Colobreathe 1.662.500 UI powder for inhalation, hard capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Colobreathe 1,662,500 IU powder for inhalation, hard capsules

colistimethate sodium

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, ask your doctor or pharmacist.
• 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, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Colobreathe is and what it is used for

Colobreathe contains colistimethate sodium, a type of antibiotic called a polymyxin.

Colobreathe is used to control chronic pulmonary infections caused by the bacterium Pseudomonas aeruginosa in adult and pediatric patients aged 6 years and older with cystic fibrosis. Pseudomonas aeruginosa is a very common bacterium that infects nearly all patients with cystic fibrosis at some point in their lives. Some individuals acquire this infection at a very young age, while in others it occurs much later. If this infection is not adequately controlled, it will cause lung damage.

How it works

Colobreathe works by destroying the bacterial cell membrane, resulting in a lethal effect on these bacteria.

2. What you need to know before using Colobreathe

Do not use Colobreathe:

• if you/your child are allergic to colistimethate sodium, colistin sulfate, or polymyxins.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Colobreathe.

Inform your doctor if you/your child have ever had any of the following conditions:

• previously had an adverse reaction to inhaled dry powder medicines, unless this has already been discussed with your doctor;
• already have a known muscle disease called myasthenia gravis or the inherited condition porphyria;
• blood in the sputum (the substance expelled when coughing).

After each inhalation of Colobreathe, rinse the mouth with water. The rinse should not be swallowed. Rinsing may reduce the risk of developing oral fungal superinfections during treatment and may also reduce the unpleasant taste associated with colistimethate sodium.

When you/your child start using Colobreathe, you/your child may experience coughing, difficulty breathing, chest tightness, or wheezing (a whistling sound when breathing). The frequency of these adverse effects may decrease with continued use of the inhaler, or your doctor may prescribe a bronchodilator to be used before or after taking Colobreathe. If any of these effects become problematic, please contact your doctor, who may adjust your treatment.

If you/your child have any kidney or nerve problems, extra caution should be taken when administering Colobreathe, although your doctor will already be aware of this.

If you/your child require other forms of colistimethate, either by injection or nebulization, extra precautions should be taken, although your doctor will already be aware of this.

Children

Do not administer Colobreathe to children under 6 years of age, as it is not suitable for them.

Other medicines and Colobreathe

Inform your doctor if you/your child are taking, have recently taken, or might need to take any other medicines, and particularly:

• if you/your child are taking aminoglycoside antibiotics, used to treat infections, extra precautions should be taken;
• if you/your child have myasthenia gravis and are taking macrolide-type antibiotics such as azithromycin and clarithromycin, or fluoroquinolones such as norfloxacin and ciprofloxacin. Taking these together with Colobreathe may cause muscle weakness problems;
• if you/your child are receiving colistimethate by injection or nebulization, extra precautions should be taken;
• if you/your child require general anesthesia, extra precautions should be taken.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is no information on the safety of Colobreathe in pregnant women. Your doctor should advise you whether the benefits of the medicine outweigh the risks before using Colobreathe.

Colistimethate sodium may pass into breast milk. Discuss the use of Colobreathe with your doctor.

Driving and use of machines

While using Colobreathe, you may experience dizziness, confusion, or vision problems. Do not drive or operate machinery until these symptoms have resolved.

Colobreathe contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; hence, it is essentially “sodium-free”.

3. How to use Colobreathe

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor. If in doubt, ask your doctor if you/your child have any questions.

The first dose must be administered under medical supervision.

Recommended dose

Adults and children aged 6 years and older

• The contents of one Colobreathe capsule must be inhaled twice daily using the Turbospin inhaler.
• There must be a 12-hour interval between doses.

Order in which other treatments should be taken

If you/your child are taking other treatments for cystic fibrosis, you/your child should take them in the following order:

• Inhaled bronchodilators
• Respiratory physiotherapy
• Other inhaled medications
• Then Colobreathe

You/your child should confirm the order of treatments with your doctor.

