What you need to know before you take it

e NEVER place a capsule directly into the Braltus mouthpiece. If you have any problems using Do not use Braltus: the Zonda inhaler, ask your doctor, pharmacist

• if you are allergic (hypersensitive) to or nurse to show you how it works. tiotropium or any of the other ingredients If necessary, you may wipe the mouthpiece of of this medicine (listed in section 6) your Zonda inhaler after use with a dry cloth
• if you are allergic (hypersensitive) to atropine or tissue. or substances related to it, e.g. ipratropium Make sure you do not blow into the Zonda or oxitropium
• if you are allergic (hypersensitive) to lactose inhaler. When using Braltus, take care not to let any of the powder enter your eyes. If any or any other sugars powder does get into your eyes, you may get Warnings and precautions blurred vision, eye pain and/or red eyes; you Talk to your doctor, pharmacist or nurse before should wash your eyes in warm water using Braltus: immediately. Then talk to your doctor
• if you are taking any other medicinal products immediately for further advice. containing ipratropium or oxitropium If you feel that your breathing is worsening, you
• if you are suffering from narrow angle should tell your doctor as soon as possible. glaucoma, prostate problems or have difficulty passing urine Use in children and adolescents
• if you have any kidney problems Braltus should not be used in children and
• if you have suffered from a heart attack adolescents under the age of 18 years. (myocardial infarction) during the last 6 If you use more Braltus than you should months, or from any unstable or If you inhale the contents of more than 1 life-threatening irregular heart beat or severe capsule of Braltus in a day, you should talk to heart failure in the past year. your doctor immediately. You may be at a Braltus is indicated for maintenance treatment higher risk of experiencing side effects such as of your chronic obstructive pulmonary disease; dry mouth, constipation, difficulties passing it should not be used to treat a sudden attack urine, increased heart beat, or blurred vision. of breathlessness or wheezing. If you forget to use Braltus Immediate allergic reactions such as rash, If you forget to administer a dose, do this as swelling, itching, wheezing or breathlessness soon as you remember, but do not administer may occur after administration of Braltus. If this two doses at the same time or on the same occurs, please consult your doctor day. Then administer your next dose as usual. immediately (see section 4). Do not administer a double dose to make up Inhaled medicines such as Braltus may cause for a forgotten dose. tightness of the chest, coughing, wheezing or If you stop using Braltus breathlessness (bronchospasm) immediately Before you stop using Braltus, you should talk after inhalation. In such instances you should to your doctor or pharmacist. If you stop using immediately use a fast-acting 'reliever' inhaler, this medicine, the signs and symptoms of such as salbutamol. If these symptoms occur COPD may get worse. stop using Braltus inhaler and please consult If you have any further questions on the use of your doctor immediately. this medicine, ask your doctor, pharmacist or Take care not to let the inhalation powder nurse. enter your eyes as this may result in watering 4. Possible side effects eyes or it may cause narrow-angle glaucoma Like all medicines, this medicine can cause side or may worsen this condition. Narrow-angle effects, although not everybody gets them. glaucoma is a disease of the eyes. Eye pain or discomfort, blurred vision, seeing halos around Serious side effects including allergic reactions lights or coloured images in association with which cause swelling of the face or throat red eyes may be signs of an acute attack of (angioedema) or other hypersensitivity reactions narrow-angle glaucoma. Eye symptoms may be (such as sudden reduction of your blood accompanied by headache, nausea or pressure or dizziness) or increased wheezing and vomiting. You should stop using this medicine shortness of breath may occur individually or and immediately consult your doctor, as part of severe allergic reaction (anaphylactic preferably an eye specialist, when signs and reaction) after using this medicine. Such serious symptoms of narrow-angle glaucoma appear. side effects are rare. In addition, in common The medicine in your inhaler may decrease the with all inhaled medicines, some patients may experience unexpected tightness of the chest, normal secretions (saliva) in your mouth and make your mouth feel dry. Long-term this may coughing, wheezing or breathlessness be associated with dental caries (tooth decay). immediately after inhalation (known as bronchospasm). Therefore, please remember to pay attention If any of these side effects occur, please to oral hygiene, rinse your mouth out and consult your doctor immediately. brush your teeth regularly. Do not use your Braltus, inhaler again until you If you have suffered from a heart attack (myocardial infarction) during the last 6 months, have seen or at least spoken with, your doctor. If you are wheezy and short of breath you or from any unstable or life-threatening irregular heart beat or severe heart failure in the should use your fast-acting 'reliever' (rescue) inhaler straightaway. past year, please inform your doctor. This is Other side effects have been experienced by important so that the doctor can decide people using this medicine, and they are listed whether or not Braltus is the right treatment below according to their frequency. for you to use. Common: may affect up to 1 in 10 people Do not use this medicine more than once
• Dry mouth: this is usually mild daily (see section 3). Uncommon: may affect up to 1 in 100 people Children and adolescents
• Dizziness Braltus should not be used in children and
• Headache adolescents under the age of 18 years.
• Taste disorders

