Braltus

Patient Information Leaflet

Braltus, 10 micrograms per delivered dose, inhalation powder in hard capsules
Tiotropium
Please read all of this leaflet carefully before you start using this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Braltus is and what it is used for
2. What you need to know before you use 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 better. COPD is a chronic lung disease that causes breathlessness and cough. The term COPD refers to chronic bronchitis and emphysema.
COPD is a chronic condition, so the medicine must be taken every day, not only when breathing problems or other COPD symptoms occur.
Braltus is a long-acting bronchodilator medicine that helps to open up the airways and makes it easier for air to flow in and out of the lungs. Regular use of this medicine may also help reduce persistent breathlessness caused by the disease and help lessen the impact of the disease on daily life. The medicine helps maintain physical activity for longer. Daily use of Braltus also helps prevent sudden, short-term worsening of COPD symptoms, which may last for several days. The effect of the medicine lasts for 24 hours, so it should be taken only once daily.
Braltus must not be used as a rescue medicine to relieve sudden chest tightness, cough, or sudden attacks of breathlessness or wheezing. In such cases, a fast-acting reliever inhaler, such as salbutamol, should be used. You should always carry a fast-acting reliever inhaler with you.

2. Important information before using Braltus

When not to use Braltus:

• if the patient is allergic (hypersensitive) to tiotropium or any of the other ingredients of this medicine (listed in section 6)
• if the patient is allergic (hypersensitive) to atropine or its derivatives, such as ipratropium or oxitropium
• if the patient is allergic (hypersensitive) to lactose or other sugars

Warnings and precautions
Before starting treatment with Braltus, discuss with your doctor, pharmacist or nurse if:

• the patient is taking other medicines containing ipratropium or oxitropium
• the patient has narrow-angle glaucoma, prostate problems or difficulty passing urine
• the patient has any kidney problems
• the patient has suffered a heart attack, experienced heart rhythm disorders or life-threatening irregular heartbeat within the last 6 months, or severe heart failure within the last year. Braltus is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD). This medicine should not be used to treat sudden episodes of breathlessness or wheezing.

Immediate allergic reactions such as rash, swelling, itching, wheezing and shortness of breath may occur during treatment with Braltus. In such cases, immediately contact a doctor (see section 4).
Inhaled medicines such as Braltus may cause chest tightness, cough, wheezing or shortness of breath (bronchospasm) immediately after use. In such cases, a fast-acting rescue inhaled medicine (e.g. salbutamol) should be used immediately. If any of these symptoms occur, stop using Braltus and promptly contact your doctor.
Do not allow the inhaled powder to enter the eyes, as this may cause tearing or trigger or worsen symptoms of narrow-angle glaucoma, an eye condition.
Eye pain or discomfort, blurred vision, seeing halos around lights or changes in colour vision, together with redness of the eyes, may be signs of acute narrow-angle glaucoma. These eye symptoms may be accompanied by headache, nausea and vomiting. If symptoms of narrow-angle glaucoma occur, stop using this medicine and contact a doctor immediately, preferably an ophthalmologist.
The medicine contained in the inhaler may reduce saliva production in the mouth and cause dry mouth. Over time, this may increase the risk of dental caries. Therefore, it is important to maintain good oral hygiene, rinse the mouth and brush teeth regularly.
If the patient has suffered a heart attack, experienced heart rhythm disorders or life-threatening irregular heartbeat within the last 6 months, or severe heart failure within the last year, inform the doctor. This will allow the doctor to determine whether Braltus is appropriate treatment for the patient.
This medicine must not be used more than once daily (see section 3).
Children and adolescents
Braltus must not be used in children and adolescents under 18 years of age.
Other medicines and Braltus
Inform your doctor or pharmacist about all medicines currently or recently taken, including inhaled medicines and those available without prescription.
Inform your doctor or pharmacist if you are currently taking or have previously taken other medicines for lung disease, such as ipratropium or oxitropium.
No specific adverse interactions have been reported when this medicine is used together with other medicines used in the treatment of COPD, such as: rescue inhaled medicines (e.g. salbutamol), methylxanthines (e.g. theophylline) and/or oral or inhaled corticosteroids (e.g. prednisolone).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine. This medicine should not be used unless specifically recommended by a doctor.
Driving and using machines
Dizziness, blurred vision or headache may affect the ability to drive or operate machinery.
Braltus contains lactose
Lactose is a type of sugar found in milk. If the patient has previously been diagnosed with an allergy to certain sugars, the patient should consult a doctor before taking this medicine. Lactose may contain small amounts of milk proteins, which may cause allergic reactions in people with severe hypersensitivity or allergy to milk proteins. When used according to the recommended dose of one capsule once daily, each dose delivers up to 18 mg of monohydrate lactose.

