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

2. What you need to know before you use Colobreathe

Do not use Colobreathe:

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

Warnings and precautions

Talk to your doctor or pharmacist before you start using Colobreathe.

Tell your doctor if you/your child has ever had any of the following conditions:

• has had a bad reaction to inhaling dry powder medicines before, unless this has already been discussed with your doctor.
• already has a known muscle disease called myasthenia gravis or the hereditary disease porphyria
• has blood in their sputum (the matter they cough up)

After each inhalation of Colobreathe, you/your child should rinse their mouth with water. The rinse should not be swallowed. The rinse can reduce the risk of developing oral thrush (a fungal infection) during treatment and can also reduce the unpleasant taste associated with colistimethate sodium.

When you/your child starts using Colobreathe, you/your child may find that they have a cough, difficulty breathing, chest tightness, or wheezing (a whistling sound when breathing). The number of these side effects can be reduced as you continue using the inhaler, or your doctor may prescribe a bronchodilator for use before or after taking Colobreathe. If any of these effects become a problem, please contact your doctor who may change your treatment.

If you/your child has any kidney or nerve problems, you/your child should be careful when taking Colobreathe, although your doctor will already be aware of this.

If you/your child needs to take other forms of colistimethate, either by injection or by nebulization, you/your child should be careful, although your doctor will already be aware of this.

Children

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

Other medicines and Colobreathe

Tell your doctor if you/your child is taking, has recently taken, or might take any other medicines, and in particular:

• if you/your child is taking aminoglycoside antibiotics used to treat infections, you/your child should be careful;
• if you/your child has myasthenia gravis and is taking macrolide antibiotics such as azithromycin and clarithromycin, or fluoroquinolones such as norfloxacin and ciprofloxacin. Taking these at the same time as Colobreathe may cause muscle weakness problems;
• if you/your child is taking colistimethate by injection or nebulization, you/your child should be careful;
• if you/your child needs a general anesthetic, you/your child should be careful.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

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

Driving and using machines

You may feel dizzy, confused, or have problems with your vision while using Colobreathe. Do not drive or use machines until the symptoms have gone.

Colobreathe contains sodium

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

3. How to use Colobreathe

Follow the instructions for administration of the medicine contained in this leaflet or as directed by your doctor. If you are unsure, ask your doctor if you/your child has any doubts.

The first dose should be given under medical supervision.

The recommended dose is

Adults and children aged 6 years and older

• The contents of one Colobreathe capsule should be inhaled twice a day using the Turbospin inhaler.
• There should be a 12-hour gap between doses.

The order in which you should take or use other treatments

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

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

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

Method of administration

Colobreathe is inhaled into the lungs as a powder from the capsule using the Turbospin manual inhaler. 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 hood by gently pulling it off.

1. Unscrew the mouthpiece, exposing the Turbospin inhaler chamber.

1. Remove one capsule from the blister pack. Once you have removed the capsule, you must use it immediately.

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

1. Now replace the mouthpiece by screwing it back into place.

Piercing the capsule and inhaling the medicine

1. To pierce the capsule:

• Hold the inhaler with the mouthpiece upwards, push the piston gently upwards until you reach the visible line; you will feel resistance at this point, and this will fix the capsule in place, ready to be pierced. Hold this position before proceeding to pierce the capsule.
• Now, with the capsule fixed in place, continue pushing the piston until you reach the stop, then release it.
• The capsule is now pierced, and the contents can be inhaled.
• Do notpierce the capsule more than once. You may see a little powder coming out of the capsule chamber after piercing, which is normal.

1. Exhale slowly. Place the mouthpiece between your lips and teeth. Make sure to create a 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 that allows 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 you feel comfortable, then exhale slowly.
4. If you do not hear the capsule spinning, it may be stuck in the compartment. If this happens, you can loosen it by gently tapping the inhaler chamber. Do not try to loosen the capsule by pressing the piston repeatedly. If the capsule cannot be loosened and the powder cannot be inhaled, discard the broken capsule and any remaining powder, and use another one.
5. Inhale the medicine again by repeating steps 7 and 8 to ensure that the capsule is empty.
6. You can check if the capsule is empty by unscrewing the mouthpiece and checking the capsule. If it is not empty, repeat steps 7, 8, and 9 until you have inhaled all the contents.
7. When you have inhaled all the contents, rinse your mouth well 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 in slowly, you draw air through the Turbospin inhaler body into the capsule chamber. The tiny medicine particles from the capsule are picked up by the airflow and carried through your airways to your lungs.

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

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

Cleaning the Turbospin device

Clean the Turbospin inhaler after each dose by following the procedure below:

1. Press the piston fully a couple of times while keeping 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, put the cap on, and the inhaler will be ready for use for the next dose.

If you/your child uses more Colobreathe than they should, or if they have accidentally swallowed a capsule,contact your doctor immediately for advice.

If you/your child misses a dose of Colobreathe

If you/your child forgets to take a dose of Colobreathe, then you/your child should take the missed dose as soon as you/your child remembers. You/your child should not take 2 doses in less than 12 hours. Continue from there as directed.

If you/your child stops treatment with Colobreathe

Do not stop your treatment prematurely unless your doctor tells you to. Your doctor will decide how long your treatment/your child's treatment should last.

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

4. Possible side effects

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

Allergic reactions

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

Other possible side effects

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

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

• Breathing difficulties
• Cough, sore throat
• Hoarse 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 ears, balance problems.
• Coughing up blood, wheezing (a whistling sound when breathing), chest discomfort, asthma, productive cough (cough that produces mucus), lung infection, crackling in the lungs (heard by the doctor when listening to the lungs with a stethoscope)
• Vomiting, nausea
• Changes in lung function (found 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 changes, decreased appetite

• Anxiety

• Seizures
• Drowsiness
• Ear blockage
• Chest pain
• Breathing difficulties
• Nosebleeds, runny nose (mucus in the nose, which can make you feel blocked), cough with thick green mucus, sore throat and sinuses
• Abnormal sounds in the chest (heard by the doctor when listening to the lungs with a stethoscope)
• Diarrhea, gas
• Excessive saliva production
• Toothache
• Protein in the urine (found in tests)
• Thirst

The side effects described above have been seen in people of all ages with a similar frequency.

Reporting of side effects

If you experience 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 Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Colobreathe

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 outer packaging and on the blister pack after EXP. The expiry date is the last day of the month stated.

Do not store Colobreathe above 25°C.

Store in the original package until immediately before use to protect from moisture.

If you/your child accidentally peels off the foil and a capsule is exposed, please discard that capsule.

Discard the Turbospin inhaler after finishing a treatment pack.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Colobreathe

The active ingredient 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 Container Content

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

The Turbospin is a dry powder inhaler driven by the inspiratory flow, manufactured from polypropylene and stainless steel.

The capsules are packaged in blisters, which are supplied in boxes containing:

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

Territorials Street, Zone 1,

Central Business District,

Birkirkara, CBD 1070,

Malta

Manufacturer

Teva Pharmaceuticals Europe BV

Swensweg 5

2031 GA Haarlem

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.

Miralcampo Avenue, 7, Industrial Estate

Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the last revision of this leaflet: February 2024.

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