Prospecto: information for thepatient

Braltus 10 micrograms/dosereleasedpowder for inhalation (hard capsule)

tiotropio

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
  If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus. See section 4.

1. What isBraltusand for what it is used

2. What you need to know before starting to useBraltus

3. How to useBraltus

4. Possible adverse effects

5. Conservation ofBraltus

6. Contents of the package and additional information

Braltus contains the active ingredient tiotropium. Tiotropium helps people with chronic obstructive pulmonary disease (COPD) to breathe more easily. Chronic obstructive pulmonary disease (COPD) is a chronic lung disease that causes difficulty breathing and coughing. The term COPD is associated with chronic bronchitis and emphysema. Since COPD is a chronic disease, you must use this medication every day and not just when you have respiratory problems or other COPD symptoms.

Braltus is a long-acting bronchodilator that helps to open up the airways and facilitates the intake and expulsion of air from the lungs. Regular use of this medication can also help you when you have persistent difficulty breathing due to your disease and will help you to minimize the effects of the disease on your daily life. It will also help you to be active for a longer time. Daily use of this medication will also help you to prevent sudden and short-term symptoms of COPD exacerbation, which can last for several days. The effect of this medication lasts 24 hours, so you only need to use it once a day.

This medication should not be used as rescue therapy for the treatment of sudden chest tightness, cough, wheezing, or shortness of breath. Please use a rapid-acting inhaler (rescue), such as salbutamol. Carry this rescue inhaler with you at all times.

Do not use Braltus:

• if you are allergic to tiotropium or any of the other components of this medication (listed in section 6).
• if you are allergic to atropine or similar medications such as ipratropium or oxitropium
• if you are allergic to lactose or other sugars

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Braltus:

• if you are taking other medications that contain ipratropium or oxitropium
• if you suffer from narrow-angle glaucoma, prostate problems, or have difficulty urinating
• if you have any kidney problems
• if you have had a myocardial infarction in the last 6 months, unstable irregular heartbeats that have endangered your life, or severe heart failure in the past year.

Braltus is indicated for the maintenance treatment of your chronic obstructive pulmonary disease, it should not be used to treat a sudden episode of shortness of breath or wheezing.

After administration of Braltus, immediate allergic reactions such as rash, swelling, itching, wheezing, or shortness of breath may occur. Please consult your doctor immediately if this happens.

Inhaled medications like Braltus can cause chest tightness, cough, wheezing, or shortness of breath immediately after inhalation. If this occurs, use a rescue inhaler (such as salbutamol) immediately. If these symptoms appear, discontinue use of Braltus and consult your doctor immediately.

Be careful not to let the inhalation powder get into your eyes, as this can cause eye redness, and could provoke or worsen narrow-angle glaucoma, a disease of the eyes. Eye pain or discomfort, blurred vision, halos, or colored images associated with eye redness may be signs of an acute episode of narrow-angle glaucoma. Ocular symptoms may be accompanied by headache, nausea, or vomiting. You should discontinue use of this medication and consult your doctor immediately, preferably an ophthalmologist, when signs and symptoms of narrow-angle glaucoma appear.

Inhaled medications can decrease normal saliva secretion in your mouth and cause dry mouth. It may be associated with long-term dental caries. Therefore, remember to take care of your oral hygiene, rinse your mouth, and brush your teeth regularly.

If you have had a myocardial infarction in the last 6 months, unstable irregular heartbeats that have endangered your life, or severe heart failure in the past year, inform your doctor. This is important to decide if Braltus is the appropriate medication for you.

You should not use this medication more than once a day (see section 3).

Children and adolescents

Braltus is not recommended for children and adolescents under 18 years old.

Use of Braltus with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including any other inhaler and over-the-counter medications.

Inform your doctor or pharmacist if you are using or have used similar medications for your lung disease, such as ipratropium or oxitropium.

No specific adverse reactions have been reported when this medication has been used with other medications commonly used for the treatment of COPD, such as rescue inhalers (e.g. salbutamol), methylxanthines (e.g. theophylline), and oral or inhaled corticosteroids (e.g. prednisolone).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.You should not use this medication unless your doctor specifically recommends it.

