Pseudoneb

Package leaflet: Information for the user

PSEUDONEB 1 million or 2 million International Units

Powder for injectable solution, for infusion or for inhalation
Sodium colistimethate
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor.

Contents of this leaflet:

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

1. What Pseudoneb is and what it is used for

Pseudoneb contains the active substance colistimethate sodium. Colistimethate sodium is an antibiotic belonging to the class of so-called polymyxins.
Pseudoneb works by killing certain types of bacteria that can cause various infections in people. Like all antibiotics, Pseudoneb is effective only against certain types of bacteria, and is therefore suitable for treating only specific types of infections.

• Pseudoneb can be used to treat chest infections in adults and children with cystic fibrosis when these infections are caused by a bacterium called Pseudomonas aeruginosa. Pseudoneb is usually administered to these patients by inhalation (via nebulisation), meaning that patients inhale fine droplets of Pseudoneb solution as a mist, allowing the medicine to enter the lungs and reach the areas where bacteria are causing the infection.
• Occasionally, Pseudoneb is given by intravenous infusion to adults and children as a solution to treat serious infections caused by certain types of bacteria. These infections include some types of pneumonia and infections of the bladder and kidneys. Pseudoneb is not commonly used to treat these types of infections but may be used when, for some reason, other antibiotics are unsuitable – for example, if the infected person is allergic to other types of antibiotics or if the bacteria are resistant to those antibiotics.

2. What you need to know before using Pseudoneb

Do not use Pseudoneb:

• if you are allergic to Pseudoneb (also known as colistin or sodium colistimethate) or to another antibiotic called polymyxin B
• if you have myasthenia gravis (a disease causing muscle weakness and excessive fatigue).

Warnings and precautions

• Consult your doctor before using Pseudoneb if you have porphyria (a rare, often hereditary disease).
• Consult your doctor before using Pseudoneb if you have kidney problems.
• During inhalation of Pseudoneb, some people may experience a sensation of tightness in the chest due to narrowing of the airways. To prevent or treat this sensation, your doctor may prescribe other inhaled medicines to be used just before or immediately after Pseudoneb.

Other medicines and Pseudoneb
Inform your doctor if you are taking, have recently taken, or might take any other
medicines.
If you are taking any of the following medicines, you may or may not be able to take
Pseudoneb. Sometimes other medicines must be stopped (even if only temporarily), or
the dose of Pseudoneb may need to be reduced, or you may need to be monitored
during treatment with Pseudoneb. In some cases, it may be necessary to periodically measure
the levels of Pseudoneb in your blood to ensure you are receiving the correct dose.

• Are you taking other antibiotics called aminoglycosides (including gentamicin, tobramycin, amikacin, and netilmicin)? Concomitant administration of Pseudoneb with an antibiotic belonging to the aminoglycoside class may increase the risk of kidney problems or cause adverse effects on the ear and other parts of the nervous system (see section 4 of this leaflet).
• Are you taking other antibiotics called cephalosporins? Concomitant use of cephalosporins and Pseudoneb may increase the risk of kidney problems.
• Are you taking muscle relaxants? Muscle relaxants are generally used in general anesthesia; therefore, before undergoing surgery, make sure to inform the anesthetist that you are taking Pseudoneb. Concomitant use of a muscle relaxant and Pseudoneb may increase and prolong muscle relaxation effects.
• If for any reason you are likely to be given ether (a substance sometimes used as an anesthetic), inform your doctor that you are also taking Pseudoneb.

Pregnancy and breastfeeding
It is not known whether Pseudoneb has harmful effects on the fetus, but, like all medicines, it should be
administered to pregnant women only if clearly needed. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine.
Are you breastfeeding? Small amounts of Pseudoneb pass into breast milk. If you cannot stop breastfeeding during treatment with Pseudoneb, you must closely monitor your child for signs of illness and inform your doctor if you notice anything unusual.
Driving and using machines
If Pseudoneb is administered intravenously, side effects such as dizziness, confusion, or vision problems may occur. If this happens, you must not drive or operate machinery.

3. How to use Pseudoneb

Depending on the reason for which it has been prescribed to you (see section 1 of this leaflet), Pseudoneb
may be administered either by rapid injection (lasting 5 minutes, via a special tube inserted into a vein) or by slow injection (infusion lasting approximately 30 minutes) into a vein.
Pseudoneb can also be inhaled into the lungs as a fine spray through a device called a nebulizer. The spray droplets produced by the nebulizer are sufficiently small to penetrate into the lungs, allowing Pseudoneb to reach the site of bacterial infection.
Always use Pseudoneb exactly as your doctor has instructed. If you have any doubts, consult your doctor.

For use in a nebulizer
Dose

• When Pseudoneb is to be administered by inhalation via a nebulizer, the usual dose for children under two years of age is between 500,000 and 1 million units twice daily.
• For most older children and adults, the dose is 1 or 2 million units twice daily, up to a maximum of 2 million units three times daily.

Method of administration
If you are being treated at home, your doctor or nurse will show you how to use Pseudoneb with the nebulizer before you start treatment. The following instructions are general guidelines.
Lift off the plastic cap and carefully remove the metal seal around the top of the vial, taking care to remove it completely. Carefully pull out the rubber stopper and add sterile water or sterile saline solution to each vial to dissolve the powder as follows:
1 million units/vial: 2 ml of sterile water/saline solution
2 million units/vial: 4 ml of sterile water/saline solution
Then pour the solution into the nebulizer.
IMPORTANT: Do not mix Pseudoneb with any other nebulized product at the same time.

