SODIUM COLISTIMETHATE ACCORDPHARMA 2 Million IU POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

2. What you need to know before you use Colistimethate Sodium Accordpharma

Do not use Colistimethate Sodium Accordpharma

• 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 this medicine

• If you have or have had kidney problems
• If you have myasthenia gravis
• If you have porphyria
• 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.

Children

In premature and newborn infants, caution should be exercised when using colistimethate sodium because the kidneys are not yet fully developed.

Other Medicines and Colistimethate Sodium Accordpharma

Tell your doctor or pharmacist 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 colistimethate sodium.

Sometimes other medicines need to be stopped (even if only for a while) or you may need a lower dose of colistimethate sodium or need to be monitored while taking colistimethate sodium.

In some cases, it may be necessary to measure the level of colistimethate sodium in your blood from time to time to make sure you are taking the correct dose.

• Medicines such as aminoglycoside antibiotics (including gentamicin, tobramycin, amikacin, and netilmicin) and cephalosporins may affect how your kidneys work. Taking these medicines at the same time as colistimethate sodium may increase the risk of kidney damage (see section 4 of the package leaflet).
• Medicines such as aminoglycoside antibiotics (including gentamicin, tobramycin, amikacin, and netilmicin) may affect the nervous system. Taking these medicines at the same time as colistimethate sodium may increase the risk of adverse effects on the ears or other parts of your nervous system (see section 4 of the package leaflet).
• Medicines called muscle relaxants, used often during general anesthesia. Colistimethate sodium may increase the effects of these medicines. If you are going to be given a general anesthetic, tell your anesthetist that you are using colistimethate sodium.

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 this medicine increases the risk of muscle weakness and breathing difficulties even more.

Pregnancy and Breastfeeding

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.

Pregnancy

There are no adequate data on the use of this medicine in pregnant women. Your doctor should only give you this medicine if the expected benefit outweighs any potential risk to the fetus.

Breastfeeding

Small amounts of colistimethate sodium may pass into breast milk. Breastfeeding is not recommended during treatment with this medicine.

Driving and Using Machines

When colistimethate sodium is administered intravenously, it may cause dizziness, confusion, or visual problems. If this occurs, you should not drive or use machinery.

Colistimethate Sodium Accordpharma contains Sodium

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

3. How to use Colistimethate Sodium Accordpharma

Depending on the reason (see section 1 of the package leaflet), this medicine may be administered as a rapid injection (over 5 minutes into a vein through a special tube) or as a slow injection (infusion over 30 to 60 minutes) into a vein. Sometimes, colistimethate sodium may be administered as an injection into the brain or spinal cord.

Follow your doctor's or pharmacist's instructions for administering this medicine exactly. If you are unsure, consult your doctor or pharmacist again.

Use for Infusion or Injection

The usual daily dose in adults is 9 million units, divided into two or three doses. If you are very ill, you may be given a higher 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 who weigh up to 40 kg is 75,000 to 150,000 units per kilogram of body weight, divided into three doses.

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 colistimethate sodium.

Method of Administration

Colistimethate sodium is administered as an injection, mainly in hospitals. Your doctor will administer colistimethate sodium as an infusion into a vein over 30 to 60 minutes. If you need to treat yourself at home, your doctor, pharmacist, or nurse will show you how to dissolve the powder and inject the correct dose of solution.

Duration of Treatment

Your doctor will decide the duration of treatment based on the severity of the infection. When treating bacterial infections, it is essential to complete the treatment to avoid worsening the existing infection.

If you use more Colistimethate Sodium Accordpharma than you should

If you think you have been given too much colistimethate sodium, contact your doctor or nurse immediately for advice, or if they are not available, contact or go to the emergency department of the nearest hospital.

If colistimethate sodium is accidentally given in excess, the side effects can be severe and may include kidney problems, muscle weakness, and difficulty breathing (or even respiratory arrest).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 5620420, indicating the medicine and the amount ingested.

