Colistimethate Sodium 2 MIU powder for nebuliser solution – patient leaflet, side effects, dosage

1. WHAT COLISTIMETHATE SODIUM IS AND WHAT IT IS USED FOR

Colistimethate sodium is an antibiotic. It belongs to a group of antibiotics that are called polymyxins.

Colistimethate sodium is given as an inhalation to treat chronic chest infections in patients with cystic fibrosis. Colistimethate sodium is used when these infections are caused by specific bacteria called Pseudomonas aeruginosa.

If chest tightness occurs despite the use of a bronchodilator, please tell your doctor because this may indicate an allergic reaction and the treatment should be discontinued. During treatment with Colistimethate sodium neurotoxicity may occur with the possibility of dizziness, confusion or visual disturbance. If you do experience any side effects such as dizziness, confusion or visual disturbance or also ones not listed in this patient information, please tell your doctor.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE COLISTIMETHATE SODIUM

Do not use Colistimethate sodium:

• If you are allergic (hypersensitive) to

  colistimethate sodium, colistin or to other polymyxins.

Warnings and precautions

Talk to your doctor before using Colistimethate sodium

• if you have or have had kidney problems
• if you suffer from myasthenia gravis
• if you suffer from porphyria
• if you suffer from asthma

Some people may experience a feeling of tightness in the chest due to narrowing of the airways when inhaling Colistimethate sodium. Your doctor may prescribe other medicines for inhalation directly before or after using Colistimethate sodium in order to prevent or treat this.

In premature and new-born babies, special care should be taken when using Colistimethate sodium as the kidneys are not yet fully developed.

Other medicines and Colistimethate sodium

Tell your doctor if you are using, have recently used or might use any other medicines.

If you are taking any of the following medicines, you may or may not be able to take

Colistimethate sodium.

Sometimes the other medicines must be stopped (if only for a while) or you may need a lower dose of Colistimethate sodium or you may need to be monitored while you are taking Colistimethate sodium. In some cases, the level of Colistimethate sodium in your blood may have to be measured from time to time to make sure that you are having the right dose.

• Medicines which can affect how your

  kidneys function. Taking such medicines at the same time as Colistimethate sodium can increase the risk of damage to the kidneys.

• Medicines which can affect your nervous

  system. Taking such medicines at the same time as Colistimethate sodium can increase the risk of side effects in your nervous system.

• Medicines called muscle relaxant, often

  used during general anesthesia. Colistimethate sodium can increase the effects of these medicines. If you have a general anesthetic let your anesthetist know that you are having Colistimethate sodium.

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 Colistimethate sodium further increases the risk of muscle weakness and breathing difficulties.

Having Colistimethate sodium as an infusion at the same time as receiving Colistimethate sodium as an inhalation can increase your risk of side effects.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

You may be given Colistimethate sodium if you are pregnant or trying to get pregnant if your doctor considers the benefits are greater than the possible risks. It is unknown if having Colistimethate sodium may harm your unborn baby.

It is not recommended that you breast-feed while you are taking this medicine as Colistimethate sodium can pass into breast milk.

Driving and using machines

Colistimethate sodium may make you feel dizzy, confused, or have problems with your sight such as blurred vision. If this happens to you, do not drive or use any tools or machines.

Colistimethate sodium contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium free’.

3. HOW TO USE COLISTIMETHATE SODIUM

Colistimethate sodium is breathed into the lungs as a fine spray made using a machine called a nebuliser. The droplets of the spray produced by the nebuliser are small enough to enter the lungs so that Colistimethate sodium can reach the site of the bacterial infection.

Always use Colistimethate sodium exactly as your doctor has told you. Check with your doctor if you are not sure.

Dose:

• When Colistimethate sodium is to be given

  by inhalation using a nebuliser, the usual dose for adults, adolescents and children aged 2 years or older is 1-2 million units two to three times per day (maximum 6 million units per day).

• The usual dose for children less than 2 years

  old is 0.5-1 million units twice daily (maximum 2 million units per day).

Your doctor may decide to adjust the dose depending on your circumstances. If you also take other inhaled medicines, your doctor will tell you which order to take them in.

Method of administration

If you are treating yourself at home, your doctor or nurse will show you how to use

Colistimethate sodium in your nebuliser when you first start the treatment. The following are general instructions.

1. 1. Remove the plastic cap.
2. 2.

   Using a syringe, withdraw the required

   volume of solvent from the solvent container (sterile water or sterile salt water (saline) or a 50:50 mixture of sterile water and sterile 0.9% saline to dissolve the powder as follows: 1 million unit vial: 3 ml sterile water or 3 ml sterile 0.9% saline or 1.5 ml sterile water and 1.5 ml sterile 0.9% saline).

