Promixin
Italy
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
Promixin
1 Million International Units (IU)
Powder for solution for nebulizer
sodium colistimethate
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, nurse, physiotherapist, or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
- If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:
- What Promixin is and what it is used for
- What you need to know before taking Promixin
- How to take 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 for the treatment of chronic chest 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 adequately controlled, it will continue to damage the lungs, leading to further complications.
To administer Promixin, the powder contained in the vial must be dissolved with an appropriate diluent solution, sterile saline (salt water), or sterile water, and then inhaled into the lungs using any suitable nebulizing system, allowing a greater amount of antibiotic to act against the bacteria causing the infection.
2. What you need to know before taking Promixin
Under certain circumstances, your doctor may decide not to prescribe Promixin to you.
Do not use Promixin
- If you are allergic to colistimethate sodium, colistin, or other polymyxins.
If any of the following apply to you, consult your doctor before taking Promixin.
Warnings and precautions with Promixin – inform your doctor if:
- you have or have had kidney problems;
- you suffer from severe myasthenia gravis (a rare disease in which muscles are extremely weak and tire very quickly);
- you suffer from porphyria (a rare metabolic disorder some people have from birth);
- you suffer from asthma.
If any of these conditions apply to you, inform your doctor.
Particular care should be taken 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 effectiveness of Promixin.
- Medicines that may affect kidney function. If you take this type of medicine at the same time as Promixin, the risk of kidney damage may increase.
- Medicines that may affect the nervous system. If you take this type of medicine at the same time as Promixin, the risk of nervous system side effects may increase.
- Medicines known as muscle relaxants, often used during general anesthesia. Promixin may enhance the effects of these medicines. If you are given a general anesthetic, inform the anesthetist that you are using Promixin. If you have severe myasthenia gravis and are also taking other antibiotics known as 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.
If you receive colistimethate sodium simultaneously via infusion and inhalation, the risk of adverse effects may increase.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, if you suspect you may be pregnant, or if you are planning a pregnancy, consult your doctor or pharmacist before taking this medicine. There is no information available regarding the safety of using Promixin in pregnant women. Your doctor will advise you, weighing the benefits of using the medicine against the potential risks.
Colistimethate sodium may pass into breast milk. 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, do not drive and do not operate tools or machinery.
3. How to take Promixin
Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Inform your doctor if you have kidney problems, as you may need to take a lower dose of Promixin.
You must take the first dose of Promixin in the presence of your doctor or nurse.
Take Promixin after physiotherapy (if you undergo physiotherapy) to ensure your lungs are clear and Promixin can work effectively. If you are taking other inhaled medicines, your doctor will tell you the order in which you should take them.
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 a day (maximum 6 million units per day).
The recommended dose for children under 2 years of age is half or one vial (0.5–1 million units) twice a day (maximum 2 million units per day).
Your doctor may decide to adjust the dose depending on individual circumstances.
Promixin is inhaled using a device called a nebulizer. Promixin can be taken using any nebulizing system suitable for delivering the antibiotic as a mist into the lungs. In countries where the I-neb AAD is available, Promixin is supplied with a Promixin Disc so it can be used with the I-neb AAD system. To learn how to use Promixin with the I-neb system, read the instructions provided with the device. If you use a different nebulizer, ensure the room 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, it must be dissolved in sterile water, 0.9% sterile saline solution (salt water), or a solution made of half sterile water and half 0.9% sterile saline solution (salt water), as explained below. Your doctor or nurse will tell you the correct volume of liquid to add to each vial of Promixin and the number of vials of Promixin to prepare and use for each dose with the nebulizer.
- Locate the tab on the red plastic cap next to the arrow marked “FLIP UP”. Then, holding the vial in one hand and the plastic cap in the other, gently rotate the cap counterclockwise. Place your thumb under the tab and lift the cap to about 90° (see Figure 1).
- Hold the plastic cap as shown in Figure 2 and slowly open it by levering it up to nearly 180°.
