Prospecto: information for the user

PROMIXIN

1 million of International Units (UI)

powder for solution

for inhalation by nebulizer

Colistimethate sodium

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What isPromixinand for what it is used

2. What you need to know before starting to usePromixin

3. How to usePromixin

4. Possible adverse effects

5. Conservation ofPromixin

6. Contents of the package and additional information

Promixin contains the active ingredient colistimethate sodium, andis administered by inhalation to treatchronic respiratory infectionsin patients with cystic fibrosis. Promixin is used when such infections are causedby a specific type of bacteriacalledPseudomonas aeruginosa.

This is a very common type of bacteria that infects the lungs of almost all patients with cystic fibrosis at some point in their lives. If the infection is not controlled properly, it will continue to damage the lungs and cause further problems.

To administer Promixin, the powder contained in the vial must be dissolved with an appropriate dissolving solution, sterile saline solution, or sterile water, and thenaspirated (inhaled) into the lungs using an appropriate inhalation device, so that the majority of the antibiotic can target the bacteria causing the infection.

In certain circumstances, your doctor may decide not to prescribe Promixin for you.

Do not use Promixin:

• If you areallergic(hypersensitive) to colistimethate sodium,colistin, orother polymyxins;

If you are in this situation, inform your doctor before starting to take Promixin.

Warnings and precautions with Promixin and inform your doctor:

• If you have or have hadkidney problems;
• If you havemyasthenia gravis(a rare disease in which your muscles are extremely weak and tire quickly);
• If you haveporphyria(a rare metabolic disorder that some people are born with);
• If you haveasthma.

If you are in any of these situations, inform your doctor.

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

Other medications and Promixin:

Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medication.These medications may interfere with the effects of Promixin.

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

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 Promixin increases your risk of muscle weakness and respiratory difficulties even more.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist for advice on the use of this medication.

There is no information on the safety of Promixin in pregnant women. Your doctor should advise you before using Promixin when the benefits of the medication outweigh the risks.

Colistimethate sodium may be secreted in breast milk. Please discuss the use of Promixin with your doctor.

Driving and operating machinery

Promixin may cause dizziness, confusion, or vision problems, such as blurred vision. If this happens, do not drive or use tools or machines.

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

Consult your doctor if you havekidney problems, as you may need a lower dose of Promixin.

You should use yourfirst doseof Promixin in the presence of your doctor or nurse.

Use Promixinafter physical therapy(if you have physical therapy).This will ensure that your lungs are clear so that Promixin can work effectively.If you are also taking other inhaled medications, your doctor will indicate in what order you should take them.

The recommended dose in adults, adolescents, and children 2 years of age or older is1-2 vials(1-2 million units)two or three times a day(up to 6 million units per day).

The recommended dose in children under 2 years of age is half to 1 vial (0.5-1 million units) two times a day (up to 2 million units per day).

Your doctor may decide to adjust the dose depending on your circumstances.

Promixin is inhaled from a device called a nebulizer. Promixin can be administered using any nebulization system that can be used to release antibiotics in the lungs in the form of a mist.In countries where the I-neb AAD system is available,Promixin is presented with a Promixin Disk that can be used with the I-neb AAD system. For information on using Promixin with the I-neb system, consult the detailed instructions provided with the device. If you use a different nebulizer, make sure the room you are in is well ventilated.

How to prepare Promixin

Your doctor or nurse will show you how to prepare and use Promixin with the nebulizer.

Before placing Promixin in the nebulizer and inhaling it, you must first dissolve it withsterile water, sterile 0.9% saline solution, ora 1:1 mixture of sterile water and sterile 0.9% saline solutionas indicated below.Your doctor or nurse will indicate the correct volume of liquid to add to each vial of Promixin and how many vials of Promixin to use for each dose with your nebulizer.

1)Locate the tab on the red plastic cap near the arrow with the "FLIP UP" mark. Then, holding the vial with one hand and the plastic cap with the other,turn the cap a little counterclockwise.Place your thumb under the tab and push the cap up about 90° (see diagram 1).

2)Take the plastic cap as shown in the diagram 2 and pull it slowly, like a hinge, until almost 180°.

