Medication Information Leaflet

What is this medication for?

Spiolto inhaler is used for the treatment of chronic obstructive pulmonary disease (COPD). COPD is a disease affecting the lungs which makes it harder for the person to breathe as the disease gets worse.

Spiolto contains two ingredients, olodaterol and tiotropium. Both ingredients work by relaxing the airway muscles, thus opening up the airways to make breathing easier.

How should I take or use this medication?

• Use your Spiolto inhaler every day to control your condition.
• Do not stop using your inhaler without checking with your healthcare professionals.
• Please refer to the Spiolto inhaler’s patient information leaflet to learn how to use the inhaler.

What should I do if I forget to take or use this medication?

If you forget to take a dose, take it as soon as you remember. Then take your next dose at the usual time. Do not take two doses to make up for the missed dose.

What precautions should I take when taking or using this medication?

Inform your healthcare professional if:

• You are allergic to this medication or any of the other ingredients of this medication
• You are pregnant, planning to become pregnant, or breastfeeding.
• You are taking any other medications, including supplements, traditional medications and herbal remedies.
• You have any of the following medical conditions:
• Cystic fibrosis (a type of illness in which thick mucus build up in the lungs and digestive system)
• Diabetes
• Glaucoma (a type of eye condition where the pressure in the eye is increased)
• High blood pressure
• Low potassium level in the blood
• Myasthenia gravis (a type of illness linked to muscle weakness)
• Prostate problems or difficulty passing urine
• Heart conditions such as a history of chest pain or heart attack, heart failure or irregular heartbeat
• Hyperthyroidism (a condition where there is too much thyroid hormone in the body)
• Kidney problems
• Heart conditions such as chest pain or heart failure

What are some common side effects of this medication?

Common side effects include:

• Symptoms of upper respiratory tract infections such as cough, runny nose, sore throat and pain at the cheek and forehead areas
• Painful and frequent urination, which may be signs of a urinary tract infection
• Fast heartbeat
• Uncontrolled shaking (tremors)
• Nervousness, Restlessness
• Dry mouth
• Nausea
• Constipation
• Headache
• Cough/ Throat irritation
• Dizziness

These symptoms may happen but should get better over time. Check with your healthcare professionals if any of these symptoms are serious or do not go away.

What are some rare but serious side-effects that I need to seek medical advice immediately?

In very rare cases, some patients might experience the following:

• Irregular heartbeat, where your heartbeat is uneven or has an extra beat
• Low potassium level, where you may experience the following symptoms:
• Muscle weakness
• Muscle pain
• Nausea or vomiting
• Tingling or numbness at your fingers and toes

The symptoms of a drug allergy include one or more of the following:

• Swollen face/eyes/lips/tongue
• Difficulty in breathing
• Itchy skin rashes over your whole body

If you experience any of these symptoms, you should stop your medication and see your healthcare professional immediately.

How should I store this medication?

Store in a cool and dry place, away from direct sunlight. Keep this medication away from children.

How do I throw away this medication safely?

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