For intravenous infusion or injection
Dose
When Pseudoneb is administered intravenously to treat serious infections (see section 1 of this leaflet), the dose is determined based on the patient's age, body weight, kidney function, and the type of infection being treated.

• The usual dose for children and adults weighing up to 60 kg is 50,000–75,000 units per kilogram of body weight per day. This dose is divided into three doses given approximately every 8 hours.
• The usual dose for patients weighing more than 60 kg is 1 to 2 million units three times daily, approximately 8 hours apart. The maximum dose is 6 million units per day.

Lower doses are generally required for patients with kidney problems, as the recommended usual dose may increase blood levels of Pseudoneb, thereby increasing the risk of certain adverse effects.
Your doctor may take blood samples and perform tests to ensure that the prescribed dose of Pseudoneb is appropriate.
Sometimes, it may also be necessary to monitor Pseudoneb levels in the blood of newborns and patients with cystic fibrosis.

Method of administration
Pseudoneb is usually administered by injection primarily in a hospital setting. If you are being treated at home, your doctor or nurse will show you how to dissolve the powder and correctly inject the proper dose of solution.

Treatment duration
Your doctor will decide how long the treatment should last. For intravenous infusion or injection, a minimum treatment duration of 5 days is recommended. For the treatment of infections in patients with cystic fibrosis using infusion or injection, treatment should continue for up to 12 days. For nebulized solution use, your doctor will provide guidance on the course of treatment.
When treating bacterial infections, it is important to complete the full course of therapy to prevent worsening of the existing infection.

If you use more Pseudoneb than you should
If you think you have administered too much Pseudoneb, contact your doctor or nurse immediately, or if they are unavailable, contact or go to the nearest hospital. If an overdose of Pseudoneb is accidentally administered, serious adverse effects may occur, including kidney problems, muscle weakness, breathing difficulties, or even respiratory arrest.
If you are being treated in a hospital or at home under the supervision of a doctor or nurse and you suspect that you may have missed a dose or received an overdose of Pseudoneb, contact your doctor, nurse, or pharmacist.

If you forget to use Pseudoneb
If you self-administer Pseudoneb and have missed a dose, take the missed dose as soon as you remember, then take the next dose 8 hours later if you are using Pseudoneb three times daily, or 12 hours later if you are using it twice daily. Continue following your regular schedule. Do not take a double dose to make up for a missed dose.

If you stop using Pseudoneb
Do not stop treatment prematurely unless your doctor tells you to do so. Your doctor will determine the duration of treatment. If you have any questions about using this medicine, consult your doctor.

4. Possible side effects

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

Allergic reactions

Pseudoneb administered intravenously or by inhalation may cause an allergic reaction. Severe allergic reactions may occur even after the first dose and may include rapid onset of skin rashes, swelling of the face, tongue and neck, difficulty breathing due to narrowing of the airways, and loss of consciousness.

If you experience signs of an allergic reaction, seek immediate medical attention.

Less severe allergic reactions include skin rashes that may appear later during treatment.

Side effects associated with intravenous injection of Pseudoneb

Nervous system side effects are more likely to occur when the dose of Pseudoneb is too high, in patients with kidney problems, or in those taking muscle relaxants or other medicines with similar effects on nerve function.

The most serious of these possible nervous system side effects is the inability to breathe due to paralysis of the chest muscles. If you experience difficulty breathing, seek immediate medical attention.

Other possible side effects include numbness or tingling (especially around the face), dizziness or loss of balance, rapid changes in blood pressure or blood flow (including fainting and flushing), difficulty speaking, vision problems, confusion, and mental disturbances (including loss of touch with reality). Injection site reactions such as irritation may also occur.

Kidney problems may also occur. These are more likely in patients who already have kidney problems, in those receiving Pseudoneb together with other medicines that may cause kidney-related side effects, or in those receiving an excessive dose of Pseudoneb. These problems generally improve when treatment is stopped or the dose of Pseudoneb is reduced.

If you experience any side effect, including those not listed in this leaflet, consult your doctor.

Side effects associated with inhalation of Pseudoneb (nebulization)

When administered by inhalation, the risk of side effects is generally much lower because, with this route of administration, only a minimal amount of Pseudoneb reaches the bloodstream.

Possible side effects include cough, a sensation of tightness in the chest due to narrowing of the airways, mouth inflammation or sore throat, and oral or throat fungal infections (Candida).

If you experience any side effect, including those not listed in this leaflet, consult your doctor.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pseudoneb

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label after
Exp.. The expiry date refers to the last day of that month.
Do not store the vials at temperatures above 25°C.
Keep the vials in the outer packaging to protect the medicine from light.
Pseudoneb injectable solution must be used immediately after preparation.
Pseudoneb inhalation solution should preferably be administered immediately. If this is not
possible, the solutions must not be refrigerated for more than 24 hours. Discard
any remaining solution.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Pseudoneb contains
Each vial contains the active substance sodium colistimethate (also known as colistin) in powder form, in an amount equivalent to 1 or 2 million units. It contains no other ingredients. This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is practically 'sodium-free'.

Description of the appearance of Pseudoneb and contents of the pack
Pseudoneb, powder for solution for injection, infusion or inhalation, is a white to cream-coloured powder in single-dose vials of:

• 1 million units of sodium colistimethate per vial: red cap (1.0 MUI)
• 2 million units of sodium colistimethate per vial: lilac cap (2.0 MUI).

Each carton contains ten vials.

Marketing Authorization Holder
TEVA ITALIA SRL
PIAZZALE LUIGI CADORNA, 4
20123 MILAN, ITALY

Responsible manufacturer for batch release
Penn Pharmaceutical Services
Tredegar
Gwent
NP22 3AA
United Kingdom