Braltus 10 micrograms/dose released powder for inhalation (hard capsule)

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Braltus 10 micrograms/dose delivered powder for inhalation (hard capsule)

tiotropio

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Braltus is and what it is used for

Braltus contains the active substance 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 condition, you must use this medicine every day, not only when you have breathing problems or other COPD symptoms.

Braltus is a long-acting bronchodilator that helps open the airways and makes it easier to breathe in and out. Regular use of this medicine can also help when you have ongoing breathing difficulties due to your disease, and it will help minimize the impact of the disease on your daily life. It also helps you stay active for longer. Daily use of this medicine will also help prevent sudden, short-term worsening symptoms of your COPD, which may last for several days. The effect of this medicine lasts for 24 hours; therefore, you only need to take it once a day.

This medicine must not be used as a rescue therapy to treat sudden chest tightness, cough, wheezing, or shortness of breath. Please use a fast-acting (rescue) inhaler, such as salbutamol. Always carry this rescue inhaler with you.

2. What you need to know before using Braltus

Do not use Braltus:

• 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 medicines similar to it, such as ipratropium or oxitropium
• if you are allergic to lactose or other sugars

Warnings and precautions

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

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

Braltus is indicated for the maintenance treatment of your chronic obstructive pulmonary disease (COPD); it should not be used to treat a sudden episode of breathlessness or wheezing (wheezing).

Immediately after administration, immediate allergic reactions such as rash, swelling, itching, wheezing, or difficulty breathing may occur. If this happens, please consult your doctor immediately.

Inhaled medicines such as Braltus may cause chest tightness, cough, wheezing, or shortness of breath immediately after inhalation. If this occurs, use a fast-acting (rescue) inhaler immediately, such as salbutamol. If these symptoms occur, stop using Braltus and consult your doctor immediately.

Be careful to avoid letting the inhaled powder enter your eyes, as this may cause watery eyes and could trigger or worsen narrow-angle glaucoma, an eye condition. Eye pain or discomfort, blurred vision, halos around lights, or colored images associated with eye redness may be signs of an acute episode of narrow-angle glaucoma. Eye symptoms may be accompanied by headache, nausea, or vomiting. You must stop using this medicine and consult your doctor immediately, preferably an ophthalmologist, if signs or symptoms of narrow-angle glaucoma appear.

Inhaled medicines may reduce normal saliva production in your mouth and cause dry mouth. Long-term dry mouth may be associated with dental caries. Therefore, remember to maintain good oral hygiene, rinse your mouth, and brush your teeth regularly.

If you have had a myocardial infarction (heart attack) within the last 6 months, unstable or life-threatening irregular heartbeats, or severe heart failure in the past year, inform your doctor. This is important in deciding whether Braltus is the appropriate medicine for you.

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

Children and adolescents

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

Using Braltus with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including other inhalers and medicines obtained without a prescription.

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. You should not use this medicine unless specifically advised by your doctor.

Driving and using machines

Dizziness, blurred vision, or headache may affect your ability to drive or 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 him before using this medicine. It may cause allergic reactions in patients allergic to cow's milk protein.

When administered at the recommended dose—one capsule once daily—each dose provides up to 18 mg of lactose monohydrate.

3. How to use Braltus

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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 (released dose of 10 micrograms of tiotropium). Do not exceed the recommended dose.

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

Make sure you know how to use the Zonda inhaler correctly. Instructions for using the inhaler are provided at the back of this leaflet. Remember to carefully follow these instructions. Additional images showing the correct placement of the capsule in the inhaler are also provided inside the cap of the packaging. To avoid the risk of choking, NEVER place a capsule directly into the mouthpiece. If you have any difficulty using the Zonda inhaler, ask your doctor, nurse, or pharmacist to show you how it works.

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

Make sure you do not blow into the Zonda inhaler. When using Braltus, be careful not to let the powder enter your eyes. If powder gets into your eyes, it may cause blurred vision, eye pain and/or eye redness. You should rinse your eyes immediately with lukewarm water. Consult your doctor immediately for further advice.

If you notice 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 of age.

If you use more Braltus than you should

If you inhale more than 1 Braltus capsule in one day, you must speak to your doctor immediately. You may have an increased risk of experiencing an adverse reaction such as dry mouth, constipation, difficulty urinating, increased heart rate, or blurred vision.

If you forget to use Braltus

If you have forgotten 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. Then take your next dose as usual. Do not take a double dose to make up for a missed dose.

If you stop using Braltus

Before stopping treatment with Braltus, you should speak to your doctor or pharmacist. If you stop using this medicine, your COPD signs and symptoms may worsen.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

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

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

Do not use Braltus again until you have seen or at least spoken to your doctor. If you experience wheezing and shortness of breath, use your fast-acting (rescue) inhaler immediately.

Other adverse effects have been reported by people who have used this medicine and are listed below according to their frequency:

Frequent: may affect up to 1 in 10 people

• Dry mouth: this is usually mild

Uncommon: may affect up to 1 in 100 people

• dizziness
• headache
• taste disturbances
• blurred vision
• irregular heartbeat (atrial fibrillation)
• throat inflammation (pharyngitis)
• hoarseness (dysphonia)
• cough
• heartburn (gastroesophageal reflux)
• constipation
• fungal infection in the mouth or throat (oropharyngeal candidiasis)
• rash
• difficulty urinating (urinary retention)
• pain when urinating (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 intraocular pressure
• irregular heartbeat (supraventricular tachycardia)
• increased heart rate (tachycardia)
• palpitations
• chest tightness, associated with cough, wheezing, or difficulty breathing immediately after inhalation (bronchospasm)
• nosebleeds (epistaxis)
• inflammation of the larynx (laryngitis)
• inflammation of the paranasal sinuses (sinusitis)
• intestinal blockage or absence of intestinal movement (intestinal obstruction including paralytic ileus)
• gum inflammation (gingivitis)
• inflammation of the tongue (glossitis)
• difficulty swallowing (dysphagia)
• inflammation of the mouth (stomatitis)
• sensation of dizziness (nausea)
• hypersensitivity, including immediate reactions
• severe allergic reaction causing swelling of the face and throat (angioedema)
• urticaria
• itching (pruritus)
• urinary tract infection

Not known: cannot be estimated from available data

• loss of body water (dehydration)
• dental caries
• skin infections or ulcerations
• dry skin
• joint swelling

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Braltus

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 label of the bottle after CAD or EXP. The expiry date refers to the last day of the month indicated.

