TIOTROPIO 10 MICROGRAMS Inhalation powder, hard capsule

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1. tiotropium
   1. What is Tiotropio Teva Italia and what is it used for
   2. What you need to know before you take Tiotropio Teva Italia
   3. How to take Tiotropio Teva Italia
   4. Possible side effects
   5. How to store Tiotropio Teva Italia
   6. Content of the pack and other information

Tiotropio Teva Italia 10 micrograms per delivered dose inhalation powder, hard capsule

tiotropium

Generic medicine

Read this leaflet carefully before you start taking 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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Tiotropio Teva Italia is and what it is used for
• 2. What you need to know before you take Tiotropio Teva Italia
• 3. How to take Tiotropio Teva Italia
• 4. Possible side effects
• 5. How to store Tiotropio Teva Italia
• 6. Contents of the pack and other information

1. What is Tiotropio Teva Italia and what is it used for

Tiotropio Teva Italia contains the active ingredient tiotropium. Tiotropium 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, you must take this medicine every day and not only
when you experience difficulty breathing or other symptoms of COPD.
Tiotropio Teva Italia 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 this medicine can also be helpful when
you develop shortness of breath related to the disease and will help you minimize the effects of the disease on your life
daily. It also allows you to be active for longer. Daily use of this medicine also helps to
prevent the sudden worsening of COPD symptoms in the short term, which can last for several
days. The effect of this medicine lasts 24 hours, therefore you should take it only once a day.
This medicine should not be used as emergency therapy for the treatment of unexpected sensation
of chest tightness, cough or sudden attacks of shortness of breath or wheezing. In these cases, use instead
a "relief" (emergency) inhaler of rapid action, such as salbutamol. Carry this "relief"
inhaler with you at all times.

2. What you need to know before you take Tiotropio Teva Italia

Do not take Tiotropio Teva Italia:

• if you are allergic (hypersensitive) to tiotropium or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic (hypersensitive) to atropine or similar substances such as ipratropium or oxitropium
• if you are allergic (hypersensitive) to lactose or any other sugar

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Tiotropio Teva Italia:

• if you are taking any other medicine that contains ipratropium or oxitropium
• if you suffer from closed-angle glaucoma, prostate problems or difficulty urinating
• if you suffer from kidney problems
• if you have had a heart attack (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.

Tiotropio Teva Italia 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 wheezing.
Immediate allergic reactions such as
skin rash, swelling, itching, wheezing or shortness of breath may occur after the administration of Tiotropio Teva Italia. Consult your doctor immediatelyif
these occur (see section 4).
Medicines taken by inhalation, such as Tiotropio Teva Italia, can cause chest tightness, coughing,
wheezing or shortness of breath (bronchospasm) immediately after inhalation. In these cases, use
immediately a fast-acting "reliever" inhaler, such as salbutamol. If these symptoms occur,
stop taking Tiotropio Teva Italia and consult your doctor immediately.
Carefully avoid contact of the inhaled powder with the eyes, as this may cause tearing or
the occurrence or worsening of closed-angle glaucoma. Closed-angle glaucoma 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. The eye symptoms may be accompanied by headache, nausea or vomiting.
You should stop taking this medicine and consult your doctor immediately, preferably
an eye specialist, if signs and symptoms of closed-angle glaucoma appear.
The medicine in the inhaler may reduce normal secretions (saliva) in the mouth and cause a feeling of
dry mouth, which over the long term may be associated with tooth decay. It is therefore important
to pay attention to oral hygiene, rinse your mouth and brush your teeth regularly.
If you have had a heart attack (myocardial infarction) in the last 6 months or any form of irregular
heartbeat that is unstable or life-threatening or severe heart failure in the past year, tell your
doctor. This information is important to establish whether Tiotropio Teva Italia is the right medicine for you.

Do nottake this medicine more than once a day (see section 3).

Children and adolescents
Tiotropio Teva Italia should not be taken by children and adolescents under 18 years of age.

Other medicines and Tiotropio Teva Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including any other medicines by inhalation or any medicines bought without
a prescription.
Tell your doctor or pharmacist if you are taking or have recently taken medicines similar for your
lung disease, such as ipratropium or oxitropium.
No specific adverse effects have been reported following the taking of this medicine in
association with other medicines used for the treatment of COPD, such as "reliever" inhalers like
salbutamol, methylxanthines like theophylline, and/or steroids administered orally or by inhalation like
prednisolone.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine. Do not use this
medicine unless specifically recommended by your doctor.

Driving and operating machinery
Dizziness, blurred vision or headache may affect your ability to drive and operate machinery.

