Spiolto Respimat

Leaflet attached to the packaging: information for the user

Spiolto 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, 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

What is Spiolto Respimat

Spiolto 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 Spiolto Respimat used for

Spiolto 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. Spiolto Respimat expands the airways, helping to open up the airways and making it easier to breathe. Regular use of Spiolto 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 Spiolto Respimat every day, not just when breathing problems or other COPD symptoms occur.

2. Important information before using Spiolto Respimat

When not to use Spiolto Respimat:

Warnings and precautions

Before starting treatment with Spiolto Respimat, discuss with your doctor or pharmacist:

While using Spiolto Respimat

• If you experience 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 your breathing worsens or you experience a rash, swelling, or itching immediately after using the inhaler, stop using it and inform your doctor immediately (see section 4).
• If you experience any side effects related to the heart (increased heart rate, increased blood pressure, or worsening of symptoms such as chest pain), inform your doctor immediately (see section 4).
• If you experience muscle spasms, muscle weakness, or irregular heartbeat, consult your doctor, as this may be related to low potassium levels in the blood (see section 4).

While using Spiolto Respimat, do not allow the medicine to come into contact with 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 redness of the eyes (narrow-angle glaucoma). Eye symptoms may be accompanied by headaches, nausea, and vomiting. Rinse your eyes with warm water, stop taking Spiolto Respimat, and consult your doctor immediately. Spiolto Respimat is indicated for maintenance therapy in patients with chronic obstructive pulmonary disease. The medicine should not be used in the event of a sudden attack of shortness of breath or wheezing.Do not take Spiolto Respimat in combination with certain medicines containing long-acting beta2-adrenergic receptor agonists, such as salmeterol or formoterol. If you regularly take certain medicines containing short-acting beta2-adrenergic receptor agonists, such as salbutamol, they should only be continued for the treatment of acute symptoms, such as shortness of breath.

Children and adolescents

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

Spiolto Respimat and other medicines

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take the medicine unless your doctor has told you to.

Driving and using machines

No studies have been conducted on the effects of the medicine on the ability to drive and use machines. If you experience dizziness or blurred vision while taking Spiolto Respimat, do not drive, use tools, or operate machinery.

Spiolto Respimat contains benzalkonium chloride

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

3. How to use Spiolto Respimat

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Spiolto Respimat is for inhalation use only.

Dosage

The recommended dose is: Spiolto Respimat works for 24 hours, so it should be taken ONCE A DAY, at the same time every day. Each time, two actuations should be performed. Since COPD is a chronic disease, Spiolto Respimat should be used every day, not just when breathing problems occur. Do not exceed the recommended dose. Make sure you know how to use the Respimat multi-dose inhaler (re-usable) properly. Instructions for using the Respimat multi-dose inhaler (re-usable) can be found at the end of this leaflet, see the section "Instructions for using the Respimat multi-dose inhaler (re-usable)".

Use in children and adolescents

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

Using a higher dose of Spiolto Respimat than recommended

The patient may be at increased 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).

Missing a dose of Spiolto Respimat

If you miss a dose, take only one dose the next day at the same time. Do not take a double dose to make up for a missed dose.

Stopping treatment with Spiolto Respimat

Before stopping treatment with Spiolto Respimat, talk to your doctor or pharmacist. Stopping treatment with Spiolto Respimat may worsen COPD symptoms. If you have any further questions about using 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 you experience any of the following symptoms, stop taking this medicineand consult your doctor immediately.

• Immediate allergic reactions to Spiolto Respimat are rare (may occur less frequently than 1 in 1000 patients). Reactions may occur alone or as part of a severe allergic reaction (anaphylaxis) after administration of Spiolto Respimat. They include: rash, hives, swelling of the mouth and face, sudden breathing difficulties (angioedema), or other hypersensitivity reactions (such as a sudden drop in blood pressure or mild headache).
• As with 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 redness of the eyes (narrow-angle glaucoma). The frequency cannot be estimated from the available data.
• Bowel obstruction or absence of bowel movements (bowel obstruction, including paralytic ileus). The frequency cannot be estimated from the available data.

