YANIMO RESPIMAT 2.5 micrograms / 2.5 micrograms SOLUTION FOR INHALATION

Introduction

Package Leaflet: Information for the User

Yanimo Respimat 2.5 micrograms/2.5 micrograms, inhalation solution

tiotropium/olodaterol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Yanimo Respimat and what is it used for
2. What you need to know before you take Yanimo Respimat
3. How to take Yanimo Respimat
4. Possible side effects
5. Storage of 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 called tiotropium and olodaterol. These belong to a group of medicines called long-acting bronchodilators. Tiotropium belongs to the subgroup of anticholinergics; olodaterol belongs to the subgroup of long-acting beta2 agonists.

What is Yanimo Respimat used for

Yanimo Respimat helps adult patients with chronic obstructive pulmonary disease (COPD) to breathe more easily. COPD is a long-term lung disease that causes difficulty breathing and coughing. The term COPD is associated with chronic bronchitis and emphysema.

Yanimo Respimat helps to open up the airways and makes it easier to get air in and out of the lungs. Regular use of Yanimo Respimat can also help when you have ongoing difficulty breathing due to your disease and will help minimize the effects of the disease on your daily life. Since COPD is a long-term disease, you should use Yanimo Respimat every day and not just when you have breathing problems or other COPD symptoms.

2. What you need to know before you take Yanimo Respimat

Do not take Yanimo Respimat

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

Warnings and precautions

Consult your doctor or pharmacist before you take Yanimo Respimat

• if you have asthma (you should not take Yanimo Respimat for the treatment of asthma)
• if you have heart problems
• if you have high blood pressure
• if you have epilepsy
• if you have a specific thyroid gland problem called thyrotoxicosis
• if you have an abnormal enlargement of an artery called an aneurysm
• if you have diabetes
• if you have severe liver disease
• if you have kidney disease
• if you are scheduled for surgery
• if you have a problem in your eyes called narrow-angle glaucoma
• if you have prostate problems or difficulty urinating.

During treatment with Yanimo Respimat

• Stop taking the medicine and consult your doctor immediatelyif you feel a tightness in the chest, have a cough, wheezing or difficulty breathing immediately after taking the medication. These may be symptoms of a condition called bronchospasm (see section 4).

• If your breathing problems worsen or rashes, swelling, or itching occur immediately after using your inhaler, stop using it and consult your doctor immediately (see section 4).

• If you experience any side effects related to the heart (increased heart rate, increased blood pressure, and/or increased symptoms such as chest pain), consult your doctor immediately (see section 4).

• If you experience muscle spasms, muscle weakness, or an abnormal heart rhythm, consult your doctor, as these symptoms may be related to low potassium levels in the blood (see section 4).

When using Yanimo Respimat, be careful not to get any spray in your eyes. This can cause eye pain or discomfort, blurred vision, halos around lights, or colored images associated with redness of the eyes (i.e., narrow-angle glaucoma). Eye symptoms may be accompanied by headache, nausea, or vomiting. Rinse your eyes with warm water, interrupt the intake of Yanimo Respimat, and consult your doctor immediately for more information.

Yanimo Respimat is indicated for the maintenance treatment of your chronic obstructive pulmonary disease. It should not be taken to treat a sudden episode of shortness of breath or wheezing.

Do not take Yanimo Respimat with certain medications that contain long-acting beta-adrenergic agonists, such as salmeterol or formoterol.

If you regularly take certain medications called short-acting beta-adrenergic agents, such as salbutamol, continue taking them only to relieve acute symptoms such as shortness of breath.

Dry mouth that has been observed with long-term anticholinergic treatment may be associated with dental caries. Therefore, remember to take care of your oral hygiene.

Do not use Yanimo Respimat more than once a day.

Children and adolescents

Do notgive Yanimo Respimat to children or adolescents (under 18 years of age).

Other medicines and Yanimo Respimat

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, inform your doctor or pharmacist if you are taking:

• certain medications that may be similar to Yanimo Respimat (contain similar active substances such as anticholinergics or beta-adrenergic agents). You may be more likely to experience side effects.