- Rotate the vial so that the plastic cap faces you. Holding the cap in the center as shown, pull it downward and slightly to the right (Figure 3a) or left to break the metal seal on one side only (Figure 3b).
- Once the seal is broken, hold the vial firmly and remove the metal seal to fully expose the rubber stopper (Figure 4).
- Remove the rubber stopper from the Promixin vial by touching only the outer edge, and place the stopper upside down on a clean surface. Slowly add sterile water, 0.9% sterile saline solution, or the solution of sterile water and 0.9% sterile saline solution to the vial, according to the volume of liquid indicated by your doctor or nurse.
- Replace the rubber stopper and gently invert the vial twice (Figure 6).
- Gently swirl the vial between your hands to dissolve all visible Promixin powder at the bottom and sides of the vial (Figure 7). Do not shake the vial vigorously to avoid creating foam.
- After most of the powder has dissolved, wait 5–10 minutes to allow any foam to dissipate and any remaining powder to dissolve.
Pour the solution into the nebulizer and inhale immediately. If the solution cannot be used immediately, reapply the stopper to the vial and store it in the refrigerator for no more than 24 hours. Do not use solutions prepared more than 24 hours previously. For instructions on how to store or dispose of any unused product, see section 5 “How to store Promixin”.
If you take more Promixin than you should
If you realize you have taken more Promixin than recommended by your doctor (or if someone else has taken your Promixin), contact your doctor immediately.
If you have taken too much Promixin, the following symptoms may occur:
- Tingling or numbness around the lips and face
- Drowsiness, dizziness (vertigo)
- Difficulty speaking clearly
- Vision disturbances
- Confusion
- Mental confusion
- Flushing (reddening of the face)
If you forget to take Promixin
Take a 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 a missed dose.
If you stop taking Promixin
Do not stop treatment without consulting your doctor. Your doctor will advise you on the duration of treatment.
If you have any further questions about the use of this medicine, consult your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Promixin may sometimes cause allergic reactions such as rashes. If this occurs, you must
stop taking Promixin and inform your doctor immediately.
Inhaling Promixin through a nebulizer may cause some people to experience tightness in the
chest, shortness of breath, cough, or a sensation of not being able to breathe (sometimes
described as a choking sensation). For this reason, the first dose should be taken in the
presence of a doctor or nurse. Your doctor may also advise you to take a medicine to counteract
the sensation of breathlessness. Your doctor will monitor your breathing during visits.
Promixin may also affect the kidneys, particularly if the dose is high or if you are taking other
medicines that may affect the kidneys.
Sometimes Promixin may cause mouth ulcers or sore throat.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or
pharmacist. You can also report side effects directly via the national reporting system at
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you
can help provide more information on the safety of this medicine.
5. How to store 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 that month.
Unopened vials of Promixin do not require any special storage conditions.
Promixin does not contain preservatives. Once reconstituted, Promixin solutions should preferably be used immediately. If this is not possible, the solutions should be stored in a refrigerator for no longer than 24 hours. Do not use solutions prepared more than 24 hours previously.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Promixin contains
The active substance is colistimethate sodium.
Each vial contains 1 million International Units (IU) of colistimethate sodium, weighing
approximately 80 milligrams (mg). There are no other ingredients.
Description of the appearance of Promixin and contents of the pack
Promixin is a powder for solution for nebulizer, supplied as a white to off-white powder in a glass vial.
Promixin is supplied in packs containing 30 vials. In countries where the I-neb AAD is available, each pack also contains one Promixin Disc for use with the I-neb AAD system.
Marketing Authorization Holder
Zambon S.p.A.
Via Lillo del Duca 10
20091 Bresso (MI)
Italy
Selling Authorization Holder in Italy:
Zambon Italia S.r.l.
Via Lillo del Duca, 10
20091 Bresso, (MI)
Italy
Manufacturer
Xellia Pharmaceuticals ApS
Dalslandsgade 11
DK-2300
Copenhagen S
Denmark
This medicinal product is authorized in the European Economic Area Member States 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