Spiolto Respimat

Package leaflet: Information for the user

Srivasso 18 micrograms inhalation powder, hard capsule
tiotropium
Please read all of this leaflet carefully before you start using this medicine because 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Srivasso 18 micrograms is and what it is used for

Srivasso 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 chronic bronchitis and emphysema. Since COPD is a chronic disease, Srivasso 18 micrograms must be used every day, not only when breathing difficulties or other COPD symptoms occur.
Srivasso 18 micrograms is a long-acting bronchodilator that helps to widen the airways and makes it easier for air to move in and out of the lungs. Regular use of Srivasso 18 micrograms can also help when shortness of breath related 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 Srivasso 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 used once daily.

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

Do not use Srivasso 18 micrograms

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

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

• Inform your doctor if you have narrow-angle glaucoma, prostate problems, or difficulty urinating.
• If you have kidney problems, consult your doctor.
• Srivasso 18 micrograms is indicated for maintenance treatment of chronic obstructive pulmonary disease (COPD); it must not be used to treat sudden attacks of breathlessness or shortness of breath.
• Immediate allergic reactions such as skin rash, swelling (edema), itching, wheezing, or shortness of breath may occur after administration of Srivasso 18 micrograms. If this happens, consult your doctor immediately.
• Medicines taken by inhalation, such as Srivasso 18 micrograms, may cause chest tightness, cough, wheezing, or shortness of breath immediately after administration. If this occurs, consult your doctor immediately.
• Take care to avoid contact of the inhaled powder with your eyes, as this may precipitate or worsen narrow-angle glaucoma, an eye condition. Pain or discomfort in the eyes, blurred vision, seeing halos around lights, or colored images associated 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 consult your doctor immediately, preferably an ophthalmologist, if signs and 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, careful dental hygiene is recommended.
• If you have suffered a myocardial infarction within the last 6 months, or if you have 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 Srivasso is the appropriate medicine for you.
• Do not use Srivasso 18 micrograms more frequently than once daily.

Children and adolescents
Srivasso 18 micrograms is not recommended for children and adolescents under 18 years of age.
Other medicines and Srivasso 18 micrograms
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those 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 Srivasso 18 micrograms in combination with other medicines used to treat COPD, such as inhaled medications that relieve symptoms like salbutamol, methylxanthines such as theophylline, and/or oral and inhaled steroids such as prednisolone.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking 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 or operate machinery.
Srivasso 18 micrograms contains monohydrate lactose.
When taken according to the recommended dosage (one capsule once daily), each dose provides up to 5.5 mg of monohydrate lactose. 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 take Srivasso 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 the inhalation of the contents of one capsule (18 micrograms of tiotropium)
once daily. Do not use a higher dose than recommended.
Srivasso 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 Srivasso 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 Srivasso capsule must be placed, pierces the capsule and allows
you to inhale the powder.
Make sure you have a HandiHaler and know how to use it correctly. Instructions for using the HandiHaler
are provided on the reverse side of this patient information 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 patient information leaflet.
When taking Srivasso 18 micrograms, take care to avoid the powder entering your eyes. If this happens,
you may experience blurred vision, eye pain and/or redness. In such a case, 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 Srivasso 18 micrograms than you should
If you inhale the contents of more than one Srivasso 18 micrograms capsule in one day, you must contact
your doctor immediately. You may be at increased risk of experiencing side effects such as dry mouth,
constipation, difficulty urinating, increased heart rate, or blurred vision.
If you forget to use Srivasso 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 your next dose at the usual time.
If you stop using Srivasso 18 micrograms
Before stopping treatment with Srivasso 18 micrograms, speak to your doctor or pharmacist.
If you stop treatment with Srivasso 18 micrograms, your COPD symptoms may worsen.
If you have any questions about the use of 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 in people taking 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)
• Sore throat (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)
• Rapid heartbeat (tachycardia)
• Awareness of heartbeat (palpitations)
• Chest tightness, associated with cough, wheezing, or shortness of breath immediately after inhalation (bronchospasm)
• Nosebleeds (epistaxis)
• Inflammation of the larynx (laryngitis)
• Inflammation of the sinuses (sinusitis)
• Bowel obstruction 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)
• Hives (urticaria)
• Itching (pruritus)
• 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 Srivasso 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 alone 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, wheezing, or shortness of breath immediately after inhalation (bronchospasm). If any of these effects occur, seek immediate medical advice.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Srivasso 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 taking the first capsule from the blister, you must continue taking the capsules for the following 9 days, one capsule daily, 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 any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Srivasso 18 micrograms contains

• The active substance is tiotropium. Each capsule contains 18 micrograms of the active substance tiotropium (as monohydrate bromide). The delivered dose (the dose released from the mouthpiece of the HandiHaler device) is 10 micrograms of tiotropium.
• The other component is lactose monohydrate (which may contain trace amounts of milk proteins).

Description of the appearance of Srivasso 18 micrograms and package contents
Srivasso 18 micrograms inhalation powder, hard capsule is a light green hard capsule containing the inhalation powder, 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 boxes of 30 capsules and 1 HandiHaler device
Hospital pack: containing 5 boxes of 60 capsules

Not all pack sizes may be marketed.

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

The manufacturer of Srivasso 18 micrograms and 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 Srivasso capsules, which your doctor has prescribed for your breathing problems.

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

Description of the 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 Srivasso capsule from the blister (only immediately before use) and place it into the central chamber (5), as shown. The orientation of the capsule inside 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 fully down 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 upright and inhale slowly and deeply, but at a sufficient speed to hear or feel the capsule vibrating. Breathe in until your lungs are full, then hold your breath as long as possible while removing the HandiHaler device from your mouth. Resume normal breathing.
   Repeat steps 6 and 7 once to ensure the capsule is completely emptied.

8. Open the mouthpiece again. Remove and discard the used capsule. 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 any powder residue. Dry the HandiHaler thoroughly by shaking out excess water onto a paper towel and leaving it to air-dry, with the dust cap, mouthpiece, and base left open. As 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 part of the mouthpiece may be wiped with a damp (not wet) cloth.

Use of the blister pack

A. Tear the blister pack 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.
Srivasso capsules contain only a small amount of powder, so the capsule appears only partially filled.

Manufacturer of the HandiHaler device
Boehringer Ingelheim Pharma GmbH & Co. KG
D-55216 Ingelheim am Rhein
Germany