3)Turn the vial so that the plastic cap is facing you. Holding the cap by the center as shown,pull it down and turn it slightly to the right (diagram 3a) or to the left to break the metal seal only on one side (diagram 3b).

4)Once the seal is broken, hold the vial firmly and remove the metal seal to expose the entire rubber stopper (diagram 4).

5) Remove the rubber stopper from the Promixin vial by holding only the outer edge of the stopper and place it upside down on a clean surface. Add sterile water, sterile 0.9% saline solution, or a 1:1 mixture of sterile water and sterile 0.9% saline solution to the vial,until you reach the volume of liquid indicated by your doctor or nurse.

6)Put the rubber stopper back and turn the vial upside down carefully two times (diagram 6).

7)Roll the vial carefully between your hands to dissolve all the visible Promixin powder at the bottom and side of the vial (diagram 7). Do not shakethe vial too hard as this could cause the solution to foam.

8)When most of the powder has dissolved, leave the vial to rest for 5-10 minutes to allow any foam to disappear and for any remaining powder to dissolve.

Empty the solution into the nebulizer and inhale immediately.If it is not possible to use the solution immediately, reseal the vial and store it in the refrigerator for a maximum of 24 hours.Do not use any solution that has been prepared for more than 24 hours.See section 5 "Storage of Promixin" for instructions on how to store or dispose of any unused Promixin.

If you use more Promixin than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of using too much Promixin may include:

• tingling or numbness around the lips and face
• dizziness and sensation of vertigo
• slurred speech
• visual disturbances
• confusion
• mental alteration
• flushing (redness of the face)

If you forget to use Promixin

Apply your dose as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed dose.

If you stop using Promixin

Do not stop your treatment prematurely unless your doctor tells you to.

Your doctor will tell you the duration of your treatment.

If you have any questions about the use of this medication, ask your doctor or nurse.

Like all medications, this medication may have adverse effects, although not everyone will experience them.

Promixin may sometimes produce allergic reactions, such asskin eruptions. If this occurs, you shouldstop using Promixinand inform your doctor immediately.

Inhaling Promixin through a nebulizer may cause some people to experiencechest tightness, wheezing, coughing, or a sensation of lacking air (sometimes described as a sensation of choking). For this reason, the first dose should be administered in the presence of your doctor or nurse. Your doctor may also advise you to take a medication to prevent breathing difficulties. Your doctor should monitor your breathing during visits.

Promixin may also affect thekidneys, generally if the dose is high or if you are taking other medications that may affect the kidneys.

Promixin may sometimes causemouth or throat pain.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance for Human Use Medications:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the vial and on the box after Expiration Date. The expiration date is the last day of the month indicated.

Unopened vials of Promixin do not require special storage conditions.

Promixin does not contain preservatives. Once prepared, Promixin solutions should be used preferably immediately. If this is not possible, solutions should not be stored for a period exceeding 24 hours in a refrigerator.Do not use any solution that has been prepared for more than 24 hours.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of containers and medications that you no longer need. This will help protect the environment.

Composition of Promixin

The active principle is colistimethate sodium.

Each vial contains 1 million International Units (UI) of colistimethate sodium, weighing approximately 80 milligrams (mg). It does not contain other components.

Appearance of the product and contents of the packaging

Promixin is a powder for inhalation solution for nebulizer, supplied as a white or off-white powder in a glass vial.

Promixin is supplied in containers containing 30 vials.In countries where the I-neb AAD system is available,each container also contains a Promixin Disk for use with the I-neb AAD system.

Marketing Authorization Holder

Zambon S.p.A.

Via Lillo del Duca 10

20091 Bresso (MI) – Italy

Phone: +39 02 665241

Email: [email protected]

Responsible for Manufacturing

Xellia Pharmaceuticals ApS

Dalslandsgade 11,

DK- 2300, Copenhagen S, Denmark.

For further information about this medicine, please contact the local representative of the marketing authorization holder

Zambon S.A.U.

Maresme 5. Pol. Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda – Barcelona

Phone: 93 544 64 00

Fax: 93 574 04 36

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Netherlands, Sweden, France: Tadim

Germany, Denmark, Norway, United Kingdom (Northern Ireland), Italy, Spain, Portugal: Promixin

Last review date of this leaflet: June 2022

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