Prospect: information for the user

Spiolto Respimat 2.5 micrograms/2.5 micrograms, inhalation solution

tiotropio/olodaterol

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

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

2. What you need to know before starting to take Spiolto Respimat

3. How to take Spiolto Respimat

4. Possible adverse effects

5. Storage of Spiolto Respimat

6. Contents of the package and additional information

What is Spiolto Respimat

Spiolto Respimat contains two active ingredients called tiotropio and olodaterol. These belong to a group of medicines called long-acting bronchodilators. Tiotropio belongs to the subgroup of anticholinergics; olodaterol belongs to the subgroup of long-acting beta2 agonists.2agonists.

What is Spiolto Respimat used for

Spiolto 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.

Spiolto Respimat helps to open your airways and facilitates the intake and expulsion of air from the lungs. Regular use of Spiolto Respimat can also help you when you have persistent difficulty breathing due to your disease and will help you to minimize the effects of the disease on your daily life. Since COPD is a long-term disease, you must take Spiolto Respimat every day and not just when you have respiratory problems or other COPD symptoms.

Do not take Spiolto Respimat

-if you are allergic to tiotropium or olodaterol or to 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 starting to take Spiolto Respimat

• if you have asthma (you should not take Spiolto 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 hyperthyroidism
• if you have an abnormal widening 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 an operation
• if you have a problem with your eyes called narrow-angle glaucoma
• if you have prostate problems or difficulty urinating.

During treatment with Spiolto Respimat

• Stop taking the medicine and consult your doctor immediatelyif you feel a tightness in your chest, have coughing, 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 you experience skin rashes, swelling or itching immediately after using your inhaler, stop using it and consult your doctor immediately (see section 4).

• if you experience any heart-related side effects (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 Spiolto Respimat, be careful not to get any of the aerosol into your eyes. This may cause eye pain or discomfort, blurred vision, halos around lights or coloured images associated with eye redness (i.e. narrow-angle glaucoma). Eye symptoms may be accompanied by headache, nausea or vomiting. Rinse your eyes with warm water, stop taking Spiolto Respimat and consult your doctor immediately for further information.

Spiolto Respimat is indicated for the maintenance treatment of your chronic obstructive pulmonary disease.Do not take it to treat a sudden episode of shortness of breath or wheezing.

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

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

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

Do not use Spiolto Respimat more than once a day.

Children and adolescents

Do notadminister Spiolto Respimatto children or adolescents (under 18 years).

Other medicines and Spiolto Respimat

Inform your doctor or pharmacist if you are taking, have taken recently or might have to take any other medicine.

Particularly, inform your doctor or pharmacist if you are taking:

• medicines that may be similar to Spiolto Respimat (containing active substances similar to anticholinergics or beta-adrenergic agents). You may be more prone to side effects.

• medicines 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 Spiolto Respimat.

• medicines that lower potassium levels in the blood. For example:

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

The simultaneous use of these medicines with Spiolto Respimat may cause muscle spasms, muscle weakness or abnormal heart rhythm.

• medicines called tricyclic antidepressants or MAO inhibitors (such as selegiline or moclobemide), used to treat neurological or psychiatric disorders such as Parkinson's disease or depression; the use of these medicines 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 intend to become pregnant, consult your doctor or pharmacist before taking this medicine. Do not take this medicine unless your doctor has specifically recommended it.

Driving and operating machinery

No studies have been conducted on the effects on driving and operating machinery.

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

Spiolto 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.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Spiolto Respimat should only be used by inhalation.

Dosage

The recommended dose is:

Spiolto Respimat has a 24-hour effect, so you should take Spiolto Respimat onlyONCE A DAY, if possible at the same time every day. Each time you use it, inhale 2 puffs.

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

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

Use in children and adolescents

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

If you take more Spiolto Respimat than you should

You may have a higher risk of experiencing an adverse effect such as dry mouth, constipation, difficulty urinating, blurred vision, chest pain, high or low blood pressure, rapid or irregular heartbeat, palpitations, dizziness, nervousness, difficulty sleeping, anxiety, headache, tremors, muscle cramps, nausea, fatigue, discomfort, low potassium levels in the blood (which can cause muscle spasms, muscle weakness, or abnormal heart rhythm), high blood sugar levels or excessive acidity 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Spiolto 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 compensate for the missed doses.