Do not refrigerate or freeze.

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

Use this medicine within 30 days (15-capsule bottle) or 60 days (30-capsule bottle) after opening the bottle.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

The inhalation device should be disposed of according to local requirements.

6. Contents of the pack and other information

Composition of Braltus 10 micrograms per delivered dose powder for inhalation

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

• The other components are lactose monohydrate (capsule contents) and hypromellose (capsule shell).

Appearance of the product and contents of the pack

Braltus 10 micrograms per delivered dose powder for inhalation is a colourless, transparent hard capsule containing white powder.

This medicine is supplied in bottles with screw caps. The bottle is supplied in a carton with the Zonda inhaler. The Zonda inhaler has a green body and cap with a white button.

Braltus is available in the following pack sizes:

• 20 ml or 35 ml bottle containing 15 capsules and one Zonda inhaler
• 35 ml bottle containing 30 capsules and one Zonda inhaler
• Multipack containing 60 capsules (2 packs of 30 capsules) and 2 Zonda inhalers
• Multipack containing 90 capsules (3 packs of 30 capsules) and 3 Zonda inhalers
• Packaged pack: pack with 30 capsules (bottle) packaged separately with another pack containing 1 Zonda inhaler.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.
C/Anabel Segura, 11 Edificio Albatros B, 1st Floor
Alcobendas, 28108 Madrid (Spain)

Manufacturer

Laboratorios LICONSA S.A.
Avda. Miralcampo, No 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara
Spain

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 medicinal product is authorised in the Member States of the European Economic Area under the following names:

Austria: Braltus 10 Mikrogramm pro abgegebener Dosis Kapseln mit Inhalationspulver
Belgium: Braltus 10 micrograms Inhalatiepoeder in harde capsule / Poudre pour inhalation en gélule / Hartkapsel mit Pulver zur Inhalation
Bulgaria: Braltus 10 микрограма на доставена доза, прах за инхалация, твърда капсула
Cyprus: Braltus 10 μικρογραμμάρια ανά χορηγούμενη δόση, κόνις για εισπνοή, καψούλιο, σκληρό
Czech Republic: Braltus 10 mikrogramu/dávka, prášek k inhalaci ve tvrdých tobolkách
Germany: Braltus 10 Mikrogramm Hartkapseln mit Pulver zur Inhalation
Denmark: Braltus
Greece: Braltus 10 μικρογραμμάρια ανά χορηγούμενη δόση, κόνις για εισπνοή, καψούλιο, σκληρό
Spain: Braltus 10 microgramos/dosis liberada polvo para inhalación (cápsula dura)
Finland: Braltus 10 mikrog / vapautunut annos inhalaatiojauhe, kapseli, kova
Croatia: Braltus 10 mikrograma po isporucenoj dozi, prah inhalata, tvrde kapsule
Hungary: Braltus 10 mikrogramm adagolt inhalációs por kemény kapszulában
Ireland: Braltus 10 microgram per delivered dose inhalation powder, hard capsule
Italy: Tiotropio Teva Italia 10 microgrammi per dose erogata polvere per inalazione, capsula rigida
Luxembourg: Braltus 10 Mikrogramm pro abgegebener Dosis Kapsel mit Inhalationspulver
Netherlands: Tiotrus 10 microgram per afgegeven dosis inhalatiepoeder in harde capsules
Norway: Braltus
Poland: Braltus
Portugal: Braltus
Romania: Gregal 10 micrograme pulbere de inhalat, capsula
Sweden: Braltus
Slovakia: Braltus 10 mikrogramov
United Kingdom: Braltus 10 microgram per delivered dose inhalation powder, hard capsule

Date of the most recent revision of this leaflet: August 2018

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (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 prescribed by your doctor for your respiratory condition.

Remember to follow your doctor's instructions carefully when using Braltus. The Zonda inhaler is specifically designed for Braltus capsules and must not be used with any other medicine.

The capsules must 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, as it may not work properly.

The Zonda inhaler should be used only with the bottle of capsules supplied in the same pack or in a separate pack packaged together with the inhaler. Do not reuse the inhaler with any other bottle of capsules. Dispose of the Zonda device once all the supplied capsules have been used.

Zonda

1. Protective cap

2. Mouthpiece

3. Base

4. Piercing button

5. Central chamber

6. Pull the protective cap upwards.

1. Hold the base of the inhaler firmly. Open the mouthpiece by lifting it upwards in the direction of the arrow.

1. Remove one Braltus 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.

1. To avoid the risk of choking, NEVER place a capsule directly into the mouthpiece.

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

1. Hold the inhaler with the mouthpiece pointing upwards. Press the piercing button fully down once and release it. This action pierces the capsule and allows the medicine to be released when you inhale.

1. Breathe out fully. Important: Never breathe out into the mouthpiece.

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

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

The Zonda inhaler is a Medical Device (CE)

Manufacturer:

Laboratorios LICONSA S.A.
Avda. Miralcampo, No 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara
Spain

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