Spiolto Respimat 2.5 micrograms/2.5 micrograms solution for inhalation

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Spiolto Respimat 2.5 micrograms/2.5 micrograms, solution for inhalation

tiotropium/olodaterol

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Spiolto Respimat is and what it is used for
2. What you need to know 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 called tiotropium and olodaterol. These belong to a group of medicines known as long-acting bronchodilators. Tiotropium belongs to the subgroup of anticholinergics; olodaterol belongs to the subgroup of long-acting beta2 agonists.

What Spiolto Respimat is 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 makes it easier to move air in and out of the lungs. Regular use of Spiolto Respimat can also help when you have ongoing breathing difficulties due to your disease, and will assist in minimizing the impact of the disease on your daily life. Since COPD is a long-term condition, you must take Spiolto Respimat every day, not only when you experience breathing problems or other COPD symptoms.

2. What you need to know before using Spiolto Respimat

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 use 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 condition called thyrotoxicosis
• 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 surgery
• if you have a condition in the 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 immediately if you feel tightness in the chest, develop cough, wheezing, or difficulty breathing right after taking the medicine. These may be symptoms of a condition called bronchospasm (see section 4).

• If your breathing problems worsen or you develop rashes, swelling, or itching 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 pulse, increased blood pressure and/or worsening of symptoms such as chest pain), consult your doctor immediately (see section 4).

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

When using Spiolto Respimat, take care not to get any of the aerosol into your eyes. This may cause eye pain or discomfort, blurred vision, visual halos around lights, or colored images associated with eye redness (i.e., narrow-angle glaucoma). Eye symptoms may be accompanied by headache, nausea, or vomiting. Rinse your eyes with lukewarm water, discontinue use of Spiolto Respimat, and consult your doctor immediately for further advice.

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

Do not take Spiolto Respimat together with certain medicines containing 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 use them only for relief of acute symptoms such as shortness of breath.

Dry mouth, which has been observed with long-term anticholinergic treatment, may be associated with dental caries. Therefore, remember to maintain good oral hygiene.

Do not use Spiolto Respimat more than once a day.

Children and adolescents

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

Other medicines and Spiolto Respimat

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

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

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

• medicines called beta-blockers used for high blood pressure or heart problems (such as propranolol), or for an eye condition known as glaucoma (such as timolol). These may reduce the effect of Spiolto Respimat.

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

• steroids (e.g. prednisolone),

• diuretics (medicines to increase urination),

• medicines for breathing problems such as theophylline.

Taking these medicines together with Spiolto Respimat may cause muscle cramps, muscle weakness, or irregular heartbeat.

• 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; using these medicines increases the risk of heart-related side effects.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine. You should not take this medicine unless specifically advised by your doctor.

Driving and using machines

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

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

Spiolto Respimat contains Benzalkonium chloride

This medicine contains 0.0011 mg of benzalkonium chloride per puff.

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

3. How to take Spiolto Respimat

Follow exactly the instructions for use of this medicine as given by your doctor. If in 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; therefore, you should take Spiolto Respimat only ONCE DAILY, preferably always at the same time each day. Each time you use it, inhale TWO PUFFS.

Since COPD is a long-term condition, 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 correctly use your reusable Respimat inhaler. Instructions for use of the reusable Respimat inhaler are included at the end of this leaflet; see “Instructions on how to use the reusable Respimat inhaler”.

Use in children and adolescents

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

If you take more Spiolto Respimat than you should

You may be at increased risk of experiencing an adverse reaction such as dry mouth, constipation, difficulty urinating, blurred vision, chest pain, high or low blood pressure, rapid or irregular pulse or palpitations, dizziness, nervousness, difficulty sleeping, anxiety, headache, tremor, muscle cramps, nausea, fatigue, malaise, low potassium levels in the blood (which may cause muscle spasms, muscle weakness, or abnormal heart rhythm), high blood sugar levels, or excess acid in the blood (which may 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 at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Spiolto Respimat

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

Do not use a double dose to make up for a missed dose.

