Your medicine is called Spiriva Respimat 2.5 micrograms, inhalation solution, but will be referred to as Spiriva Respimat throughout the following Patient Information Leaflet.

What is in this leaflet

1.    What Spiriva Respimat is and what it is used for

2.    What you need to know before you take Spiriva Respimat

3.    How to take Spiriva Respimat

4.    Possible side effects

5.    How to store Spiriva Respimat

6.    Contents of the pack and other information

1.    What Spiriva Respimat is and what it is used for

Spiriva Respimat helps people who have chronic obstructive pulmonary disease (COPD) or asthma to breathe more easily. COPD is a long-term lung disease that causes shortness of breath and coughing. The term COPD is associated with the conditions chronic bronchitis and emphysema. Asthma is a long-term disease characterised by airway inflammation and narrowing of the airways. As COPD and asthma are long-term diseases you should take Spiriva Respimat every day and not only when you have breathing problems or other symptoms. When used to treat asthma you should use Spiriva Respimat in addition to so-called inhaled corticosteroids and long-acting B₂ agonists.

Spiriva Respimat is a long-acting bronchodilator that helps to open your airways and makes it easier to get air in and out of the lungs. Regular use of Spiriva Respimat 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. Daily use of Spiriva Respimat will also help to prevent any sudden, short-term worsening of your COPD symptoms which may last for several days.

For correct dosing of Spiriva Respimat please see section 3. How to take Spiriva Respimat and the instructions for use provided on the other side of the leaflet.

2.    What you need to know before you take Spiriva Respimat

Please read the following questions carefully. If you can answer any of these questions with ‘Yes’ please discuss this with your doctor before taking Spiriva Respimat.

-    are you allergic (hypersensitive) to tiotropium, atropine or similar drugs such as ipratropium or oxitropium?

-    are you taking any other medicinal products containing ipratropium or oxitropium?

-    are you pregnant, do you think you are pregnant, or are you breast-feeding?

-    are you suffering from blurred vision, eye pain and/or red eyes, prostate problems or have difficulty passing urine?

-    do you have any kidney problems?

-    have you suffered from a myocardial infarction during the last 6 months or from any unstable or life threatening irregular heart beat or severe heart failure within the past year?

Do not use Spiriva Respimat

-    if    you    are    allergic    (hypersensitive)    to

tiotropium, its active ingredient or any of the other ingredients of this medicine (listed in section 6)

-    if    you    are    allergic    (hypersensitive)    to

atropine or substances related to it, e.g. ipratropium or oxitropium

Warnings and precautions

Talk to your doctor before taking Spiriva Respimat.

When taking Spiriva Respimat take care not to let any spray enter your eyes. This may result in eye pain or discomfort, blurred vision, seeing halos around lights or coloured images in association with red eyes (i.e. narrow angle glaucoma). Eye symptoms may be accompanied by headache, nausea or vomiting. Wash your eyes in warm water, stop using tiotropium bromide and immediately consult your doctor for further advice.

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.

Dry mouth which has been observed with anti-cholinergic treatment may in the long term be associated with dental caries. Therefore, please remember to pay attention to oral hygiene.

Spiriva Respimat is indicated for the maintenance treatment of your chronic obstructive pulmonary disease or asthma. Do not use this medicine to treat a sudden attack of breathlessness or wheezing. Your doctor should have given you another inhaler (“rescue medication”) for this. Please follow the instructions your doctor has given you.

If you have been prescribed Spiriva Respimat for your asthma it should be added on to inhaled corticosteroids and long-acting B₂ agonists. Continue taking the inhaled corticosteroids as prescribed by your doctor, even if you feel better.

In case you have suffered from a myocardial infarction during the last 6 months or from any unstable or life threatening irregular heart beat or severe heart failure within the past year, please, inform your doctor. This is important to decide if Spiriva is the right medicine for you to take.

Do not take Spiriva Respimat more frequently than once daily.

You should also contact your doctor if you feel that your breathing is worsening.

If you have cystic fibrosis, tell your doctor because Spiriva Respimat could make your cystic fibrosis symptoms worse.

Children and adolescents

Spiriva Respimat is not recommended for children and adolescents under 18 years.

Other medicines and Spiriva Respimat

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

In particular, please tell your doctor or pharmacist if you are taking/have taken anticholinergic drugs, e.g. ipratropium or oxitropium.

No interaction side effects have been reported when Spiriva Respimat has been taken with other products used to treat COPD such as reliever inhalers (e.g. salbutamol), methylxanthines (e.g. theophylline), antihistamines, mucolytics (e.g. ambroxol), leukotriene modifiers (e.g. montelukast), cromones, anti-IgE treatment (e.g. omalizumab) and/or inhaled or oral steroids (e.g. budesonide, prednisolone).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You should not use this medicine unless specifically recommended by your doctor.

Driving and using machines

No studies on the effects and the ability to drive and use machines have been performed. In case dizziness or blurred vision occurs the ability to drive and use machinery may be influenced.

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