Printed by Andy Lau, 14 Oct 2025 13:51:07 (UTC +01:00)

page 1 of 3 pages

250208_s2 P Tiotropium (BRALTUS) UK Inha Caps 10mcg 30 CHEM_V4.pdf, Cycle:4, Status:Null

• Blurred vision
• Irregular heart beat (atrial fibrillation)
• Sore throat (pharyngitis)
• Hoarseness (dysphonia)
• Cough
• Heart burn (gastrooesophageal reflux disease)
• Constipation
• Fungal infections of the mouth and throat (oropharyngeal candidiasis)
• Rash
• Difficulty passing urine (urinary retention)
• Painful urination (dysuria) Rare: may affect up to 1 in 1,000 people
• Difficulty in sleeping (insomnia)
• Seeing halos around lights or coloured images in association with red eyes (glaucoma)
• Increase of the measured eye pressure
• Irregular heart beat (supraventricular tachycardia)
• Faster heart beat (tachycardia)
• Feeling your heart beat (palpitations)
• Tightness of the chest, associated with coughing, wheezing or breathlessness immediately after inhalation (bronchospasm)
• Nosebleed (epistaxis)
• Inflammation of the larynx (laryngitis)
• Inflammation of the sinuses (sinusitis)
• Blockage of intestines or absence of bowel movements (intestinal obstruction including ileus paralytic)
• Inflammation of the gums (gingivitis)
• Inflammation of the tongue (glossitis)
• Difficulties swallowing (dysphagia)
• Inflammation of the mouth (stomatitis)
• Feeling sick (nausea)
• Nettle rash (urticaria)
• Itching (pruritus)
• Infections of the urinary tract Frequency cannot be estimated from the available data:
• Depletion of body water (dehydration)
• Tooth decay (dental caries)
• Infections or ulcerations of the skin
• Dryness of the skin
• Swelling of joints Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

How to take it

Braltus Braltus contains the active substance tiotropium. Always use this medicine exactly as your doctor Tiotropium helps people who have chronic obstructive pulmonary disease (COPD) to breathe has told you. Check with your doctor or more easily. COPD is a chronic lung disease that pharmacist if you are not sure. causes shortness of breath and coughing. The The recommended dose is to inhale the term COPD is associated with the conditions contents of one capsule once daily with the chronic bronchitis and emphysema. As COPD is Zonda inhaler. One capsule provides the a chronic disease you should use this medicine required daily dose of tiotropium (a delivered every day and not only when you have breathing dose of 10 micrograms of tiotropium); do not problems or other symptoms of COPD. use more than the recommended dose. Braltus is a long-acting bronchodilator that You should try to use this medicine at the same helps to open your airways and makes it easier time every day. This is important because this to get air in and out of the lungs. Regular use medicine is effective over 24 hours. of this medicine can also help you when you The capsules are only for inhalation and not have on-going shortness of breath related to for oral intake. your disease and will help you to minimise the Do not swallow the capsules. effects of the disease on your everyday life. It also helps you to be active longer. Daily use of The Zonda inhaler, which you should put the this medicine will also help to prevent sudden, Braltus capsule into, makes holes in the short-term worsening of your COPD symptoms capsule and allows you to breathe in the powder. The capsules must only be inhaled which may last for several days. The effect of using the Zonda inhaler. Do not use any other this medicine lasts for 24 hours, so you only inhalers to administer Braltus capsules. need to use it once a day. Make sure you know how to use the Zonda This medicine should not be used as a rescue inhaler properly. The instructions for use of the therapy for the treatment of unexpected Zonda inhaler are provided on the other side tightness of the chest, coughing or sudden of this leaflet. Remember to carefully follow attacks of breathlessness or wheezing. Please use a fast-acting 'reliever' (rescue) inhaler, such these instructions for use. Pictures for the correct insertion of the capsule into the as salbutamol instead. Please keep this inhaler are also provided on the inside of the 'reliever' inhaler with you at all times. lid of the carton. To avoid the risk of choking

Possible side effects

not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

Braltus 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 carton and the bottle label after EXP. The expiry date refers to the last day of that month.

