SPIOLTO 2.5 MICROGRAMS/2.5 MICROGRAMS Inhalation solution

Зміст інструкції

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

Srivasso 18 micrograms powder for inhalation, hard capsule
tiotropium

Read this leaflet carefully before you start to use 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you use 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 is Srivasso 18 micrograms and what is it used for

Srivasso 18 micrograms helps people affected by 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 is associated with chronic conditions of bronchitis and emphysema. Because COPD is a
chronic disease Srivasso 18 micrograms must be used every day and 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 facilitates the entry and exit of air from the lungs. Regular use of Srivasso 18 micrograms can also
be helpful when shortness of breath related to the disease develops and will help to minimize the effects
of the disease on your daily life. It also allows you to be active for longer. Daily use
of Srivasso 18 micrograms helps to prevent the sudden short-term worsening of COPD symptoms,
which can last for several days.
The effect of this medicine lasts 24 hours, therefore it must be used once a day.

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

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

• Tell your doctor if you suffer from closed-angle glaucoma, prostate problems or difficulty urinating.
• If you suffer from kidney problems, consult your doctor.
• Srivasso 18 micrograms is indicated for the maintenance therapy of chronic obstructive pulmonary disease, it should not be used to treat a sudden attack of shortness of breath or breathlessness.
• Immediate allergic reactions such as skin rash, edema, itching, wheezing or shortness of breath may occur after the 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 happens, consult your doctor immediately.
• Carefully avoid contact of the inhaled powder with the eyes, as this may cause precipitation or worsening of closed-angle glaucoma, which is an eye disease. Pain or a feeling of discomfort in the eyes, blurred vision, seeing halos around lights or colored images in association with red eyes may be signs of an acute attack of closed-angle glaucoma. Ocular symptoms may be accompanied by headache, nausea or vomiting. Stop taking tiotropium bromide and consult your doctor immediately, preferably an eye specialist, if signs and symptoms of closed-angle glaucoma appear.
• Dry mouth, which has been observed during treatment with anticholinergics, may be associated with dental caries in the long term. Therefore, careful dental hygiene is recommended.
• If you have had a myocardial infarction in the last 6 months or any form of unstable or life-threatening irregular heartbeat or severe heart failure in the past year, tell your doctor. This information is important to establish whether Srivasso is the right medicine for you.
• Do not use Srivasso 18 micrograms more frequently than once a day.

Children and adolescents
Srivasso 18 micrograms is not recommended for children and adolescents under 18 years of age.

Other medicines and Srivasso 18 micrograms
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including over-the-counter medicines.
Tell your doctor or pharmacist if you are using or have recently used similar medicines for your
lung disease, 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 for the treatment of COPD such as medicines taken by
inhalation that relieve symptoms like salbutamol, methylxanthines such as theophylline and/or steroids
administered orally and by inhalation such as prednisolone.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine. Do not use
this medicine unless specifically recommended by your doctor.

Driving and using machines
The onset of dizziness, blurred vision or headache may affect your ability to drive
vehicles or use machines.

Srivasso 18 micrograms contains lactose monohydrate.
When taken according to the recommended dosage, one capsule once a day, each dose provides
up to 5.5 mg of lactose monohydrate. If your doctor has diagnosed you with an intolerance to some sugars
or an allergy to milk proteins (which may be contained in small quantities in the lactose monohydrate component), contact him/her before taking this medicine.

3. How to take Srivasso 18 micrograms

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The recommended dose is the inhalation of the contents of one capsule (18 micrograms of tiotropium) once
a day. 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 each day. This is important because Srivasso 18
micrograms is effective for 24 hours.
The capsules are for inhalation only and not for oral administration.
Do not swallow the capsules.
The HandiHaler device, inside which the Srivasso capsule must be placed, pierces the capsule
and allows the inhalation of the powder.
Make sure you have a HandiHaler and know how to use it properly. Instructions for
Make sure you do not blow into the HandiHaler.
If you have any doubts about using the HandiHaler, ask your doctor, nurse or pharmacist to
show you how it works.
The HandiHaler should be cleaned once a month. Instructions for cleaning the HandiHaler are
When you take Srivasso 18 micrograms, make sure that the powder does not get into your eyes. If this
happens, you may experience blurred vision, pain and/or redness of the eyes, in
which case you should immediately rinse your eyes with lukewarm water. Then consult
your doctor immediately for further advice.
If you notice that your breathing has worsened, 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 should contact
your doctor immediately. You may be at greater risk of experiencing undesirable 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 the next dose as usual.