Method of administration

Colobreathe is inhaled into the lungs as a powder from the capsule using a hand-held inhaler called the Turbospin. Colobreathe can only be administered using this device.

Do not swallow the Colobreathe capsules.

To inhale Colobreathe from the capsule using the Turbospin inhaler, follow the procedure described below. Your doctor, pharmacist, or nurse should show you/your child how to inhale the medicine when you/your child start treatment:

Using Colobreathe with the Turbospin inhaler

Preparing the Turbospin

1. Remove the cap by gently pulling it off.

1. Unscrew the mouthpiece to expose the chamber of the Turbospin inhaler.

1. Remove a single capsule from the blister pack. Once the capsule has been removed, it should be used immediately.

1. Gently insert the capsule into the chamber with the wider end first. Do not force it.

1. Now screw the mouthpiece back into place.

Puncturing the capsule and inhaling the medicine

1. To puncture the capsule:

• Hold the inhaler with the mouthpiece pointing upwards. Gently push the plunger upwards until you reach the visible line. You will feel resistance at this point, which secures the capsule in place, ready for puncturing. Maintain this position before proceeding to puncture.
• Now, with the capsule secured, continue pushing the plunger until it reaches the end stop, then release it.
• The capsule is now punctured and the contents can be inhaled.
• Do not puncture the capsule more than once. You may see a small amount of powder escaping from the capsule chamber after puncturing, which is normal.

1. Breathe out slowly. Place the mouthpiece between your lips and teeth. Make sure to create an airtight seal between your lips and the mouthpiece. Be careful not to block the air vents with your fingers or mouth during inhalation.
2. Then, inhale slowly and deeply through your mouth at a rate sufficient for you to hear or feel the capsule spinning.
3. Remove the Turbospin inhaler from your mouth and hold your breath for about 10 seconds, or for as long as comfortable, then breathe out slowly.
4. If you do not hear the capsule spinning, it may be stuck in the compartment. If this happens, you can dislodge it by gently tapping the inhaler chamber. Do not attempt to dislodge the capsule by repeatedly pressing the plunger. If the capsule cannot be dislodged and the powder cannot be inhaled, discard the punctured capsule and any remaining powder inside it, and use a new one.
5. Inhale the medicine again by repeating steps 7 and 8 to ensure that the capsule has been emptied.
6. You can check whether the capsule is empty by unscrewing the mouthpiece and inspecting the capsule. If it is not empty, repeat steps 7, 8, and 9 until all the contents have been inhaled.
7. After inhaling all the contents, rinse your mouth thoroughly with water and then spit it out.

Removing the empty capsule from the Turbospin

1. When the capsule is empty, unscrew the mouthpiece, then remove and discard the empty capsule.

Additional information

When you breathe slowly, you draw air through the body of the Turbospin inhaler into the capsule chamber. The tiny medicine particles from the capsule are picked up by the airflow and carried into your lungs via your airways.

Occasionally, very small fragments of the capsule shell may enter the mouth or airways.

• If this happens, you may notice these fragments on the tongue or in the airways.
• The capsule shell is made of gelatin, which is harmless to humans if swallowed or inhaled.
• The likelihood of the capsule breaking into fragments increases if the capsule is punctured more than once during step 6.

Cleaning the Turbospin device

Clean the Turbospin inhaler after each dose using the following procedure:

1. Press the plunger fully down a few times while holding the chamber upside down.
2. Wipe the chamber with a cloth or cotton swab. Do not use water.
3. Screw the mouthpiece firmly back into place, replace the cap, and the inhaler will be ready for the next dose.

If you/your child use more Colobreathe than you should, or if the capsule has been swallowed accidentally, contact your doctor immediately for assistance.

If you/your child forget to use Colobreathe

If you/your child forget to take a dose of Colobreathe, take the missed dose as soon as you/your child remember. Do not take two doses within less than 12 hours. Continue as instructed from that point.

