Spiolto respimat

Patient Information Leaflet

Spiolto Respimat, 2.5 micrograms + 2.5 micrograms, inhalation solution
tiotropium + olodaterol
Please read this leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult 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 effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

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

What Spiolto Respimat is
Spiolto Respimat contains two active substances, tiotropium and olodaterol. They belong to a group of medicines called long-acting bronchodilators. Tiotropium belongs to a subgroup called anticholinergics, while olodaterol belongs to a subgroup called long-acting beta-adrenergic receptor agonists.

What Spiolto Respimat is used for
Spiolto Respimat helps improve breathing in adult patients with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease causing breathlessness and cough. The term COPD includes chronic bronchitis and emphysema.

Spiolto Respimat works by relaxing and widening the airways, making breathing easier. Regular use of Spiolto Respimat may also help reduce breathlessness caused by the disease and may minimize the impact of COPD on daily life.

Since COPD is a chronic condition, you should use Spiolto Respimat every day, not only when you have breathing problems or other symptoms of COPD.

2. Important information before using Spiolto Respimat

When not to take Spiolto Respimat:

• if the patient is allergic to tiotropium or olodaterol, or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to atropine or related substances, e.g. ipratropium or oxytropium.

Warnings and precautions
Before starting to use Spiolto Respimat, discuss this with your doctor or
pharmacist:

• if the patient suffers from asthma (Spiolto Respimat should not be used for the treatment of asthma),
• if the patient has heart disease,
• if the patient has high blood pressure,
• if the patient suffers from epilepsy,
• if the patient has hyperthyroidism,
• in case of abnormal enlargement of an artery – aneurysm,
• if the patient suffers from diabetes,
• if the patient has severe liver disease,
• if the patient has kidney disease,
• if surgery is planned,
• if the patient has an eye condition – narrow-angle glaucoma,
• if the patient has prostate problems or difficulty passing urine.

While using Spiolto Respimat

• If the patient experiences chest tightness, cough, wheezing, or shortness of breath immediately after taking the medicine, stop using the medicine and inform the doctor immediately. These may be symptoms of bronchospasm (see section 4).
• If breathing worsens or if rash, swelling, or itching occurs immediately after using the inhaler, stop using it and contact the doctor without delay (see section 4).
• If any heart-related adverse effects occur (such as increased heart rate, increased blood pressure, or worsening symptoms such as chest pain), inform the doctor immediately (see section 4).
• If muscle cramps, muscle weakness, or irregular heartbeat occur, consult the doctor, as these may be related to low potassium levels in the blood (see section 4).

While using Spiolto Respimat, avoid allowing the medicine to enter the eyes.
This may cause eye pain or discomfort, blurred vision, seeing colored halos around lights or colored images associated with eye redness (narrow-angle glaucoma). Eye symptoms may be accompanied by headache, nausea, and vomiting.
Rinse the eyes with warm water, stop using Spiolto Respimat, and contact the doctor immediately.
Spiolto Respimat is indicated for maintenance therapy in patients with chronic obstructive pulmonary disease (COPD). The medicine should not be used to treat sudden attacks of breathlessness or
wheezing.
Do not use Spiolto Respimat in combination with certain medicines containing long-acting beta-adrenergic agonists such as salmeterol or formoterol.
If the patient regularly uses certain medicines containing short-acting beta-adrenergic agents such as salbutamol, these should continue to be used only for the relief of acute symptoms such as breathlessness.
Dryness of the oral mucosa observed during treatment with anticholinergic medicines may, over time, lead to dental caries. Therefore, maintaining good oral hygiene is important.
Do not use Spiolto Respimat more than once a day.

Children and adolescents
Spiolto Respimat must not be given to children and adolescents (under 18 years of age).

Spiolto Respimat with other medicines
Tell your doctor or pharmacist about any medicines the patient is currently taking or has recently taken.
In particular, inform the doctor if the patient is taking:

• medicines similar to Spiolto Respimat (containing similar active substances such as anticholinergics or beta-adrenergic agents). The patient may be at increased risk of experiencing adverse effects;
• medicines belonging to the group of beta-adrenergic receptor blockers used to treat high blood pressure or other heart conditions (such as propranolol), or medicines used to treat an eye condition called glaucoma (such as timolol). These may weaken the effect of Spiolto Respimat;
• medicines that lower potassium levels in the blood, such as:
• corticosteroids (e.g. prednisolone),
• diuretics,
• medicines used for breathing problems, such as theophylline.
  Using these medicines together with Spiolto Respimat may cause symptoms such as muscle cramps, muscle weakness, or heart rhythm disturbances;
• tricyclic antidepressants or MAO inhibitors (e.g. selegiline or moclobemide), used in the treatment of neurological and psychiatric disorders such as Parkinson's disease or depression; using these medicines together increases the likelihood of heart-related adverse effects.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. Do not take the medicine unless specifically advised by a doctor.

