INFORMATION FOR THE USER

Bronchitol 40 mg powder for inhalation, hard capsules

Manitol

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Contents of this prospect

1. What Bronchitol is and for what it is used
2. What you need to know before starting to use Bronchitol
3. How to use Bronchitol
4. Possible adverse effects
5. Storage of Bronchitol
6. Contents of the package and additional information

What is Bronchitol

Bronchitol contains a medication called mannitol, which is a mucolytic.

What is Bronchitol used for

Bronchitol is used in adults 18 years and older. In addition to using Bronchitol, the patient will continue to take their usual medication for cystic fibrosis.

How Bronchitol works

Bronchitol is inhaled into the lungs to improve cystic fibrosis, a hereditary disease that affects the glands present in the lungs, intestine, and pancreas, which secrete fluids such as mucus and digestive juices.

Bronchitol helps to increase the amount of water present on the surface of the respiratory tract and in the mucus. In this way, the lungs can eliminate mucus more easily. It also helps to improve the condition of the lungs and breathing. As a result, a 'productive cough' may appear, which also helps to eliminate mucus from the lungs.

Do not use Bronchitol

• if you are allergic (hypersensitive) to mannitol.
• if you are sensitive to mannitol. Before starting to use Bronchitol, your doctor will check if your airways are too sensitive to mannitol. If you are too sensitive to mannitol, your airways will narrow and you may have difficulty breathing.

If any of the above situations apply to you (or if you are unsure), consult your doctor or pharmacist before using this medication.

Warnings and precautions

Consult your doctor or pharmacist before using this medication.

• if you have asthma;
• if you have ever coughed up blood or have coughed up sputum with blood;
• if you have severe cystic fibrosis, especially if your lung function measured by the forced expiratory volume in the first second of expiration (FEV1) is usually less than 30%,

Inhalation of medications can cause chest tightness and wheezing, in some cases immediately after taking the medication. Your doctor will help you take your first dose of Bronchitol and check your lung function before, during, and after administration. Your doctor may ask you to use other medications such as a bronchodilator before taking Bronchitol.

Inhalation of medications can also cause coughing, which may occur with Bronchitol. Consult your doctor if the cough does not go away or if it concerns you.

Children and adolescents

Bronchitol should not be used in children and adolescents under 18 years of age. This recommendation is due to the limited information available in this patient group.

Use of Bronchitol with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

You can continue to take your medications for cystic fibrosis when using Bronchitol, including inhaled antibiotics such as tobramycin and colistimethate sodium. If you have doubts, consult your doctor or pharmacist before taking Bronchitol.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication. You should not take this medication if you are pregnant.
• If you are breastfeeding or plan to do so, consult your doctor before using this medication. It is unknown if this medication is excreted in breast milk.

Driving and operating machinery

It is unlikely that Bronchitol will affect your ability to drive or use tools or machines.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Always take your bronchodilator before using Bronchitol.

Recommended dose

Adults 18 years of age or older

Initial dose

Before your doctor prescribes Bronchitol, your doctor will help you take your first dose of Bronchitol and perform a pulmonary function test at each step to check that you are not sensitive to mannitol. The first dose is taken in four steps:

Step 1 – 1 capsule (40 mg)

Step 2 – 2 capsules (80 mg)

Step 3 – 3 capsules (120 mg)

Step 4 – 4 capsules (160 mg)

At the end of the initial dose, you will have taken 10 capsules (400 mg), which is the normal dose.

Treatment dose (packs for 2 weeks)

• • You must use Bronchitol every day.
• The normal dose is 10 capsules (400 mg) inhaled in the morning, and 10 capsules inhaled at night.
• The nighttime dose should be administered at least 2 to 3 hours before bedtime.
• To achieve better results, inhale the capsules consecutively, allowing the shortest time possible between them.

Order for use of this medication

Use Bronchitol as part of your normal daily treatment routine. The suggested order is as follows, unless otherwise indicated by your doctor:

1. Use your bronchodilator
2. Wait between 5 and 15 minutes
3. Use Bronchitol before physical therapy if it is part of your treatment routine.
4. Dornase alfa (Pulmozyme) if it is part of your treatment routine
5. Inhaled antibiotics if they are part of your treatment routine

How to use Bronchitol

• Bronchitol is inhaled (aspirated) like a powder from a capsule using the inhaler provided in the package. It should only be inhaled and not administered by any other route.
• The capsules should not be swallowed.
• Only the powder contained in the capsules should be inhaled using the inhaler provided in the package.
• Use a new inhaler every week.
• Place one capsule at a time in the inhaler.
• Inhale the contents of the capsule with the inhaler, taking one or two breaths.

For instructions on using the inhaler, see the end of the prospectus.

If you use more Bronchitol than you should

If you think you have taken an excessive amount of medication, inform your doctor or pharmacist immediately. You may:

• feel like you cannot breathe;
• present with wheezing;
• be coughing a lot.

Your doctor will provide you with oxygen and medications to help you breathe.

