Spiriva

• Reduces respiratory distress due to asthma and COPD
• Inhalation medicine (puffer)
• Use every day
• Not suitable for children under six years of age

Spiriva Respimat is an inhalation medicine (puffer). It is prescribed by doctors to provide relief from symptoms of asthma and chronic obstructive pulmonary disease (COPD). The active ingredient tiotropium widens the airways, reducing symptoms such as chest tightness and shortness of breath. Spiriva Respimat should be used every day and not only when you have breathing problems or other symptoms. This will help to prevent breathing problems.

Spiriva inhalation solution is used with the Respimat re-usable inhaler. This inhaler device generates a spray for inhalation. The medicine can then be inhaled through the mouthpiece. The package leaflet contains step-by-step instructions on how to use the Respimat inhaler. Follow these instructions closely. The general guidelines for use are as follows.

• Insert the cartridge with inhalation solution into the inhaler according to the instructions.
• Prepare the inhaler for use according to the instructions.
• Breathe out slowly and fully.
• Open the cap and place the mouthpiece gently between your lips.
• While taking a slow, deep breath through your mouth, press the grey doserelease button to release the medicine.
• Continue to breathe in slowly for as long as possible and comfortable.
• Hold your breath for 10 seconds or for as long as comfortable.
• Breathe out gently.
• Press the grey button again for a second puff and repeat the previous steps to inhale the medicine.

Close the cap until you use your inhaler again. Exchange the cartridge at the latest three months after insertion. Do not use the Respimat re-usable inhaler for more than one year. Recommended use: a maximum of six cartridges per inhaler, after which you should order a new Spiriva Respimat pack with inhaler.

Avoid accidentally getting this medicine into your eyes. See also section ‘When should this medicine be used with caution’.

Do not take this medicine to treat a sudden attack of COPD or asthma with breathlessness or wheezing. Your doctor should have given you another inhaler for this.

If you have been prescribed Spiriva Respimat for your asthma, it should be added on to your treatments that include an inhaled corticosteroid and long-acting bronchodilator. Continue taking the inhaled corticosteroid as prescribed by your doctor, even if you feel better.

Dosage

Dosage should be determined by a doctor. The recommended dose in adults is:

• Two puffs once a day, preferably around the same time each day.

Do not take more than two puffs a day. This medicine is not suitable for children below six years of age. For children aged six and up the dosage should be determined by a doctor.

Driving/alcohol

In case dizziness or blurred vision occurs the ability to drive may be influenced. Do not drive until the symptoms have passed.

This medicine does not interact with alcohol.

If you use too much/forget to use/stop using Spiriva Respimat

If you take more Spiriva Respimat than two puffs in one day, consult your doctor or pharmacist.

If you forget to take a dose (two puffs once a day), take it as soon as you remember but do not take two doses on the same day.

Do not stop using Spiriva without talking to your doctor.

Spiriva Respimat is not suitable for everyone. Do not use this medicine if:

• You are allergic (hypersensitive) to any of the ingredients in this medicine (see section ‘What Spiriva Respimat contains').
• You are allergic (hypersensitive) to atropine or atropine derivatives such as ipratropium or oxitropium.

When should this medicine be used with caution?

Talk to our doctor if:

• You suffer from narrow angle glaucoma (elevated eye pressure).
• You have prostate problems or have difficulty passing urine.
• You have problems with your kidneys.
• Any spray gets in your eyes. Wash your eyes in lukewarm water right away, stop using this medicine and consult your doctor immediately.
  Eye symptoms that may occur are:
  • Eye pain or discomfort.
  • Blurred vision.
  • Seeing halos around lights or coloured images in association with red eyes (narrow angle glaucoma).
  • Headache.
  • Nausea, vomiting.
• Your breathing has got worse or if you experience rash, swelling or itching directly after using your inhaler. Stop using this medicine and contact your doctor immediately.
• You have had a heart attack during the last six months or suffered from other heart problems within the past year. Your doctor will decide whether or not you should be given this medicine.
• You have cystic fibrosis. This medicine could make your cystic fibrosis symptoms worse. Ask your doctor for advice before taking this medicine.
• You should also contact your doctor if you feel that your breathing is worsening.

Pregnancy and breastfeeding

Consult a doctor before using Spiriva Respimat if you are pregnant or breastfeeding.

Other medicines and Spiriva Respimat

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. In particular, please tell your doctor or pharmacist if you are taking/have taken anticholinergic drugs, such as ipratropium or oxitropium.

See the package leaflet for more information.

Like all medicines, this medicine can cause side effects, although some people may not experience any. Side effects that are known to be associated with Spiriva Respimat include:

Common (may affect up to 1 in 10 people):

• Dry mouth. This increases your risk of cavities. Therefore, it is important to practise good dental hygiene.

Uncommon (may affect up to 1 in 100 people):

• Hoarseness.
• Cough.
• Headache.
• Inflammation of the throat (laryngitis).
• Pain during urination.
• Dizziness.
• Fungal infections in the mouth or throat (thrush).
• Skin rash.

For a complete list of side effects, see the package leaflet. Consult a doctor or pharmacist if you experience any side effects.

Contact your doctor immediately if:

• You have an immediate allergic reaction, such as rash, nettle rash (urticaria), swelling of the mouth and face or sudden difficulties in breathing (angioneurotic oedema).
• You have other hypersensitivity reactions (such as sudden reduction of your blood pressure or dizziness).

These may occur individually or as part of severe allergic reaction (anaphylactic reaction) after administration of Spiriva Respimat.

If you experience an unexpected tightness of the chest, coughing, wheezing or breathlessness (bronchospasm) immediately after inhalation, contact your doctor immediately.

The active substance is tiotropium. The delivered dose is 2.5 micrograms tiotropium per puff (two puffs comprise one medicinal dose) and is equivalent to 3.124 micrograms tiotropium bromide monohydrate.

Read the package leaflet before use. The official package leaflet of Spiriva Respimat is available for download here.