Tiotropio Teva Italia contains lactose.
Lactose is a type of sugar present in milk. If you know you are allergic to certain sugars, ask your
doctor for advice before using this medicine. Lactose may contain very small amounts of milk proteins, which may cause allergic reactions in patients who suffer from severe hypersensitivity or allergy to
milk proteins. When taken in accordance with the recommended dose of one capsule a day,
each dose provides up to 18 mg of lactose monohydrate.

3. How to take Tiotropio Teva Italia

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is inhalation of the contents of onecapsule once a dayusing the
Zonda inhaler. Onecapsule provides the daily dose of tiotropium needed (a delivered dose of 10 micrograms
of tiotropium); donot take a dose higher than that recommended.
Try to take this medicine every day at the same time. This is important because this medicine
is effective for 24 hours.
The capsules are only for inhalation and not for oral administration.
Do not swallow the capsules.
The Zonda inhaler, into which the Tiotropio Teva Italia capsule must be placed, pierces the capsule and
allows inhalation of the powder.
The capsules must be inhaled using only the Zonda inhaler. Do not use other inhalers to take the
Tiotropio Teva Italia capsules.
Make sure you know how to use the Zonda inhaler correctly. Instructions for use of the Zonda inhaler
use. Images for the correct insertion of the capsule into the inhaler are also included inside the box lid. To avoid the risk of choking,never insert a capsule
directly into the mouthpiece.If you have problems using the Zonda inhaler, contact your
doctor, pharmacist or nurse, who will show you how it works.
If necessary, after use, you can clean the mouthpiece of the Zonda inhaler with a dry cloth or a
tissue.
Make sure you do not blow into the Zonda inhaler. When you take Tiotropio Teva Italia, be careful
that the powder does not get into your eyes. If this happens, blurred vision and
eye pain and/or redness may occur; in this case you should rinse your eyes immediatelywith lukewarm water.
Then contact your doctor immediatelyfor further advice.
If you find that your breathing has worsened, tell your doctor as soon as possible.

Use in children and adolescents
Tiotropio Teva Italia should not be taken by children and adolescents under 18 years of age.

If you take more Tiotropio Teva Italia than you should
If you inhale the contents of more than one Tiotropio Teva Italia capsule in a day, you should contact

immediatelyyour doctor. You may be at increased risk of experiencing undesirable effects such as
dry mouth, constipation, difficulty urinating, increased heart rate or blurred
vision.

If you forget to take Tiotropio Teva Italia
If you forget to take a dose, take it as soon as you remember, but donot take two doses at
the same time or on the same day. Take the next dose as usual. Donot take a double
dose to make up for a missed dose.

If you stop taking Tiotropio Teva Italia
Before stopping treatment with Tiotropio Teva Italia , you should talk to your doctor or pharmacist. If
you stop treatment with this medicine, the signs and symptoms of COPD may worsen.
If you have any questions about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects, including allergic reactions that cause swelling of the face or throat
(angioedema) or other hypersensitivity reactions (such as a sudden drop in blood pressure or
dizziness) or wheezing and shortness of breath may occur individually or as part of a
serious allergic reaction (anaphylactic reaction) after taking this medicine. Such serious side effects
are rare. Also, as happens with all inhaled medicines, some patients may
experience unexpected chest tightness, coughing, wheezing or shortness of breath immediately after
inhalation (bronchospasm).
If any of these side effects occur, consult immediatelyyour doctor.
Do not use Tiotropio Teva Italia again until you have consulted your doctor. If you experience wheezing or shortness of
breath, you should immediately use a fast-acting "reliever" (emergency) inhaler.
Other side effects have been observed in patients who have taken this medicine and are listed below
according to their frequency.

Common: may affect up to 1 in 10 people

• dry mouth: usually mild

Uncommon: may affect up to 1 in 100 people

• dizziness
• headache
• altered taste
• 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 (oral and pharyngeal candidiasis)
• skin rash
• difficulty urinating (urinary retention)
• painful urination (dysuria)

Rare: may affect up to 1 in 1000 people

• difficulty sleeping (insomnia)
• halos around lights or colored images in association with red eyes (glaucoma)
• increased eye pressure measured
• irregular heartbeat (supraventricular tachycardia)
• fast heartbeat (tachycardia)
• awareness of heartbeat (palpitations)
• chest tightness, associated with coughing, wheezing or shortness of breath immediately after inhalation (bronchospasm)
• nosebleeds (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)
• nausea
• hives
• itching
• urinary tract infections

Frequency cannot be estimated based on available data:

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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa. By reporting side effects you can help provide more information
on the safety of this medicine.

