- colistimethate sodium
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 31654/0008.
Promixin 1 million International Units (IU) Powder for Nebuliser Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
1 million International Units (IU)
Powder for Nebuliser Solution
Read all of this leaflet carefully before you start taking this medicine
In this leaflet
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
1. WHAT PROMIXIN IS AND WHAT IT IS USED FOR
Promixin contains colistimethate sodium, and is given as an inhalation to treat chronic chest infections in patients with cystic fibrosis. Promixin is used when these infections are caused by specific bacteria called Pseudomonas aeruginosa.
This is a very common bacteria that infects the lungs of nearly all patients with cystic fibrosis at some time during their lives. If the infection is not properly controlled it will continue to damage the lungs, causing further problems.
Promixin is dissolved in sterile saline (salt water) or sterile water and then breathed (inhaled) into the lungs so that more of the antibiotic can target the bacteria causing the infection.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROMIXIN
In certain circumstances your doctor may decide not to prescribe Promixin.
Do not use Promixin and tell your doctor if:
If this applies to you, see your doctor before you start taking Promixin.
Take special care with Promixin and tell your doctor if:
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.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines you bought without a prescription. These medicines may interfere with the effect of 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 inhalation at the same time as receiving colistimethate sodium as an infusion can increase your risk of side effects.
Pregnancy and breast-feeding
You must not take Promixin if you are pregnant or trying to get pregnant. Promixin may harm your unborn baby.
Do not breast-feed while you are taking this medicine. 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.
3. HOW TO TAKE PROMIXIN
Always take Promixin exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Tell your doctor if you have problems with your kidneys as you may need to take a lower dose of Promixin.
You should take your first dose of Promixin when you are with your doctor or nurse.
Take your Promixin after physiotherapy (if you have physiotherapy). This will ensure that your lungs are clear so that Promixin can work effectively. If you also take other inhaled medicines, your doctor will tell you which order to taken them in.
The usual dose for adults, adolescents and children aged 2 years or older is 1-2 vials (1-2 million units) two or three times a day (maximum 6 million units per day).
The usual dose for children less than 2 years old is half to 1 vial (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.
Promixin is inhaled from a device called a nebuliser. Promixin can be taken using any nebuliser system that can be used to deliver antibiotics to the lungs in the form of a mist.
In countries where the I-neb AAD is available Promixin comes with a Promixin Disc so that it can be used with the I-neb AAD System. To find out how to use Promixin with the I-neb, see the detailed instructions which come with the device. If you use a different nebuliser you should make sure the room is well ventilated.
How to prepare Promixin
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 take more Promixin than you should
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:
If you forget to take Promixin
Take the dose as soon as you remember, unless it is near the time for your next dose. You do not need to make up for the dose you have missed.
If you stop taking Promixin
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 have any questions on the use of this medicine ask your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Promixin can cause side effects, although not everybody gets them.
Promixin can sometimes cause allergic reactions like skin rash. If this happens you should stop taking Promixin and tell your doctor immediately.
Breathing in Promixin 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.
Promixin might also affect your kidneys, usually if the dose is high or you are taking other medicines that may affect your kidneys.
Promixin may sometimes cause you to have a sore mouth or sore throat.
Reporting of side effects
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.
5. HOW TO STORE PROMIXIN
Keep Promixin out of the sight and reach of children.
Do not use Promixin after the expiry date which is stated on the vial and carton. The expiry date refers to the last day of that month.
Unopened Promixin vials do not require any special storage conditions.
Promixin contains no preservatives. Once prepared, Promixin solutions should preferably be used immediately. If this is not possible, solutions should not be stored for longer than 24 hours in a refrigerator. Do not use any solutions that have been prepared for more than 24 hours.
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 to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
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 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 contains a Promixin Disc for use with the I-neb AAD system.
Marketing Authorisation Holder
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 medicinal product is authorised in the Member States of the EEA under the following names:
Austria, Netherlands, Sweden, Greece, Luxemburg, France: Tadim
Germany, Denmark, Norway, United Kingdom, Ireland, Italy, Spain, Portugal: Promixin
This leaflet was last approved in JANUARY 2018
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