• medications called beta-blockers used for high blood pressure or heart problems (such as propranolol) or for a problem in the eye known as glaucoma (such as timolol). This may reduce the effect of Yanimo Respimat.

• medications that decrease potassium levels in the blood. For example:

• corticosteroids (e.g., prednisolone),
• diuretics (medications to urinate),
• medications for respiratory problems such as theophylline.

Taking these medications with Yanimo Respimat may cause muscle spasms, muscle weakness, or an abnormal heart rhythm.

• medications called tricyclic antidepressants or MAO inhibitors (such as selegiline or moclobemide), which are used to treat neurological or psychiatric disorders such as Parkinson's disease or depression; the use of these medications will increase the risk of experiencing heart-related side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine. You should not take this medicine unless your doctor has specifically recommended it.

Driving and using machines

No studies have been conducted on the effects on driving and using machines.

If you feel dizzy or experience blurred vision while taking Yanimo Respimat, do not drive or use tools or machines.

Yanimo Respimat contains Benzalkonium chloride

This medicine contains 0.0011 mg of benzalkonium chloride in each puff.

Benzalkonium chloride may cause wheezing and breathing difficulties (bronchospasm), especially in patients with asthma.

3. How to take Yanimo Respimat

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Yanimo Respimat should only be used by inhalation.

Dosage

The recommended dose is:

Yanimo Respimat has a 24-hour effect, so you should take Yanimo Respimat only ONCE A DAY, if possible always at the same time of day. Each time you use it, inhale TWO PUFFS.

Since COPD is a long-term disease, you should take Yanimo Respimat every day and not just when you have difficulty breathing. Do not take more than the recommended dose.

Make sure you know how to use your Respimat inhaler correctly. The instructions for use of the Respimat inhaler are included at the end of this leaflet, see "Instructions on how to use the Respimat inhaler".

Use in children and adolescents

There is no specific recommendation for the use of Yanimo Respimat in the pediatric population (under 18 years of age).

If you take more Yanimo Respimat than you should

You may have a greater risk of experiencing a side effect such as dry mouth, constipation, difficulty urinating, blurred vision, chest pain, high or low blood pressure, rapid or irregular heartbeat or palpitations, dizziness, nervousness, difficulty sleeping, anxiety, headache, tremor, muscle cramps, nausea, fatigue, discomfort, low potassium levels in the blood (which can cause muscle spasms, muscle weakness, or an abnormal heart rhythm), high blood sugar levels, or too much acid in the blood (which can cause symptoms such as nausea, vomiting, weakness, muscle cramps, and rapid breathing).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Yanimo Respimat

If you have forgotten to inhale a dose, inhale a single dose the next day at the usual time.

Do not use a double dose to make up for forgotten doses.

If you stop taking Yanimo Respimat

Before stopping treatment with Yanimo Respimat, you should talk to your doctor or pharmacist. If you stop treatment with Yanimo Respimat, the signs and symptoms of COPD may worsen.

If you have any further questions on 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.

If any of these reactions occur, please stop taking this medicineand consult your doctor immediately.

• Immediate allergic reactions to Yanimo Respimat are rare (may affect up to 1 in 1,000 people). These reactions can occur individually or as part of a severe allergic reaction (anaphylactic reaction) after administration of Yanimo Respimat. These include rash, hives, swelling of the mouth and face, sudden difficulty breathing (angioedema), or other hypersensitivity reactions (such as a sudden drop in blood pressure or dizziness).
• As with all inhaled medications, some patients may experience chest pressure associated with coughing, wheezing, or difficulty breathing immediately after inhalation (paradoxical bronchospasm). The frequency cannot be estimated from the available data.
• Visual halos or colored images associated with redness of the eyes (glaucoma). The frequency cannot be estimated from the available data.
• Intestinal blockage or absence of bowel movement (intestinal obstruction including paralytic ileus). The frequency cannot be estimated from the available data.