Driving and operating machinery

The appearance of dizziness, blurred vision, or headache may affect your ability to drive and operate machinery.

Braltus contains lactose

Lactose is a type of sugar found in cow's milk. If your doctor has told you that you have an intolerance to certain sugars, consult with them before using this medication. It may cause allergic reactions in patients with an allergy to cow's milk protein.

If administered according to the recommended dose, one capsule once a day, each dose provides up to 18 mg of lactose monohydrate.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.Consult your doctor or pharmacist again if you are unsure.

The recommended dose is the inhalation of the contents ofonecapsule once a day with the inhaler Zonda. One capsule provides the daily dose of tiotropium (dose released of 10 micrograms of tiotropium). Do not use more than the recommended dose.

You should try to use this medication at the same time every day. This is important since this medication is effective for 24 hours.

The capsules are for inhalation only and not for oral ingestion.

Do not ingest the capsules.

The inhaler Zonda, in which you must insert the Braltus capsule, pierces the capsule and allows you to inhale the powder. The capsules should only be inhaled using the inhaler Zonda. Do not use other inhalers to administer the Braltus capsules.

Make sure you know how to use the inhaler Zonda correctly. The usage instructions for the inhaler are located behind this prospectus.Remember to carefully follow these usage instructions. Additionally, additional images are provided for the correct placement of the capsule in the inhaler inside the packaging.To avoid the risk of asphyxiation, NEVER place a capsule directly into the mouthpiece..If you have any problem using the inhaler Zonda, ask your doctor, nurse, or pharmacist to teach you how it works.

If necessary, you can clean the mouthpiece of your inhaler Zonda after use with a dry paper towel.

Make sure you do not blow into the inhaler Zonda.When using Braltus, be careful and do not let the powder enter your eyes. If powder enters your eyes, it could cause blurry vision, pain, and/or eye redness. You should wash your eyesimmediatelywith warm water. Consult your doctorimmediatelyfor more information.

If you notice that your breathing worsens, consult your doctor as soon as possible.

Use in children and adolescents

Braltus is not recommended for children and adolescents under 18 years old.

If you use more Braltus than you should

If you inhale more than 1 Braltus capsule in a day, you should talk to your doctorimmediately. You may have a higher risk of experiencing an adverse reaction such as dry mouth, constipation, difficulty urinating, increased heart rate, or blurry vision.

If you forgot to use Braltus

If you have forgotten to administer a dose, do it as soon as you remember, butdo nottake two doses at once or on the same day. Then administer your next dose as usual.Do not administer a double dose to compensate for the missed doses.

If you interrupt treatment with Braltus

Before interrupting treatment with Braltus, you should talk to your doctor or pharmacist. If you interrupt the use of this medication, the symptoms and signs of COPD may worsen.

If you have any other questions about the use of thismedication, ask your doctor,pharmacistor nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

After using this medicine, severe adverse reactions may occur individually or as part of a severe allergic reaction (anaphylactic reaction) that include allergic reactions causing swelling of the face and throat (angioedema) or other hypersensitivity reactions (such as sudden decrease in blood pressure or dizziness), or increased wheezing and shortness of breath. Additionally, as occurs with all inhaled medications, some patients may experience unexpected chest pressure, cough, wheezing, or immediate difficulty breathing after inhalation (bronchospasm).

If you experience any of these reactions, consult your doctor immediately.immediately.

Do not use Braltus again until you see or at least speak with your doctor. If you have wheezing and shortness of breath, use your rescue inhaler immediately.

Other side effects have been experienced by people who have used this medicine and are listed according to their frequency:

Frequent: may affect up to 1 in 10 people

- Dry mouth: this is generally mild

Rare: may affect up to 1 in 100 people

- Dizziness

- Headache

- Taste alterations

- Blurred vision

- Irregular heart rhythm (atrial fibrillation)

- Throat inflammation (pharyngitis)

- Hoarseness (dysphonia)

- Cough

- Heartburn (gastroesophageal reflux)

- Constipation

- Fungal infection in the oral cavity or throat (oropharyngeal candidiasis)

- Rash

- Difficulty urinating (urinary retention)

- Painful urination (dysuria)