If you/your child interrupt treatment with Colobreathe

Do not stop treatment prematurely unless your doctor tells you it is safe to do so. Your doctor will decide how long your/your child’s treatment should last.

If you/your child have any further questions about the use of this medicine, ask your doctor.

4. Possible adverse effects

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

Allergic reactions

An allergic reaction to Colobreathe is possible (usually severe allergic reactions can cause skin rashes, swelling of the face, tongue and neck, difficulty breathing due to narrowing of the airways, and loss of consciousness). If you/your child experience signs of an allergic reaction, seek urgent medical attention.

Other possible adverse effects

You/your child may experience an unpleasant taste in the mouth after inhaling Colobreathe.

Very common (may affect more than 1 in 10 people):

• Difficulty breathing
• Cough, throat irritation
• Hoarseness or weak voice, or even loss of voice
• Unpleasant taste

Common (may affect up to 1 in 10 people):

• Headache
• Ringing or buzzing in the ear, problems with balance
• Coughing up blood, wheezing (a whistling sound when breathing), chest discomfort, asthma, productive cough (cough that produces mucus), lung infection, crackles in the lungs (this is what the doctor hears when listening to the lungs with a stethoscope)
• Vomiting, nausea
• Changes in lung function (detected in tests)
• Joint pain
• Lack of energy, tiredness
• Increased temperature

Uncommon (may affect up to 1 in 100 people):

• Allergic reactions (hypersensitivity); signs may include rash and itching
• Weight fluctuation, decreased appetite
• Anxiety
• Seizures
• Drowsiness
• Ear blockage
• Chest pain
• Difficulty breathing
• Nosebleeds, cold (nasal mucus, which may cause a blocked feeling), cough with thick green mucus, sore throat and sinus pain
• Unusual lung sounds (your doctor would hear this when listening to the lungs with a stethoscope)
• Diarrhea, flatulence
• Excessive salivation
• Toothache
• Protein in the urine (detected in tests)
• Thirst

The adverse effects described above have been observed in people of all ages with similar frequency.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Colobreathe

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the outer packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store Colobreathe above 25°C.

Keep in the original packaging until immediately before use to protect it from moisture.

If you/your child accidentally peel back the foil and any capsule becomes exposed, please discard that capsule.

Dispose of the Turbospin inhaler after completing a course of treatment.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Colobreathe

The active substance is sodium colistimethate. Each capsule contains 1,662,500 IU (approximately equivalent to 125 mg) of sodium colistimethate.

The other components are:

Capsule shell

Gelatin

Polyethylene glycol

Sodium lauryl sulfate

Purified water

Appearance of the product and contents of the pack

Colobreathe powder for inhalation, hard capsule (powder for inhalation) is supplied as small, hard, transparent gelatin capsules containing a fine white powder.

The Turbospin is a dry powder inhaler activated by the patient's inspiratory flow, made of polypropylene and stainless steel.

The capsules are packaged in blisters and supplied in cartons containing:

• 56 hard capsules and one Turbospin dry powder inhaler device, sufficient for 4 weeks of use.
• 8 hard capsules and one Turbospin dry powder inhaler device, sufficient for 4 days of use.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Essential Pharma Limited,
Vision Exchange Building,
Triq it-Territorjals, Zone 1,
Central Business District,
Birkirkara, CBD 1070,
Malta

Manufacturer

Teva Pharmaceuticals Europe BV
Swensweg 5
2031 GA Haarlem
The Netherlands.

Millmount Healthcare Limited
Block 7, City North Business Campus
Stamullen
Co Meath
K32 YD60
Ireland

Merckle GmbH
Ludwig-Merckle-Str-3
89143 Blaubeuren
Germany

Laboratorios Liconsa, S.A.
Avda. Miralcampo, 7, Pol. Ind.
Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

Date of the most recent revision of this leaflet: February 2024.

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