Promixin 1 million international units (UI), powder for solution for inhalation by nebulizer
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
PROMIXIN
1 million International Units (IU)
powder for solution
for nebulization
Colistimethate sodium
Read all of this 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 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.
Contents of the leaflet
- What Promixin is and what it is used for
- What you need to know before using Promixin
- How to use Promixin
- Possible side effects
- How to store Promixin
- Contents of the pack and other information
1. What Promixin is and what it is used for
Promixin contains the active substance sodium colistimethate, and is administered by inhalation to treat chronic respiratory infections in patients with cystic fibrosis. Promixin is used when these infections are caused by a specific bacterium called Pseudomonas aeruginosa.
This bacterium is very common and infects the lungs of almost all patients with cystic fibrosis at some point in their lives. If the infection is not properly controlled, it will continue to damage the lungs, leading to further complications.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.
It is important that you follow your doctor's instructions regarding dose, frequency, and duration of treatment.
Do not store or reuse this medicine. If you have any antibiotic left after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.
To administer Promixin, the powder in the vial must be dissolved with an appropriate solvent solution, sterile saline, or sterile water, and then inhaled into the lungs using a suitable inhalation device, so that most of the antibiotic reaches the bacteria causing the infection.
2. What you need to know before using Promixin
Under certain circumstances, your doctor may decide not to prescribe Promixin to you.
Do not use Promixin:
- If you are allergic (hypersensitive) to sodium colistimethate, colistin, or other polymyxins;
If you are in this situation, inform your doctor before starting Promixin.
Warnings and precautions with Promixin – inform your doctor:
- If you have or have had kidney problems;
- If you have myasthenia gravis (a rare condition in which your muscles are extremely weak and tire easily);
- If you have porphyria (a rare metabolic disorder some people are born with);
- If you have asthma.
If you are in any of these situations, inform your doctor.
Caution should be exercised when using Promixin in premature infants and newborns, as their kidneys are not yet fully developed.
Other medicines and Promixin:
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. These medicines may interfere with the effects of Promixin.
- Medicines that may affect how your kidneys function. Taking such medicines together with Promixin may increase the risk of kidney damage.
- Medicines that may affect the nervous system. Taking such medicines together with Promixin may increase the risk of adverse effects on your nervous system.
- Medicines known as muscle relaxants, often used during general anesthesia. Promixin may enhance the effects of these medicines. If you are to receive general anesthesia, inform your anesthetist 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 known as fluoroquinolones (such as ofloxacin, norfloxacin, and ciprofloxacin), taking Promixin further increases the risk of muscle weakness and breathing difficulties.
Receiving sodium colistimethate by intravenous infusion at the same time as receiving Promixin by inhalation may increase your risk of experiencing adverse effects.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, if you think you may be pregnant, or if you are planning to have a baby, consult your doctor or pharmacist for advice on using this medicine.
There is no information available on the safety of Promixin in pregnant women. Your doctor should advise you before using Promixin when the benefits of the medicine outweigh the risks.
Sodium colistimethate may be excreted in breast milk. Please discuss the use of Promixin with your doctor.
Driving and using machines
Promixin may cause dizziness, confusion, or vision problems such as blurred vision. If this occurs, you must not drive or operate tools or machinery.
3. How to use Promixin
Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Consult your doctor if you have kidney problems, as you may require a lower dose of Promixin.
You should take your first dose of Promixin in the presence of your doctor or nurse.
Use Promixin after physiotherapy (if you are receiving physiotherapy). This will ensure your lungs are clear so that Promixin can work effectively. If you are also taking other inhaled medicines, your doctor will advise you on the order in which they should be taken.
The recommended dose for adults, adolescents, and children aged 2 years and older is 1–2 vials (1–2 million units) two or three times daily (maximum 6 million units per day).
The recommended dose for children under 2 years of age is half to one vial (0.5–1 million units) twice daily (maximum 2 million units per day).
Your doctor may decide to adjust the dose depending on your individual circumstances.
Promixin is inhaled using a device called a nebulizer. Promixin can be administered using any nebulization system suitable for delivering antibiotics to the lungs in mist form. 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 into the nebulizer and inhaling it, you must first dissolve it with sterile water, 0.9% sterile saline solution, or a mixture of equal parts sterile water and 0.9% sterile saline solution, as described below. Your doctor or nurse will tell you the correct volume of liquid to add to each vial of Promixin and how many vials of Promixin you should use for each dose with your nebulizer.
