Tiotropium Teva Italia

Package leaflet: Information for the patient

Tiotropio Teva Italia 10 micrograms per delivered dose powder for inhalation, hard capsule
tiotropium
Generic medicine
Please read all of this leaflet carefully before you start taking 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to 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 taking 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 Tiotropio Teva Italia is and what it is used for

Tiotropio Teva Italia contains the active substance tiotropium. Tiotropium 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 is associated with chronic bronchitis and emphysema. Since COPD is a chronic disease, you must take this medicine every day, not only when you have breathing difficulties or other COPD symptoms.
Tiotropio Teva Italia is a long-acting bronchodilator that helps to open up the airways and makes it easier for air to move in and out of the lungs. Regular use of this medicine can also help when you develop breathlessness due to the disease 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 this medicine also 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, you should take it only once a day.
This medicine must not be used as emergency treatment for sudden chest tightness, cough, or sudden attacks of shortness of breath or wheezing. In such cases, use a fast-acting "reliever" (rescue) inhaler instead, such as salbutamol. Always carry your "reliever" inhaler with you.

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

Do not take Tiotropio Teva Italia:

• if you are allergic (hypersensitive) to tiotropium or to 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 to 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 containing ipratropium or oxitropium
• if you have narrow-angle glaucoma, prostate problems, or difficulty urinating
• if you have kidney problems
• if you have had a heart attack (myocardial infarction) within the last 6 months, or any unstable or life-threatening irregular heartbeat, or severe heart failure in the past year.

Tiotropio Teva Italia is indicated for the 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 Tiotropio Teva Italia.
Contact your doctor immediately if any of these occur (see section 4).
Medicines taken by inhalation, such as Tiotropio Teva Italia, may cause chest tightness, cough, wheezing, or shortness of breath (bronchospasm) immediately after inhalation.
In such cases, use a fast-acting "reliever inhaler" such as salbutamol immediately. If these symptoms occur, stop using Tiotropio Teva Italia and contact your doctor immediately.
Avoid carefully allowing the inhaled powder to come into contact with the eyes, as this may cause tearing or the onset or worsening of narrow-angle glaucoma.
Narrow-angle glaucoma is an eye disease. Pain or discomfort in the eyes, blurred vision, seeing halos around lights or colored images, together with red eyes, may be signs of an acute attack of narrow-angle glaucoma.
Ocular symptoms may be accompanied by headache, nausea, or vomiting.
You must stop taking this medicine and contact your doctor immediately, preferably an eye specialist, if signs or symptoms of narrow-angle glaucoma appear.
The medicine in the inhaler may reduce normal secretions (saliva) in the mouth and cause a dry mouth sensation, which over time may be associated with dental caries.
Therefore, it is important to maintain good oral hygiene, rinse your mouth, and brush your teeth regularly.
If you have had a heart attack (myocardial infarction) within the last 6 months, or any unstable or life-threatening irregular heartbeat, or severe heart failure in the past year, inform your doctor.
This information is important to determine whether Tiotropio Teva Italia is the appropriate medicine for you.
Do not take this medicine more than once a day (see section 3).

Children and adolescents
Tiotropio Teva Italia must not be used in children and adolescents under 18 years of age.

Other medicines and Tiotropio Teva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including any other inhaled medicines or any medicines purchased without a prescription.
Inform your doctor or pharmacist if you are taking or have recently taken similar medicines for your lung condition, such as ipratropium or oxitropium.
No specific adverse effects have been reported following the use of this medicine in combination with other medicines used to treat COPD, such as reliever inhalers like salbutamol, methylxanthines such as theophylline, and/or oral or inhaled steroids such as prednisolone.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, 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
Dizziness, blurred vision, or headache may affect your ability to drive vehicles or operate machinery.

Tiotropio Teva Italia contains lactose.
Lactose is a type of sugar found 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 with severe hypersensitivity or allergy to milk proteins.
When taken according to the recommended dose of one capsule once daily, each dose provides up to 18 mg of lactose monohydrate.

3. How to take Tiotropio Teva Italia

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is the inhalation of the contents of one capsule once daily using the Zonda inhaler. One capsule provides the daily required dose of tiotropium (one delivered dose of 10 micrograms of tiotropium); do not take a higher dose than recommended.
Try to take this medicine at the same time each day. This is important because this medicine is effective for 24 hours.
The capsules are for inhalation only and must not be taken orally.
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 only be inhaled using the Zonda inhaler. Do not use other inhalers to take Tiotropio Teva Italia capsules.
Make sure you know how to use the Zonda inhaler correctly. Instructions for using the Zonda inhaler are provided on the reverse side of this leaflet. Remember to follow these instructions carefully. Images showing 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 any problems using the Zonda inhaler, consult your doctor, pharmacist, or nurse, who will demonstrate its correct use.
If necessary, after use, the mouthpiece of the Zonda inhaler may be cleaned with a dry cloth or tissue.
Make sure you do not blow into the Zonda inhaler. When taking Tiotropio Teva Italia, take care to avoid the powder entering your eyes. If this happens, symptoms such as blurred vision and eye pain and/or redness may occur; in this case, you must immediately rinse your eyes with lukewarm water. Then contact your doctor immediately for further advice.
If you notice that your breathing worsens, inform your doctor as soon as possible.

