Spiriva respimat

Patient Information Leaflet

Spiriva Respimat, 2.5 micrograms/dose, solution for inhalation
Tiotropium
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Spiriva Respimat is and what it is used for
2. Important information 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 chronic lung disease that causes breathlessness and cough. COPD is associated with chronic bronchitis and emphysema. Asthma is a chronic condition characterized by inflammation and narrowing of the airways.
COPD and asthma are chronic diseases, therefore Spiriva Respimat must be used every day, not only when breathing problems or other symptoms occur. In the treatment of asthma, Spiriva Respimat should be used as an add-on therapy together with inhaled corticosteroids and long-acting beta-2-agonists.
Spiriva Respimat is a long-acting bronchodilator that helps open the airways and allows air to flow in and out of the lungs more easily. Regular use of Spiriva Respimat may also help reduce persistent breathlessness associated with the disease and may improve the impact of the disease on daily life. Daily use of Spiriva Respimat also helps prevent sudden, short-term worsening of COPD symptoms, which may last for several days.
For correct dosing and use of Spiriva Respimat, see section 3. How to use Spiriva Respimat and the instructions for use of the reusable Respimat inhaler at the end of this 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, e.g. 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,
problems with the prostate gland or difficulty passing urine.
If the patient has kidney problems, consult a doctor.
When inhaling Spiriva Respimat, care should be taken to avoid getting the medicine into the eyes, as this may cause: eye pain or discomfort, blurred vision, seeing rainbow-coloured halos around lights, or changes in colour vision accompanied by eye redness (i.e. narrow-angle glaucoma). Eye-related adverse symptoms may be accompanied by headache, nausea or vomiting. If the medicine gets into the eyes, rinse them with warm water, stop using tiotropium bromide and contact a doctor immediately for further advice.
If breathing difficulties worsen or if rash, swelling or itching occur immediately after inhalation, stop using the medicine and contact a doctor immediately.
Dryness of the oral mucosa, which may occur during treatment with anticholinergic medicines, may lead to dental caries over time; therefore, good oral hygiene should be maintained.
Spiriva Respimat is indicated for maintenance treatment of chronic obstructive pulmonary disease (COPD) or asthma. Do not use this medicine to treat sudden attacks of breathlessness or wheezing. For such episodes, 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, it should be used as an add-on therapy to treatment with inhaled corticosteroids and long-acting beta-2 agonists. Continue using the inhaled corticosteroid as directed by the doctor, even if the patient feels better.
Inform the doctor if the patient has had a heart attack in the past 6 months, experienced heart rhythm disorders or life-threatening irregular heartbeat, or severe heart failure within the past year. This will help determine whether Spiriva Respimat remains appropriate for continued use.
Do not use Spiriva Respimat more than once daily.
Also contact a doctor if difficulty in breathing occurs.
Patients with cystic fibrosis should inform their doctor, as Spiriva Respimat may worsen 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 the doctor or pharmacist about all medicines the patient is currently taking, has recently taken or plans to take, including over-the-counter medicines.
In particular, inform the doctor or pharmacist about the use of other anticholinergic medicines, such as ipratropium or oxytropium.
No adverse interactions have been reported when Spiriva Respimat is used together with other medicines commonly used in the treatment of COPD and asthma, such as rescue inhalers (e.g. salbutamol), methylxanthines (e.g. theophylline), antihistamines, mucolytics (e.g. ambroxol), anti-leukotriene agents (e.g. montelukast), cromoglycates, 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, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor before using this medicine.
Do not take this medicine unless specifically advised by a doctor.

Driving and operating machinery
No studies on the effects of this medicine on the ability to drive or operate machinery have been conducted. If dizziness or blurred vision occurs, the ability to drive or operate machinery may be impaired.

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

3. How to use Spiriva Respimat

This medicine should always be used exactly as prescribed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Spiriva Respimat is intended for inhalation use only.
The recommended dose for patients aged 6 years and older is:
Spiriva Respimat works for 24 hours; therefore, it should be used ONCE DAILY, preferably at the same time each day.
With each use, TWO PUFFS should be administered.
Since COPD and asthma are chronic conditions, Spiriva Respimat should be used every day, not only when breathing problems occur. Do not exceed the recommended dose.
Ensure you are using the Respimat reusable inhaler correctly.
Instructions for using the Respimat reusable inhaler are provided at the end of this leaflet, see section “Instructions for using the Respimat reusable 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 use more Spiriva Respimat than you should
If you use more than the recommended dose of Spiriva Respimat (more than two puffs per day), contact your doctor immediately.
The risk of experiencing side effects may increase, such as dry mouth, constipation, difficulty in passing urine, rapid heartbeat, or blurred vision.

