Label: information for the user

Colfinair 2 million IUpowder for inhalation solution for nebulizer

sodium colistimethate

Read this label carefully before starting to use this medication,because it contains important information for you.

• Keep this label. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone,and you should not give it to others 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, evenifthey are not listed in this label. See section 4.

Colfinair is administered via inhalation to treat chronic respiratory infections in patients with cystic fibrosis. Colfinair is used when such infections are caused by a specific bacteria calledPseudomonas aeruginosa.

No use Colfinair

• If you are allergic (hypersensitive) to colistimethate sodium, colistin, or other polymyxins.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Colfinair:

• If you have or have had kidney problems
• If you have myasthenia gravis
• If you have porphyria
• If you have asthma.

Caution should be exercised when using Colfinair in premature children and newborns, as their kidneys are not yet fully developed.

Coughing and chest tightness may lead to interruption. This may be alleviated by using an inhaled bronchodilator (e.g. salbutamol) before using Colfinair. Your doctor will supervise your first dose of Colfinair and check your lung function before and after administration.

If you experience chest tightness despite using a bronchodilator, inform your doctor as this may indicate an allergic reaction and treatment should be discontinued.

During treatment with Colfinair, neurotoxicity may occur with a possibility of dizziness, confusion, or visual disturbances. If you experience adverse effects such as dizziness, confusion, or visual disturbances, or any not mentioned in this leaflet, inform your doctor.

Colfinair use with other medications

• Medications that may affect how your kidneys function. Taking these medications at the same time as Colfinair may increase the risk of kidney damage
• Medications that may affect the nervous system. Taking these medications at the same time as Colfinair may increase the risk of adverse effects on your nervous system
• Medications called muscle relaxants, often used during general anesthesia. Colfinair may increase the effects of these medications. If you are to receive general anesthesia, inform your anesthesiologist that you are using Colfinair.

If you have myasthenia gravis and are also taking other antibiotics called macrolides (such as azithromycin, clarithromycin, or erythromycin), or antibiotics called fluoroquinolones (such as ofloxacin, norfloxacin, and ciprofloxacin), taking Colfinair increases your risk of muscle weakness and respiratory difficulties even further.

Receiving colistimethate sodium as an infusion at the same time as receiving Colfinair as an inhalation may increase your risk of adverse effects.

Colfinair must not be mixed with any other medication in the nebulizer!

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

Colfinair has a moderate influence on your ability to drive and operate machinery. During treatment with Colfinair, neurotoxicity may occur with a possibility of dizziness, confusion, or visual disturbances. If you experience any adverse effects such as dizziness, confusion, or visual disturbances, do not drive or operate machinery and consult your doctor or pharmacist.

Colfinair is for inhalation use.

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

The recommended dose is:

Your doctor may decide to adjust the dose depending on your circumstances. If you are also taking other inhaled medications, your doctor will tell you in what order to take them.

Observe that Colfinair is also available in a 1 million UI vial, which may be a more suitable dose depending on the prescribed regimen by your doctor.

For use in children under 2 years of age, it is recommended to use PARI LC SPRINT Baby (red nozzle adapter with mask).

Your doctor will tell you how long your treatment with Colfinair will last. Do not stop treatment before time because when treating bacterial infections, it is essential to complete the full treatment course to reduce the risk of developing resistance to the infectious bacteria.

Preparation for inhalation treatment

If you are being treated at home, your doctor or nurse will show you how to use Colfinair in your nebulizer when you start this treatment.

How to prepare Colfinair for inhalation

Before you can introduce Colfinair into the nebulizer and inhale it, you must dissolve it with 3 ml of sterile inhalation solution of NaCl 0.9%. A vial contains the correct volume to dissolve Colfinair.

Colfinair must be used immediately after dissolution. Do not dissolve Colfinair until you are ready to administer a dose (see also section 5).

Step 5

• Add 4 ml of sterile inhalation solution of NaCl 0.9% to Colfinair 2 million UI (lavender tap)
• Replace the rubber stopper and turn the vial gently two times.
• Roll the vial gently between your hands to dissolve all the visible powder of Colfinair at the bottom and sides of the vial. Do not shake the vial too hard, as this can make the solution foam.
• Once most of the powder has dissolved, let the vial rest for the foam to disappear and the remaining powder to dissolve. This may take a few minutes.