Other possible side effects:

Uncommon (may occur in less than 1 in 100 patients)

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

Rare (may occur in less than 1 in 1000 patients)

• irregular heartbeat (atrial fibrillation)
• fast heart rate (supraventricular tachycardia)
• feeling of rapid 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 and pharyngeal candidiasis)
• nasal congestion
• sleep disturbances (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
• nasopharyngitis
• 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 when using other medicines similar to Spiolto Respimat (beta2-adrenergic receptor agonists) 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 the Office for Registration 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 Spiolto Respimat

Store 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 cartridge after EXP. The expiry date refers to the last day of the month. Do not freeze. Shelf life after first use The cartridge should be replaced no later than three months after it has been placed in the inhaler. The Respimat multi-dose inhaler (re-usable) should not be used for more than one year. Recommended use: 6 cartridges per inhaler. Not all pack sizes may be marketed.

6. Contents of the pack and other information

What Spiolto 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 actuation. The delivered dose is the dose that is available for 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 the pH.

What Spiolto Respimat looks like and contents of the pack

Spiolto Respimat consists of one cartridge containing the inhalation solution and one Respimat multi-dose inhaler. Before first use, the cartridge should be inserted into the inhaler. Single pack: 1 Respimat multi-dose inhaler (re-usable) and 1 cartridge containing 60 actuations (30 medicinal doses). Triple pack: 1 Respimat multi-dose inhaler (re-usable) and 3 cartridges, each containing 60 actuations (30 medicinal doses). Single refill pack: 1 cartridge containing 60 actuations (30 medicinal doses). Triple refill pack: 3 cartridges, each containing 60 actuations (30 medicinal doses). 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 more information, contact the marketing authorization holder representative: 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, 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: Spiolto Respimat. Finland: Inspiolto Respimat. Bulgaria: Спиолто 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 intended 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 Spiolto Respimat. This inhaler should be used ONCE A DAY. Each time, inhale the medicine released during TWO ACTUATIONS.

• If Spiolto Respimat has not been used for more than 7 days, perform one actuation with the inhaler pointed downwards.
• If Spiolto Respimat has not been used for more than 21 days, repeat the steps described in points 4-6 in the "Preparing for use" section until a visible mist is seen. 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 change in the color of the mouthpiece does not affect the performance 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 Spiolto Respimat pack containing an inhaler. The Respimat multi-dose inhaler (re-usable) should not be used for more than one year from the first cartridge insertion.

Preparing for use

1. Remove the transparent base Keep the cap closed. Press the safety button while pulling the transparent base with your 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 by clicking it into place.
4. Turn Keep the cap closed. Turn the transparent base in the direction of the arrows until you hear a click (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 visible mist is seen. Then repeat the steps described in points 4-6 three more times. The inhaler is now ready for 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 until you hear a click (half a turn).
OPEN OPEN the cap fully.
PRESS Exhale slowly and fully. Place the mouthpiece in your mouth, making sure not to cover the air intake channel. Point the inhaler towards the back of your throat. While taking a slow and deep breath in through your mouth, PRESS the dose release button and continue breathing in 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 actuations. Close the cap to prepare the inhaler for the next use.

When to replace the Spiolto Respimat cartridge

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

60 actuations remaining.

Less than 10 actuations remaining. 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 you hear a click (see point 2). The 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 into the inhaler

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?The new cartridge will protrude more than the first cartridge. Insert it until you hear a click, and then replace the transparent base.

Unable to 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 in the direction of the arrows until you hear a click (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.

Unable to 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 has already been turned, to take the medicine, perform the steps described in points OPEN and PRESS in the "Daily use" section.

The Spiolto Respimat inhaler is emptying too quickly

Is Spiolto Respimat being used as recommended (two actuations once daily)?Each cartridge contains enough medicine for 30 days when used as recommended.

Is the inhaler being actuated frequently to check its proper function?

Are you replacing the cartridge?The new cartridge will protrude more than the first cartridge. Insert it until you hear a click, and then replace the transparent base. 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 actuation.

The Spiolto Respimat inhaler is not actuating

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

The Spiolto Respimat inhaler is actuating on its own

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 in a continuous motion until you hear a click (half a turn). The dose counter is reduced by each incomplete turn, and the number of actuations left is reduced. Was the cap open when replacing the cartridge?Close the cap, then replace the cartridge.