What is a Patient Information Leaflet and why is it useful?

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 31654/0009.


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

PACKAGE LEAFLET: INFORMATION FOR THE USER

Promixin

1 million International Units (IU)

Powder for Solution for Infusion

colistimethate sodium

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

1. WHAT PROMIXIN IS AND WHAT IT IS USED FOR

Promixin contains colistimethate sodium. It is an antibiotic that is given by injection to treat some types of serious infections caused by certain bacteria.

Promixin is used when other antibiotics are not suitable.

2. BEFORE YOU ARE GIVEN PROMIXIN

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

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.

3. HOW YOU WILL BE GIVEN PROMIXIN

Your treatment with Promixin will be given to you by your doctor as an infusion into a vein over 30 – 60 minutes.

The usual daily dose in adults is 9 million international units, divided into two or three doses. If you are quite unwell, you will be given a higher dose of 9 million international units once at the start of treatment.

In some cases, your doctor may decide to give a higher daily dose of up to 12 million international units.

The usual daily dose in children weighing up to 40 Kg is 75,000 to 150,000 international units per kilogram body weight, divided into three doses. Higher doses have occasionally been given in cystic fibrosis.

Children and adults with kidney problems, including those on dialysis, are usually given lower doses. Your doctor will monitor your kidney function regularly while you receive Promixin.

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.

If you have any further questions on the use of this product, ask your doctor.

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 or red and lumpy skin rash, swollen eyelids, face, lips, mouth or tongue, itching, difficulty breathing or swallowing. If this happens, your Promixin treatment will be stopped immediately.

Promixin can also affect your kidneys, especially if the dose is high or you are taking other medicines that may affect your kidneys.

Very common side effects (affecting more than 1 person in 10)

  • blood tests may show changes in the way the kidneys are working
  • headache
  • tingling or numbness around the mouth, lips and face
  • itching
  • muscle weakness

Rare side effects (affecting less than 1 person in 1,000)

  • kidney failure

Other side effects can include:

  • dizziness
  • difficulty in controlling movements
  • soreness at the site of injection

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

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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 or carton. The expiry date refers to the last day of that month.

Do not store above 25°C.

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

Your doctor or nurse will dispose of any unused medicine safely. These measures will help to protect the environment.

6. FURTHER 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 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.

Marketing Authorisation Holder

Zambon S.p.A.
Via Lillo del Duca 10
20091 Bresso (MI)
Italy
Tel: +39 02 665241

Manufacturer

Xellia Pharmaceuticals ApS
Dalslandsgade 11
DK-2300
Copenhagen S
Denmark

Distributor

Profile Pharma Limited
Bicentennial Building
Southern Gate
Chichester
West Sussex
PO19 8EZ
UK
Tel: +44 (0) 800 0288 942

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria, The Netherlands, Sweden: Tadim

Germany, Denmark, Norway, United Kingdom: Promixin

This leaflet was last approved in January 2018.