Colistimethate sodium Noridem

PACKAGE LEAFLET

Package leaflet: Information for the user

Colistimetato sodico Noridem 1 million IU powder for solution for nebulization, 2 million IU powder for solution for nebulization

Sodium colistimethate
Equivalent medicine
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others. Even if their symptoms are the same as yours, it could be harmful.
• If you experience any side effect, contact your doctor. This includes possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Colistimetato sodico Noridem is and what it is used for

This medicine contains the active substance sodium colistimethate. Sodium colistimethate is an antibiotic. It belongs to a group of antibiotics called polymyxins.
This medicine is administered by inhalation to treat chronic lung infections in patients with cystic fibrosis. Colistimetato sodico Noridem is used when these infections are caused by a specific bacterium called Pseudomonas aeruginosa.

2. What you need to know before taking Colistimetato sodico Noridem

Do not use Colistimetato sodico Noridem

• if you are allergic to sodium colistimethate, colistin, or other polymyxins.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Colistimetato sodico Noridem if:

• you have had or currently have kidney problems
• you suffer from myasthenia gravis (a disease characterized by muscle weakness)
• you suffer from porphyria
• you suffer from asthma

Some people may experience a feeling of chest tightness due to airway constriction when inhaling Colistimetato sodico Noridem. Your doctor may prescribe other inhaled medications to be used immediately before or after Colistimetato sodico Noridem to prevent or treat this effect.
Children
Special caution should be exercised when using Colistimetato sodico Noridem in neonates and premature infants, as their kidneys are not yet fully developed.
Other medicines and Colistimetato sodico Noridem
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 Colistimetato sodico Noridem. Sometimes other medicines must be discontinued (even if only temporarily), or you may need a lower dose of Colistimetato sodico Noridem, or you may need to be monitored while taking this medicine. In some cases, your blood levels of Colistimetato sodico Noridem may need to be measured periodically to ensure you are receiving the correct dosage.

• Medicines such as antibiotics called aminoglycosides (including gentamicin, tobramycin, amikacin, and netilmicin) and cephalosporins, which may affect your kidney function. Taking these medicines together with Colistimetato sodico Noridem may increase the risk of kidney damage (see section 4 of this leaflet).
• Medicines such as antibiotics called aminoglycosides (including gentamicin, tobramycin, amikacin, and netilmicin) which may affect your nervous system. Taking these medicines together with Colistimetato sodico Noridem may increase the risk of adverse effects on the ear and other parts of your nervous system (see section 4 of this leaflet).
• Medicines called muscle relaxants, often used during general anesthesia. Colistimetato sodico Noridem may enhance the effect of these medicines. If you are undergoing general anesthesia, inform your anesthesiologist that you are taking Colistimetato sodico Noridem.

If you suffer from myasthenia gravis (muscle weakness) 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 Colistimetato sodico Noridem may further increase the risk of muscle weakness and breathing difficulties.
Receiving Colistimetato sodico Noridem by infusion at the same time as inhaled administration of Colistimetato sodico Noridem may increase the risk of adverse effects.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Small amounts of Colistimetato sodico Noridem may be excreted in breast milk; therefore, breastfeeding is not recommended. If you cannot stop breastfeeding while taking Colistimetato sodico Noridem, you should closely monitor your baby for any signs of illness and inform your doctor if you notice any abnormalities.
There are no data available on the potential impact of Colistimetato sodico Noridem on human fertility.
Driving and using machines
Sodium colistimethate may cause dizziness, confusion, or vision problems such as blurred vision. Do not drive or operate machinery if this occurs.
Colistimetato sodico Noridem contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e., essentially "sodium-free".

3. How to use Colistimethate Sodium Noridem

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Colistimethate Sodium Noridem is inhaled into the lungs as a nebulized spray using a
machine called a nebulizer. The droplets produced by the nebulizer are small enough
to reach the lungs, allowing Colistimethate Sodium Noridem to reach the site of bacterial infection.
The recommended dose for adults, adolescents, and children aged 2 years and older is 1–2 million units
two to three times a day (maximum 6 million units per day).
The recommended dose for children under 2 years of age is 0.5–1 million units twice daily
(maximum 2 million units per day).
Your doctor may decide to adjust the dosage based on your individual circumstances. If you are also
taking other inhaled medications, your doctor will advise you on the order in which to take them.

