COLFINAIR 2 MILLION IU POWDER FOR SOLUTION FOR NEBULIZER INHALATION

Introduction

Package Leaflet: Information for the User

Colfinair 2 million UIpowder for solution for inhalation by nebulizer

colistimethate sodium

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

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

1. What is Colfinair and what is it used for

Colfinair is administered by inhalation to treat chronic respiratory infections in patients with cystic fibrosis. Colfinair is used when these infections are caused by a specific bacterium called Pseudomonas aeruginosa.

2. What you need to know before you use Colfinair

Do not 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.

In premature infants and newborns, caution should be exercised when using Colfinair because the kidneys are not yet fully developed.

Coughing and chest tightness may lead to interruption. This can be alleviated with the use of 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, despite using a bronchodilator, you experience chest tightness, inform your doctor because this may indicate an allergic reaction and treatment should be discontinued.

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

Taking Colfinair with other medicines

• medicines that may affect how your kidneys work. Taking these medicines at the same time as Colfinair may increase the risk of kidney damage
• medicines that may affect the nervous system. Taking these medicines at the same time as Colfinair may increase the risk of side effects on your nervous system
• medicines called muscle relaxants, often used during general anesthesia. Colfinair may increase the effects of these medicines. If you are going to be given a general anesthetic, 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 the risk of muscle weakness and respiratory difficulties even more.

Receiving colistimethate sodium by infusion at the same time as receiving Colfinair by inhalation may increase your risk of experiencing side effects.

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

Pregnancy, breastfeeding, and fertility

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.

Driving and using machines

Colfinair has a moderate influence on the ability to drive and use machines. During treatment with Colfinair, neurotoxicity may occur with possible dizziness, confusion, or visual disturbances. If you experience any side effects such as dizziness, confusion, or visual disturbances, do not drive or use machines and consult your doctor or pharmacist.

3. How to use Colfinair

Colfinair is for inhalation use only.

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in 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 medicines, your doctor will tell you in what order to take them.

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

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

Your doctor will tell you how long your treatment with Colfinair will last. Do not stop treatment early because when treating bacterial infections, it is essential to complete the full course of treatment 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, it must be dissolved with 3 ml of sterile NaCl 0.9% solution for inhalation. An ampoule 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 NaCl 0.9% solution for inhalation to Colfinair 2 million UI (lavender cap)
• Replace the rubber stopper and gently turn the vial twice.
• Roll the vial gently between your hands to dissolve all visible Colfinair powder at the bottom and side of the vial. Do not shake the vial too hard, as this can cause the solution to foam.
• Once most of the powder has dissolved, let the vial sit for a few minutes to allow the foam to disappear and the remaining powder to dissolve.

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 only with a suitable nebulizer (e.g., eFlowrapidor PARI LC SPRINT).

Read the nebulizer's instructions for use carefully to obtain more information about handling the nebulization system.

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

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

Inhalation should be done in a well-ventilated room.

After inhaling Colfinair

Consult the manufacturer's instructions for use of the nebulizer for cleaning and disinfecting it.

If you use more Colfinair than you should

If you have used more Colfinair than you should, consult your doctor or pharmacist immediately. If too much Colfinair is administered accidentally, the effects can be severe and may include kidney problems, muscle weakness, and respiratory difficulty (even 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, you should take the forgotten dose as soon as you remember and then the next dose 8 or 12 hours later, and continue from then on as instructed.

Do not take a double dose to make up for forgotten doses.

If you stop using Colfinair

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

If you have any other questions about the use of 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.

An allergic reaction may occur. Severe allergic reactions can occur even with the first dose and may include rapid onset of rash, swelling of the face, tongue, and throat, inability to breathe due to narrowing of the airways, and loss of consciousness. Urgent medical attention will be needed.

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.

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

Frequency not known: cannot be estimated from the available data.

• Patients with severe kidney 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 effects, inform your doctor immediately.

Other possible side effects

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

• Sores in the mouth or throat
• Cough
• Breathing difficulties
• Wheezing
• Worsening of lung function test results
• Transient absence of spontaneous breathing

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

Frequency not known: cannot be estimated from the available data.

• Subjective skin sensations
• Speech disorder
• Dizziness
• Kidney failure

Other possible side effects include thrush in the mouth or throat.

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 Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es

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

5. Storage of Colfinair

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 carton or vial label after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

Keep the vial in the outer carton 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.

Any leftover solution should be discarded.

For single use only.

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. Contents of the pack and further information

Composition of Colfinair

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

Appearance and packaging of the product

Colfinair is a powder for solution for inhalation by nebulizer.

The product is available in the following pack sizes:

Carton box containing:

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

Marketing authorization holder and manufacturer

PARI Pharma GmbH

Moosstrasse 3

82319 Starnberg

Germany

Tel.: +49 (0) 89/74 28 46 – 10

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

PARI Pharma Iberia S.L.

Miguel Yuste 17, 4th floor C.

28037 Madrid

This medicine is authorized in the Member States of the European Economic Area under 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 2 million UI powder for solution for inhalation by nebulizer

ItalyColfinair 2.000.000 U Polvere per soluzione per nebulizzatore

Date of last revision of this leaflet: 05/2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/