- Locate the edge on the red plastic cap near the arrow marked “FLIP UP”. Holding the vial in one hand and the plastic cap in the other, turn the cap slightly counterclockwise. Place your thumb under the edge and push the cap upward by about 90° (see diagram 1).
- Hold the plastic cap as shown in diagram 2 and slowly pull it up like a hinge until it is almost 180°.
- Turn the vial so that the plastic cap faces you. Holding the cap in the center as shown, pull it downward and slightly twist either to the right (diagram 3a) or to the left (diagram 3b) so that the metal seal breaks on one side only.
- Once the seal is broken, hold the vial firmly and remove the metal seal completely to expose the entire rubber stopper (diagram 4).
-
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. Gradually add sterile water, 0.9% sterile saline solution, or the mixture of sterile water and 0.9% sterile saline solution to the vial until the liquid reaches the volume specified by your doctor or nurse.
-
Replace the rubber stopper and gently invert the vial twice (diagram 6).
- Gently roll the vial between your hands to dissolve all visible Promixin powder at the bottom and sides of the vial (diagram 7). Do not shake the vial too vigorously, as this may cause foaming.
- Once most of the powder has dissolved, let the vial stand for 5–10 minutes to allow any foam to dissipate and any remaining powder to dissolve completely.
Pour the solution into the nebulizer and inhale immediately. If immediate use is not possible, recap the vial and store it in the refrigerator for no more than 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, stating the medicine and the amount ingested.
Symptoms of using too much Promixin may include:
- tingling or numbness around the lips and face
- dizziness and vertigo
- slurred speech
- visual disturbances
- confusion
- mental disturbances
- flushing (redness of the face)
If you forget to use Promixin
Take your dose as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for a missed one.
If you stop using Promixin
Do not stop your treatment early unless your doctor tells you to do so.
Your doctor will advise you on the duration of your treatment.
If you have further questions about the use of this medicine, ask your doctor or nurse.
4. Possible adverse effects
Like all medicines, this medicine can have adverse effects, although not everyone will experience them.
Promixin may sometimes cause allergic reactions such as skin rashes. If this occurs, you should stop using Promixin and inform your doctor immediately.
Inhaling Promixin via a nebulizer may cause some people to experience chest tightness, wheezing, cough, or a sensation of breathlessness (sometimes described as a choking sensation). 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 medicine to help prevent breathing difficulties. Your doctor should review your breathing during visits.
Promixin may also affect the kidneys, usually if the dose is high or if you are taking other medicines that can affect the kidneys.
Promixin may sometimes cause pain in the mouth or throat.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Promixin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton after Exp. The expiry date refers to the last day of the month indicated.
Unopened vials of Promixin do not require special storage conditions.
Promixin does not contain preservatives. Once reconstituted, Promixin solutions should preferably be used immediately. If this is not possible, the solutions must not be stored for longer than 24 hours in a refrigerator. Do not use any solution that has been prepared for more than 24 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Promixin
The active substance is colistimethate sodium.
Each vial contains 1 million International Units (IU) of colistimethate sodium, which weighs approximately 80 milligrams (mg). It contains no other components.
Appearance of the product and contents of the pack
Promixin is a powder for solution for inhalation by nebulizer, supplied as a white or almost white powder in a glass vial.
Promixin is supplied in packs containing 30 vials.
Marketing Authorization Holder
Zambon S.p.A.
Via Lillo del Duca 10
20091 Bresso (MI) – Italy
Tel: +39 02 665241
e-mail: [email protected]
Manufacturer responsible
Xellia Pharmaceuticals ApS
Dalslandsgade 11,
DK- 2300, Copenhagen S, Denmark.
You can request further information about this medicine by contacting the local representative of the Marketing Authorization Holder
Zambon S.A.U.
Maresme 5. Pol. Can Bernades-Subirà
08130 Sta. Perpètua de Mogoda – Barcelona
Tlf: 93 544 64 00
Fax: 93 574 04 36
This medicine is authorized in the European Economic Area countries 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
Date of latest revision of this leaflet: June 2022
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.