If you interrupt treatment with Spiolto Respimat

Before interrupting treatment with Spiolto Respimat, you should talk to your doctor or pharmacist. If you interrupt treatment with Spiolto Respimat, the signs and symptoms of COPD may worsen.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

Other possible side effects:

Rare (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 heart rhythm(Atrial fibrillation)

-Accelerated heart rate (supraventricular tachycardia)

- Palpitations

- High blood pressure (hypertension)

- Urinary retention difficulties

- Urinary tract infections

- Painful urination (dysuria)

- Throat inflammation (pharyngitis)

- Laryngeal inflammation (laryngitis)

- Gingivitis

- Stomatitis

- Oral or pharyngeal fungal infection (oropharyngeal candidiasis)

- Nasal bleeding (epistaxis)

- Difficulty sleeping (insomnia)

- Blurred vision

- Chest tightness, associated with cough, wheezing or immediate difficulty breathing after inhalation (bronchospasm)

- Constipation

- Nausea

- Itching (pruritus)

- Joint pain (arthralgia)

- Swelling of the joint

- Back pain.

Unknown (frequency cannot be estimated from available data)

- Increased eye pressure

- Nasopharyngitis

- Sinusitis

- Difficulty swallowing (dysphagia)

- Inflammation of the tongue (glossitis)

- Heartburn (gastroesophageal reflux)

- Tooth decay

- Skin infections or ulcers

- Dry skin

- Dehydration.

You may experience side effects that appear with other medications similar to Spiolto Respimat (beta-adrenergic agents) for respiratory problems. These may be irregular pulse, chest pain, low blood pressure, tremors, nervousness, muscle cramps, fatigue, discomfort, low potassium levels in the blood (which may cause muscle spasms, muscle weakness or abnormal heart rhythm), high blood sugar levels or excessive acid in the blood (which may cause symptoms such as nausea, vomiting, weakness, muscle cramps and rapid breathing).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the cartridge label after CAD. The expiration date is the last day of the month indicated.

Do not freeze.

Shelf life in use:

Replace the cartridge no more than three months after its insertion.

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

Recommended use: 6 cartridges per inhaler.

Nota: the operation of the rechargeable RESPIMAT inhaler has been demonstrated in tests for 540 pulses (corresponding to 9 cartridges).

Medicines should not be thrown into the drains or trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of your usual pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Spiolto Respimat

The active principles are tiotropio and olodaterol. The released dose is 2.5 micrograms of tiotropio (as bromide monohydrate) and 2.5 micrograms of olodaterol (as hydrochloride) per pulse.

The released 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 package

Spiolto 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.

Individual package: 1 rechargeable Respimat inhaler and 1 cartridge that provides 60 pulses (30 doses).

Triple package:1 rechargeable Respimat inhaler and 3 cartridges that provide 60 pulses (30 doses) each.

Replacement individual package: 1 cartridge that provides 60 pulses (30 doses).

Replacement triple package: 3 cartridges that provide 60 pulses (30 doses) each.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

The marketing authorization holder of Spiolto Respimat is:

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

The manufacturer of Spiolto 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 medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with 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: ??????? ????????

Last review date of this leaflet: December 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.

Instructions for using the rechargeable Respimat inhaler

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

Read these instructions before starting to use Spiolto Respimat.

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

• If Spiolto Respimat has not been used for more than 7 days, perform a pulse towards the floor.
• If Spiolto 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 rechargeable Respimat inhaler

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

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

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

When to change the inhaler

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

Preparation for use

Daily use

When to change the Spiolto Respimat cartridge

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

There are 60 pulses left.

There are less than 10 pulses left. 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 put the transparent base back to unlock the inhaler.

Answers to frequently asked questions

It is difficult to insert the cartridge deep enough.

Have you accidentally turned the transparent base before inserting the cartridge?Open the cap, pulse 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 put the transparent base back.

I cannot pulse the dose release button.

Have you put the transparent base back?If not, put the transparent base back to unlock the inhaler. The Respimat 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 turn). The dose counter will count each incomplete turn and the remaining doses will decrease.

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

It is difficult to remove the cartridge once it is empty.

Try to pull and turn the cartridge at the same time.

I cannot turn or put the transparent base back.

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 “PULSE” described in “Daily use” to use your medicine.

My Spiolto Respimat has run out too soon.

Have you used SpioltoRespimat as indicated (two pulses/once a day)?Each cartridge will last 30 days if you perform two pulses once a day.

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

Have you removed and put the transparent base back 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 will register a pulse and the remaining doses will decrease.

My Spiolto Respimat is not spraying.

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

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

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

My Spiolto Respimat is spraying automatically.

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

Have you pressed 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.

Have you stopped turning the transparent base before it clicked?Turn the transparent base with a continuous movement until it clicks (half turn). The dose counter will count each incomplete turn and the remaining doses will decrease.

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 medicine by scanning the QR code included in the section“Instructions for using the rechargeable Respimat inhaler” of this leaflet and the packaging. You can also access this information on the following internet address: https://cima.aemps.es/info/79967.