Ianimo Respimat

Leaflet accompanying the packaging: information for the user

Yanimo Respimat, 2.5 micrograms + 2.5 micrograms, inhalation solution
tiotropium + olodaterol

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

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

Table of contents of the leaflet

• 1. What is Yanimo Respimat and what is it used for
• 2. Important information 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 is Yanimo Respimat and what is it used for

What is Yanimo Respimat

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 beta2-adrenergic receptor agonists.

What is Yanimo Respimat used for

Yanimo Respimat makes it easier for adult patients with chronic obstructive pulmonary disease (COPD) to breathe. COPD is a chronic lung disease that causes shortness of breath and coughing. The term COPD includes chronic bronchitis and emphysema. Yanimo Respimat expands the airways, helping to open up the airways and making it easier to breathe. Regular use of Yanimo Respimat may also help reduce shortness of breath associated with the disease and may help minimize the impact of the disease on daily life. Because COPD is a chronic disease, the patient should use Yanimo Respimat every day, not just when breathing problems or other COPD symptoms occur.

2. Important information before using Yanimo Respimat

When not to use 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 atropine-like substances, such as ipratropium or oxytropium.

Warnings and precautions

Before starting to use Yanimo Respimat, discuss with your doctor or pharmacist:

• if the patient has asthma (Yanimo Respimat should not be used to treat asthma),
• if the patient has heart disease,
• if the patient has high blood pressure,
• if the patient has epilepsy,
• if the patient has hyperthyroidism,
• in case of abnormal widening of the artery - aneurysm,
• if the patient has diabetes,
• if the patient has severe liver disease,
• if the patient has kidney disease,
• if surgery is planned,
• if the patient has eye disease - narrow-angle glaucoma,
• if the patient has prostate problems or difficulty urinating.

During use of Yanimo Respimat

• If the patient experiences chest tightness, coughing, wheezing, and shortness of breath immediately after taking the medicine, stop taking the medicine and inform your doctor immediately. These may be symptoms of bronchospasm (see section 4).
• If breathing worsens or a rash, swelling, or itching occurs immediately after using the inhaler, stop using it and inform your doctor immediately (see section 4).
• If any heart-related side effects occur (increased heart rate, increased blood pressure, or worsening of symptoms such as chest pain), inform your doctor immediately (see section 4).
• If muscle spasms, muscle weakness, or irregular heartbeat occur, consult your doctor, as this may be related to low potassium levels in the blood (see section 4).

When using Yanimo Respimat, do not allow the medicine to get into your eyes. This can cause eye pain or discomfort, blurred vision, seeing a rainbow-colored ring around a light source, or colored images associated with eye redness (narrow-angle glaucoma). Eye symptoms may be accompanied by headaches, nausea, and vomiting. Rinse your eyes with warm water, stop taking Yanimo Respimat, and contact your doctor immediately. Yanimo Respimat is indicated for maintenance therapy in patients with chronic obstructive pulmonary disease. Do not use the medicine in case of sudden shortness of breath or wheezing.Do not take Yanimo Respimat in combination with certain medicines containing long-acting beta2-adrenergic receptor agonists, such as salmeterol or formoterol. If the patient regularly uses certain medicines containing short-acting beta2-adrenergic receptor agonists, such as salbutamol, they should only be taken to treat acute symptoms, such as shortness of breath.

Children and adolescents

Yanimo Respimat should not be given to children and adolescents (under 18 years of age).

Yanimo Respimat and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken. In particular, inform your doctor about:

• medicines that are similar to Yanimo Respimat (containing similar active substances, such as anticholinergic or beta2-adrenergic receptor agonists). The patient may be more likely to experience side effects;
• medicines that block beta2-adrenergic receptors used to treat high blood pressure or other heart conditions (such as propranolol) or medicines used to treat eye disease called glaucoma (such as timolol). This may weaken the effect of Yanimo Respimat;
• medicines that lower potassium levels in the blood. These include:
• corticosteroids (e.g., prednisolone),
• diuretics,
• medicines taken for breathing problems, such as theophylline. Taking these medicines with Yanimo Respimat may cause symptoms such as muscle spasms, muscle weakness, or irregular heartbeat;
• tricyclic antidepressants or monoamine oxidase inhibitors (e.g., selegiline or moclobemide), which are used to treat neurological and psychiatric disorders, such as Parkinson's disease or depression; taking these medicines with Yanimo Respimat increases the risk of side effects affecting the heart.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. The medicine should not be used unless advised 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 while using Yanimo Respimat, do not drive vehicles, use tools, or operate machines.

Yanimo 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 use Yanimo Respimat

This medicine should always be used as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. Yanimo Respimat is for inhalation use only.