5. How to store Tiotropio Teva Italia

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 label of the vial after EXP. The expiry date refers to the last day of that month.

Do not refrigerate or freeze.
Keep the vial tightly closed. Store it in the original packaging to protect the medicine from moisture.
Use the product within 30 days (15 capsule vial) or 60 days (30 capsule vial) from opening the
vial.
The Zonda inhaler must only be used with the supplied capsule vial. Do not reuse the inhaler for
another capsule vial.
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. Content of the pack and other information

What Tiotropio Teva Italia contains

• The active ingredient is tiotropium. Each capsule contains 13 micrograms of active ingredient tiotropium (as bromide). During inhalation, 10 micrograms of tiotropium per capsule are delivered to the patient and inhaled into the lungs from the Zonda inhaler mouthpiece.
• The other ingredients are lactose monohydrate (capsule content) and hypromellose (capsule shell).

Description of the appearance of Tiotropio Teva Italia and content of the pack
Tiotropio Teva Italia 10 micrograms per delivered dose powder for inhalation, hard capsule is a
colorless and transparent hard capsule containing a white powder.
This medicine is supplied in bottles with a screw-cap closure. The bottle is supplied in a carton
containing a Zonda inhaler. The Zonda inhaler has a green body and a cap with a white button.
Tiotropio Teva Italia is available in packs containing 15 or 30 capsules and a Zonda inhaler, and in
multipacks containing either 60 capsules (2 packs of 30 capsules) and 2 Zonda inhalers or 90 capsules (3
packs of 30 capsules) and 3 Zonda inhalers.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 – 20123 Milan

Distributor for sale:
Levante Pharma S.r.l.
Via San Giuseppe Cottolengo, 15
20143 Milan

Manufacturer:
Laboratorios LICONSA S.A.
Avda. Miralcampo, No 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara
Spain
Teva Pharma B.V.
Swensweg 5, 2031 GA Haarlem
Netherlands
Teva Operations Poland Sp. z.o.o
ul. Mogilska 80, 31-546 Cracow
31-546
Poland
Actavis Ltd
BLB015, BLB016, Bulebel Industrial Estate,
Zejtun, ZTN3000,
Malta

Instructions for use of Zonda
Dear patient,
the Zonda inhaler allows you to inhale the medicine contained in the Tiotropio Teva Italia capsule which your
doctor has prescribed for your breathing problems.
Remember to carefully follow the instructions provided by your doctor for using Tiotropio Teva Italia .
The Zonda inhaler has been specifically designed for Tiotropio Teva Italia capsules. Do not
use it to take other medicines. The capsules must only be inhaled using the Zonda inhaler. Do notuse other inhalers to take Tiotropio Teva Italia capsules. Each capsule contains only a
small amount of powder. Do notopen the capsule as this may compromise its action.
The Zonda inhaler must only be used with the supplied bottle of capsules. Do not reuse the inhaler for
another bottle of capsules. Dispose of the Zonda device after 15 uses (if used with a 15-capsule bottle) or 30 uses (if used with a 30-capsule bottle).

Zonda

• 1. Dust cover cap
• 2. Mouthpiece
• 3. Base

• 4. Piercing button
• 5. Central chamber
• 1. Lift the dust cover cap.

• 2. Holding the base of the inhaler firmly, open the mouthpiece by pushing it upwards, in the direction indicated by the arrow.

• 3. Remove a Tiotropio Teva Italia capsule from the bottle immediately before use and close the bottle tightly. Insert a capsule into the appropriate central chamber in the base of the inhaler. Do notstore the capsule in the Zonda inhaler.

• 4. To avoid the risk of choking, never insert the capsule directly into the mouthpiece.

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

• 6. Holding the inhaler with the mouthpiece facing upwards, press the piercing button firmly once and release it. This action pierces the capsule allowing the drug to be released during inhalation.

• 7. Exhale completely while keeping your mouth away from the mouthpiece. Always avoid breathing into the mouthpiece.

• 8. Bring the mouthpiece to your mouth and keep your head in an upright position. Close your lips around the mouthpiece and inhale slowly and deeply but at a speed sufficient to hear or feel the capsule vibrating inside the central chamber. Hold your breath for as long as possible and at the same time remove the inhaler from your mouth. Resume normal breathing. Repeat steps 7 and 8 to completely empty the capsule.

• 9. After use, open the mouthpiece again, turn the empty capsule upside down and remove it. Close the mouthpiece and the dust cover cap and store the Zonda inhaler.

The Zonda inhaler is a medical device (CE)
Manufacturer:
Plastiape S.p.A.
Via 1 Maggio, 8
23875 Osnago LC
Italy