Method of administration
For inhalation use only.
If you are treating yourself at home, your doctor or nurse will show you how to use Colistimethate
Sodium Noridem with your nebulizer when starting treatment. You should sit upright with your back
straight and breathe normally during inhalation. The following are general instructions.

Preparation for inhalation treatment
Before Colistimethate Sodium Noridem can be used, it must be dissolved in isotonic physiological
solution (saline solution).
To begin your treatment, you will need the following:

• One clear glass vial of Colistimethate Sodium Noridem 1 million IU
• Solvent to dissolve the powder (3 ml of isotonic physiological solution)
• A suitable nebulizer for inhalation of Colistimethate Sodium Noridem 1 million IU (e.g., PARI LC PLUS, PARI LC SPRINT, or eFlow rapid)

To begin your treatment, you will need the following:

• One clear glass vial of Colistimethate Sodium Noridem 2 million IU
• Solvent to dissolve the powder (4 ml of isotonic physiological solution)
• A suitable nebulizer for inhalation of Colistimethate Sodium Noridem 2 million IU (e.g., PARI LC PLUS, PARI LC SPRINT, or eFlow rapid)

It is important that your nebulization system is functioning properly before starting treatment with
Colistimethate Sodium Noridem. Carefully read the instructions for use of your nebulizer for further
information on how to operate the nebulization system.
Place the components of your nebulizer on a clean, flat surface and follow the manufacturer’s
instructions for use.

Preparing your Colistimethate Sodium Noridem for inhalation
Colistimethate Sodium Noridem must be used immediately after reconstitution. Do not reconstitute
Colistimethate Sodium Noridem until you are ready to administer a dose (see also section 5).

Step 1: Take a vial of Colistimethate Sodium Noridem and gently tap the glass vial so that the powder
settles to the bottom. This helps ensure you receive the correct dose of the medicine.

Step 2: For Colistimethate Sodium Noridem 1 million IU: Add the solvent (3 ml of isotonic
physiological solution) to the corresponding vial to dissolve the powder.
For Colistimethate Sodium Noridem 2 million IU: Add the solvent (4 ml of isotonic physiological
solution) to the corresponding vial to dissolve the powder.
Gently shake until all the powder is completely dissolved, avoiding excessive foaming. Pour the
solution into the nebulizer. Do not use Colistimethate Sodium Noridem if you notice visible particles
in the solution after reconstitution.
Once prepared, Colistimethate Sodium Noridem must be used immediately. Any unused solution must
be discarded.

Using your Colistimethate Sodium Noridem
Colistimethate Sodium Noridem is for inhalation use only, using an appropriate nebulizer (e.g.,
PARI LC PLUS, PARI LC SPRINT, or eFlow rapid). For more detailed information on the correct use of
your chosen nebulizer, follow the manufacturer’s instruction manual. Inhalation should take place in a
well-ventilated room.

After inhaling Colistimethate Sodium Noridem
Please refer to the manufacturer’s instructions for your nebulizer regarding usage, cleaning, and
disinfection.
IMPORTANT: Do not mix Colistimethate Sodium Noridem with any other nebulization product at the same time.

Duration of treatment
Your doctor will advise you on the duration of your nebulization treatment.

If you take more Colistimethate Sodium Noridem than you should
If you think you have taken too much Colistimethate Sodium Noridem, contact your doctor or nurse
immediately for advice. If they are not available, contact or go to the nearest emergency department.
If an overdose of Colistimethate Sodium Noridem is accidentally administered, side effects may be
serious and may include kidney problems, muscle weakness, and breathing difficulties (or even
respiratory arrest).
If you are receiving treatment in hospital or at home from a doctor or nurse and think you may have
missed a dose or received too much Colistimethate Sodium Noridem, please ask your doctor, nurse, or
pharmacist for clarification.

If you forget to take Colistimethate Sodium Noridem
If you are self-administering the medicine and forget a dose, take the missed dose as soon as you
remember. Then take the next dose 8 hours later if you are using Colistimethate Sodium Noridem three
times a day, or 12 hours later if you are using it twice a day. Continue your treatment as directed. Do
not take a double dose to make up for a missed dose.

