BRONCHITOL 40 mg Hard Capsules

Зміст інструкції

1. Bronchitol 40 mg powder for inhalation, hard capsules
   1. What is Bronchitol and what is it used for
   2. What you need to know before using Bronchitol
   3. How to use Bronchitol
   4. Possible side effects
   5. How to store Bronchitol
   6. Contents of the pack and other information
   7. Removing the cap
   8. Opening the inhaler
   9. Inserting the capsule
   10. Closing the inhaler
   11. Capsule Puncture
   12. Preparation for Inhalation
   13. Inhalation
   14. Expiration
   15. Capsule Check
   16. Used Capsule Removal
   17. Repeat steps 3 to 10 for each capsule.

Bronchitol 40 mg powder for inhalation, hard capsules

Mannitol

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Bronchitol and what is it used for

What is Bronchitol
Bronchitol contains a medicine called mannitol which is a mucolytic substance.

What is Bronchitol used for
Bronchitol is indicated in adults starting from 18 years of age. You can continue to take other medicines that are part of your cystic fibrosis therapy alongside Bronchitol.

How Bronchitol works
Bronchitol is inhaled into the lungs in cases of cystic fibrosis, a hereditary disease that affects the
glands of the lungs, intestines and pancreas which secrete fluids such as mucus and gastric juices.
Bronchitol helps to increase the amount of water on the surface of the airways and in the mucus.
This promotes the elimination of mucus from the lungs. It also helps to improve the
condition of the lungs and breathing. As a result, a ‘productive cough’ occurs, which
also promotes the removal of mucus from the lungs.

2. What you need to know before using Bronchitol

Do not use Bronchitol

• if you are allergic to mannitol
• if you are sensitive to mannitol. Before starting therapy with Bronchitol, your doctor will assess the sensitivity of your airways to mannitol. If you have hypersensitivity to mannitol, your airways will narrow, resulting in difficulty breathing. If any of the above points apply to you (or if you are unsure), consult your doctor or pharmacist before using this medicine.

Warnings and precautions
Consult your doctor or pharmacist before using this medicine.

• In case of asthma;
• In case of cough with bleeding or blood in the sputum;
• In case of severe cystic fibrosis, especially if lung function measured by forced expiratory volume in the first second of expiration (FEV) is usually less than 30%.

Inhalation medicines can cause a feeling of chest tightness and difficulty breathing and
this can occur immediately after taking Bronchitol. Your doctor will help you
take the first dose of Bronchitol and will monitor your lung function before, during and
after the dose. Your doctor may suggest you use other medicines, such as a bronchodilator,
before taking Bronchitol.
Bronchitol, like other inhalation medicines, can cause coughing. Consult your doctor if the cough
persists or worries you.

Children and adolescents
Bronchitol should not be used by children and adolescents under 18 years of age. This
is because there is limited information for this patient group.

Other medicines and Bronchitol
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
You can continue to use medicines for cystic fibrosis during therapy with Bronchitol,
including inhaled antibiotics such as tobramycin and colistimetate sodium. If you have any doubts,
consult your doctor or pharmacist before using Bronchitol.

Pregnancy and breastfeeding

• If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for advice before using this medicine. The use of this medicine should be avoided during pregnancy.
• If you are breastfeeding or are planning to breastfeed, ask your doctor for advice before using this medicine. It is not known whether this medicine passes into breast milk.

Driving and using machines
Bronchitol does not impair the ability to drive vehicles or use tools or machinery.

3. How to use Bronchitol

Use this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Always take a bronchodilator before using Bronchitol.

Amount to use
Adults from 18 years of age
Initial dose
Before Bronchitol is prescribed to you, your doctor will help you take the first dose of Bronchitol and
check your lung function at each stage to rule out your sensitivity to
mannitol. The first dose is taken in 4 stages:
Stage 1 – 1 capsule (40 mg)
Stage 2 – 2 capsules (80 mg)
Stage 3 – 3 capsules (120 mg)
Stage 4 – 4 capsules (160 mg)
At the end of the initial dose, you will have taken 10 capsules (400 mg) which is the same amount as the
normal dose.
Treatment dose (pack for 2 weeks)

• You must take Bronchitol every day.
• The usual dose is 10 capsules (400 mg) inhaled in the morning and 10 capsules inhaled in the evening.
• Take the evening dose 2-3 hours before going to bed.
• For optimal results, inhale each capsule one after the other so that there is as little delay as possible between capsule intakes.

Order of use of the medicine
Use Bronchitol as part of your normal daily treatment procedure. The suggested order is as follows, unless otherwise recommended by your doctor:

• 1. Use the bronchodilator;
• 2. Wait 5-15 minutes;
• 3. Use Bronchitol before physiotherapy if this is part of the treatment procedure.
• 4. Dornase alfa (Pulmozyme) if it is part of the treatment procedure.
• 5. Inhaled antibiotics if they are part of the treatment procedure.