Driving and operating machinery
No studies have been conducted on the effects of the medicine on the ability to drive or operate machinery.
If dizziness or blurred vision occurs while using Spiolto Respimat, the patient should not drive, use tools, or operate machinery.

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

3. How to use Spiolto Respimat

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Spiolto Respimat is intended for inhalation use only.
Dosage
The recommended dose is:
Spiolto Respimat works for 24 hours; therefore, it should be used ONCE DAILY, preferably at the same time each day. Each time, TWO PUFFS should be administered.
Since COPD is a chronic condition, Spiolto Respimat should be used every day, not only when breathing problems occur. Do not exceed the recommended dose.
Ensure that the patient knows how to correctly use the reusable Respimat inhaler. Instructions for using the reusable Respimat inhaler are provided at the end of this leaflet, see section "Instructions for use of the reusable Respimat inhaler".
Use in children and adolescents
Spiolto Respimat is not recommended for use in children and adolescents (under 18 years of age).
Taking more Spiolto Respimat than prescribed
There may be an increased risk of adverse effects, such as: dry mouth, constipation, difficulty passing urine, blurred vision, chest pain, high or low blood pressure, faster heartbeat or sensation of irregular heartbeat or palpitations, dizziness, nervousness, sleep disturbances, anxiety, headache, tremor, muscle cramps, nausea, fatigue, malaise, low blood potassium levels (which may cause muscle cramps, muscle weakness, and heart rhythm disturbances), high blood glucose levels, or excessive acid in the blood (which may cause symptoms such as nausea, vomiting, weakness, muscle cramps, and rapid breathing).
Missing a dose of Spiolto Respimat
If a dose is missed, inhale only one dose the next day at the usual time.
Do not use a double dose to make up for a missed dose.
Stopping Spiolto Respimat
Before stopping Spiolto Respimat, speak to your doctor or pharmacist. Stopping treatment with Spiolto Respimat may lead to worsening of COPD symptoms.
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 they do not occur in everyone.
If any of the following symptoms occur, you must stop taking this medicine
and consult a doctor immediately.

• Immediate allergic reactions to Spiolto Respimat are rare (may occur in fewer than 1 in 1,000 people). Reactions may occur individually or as part of a severe allergic reaction (anaphylactic reaction) following administration of Spiolto Respimat. These include: rash, urticaria, swelling of the mouth and face, sudden breathing difficulties (angioedema) or other hypersensitivity reactions (such as sudden drop in blood pressure or mild headache).
• As with all inhaled medicines, chest tightness associated with cough, wheezing or shortness of breath may occur immediately after inhalation (paradoxical bronchospasm). Frequency cannot be determined from available data.
• Seeing rainbow-colored halos around light sources or colored images in combination with redness of the eyes (glaucoma). Frequency cannot be determined from available data.
• Bowel obstruction or lack of bowel movements (intestinal obstruction, including paralytic ileus). Frequency cannot be determined from available data.

Other possible adverse reactions:
Uncommon (may occur in fewer than 1 in 100 people)

• Fast heartbeat (tachycardia)
• Dizziness
• Headache
• Cough
• Hoarseness (dysphonia)
• Dry mouth

Rare (may occur in fewer than 1 in 1,000 people)

• Irregular heartbeat (atrial fibrillation)
• Fast heartbeat (supraventricular tachycardia)
• Sensation of rapid heartbeat (palpitations)
• High blood pressure (hypertension)
• Difficulty passing urine (urinary retention)
• Urinary tract infections
• Painful urination
• Sore throat (pharyngitis)
• Laryngitis
• Gingivitis
• Stomatitis
• Fungal infections of the mouth and throat (oral and pharyngeal candidiasis)
• Nosebleeds
• Difficulty sleeping (insomnia)
• Blurred vision
• Chest tightness, cough, wheezing or shortness of breath immediately after inhalation (bronchospasm)
• Constipation
• Nausea
• Itching
• Joint pain
• Joint swelling
• Back pain

Unknown frequency (frequency cannot be determined from available data)

• Increased intraocular pressure
• Nasopharyngitis
• Sinusitis
• Swallowing difficulties
• Glossitis
• Heartburn (gastroesophageal reflux)
• Dental caries
• Skin infection or ulceration
• Dry skin
• Dehydration