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

- Difficulty sleeping (insomnia)

- Visual halos or colored images associated with eye redness (glaucoma)

- Increased eye pressure

- Irregular heart rhythm (supraventricular tachycardia)

- Increased heart rate (tachycardia)

- Palpitations

- Chest pressure, associated with cough, wheezing, or immediate difficulty breathing after inhalation (bronchospasm)

- Nasal bleeding (epistaxis)

- Laryngitis

- Sinusitis

- Intestinal obstruction or absence of intestinal movement (intestinal obstruction including paralytic ileus)

- Gingivitis

- Glossitis

- Difficulty swallowing (dysphagia)

- Stomatitis

- Nausea

- Hypersensitivity, including immediate reactions

- Severe allergic reaction causing swelling of the face and throat (angioedema)

- Urticaria

- Itching (pruritus)

- Urinary tract infection

Unknown: cannot be estimated from available data

- Dehydration

- Tooth decay

- Skin infections or ulcers

- Dry skin

- Joint swelling

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box and label of the bottleafter CAD or EXP. The expiration date is the last day of the month indicated.

Do not refrigerate or freeze.

Keep the bottle perfectly closed. Store in the original packaging to protect it from moisture.

Use this medication within 30 days (bottle of 15 capsules) or 60 days (bottle of 30 capsules) after opening the bottle.

The Zonda inhaler can only be used with the capsule bottle that can be provided in the same package along with the inhaler, or packaged in a separate box from the inhaler. Do not reuse the inhaler for another capsule bottle.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

The inhaler device should be disposed of in accordance with local requirements.

Composition of Braltus 10 micrograms/dose released powder for inhalation

• The active ingredient is tiotropium. Each capsule contains 13 micrograms of active ingredient tiotropium (as bromide of tiotropium). During inhalation, 10 micrograms of tiotropium are released from each capsule from the Zonda inhaler mouthpiece and inhaled into the lungs.

• The other components are lactose monohydrate (capsule content) and hydroxypropylmethylcellulose (capsule coating).

Appearance of the product and contents of the package

Braltus 10 micrograms/dose released powder for inhalation is a hard, colorless, and transparent capsule containing white powder.

This medicine is presented in bottles with screw-top caps. The bottle is presented in a box with the Zonda inhaler. The Zonda inhaler has a green body and a white top with a white button.

Braltus is available in the following packaging:

20 ml or 35 ml bottle with 15 capsules and a Zonda inhaler

35 ml bottle with 30 capsules and a Zonda inhaler

Multi-pack with 60 capsules (2 x 30 capsules) and 2 Zonda inhalers

Multi-pack with 90 capsules (3 x 30 capsules) and 3 Zonda inhalers

Packaged bottle: a bottle with 30 capsules (bottle) packaged with another bottle with 1 Zonda inhaler separately.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st Floor

Alcobendas, 28108 Madrid (Spain)

Responsible manufacturer

Laboratorios LICONSA S.A.

Avda. Miralcampo, No 7, Industrial Estate Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

or

Teva Pharma B.V.

Swensweg 5, 2031 GA Haarlem, Netherlands

or

Teva Operations Poland Sp.z.o.o.

Ul. Mogilska 80

31-546 Krakow, Poland

or

Actavis Ltd

BLB015, BLB016, Bulebel Industrial Estate, Zejtun, ZTN3000, Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria: Braltus 10 Mikrogramm pro abgegebener Dosis Kapseln mit Inhalationspulver

Bélgica: Braltus 10 micrograms Inhalatiepoeder in harde capsule/ Poudre pour inhalation en gélule/ Hartkapsel mit Pulver zur Inhalation

Bulgaria: Braltus 10 ?????????? ?? ????????? ???? ???? ?? ????????? , ?????? ???????

Chipre: Braltus 10 μικρογραμμ?ρια αν? χορηγο?μενη δ?ση , κ?νις για εισπνο? , καψ?κιο , σκληρ?

República Checa: Braltus 10 mikrogramu/dávka, prášek k inhalaci ve tvrdých tobolkách

Alemania: Bralt us 10 Mikrogramm Hartkapseln mit Pulver zur Inhalation

Dinamarca: Braltus

Estonia: Braltus

Grecia: Braltus 10 μικρογραμμ?ρια αν? χορηγο?μενη δ?ση , κ?νις για εισπνο? , καψ?κιο , σκληρ?