Dosage

The recommended dose is: Yanimo Respimat works for 24 hours, so it should be taken ONCE A DAY, at the same time every day. Take TWO SPRAYSeach time. Since COPD is a chronic disease, Yanimo Respimat should be used every day, not just when breathing problems occur. Do not exceed the recommended dose. Make sure the patient knows how to use the Respimat multi-dose inhaler (re-usable) correctly. Instructions for using the Respimat multi-dose inhaler (re-usable) can be found at the end of this leaflet, see "Instructions for using the Respimat multi-dose inhaler (re-usable)".

Use in children and adolescents

There is no indication for the use of Yanimo Respimat in children and adolescents (under 18 years of age).

Overdose of Yanimo Respimat

The patient may be at higher risk of experiencing side effects, such as dry mouth, constipation, difficulty urinating, blurred vision, chest pain, high or low blood pressure, faster heart rate, or irregular heartbeat, dizziness, nervousness, sleep disturbances, anxiety, headache, tremors, muscle spasms, nausea, fatigue, malaise, low potassium levels in the blood (which may cause muscle spasms, muscle weakness, and irregular heartbeat), high glucose levels in the blood, or too much acid in the blood (which may cause symptoms such as nausea, vomiting, weakness, muscle spasms, 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 take a double dose to make up for a missed dose.

Stopping use of Yanimo Respimat

Before stopping use of Yanimo Respimat, consult your doctor or pharmacist. Stopping use of Yanimo Respimat may worsen COPD symptoms. If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following symptoms, stop taking this medicineand consult your doctor immediately.

• Immediate allergic reactions to Yanimo Respimat are rare (may occur less frequently than 1 in 1000 people). Reactions may occur alone or as part of a severe allergic reaction (anaphylaxis) after administration of Yanimo Respimat. They include: rash, hives, swelling of the mouth and face, sudden breathing difficulties (angioedema), or other hypersensitivity reactions (such as sudden drop in blood pressure or mild headache).
• Similar to all inhaled medicines, chest tightness associated with coughing, wheezing, or shortness of breath may occur immediately after inhalation (paradoxical bronchospasm). The frequency cannot be estimated from the available data.
• Seeing a rainbow-colored ring around a light source or colored images associated with eye redness (narrow-angle glaucoma). The frequency cannot be estimated from the available data.
• Bowel obstruction or lack of bowel movements (bowel obstruction, including paralytic ileus). The frequency cannot be estimated from the available data.

Other possible side effects:

Uncommon (may occur less frequently than 1 in 100 people)

• faster heart rate (tachycardia)
• dizziness
• headache
• cough
• hoarseness (dysphonia)
• dry mouth

Rare (may occur less frequently than 1 in 1000 people)

• irregular heartbeat (atrial fibrillation)
• fast heart rate (supraventricular tachycardia)
• feeling of fast heartbeat (palpitations)
• high blood pressure (hypertension)
• difficulty urinating (urinary retention)
• urinary tract infections
• painful urination
• sore throat (pharyngitis)
• laryngitis
• gingivitis
• stomatitis
• fungal infections of the mouth and throat (oral thrush)
• nasal bleeding
• difficulty sleeping (insomnia)
• blurred vision
• chest tightness, coughing, wheezing, or shortness of breath immediately after inhalation (bronchospasm)
• constipation
• nausea
• itching
• joint pain
• joint swelling
• back pain

Unknown (frequency cannot be estimated from the available data)

• increased intraocular pressure
• pharyngitis
• sinusitis
• swallowing difficulties
• glossitis
• gastroesophageal reflux disease (GERD)
• tooth decay
• skin infection or ulceration
• dry skin
• dehydration

The patient may also experience side effects that occur with the use of other medicines similar to Yanimo Respimat (beta2-adrenergic receptor agonists) used for breathing problems. This may include irregular heartbeat, chest pain, low blood pressure, muscle tremors, nervousness, muscle spasms, fatigue, malaise, low potassium levels in the blood (which may cause muscle spasms, muscle weakness, and irregular heartbeat), high glucose levels in the blood, or too much acid in the blood (which may cause symptoms such as nausea, vomiting, weakness, muscle spasms, and rapid breathing).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 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 inhaler after EXP. The expiry date refers to the last day of the month. Do not freeze. Shelf life after first use The inhaler should be replaced no later than three months after the first use. Do not use the Respimat multi-dose inhaler (re-usable) for more than one year. Recommended use: 6 cartridges per inhaler. Note: Not all pack sizes may be marketed.

6. Contents of the pack and other information

What Yanimo Respimat contains

The active substances are tiotropium and olodaterol. The delivered dose is 2.5 micrograms of tiotropium (as bromide monohydrate) and 2.5 micrograms of olodaterol (as hydrochloride) per spray. The delivered dose is the dose 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 hydrochloric acid 1M to adjust pH.