If you forget to use Spiriva Respimat
If you miss a dose (TWO PUFFS ONCE DAILY), take the missed dose as soon as possible. However, do not use two doses at the same time or on the same day. Take the next dose at your usual time.

Stopping Spiriva Respimat
Before stopping Spiriva Respimat, consult your doctor or pharmacist.
After stopping Spiriva Respimat, symptoms of COPD or asthma may worsen.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The assessment of adverse reactions was based on the following frequency convention:
Common: may occur in less than 1 in 10 patients
Uncommon: may occur in less than 1 in 100 patients
Rare: may occur in less than 1 in 1000 patients
Frequency not known: frequency cannot be estimated from the available data
The following adverse reactions occurred in patients taking the medicine and have been categorized
according to frequency as common, uncommon, rare, or frequency not known.

After using Spiriva Respimat, immediate allergic reactions such as rash,
urticaria, swelling of the mouth or face, or sudden breathing difficulties (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, immediately after inhalation of Spiriva Respimat, some patients may experience sudden chest tightness, cough, wheezing, or shortness of breath (bronchospasm).
If any of these symptoms occur, contact a doctor immediately.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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.
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store 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 carton and on the label of the medicine cartridge after: EXP. The expiry date refers to the last day of the stated month.
Do not freeze.
Period of validity after first use:
Replace the medicine cartridge no later than three months after inserting it into the inhaler.
Do not use the Respimat reusable inhaler for longer than one year.
Recommended usage: 6 medicine cartridges per inhaler.
Note: The performance of the Respimat reusable inhaler has been demonstrated in studies for 540 actuations (equivalent to 9 medicine cartridges).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Spiriva Respimat contains
The active substance is tiotropium. The metered dose contains 2.5 micrograms of tiotropium per
spray (two sprays constitute one therapeutic dose), corresponding to 3.124 micrograms of
tiotropium bromide monohydrate. The metered dose is the amount that becomes 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 for pH adjustment.

What Spiriva Respimat looks like and contents of the pack
Spiriva Respimat 2.5 micrograms per metered dose consists of one cartridge containing a solution
for inhalation and one Respimat inhaler. The cartridge must be inserted into the inhaler before first
use.
Single pack: 1 reusable Respimat inhaler and 1 medicine cartridge providing 60 sprays (30
therapeutic doses).
Triple pack: 1 reusable Respimat inhaler and 3 medicine cartridges, each providing 60 sprays (30
therapeutic doses).
Single refill pack: 1 medicine cartridge providing 60 sprays (30 therapeutic doses).
Triple refill pack: 3 medicine cartridges, each providing 60 sprays (30 therapeutic doses).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Boehringer Ingelheim International GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Manufacturers:
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Boehringer Ingelheim España, S.A.
c/ Prat de la Riba, 50
08174 Sant Cugat del Vallès (Barcelona)
Spain
Boehringer Ingelheim France
100-104 Avenue de France
75013 Paris
France

For further information, contact the local representative of the Marketing Authorisation Holder:
Poland
Boehringer Ingelheim Sp. z o.o.
Tel: +48 22 699 0 699

This medicinal product is authorised 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: Спирива Респимат

Instructions for use of the reusable Respimat inhaler
Respimat is an inhaler that generates an inhalation aerosol. Respimat is intended for use by a single
patient only. One medicine cartridge provides multiple doses. The reusable Respimat inhaler allows
cartridge replacement and can be used with up to 6 cartridges.
Please read the following instructions before starting to use Spiriva Respimat.
This inhaler must be used ONCE DAILY. Each time, inhale the medication released by TWO
SPRAYS.

• If Spiriva Respimat has not been used for more than 7 days, release one spray with the inhaler pointed away from you.
• If Spiriva Respimat has not been used for more than 21 days, repeat the steps described in points 4–6 in the section "Preparing for use" until a mist becomes visible. Then repeat steps 4 to 6 three more times.

How to care for the reusable Respimat inhaler
Clean the mouthpiece, including the metal part inside, at least once a week using only a damp cloth or wipe.
Slight discolouration of the mouthpiece does not affect the performance of the reusable Respimat inhaler.
If necessary, wipe the outer surface of the reusable Respimat inhaler with a damp cloth.

When to replace the inhaler
After using the inhaler with 6 cartridges, purchase a new Spiriva Respimat pack containing a new inhaler. The reusable Respimat inhaler should not be used for longer than one year from the date the first cartridge was inserted.

