Leaflet: information for the user

Colistimethate sodium Altan Pharma 1 million IU powder for injectable solution and for infusion

Read 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, consult your doctor, pharmacist or nurse.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Content ofthe leaflet

1. What is Colistimethate sodium Altan Pharma and what it is used for

2. What you need to know before starting to use Colistimethate sodium Altan Pharma

3. How to use Colistimethate sodium Altan Pharma

4. Possible side effects

5. Storage of Colistimethate sodium Altan Pharma

6. Contents of the package and additional information

This medication is an antibiotic belonging to the group of polymyxins.

Colistimete Sulfate Altan Pharma is an antibiotic that can be used:

• By intravenous route. It is administered through injection to treat certain types of severe infections caused by certain bacteria. Colistimete Sulfate Altan Pharma is used when other antibiotics are not suitable.

• By inhalation route. It is administered in the form of inhalation to treat chronic respiratory infections in patients with cystic fibrosis. Colistimete Sulfate Altan Pharma is used when such infections are caused by a specific bacteria calledPseudomonas aeruginosa.

No use Colistimethate Sodium Altan Pharma

If you are allergic (hypersensitive) to colistimethate sodium, colistin, or other polymyxins.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Colistimethate Sodium Altan Pharma

• If you have or have had kidney problems.
• If you have myasthenia gravis.
• If you have porphyria.
• If you have asthma (in inhalation use).

Special caution should be taken when using Colistimethate Sodium Altan Pharma in premature children and newborns, as their kidneys are not yet fully developed.

If you experience muscle spasms, fatigue, or increased urine production at any time, inform your doctor immediately, as these episodes may be related to a condition known as pseudo-Bartter syndrome.

Use of Colistimethate Sodium Altan Pharma with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Inform your doctor if you are using:

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

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 Colistimethate Sodium Altan Pharma increases the risk of muscle weakness and respiratory difficulties even further.

Receiving Colistimethate Sodium Altan Pharma as a perfusion at the same time as receiving Colistimethate Sodium Altan Pharma as an inhalation may increase your risk of adverse effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Colistimethate Sodium Altan Pharma should only be administered to pregnant patients if the expected benefit outweighs any potential risk.

Breastfeeding should be discontinued during treatment with Colistimethate Sodium Altan Pharma, as this medication may pass into breast milk.

Driving and operating machinery

Colistimethate Sodium Altan Pharma may cause dizziness, confusion, or visual problems, so you should not drive or use any hazardous tools or machinery in these cases.

Colistimethate Sodium Altan Pharma contains sodium

This medication contains less than 23 mg (1 mmol) of sodium per dose, which is essentially "sodium-free".

• Intravenous route:

Your doctor has prescribed Colistimethate sodium Altan Pharma as an infusion through a vein for 30 to 60 minutes.

The usual dose in adults is 9 million units, divided into two or three doses. If you are quite ill, you will be given a single dose of 9 million units at the start of treatment.

In some cases, your doctor may decide to give you a higher daily dose of up to 12 million units.

The usual daily dose in children weighing up to 40 kg is 75,000 to 150,000 units per kilogram of body weight, divided into three doses.

In cases of cystic fibrosis, higher doses have been administered on occasion.

Children and adults with kidney problems, including those on dialysis, are usually given lower doses.

Your doctor will regularly monitor your renal function while you are receiving Colistimethate sodium Altan Pharma.

• Inhalation route:

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

The usual dose in children under 2 years of age is 0.5 – 1 million units, twice a day (up to 2 million units per day).

Your doctor may adjust the dose based on your circumstances. If you are also taking other inhaled medications, your doctor will instruct you on the order in which to administer them.

If you use more Colistimethate sodium Altan Pharma than you should

If you have used more Colistimethate sodium Altan Pharma than you should, you may experience breathing difficulties, muscle weakness, and kidney function problems.

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

If you forget to use Colistimethate sodium Altan Pharma

Do not take a double dose to make up for the missed doses.

If you are receiving this medication intravenously and it has not been more than 3 hours since you should have received your dose, you can request that the dose be administered to you. If more than 3 hours have passed since the missed dose, wait until the next scheduled administration.

If the administration is via inhalation, take the missed dose as soon as you remember and continue with the next scheduled dose normally.

If you interrupt treatment with Colistimethate sodium Altan Pharma

Your doctor will inform you of the duration of treatment with Colistimethate sodium Altan Pharma. Do not discontinue treatment prematurely, as there is a risk of the infection recurring.

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

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

The observed side effects have been classified by organs and systems and by frequencies using the following convention: very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people); frequency not known (cannot be estimated from available data).

In the case of colistimethate sodium, these affect mainly the nervous system and kidney function. The most common side effects after nebulization are cough and difficulty breathing.

Side effects possible after intravenous administration:

After intravenous administration, you may experience the following symptoms that may be related to a known disease called pseudo-Bartter syndrome (see section 2):

- muscle spasms

- increased urine production

- fatigue

Side effects possible after inhalation administration:

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store below 25°C.

Once reconstituted, this medication must be used immediately.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe any visible sign of deterioration.

Medications should not be disposed of through drains or in the trash. This will help protect the environment.

Composition of Colistimethate Sodium Altan Pharma

The active ingredient is colistimethate sodium. Each vial contains 1 Million International Units (1 MUI) which is approximately equivalent to 80 mg of colistimethate sodium.

Appearance of the product and contents of the package

Powder for injectable solution and for infusion.

White powder.

Each package contains 10 vials. The vials are type I glass, with a bromobutyl stopper and an aluminum flip-off cap.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the Marketing Authorization:

Altan Pharmaceuticals S.A.

C/ Cólquide, nº 6. Portal 2, 1st floor. Office F Edificio Prisma 28230 - Las Rozas (Madrid) - Spain

Responsible for Manufacturing:

Altan Pharmaceuticals S.A.

Avda. de la Constitución 198-199, Polígono Industrial Monte Boyal

45950 Casarrubios del Monte (Toledo) – Spain

Date of the last review of this leaflet: June 2023

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

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This information is intended solely for healthcare professionals:

Intravenous route:

Injection

Reconstitute the contents of the vial with a maximum of 10 ml of water for injectable preparations or sodium chloride 0.9%.

Infusion

To administer this medication by infusion, the reconstituted vial must be diluted in a volume of 50 ml.

Compatible infusion solutions are: sodium chloride 0.9%.

To reconstitute, a sodium chloride 0.9% solution or water for injectable preparations may be used. The solution after reconstitution must be a clean and particle-free solution. In case of observing particles in suspension, the solution must be discarded.

Colistimethate sodium Altan Pharma solutions for parenteral administration should be prepared preferably at the time of administration and from a microbiological point of view, the solution must be used immediately. The reconstituted solution must be administered immediately.

The solution is for single use and any unused solution must be discarded.

Inhalation route:

Reconstitute the contents of the vial with water for injectable preparations to produce a hypotonic solution or with a 50:50 mixture of water for injectable preparations and sodium chloride 0.9% to produce an isotonic solution or with sodium chloride 0.9% to produce a hypertonic solution.

The reconstitution volume will depend on the instructions for use of the nebulizer administration device, and normally does not exceed 4 ml.

The solution after reconstitution must be a clean and particle-free solution. In case of observing particles in suspension, the solution must be discarded.

When reconstituted, Colistimethate sodium Altan Pharma may be used with any conventional nebulizer suitable for the administration of antibiotic solutions.

The solution is for single use and any unused solution must be discarded.