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Promixin 1 million International Units (IU) Powder for Nebuliser Solution

Last Updated on eMC 12-Apr-2011 View changes  | Profile Pharma Limited Contact details

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.

Please click on the link to the left to view the PIL in PDF format.

Text only version for the visually impaired
Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link to the left. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000. The product code(s) for this leaflet is/are: PL 19419/0001.



Promixin 1 million International Units (IU) Powder for Nebuliser Solution

PACKAGE LEAFLET: INFORMATION FOR THE USER

Promixin®

1 million International Units (IU)

Powder for nebuliser solution

colistimethate sodium

Read all of this leaflet carefully before you start taking this medicine

  • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

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

1. WHAT PROMIXIN IS AND WHAT IT IS USED FOR

Promixin contains colistimethate sodium, an antibiotic that fights infections caused by Pseudomonas aeruginosa.

This is a very common bacterium 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 used to treat chest infections caused by Pseudomonas in people with cystic fibrosis. Promixin is breathed into the lungs (inhaled) so that more of the antibiotic can work against the bacteria causing the infection.

2. BEFORE YOU TAKE PROMIXIN

In certain circumstances your doctor may decide not to prescribe Promixin.

Do not use Promixin and tell your doctor if:

  • you are pregnant or could get pregnant (please read the section ‘Pregnancy and breast-feeding’ below);
  • you are breast-feeding (please read the section ‘Pregnancy and breast-feeding’ below).
  • you are allergic (hypersensitive) to colistimethate sodium or other polymyxins;
  • you suffer from myasthenia gravis (a rare disease where your muscles are extremely weak and get tired very quickly).

If any of these apply to you, see your doctor before you start taking Promixin.

Take special care with Promixin and tell your doctor if:

  • you have or have had kidney problems;
  • 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.

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 are taking antibiotics such as cephalothin sodium, gentamicin, amikacin, netilmicin and tobramycin, please tell your doctor. Taking Promixin at the same time as these other antibiotics could increase your risk of kidney problems.
  • Promixin could prolong the effects of muscle relaxing medicines, which may be used as part of a general anaesthetic if you have an operation. If you need to have a general anaesthetic, tell the anaesthetist that you are taking Promixin.

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. You should check with your doctor or pharmacist if you are not sure.

The usual dose for adults and children over the age of two years is 1-2 vials two or three times a day. Your doctor will work out the best dose for you.

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) and after taking any other nebulised medicines that you have been prescribed.

Promixin has to be breathed in from a nebuliser. Promixin can be taken using any nebuliser system that can be used to deliver antibiotics to the lungs. 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 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 use Promixin with your nebuliser.

Before Promixin can be taken it must be dissolved in sterile water or a half and half mixture of sterile water and sterile saline (salt water).

The following are general instructions on how to dissolve Promixin.

  • Flip open the Promixin plastic cap.
  • Carefully rip the foil seal from the top of the vial and remove it completely.
  • Take out the rubber bung carefully.
  • Slowly add sterile water or sterile water and sterile saline to the vial (the instructions with the nebuliser will tell you the correct volume of liquid to add to the Promixin vial.)
  • Roll the vial gently between both hands to dissolve the Promixin in the liquid. This will reduce foaming.
  • Avoid shaking the vial too hard.
  • Pour the solution into the nebuliser.
  • Any unused solution should be disposed of (see section 5 ‘How to store Promixin’ for instructions on how to dispose of Promixin).

Once prepared Promixin should be used immediately.

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:

  • 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)

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.

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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE PROMIXIN

Keep Promixin out of the reach and sight of children.

Do not use Promixin after the expiry date which is stated on the vial or carton. The expiry date refers to the last day of that month.

Promixin does not require any special storage conditions.

Promixin contains no preservatives. Once prepared, Promixin should be used immediately.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer require. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Promixin contains

The active substance is colistimethate sodium (also known as colistin).

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. Each pack contains a Promixin® Disc for use with the I-neb AAD System.

Marketing Authorisation Holder

Profile Pharma Limited
Chichester Business Park
City Fields Way
Tangmere
Chichester
West SussexPO20 2FT
UK
Tel:+44 (0) 800 1300 855
Fax: +44 (0) 800 1300 856
Email: info@profilepharma.com

Manufacturer

Axellia Pharmaceuticals ApS
Dalslandsgade 11
DK- 2300
Copenhagen S
Denmark

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 unit powder for nebuliser solution unit dose vials.

Reference number: 19419/0001

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

This leaflet was last approved in 11/2010

Company contact details

Profile Pharma Limited

Company image
Address

Bicentennial Building, Southern Gate, Tangmere, Chichester, West Sussex, PO19 8EZ

Fax

+44 (0)800 1300 856

Medical Information e-mail
Telephone

+44 (0)800 1300 855

Medical Information Direct Line

+44 (0)870 423 1475

Out of Hours contact

+44 (0)700 593 8988

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

colistimethate sodium

Legal categories

POM - Prescription Only Medicine

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