Use Colfinair only when all the powder has dissolved and there are no visible particles in the solution.

How to use Colfinair

Colfinair is for inhalation use with a suitable nebulizer (e.g. eFlow rapid or PARI LC SPRINT).

Read the nebulizer usage instructions carefully for more information on handling the nebulization system.

It is essential that your nebulization system works correctly before starting treatment with Colfinair.

Place the components of your nebulizer on a flat and clean surface and follow the manufacturer's usage instructions.

Inhalation should be done in a well-ventilated room.

After inhaling Colfinair

Consult the manufacturer's usage instructions for the nebulizer for cleaning and disinfection.

If you use more Colfinair than you should

If you have used more Colfinair than you should, consult your doctor or pharmacist immediately. If you accidentally administer too much Colfinair, the effects can be severe and may include kidney problems, muscle weakness, and respiratory difficulty (even respiratory arrest).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 915 620 420 (indicating the medication and the amount ingested) or go to the nearest hospital.

If you forget to use Colfinair

If you are treating yourself and have forgotten a dose, administer the missed dose as soon as you remember and then the next dose 8 or 12 hours later and continue as instructed.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Colfinair

Do not stop using Colfinair as prescribed without consulting your doctor first.

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

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

A severe allergic reaction may occur. Even with the first dose, severe allergic reactions can include rapid onset of rashes, swelling of the face, tongue, and neck, inability to breathe due to narrowing of the airways, and loss of consciousness. Urgent medical attention is required.

If you think you have an allergic reaction to Colfinair, inform your doctor immediately.

Some side effects can be serious.

Very common: may affect more than 1 in 10 people.

• Chest tightness due to narrowing of the airways (may not always be a true allergic reaction)

Frequency not known: cannot be estimated from available data.

• Patients with severe renal impairment and at higher doses may experience side effects known for intravenous administration
• Confusion
• Psychotic disorder
• Visual disturbance
• Dizziness

If you experience any of these side effects, inform your doctor immediately..

Other possible side effects

Very common:may affect more than 1 in 10 people.

• Mouth or throat ulcers
• Cough
• Dyspnea
• Wheezing
• Worsening of pulmonary function test results
• Transient absence of spontaneous respiration

If any of these problems affect you severely, inform your doctor.

Frequency not known: cannot be estimated from available data.

• Subjective skin sensations
• Speech disorder
• Dizziness
• Renal insufficiency

Other possible side effects are candidiasis in the mouth or throat.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box or on the vial label after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Keep the vial within the outer cardboard packaging to protect it from light.

Colfinair solution for inhalation by nebulizer should be used immediately after preparation. If this is not possible, a Colfinair solution should be stored in the refrigerator (2°C - 8°C) and not more than 24 hours.

If not used immediately, storage conditions and times are the responsibility of the user.

All leftover solution must be discarded.

For single use only.

Medications should not be thrown away through drains. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Colfinair

• The active principle is colistimethate sodium.
• Each vial of 10 ml contains 2 million UI, which is approximately equivalent to 160 mg of colistimethate sodium.

Aspect of the product and content of the packaging

Colfinair is a powder for inhalation solution for nebulizer.

The product is available in the following packaging sizes:

Carton box containing:

• 8 carton boxes of 7 vials each (56 vials),
• 2 carton boxes of inhalation solution of NaCl 0.9% with 30 ampoules of 4 ml each (60 ampoules), and a handheld nebulizer eFlow rapid.

Marketing authorization holder and responsible manufacturer

PARI Pharma GmbH

Moosstrasse 3

82319 Starnberg

Germany

Tel.: +49 (0) 89/74 28 46 – 10

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

PARI Pharma Iberia S.L.

Miguel Yuste 17, 4aplanta C.

28037 Madrid

This medication is authorized in the member states of the European Economic Area with the following names:

GermanyColiFin 2 Millionen. I.E. Pulver zur Herstellung einer Lösung für einen Vernebler

NetherlandsColiFin PARI 2.000.000 IE Poeder voor verneveloplossing

AustriaColiFin 2 Mio. I. E. Pulver zur Herstellung einer Lösung für einen Vernebler

SpainColfinair 2millions ofUIpowder for inhalation solution for nebulizer

ItalyColfinair 2.000.000 U Powder for inhalation solution for nebulizer

Revision date of this prospectus: 05/2022

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/