Do not refrigerate or freeze. Keep the bottle tightly closed. Store in the original packaging to protect from moisture. Use the product within 30 days (15 capsule bottle) or 60 days (30 capsule bottle) of opening the bottle. The Zonda inhaler should only be used with the bottle of capsules that will either be provided in the same pack as the inhaler, or in the pack bundled separately with the inhaler pack. Do not reuse the inhaler for another bottle of capsules. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. The inhaler device should be disposed of in accordance with local requirements.

Contents of the pack and other information

What Braltus contains

• The active substance is tiotropium. Each capsule contains 13 micrograms of the active ingredient tiotropium (as bromide). During inhalation, 10 micrograms of tiotropium are delivered to the patient from each capsule from the mouthpiece of the Zonda inhaler and are inhaled into the lungs.
• The other ingredients are lactose monohydrate (capsule content) and Hypromellose (capsule shell). What Braltus looks like and contents of the pack Braltus 10 microgram per delivered dose inhalation powder, hard capsule is a colourless and transparent hard capsule, containing white powder. This medicine is provided in bottles, with a screw-cap closure. The bottle is supplied in a carton with a Zonda inhaler. The Zonda Inhaler has a green body and cap with a white push button. Braltus is available in packs containing either 15 or 30 capsules and a Zonda inhaler, and in multipacks containing either 60 capsules (2 packs of 30) and 2 Zonda inhalers or 90 capsules (3 packs of 30) and 3 Zonda inhalers. Bundle pack: 30 capsules (bottle) in a pack bundled with 1 Zonda inhaler packed in a separate pack. Not all pack sizes may be marketed. Marketing Authorisation Holder: Teva UK Limited, Ridings Point, Whistler Drive, Castleford, WF10 5HX, United Kingdom Manufacturer: Laboratorios LICONSA S.A. Avda. Miralcampo, No 7, Polígono Industrial Miralcampo 19200 Azuqueca de Henares, Guadalajara Spain This leaflet was last revised in 09/2025 PL 00289/1870 250208_s2

Zonda Instructions for Use Dear Patient, The Zonda inhaler enables you to inhale the medicine contained in the Braltus capsule that your doctor has prescribed for your breathing problems. Remember to carefully follow your doctor's instructions for using Braltus. The Zonda inhaler is especially designed for Braltus capsules: you must not use it to take any other medication. The capsules must only be inhaled using the Zonda inhaler. Do not use any 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 only be used with the bottle of capsules that will either be provided in the same pack, or in the pack bundled separately with the inhaler pack. Do not reuse the inhaler for another bottle of capsules. Discard the Zonda device once the provided capsules use is completed.

Zonda

1. Dust cap 3. Base

5 3

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

2. Mouthpiece

2 1

5

4

4. Piercing button 5. Centre chamber

1

1. Pull the dust cap upwards.

6

2

2. Hold the base of the inhaler firmly and open the mouthpiece by pulling it upwards, in the direction of the arrow.

6. Hold the inhaler with the mouthpiece upwards, and firmly press the piercing button completely in once. Release the button. This will pierce the capsule and allows the medication to be released when you breathe in.

7

7. Breathe out fully. It is important to do this away from the mouthpiece. Avoid breathing into the mouthpiece at any time.

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

3

8. Place the mouthpiece in your mouth and keep your head in an upright position. Close your lips around the mouthpiece and breathe in slowly and deeply enough to hear or feel the capsule vibrating inside the centre chamber. Hold your breath for as long as you comfortably can whilst taking the inhaler out of your mouth. Then breathe normally. Repeat steps 7 and 8 to empty the capsule completely.

8

9

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

9. After use, open the mouthpiece again, and tip out the empty capsule. Close the mouthpiece and dust cap, and store your 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

4

0051

Printed by Andy Lau, 14 Oct 2025 13:51:07 (UTC +01:00)

250208_s2

page 2 of 3 pages