Promixin, 1 million International Units (IU), Powder for Solution for Infusion

Read all of this leaflet carefully before you are given this medicine

• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor, nurse or pharmacist.
• If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

In this leaflet

1. What Promixin is and what it is used for
2. Before you are given Promixin
3. How you will be given Promixin
4. Possible side effects
5. How to store Promixin
6. Further information

Do not have Promixin and tell your doctor if:

• you are allergic (hypersensitive) to colistimethate sodium, colistin or to other polymyxins;

If this applies to you, tell your doctor before you are given Promixin.

Take special care with Promixin and tell your doctor, pharmacist or nurse if:

• you have or have had kidney problems;
• you suffer from myasthenia gravis (a rare disease where your muscles are extremely weak and get tired very quickly);
• you suffer from porphyria (a rare metabolic disease that some people are born with).

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

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including non-prescription medicines. These medicines may interfere with the effects of Promixin.

• Medicines which can affect how your kidneys function. Taking such medicines at the same time as Promixin can increase the risk of damage to the kidneys.
• Medicines which can affect your nervous system. Taking such medicines at the same time as Promixin can increase the risk of side effects in your nervous system.
• Medicines called muscle relaxants, often used during general anaesthetia. Promixin can increase the effects of these medicines. If you have a general anaesthetic, let your anaesthetist know that you are having Promixin.

If you suffer from 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 Promixin further increases the risk of muscle weakness and breathing difficulties.

Having Promixin 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

You may be given Promixin 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 Promixin may harm your unborn baby.

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

Driving and using machines

Promixin 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.

If you are given too much Promixin

As a doctor or nurse will be giving you Promixin, it is unlikely that you will receive an incorrect dose. Tell your doctor or nurse if you have any concerns about the amount of medicine that you are given.

The symptoms of having too much Promixin can include:

• dizziness and spinning sensation (vertigo)
• slurred speech
• visual disturbance
• confusion
• mental disturbance
• flushing (reddening of the face)
• kidney problems
• muscle weakness
• feeling as though you cannot breathe

If you were not given Promixin when expected

If you think that you have missed a dose of Promixin and it is less than 3 hours since you should have been given the dose, tell your doctor or nurse.

If it is more than 3 hours after the missed dose the doctor or nurse will wait for your next dose.

Stopping Promixin

Your doctor will decide how long you should be given Promixin. It is important that your treatment is completed as advised by your doctor or your symptoms may get worse.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below).

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

United Kingdom

What Promixin contains

The active substance is colistimethate sodium.

Each vial contains 1 million International Units (IU) of colistimethate sodium, which weighs about 80 milligrams (mg). There are no other ingredients.

What Promixin looks like and contents of the pack

Promixin is supplied as a powder in a glass vial. The powder must be made into a solution for infusion.

Promixin is supplied in packs containing 10 vials.

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