SODIUM COLISTIMETHATE ALTAN PHARMA 1 Million IU POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

Introduction

Package Leaflet: Information for the User

Sodium Colistimethate Altan Pharma 1 million IU powder for solution for injection and infusion

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of thepackage leaflet

1. What is Sodium Colistimethate Altan Pharma and what is it used for
2. What you need to know before you start using Sodium Colistimethate Altan Pharma
3. How to use Sodium Colistimethate Altan Pharma
4. Possible side effects
5. Storage of Sodium Colistimethate Altan Pharma
6. Contents of the pack and further information

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

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

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.

It is essential to follow the instructions regarding dosage, administration, and duration of treatment as indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Sodium Colistimethate Altan Pharma is an antibiotic that can be used:

• By intravenous route. It is administered by injection to treat certain severe infections caused by specific bacteria. Sodium Colistimethate Altan Pharma is used when other antibiotics are not suitable.

• By inhalation route. It is administered as an inhalation to treat chronic respiratory infections in patients with cystic fibrosis. Sodium Colistimethate Altan Pharma is used when such infections are caused by a specific bacterium called Pseudomonas aeruginosa.

2. What you need to know before you start using Sodium Colistimethate Altan Pharma

Do not use Sodium Colistimethate Altan Pharma

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

Warnings and precautions

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

• If you have or have had kidney problems.
• If you have myasthenia gravis.
• If you have porphyria.
• If you have asthma (when used by inhalation route).

In premature infants and newborns, special caution should be exercised when using Sodium Colistimethate Altan Pharma because the 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.

Using Sodium Colistimethate Altan Pharma with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Inform your doctor if you are using:

• medicines that may affect how your kidneys work. Taking such medicines at the same time as Sodium Colistimethate Altan Pharma may increase the risk of kidney damage.
• medicines that may affect the nervous system. Taking such medicines at the same time as Sodium Colistimethate Altan Pharma may increase the risk of adverse effects on your nervous system.
• muscle relaxant medicines, often used during general anesthesia. Sodium Colistimethate Altan Pharma may increase the effects of these medicines. If you are to be given a general anesthetic, inform your anesthetist that you are using Sodium Colistimethate 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 Sodium Colistimethate Altan Pharma further increases the risk of muscle weakness and breathing difficulties.

Receiving Sodium Colistimethate Altan Pharma as an infusion at the same time as receiving Sodium Colistimethate Altan Pharma as an inhalation may increase your risk of experiencing side 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 medicine.

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

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

Driving and using machines

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

Sodium Colistimethate Altan Pharma contains sodium

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

3. How to use Sodium Colistimethate Altan Pharma

• Intravenous route:

Your doctor has prescribed Sodium Colistimethate Altan Pharma as an infusion in a vein over 30 to 60 minutes.

The usual dose in adults is 9 million units, divided into two or three doses. If you are severely ill, you may be given a larger 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 occasionally.

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

Your doctor will monitor your kidney function regularly while you are receiving Sodium Colistimethate Altan Pharma.

• Inhalation route:

The usual dose in adults, adolescents, and children over 2 years of age is 1-2 million units, two or 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 decide to adjust the dose depending on your circumstances. If you are taking other inhaled medicines, your doctor will tell you in what order to administer them.

If you use more Sodium Colistimethate Altan Pharma than you should

If you have used more Sodium Colistimethate Altan Pharma than you should, you may experience breathing problems, muscle weakness, and kidney 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 medicine and the amount ingested.

If you forget to use Sodium Colistimethate Altan Pharma

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

If you are receiving this medicine by intravenous route and it has not been more than 3 hours since the time you should have received your dose, you can ask for the dose to be administered. If more than 3 hours have passed after the forgotten dose, wait until the next administration.

In the case of inhalation administration, take the corresponding dose as soon as you remember and continue with the next dose as usual.

If you stop using Sodium Colistimethate Altan Pharma

Your doctor will indicate the duration of treatment with Sodium Colistimethate Altan Pharma. Do not stop treatment before, as there is a risk that the infection may recur.

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

4. Possible side effects

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

The side effects observed have been classified by organs and systems and by frequency 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 the available data).

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

Possible side effects after intravenous administration:

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

• muscle spasms
• increased urine production
• fatigue

Possible side effects after inhalation administration:

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sodium Colistimethate Altan Pharma

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

Store below 25°C.

Once reconstituted, this medicine should be used immediately.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. This will help protect the environment.

6. Contents of the pack and further information

Composition of Sodium Colistimethate Altan Pharma

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

Appearance of the product and pack contents

Powder for solution for injection and infusion.

White powder.

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

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Altan Pharmaceuticals S.A.

C/ Cólquide, nº 6. Portal 2, 1ª planta. Oficina F Edificio Prisma 28230 - Las Rozas (Madrid) - Spain

Manufacturer:

Altan Pharmaceuticals S.A.

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

45950 Casarrubios del Monte (Toledo) – Spain

Date of last revision of this leaflet: June 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

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This information is intended only for healthcare professionals:

Intravenous route:

Injection

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

Infusion

For administration by infusion of this medicine, the reconstituted vial should be diluted in a volume of 50 ml.

Compatible infusion solutions are: 0.9% sodium chloride.

For reconstitution, a 0.9% sodium chloride solution or water for injections can be used. The solution after reconstitution must be a clear and particle-free solution. If particles are observed in the solution, it must be discarded.

Sodium Colistimethate 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 should be discarded.

Inhalation route:

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

The volume of reconstitution 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 clear and particle-free solution. If particles are observed in the solution, it must be discarded.

Once reconstituted, Sodium Colistimethate Altan Pharma can be used with any conventional nebulizer suitable for the administration of antibiotic solutions.

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