Directions for use : Information for patients

This drug is subject to additional monitoring. This allows for rapid identification of new safety findings. You can help by reporting any side effect that occurs. Instructions for reporting side effects: see end of section 4.

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

• Keep the package leaflet. You may want to read it again later.
• If you have further questions, contact your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to anyone else. It may harm other people, even if they have the same condition as you.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to
• side effects not listed in this leaflet. See section 4.

What this leaflet says

1. What is GETWELL INHALER and what is it used for?
2. What should you be aware of before using GETWELL INHALER?
3. How should GETWELL INHALER be used?
4. What are the possible side effects?
5. How should GETWELL INHALER be stored?
6. Contents of the package and other information

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

• if you have asthma (SPIOLTO RESPIMAT is not suitable for treating asthma);
• if you have heart disease;
• if you have elevated blood pressure;
• if you have epilepsy;
• if you have severe hyperthyroidism (thyrotoxicosis);
• if you have been diagnosed with a bulging wall of an artery (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 with your eyes called narrow-angle glaucoma;
• if you have prostate problems or difficulty urinating.

Stop taking this medicine and inform a doctor immediately if you experience chest tightness, coughing, wheezing or shortness of breath immediately after use. These may be signs of a spasmodic narrowing of the airways (bronchospasm) (see section 4).

• • If your breathing worsens immediately after inhalation, or if you experience skin rash, swelling, or itching, do not inhale again, but inform a doctor immediately (see section 4).
  • If side effects occur that affect the cardiovascular system ( accelerated heartbeat , increased blood pressure and/or increased discomfort such as chest pain ), inform a doctor immediately (see section 4).
  • If muscle cramps, muscle weakness or heart rhythm disturbances occur, talk to your doctor as these may be signs of decreased potassium levels in the blood (see section 4).

Tell your doctor or pharmacist if you are taking, have recently taken, or plan to take any other medicines. In particular, tell your doctor if you are using any of the following medicines:

• • • medicines similar to GETWELL INHALER (i.e. medicines containing similar active substances, e.g. anticholinergics or betaadrenergic substances). Side effects may be increased.
    • so-called beta-blockers for the treatment of high blood pressure or other heart diseases (e.g. propranolol), or for the treatment of increased intraocular pressure (glaucoma; e.g. timolol). This could reduce the effectiveness of GETWELL INHALER.
    • Drugs that cause a decrease in the level of potassium in the blood, such as:
      • Corticosteroids (e.g. prednisolone),
      • Diuretics (dehydrating agents) ,
      • Medicines for respiratory problems (e.g., theophylline).
    • If you use these medicines together with GETWELL INHALER , you may experience symptoms such as muscle spasms, muscle weakness or cardiac arrhythmias.
    • so-called tricyclic antidepressants or MAO inhibitors (e.g. selegiline or moclobemide) for the treatment of neurological or psychiatric diseases such as Parkinson’s disease or depression. The use of these drugs may increase cardiac side effects.

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. You should not use this medicine unless specifically recommended by your doctor.

No studies have been conducted on the effects on driving and ability to operate machinery. If you experience dizziness or blurred vision during treatment with GETWELL INHALER, do not drive or operate tools or machinery.

This medicine contains 0.0011 mg benzalkonium chloride per stroke . Benzalkonium chloride may cause whistling breathing (wheezing) and difficulty breathing (bronchospasm), especially if you have asthma.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. GETWELL INHALER should only be used by inhalation.

The recommended dose is: GETWELL INHALER works for 24 hours. Therefore, use GETWELL INHALER only ONCE DAILY, preferably always at the same time of day. Inhale 2 HUBS with each application. Since COPD is a chronic disease, you should use GETWELL INHALER daily and not only when breathing problems occur. Do not inhale more than the recommended dose.

There is no relevant benefit of GETWELL INHALER in children and adolescents under 18 years of age. Make sure you know how to use the GETWELL INHALER inhaler correctly. You will find the instructions for use of GETWELL INHALER at the end of this leaflet.

The risk for the occurrence of side effects could increase, such as dry mouth, constipation, problems with urination, blurred vision, chest pain, increased or decreased blood pressure, accelerated or irregular heartbeat or palpitations, dizziness, nervousness, sleep disturbances, anxiety, headache, tremor, muscle cramps, nausea, fatigue, malaise, decreased blood potassium (may result in symptoms such as muscle cramps, muscle weakness, or heart rhythm disturbances), increased blood sugar, hyperacidity of the blood (may result in symptoms such as nausea, vomiting, weakness, muscle cramps, and accelerated breathing).

If you miss an inhalation, inhale the next dose the following day at the usual time. Do not inhale twice the amount if you forgot the previous inhalation.