If you stop using Spiolto Respimat

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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 occur individually or as part of a severe allergic reaction (anaphylactic reaction) after administration of Spiolto Respimat. These include rash, urticaria, swelling of the mouth and face, sudden breathing difficulty (angioedema), or other hypersensitivity reactions (such as sudden drop in blood pressure or dizziness).
• As with all inhaled medicines, some patients may experience chest tightness associated with cough, 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 intestinal movement (intestinal obstruction including paralytic ileus). The frequency cannot be estimated from the available data.

Other possible adverse 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)
• fast heartbeat (supraventricular tachycardia)
• palpitations
• high blood pressure (hypertension)
• difficulty urinating (urinary retention)
• urinary tract infections
• pain when urinating (dysuria)
• throat inflammation (pharyngitis)
• larynx inflammation (laryngitis)
• gum inflammation (gingivitis)
• mouth inflammation (stomatitis)
• fungal infection in the mouth or throat (oropharyngeal candidiasis)
• nosebleed (epistaxis)
• difficulty sleeping (insomnia)
• blurred vision
• chest tightness associated with cough, wheezing, or difficulty breathing immediately after inhalation (bronchospasm)
• constipation
• feeling of dizziness (nausea)
• itching (pruritus)
• joint pain (arthralgia)
• joint swelling
• back pain.

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

• increased intraocular pressure
• nasopharyngitis
• inflammation of the paranasal sinuses (sinusitis)
• difficulty swallowing (dysphagia)
• inflammation of the tongue (glossitis)
• heartburn (gastroesophageal reflux)
• dental caries
• skin infections or ulcerations
• dry skin
• loss of body water (dehydration).

You may experience adverse effects that occur with other medicines similar to Spiolto Respimat (beta-adrenergic agents) used to treat respiratory problems. These may include irregular pulse, chest pain, low blood pressure, tremor, nervousness, muscle cramps, fatigue, malaise, low levels of potassium in the blood (which may cause muscle spasms, muscle weakness, or abnormal heart rhythm), high blood sugar levels, or excess acid in the blood (which may cause symptoms such as nausea, vomiting, weakness, muscle cramps, and rapid breathing).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Spiolto Respimat

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

Do not use this medicine after the expiry date stated on the pack and on the label of the cartridge after EXP. The expiry date refers to the last day of the month indicated.

Do not freeze.

Period of validity in use:

Replace the cartridge no later than three months after insertion.

Do not use the Respimat reusable inhaler for longer than one year.

Recommended use: 6 cartridges per inhaler.

Note: The performance of the reusable RESPIMAT inhaler has been demonstrated in testing up to 540 actuations (equivalent to 9 cartridges).

Medicines should not be disposed of via wastewater or household waste. Return empty containers and unused medicines to the SIGRE point at your usual pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Spiolto Respimat

The active substances 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 actuation.

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

The other components are:

Benzalkonium chloride, disodium edetate, purified water, and hydrochloric acid for pH adjustment.

Appearance of the product and contents of the pack

Spiolto Respimat 2.5 micrograms/2.5 micrograms consists of a cartridge containing a solution for inhalation and a Respimat inhaler. Before first use, you must insert the cartridge into the inhaler.

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

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

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

The Marketing Authorization Holder for 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 medicinal product 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, 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: ??????? ????????

Date of the most recent review of this leaflet: December 2024

Detailed and up-to-date 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 reusable Respimat inhaler

Respimat is an inhalation device that generates an aerosol for inhalation. The Respimat inhaler is for your personal use only. One cartridge provides multiple doses. The reusable Respimat inhaler allows cartridge replacement and can be used with up to 6 cartridges.

Read these instructions before starting to use Spiolto Respimat.