Other possible side effects:

Uncommon (may affect up to 1 in 100 people)

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

Rare (may affect up to 1 in 1,000 people)

• irregular heartbeat (atrial fibrillation)
• rapid heartbeat (supraventricular tachycardia)
• palpitations
• high blood pressure (hypertension)
• difficulty urinating (urinary retention)
• urinary tract infections
• painful urination (dysuria)
• throat inflammation (pharyngitis)
• larynx inflammation (laryngitis)
• gum inflammation (gingivitis)
• mouth inflammation (stomatitis)
• fungal infection in the mouth or throat (oropharyngeal candidiasis)
• nasal bleeding (epistaxis)
• difficulty sleeping (insomnia)
• blurred vision
• chest pressure associated with coughing, wheezing, or difficulty breathing immediately after inhalation (bronchospasm)
• constipation
• nausea
• itching (pruritus)
• joint pain (arthralgia)
• joint swelling
• back pain.

Not known (frequency cannot be estimated from the available data)

• increased eye pressure
• nasopharyngitis
• sinusitis
• difficulty swallowing (dysphagia)
• tongue inflammation (glossitis)
• heartburn (gastroesophageal reflux)
• dental caries
• skin infections or ulcers
• dry skin
• dehydration.

You may experience side effects that occur with other medicines similar to Yanimo Respimat (beta-adrenergic agents) for treating respiratory problems. These may be irregular heartbeat, chest pain, low blood pressure, tremor, nervousness, muscle cramps, fatigue, discomfort, low potassium levels in the blood (which can cause muscle spasms, muscle weakness, or an abnormal heart rhythm), high blood sugar levels, or too much acid in the blood (which can cause symptoms such as nausea, vomiting, weakness, muscle cramps, and rapid breathing).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Yanimo Respimat

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the label of the cartridge after EXP. The expiry date is the last day of the month stated.

Do not freeze.

Shelf life:

Replace the cartridge no later than three months after insertion.

Do not use the Respimat inhaler for more than one year.

Recommended use: 6 cartridges per inhaler.

Note: The functioning of the Respimat inhaler has been demonstrated in tests for 540 puffs (corresponding 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. Contents of the pack and additional information

Composition of Yanimo Respimat

The active ingredients 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 puff.

The delivered dose is the dose available to the patient after passing through the mouthpiece.

The other components are:

Benzalkonium chloride, disodium edetate, purified water, and hydrochloric acid to adjust the pH.

Appearance of the product and contents of the pack

Yanimo Respimat 2.5 micrograms/2.5 micrograms consists of a cartridge with an inhalation solution and a Respimat inhaler. Before the first use, you must insert the cartridge into the inhaler.

Single pack: 1 Respimat inhaler and 1 cartridge providing 60 puffs (30 doses).

Triple pack: 1 Respimat inhaler and 3 cartridges providing 60 puffs (30 doses) each.

Single replacement pack: 1 cartridge providing 60 puffs (30 doses).

Triple replacement pack: 3 cartridges providing 60 puffs (30 doses) each.

Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer

The marketing authorisation holder for Yanimo Respimat is:

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

The manufacturer of Yanimo Respimat is:

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Boehringer Ingelheim España, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallès (Barcelona)

Spain

Boehringer Ingelheim France

100-104 Avenue de France

75013 Paris

France

Local representative:

Boehringer Ingelheim España, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallès (Barcelona)

Spain

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, Greece, Czech Republic, Denmark, Finland, Germany, Hungary, Iceland, United Kingdom (Northern Ireland), Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden: Yanimo Respimat

Bulgaria: ????? ????????

Date of last revision of this leaflet:December 2024

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.

Instructions on how to use the Respimat rechargeable inhaler

Respimat is an inhaler device that generates an aerosol for inhalation. Respimat is for your use only. A cartridge provides several doses. The Respimat rechargeable inhaler allows you to replace the cartridge and can be used with up to 6 cartridges.

Read these instructions before starting to use Yanimo Respimat.

You will need to use this inhaler ONCE A DAY. Each time you use it, perform TWO PUFFS.