Patients may also experience adverse reactions that occur with other medicines similar to Spiolto Respimat (beta-adrenergic medicines) used for breathing problems. These may include irregular heartbeat, chest pain, low blood pressure, muscle tremor, nervousness, muscle cramps, fatigue, malaise, low potassium levels in the blood (which may cause muscle cramps, muscle weakness and heart rhythm disturbances), high blood glucose levels, or too much acid in the blood (which may cause symptoms such as nausea, vomiting, weakness, muscle cramps and rapid breathing).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 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 Spiolto Respimat

Keep this medicine out of 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: EXP. The expiry date refers to the last day of the stated month.
Do not freeze.
Period of use 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 use: 6 medicine cartridges per inhaler.
Note: The performance of the Respimat reusable inhaler has been demonstrated in studies for 540 actuations (corresponds 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. Such measures will help protect the environment.

6. Contents of the pack and other information

What Spiolto Respimat contains
The active substances in this medicine are: tiotropium and olodaterol. The delivered dose is 2.5 micrograms
of tiotropium (as monohydrate bromide) and 2.5 micrograms of olodaterol (as hydrochloride) per spray.
The delivered dose is the amount that passes through the mouthpiece of the inhaler and becomes available to the patient.
Other ingredients are:
benzalkonium chloride, disodium edetate, purified water, and hydrochloric acid 1 M to adjust pH.

What Spiolto Respimat looks like and contents of the pack
Spiolto Respimat consists of one cartridge containing a solution for inhalation and one reusable Respimat inhaler. Before first use, the provided cartridge must be inserted into the inhaler.

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

This medicine is authorised for marketing in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Austria, Liechtenstein, Belgium, Luxembourg, Cyprus, Greece, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Iceland, Ireland, Malta, United Kingdom (Northern Ireland), Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden: Spiolto Respimat
Finland: Inspiolto Respimat
Bulgaria: Спиолто Респимат

Instructions for use of the reusable Respimat inhaler (re-usable)
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 (re-usable) allows cartridge replacement and may be used with up to 6 cartridges.

Please read the following instructions carefully before starting to use Spiolto Respimat.
This inhaler must be used ONCE DAILY. Each time, inhale the medication released during TWO SPRAYS.

• If Spiolto Respimat has not been used for more than 7 days, release one spray with the inhaler pointed away from the face.
• If Spiolto 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 is seen. Then repeat steps 4 to 6 three more times.

How to care for the reusable Respimat inhaler (re-usable)
Clean the mouthpiece, including the metal part inside, at least once a week using only a damp cloth or wipe.
A slight change in the colour of the mouthpiece does not affect the performance 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 inhaler
After using the inhaler with 6 cartridges, purchase a new Spiolto Respimat pack containing a new inhaler. The reusable Respimat inhaler (re-usable) should not be used for longer than one year from the date the first cartridge was inserted.

Preparing for use

1. Remove the clear base Keep the cap closed. Press the safety button while removing the clear 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. Track the number of used medication cartridges and reinsert the clear base Mark the box on the inhaler label to track the number of used medication cartridges. Reinsert the clear base until you hear a click.
4. Turn Keep the cap closed. Turn the clear base in the direction indicated by 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 steps 4–6 until a visible mist appears. Once the mist appears, repeat steps 4–6 three more times. The inhaler is now ready to 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. Seal your lips tightly around the mouthpiece, without covering the air intake port. Direct 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, 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 after use for next time.

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

60 sprays remain.

Fewer than 10 sprays remain. Please purchase a new cartridge.
The medicine cartridge has been used up. Rotate the transparent base to release it.
The inhaler is now locked. Remove the 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 have difficulty inserting the medicine cartridge deeply 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 place the transparent base back on.

I cannot press the dose release button.
Have you replaced the transparent base? If not, replace the transparent base. The reusable Respimat inhaler only functions 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 display 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 display 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, to take your dose perform the steps described under “OPEN” and “PUSH” in the section “Daily use”.

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

Have you frequently activated the Spiolto Respimat inhaler to check if it is working properly? After preparing the Spiolto Respimat inhaler for use, there is no need to check 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 used up. 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 Spiolto Respimat inhaler does not activate.
Have you inserted the medicine cartridge? If not, insert the medicine cartridge. After assembling the Spiolto Respimat set, do not remove the transparent base or take out the medicine cartridge until the cartridge is used up.

After inserting the medicine cartridge, did you repeat the steps Rotate, Open, Push fewer than three times? After inserting the medicine cartridge, repeat the steps Rotate, Open, Push three times, as shown in steps 4–6 in the section “Preparing for use”.

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

My Spiolto 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 registers 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.