Spiriva

Package leaflet: Information for the user

Spiriva 18 micrograms, inhalation powder, hard capsule

tiotropium
Please read this leaflet carefully before using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Spiriva 18 micrograms is and what it is used for
2. What you need to know before using Spiriva 18 micrograms
3. How to use Spiriva 18 micrograms
4. Possible side effects
5. How to store Spiriva 18 micrograms
6. Contents of the pack and other information

1. What is Spiriva 18 micrograms and what is it used for?

SPIRIVA 18 micrograms helps people with chronic obstructive pulmonary disease (COPD) to breathe more easily. COPD is a chronic lung disease that causes shortness of breath and cough. The term COPD refers to chronic conditions such as bronchitis and emphysema. Since COPD is a chronic disease, SPIRIVA 18 micrograms must be used every day, not only when breathing difficulties or other COPD symptoms occur.
SPIRIVA 18 micrograms is a long-acting bronchodilator that helps to widen the airways and makes it easier for air to flow into and out of the lungs. Regular use of SPIRIVA 18 micrograms can also help when shortness of breath due to the disease develops, and will help minimize the impact of the disease on your daily life. It also allows you to stay active for longer. Daily use of SPIRIVA 18 micrograms helps prevent sudden short-term worsening of COPD symptoms, which may last for several days.
The effect of this medicine lasts for 24 hours; therefore, it should be taken once daily. For the correct dosage of SPIRIVA 18 micrograms, please refer to section 3, "How to use SPIRIVA 18 micrograms," and to the instructions for use provided on the reverse side of the package leaflet.

2. What you need to know before using Spiriva 18 micrograms

Do not use SPIRIVA 18 micrograms

• If you are allergic (hypersensitive) to tiotropium, the active substance, or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic (hypersensitive) to atropine or substances related to it, such as ipratropium or oxitropium.

Warnings and precautions
Talk to your doctor or pharmacist before using Spiriva 18 micrograms.

• Inform your doctor if you have narrow-angle glaucoma, prostate problems, or difficulty urinating.
• If you have kidney problems, consult your doctor.
• Spiriva 18 micrograms is indicated for maintenance treatment of chronic obstructive pulmonary disease (COPD); it must not be used to treat sudden episodes of shortness of breath or wheezing.
• Immediate allergic reactions such as skin rash, swelling, itching, wheezing, or shortness of breath may occur after administration of Spiriva 18 micrograms. If this happens, contact your doctor immediately.
• Medicines taken by inhalation, such as Spiriva 18 micrograms, may cause chest tightness, cough, wheezing, or shortness of breath immediately after administration. If this occurs, contact your doctor immediately.
• Be careful to avoid contact of the inhaled powder with your eyes, as this may precipitate or worsen narrow-angle glaucoma, an eye disease. Eye pain or discomfort, blurred vision, seeing halos around lights, or colored images along with red eyes may be signs of an acute attack of narrow-angle glaucoma. Ocular symptoms may be accompanied by headache, nausea, or vomiting. Discontinue use of tiotropium bromide and contact your doctor immediately, preferably an eye specialist, if signs or symptoms of narrow-angle glaucoma occur.
• Dry mouth, which has been observed during treatment with anticholinergics, may over time be associated with dental caries. Therefore, good dental hygiene is recommended.
• If you have had a myocardial infarction within the last 6 months, or any unstable or life-threatening irregular heartbeats, or severe heart failure within the past year, inform your doctor. This information is important to determine whether Spiriva is the appropriate medicine for you.
• Do not use SPIRIVA 18 micrograms more frequently than once daily.

Children and adolescents
Spiriva 18 micrograms is not recommended for children and adolescents under 18 years of age.
Other medicines and Spiriva 18 micrograms
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription.
Inform your doctor or pharmacist if you are using or have recently used similar medicines for your lung condition, such as ipratropium or oxitropium.
No specific adverse effects have been reported following the use of SPIRIVA 18 micrograms in combination with other medicines used to treat COPD, such as inhaled medicines that relieve symptoms like salbutamol, methylxanthines such as theophylline, and/or steroids administered orally or by inhalation such as prednisolone.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use this medicine unless specifically recommended by your doctor.
Driving and using machines
Dizziness, blurred vision, or headache may affect your ability to drive vehicles or operate machinery.
Spiriva 18 micrograms contains monohydrate lactose
Each capsule delivers up to 5.5 mg of monohydrate lactose when Spiriva 18 micrograms is used according to the recommended dosage of one capsule once daily. If your doctor has diagnosed you with an intolerance to certain sugars or an allergy to milk proteins (which may be present in small amounts in the monohydrate lactose component), contact your doctor before taking this medicine.