What Yanimo Respimat looks like and contents of the pack

Yanimo Respimat consists of one cartridge containing the inhalation solution and one Respimat multi-dose inhaler. Before first use, insert the cartridge into the inhaler. Single pack: 1 Respimat multi-dose inhaler (re-usable) and 1 cartridge containing 60 sprays (30 doses). Triple pack: 1 Respimat multi-dose inhaler (re-usable) 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). Note: 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. For further information, contact the marketing authorization holder: Poland, Boehringer Ingelheim Sp. z o.o., Tel: +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, Finland, Germany, Greece, United Kingdom (Northern Ireland), Netherlands, Poland, Portugal, Romania, Spain, Sweden: Yanimo Respimat. Bulgaria: Янимо Респимат.

Date of last revision of the leaflet: 12/2024

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Instructions for using the Respimat multi-dose inhaler (re-usable)

Respimat is an inhaler that produces an aerosol for inhalation. Respimat is for use by one patient only. One cartridge contains multiple doses. The Respimat multi-dose inhaler (re-usable) allows the cartridge to be replaced and can be used with up to 6 cartridges. Read the following instructions before using Yanimo Respimat. This inhaler should be used ONCE A DAY. Each time, inhale the medicine released during TWO SPRAYS.

• If Yanimo Respimat has not been used for more than 7 days, perform one spray with the inhaler pointed downwards.
• If Yanimo Respimat has not been used for more than 21 days, repeat the steps described in points 4-6 in the "Prepare 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 Respimat multi-dose inhaler (re-usable)

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

When to replace the inhaler

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

Prepare for use

1. Remove the transparent base Keep the cap closed. Press the protective cap while pulling the transparent base with the 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 cartridges used and replace the transparent base Mark the field on the inhaler label to monitor the number of cartridges used. Replace the transparent base until it clicks into place.
4. Turn Keep the cap closed Turn the transparent base in the direction of the arrows until it clicks (half a turn).
5. Open Open the cap fully.
6. Press Point the inhaler downwards. Press the dose release button. Close the cap. Repeat the steps described in points 4-6 until a mist is visible. After a mist is visible, 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

TURN Keep the cap closed. TURN the transparent base in the direction of the arrows until it clicks (half a turn).
OPEN OPEN the cap fully.
PRESS Perform a slow and complete exhalation. Hold the mouthpiece tightly between your lips, without covering the air vent. Point the inhaler towards the back of your throat. While performing a slow and deep inhalation through your mouth, PRESS the dose release button and continue inhaling slowly for as long as it is comfortable. Hold your breath for 10 seconds or for as long as it is comfortable. Repeat the steps described in points TURN, OPEN, PRESS to take a total of 2 sprays. Close the cap to prepare the inhaler for the next use.

When to replace the Yanimo Respimat cartridge

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

60 sprays left

Less than 10 sprays left. 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 Respimat multi-dose inhaler (re-usable). Insert a new cartridge into the inhaler until it clicks (see point 2). A newly inserted cartridge will protrude more than the first cartridge (continue from point 3). Remember to replace the transparent base to unlock the inhaler.

Answers to frequently asked questions

Difficulty inserting the cartridge

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, 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 Respimat multi-dose inhaler (re-usable) only works with the transparent base in place. Was the transparent base turned?If not, turn the transparent base until it clicks (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

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. Was the transparent base already turned?If the transparent base was already turned, to take the medicine, perform the steps described in points OPEN and PRESS in the "Daily use" section.

My Yanimo Respimat inhaler is running out too quickly

Is Yanimo Respimat being used as directed (two sprays once daily)?Each cartridge contains enough medicine for 30 days when used as two sprays once daily. Is the inhaler being activated frequently to check its operation?After preparing the Yanimo Respimat inhaler for use, there is no need to check its operation 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.

My Yanimo Respimat inhaler is not working

Is the cartridge inserted?If not, insert the cartridge. After assembling the Yanimo Respimat inhaler, do not remove the transparent base or the cartridge until it is empty. Were the steps described in points TURN, OPEN, PRESS in the "Prepare for use" section repeated less than three times after inserting the cartridge?Repeat the steps described in points TURN, OPEN, PRESS three times after inserting the cartridge, as shown in points 4-6 in the "Prepare for use" section. Is the dose indicator on the cartridge showing a white arrow on a red background?Your cartridge is empty. Insert a new cartridge.

My Yanimo 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 until it clicks (half a turn). The dose counter is reduced by one spray for each incomplete turn, and the number of sprays left is reduced. Was the cap open when replacing the cartridge?Close the cap, then replace the cartridge.