If you forget to use Bronchitol

• If you forget a dose, use the inhaler as soon as you remember and continue using it as usual. However, if it is almost time for the next dose, omit the missed dose.
• Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Bronchitol

If you interrupt treatment with Bronchitol, your symptoms may worsen. Do not stop using Bronchitol without first speaking with your doctor, even if you feel better. Your doctor will indicate how long you should use this medication.

If you have any other doubts about using this medication, ask your doctor or pharmacist.

Like all medicines, Bronchitol can cause side effects, although not everyone will experience them.

Stop using Bronchitol and consult a doctor immediately if you notice any of the following serious side effects:

• • Difficulty breathing, which may be due to narrowing of the airways, worsening of asthma symptoms, or wheezing. These side effects are common and may affect 1 in 10 people.
• Coughing up blood or presence of blood in sputum. This side effect is common.

Inform your doctor immediately if you notice any of the following side effects:

• Intense coughing. This side effect is common.
• Worsening of symptoms. This side effect is common.

Other side effects are:

Common (may occur in more than 1 in 10 people)

• Coughing
• Chest discomfort
• Headache
• Pain in the back of the mouth and throat and difficulty swallowing
• Vomiting, vomiting after coughing

Uncommon (may affect 1 in 100 people)

• Burning sensation or pain in the tongue
• Diabetes related to FQ
• Chest and abdominal pain
• Change in voice
• Cold sweats
• Congestion
• Dehydration
• Loss of appetite
• Diarhea
• Ear pain
• Feeling of fatigue
• Feeling of dizziness
• Nausea
• Feeling of discomfort
• Flu and fever
• Gas
• Heartburn
• Pain in the hernia
• Hyperventilation
• Itching, skin rash, acne
• Joint stiffness and pain
• Morbid thoughts
• Sores in the mouth
• Respiratory infection
• Coughing up mucus
• Infection of the sputum
• Irritation of the throat
• Difficulty sleeping
• Fungal infection in the mouth (thrush)
• Involuntary loss of urine

Reporting of side effects

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the national notification system included in thescheme in theAppendix V*. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not use Bronchitol after the expiration date that appears on the carton box and the blister pack after "CAD". The expiration date is the last day of the month indicated.

Store below 30°C.

Store in the original packaging to protect it from moisture.

Once removed from the blister pack, the capsule must be used immediately.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Composition of Bronchitol

The active ingredient is mannitol. Each capsule contains 40 mg of mannitol. The average inhaled dose per capsule is 32.2 milligrams of mannitol.

Appearance of the product and contents of the pack

Bronchitol is a powder for inhalation in hard capsules. Bronchitol 40 mg powder for inhalation, hard capsules, is a white or almost white powder in hard, transparent, and colourless capsules with the inscription "PXS 40 mg". The powder is inhaled into the lungs with the inhaler supplied in the pack.

Each initial dose pack of Bronchitol contains 1 blister with 10 capsules and 1 inhaler. The initial dose pack is used for the initial dose evaluation with your doctor.

Each 2-week treatment pack of Bronchitol contains 28 blisters with 10 capsules each (280 capsules in total) and 2 inhalers. The 2-week treatment pack is for therapeutic use.

Marketing authorisation holder and responsible person for manufacturing

Pharmaxis Europe Limited, 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Ireland

Responsible person for manufacturing

MIAS Pharma Limited, Suite 1, Stafford House, Strand Road, Portmarnock, Co. Dublin, D13 WC83, Ireland or Arvato Supply Chain Solutions SE, Gottlieb-Daimler Straße 1, 33428 Harsewinkel, North Rhine-Westphalia, Germany.

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Date of the last revision of this leaflet: MM/YYYY.

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.There are also links to other websites on rare diseases and orphan medicines.

------------------------------------------------------------------------------------------------------------------>

How to use the inhaler

The following diagram explains how the inhaler looks. Bronchitol capsules can only be used with the inhaler supplied in the pack.

Spinning Chamber: Spinning Chamber

Mouthpiece: Mouthpiece

Filter: Filter

Piercing Buttons: Piercing Buttons

Piercing Chamber: Piercing Chamber

Inhaler

The following steps explain how to use the inhaler. If you want more information on how to care for it, go to the end of the instructions.

Additional information on caring for the inhaler

• Keep the inhaler dry and make sure your hands are dry before using it.
• Do not breathe or cough into the inhaler.
• Do not disassemble it.
• Do not place a capsule directly into the mouthpiece of the inhaler.
• Do not leave a capsule inside the inhaler.
• Use a new inhaler every week.
• If the inhaler breaks, use the second inhaler and talk to your doctor.

Cleaning the inhaler -Normally the inhaler will administer the correct dose of medication for 7 days without the need for cleaning. If you need to clean it, follow these steps:

1. Make sure the inhaler is empty.
2. Wash it with hot water with the mouthpiece open.
3. Shake it to drain off large drops.
4. Leave it to dry: turn it on its side with the mouthpiece open.
5. Leave it to dry completely, which may take up to 24 hours. While it is drying, use the other inhaler.