Tudorza Pressair (Aclidinium Bromide)

BEFORE you use TUDORZA PRESSAIR talk to your doctor or pharmacist if you:

• are pregnant or planning to become pregnant
• are a breastfeeding mother
• are taking any medications including eye drops, this includes medications you can buy without prescription
• have had heart problems recently
• have eye problems such as glaucoma, eye pain, blurred vision, see halos around lights or coloured images
• have an enlarged prostate, problems passing urine, or painful urination
• have a severe allergy to milk proteins. Ask your doctor if you are not sure
• have had allergies to atropine or related medicines, for example ipratropium, tiotropium or oxitropium
• have allergies to food or drugs

TUDORZA PRESSAIR should not be used more frequently than twice daily. Do not exceed the prescribed dose.

This medication has been prescribed for you and should not be given to other people.

Stop taking TUDORZA PRESSAIR and seek medical help immediately:

• if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine. These may be signs of a condition called bronchospasm.

Remember to tell any other doctor, dentist or pharmacist you consult that you are taking this medication.

Driving and using machines:

This medicine may cause headache and blurred vision. If you are affected by either of these side effects do not drive or use machinery until the headache has cleared and your vision has returned to normal.

Side effects may include:

• headache,
• nasopharyngitis (inflammation or irritation of the nose and throat),
• cough,
• diarrhea,
• falls and injury,
• sinus inflammation (sinusitis),
• vomiting,
• blurred vision,
• hoarseness,
• dizziness,
• mouth or tooth infection.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Inform your doctor if you have been or are using similar medicines for breathing problems, e.g., medicines containing tiotropium, ipratropium or glycopyrronium. Ask your doctor or pharmacist if you are not sure. The use of TUDORZA PRESSAIR with these medicines is not recommended.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• The recommended dose is one inhalation twice a day, once in the morning and once in the evening.
• Use TUDORZA PRESSAIR even when you have no breathing problems or other symptoms of COPD.
• Do not stop using the drug without consulting your doctor.
• You can use TUDORZA PRESSAIR anytime before or after food or drink.

Usual dose:

The recommended dose is one inhalation twice a day, once in the morning and once in the evening.

The recommended dose can be used for elderly patients and for patients with kidney or liver problems. No dose adjustments are necessary.

Overdose:

If you think you may have used more TUDORZA PRESSAIR than you should, contact your doctor or pharmacist.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

If you forget a dose of TUDORZA PRESSAIR, inhale the dose as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose.

Do not take a double dose to make up for a forgotten dose.