If you stop taking Srivasso 18 micrograms
Before stopping treatment with Srivasso 18 micrograms, you should talk to your doctor or
pharmacist.
If you stop treatment with Srivasso 18 micrograms, the signs and symptoms of COPD may
worsen.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects described below have been reported by people who have taken this
medicine and are listed by frequency, divided into 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 alterations
• blurred vision
• irregular heartbeat (atrial fibrillation)
• sore throat (pharyngitis)
• hoarse voice (dysphonia)
• cough
• heartburn (gastroesophageal reflux disease)
• constipation
• fungal infections of the mouth and throat (oropharyngeal candidiasis)
• skin rash
• difficulty urinating (urinary retention)
• painful urination (dysuria)

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

• difficulty sleeping (insomnia)
• visual halos around lights or colored images associated with red eyes (glaucoma)
• increased eye pressure measured
• irregular heartbeat (supraventricular tachycardia)
• fast heartbeat (tachycardia)
• awareness of heartbeat (palpitations)
• chest tightness, associated with cough, wheezing or shortness of breath immediately after inhalation (bronchospasm)
• nosebleed (epistaxis)
• inflammation of the larynx (laryngitis)
• inflammation of the sinuses (sinusitis)
• blockage of the intestine 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
• itching
• urinary tract infections

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

• loss of body fluids (dehydration)
• tooth decay
• severe allergic reaction (anaphylactic reaction)
• skin infections or ulcerations
• dry skin
• swollen joints

After the administration of Srivasso 18 micrograms, serious side effects may occur that
include allergic reactions causing swelling of the face or throat (angioedema) or other hypersensitivity
reactions (such as a sudden decrease in blood pressure or dizziness) that occur
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,
wheezing or shortness of breath immediately after inhalation (bronchospasm). If any of these
effects occur, contact your doctor immediately.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through 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 which is stated on the package and on the blister. The expiry
date refers to the last day of that month.
After taking the first capsule from the blister, you must continue to take the capsules for the next 9
days, one capsule a day, from the same blister.
Discard the HandiHaler device 12 months after first use.
Do not store at a temperature above 25°C.
Do not freeze.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Srivasso 18 micrograms contains

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

Description of the appearance of Srivasso 18 micrograms and contents of the pack
Srivasso 18 micrograms powder for inhalation, hard capsule is a light green hard capsule
containing the powder for inhalation, with the product code TI 01 and the company logo
printed.
The product is available in the following packs:
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 packs of 30 capsules and HandiHaler device
Hospital pack: containing 5 packs of 60 capsules
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the
following denominations:
HandiHaler instructions for use:
Dear patient,
HandiHaler allows you to inhale the medicine contained in the Srivasso capsules, which your doctor has
prescribed for your breathing problems.

Please carefully follow your doctor's instructions for
using Srivasso. The HandiHaler device has been developed
specifically for Srivasso. Do not use it to take other
medicines. You can use the HandiHaler device for up to a year to
take the medicine.

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

• 1. To unlock the dust cover cap, press the piercing button completely and then release it.

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

• 3. Remove a Srivasso capsule from the blister (only immediately before use) and insert it into the central chamber (5), as illustrated. It does not matter in which orientation the capsule is placed in the chamber.

• 4. Close the mouthpiece firmly until you hear a click, leaving the dust cover cap open.

• 5. Hold the HandiHaler device with the mouthpiece pointing upwards and press the piercing button once all the way down and then release. This action creates holes in the capsule which allows the medicine to be released during inhalation.

• 6. Exhale completely. Important: always avoid breathing into the mouthpiece.

• 7. Bring the HandiHaler device to 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 speed

sufficient to hear or feel the capsule vibrate. Inhale until
your lungs are full; then hold your breath for as long as
possible and at the same time remove the
HandiHaler device from your mouth. Resume normal breathing.
Repeat steps 6 and 7 once, in order to empty the
capsule completely.

• 8. Open the mouthpiece again. Turn the used capsule upside down and discard it. Close the mouthpiece and the dust cover cap to store the HandiHaler device.

Cleaning the HandiHaler device

Clean the HandiHaler device once a month. Open the
dust cover 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 turning the excess water onto a paper towel and leaving it
to air dry, keeping the dust cover cap, mouthpiece and
base open. As it takes 24 hours to air dry, the device
should be cleaned immediately after use so that it is ready for the next
inhalation. If necessary, the outside of the mouthpiece can be cleaned
with a damp but not wet cloth.
Using the blister

• A. Divide the blister in half by pulling along the perforated line.
• B. Lift the foil on the back side using the tab

until a capsule is fully visible (only
immediately before use).
If a second capsule is inadvertently exposed to the air,
it must be discarded.

• C. Remove the capsule.

Srivasso capsules contain only a small amount of powder, so the capsule is only filled
partially.

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