Yanimo respimat

Patient Information Leaflet

Yanimo 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 so that you can read it again if needed.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

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

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

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

What Yanimo Respimat is used for
Yanimo Respimat helps adult patients with chronic obstructive pulmonary disease (COPD) to breathe more easily. COPD is a chronic lung disease that causes breathlessness and cough. The term COPD includes chronic bronchitis and emphysema.

Yanimo Respimat works by widening the airways, helping to open the breathing passages and making breathing easier. Regular use of Yanimo Respimat may also help reduce breathlessness associated with the disease and may minimize the impact of the disease on daily life.

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

2. Important information before using Yanimo Respimat

When not to take Yanimo Respimat:

• if the patient is allergic to tiotropium or olodaterol, or to 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 oxitropium.

Warnings and precautions
Before starting treatment with Yanimo Respimat, discuss this with your doctor or
pharmacist:

• if the patient suffers from asthma (Yanimo Respimat should not be used for the treatment of asthma),
• if the patient has heart diseases,
• 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 – an 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 urinating.

While using Yanimo Respimat

• If the patient experiences chest tightness, cough, wheezing, or shortness of breath immediately after taking the medicine, treatment should be stopped and the doctor should be informed 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 your 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 your doctor immediately (see section 4).
• If muscle cramps, muscle weakness, or irregular heartbeat occur, consult your doctor, as these may be related to low potassium levels in the blood (see section 4).

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

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

Yanimo Respimat and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used by the patient.
In particular, inform your doctor about the use of:

• medicines similar to Yanimo Respimat (containing similar active substances such as anticholinergics or beta-adrenergics). The patient may be more susceptible to adverse effects;
• medicines belonging to the group of beta-adrenergic receptor blockers used to treat hypertension or other heart conditions (such as propranolol), or medicines used to treat an eye condition called glaucoma (such as timolol). These may reduce the effectiveness of Yanimo Respimat;
• medicines that lower potassium levels in the blood. These include:
• corticosteroids (e.g. prednisolone),
• diuretics,
• medicines used for breathing problems, such as theophylline. Taking these medicines together with Yanimo 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; concomitant use increases the risk of cardiovascular adverse effects.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or 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 using machines
No studies on the effect of the medicine on the ability to drive or operate machinery have been conducted.
If dizziness or blurred vision occurs during treatment with Yanimo Respimat, the patient should not drive, use tools, or operate machinery.

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

3. How to use Yanimo Respimat

This medicine should always be used as directed by the physician. If in doubt, consult your doctor or pharmacist.
Yanimo Respimat is intended for inhalation use only.
Dosage
The recommended dose is:
Yanimo Respimat works for 24 hours; therefore, it should be taken ONCE DAILY, preferably at the same time each day.
Each time, TWO PUFFS should be administered.
Since COPD is a chronic condition, Yanimo Respimat must 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 Respimat reusable inhaler. Instructions for using the Respimat reusable inhaler can be found at the end of this leaflet, see section “Instructions for using the Respimat reusable inhaler”.
Use in children and adolescents
Yanimo Respimat is not indicated for use in children and adolescents (under 18 years of age).
Use of more than the recommended dose of Yanimo Respimat
The patient may experience an increased risk of adverse effects such as dry mouth, constipation, difficulty in 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 blood acidity (which may cause symptoms such as nausea, vomiting, weakness, muscle cramps, and rapid breathing).
Missed dose of Yanimo Respimat
If a dose is missed, take only one dose the next day at the usual time.
Do not use a double dose to make up for a missed dose.
Stopping treatment with Yanimo Respimat
Before stopping treatment with Yanimo Respimat, consult your doctor or pharmacist. Discontinuing treatment with Yanimo 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 not everybody will experience them.
If any of the following symptoms occur, stop taking this medicine immediately
and consult a doctor without delay.

