• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor, nurse, physiotherapist or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, nurse, physiotherapist or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Promixin is and what it is used for
2. What you need to know before you take Promixin
3. How to take Promixin
4. Possible side effects
5. How to store Promixin
6. Contents of the pack and other information

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

If this applies to you, see your doctor before you start taking Promixin.

• 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);
• you suffer from asthma.

If any of these apply to you, tell your doctor.

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

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. These medicines may interfere with the effect 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 anaesthesia. 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 colistimethate sodium as an infusion at the same time as receiving Promixin as inhalation can increase your risk of side effects.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. There is no information about the safety of Promixin in pregnant women. Your doctor should advise you before using Promixin where benefits of the medicine exceed the risk.

Colistimethate sodium may be secreted in the breast milk. Please discuss the use of Promixin with your doctor.

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.

Your doctor or nurse will show you how to prepare and use Promixin with your nebuliser.

Before Promixin can be placed into the nebuliser and inhaled it must first be dissolved with sterile water, sterile 0.9% saline (salt water) or a half and half mixture of sterile water and sterile 0.9% saline (salt water) as directed below. Your doctor or nurse will tell you the correct volume of liquid to add to each Promixin vial and how many Promixin vials you need to prepare and use for each dose with your nebuliser.

1) Locate the lip on the red plastic top near the arrow marked “FLIP UP”. Then holding the vial in one hand and the plastic top with the other hand, turn the top a small amount anti-clockwise. Place a thumb under the lip and push the top up to about 90° (see diagram 1).

2) Grasp the plastic top as shown in diagram 2 and pull open slowly, like a hinge, to almost 180°.

3) Turn the vial around so that the plastic top is pointing towards you. Holding the centre of the top as shown, pull it downwards and twist slightly to either the right (diagram 3a) or the left so that the metal seal is broken on one side only (diagram 3b).

4) Once the seal is broken, hold the vial firmly and peel off the metal seal to reveal the whole of the rubber stopper (diagram 4).

5) Remove the rubber stopper from the vial of Promixin by holding the outside edge of the stopper only and place it upside-down on a clean surface. Slowly add sterile water, sterile 0.9% saline, or sterile water and sterile 0.9% saline to the vial, adding the volume of liquid your doctor or nurse has told you.
6) Replace the rubber stopper and gently turn the vial upside down twice (diagram 6).

7) Roll the vial gently between both hands to dissolve all the Promixin powder visible on the base and side of the vial (diagram 7). Do not shake the vial too hard as this may make the solution foam.

8) Once most of the powder is dissolved leave the vial to stand for 5-10 minutes to let any foam disappear and to allow any remaining powder to dissolve.

Pour the solution into the nebuliser and inhale immediately. If it is not possible to use the solution immediately replace the stopper in the vial and store for no longer than 24 hours in a refrigerator. Do not use any solutions that have been prepared for more than 24 hours. See section 5 ‘How to store Promixin’ for instructions on how to store or dispose of any unused Promixin.

If you realise that you have taken more Promixin than your doctor has recommended (or if someone else has taken some of your Promixin), contact your doctor straight away.

The symptoms of taking too much Promixin can include:

• tingling or numbness around the lips and face
• dizziness and spinning sensation (vertigo)
• slurred speech
• visual disturbance
• confusion
• mental disturbance
• flushing (reddening of the face)

Take the dose as soon as you remember, unless it is near the time for your next dose. Do not take a double dose to make up for a forgotten dose.

Do not stop your treatment early unless your doctor says that you can. Your doctor will tell you how long your treatment will last.

If you get any side effects talk to your doctor or pharmacist. 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

Ireland

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.

Promixin is a powder for nebuliser solution, supplied as a white to off-white powder in a glass vial.

Promixin is supplied in packs containing 30 vials. In countries where the I-neb AAD is available, each pack also contains a Promixin Disc for use with the I-neb AAD system.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name: Promixin 1 million international unit powder for nebuliser solution.

Reference number: 31654/0008

This is a service provided by the Royal National Institute of Blind People.

PA 1441/003/001 (Ireland)

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Netherlands, Sweden, France: Tadim

Germany, Denmark, Norway, United Kingdom (Northern Ireland), Italy, Spain, Portugal: Promixin