If you are being treated in the hospital or at home by a doctor or nurse and think you may have missed a dose or been given too much colistimethate sodium, consult your doctor, nurse, or pharmacist about this.

If you forget to use Colistimethate Sodium Accordpharma

If you are treating yourself and forget a dose, you should administer the missed dose as soon as you remember and administer the next dose 8 hours later if you use colistimethate sodium three times a day, or 12 hours later if you use colistimethate sodium twice a day. From then on, follow the instructions. Do not take a double dose to make up for the missed dose.

If you stop using Colistimethate Sodium Accordpharma

Do not stop treatment before unless your doctor tells you to. Your doctor will tell you how long to use the treatment.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

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

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

Allergic Reactions

If colistimethate sodium is administered into a vein, an allergic reaction may occur. Severe allergic reactions can occur even with the first dose and may include rapid onset of rash, swelling of the face, tongue, and throat, difficulty breathing due to constriction of the airways, and loss of consciousness.

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

Less severe allergic reactions include rash that may occur later during treatment.

Side Effects Associated with Intravenous Injection of Colistimethate Sodium

Side effects affecting the nervous system are more likely if the dose of colistimethate sodium is too high, in people with kidney problems, or in people using muscle relaxants or other medicines that affect the nerves in a similar way.

The most serious of these nervous system side effects is the inability to breathe due to paralysis of the chest muscles. If you experience any breathing difficulties, seek urgent medical help.

Other possible side effects are numbness or tingling (especially around the face), dizziness or loss of balance, rapid changes in blood pressure or blood flow (such as fainting and flushing), difficulty speaking, vision problems, confusion, and mental problems (such as loss of sense of reality). There may be reactions at the injection site, such as irritation.

Kidney problems may also occur. These are especially likely in people who already have weak kidneys, or who are given colistimethate sodium at the same time as other medicines that may affect the kidneys, or who are given too high a dose.

These kidney problems usually improve if treatment is stopped or the dose of colistimethate sodium is reduced.

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.aemps.es/.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Colistimethate Sodium Accordpharma

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

Do not use this medicine after the expiry date which is stated on the label and carton after "EXP". The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

The diluted solutions of this medicine should be used immediately, or within 24 hours if stored in the refrigerator (between 2°C and 8°C), depending on the concentration and how the medicine is used.

If not used immediately, the storage times and conditions during use are the responsibility of the user.

The appearance of the solution should be a clear, colorless to pale yellow solution without visible particles.

Any remaining solution should be discarded.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

Composition of Colistimethate Sodium Accordpharma

The active substance is colistimethate sodium.

Each vial contains 2 million international units (IU) of colistimethate sodium.

There are no other ingredients.

Appearance of the Product and Pack Size

Colistimethate Sodium Accordpharma 2 million IU is a white lyophilized powder available in a 10 ml glass vial.

Pack sizes:

1 x 1 vial

1 x 10 vials

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Accord Healthcare, S.L.U.

Moll de Barcelona s/n,

World Trade Center Edifici Est 6ªplanta

08039 Barcelona

Spain

Manufacturer

Accord Healthcare Polska Sp.z o.o.

ul. Lutomierska 50,

95-200 Pabianice,

Poland

Or

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind.

Zona Franca, Barcelona, 08040,

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of Last Revision of this Package Leaflet: February 2024

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

This information is intended only for healthcare professionals:

Special Precautions for Disposal and Other Handling

For bolus injection:

Reconstitute the vial contents with no more than 10 ml of water for injections or sodium chloride 0.9%.

For infusion:

The reconstituted vial contents may be diluted, normally with 50 ml of sodium chloride 0.9%.

When using the intrathecal and intracerebroventricular routes of administration, the administered volume should not exceed 1 ml (reconstituted concentration 125,000 IU/ml).

Disposal of unused medicine and all materials that have come into contact with it should be carried out in accordance with local regulations.

The solution after reconstitution should be a clear, colorless to pale yellow solution without visible particles.

The solutions are for single use and any remaining solution should be discarded.