Spiolto Respimat

Spiolto Respimat is a medicine for oral inhalation (‘puffs’). It is composed of one cartridge with inhalation solution and one Respimat inhaler.

Spiolto Respimat is used for patients with chronic obstructive pulmonary disease (COPD). The inhalation solution contains two active substances called tiotropium and olodaterol. These belong to a group of medicines called long-acting bronchodilators which make breathing easier. Spiolto Respimat is effective for 24 hours, so you will need to use it only once a day.

Regular use of this medicine can also help you when you have on-going shortness of breath related to your disease and will help to minimise the effects of the disease on your everyday life.

The instructions for use in adults are as follows:

• As COPD is a long-term disease take Spiolto Respimat every day and not only when you experience breathing problems.
• Take Spiolto Respimat at the same time of the day, if possible.
• Each time you use it take two puffs.
• Do not exceed the recommended daily dose.

The package leaflet contains step-by-step instructions on how to use the Respimat inhaler. Follow these instructions closely.

In-use shelf life:

• Exchange the cartridge at the latest three months after insertion.
• Do not use the Respimat re-usable inhaler for more than one year.
• Recommended use: six cartridges per inhaler.

Driving and using machines

If you feel dizzy or if blurred vision occurs while taking Spiolto Respimat, do not drive or use any tools or machines.

Taken too much/forgot to take/stop taking Spiolto Respimat

If you take more Spiolto Respimat than you should

You may be at a higher risk of experiencing a side effect (see the package leaflet for a list of possible side effects).

If you forget to take Spiolto Respimat

If you forget to inhale a dose, inhale just one dose at the usual time the next day. Do not take a double dose to make up for the forgotten one.

If you stop taking Spiolto Respimat 

Before you stop taking Spiolto Respimat, you should talk to your doctor or your pharmacist. If you stop taking Spiolto Respimat the signs and symptoms of COPD may worsen.

Do not take Spiolto Respimat

• If you are allergic to any of the ingredients in this medicine. (see section ‘What Spiolto Respimat contains').
• If you are allergic to atropine or atropine derivatives such as ipratropium or oxitropium.

When should this medicine be used with caution?

Talk to your doctor or pharmacist before using Spiolto Respimat if:

• You have asthma (you should not take Spiolto Respimat for the treatment of asthma).
• You have diseases of the heart.
• You have high blood pressure.
• You have epilepsy.
• You have a specific thyroid gland problem called thyrotoxicosis.
• You have an abnormal widening of an artery called aneurysm.
• You have diabetes.
• You have severe hepatic (liver) disease.
• You have renal (kidney) disease.
• You have a surgery planned.
• You have an eye problem called narrow-angle glaucoma.
• You have prostate problems or have difficulty passing urine.

During treatment with Spiolto Respimat:

• Stop taking the medicine and tell your doctor immediately if you get tightness of the chest, coughing, wheezing or breathlessness immediately after taking the medicine. These may be signs of a condition called bronchospasm (shortness of breath caused by tightening of the muscles that line the airways).
• If your breathing has got worse or if you experience rash, swelling or itching directly after using your inhaler, stop using it and tell your doctor immediately.
• If you experience any side effects affecting your heart (increase in pulse rate, increase in blood pressure and/or increase in symptoms like chest pain), tell your doctor immediately.
• If you experience muscle spasm, muscle weakness or abnormal heart rhythm, consult your doctor as these may be related to low blood levels of potassium.

This list is not exhaustive. For more warnings and precautions, see the package leaflet.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, are planning to have a baby or breastfeeding, ask your doctor or pharmacist for advice before using this medicine. You should not take this medicine unless specifically recommended by your doctor.

Other medicines and Spiolto Respimat

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

If any of the following occurs, please stop taking this medicine and consult your doctor immediately:

• Immediate allergic reactions to Spiolto Respimat.
• Paradoxical bronchospasm.
• Glaucoma.
• Blockage of intestines or absence of bowel movements (intestinal obstruction, including ileus paralytic).

For more information on these side effects, see the package leaflet.

Other possible side effects:

Uncommon (may affect up to 1 in 100 people)

• Faster heartbeat (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).
• Feeling your heartbeat (palpitations).
• High blood pressure (hypertension).
• Difficulties passing urine (urinary retention).
• Infections of the urinary tract.
• Painful urination (dysuria).
• Sore throat (pharyngitis).
• Inflammation of the larynx (laryngitis).
• Inflammation of the gums (gingivitis).
• Inflammation of the mouth (stomatitis).
• Fungal infections of the mouth and throat (oropharyngeal candidiasis).
• Nosebleed (epistaxis).
• Difficulty sleeping (insomnia).
• Blurred vision (glaucoma).
• Tightness of the chest, associated with coughing, wheezing or breathlessness immediately after inhalation (bronchospasm).
• Constipation.
• Feeling sick (nausea).
• Itching (pruritus).
• Joint pain (arthralgia).
• Swelling of joint.
• Back pain.

This list is not exhaustive. For a complete list of possible side effects, see the package leaflet. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the package leaflet.

The active substances are tiotropium and olodaterol. The delivered dose is 2.5 microgram tiotropium (as bromide monohydrate) and 2.5 microgram olodaterol (as hydrochloride) per puff. The delivered dose is the dose which is available for the patient after passing the mouthpiece.

Read the package leaflet before use.