How to use the medicine

• Bronchitol is taken by inhalation as a powder from the capsule through the inhaler provided in the pack. It is for inhalation only and must not be taken in any other way. The capsules must not be swallowed.
• The powder contained in the capsules must only be inhaled using the inhaler included in the pack.
• Use a new inhaler every week.
• Each of the ten capsules must be inserted into the inhaler one at a time.
• Inhale the contents of the capsule using the inhaler, with one or two breaths.

If you use more Bronchitol than you should
If you think you have used too much of this medicine, tell your doctor or
pharmacist immediately. You may:

• feel that you cannot breathe;
• have difficulty breathing;
• cough a lot. Your doctor may give you oxygen and medicines to help you breathe.

If you forget to use Bronchitol

• If you forget a dose, take it as soon as possible and then continue as usual. However, if it is almost time for the next dose, skip the missed dose.
• Do not use a double dose to make up for a missed dose.

If you stop taking Bronchitol
If you stop taking Bronchitol, your symptoms may worsen. Do not stop
using Bronchitol without first consulting your doctor, even if you feel better. Your doctor will tell you
how long to use this medicine.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using Bronchitol and tell your doctor immediately if you notice the following
serious side effects:

• Difficulty breathing, which may be due to narrowing of the airways, worsening of asthma symptoms or wheezing. This is frequent and may affect 1 in 10 people.
• Coughing up blood or blood in sputum. This is frequent.

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

• Severe cough. This is frequent.
• Worsening of symptoms. This is frequent.

Other side effects include:
Common (may affect more than 1 in 10 people)

• Cough
• Chest discomfort
• Headache
• Pain in the back of the mouth and throat and difficulty swallowing
• Vomiting, vomiting caused by coughing

Uncommon (may affect up to 1 in 100 people)

• Burning or pain on the tongue
• Diabetes related to FC
• Chest and abdominal pain
• Change in voice
• Cold sweat
• Congestion
• Dehydration
• Loss of appetite
• Diarrhea
• Ear pain
• Feeling tired
• Feeling dizzy
• Feeling unwell (nausea)
• General feeling of discomfort
• Flu and fever
• Flatulence
• Heartburn
• Pain from hernia
• Hyperventilation
• Itching, rash, acne
• Joint stiffness and pain
• Morbid thoughts
• Mouth ulcers
• Respiratory tract infection
• Runny nose
• Infection in sputum
• Throat irritation
• Restless sleep
• Oral thrush (candidiasis)
• Involuntary urination

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Bronchitol

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 box and blister after
EXP. The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Store in the original package to protect the medicine from moisture.
Once removed from the blister, a capsule must be used immediately.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

Description of the appearance of Bronchitol and contents of the pack:
Bronchitol is a powder for inhalation contained in hard capsules. Bronchitol 40 mg powder for
inhalation, hard capsules contains a white or almost white powder in transparent, colourless,
hard capsules with “PXS 40 mg” imprinted on them. The powder is inhaled into the lungs using
the inhaler provided in the pack.
A starter pack of Bronchitol contains 1 blister with 10 capsules and 1 inhaler. The
starter pack is intended for the assessment of the initial dose by the doctor.
A pack for 2 weeks of treatment contains 28 blisters with 10 capsules each
(280 capsules in total) and 2 inhalers. The pack for 2 weeks of treatment is indicated for
maintenance therapy.

Marketing Authorisation Holder
Pharmaxis Europe Limited, 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29,

Manufacturer
MIAS Pharma Limited, Suite 1, Stafford House, Strand Road, Portmarnock, Co. Dublin, D13 WC83,
Ireland.
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/BelgienLietuva
Pharmaxis Europe Limited
Tél/Tel: +353 (0) 1431 9816
Pharmaxis Europe Limited
Tél/Tel: + 353 (0) 1431 9816

България
Pharmaxis Europe Limited
Teл.: +353(0)14319816

Luxembourg/Luxemburg
Pharmaxis Europe Limited
Tél/Tel: + 353 (0) 1431 9816

Českárepublika
4 Life Pharma CZ, s.r.o.

Magyarország
Pharmaxis Europe Limited
Tel: +420 244 403 003 Tel.:+353 (0) 1431 9816

Danmark
Pharmaxis Europe Limited
Tlf: +353 (0) 1431 9816

Malta
Pharmaxis Europe Limited
Tel: + 353 (0) 1431 9816

Deutschland
Pharmaxis Europe Limited

Nederland
Pharmaxis Europe Limited
Tel: +353 (0) 1431 9816 Tel: +353 (0) 1431 9816

Norge
Pharmaxis Europe Limited
Tlf: +353 (0) 1431 9816

Ελλάδα
Pharmaxis Europe Limited
Τηλ: +353 (0) 1431 9816

Eesti
Pharmaxis Europe Limited
Tél/Tel: + 353 (0) 1431 9816

Österreich
Pharmaxis Europe Limited
Tel: +353 (0) 1431 9816

España
Pharmaxis Europe Limited
Tel: +353 (0) 1431 9816

Polska
Pharmaxis Europe Limited
Tel: + 353 (0) 1431 9816

France
Pharmaxis Europe Limited

Portugal
Pharmaxis Europe Limited
Tel: + 353 (0) 1431 9816

Hrvatska
Pharmaxis Europe Limited
Tél/Tel: + 353 (0) 1431 9816
Tél: + 353 (0) 1431 9816