• Immediate allergic reactions to Yanimo 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 Yanimo Respimat. These include: rash, urticaria, oral and facial swelling, 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 vision combined 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 Yanimo 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 excess 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 adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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. By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Yanimo 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 medicine cartridge: EXP. The expiry date refers to the last day of the stated month.
Do not freeze.
Shelf-life after first use
The medicine cartridge should be replaced 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 (corresponding 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 Yanimo 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 of medicine available to the patient after passing through the inhaler mouthpiece.
Other ingredients are:
benzalkonium chloride, disodium edetate, purified water, and hydrochloric acid 1 M to adjust pH.

What Yanimo Respimat looks like and contents of the pack
Yanimo 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 delivering 60 sprays (30 therapeutic doses).
Triple pack: 1 reusable Respimat inhaler and 3 medicine cartridges, each delivering 60 sprays (30 therapeutic doses).
Single refill pack: 1 medicine cartridge delivering 60 sprays (30 therapeutic doses).
Triple refill pack: 3 medicine cartridges, each delivering 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 medicine is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Austria, Liechtenstein, Belgium, Luxembourg, Cyprus, Finland, Germany, Greece, United Kingdom (Northern Ireland), Netherlands, Poland, Portugal, Romania, Spain, Sweden: Yanimo Respimat
Bulgaria: Янимо 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 delivers multiple doses. The reusable Respimat inhaler allows cartridge replacement and can be used with up to 6 cartridges.

Please read the following instructions carefully before starting treatment with Yanimo Respimat.
This inhaler must be used ONCE DAILY. Each time, inhale the medicine released during TWO SPRAYS.

• If Yanimo Respimat has not been used for more than 7 days, release one spray with the inhaler pointing away from the face.
• If Yanimo Respimat has not been used for more than 21 days, repeat steps 4–6 in the section "Preparing for use" until a mist is 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.
Minor 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 Yanimo Respimat pack containing a new inhaler. Do not use the reusable Respimat inhaler 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 until the cartridge clicks into place.
3. Monitor the number of used medication cartridges and reinsert the transparent base Mark the box on the inhaler label to track the number of used cartridges. Reinsert the transparent base until you hear a click.
4. Rotate Keep the cap closed. Rotate the transparent base in the direction indicated by the arrows until you hear a click (half a turn).
5. Open Open the cap fully by lifting it up.
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 steps 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 you hear a click (half a turn).
OPEN OPEN the cap fully.
PRESS Breathe out slowly and fully. Place your mouth tightly around the mouthpiece without covering the air inlet. Direct 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 for as long as comfortable. Repeat the ROTATE, OPEN, PRESS steps to take a total of 2 sprays. Close the cap for the next use of the inhaler.

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

60 sprays remaining

Fewer than 10 sprays remaining. You should purchase a new cartridge.
The cartridge is empty. Rotate the transparent base to release it.
The inhaler is now locked. Remove the used cartridge from the reusable inhaler.
Insert a new cartridge into the inhaler until you hear a click (see step 2).
The newly inserted cartridge will protrude more than the original cartridge (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 cartridge deeply enough.
Did you accidentally rotate 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 original 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 functions when the transparent base is correctly in place.

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 cartridge display 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 after it is empty.
Pull and simultaneously rotate the cartridge to remove it.

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

Have you already rotated the transparent base?
If the transparent base has already been rotated, you need to perform the steps described under “OPEN” and “PRESS” in the “Daily use” section to prepare the inhaler for use.

My Yanimo Respimat inhaler ran out too quickly.
Are you using Yanimo Respimat as directed (two sprays once daily)? Each cartridge contains enough medication for 30 days when two sprays are used once daily.

Have you frequently activated the Yanimo Respimat inhaler to check if it is working properly? After preparing the Yanimo 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 until the cartridge is empty. Each time the transparent base is removed and replaced without replacing the cartridge, the dose counter records one spray, reducing the number of doses remaining.

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

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

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

My Yanimo 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 hearing 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, reducing the number of doses remaining.

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