España: Braltus 10 microgramos/dosis liberada polvo para inhalación (cápsula dura)

Finlandia: Braltus 10 mikrog / vapautunut annos inhalaatiojauhe, kapseli, kova

Croacia: Braltus 10 mikrograma mikrograma po isporucenoj dozi, prašak inhalata, tvrde kapsule

Hungría: Braltus 10 mikrogramm adagolt inhalációs por kemény kapszu lában

Irlanda: Braltus 10 microgram per delivered dose inhalation powder, hard capsule

Italia: Tiotropio Teva Italia 10 microgrammi per dose erogata polvere per inalazione, capsula rigida

Lituania: Braltus 10 mikrogramu/dozeje ikvepiamieji milteliai (kietosios kapsules)

Luxemburgo: Braltus 10 Mikrogramm pro abgegebener Dosis Kapsel mit Inhalationspulver

Letonia: Braltus 10 mikrogrami sanemtaja deva, inhalacijas pulveris cietas kapsulas

Países Bajos: Tiotrus 10 microgram per afgegeven dosis inhalatie poeder in harde capsules

Noruega: Braltus

Polonia: Braltus

Portugal: Braltus

Rumanía: Gregal 10 micrograme pulbere de inhalat, capsula

Suecia: Braltus

Eslovenia: Braltus 10 mikrogramov na dovedeni odmerek, prašek za inhaliranje, trde kapsule

Eslovaquia: Braltus 10 mikrogramov

Reino Unido: Braltus 10 microgram per delivered dose inhalation powder, hard capsule

Last review date of this prospectus: August 2018

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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Instructions for use of Zonda

Dear patient,

The Zonda inhaler allows you to inhale the medicine contained in the Braltus capsule that your doctor has prescribed for your respiratory problems.

Remember to follow your doctor's instructions carefully to use Braltus. The Zonda inhaler is specifically designed for Braltus capsules, so do not use it for any other medicine.

The capsules should only be inhaled using the Zonda inhaler. Do not use other inhalers to administer Braltus capsules. Each capsule contains only a small amount of powder.

Do not open the capsule or it may not work.

The Zonda inhaler should be used with the bottle of capsules that will be provided in the same package, or in a separate package and packaged with another package with the inhaler. Do not reuse the inhaler for any other bottle of capsules. Dispose of the Zonda device after 15 uses (if you have used the 15-capsule bottle) or 30 uses (if you have used the 30-capsule bottle).

Zonda

1. Protective cap

2. Mouthpiece

3. Base

4. Piercing button

5. Central chamber

1. Pull the protective cap upwards

2. Keep the base of the inhaler firmly in place. After opening the mouthpiece, lift it upwards in the direction of the arrow.

3. Remove a Braltus capsule from the bottle immediately before use and close the bottle perfectly. Place a capsule in the central chamber at the base of the inhaler. Do not store the capsule in the Zonda inhaler.

4. To avoid the risk of asphyxiation, NEVER place a capsule directly inside the mouthpiece .

5. Close the mouthpiece firmly until you hear a click, leaving the protective cap open.

6. Hold the inhaler with the mouthpiece upwards, press the piercing button firmly once and release it. This action pierces the capsule and allows the medicine to be released when you inhale.

7. Breathe out fully. Important: do not breathe out into the mouthpiece.

8. Hold the inhaler to your mouth and keep your head in a straight position. Close your lips tightly around the mouthpiece and inhale slowly and deeply but enough to hear or feel the capsule vibrating inside the central chamber. Hold your breath for as long as you feel comfortable while removing the inhaler from your mouth. Continue breathing normally. Repeat steps 7 and 8 once more; this will empty the capsule completely.

9. After use, open the mouthpiece again and discard the empty capsule. Close the mouthpiece and protective cap to store the Zonda inhaler.

The Zonda inhaler is a Medical Device (CE)

Manufacturer:

Laboratorios LICONSA S.A.

Avda. Miralcampo, No 7, Industrial Estate Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

0051