Preparing for use

1. Remove the transparent base Keep the cap closed. Press the safety button while removing the transparent base with the other hand.
2. Insert the medication cartridge Insert the medication cartridge into the inhaler. Place the inhaler on a hard surface and press down firmly until the cartridge clicks into place.
3. Monitor the number of used medication cartridges and replace the transparent base Mark the box on the inhaler label to track the number of used cartridges. Replace the transparent base until you hear a click.
4. Turn Keep the cap closed. Turn the transparent base in the direction of the arrows until you hear a click (half a turn).
5. Open Open the cap fully by flipping it open.
6. Press Point the inhaler downward toward the ground. Press the dose release button. Close the cap. Repeat the steps described in points 4–6 until a visible mist appears. Once the mist appears, repeat the steps described in points 4–6 three more times. The inhaler is now ready for use and will deliver 60 sprays (30 doses).

Daily use

ROTATE Keep the cap closed. ROTATE the transparent base in the direction of the arrows until a click is heard (half a turn).
OPEN OPEN the cap fully.
PRESS Breathe out slowly and fully. Close your lips tightly around the mouthpiece without covering the air inlet port. Point the inhaler towards the back of your throat. While breathing in slowly and deeply through your mouth, PRESS the dose release button and continue inhaling slowly for as long as comfortable. Hold your breath for 10 seconds or as long as comfortable. Repeat steps ROTATE, OPEN, PRESS to take a total of 2 sprays. Close the cap for future use of the inhaler.

When to replace the Spiriva Respimat medicine cartridge
The dose indicator shows the number of sprays remaining in the medicine cartridge.

60 sprays remaining

Fewer than 10 sprays remaining. You should purchase a new medicine cartridge.
The medicine cartridge is empty. Rotate the transparent base to release it.
The inhaler is now locked. Remove the medicine cartridge from the reusable inhaler.
Insert a new medicine cartridge into the inhaler until you hear a click (see step 2).
The newly inserted cartridge will protrude more than the first one inserted (continue
from step 3). Remember to replace the transparent base to unlock
the inhaler.

Answers to frequently asked questions

I am having difficulty inserting the medicine cartridge deep enough.
Have you accidentally rotated the transparent base before inserting the medicine cartridge?
Open the cap, press the dose release button, and then insert the medicine cartridge.

Are you replacing the cartridge?
The next, new cartridge will protrude more than the first one. Insert it until
you hear a click, then replace the transparent base.

I cannot press the dose release button.
Have you replaced the transparent base? If not, replace the transparent base.
The Respimat reusable inhaler only works when the transparent base is correctly positioned.

Have you rotated the transparent base? If not, rotate the transparent base in one continuous motion
until you hear a click (half a turn).

Does the dose indicator on the medicine cartridge show a white arrow on a red background?
Your medicine cartridge is empty. Insert a new cartridge and replace the transparent base.

It is difficult to remove the medicine cartridge after it has been used.
Pull and simultaneously rotate the medicine cartridge.

I cannot rotate or replace the transparent base.
Is the transparent base loose and does the dose indicator on the medicine cartridge
show a white arrow on a red background? Your medicine cartridge is empty. Insert a new cartridge.

Have you already rotated the transparent base?
If the transparent base has already been rotated, perform the steps described under “OPEN” and “PRESS” in the “Daily use” section to take your dose.

My Spiriva Respimat inhaler ran out too quickly.
Are you using Spiriva Respimat as directed (two sprays once daily)? Each
medicine cartridge contains 30 days’ supply when two sprays are used once daily.

Are you frequently activating the Spiriva Respimat inhaler to check if it is working properly?
After preparing the Spiriva Respimat inhaler for use, there is no need to test its function
if it is used daily.

Have you repeatedly removed and replaced the transparent base?
Do not remove the transparent base before the cartridge is empty. Each time
the transparent base is removed without replacing the cartridge, the dose counter records one spray, and the number of remaining doses is reduced.

My Spiriva Respimat inhaler does not activate.
Have you inserted the medicine cartridge? If not, insert the medicine cartridge. After assembling the Spiriva Respimat set, do not remove the transparent base or the medicine cartridge until the cartridge is empty.

After inserting the medicine cartridge, did you repeat the steps Rotate, Open, Press fewer than three times?
Repeat the steps ROTATE, OPEN, PRESS three times after inserting the medicine cartridge, as shown in steps 4–6 of the “Preparing for use” section.

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

My Spiriva Respimat inhaler activates on its own.
Was the cap open while rotating the transparent base? Close the cap, then rotate the transparent base.

Did you press the dose release button while rotating the transparent base? Close the cap so that the dose release button is covered, then rotate the transparent base.

Did you stop rotating the transparent base before the click? Rotate the transparent base in one continuous motion until you hear a click (half a turn). The dose counter records each incomplete rotation, and the number of remaining doses is reduced.

Was the cap open when replacing the medicine cartridge? Close the cap, then replace the cartridge.