3. 3.

   Pierce the stopper in the centre with the

   syringe and inject its content slowly into the vial.

4. 4. Gently turn the vial upside down twice.
5. 5.

   Roll the vial gently between both hands to

   dissolve all the Colistimethate sodium powder visible on the bottom and side off the vial. Do not shake the vial too hard as this may make the solution foam.

6. 6.

   Turn the vial and withdraw all the final

   solution with the syringe.

7. 7.

   Remove the needle from the syringe and fill

   the solution into the nebulizer. Then, inhale as usual. Use the nebulizer according to the instructions of the manufacturer.

IMPORTANT: Do not mix Colistimethate sodium with any other product for nebulisation at the same time.

Duration of treatment

Your doctor will decide how long your treatment should last depending on the severity of the infection. When treating bacterial infections, it is important to complete the full course of treatment so as to prevent worsening of the existing infection.

If you use more Colistimethate sodium than you should

If you think that you have given yourself too much Colistimethate sodium, you should contact your doctor or nurse immediately for advice or, if Package leaflet: Information for the user

Colistimethate sodium 1 MIU Powder for nebuliser solution

colistimethate sodium

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they are not available, contact or go to your nearest hospital accident and emergency department. If too much Colistimethate sodium is accidentally given, the side effects can be serious and can include kidney problems, muscle weakness and difficulty (or even stopping) breathing.

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

If you forget to use Colistimethate sodium

If you are treating yourself and have missed any doses, you should give the missed dose as soon as you remember and then give the next dose 8 hours later if using Colistimethate sodium three times a day, or 12 hours later if using Colistimethate sodium twice a day. Carry on from there as instructed. Do not take a double dose to make up for a forgotten dose.

If you stop using Colistimethate sodium

Do not stop your treatment early unless your doctor says you can. Your doctor will decide how long your treatment should last. If you have any further questions on the use of this medicine, ask your doctor.

4. POSSIBLE SIDE EFFECTS

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

Allergic reactions

When Colistimethate sodium is given by inhalation, an allergic reaction is possible. Serious allergic reactions can happen even with the very first dose and can include rapid development of rashes, swelling of the face, tongue and neck, inability to breathe due to narrowing of the airways and loss of consciousness.

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

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

If this happens, you should stop taking Colistimethate sodium and tell your doctor. Breathing in Colistimethate sodium through a nebuliser can make some people notice tightness in their chest, feel wheezy, cough or become breathless. For this reason the first dose should be taken when you are with your doctor or nurse. Your doctor may also advise you to take a medicine to help prevent any breathlessness. Your doctor may check your breathing at your clinic visits.

Very common (may affect more than 1 in 10 people):

• A feeling of tightness in the chest due to

  narrowing of the airways (may not always be a true allergic reaction)

Not known (frequency cannot be estimated from the available data):

• Patients with severe kidney impairment and

  higher dosages may experience side effects known for intravenous administration

• Confusion
• Psychotic disorder
• Visual disturbance
• Dizziness

If you experience any of these, tell your doctor straight away.

Other possible side effects:

Very common (may affect more than 1 in 10 people):

• Mouth or throat sore
• Coughing
• Shortness of breath
• Wheezing
• Worsening of lung function test results

• Transient absence of spontaneous

  respiration

If any of these affects you severely, tell your doctor.

Not known (frequency cannot be estimated from the available data):

• Subjective skin sensations
• Speech disorder
• Vertigo
• Renal failure

Reporting of side effects

If you get any side effects, talk to your doctor, this includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE COLISTIMETHATE SODIUM

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 vial label after EXP. The expiry date refers to the last date of that month.

Do not store the vials above 25 ºC.

Keep the vials in the outer carton in order to protect from light.

Colistimethate sodium solutions for inhalation should preferably be given immediately. If this is not possible, solutions should not be stored for longer than 6 hours in a refrigerator and 2 hours at room temperature. Any remaining solution should be discarded.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Colistimethate sodium contains

Each vial contains 1 million International Units of colistimethate sodium. There are no other ingredients.

What Colistimethate sodium looks like and contents of the pack

Colistimethate sodium is supplied as a white powder in single dose vials.

Each box contains 1 or 10 vials.

Marketing Authorisation Holder and manufacturer

Marketing Authorisation Holder

Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó, nº8, 8A/8B Fervença 2705-906 Terrugem SNT

Portugal

Manufacturer

Hikma Itália S.p.A.

Viale Certosa, 10,

27100 Pavia

Itália

This leaflet was last revised in November 2024