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PROMIXIN 1 MILLION INTERNATIONAL UNITS (IU) POWDER FOR NEBULISER SOLUTION.

Active substance(s): COLISTIMETHATE SODIUM

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1 million International Units (IU)
Powder for Nebuliser Solution
colistimethate sodium

Promixin

PACKAGE LEAFLET: INFORMATION FOR THE USER

PL388 Issue 14 UK

1. WHAT PROMIXIN IS AND WHAT IT IS USED FOR

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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
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 get serious, or you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

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

Do not use Promixin and tell your doctor if:
you are allergic (hypersensitive) to colistimethate sodium, colistin
or other polymyxins;
If this applies to you, see your doctor before you start
taking Promixin.


Take special care with Promixin and tell your
doctor if:



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



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.

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.


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.

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.

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.

Having Promixin as an inhalation at the same time as receiving
colistimethate sodium as an infusion can increase your risk of
side effects.

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.

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.

Your doctor may decide to adjust the dose depending on your
circumstances.

6. Contents of the pack and other information

3 a
3

3
3 b

3
3

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
6 either the right
(diagram6 3a) or the left
so that the metal seal is
broken on one side only
(diagram6 3b).
6

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
1-4
5-9
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. The instructions
provided with the nebuliser will tell you the correct volume of
liquid to add to the Promixin vial.

4. Possible side effects
5. How to store Promixin

3
3

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).

You must not take Promixin if you are pregnant or trying to get
pregnant. Promixin may harm your unborn baby.

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

Tell your doctor if you have problems with your kidneys as you
may need to take a lower dose 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.

Pregnancy and breast-feeding

2
2

1

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).

4
4

4
4

4) Once the7seal is broken, hold
7
the vial firmly
and peel off the
metal seal to reveal the whole
of the rubber stopper
(diagram 74).
7

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 (the
instructions with the nebuliser will tell you the correct
volume of liquid to add).

Turn over
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6
6

6) Replace the rubber stopper
and gently turn the vial upside
down twice (diagram 6).

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:

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.

7
7

10



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
8

5 -1 0

Mi
nu
s
te

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.

Replace the stopper in the vial and store or discard as
appropriate. 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.

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.

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.

What Promixin contains

Unopened Promixin vials do not require any special storage
conditions.

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

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 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.

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

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.

Promixin may sometimes cause you to have a sore mouth or sore
throat.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION

The active substance is colistimethate sodium.

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

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.

Profile Pharma Limited
Bicentennial Building
Southern Gate
Chichester
West Sussex
PO19 8EZ
UK

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

Tel:
+44 (0) 800 1300 855
Fax: +44 (0) 800 1300 856
Email: info@profilepharma.com

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie

Manufacturer

Reporting of side effects

Xellia 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 international unit powder for
nebuliser solution.
Reference number: 19419/0001
This is a service provided by the Royal National Institute of Blind
People.
PA 1141/01/01 (Ireland)
This leaflet was last approved in OCTOBER/2015
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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