3. How to use Braltus

This medicine should always be used exactly as directed by the physician. In case of doubt, consult a
physician or pharmacist.
It is recommended to inhale the contents of one capsule once daily using the Zonda inhaler. One capsule
provides the required daily dose of tiotropium (delivered dose 10 micrograms of tiotropium); do not
use a higher dose than recommended.
It is advisable to use the medicine at the same time each day. This is important because the medicine works
for 24 hours.
The capsules must only be used by inhalation. Do not use orally.
Do not swallow the capsules.
The Zonda inhaler, into which the Braltus capsule must be inserted, pierces the capsule and allows the powder to be inhaled.
The capsules must only be administered using the Zonda inhaler. Do not use any other devices for administering Braltus capsules.
Ensure that the patient is able to use the Zonda inhaler correctly. Instructions for using the Zonda inhaler are provided on the reverse side of the leaflet. Follow the instructions precisely.
Illustrations showing the correct placement of the capsule in the inhaler are also available on the inside of the box flap. To avoid the risk of choking, NEVER insert the capsule directly into the mouthpiece.
If any difficulties arise when using the Zonda inhaler, ask the physician, pharmacist, or nurse for assistance.
If necessary, the mouthpiece of the Zonda inhaler may be wiped with a dry piece of cloth or tissue.
Do not exhale into the Zonda inhaler. When using Braltus, take care not to get the powder into the eyes, as this may cause blurred vision, eye pain, and/or eye redness; immediately rinse the eyes with warm water and promptly consult a physician for further advice.
If breathing difficulties worsen, contact the physician as quickly as possible.

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

Use of a higher than recommended dose of Braltus
If the contents of more than one Braltus capsule have been inhaled in one day, contact a physician immediately.
The risk of adverse effects such as dry mouth, constipation, difficulty in urination, rapid heartbeat, or blurred vision may increase in the patient.

Missed dose of Braltus
If a dose has been missed, take it as soon as possible, but never do not take two doses at the same time or on the same day. Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Braltus treatment
Before stopping Braltus, consult a physician or pharmacist. After discontinuation, symptoms of COPD may worsen.
If there are any further doubts regarding the use of this medicine, consult a physician, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
After administration of the medicine, severe allergic reactions such as swelling of the face or throat (angioedema) or other hypersensitivity reactions (such as sudden drop in blood pressure or dizziness), or wheezing or shortness of breath may occur either alone or as part of a severe allergic reaction (anaphylactic reaction). Such serious adverse effects are rare. Additionally, as with other inhaled medicines, immediately after inhalation some patients may experience sudden chest tightness, cough, wheezing or shortness of breath (so-called bronchospasm).
If any of these symptoms occur, you must contact your doctor immediately.
You should consult your doctor before using Braltus again. If wheezing or shortness of breath occurs, a fast-acting inhaled bronchodilator should be used.

Other adverse effects reported by people using this medicine are listed below, classified by frequency of occurrence.
Common: may affect up to 1 in 10 people

• dryness of the oral mucosa (usually mild)

Uncommon: may affect up to 1 in 100 people

• dizziness
• headache
• taste disturbances
• blurred vision
• irregular heartbeat (atrial fibrillation)
• pharyngitis (inflammation of the throat)
• hoarseness (dysphonia)
• cough
• gastroesophageal reflux disease, including heartburn
• constipation
• fungal infections of the mouth and throat (oral and pharyngeal candidiasis)
• rash
• difficulty in urination (urinary retention)
• painful or difficult urination

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

• difficulty sleeping (insomnia)
• seeing rainbow-colored halos around lights or altered color vision, together with redness of the eyes (glaucoma)
• increased intraocular pressure
• irregular heartbeat (supraventricular tachycardia)
• increased heart rate (tachycardia)
• palpitations
• chest tightness associated with cough, wheezing or shortness of breath occurring immediately after inhaling the medicine (bronchospasm)
• nosebleeds
• laryngitis
• sinusitis
• intestinal atony or absence of intestinal peristalsis (intestinal obstruction, including paralytic ileus)
• gingivitis
• glossitis
• difficulty swallowing (dysphagia)
• stomatitis
• nausea
• urticaria
• itching
• urinary tract infection

Frequency cannot be estimated from the available data:

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Braltus

Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the cardboard box and on the label of the bottle following EXP. The expiry date refers to the last day of the stated month.
Do not store in the refrigerator or freeze.
Keep the bottle tightly closed. Store in the original packaging to protect from moisture.
Shelf-life after first opening of the bottle: 30 days (bottles containing 15 capsules) or 60 days (bottles containing 30 capsules).
The Zonda inhaler should only be used with capsules from the bottle supplied in the same package as the inhaler, or from the bottle supplied in the package attached to the inhaler package.
Do not reuse the inhaler for a second bottle of capsules.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.
Dispose of the inhaler according to local regulations.

