Respimat more often than once a day.
Also, consult a doctor if there is a feeling of difficulty breathing.
Patients with cystic fibrosis should inform their doctor, as Spiriva Respimat may worsen the symptoms of cystic fibrosis.

Children and adolescents

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

Spiriva Respimat and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take, including those available without a prescription.
In particular, inform your doctor or pharmacist about taking other medicines with anticholinergic action, such as ipratropium or oxytropium.
No interactions have been reported when taking Spiriva Respimat with other medicines 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), cromones, anti-IgE medicines (e.g., omalizumab), and/or inhaled or oral steroids (e.g., budesonide, prednisolone).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult a doctor before taking this medicine.
Do not take this medicine unless advised to do so by a doctor.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines. If dizziness or blurred vision occurs, the ability to drive and use machines may be impaired.

Spiriva Respimat contains benzalkonium chloride

This medicine contains 0.0011 mg of benzalkonium chloride in each spray.
Benzalkonium chloride may cause wheezing or breathing difficulties (bronchospasm), especially in patients with asthma.

3. How to take Spiriva Respimat

Always take this medicine exactly as the doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Spiriva Respimat is for inhalation use only.
The recommended dose for patients 6 years of age and older is:
Spiriva Respimat works for 24 hours, so it should be taken ONCE A DAY, at the same time each day.
Take TWO SPRAYS each time you use it.
Since COPD and asthma are chronic diseases, Spiriva Respimat should be taken every day, not just when breathing problems occur. Do not exceed the recommended dose.
Make sure you are using the reusable Respimat inhaler correctly. The instructions for using the reusable Respimat inhaler are at the end of the leaflet, see the section "Instructions for using 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 a lack of data on safety and efficacy.

Taking a higher dose of Spiriva Respimat than recommended

If more than the recommended dose of Spiriva Respimat is taken (i.e., more than two sprays per day), consult a doctor immediately.
The patient may be at increased risk of experiencing side effects, such as dryness of the oral mucosa, constipation, difficulty urinating, rapid heartbeat, or blurred vision.

Missing a dose of Spiriva Respimat

If a dose is missed (TWO SPRAYS ONCE A DAY), take the missed dose as soon as possible, but do not take two doses at the same time or on the same day. Take the next dose at the usual time.

Stopping Spiriva Respimat

Before stopping Spiriva Respimat, consult a doctor or pharmacist.
After stopping Spiriva Respimat, COPD and asthma symptoms may worsen.
If you have any further questions about 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 assessment of side effects was based on the following frequency convention:
Very common:
may affect up to 1 in 10 people
Common:
may affect up to 1 in 100 people
Uncommon:
may affect up to 1 in 1,000 people
Frequency not known:
cannot be estimated from the available data
The following side effects have occurred in patients taking the medicine and have been classified according to their frequency as very common, common, uncommon, or frequency not known.

After taking Spiriva Respimat, immediate allergic reactions, such as rash, hives, swelling of the mouth and face, or sudden difficulty breathing (angioedema) or other hypersensitivity reactions (such as sudden drop in blood pressure or dizziness), may occur alone or as part of a severe allergic reaction (anaphylactic reaction).
As with other inhaled medicines, sudden chest tightness, cough, wheezing, or shortness of breath (bronchospasm) may occur immediately after inhaling Spiriva Respimat in some patients.
If any of these symptoms occur, consult a doctor immediately.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Spiriva Respimat

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the cartridge after EXP. The expiry date refers to the last day of the month.
Do not refrigerate.
Shelf life after first use:
The cartridge should be replaced no later than 3 months after insertion into the inhaler.
The reusable Respimat inhaler should not be used for more than 1 year.
Recommended use: 6 cartridges per inhaler.
Note: The reusable Respimat inhaler has been tested for 540 sprays (equivalent 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. Package contents and other information

What Spiriva Respimat contains

The active substance is tiotropium. The dose contains 2.5 micrograms of tiotropium in one spray (one dose consists of two sprays), which corresponds to 3.124 micrograms of tiotropium bromide monohydrate. The dose is the amount of medicine that is available to the patient after passing through the mouthpiece of the inhaler.
The other ingredients are benzalkonium chloride, disodium edetate, purified water, and 3.6% hydrochloric acid to adjust the pH.

What Spiriva Respimat looks like and contents of the pack

Spiriva Respimat 2.5 micrograms/dose, inhalation solution, consists of one cartridge with the inhalation solution and one Respimat inhaler. The cartridge must be inserted into the inhaler before first use.
Single pack: 1 reusable Respimat inhaler and 1 cartridge containing 60 sprays (30 doses).
Triple pack: 1 reusable Respimat inhaler and 3 cartridges, each containing 60 sprays (30 doses).
Single refill pack: 1 cartridge containing 60 sprays (30 doses).
Triple refill pack: 3 cartridges, each containing 60 sprays (30 doses).
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Boehringer Ingelheim International GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Manufacturer:
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Boehringer Ingelheim España, SA
c/ Prat de la Riba, 50
08174 Sant Cugat del Vallès (Barcelona)
Spain
Boehringer Ingelheim France
100-104 Avenue de France
75013 Paris
France
To obtain more detailed information, contact the marketing authorization holder's representative:
Poland
Boehringer Ingelheim Sp. z o.o.
Phone: +48 22 699 0 699

This medicine 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: Spiriva Respimat
Bulgaria: Спирива Респимат

Date of last revision of the leaflet: 12/2024

Instructions for using the reusable Respimat inhaler

Respimat is an inhaler that generates an aerosol for inhalation. Respimat is intended for use by one patient only. One cartridge contains multiple doses. The reusable Respimat inhaler allows the cartridge to be replaced and can be used with up to 6 cartridges.
Read the following instructions before starting to use Spiriva Respimat.
This inhaler should be used only ONCE A DAY. Each time, inhale the medicine released during TWO SPRAYS.

