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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 anticholinergic 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 B₂agonists. 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.

3. How to take Spiriva Respimat

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Spiriva Respimat is for inhalation use only.

The recommended dose for adults is:

Spiriva Respimat is effective for 24 hours so you will need to use Spiriva Respimat only ONCE A DAY, if possible at the same time of the day. Each time you use it take TWO PUFFS.

As COPD and asthma are long-term diseases take Spiriva Respimat every day and not only when you experience breathing problems. Do not take more than the recommended dose.

Spiriva Respimat is not recommended for use in children and adolescents below 18 years due to lack of data on safety and efficacy.

Make sure that you know how to use your Spiriva Respimat inhaler properly. The instructions for use of the Spiriva Respimat inhaler are provided on the other side of this leaflet.

If you take more Spiriva Respimat than you should

If you take more Spiriva Respimat than two puffs in one day talk to your doctor immediately. You may be at a higher risk of experiencing a side effect such as dry mouth, constipation, difficulties passing urine, increased heart beat or blurred vision.

Immediate allergic reactions such as rash, nettle rash (urticaria), swelling of the mouth and face or sudden difficulties in breathing (angioneurotic oedema) or other hypersensitivity reactions (such as sudden reduction of your blood pressure or dizziness) may occur individually or as part of severe allergic reaction (anaphylactic reaction) after administration of Spiriva Respimat. If any of these occur, please consult your doctor immediately.

In addition, in common with all inhaled medicines, some patients may experience an unexpected tightness of the chest, coughing, wheezing or breathlessness immediately after inhalation (bronchospasm).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Ireland

HPfRA Pharmacovigilance Earlsfort Terrace, IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie

Malta

ADR Reporting, The Medicines Authority, Post-Licensing Directorate,

203 Level 3, Rue D’Argens, GZR-1368 Gzira Website: www.medicinesauthority.gov.mt e-mail: postlicensing.medicinesauthority@gov.mt

5. How to store Spiriva 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. The expiry date refers to the last day of the month. Spiriva Respimat inhaler should be discarded at the latest 3 months after first use (see Instructions for Use overleaf).

Do not freeze.

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.

6. Contents of the pack and other information

What Spiriva Respimat contains

The active substance is tiotropium. The delivered dose is 2.5 microgram tiotropium per puff (2 puffs comprise one medicinal dose) and is equivalent to 3.124 microgram tiotropium bromide monohydrate. The delivered dose is the dose which is available for the patient after passing the mouthpiece.

The other ingredients are:

Benzalkonium chloride, disodium edetate, purified water, and hydrochloric acid 3.6% for pH adjustment.

What Spiriva Respimat looks like and contents of the pack

Spiriva Respimat 2.5 microgram is composed of one cartridge with inhalation solution and one Respimat inhaler. The cartridge has to be inserted into the inhaler before the first use.

1    Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses)

2    single packages, each containing 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses)

3    single packages, each containing 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses)

8 single packages, each containing 1 Respimat inhaler and 1 cartridge, providing 60 puffs (30 medicinal doses)

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder for Spiriva Respimat is:

Boehringer Ingelheim International GmbH Binger StraBe 173

D-55216 Ingelheim am Rhein, Germany

The manufacturer for Spiriva Respimat is:

Boehringer Ingelheim Pharma GmbH & Co. KG Binger StraBe 173

D-55216 Ingelheim am Rhein, Germany This leaflet was last revised in 02/2016

•    Your Spiriva Respimat inhaler contains 60 puffs (30 doses) if used as indicated (two puffs/ once daily).

•    The dose indicator shows approximately how much medication is left.

•    When the dose indicator enters the red area of the scale you need to get a new prescription; there is approximately medication for 7 days left (14 puffs).

•    Once the dose indicator reaches the end of the red scale, your Spiriva Respimat locks automatically - no more doses can be released. At this point, the clear base cannot be turned any further.

•    Spiriva Respimat should be discarded three months after you have prepared it for first use, even if it has not been fully used or used at all.

Open

• Open the cap until it snaps fully open.

Press

•    Point the inhaler toward the ground.

•    Press the dose-release button

•    Close the cap.

•    Repeat steps 4-6 until a cloud is visible.

•    After a cloud is visible, repeat steps 4-6 three more times.

Your inhaler is now ready to use. These steps will not affect the number of doses available. After preparation your inhaler will be able to deliver 60 puffs (30 doses).