Spiolto Respimat

What you need to know before you take Spiolto Respimat

Do not use Spiolto Respimat

• if you are allergic to tiotropium or olodaterol or any of the other ingredients of this medicine 
• if you are allergic to atropine or substances related to it, e.g. ipratropium or oxitropium

Warnings and precautions

Talk to your doctor or pharmacist before using Spiolto Respimat

• if you have asthma (you should not use Spiolto

Respimat for the treatment of asthma).

• if you have diseases of the heart.
• if you have high blood pressure.
• if you have epilepsy.
• if you have a specific thyroid gland problem called thyrotoxicosis.
• if you have an abnormal widening of an artery called aneurysm.
• if you have diabetes.
• if you have severe hepatic impairment.
• if you have renal impairment.
• in case of a planned surgery.
• if you have an eye problem called narrow-angle glaucoma.
• if you have prostate problems or have difficulty passing urine.

How to take Spiolto Respimat

• Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• Spiolto Respimat is for inhalation use only.

Dosage

The recommended dose is:

• Spiolto Respimat is effective for 24 hours so you will need to use Spiolto Respimat only ONCE A DAY, if possible at the same time of the day. Each time you use it take TWO PUFFS.
• As COPD is a long-term disease take Spiolto Respimat every day and not only when you experience breathing problems.
• Do not take more than the recommended dose.

Use in children and adolescents

• There is no relevant use of Spiolto Respimat in the paediatric population (under 18 years).
• Make sure that you know how to use your Spiolto Respimat inhaler properly. 

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the following occurs, please stop using this medicine and consult your doctor immediately.

• Immediate allergic reactions to Spiolto Respimat are rare (they 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, nettle rash (urticaria), swelling of the mouth and face, sudden difficulties in breathing (angioneurotic oedema) or other hypersensitivity reactions (such as sudden reduction of your blood pressure or light headedness).
• As with all inhaled medications , tightness of the chest, associated with coughing, wheezing or breathlessness may occur immediately after inhalation (paradoxical bronchospasm).
• seeing halos around lights or coloured images in association with red eyes (glaucoma). The frequency cannot be estimated from the available data.
• blockage of intestines or absence of bowel movements (intestinal obstruction, including ileus paralytic). The frequency cannot be estimated from the available data.

Other possible side effects:

Common (may affect up to 1 in 10 people)

• dry mouth

Uncommon (may affect up to 1 in 100 people)

• dizziness
• difficulty in sleeping (insomnia)
• headache
• high blood pressure (hypertension)
• irregular heart beat (atrial fibrillation) - faster heart beat (tachycardia)
• feeling your heartbeat (palpitations) - cough
• hoarseness (dysphonia)
• constipation

Rare (may affect up to 1 in 1,000 people)

• nasopharyngitis
• blurred vision
• rapid heartbeat (supraventricular tachycardia) - inflammation of the larynx (laryngitis)
• sore throat (pharyngitis)
• nosebleed (epistaxis)
• fungal infections of the mouth and throat (oropharyngeal candidiasis)
• inflammation of the gums (gingivitis)
• feeling sick (nausea)
• itching (pruritus)
• joint pain (arthralgia)
• back pain
• difficulties passing urine (urinary retention) - infections of the urinary tract
• painful urination (dysuria)

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

• tightness of the chest, associated with coughing, wheezing or breathlessness immediately after inhalation (bronchospasm)
• seeing halos around lights or coloured images in association with red eyes (glaucoma)
• increase of the measured eye pressure
• inflammation in sinuses (sinusitis)
• blockage of intestines or absence of bowel movements (intestinal obstruction, including ileus paralytic)
• heart burn (gastrooesophageal reflux disease)
• difficulties swallowing (dysphagia)
• inflammation of the tongue (glossitis)
• inflammation of the mouth (stomatitis)
• dental caries
• infections or ulcerations of the skin
• dryness of the skin
• swelling of joint
• depletion of body water (dehydration)

You may also experience side effects which are known to occur with certain medicines for breathing problems similar to Spiolto Respimat (beta-adrenergic agents). These may be irregular heartbeat, chest pain, low blood pressure, shaking, nervousness, muscle cramps, fatigue, malaise, low blood levels of potassium (which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm), high blood sugar, or too much acid in your blood (which may cause symptoms of nausea, vomiting, weakness, muscle cramps and more rapid breathing).

How to store Spiolto Respimat

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and on the inhaler label after EXP. The expiry date refers to the last day of the month.
• Do not freeze.
• Spiolto Respimat inhaler should be discarded at the latest 3 months after first use.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

References:

https://www.medicines.org.uk/emc/medicine/30495

http://www.medicines.ie/medicine/16407/SPC

https://www.medicines.org.uk/emc/files/pil.6902.pdf?filename=PIL.6902.pdf

https://spiolto.com/product-information/summary-product-characteristics

https://www.boehringer-ingelheim.com/products/spiolto-respimat

https://www.hpra.ie/img/uploaded/swedocuments/2177664.PA0775_009_001.4248a745-1b7d-4855-9c0e-dc5898dc6749.000001Product%20Leaflet%20Approved.160624.pdf