• If Spiriva Respimat has not been used for more than 7 days, perform one spray with the inhaler pointing downwards.
• If Spiriva Respimat has not been used for more than 21 days, repeat the steps described in points 4-6 in the "Preparing for use" section until a mist is visible. Then repeat the steps described in points 4-6 three more times.

How to care for the reusable Respimat inhaler

Clean the mouthpiece, including the metal part inside, with a damp cloth or tissue at least once a week.
A slight discoloration of the mouthpiece does not affect the function of the reusable Respimat inhaler (re-usable).
If necessary, wipe the outer surface of the reusable Respimat inhaler (re-usable) with a damp cloth.

When to replace the reusable Respimat inhaler

After using the reusable Respimat inhaler with 6 cartridges, purchase a new Spiriva Respimat pack containing an inhaler. Do not use the reusable Respimat inhaler (re-usable) for more than 1 year from the first cartridge insertion.

Preparing for use

1. Remove the transparent base Keep the cap closed. Press the safety catch while pulling the transparent base with your other hand.
2. Insert the cartridge Insert the cartridge into the inhaler. Place the inhaler on a hard surface and press down until the cartridge clicks into place.
3. Monitor the number of used cartridges and replace the transparent base Mark the field on the inhaler label to monitor the number of used cartridges. Replace the transparent base until it clicks into place.

4. Turn Keep the cap closed. Turn the transparent base in the direction indicated by the arrows until you hear a click (half a turn).
5. Open Open the cap fully.
6. Press Point the inhaler downwards. Press the dose release button. Close the cap. Repeat steps 4-6 until a mist is visible. After a mist is visible, repeat steps 4-6 three more times. The inhaler is now ready for use and will deliver 60 sprays (30 doses).

Daily use

TURN Keep the cap closed. TURN the transparent base in the direction indicated by the arrows until you hear a click (half a turn).
OPEN OPEN the cap fully.
PRESS Take a slow and complete exhalation. Seal your lips around the mouthpiece, without covering the air vents. Point the inhaler towards the back of the throat. While taking a slow and deep breath in through your mouth, PRESS the dose release button and continue breathing in slowly, as long as it is comfortable. Hold your breath for 10 seconds or as long as it is comfortable. Repeat the steps TURN, OPEN, PRESS to take a total of 2 sprays. Close the cap to use the inhaler again.

When to replace the Spiriva Respimat cartridge

The dose indicator shows the number of sprays left in the cartridge.

60 sprays remaining

Less than 10 sprays remaining. Purchase a new cartridge.

The cartridge is empty. Turn the transparent base to release it.
The inhaler is now locked. Remove the cartridge from the reusable Respimat inhaler.
Insert a new cartridge into the inhaler until it clicks into place (see step 2).
A newly inserted cartridge will protrude more than the first cartridge (continue from step 3). Remember to replace the transparent base to unlock the inhaler.

Answers to frequently asked questions

Difficulty inserting the cartridge into the inhaler.

Was the transparent base turned before inserting the cartridge?

Open the cap, press the dose release button, and then insert the cartridge.

Are you replacing the cartridge?

A new cartridge will protrude more than the first cartridge. Insert it until it clicks into place, and then replace the transparent base.

Cannot press the dose release button.

Is the transparent base in place?If not, replace the transparent base. The reusable Respimat inhaler (re-usable) only works with the transparent base in place.
Was the transparent base turned?If not, turn the transparent base with a continuous motion until you hear a click (half a turn).

Is the dose indicator on the cartridge showing a white arrow on a red background?

Your cartridge is empty. Insert a new cartridge and replace the transparent base.

Difficulty removing the empty cartridge from the inhaler.

Pull and turn the cartridge at the same time.

Cannot turn or replace the transparent base.

Is the transparent base loose and is the dose indicator on the cartridge showing a white arrow on a red background?

Your cartridge is empty.Insert a new cartridge.

Has the transparent base already been turned?

If the transparent base has already been turned, to take the medicine, follow the steps OPEN and PRESS in the "Daily use" section.

The Spiriva Respimat inhaler is emptying too quickly.

Is Spiriva Respimat being used as directed (two sprays once a day)?Each cartridge contains enough medicine for 30 days when two sprays are used once a day.
Is the Spiriva Respimat inhaler being activated frequently to check its function?Once the Spiriva Respimat inhaler is prepared for use, there is no need to check its function, if it is used daily.
Is the transparent base being removed and replaced frequently?Do not remove the transparent base before the cartridge is empty. Each time the transparent base is removed and replaced without replacing the cartridge, the dose counter is reduced by one spray.

The Spiriva Respimat inhaler is not activating.

Is the cartridge inserted?If not, insert the cartridge. Once the Spiriva Respimat inhaler is assembled, do not remove the transparent base or the cartridge until the cartridge is empty.
Were the steps in points 4-6 in the "Preparing for use" section repeated less than three times after inserting the cartridge?Repeat the steps in points 4-6 in the "Preparing for use" section three times after inserting the cartridge.
Is the dose indicator on the cartridge showing a white arrow on a red background?Your cartridge is empty. Insert a new cartridge.

The Spiriva Respimat inhaler is activating by itself.

Was the cap open while turning the transparent base?Close the cap, then turn the transparent base.
Was the dose release button pressed while turning the transparent base?Close the cap to cover the dose release button, then turn the transparent base.
Did you stop turning the transparent base before it clicked?Turn the transparent base with a continuous motion until you hear a click (half a turn). The dose counter is reduced by one spray for each incomplete turn, and the number of sprays left is reduced.