• If Yanimo Respimat has not been used for more than 7 days, perform a puff towards the ground.
• If Yanimo Respimat has not been used for more than 21 days, repeat the steps from 4 to 6 described in “Preparation for use” until you observe a cloud. Then repeat the steps from 4 to 6 three more times.

How to maintain your Respimat rechargeable inhaler

Clean the mouthpiece, including the metal part inside it, only with a damp cloth or a handkerchief, at least once a week.

Any slight discoloration of the mouthpiece does not affect the functioning of your Respimat rechargeable inhaler.

If necessary, clean the outside of your Respimat rechargeable inhaler with a damp cloth.

When to change the inhaler

When you have used 6 cartridges with the same inhaler, get a new pack of Yanimo Respimat containing an inhaler. Do not use the Respimat rechargeable inhaler for more than one year after inserting the first cartridge.

Preparation for use

Daily use

When to change the Yanimo Respimat cartridge

The dose indicator shows how many puffs are left in the cartridge.

60 puffs remaining.

Less than 10 puffs remaining. Get a new cartridge.

Your cartridge is empty. Turn the transparent base to loosen it. Your inhaler is now blocked. Remove the cartridge from the inhaler. Insert a new cartridge until it clicks (see step 2). The new cartridge will protrude more than the first cartridge (continue with step 3). Remember to replace the transparent base to unblock the inhaler.

Frequently asked questions

It is difficult to insert the cartridge deep enough.

Have you turned the transparent base accidentally before inserting the cartridge?Open the cap, press the dose release button, and then insert the cartridge.

Are you changing the cartridge?The new cartridge will protrude more than the first cartridge. Insert the cartridge until it clicks, then replace the transparent base.

I cannot press the dose release button.

Have you replaced the transparent base?If not, replace the transparent base to unblock the inhaler. The Respimat rechargeable inhaler only works with the transparent base in place.

Have you turned the transparent base?If not, turn the transparent base with a continuous movement until it clicks (half a turn). Does the dose indicator on your cartridge show 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 once it is empty.

Pull and turn the cartridge at the same time.

I cannot turn or replace the transparent base.

Is the transparent base loose and the dose indicator on your cartridge showing a white arrow on a red background?Your cartridge is empty. Insert a new cartridge.

Have you already turned the transparent base?If you have already turned the transparent base, follow the steps “OPEN” and “PUFF” described in “Daily use” to use your medication.

My Yanimo Respimat has run out too soon.

Have you used Yanimo Respimat as indicated (two puffs/once a day)?Each cartridge will last 30 days if two puffs are performed once a day.

Have you sprayed into the air frequently to check if Yanimo Respimat is working?Once you have prepared Yanimo Respimat for use, it is not necessary to test its functioning by spraying the solution if it is used daily.

Have you removed and replaced the transparent base several times?Do not remove the transparent base before the cartridge is empty. Each time you remove the transparent base without changing the cartridge, the dose counter registers a puff and the remaining doses are reduced.

My Yanimo Respimat does not spray.Have you inserted a cartridge?If not, insert a cartridge. Once your Yanimo Respimat is assembled, do not remove the transparent base or the cartridge until the cartridge is empty.

Have you repeated the steps TURN, OPEN, PUFF less than three times after inserting the cartridge?Repeat the steps TURN, OPEN, PUFF three times after inserting the cartridge as described in steps 4 to 6 in “Preparation for use”.

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

My Yanimo Respimat sprays automatically.

Was the cap open when you turned the transparent base?Close the cap, then turn the transparent base.

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

Did you stop turning the transparent base before it clicked?Turn the transparent base with a continuous movement until it clicks (half a turn). The dose counter will count each incomplete turn and the number of remaining doses will be reduced.

Was the cap open when you changed the cartridge?Close the cap, then change the cartridge.

Other sources of information

You can access detailed and updated information on how to administer this medicinal product by scanning the QR code included in the section “Instructions on how to use the Respimat rechargeable inhaler” of this leaflet and on the packaging with your smartphone. You can also access this information on the following internet address: https://cima.aemps.es/info/79966.