Use in children and adolescents
Tiotropio Teva Italia must not be used in 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 one day, you must contact your doctor immediately. You may have an increased risk of experiencing side effects such as dry mouth, constipation, difficulty passing urine, 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 do not take two doses at the same time or on the same day. Take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop treatment with Tiotropio Teva Italia
Before stopping treatment with Tiotropio Teva Italia, you must speak 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 how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Serious side effects, including allergic reactions causing swelling of the face or throat (angioedema) or other hypersensitivity reactions (such as sudden drop in blood pressure or dizziness), or increased wheezing and shortness of breath, may occur individually or as part of a severe allergic reaction (anaphylactic reaction) after taking this medicine. These serious side effects are rare. In addition, as with all inhaled medicines, some patients may experience unexpected chest tightness, cough, wheezing or shortness of breath immediately after inhalation (bronchospasm).
If any of these side effects occur, consult your doctor immediately.
Do not use Tiotropio Teva Italia again until you have consulted your doctor. If you experience wheezing or shortness of breath, you must immediately use a fast-acting "reliever" (rescue) inhaler.
Other side effects that have occurred in patients taking this medicine 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
• 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 colored images associated with red eyes (glaucoma)
• Increased measured intraocular 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)
• Nausea
• Hives (urticaria)
• Itching (pruritus)
• Urinary tract infections

Frequency cannot be estimated from the available data:

• Loss of body fluids (dehydration)
• Dental caries
• Skin infections or ulcerations
• Dry skin
• Swelling of the joints

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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 stated on the carton and on the label of the bottle after EXP. The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
Keep the bottle tightly closed. Store it in the original packaging to protect the medicine from moisture.
Use the product within 30 days (bottle of 15 capsules) or 60 days (bottle of 30 capsules) after opening the bottle.
The Zonda inhaler must only be used with the provided capsule bottle. Do not reuse the inhaler for another bottle of capsules.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Tiotropio Teva Italia contains

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

Description of the appearance of Tiotropio Teva Italia and contents of the pack
Tiotropio Teva Italia 10 micrograms per delivered dose, inhalation powder, hard capsule is a colourless and transparent hard capsule containing a white powder.
This medicine is supplied in bottles with screw caps. The bottle is supplied in a box 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 one Zonda inhaler, and in multiple packs 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 Authorization Holder:
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 – 20123 Milano
Marketing Authorization Holder for Sale:
Levante Pharma S.r.l.
Via San Giuseppe Cottolengo, 15
20143 Milano
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
The Netherlands
Teva Operations Poland Sp. z.o.o
ul. Mogilska 80, 31-546 Kraków
Poland
Actavis Ltd
BLB015, BLB016, Bulebel Industrial Estate,
Zejtun, ZTN3000,
Malta

Reverse of the package leaflet:
Instructions for use of Zonda
Dear patient,
the Zonda inhaler allows you to inhale the medicine contained in the Tiotropio Teva Italia capsule prescribed by your doctor for your respiratory problems.
Please remember to carefully follow the instructions provided by your doctor for the use of Tiotropio Teva Italia.
The Zonda inhaler has been specifically designed for use with Tiotropio Teva Italia capsules. Do not use it to take any other medicines. The capsules must be inhaled only using the Zonda inhaler. Do not use other inhalers to take Tiotropio Teva Italia capsules. Each capsule contains only a small amount of powder. Do not open the capsule, as this may impair its effectiveness.
The Zonda inhaler must only be used with the bottle of capsules supplied. Do not reuse the inhaler for another bottle of capsules. Discard 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 cap

2. Mouthpiece

3. Base

4. Piercing button

5. Central chamber

6. Lift the dust 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 one Tiotropio Teva Italia capsule from the bottle immediately before use and close the bottle tightly. Place one capsule into the central chamber in the base of the inhaler. Do not store 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 cap open.

6. Holding the inhaler with the mouthpiece pointing upwards, press the piercing button fully down once and release it. This action pierces the capsule, allowing the medicine to be released during inhalation.

7. Breathe out fully, keeping away from the mouthpiece. Never breathe into the mouthpiece.

8. Place the mouthpiece in your mouth and keep your head upright. 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 as long as possible, then 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 out the empty capsule and remove it. Close the mouthpiece and the dust 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