România
Pharmaxis Europe Limited
Tel: + 353 (0) 1431 9816

Slovenija
Pharmaxis Europe Limited
Tél/Tel: + 353 (0) 1431 9816

Ireland
Pharmaxis Europe Limited.
Tel: +353 (0) 1431 9816

Ísland
Pharmaxis Europe Limited

Slovenská republika
4 Life Pharma SK, s.r.o.
Tel: + 420 244 403 003

Italia
Pharmaxis Europe Limited
Tel: +353 (0) 1431 9816
Sími: +353 (0) 1431 9816

Suomi/Finland
Pharmaxis Europe Limited
Puh/Tel: +353 (0) 1431 9816

Κύπρος
Pharmaxis Europe Limited
Τηλ: +353 (0) 1431 9816

Sverige
Pharmaxis Europe Limited
Tel: +353 (0) 1431 9816

Latvija
Pharmaxis Europe Limited
Tél/Tel: + 353 (0) 1431 9816

United Kingdom (Northern Ireland)
Pharmaxis Europe Limited
Tel: + 353 (0) 1431 9816

Altre fonti di informazioni
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/. In addition, there are links to other websites on rare diseases
and related therapeutic treatments.

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How to use the inhaler
Below is a diagram showing the appearance of the inhaler. Use Bronchitol
capsules only with the inhaler provided in the pack.

Inhaler device
The following steps explain how to use the inhaler. For further information on how to
maintain the inhaler, see the end of these instructions.

1. Removing the cap

• Using both hands, hold the inhaler in a vertical position and remove the cap.

2. Opening the inhaler

• Hold the base of the inhaler firmly with one hand.
• You must hold the inhaler at the base to avoid pressing the ‘piercing’ buttons.
• Then open it by turning the mouthpiece in the direction of the arrow on the inhaler.

3. Inserting the capsule

• Make sure your hands are dry.
• Then remove a capsule from the blister (remove the capsule only before using it).
• Insert the capsule into the appropriate space at the bottom of the inhaler.

4. Closing the inhaler

• Hold the inhaler in a vertical position.
• Then rotate the mouthpiece to the closed position until you hear a ‘click’.

5. Capsule Puncture

• This operation allows the powder contained in the capsule to be released when you inhale. In this leaflet, we refer to the puncture as ‘piercing’.
• Hold the inhaler in a vertical position and press both ‘piercing’ buttons on the sides of the inhaler simultaneously, pressing them fully in, then release them. Perform this operation only once. Indeed, puncturing the capsule more than once may cause it to tear or break.

6. Preparation for Inhalation

• Tilt the inhaler so that the mouthpiece is slightly pointing downwards.
• This allows the capsule to fall forward into the rotating chamber.
• Keep the inhaler tilted in this way and exhale completely (away from the inhaler).

7. Inhalation

• Tilt your head back slightly.
• Holding the inhaler tilted downwards, put it in your mouth and close your lips tightly around the mouthpiece.
• Inhale steadily and deeply to fill your lungs - then hold your breath for 5 seconds. While inhaling, you should hear a ‘rattling’ sound as the capsule rotates in the inhaler. If this does not happen, the capsule may be blocked.
• If you do not hear the rattling, hold the inhaler with the mouthpiece pointing downwards and tap the base of the inhaler firmly. Do not try to dislodge the capsule by pressing the 'piercing' buttons again. Repeat the inhalation to take the dose.

8. Expiration

• Hold the inhaler away from your mouth.
• Exhale and then breathe normally.

9. Capsule Check

• Check that the capsule is empty - the capsule must rotate within the inhaler to empty. If the capsule has not emptied, repeat steps 6 to 8.

10. Used Capsule Removal

• Turn the inhaler upside down, tap the base, and remove the empty capsule.

11. Repeat steps 3 to 10 for each capsule.

• Perform these steps for each of the ten capsules.
• To obtain optimal results from taking Bronchitol, inhale the capsules one after the other.

Further information on inhaler maintenance

• Keep the inhaler dry and always make sure your hands are dry before using it.
• Never breathe or cough into the inhaler.
• Do not leave the inhaler unattended.
• Never insert a capsule directly into the mouthpiece of the inhaler.
• Never leave a used capsule in the designated compartment of the inhaler.
• Use a new inhaler every week.
• If the inhaler breaks, use the second inhaler available and consult your doctor.

Inhaler Cleaning– Usually the inhaler provides the correct dose of medication for 7 days
without needing to be cleaned. However, if cleaning is necessary, do the following:

• 1. Make sure the inhaler is empty.
• 2. Wash the inhaler with warm water with the mouthpiece open.
• 3. Shake it until the larger drops of water inside the inhaler are eliminated.
• 4. Let it air dry – place it on its side with the mouthpiece open.
• 5. It must dry completely and this may take 24 hours. While it is drying, use the other inhaler available.