3. How to use Spiriva 18 micrograms

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is inhalation of the contents of one capsule (18 micrograms of tiotropium) once
daily. Do not use a higher dose than recommended.
Spiriva 18 micrograms is not recommended for children and adolescents under 18 years of age.
The capsule should be used at the same time every day. This is important because Spiriva 18
micrograms is effective for 24 hours.
The capsules are for inhalation only and must not be taken orally.
Do not swallow the capsules.
The HandiHaler device, into which the Spiriva capsule must be placed, pierces the capsule and allows
the powder to be inhaled.
Make sure you have a HandiHaler and know how to use it properly. Instructions for using the HandiHaler
are provided on the reverse side of this leaflet.
Ensure that you do not blow into the HandiHaler.
If you have any doubts about how to use the HandiHaler, consult your doctor, nurse, or pharmacist, who
will demonstrate its correct use.
The HandiHaler should be cleaned once a month. Cleaning instructions for the HandiHaler are
provided on the reverse side of this leaflet.
When using Spiriva 18 micrograms, take care to avoid getting the powder in your eyes. If this
happens, you may experience blurred vision, eye pain and/or redness. In such cases, immediately
rinse your eyes with lukewarm water and then contact your doctor immediately for further advice.
If you notice that your breathing worsens, inform your doctor as soon as possible.
If you use more Spiriva 18 micrograms than you should
If you inhale the contents of more than one SPIRIVA 18 microgram capsule in one day, contact your
doctor immediately. You may have an increased risk of experiencing side effects such as dry mouth,
constipation, difficulty urinating, increased heart rate, or blurred vision.
If you forget to use Spiriva 18 micrograms
If you forget to take a dose, take it as soon as you remember, but do not take a double dose at the same
time or on the same day. Then take the next dose as usual.
If you stop using Spiriva 18 micrograms
Before stopping treatment with Spiriva 18 micrograms, speak to your doctor or pharmacist.
If you stop treatment with Spiriva 18 micrograms, your COPD symptoms may worsen.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The side effects listed below have been reported by people who have used this medicine and are listed by frequency, categorised as common, uncommon, rare or not known.
Common (may affect up to 1 in 10 people):

• dry mouth: usually mild

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

• dizziness
• headache
• taste disturbances
• blurred vision
• irregular heartbeat (atrial fibrillation)
• throat inflammation (pharyngitis)
• hoarseness (dysphonia)
• cough
• heartburn (gastroesophageal reflux disease)
• constipation
• fungal infections of the mouth and throat (oropharyngeal candidiasis)
• rash
• difficulty in urination (urinary retention)
• pain during urination (dysuria)

Rare (may affect up to 1 in 1,000 people):

• difficulty sleeping (insomnia)
• visual halos around lights or coloured images associated with red eyes (glaucoma)
• increased measured eye pressure
• irregular heartbeat (supraventricular tachycardia)
• fast heartbeat (tachycardia)
• awareness of heartbeat (palpitations)
• chest tightness, associated with cough, laboured breathing or shortness of breath immediately after inhalation (bronchospasm)
• nosebleed (epistaxis)
• inflammation of the larynx (laryngitis)
• inflammation of the paranasal sinuses (sinusitis)
• intestinal blockage or absence of bowel movements (intestinal obstruction including paralytic ileus)
• inflammation of the gums (gingivitis)
• inflammation of the tongue (glossitis)
• difficulty swallowing (dysphagia)
• inflammation of the mouth (stomatitis)
• feeling unwell (nausea)
• hypersensitivity including immediate reactions
• severe allergic reactions causing swelling of the face or throat (angioedema)
• urticaria
• itching
• urinary tract infections

Not known (frequency cannot be estimated from the available data):

• loss of body fluids (dehydration)
• dental caries
• severe allergic reaction (anaphylactic reaction)
• skin infections or ulcerations
• dry skin
• joint swelling

After administration of Spiriva 18 micrograms, serious side effects may occur including allergic reactions causing swelling of the face or throat (angioedema) or other hypersensitivity reactions (such as sudden drop in blood pressure or dizziness), occurring individually or as part of a severe allergic reaction (anaphylactic reaction). In addition, as with other inhaled medicines, some patients may experience unexpected chest tightness, cough, laboured breathing or shortness of breath immediately after inhalation (bronchospasm). If any of these effects occur, consult your doctor immediately.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Spiriva 18 micrograms

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
After removing the first capsule from the blister, continue removing one capsule per day for the following nine days from the same blister.
Dispose of the HandiHaler device 12 months after first use.
Do not store above 25°C.
Do not freeze.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Spiriva 18 micrograms contains
The active substance is tiotropium. Each capsule contains 18 micrograms of the active substance tiotropium (as
monohydrate bromide). During inhalation, 10 micrograms of tiotropium are released from the mouthpiece
of the HandiHaler.
The other component is lactose monohydrate (which may contain small amounts of milk proteins).