6. Contents of the pack and other information

What Braltus contains

• The active substance is tiotropium. Each capsule contains 13 micrograms of the active substance tiotropium (as bromide). During inhalation, each capsule delivers 10 micrograms of tiotropium through the mouthpiece of the Zonda inhaler, which is then inhaled by the patient into the lungs.
• Other ingredients are: lactose monohydrate (contents of the capsule) and hypromellose (capsule shell)

What Braltus looks like and contents of the pack
Braltus 10 micrograms/delivered dose, inhalation powder in hard capsule, is a colourless and
transparent hard capsule containing a white powder.
The medicine is supplied in a bottle with a screw cap. The bottle, together with the Zonda inhaler, is packed in
a cardboard box. The Zonda inhaler has a green body and a cap with a white button.
Braltus is available in packs containing 15 or 30 capsules and one Zonda inhaler, and in multipacks containing 60 capsules (2 packs of 30) and 2 Zonda inhalers, or 90 capsules (3 packs of 30) and 3 Zonda inhalers.
Pack: 15 or 30 capsules (bottle) in a box with 1 Zonda inhaler packed in a separate box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53,
00-113 Warsaw
tel.: (22) 345 93 00

Manufacturer:
Laboratorios LICONSA S.A
Avda. Miralcampo No 7, Polígono Industrial Miralcampo
Azuqueca de Henares
19200, Guadalajara
Spain
Actavis Ltd
BLB015, BLB016, Bulebel Industrial Estate,
Zejtun, ZTN3000,
Malta
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland

This medicinal product is authorised in the European Economic Area countries 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 прах за инхалация, твърда капсула
Croatia - Braltus 10 mikrograma po isporučenoj dozi, prašak inhalata, tvrde kapsule
Cyprus - Braltus 10 μικρογραμμάρια ανά χορηγούμενη δόση, κόνις για εισπνοή, καψάκιο, σκληρό
Czech Republic - Braltus 10 mikrogramů/dávka, prášek k inhalaci ve tvrdých tobolkách
Denmark - Braltus
Finland - Braltus 10 mikrog / vapautunut annos inhalaatiojauhe, kapseli, kova
Germany - Braltus 10 Mikrogramm Hartkapseln mit Pulver zur Inhalation
Greece - Braltus 10 μικρογραμμάρια ανά χορηγούμενη δόση, κόνις για εισπνοή, καψάκιο, σκληρό
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 - Braltus 10 microgram per afgegeven dosis inhalatiepoeder in harde capsules
Norway - Braltus
Poland - Braltus
Portugal - Braltus
Romania - Braltus 10 micrograme pulbere de inhalat, capsula
Slovakia - Braltus 10 mikrogramov
Spain - Braltus 10 microgramos/dosis liberada polvo para inhalación
Sweden - Braltus
United Kingdom - Braltus 10 microgram per delivered dose inhalation powder, hard capsule

Reverse side of the leaflet:
Instructions for using the Zonda inhaler

Dear Patient,

The Zonda inhaler allows administration of the medicine contained in Braltus capsules, prescribed by your doctor for breathing problems.

Please follow your doctor's instructions carefully when using Braltus.

The Zonda inhaler is designed exclusively for Braltus capsules; it must not be used to administer any other medicines. Braltus capsules must only be taken using the Zonda inhaler. Do not use any other inhaler to administer Braltus capsules. Each capsule contains a small amount of powder. Do not open the capsule, as this may cause the inhaler to malfunction.

The Zonda inhaler should only be used with capsules from the bottle supplied in the same pack as the inhaler, or from a bottle supplied in a pack connected to the inhaler pack. Do not reuse the inhaler for a second bottle of capsules. The Zonda inhaler should be discarded after all the supplied capsules have been used.

Zonda

1. Dust-protecting cap

2. Mouthpiece

3. Body

4. Piercing button

5. Central chamber

6. Open the dust-protecting cap by lifting it upwards.

7. Hold the inhaler body and open the mouthpiece by lifting it upwards, in the direction of the arrow.

3. Immediately before use, remove one Braltus capsule from the bottle and close the bottle tightly. Place one capsule into the central chamber of the inhaler body. Do not store the capsule in the Zonda inhaler.

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

5. Close the mouthpiece until it clicks, leaving the dust-protecting cap open.

6. Holding the inhaler with the mouthpiece pointing upwards, press the piercing button fully down once, then release it. The capsule will be pierced and the medicine will be ready for the patient to inhale.

7. Breathe out deeply. It is important to do this away from the mouthpiece. Never breathe out through the mouthpiece.

8. Place the inhaler mouthpiece in your mouth and keep your head in an upright position. Close your lips around the mouthpiece and inhale slowly and deeply, so that you can hear or feel the capsule vibrating inside the central chamber. Then hold your breath as long as possible, while removing the inhaler from your mouth. Resume normal breathing. To completely empty the capsule, repeat the steps described in points 7 and 8.

9. After use, open the mouthpiece again and remove the used capsule. Close the mouthpiece and the dust-protecting cap, and put away 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