You will need to use this inhaler ONCE DAILY. Each time you use it, perform TWO ACTUATIONS.

• If Spiolto Respimat has not been used for more than 7 days, release one spray into the air, pointing away from your eyes.
• If Spiolto Respimat has not been used for more than 21 days, repeat steps 4 to 6 described in “Preparation for use” until you see a spray. Then repeat steps 4 to 6 three more times.

How to maintain your reusable Respimat inhaler

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

Any minor discoloration of the mouthpiece does not affect the performance of your reusable Respimat inhaler.

If necessary, clean the outer surface of your reusable Respimat inhaler with a damp cloth.

When to replace the inhaler

When you have used 6 cartridges with the same inhaler, obtain a new pack of Spiolto Respimat containing a new inhaler. Do not use the reusable Respimat inhaler for longer than one year after inserting the first cartridge.

Preparation for use

Remove the transparent base Keep the cap closed. Press the safety catch while removing the transparent base with your other hand.
Insert the cartridge Insert the cartridge into the inhaler. Place the inhaler on a firm surface and press down firmly until it clicks.
Register the cartridge and replace the transparent base Mark the checkbox on the inhaler label to track the number of cartridges used. Replace the transparent base into position until it clicks.
Turn Keep the cap closed. Turn the transparent base in the direction of the arrows on the label until it clicks (half a turn).
Open Open the cap fully.
Press Point the inhaler toward the ground. Press the dose release button. Close the cap. Repeat steps 4 to 6 until you see a cloud. After seeing a cloud, repeat steps 4 to 6 three more times. Your inhaler is now ready to use and will deliver 60 actuations (30 doses).

Daily use

TURN Keep the cap closed. TURN the transparent base in the direction of the arrows on the label until it clicks (half a turn).
OPEN OPEN the cap fully.
PRESS Breathe out slowly and fully. Close your lips around the mouthpiece without covering the air vents. Point 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 as comfortably as possible. Hold your breath for 10 seconds or as long as you can. Repeat steps Turn, Open, Press to complete a total of 2 actuations. Close the cap until you use the inhaler again.

When to replace the Spiolto Respimat cartridge

The dose indicator shows how many actuations remain in the cartridge.

60 actuations remain.

Fewer than 10 actuations remain. Obtain a new cartridge.

Your cartridge is empty. Turn the transparent base to loosen it. Your inhaler is now locked. Remove the cartridge from the inhaler. Insert a new cartridge until it clicks (see step 2). The new cartridge will protrude further than the previous one (continue with step 3). Remember to replace the transparent base to unlock the inhaler.

Answers to frequently asked questions

It is difficult to insert the cartridge deeply enough.

Have you accidentally turned 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 further than the previous one. 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 unlock the inhaler. The reusable Respimat inhaler only functions when the transparent base is in place.

Have you turned the transparent base? If not, turn the transparent base with a continuous motion 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 twist the cartridge at the same time.

I cannot turn or replace the transparent base.

Is the transparent base loose and does the dose indicator on your cartridge show 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 “OPEN” and “PRESS” steps described in “Daily use” to use your medication.

My Spiolto Respimat ran out too soon.

Have you used Spiolto Respimat as directed (two actuations/once daily)? Each cartridge will last 30 days if two actuations are taken once daily.

Have you frequently sprayed into the air to check if Spiolto Respimat is working? Once Spiolto Respimat has been prepared for use, it is not necessary to test its function by spraying the solution if 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 replacing the cartridge, the dose counter records an actuation and the remaining doses are reduced.

My Spiolto Respimat does not spray.

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 TURN, OPEN, PRESS steps fewer than three times after inserting the cartridge? Repeat the TURN, OPEN, PRESS steps 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 Spiolto 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 motion 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 up-to-date information on how to administer this medicine by scanning with your mobile phone (smartphone) the QR code included in the section “Instructions on how to use the reusable Respimat inhaler” of this leaflet and on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/info/79967.