Description of the appearance of Spiriva 18 micrograms and contents of the pack
Spiriva 18 micrograms, inhalation powder, hard capsule is a hard capsule of light green colour, with the product code TI 01 and the company logo printed on it.
The product is available in the following pack sizes:
Pack containing 30 capsules
Pack containing 60 capsules
Pack containing 90 capsules
Pack containing 10 capsules and 1 HandiHaler device
Pack containing 30 capsules and 1 HandiHaler device
Hospital pack: containing 5 cartons of 30 capsules and 1 HandiHaler device
Hospital pack: containing 5 cartons of 60 capsules
Additionally, a pack containing 1 HandiHaler device is available.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
The Marketing Authorization Holder of Spiriva 18 micrograms is:
Boehringer Ingelheim International GmbH
Binger Strasse 173
D-55216 Ingelheim am Rhein
Germany

Legal representative in Italy:
Boehringer Ingelheim Italia S.p.A.
Via Lorenzini, 8
20139 Milano
Italy

The manufacturer of Spiriva 18 micrograms and of the HandiHaler device is:
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
D-55216 Ingelheim am Rhein
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the
following names:

HandiHaler instructions for use
Dear Patient,
The HandiHaler allows you to inhale the medicine contained in Spiriva capsules, which your doctor has prescribed for your respiratory problems.

Please remember to follow carefully the instructions provided by your doctor for
the use of Spiriva. The HandiHaler device has been specifically designed
for Spiriva. Do not use it for the administration of other
medicines. You may use the HandiHaler device for up to one year to
take your medicine.

Description of HandiHaler
1 Dust cap
2 Mouthpiece
3 Base
4 Piercing button
5 Central chamber

1. To unlock the dust cap, press the piercing button fully and then release it.

2. Fully open the dust cap by lifting it upwards. Then open the mouthpiece by pushing it upwards.

3. Remove one SPIRIVA capsule from the blister (only immediately before use) and place it into the central chamber (5), as shown. The orientation of the capsule in the chamber does not matter.

4. Close the mouthpiece securely until you hear a click, leaving the dust cap open.

5. Hold the HandiHaler device with the mouthpiece pointing upwards and press the piercing button down fully only once, then release. This action creates holes in the capsule, allowing the medicine to be released during inhalation.

6. Breathe out fully. Important: never breathe into the mouthpiece.
7. Place the HandiHaler device into your mouth and close your lips
   firmly around the mouthpiece. Keep your head in an upright
   position and inhale slowly and deeply, but at a sufficient speed to hear or feel the capsule vibrating. Inhale until your lungs are full; then hold your breath as long as possible while simultaneously removing the HandiHaler device from your mouth. Resume normal breathing.
   Repeat steps 6 and 7 once, in order to completely empty the capsule.

8. Open the mouthpiece again. Remove the used capsule and discard it. Close the mouthpiece and the dust cap to store the HandiHaler device.

Cleaning the HandiHaler device

Clean the HandiHaler device once a month. Open the dust cap and the mouthpiece. Then open the base by lifting the piercing button. Rinse the entire inhaler with warm water to remove dust. Dry the HandiHaler device thoroughly by pouring out excess water onto a paper towel and leaving it to air-dry, with the dust cap, mouthpiece, and base left open. Since air-drying takes 24 hours, the device should be cleaned immediately after use so that it is ready for the next inhalation. If necessary, the outer surface of the mouthpiece may be cleaned with a damp but not wet cloth.

Use of the blister

A. Tear the blister in half along the perforated line.
B. Lift the backing foil using the tab

until one capsule becomes fully visible (only immediately before use).
If a second capsule is accidentally exposed to air, it must be discarded.
C. Remove the capsule.
Spiriva capsules contain only a small amount of powder, so the capsule is only partially filled.

MANUFACTURER OF THE HANDIHALER DEVICE
Boehringer Ingelheim Pharma GmbH & Co. KG
D-55216 Ingelheim am Rhein
Germany