Talk to your doctor or pharmacist before you stop using GETWELL INHALER. If you stop using GETWELL INHALER, your COPD symptoms and discomfort may get worse. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following side effects occur, please stop using this medicine (i.e. do not inhale again) and consult your doctor immediately.

• Allergic immediate reactions to GETWELL INHALER are rare (may affect up to 1 in 1,000 people treated). These reactions may occur after use of GETWELL INHALER individually or as part of a severe allergic reaction (anaphylactic reaction ). They include skin rash, hives (urticaria), swelling of the mouth and face, sudden difficulty breathing (angioedema), or other hypersensitivity reactions (such as sudden drop in blood pressure or drowsiness).
• As with all inhaled medications, chest tightness associated with coughing, wheezing, or shortness of breath may occur immediately after inhalation (paradoxical spasmodic constriction of the airways).
• airways or paradoxical bronchospasm). The frequency cannot be estimated on the basis of the available data .
• Seeing colored rings around light sources ( eye halos ) or unreal color sensation associated with reddened eyes (glaucoma). Frequency cannot be estimated based on available data .
• Intestinal obstruction or paralysis (intestinal obstruction including paralytic ileus). Frequency cannot be estimated based on available data .

Other possible side effects:

• accelerated heartbeat (tachycardia)
• dizziness
• headache
• cough
• hoarseness (dysphonia)
• dry mouth

• Irregular heartbeat (atrial fibrillation)
• Accelerated heartbeat (supraventricular tachycardia)
• Palpitations (heart palpitations)
• High blood pressure (hypertension)
• Difficulty urinating (urinary retention)
• Urinary tract infections
• Pain while urinating (dysuria)
• Sore throat (pharyngitis)
• Laryngitis (inflammation of the larynx)
• Gum inflammation (gingivitis)
• Inflammation of the mouth (stomatitis)
• Fungal infections of the mouth and throat (oropharyngeal candidiasis)
• Nosebleeds (epistaxis)
• Sleep disturbances (insomnia)
• Blurred vision
• Chest tightness associated with coughing, whistling breathing (wheezing), or shortness of breath immediately after inhalation (bronchospasm)
• Constipation
• Nausea
• Itching (pruritus)
• Joint pain (arthralgia)
• Joint swelling
• Back pain

• Increase in measured eye pressure
• Inflammation of the nasopharynx (nasopharyngitis)
• Inflammation of the paranasal sinuses (sinusitis)
• Difficulty in swallowing (dysphagia)
• Inflammation of the tongue (glossitis)
• Heartburn (gastroesophageal reflux disease)
• Dental caries
• Infections or ulcerations of the skin
• Dryness of the skin
• Reduction of body water (dehydration)

You may also experience side effects known to occur with medicines for breathing problems that work similarly to GETWELL INHALER (betaadrenergic agents). These include: irregular heartbeat, chest pain, decreased blood pressure, tremor, nervousness, muscle cramps, fatigue, malaise, decreased blood potassium (which may result in symptoms such as muscle cramps, muscle weakness, or arrhythmia), increased blood sugar, blood acidity (which may result in symptoms such as nausea, vomiting, weakness, muscle cramps, and accelerated breathing).

If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices. By reporting side effects, you can help ensure that more information is made available about the safety of this medicine.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the label of the inhaler. The expiry date refers to the last day of the month indicated.

Do not freeze!

Shelf life of a cartridge after insertion into the GETWELL INHALER: Replace each cartridge no later than 3 months after insertion into the reusable GETWELL INHALER.

The reusable GETWELL INHALER must not be used for more than 1 year. Recommended use: maximum 6 cartridges per GETWELL INHALER.

Note: In studies, the reusable GETWELL INHALER has been shown to work for 540 strokes (corresponding to 9 cartridges).

Do not dispose of medicines in sewage or household waste . Ask your pharmacist how to dispose of the medicine when you stop using it. By doing so, you will help to protect the environment.

The active ingredients are tiotropium and olodaterol. The delivered dose is 2.5 micrograms of tiotropium (as tiotropium bromide 1 H 2 O) and 2.5 micrograms of olodaterol (as olodaterol hydrochloride) per stroke . The dose delivered is the amount available to the patient after passing through the mouthpiece .

The other ingredients are: Benzalkonium chloride, sodium edetate (Ph.Eur.), hydrochloric acid 3.6% (for pH adjustment) and purified water.

GETWELL INHALER consists of a cartridge with solution for inhalation and a GETWELL INHALER. The cartridge must be inserted into the inhaler before the first use.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Authorization holder

Funfactory Gmbh

Disneyland, 1010 Vienna

Austria

Manufacturer

Example Gmbh 

This package insert was last revised in June 2019.