If you stop using Colistimethate Sodium Noridem
Do not stop treatment early unless instructed by your doctor. Your doctor will determine the duration
of treatment.
If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Allergic reactions
When Colistimetate sodium Noridem is administered by inhalation, an allergic reaction may occur. Severe allergic reactions can occur even after the first dose and may involve 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, you must stop using colistimethate sodium and
seek immediate medical attention.
Less severe allergic reactions include rashes appearing later during treatment.
The risk of side effects is usually much lower when colistimethate is administered by inhalation, as only a very small amount of Colistimetate sodium Noridem generally reaches the bloodstream when given this way. Possible side effects include cough, chest tightness due to narrowing of the airways, mouth or throat pain, and oral or throat fungal infections (Candida).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at https://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 Colistimethate Sodium Noridem

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 and on the
packaging after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

Reconstituted solution:
Hydrolysis of colistimethate is significantly increased when reconstituted and diluted below its critical micellar concentration of approximately 80,000 IU per ml.
Solutions below this concentration must be used immediately.
Chemical and physical in-use stability of the reconstituted solution in the original vial, at a concentration ≥ 80,000 IU/ml, has been demonstrated for:

• 1 million IU for 3 hours at 2-8°C when dissolved in 3 ml of sodium chloride solution 9 mg/ml (0.9%) for injection or water for injection.
• 2 million IU for 3 hours at 2-8°C when dissolved in 4 ml of sodium chloride solution 9 mg/ml (0.9%) for injection or water for injection.

From a microbiological standpoint, unless the method of opening/reconstitution/dilution excludes the risk of microbial contamination, the product should be used immediately.
If not used immediately, the user is responsible for the duration and conditions of storage.
Any residual solution must be discarded.
Do not dispose of medicines 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 Colistimetato sodico Noridem contains
The active substance is sodium colistimethate.
Each vial contains 1 million IU of sodium colistimethate.
Each vial contains 2 million IU of sodium colistimethate.
There are no other ingredients.

Description of the appearance of Colistimetato sodico Noridem and package contents
Colistimetato sodico Noridem powder for solution for nebuliser is supplied as a white or almost white powder in single-dose glass vials.

1 million IU: Clear type I glass vial closed with a 20 mm bromobutyl rubber stopper of type I, sealed with a 20 mm grey plastic snap-off cap and aluminium seal.
2 million IU: Clear type I glass vial closed with a 20 mm bromobutyl rubber stopper of type I, sealed with a 20 mm violet plastic snap-off cap and aluminium seal.
Pack sizes: 1, 10 and 30 vials.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Noridem Enterprises Limited
Evagorou & Makariou, Mitsi Building 3, Office 115,
1065 Nicosia, Cyprus

Manufacturer:
DEMO S.A. PHARMACEUTICAL INDUSTRY,
14568 Krioneri, Attiki, Greece,
T: +30 210 8161802, F: +30 210 8161587.

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany Colistimethat-Natrium Noridem 1 Million I.E. Pulver zur Herstellung einer Lösung für einen Vernebler
Colistimethat-Natrium Noridem 2 Millionen I.E. Pulver zur Herstellung einer Lösung für einen Vernebler
Ireland Colistimethate sodium 1 million IU Powder for nebuliser solution
Colistimethate sodium 2 million IU Powder for nebuliser solution
Czech Republic Colistimethate Noridem
Colistimethate Noridem
Greece KOLELANG 1 MIU Κόνις για διάλυμα για εισπνοή με εκνεφωτή
KOLELANG 2 MIU Κόνις για διάλυμα για εισπνοή με εκνεφωτή
Austria Colistimethat-Natrium DEMO 1 Mio. I.E. Pulver zur Herstellung einer Lösung für einen Vernebler
Colistimethat-Natrium DEMO 2 Mio. I.E. Pulver zur Herstellung einer Lösung für einen Vernebler
Poland Colistimethatum natricum Noridem
Colistimethatum natricum Noridem
Slovakia Colistimethate Noridem 1 MIU Prášok na roztok pre rozprašovač
Colistimethate Noridem 2 MIU Prášok na roztok pre rozprašovač