Patient leaflet - Colicym 2 MIU powder for nebuliser solution
1. What COLICYM is and what it is used for
COLICYM is an antibiotic. It belongs to a group of antibiotics that are called polymyxins.
This medicine is given as an inhalation to treat chronic chest infections in patients with cystic fibrosis.
COLICYM is used when these infections are caused by specific bacteria called Pseudomonas aeruginosa.
If chest tightness occurs despite the use of a bronchodilator, please tell your doctor because this
may indicate an allergic reaction and the treatment should be discontinued. During treatment with COLICYM neurotoxicity may occur with the possibility of dizziness, confusion or visual disturbance. If you do experience any side effects such as dizziness, confusion or visual disturbance or also ones not listed in this patient information, please tell your doctor.
2. What you need to know before you use COLICYM
Do not use COLICYM
If you are allergic to colistimethate
sodium, colistin or to other polymyxins.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using COLICYM if:
you have or have had kidney
problems
you suffer from myasthenia gravis
(disease characterized by muscle weakness)
- you suffer from porphyria
- you suffer from asthma
Some people may experience a feeling of tightness in the chest due to narrowing of the airways when inhaling COLICYM. Your doctor may prescribe other medicines for inhalation directly before or after using COLICYM in order to prevent or treat this.
In premature and new-born babies, special care should be taken when using COLICYM as their kidneys are not yet fully developed.
Other medicines and COLICYM
Tell your doctor if you are taking, have recently taken or might take any other medicines.
If you are taking any of the following medicines, you may or may not be able to take COLICYM. Sometimes the other medicines must be stopped (if only for a while) or you may need a lower dose of COLICYM or you may need to be monitored while you are taking this medicine. In some cases, the level of COLICYM in your blood may have to be measured from time to time to make sure that you are having the right dose.
Medicines which can affect how
your kidneys function. Taking such medicines at the same time as COLICYM can increase the risk of damage to the kidneys.
Medicines which can affect your
nervous system. Taking such medicines at the same time as COLICYM can increase the risk of side effects in your nervous system.
Medicines called muscle
relaxants, often used during general anaesthesia. COLICYM can increase the effects of these medicines. If you have a general anaesthetic, let your anaesthetist know that you are having COLICYM.
If you suffer from myasthenia gravis (muscle weakness) 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 COLICYM further increases the risk of muscle weakness and breathing difficulties.
Having COLICYM as an infusion at the same time as receiving COLICYM as an inhalation can increase your risk of side effects.
Pregnancy and breast-feeding
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 taking this medicine.
You may be given COLICYM 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 COLICYM may harm your unborn baby.
It is not recommended that you breast-feed while you are taking this medicine as COLICYM can pass into breast milk.
Driving and using machines
COLICYM 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.
COLICYM contains sodium This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.
3. How to use COLICYM
COLICYM is breathed into the lungs as a fine spray made using a machine called a nebuliser. The droplets of the spray produced by the nebuliser are small enough to enter the lungs so that COLICYM can reach the site of the bacterial infection.
Always use COLICYM exactly as your doctor has told you. Check with your doctor if you are not sure.
You should take your first dose of colistimethate sodium when you are with your doctor or nurse.
Take this medicine after physiotherapy (if you have physiotherapy). This will ensure that your lungs are clear so that colistimethate sodium 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 million units two to three times per day (maximum 6 million units per day).
The usual dose for children less than 2 years old is 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. If you also
take other inhaled medicines, your doctor will tell you which order to take them in.
Method of administration
If you are treating yourself at home, your doctor or nurse will show you how to use COLICYM in your nebuliser when you first start the treatment. You should sit upright and breathe normally during inhalation. The following are general instructions.
Preparation for inhalation treatment
Before COLICYM can be used it must be dissolved in isotonic saline solution (salt water).
To start your treatment, you will need the following:
- One clear-glass vial of COLICYM 1 MIU
- The solvent for dissolving the powder (3 mL of isotonic saline solution)
- A nebuliser appropriate for the inhalation of COLICYM 1 MIU (such as PARI LC PLUS, PARI LC SPRINT, or eFlow rapid)
To start your treatment, you will need the following:
One clear-glass vial of COLICYM
2 MIU
- The solvent for dissolving the powder (4 mL of isotonic saline solution)
- A nebuliser appropriate for the inhalation of COLICYM 2 MIU (such as PARI LC PLUS, PARI LC SPRINT, or eFlow rapid)
It is important that your nebuliser system functions properly before starting your treatment with
COLICYM. Read carefully the instructions for use of the
nebuliser for further information on handling the nebuliser system.
Place the components of your nebuliser on a clean flat surface and follow the manufacturer’s instructions for use.
Preparing your COLICYM for inhalation
COLICYM must be used immediately after dissolution. Do not dissolve COLICYM until ready to administer a dose (see also section 5).
Step 1: Take one vial of COLICYM and gently tap the glass vial so that the powder settles to the bottom. This helps ensure you get the proper dose of medication.
Step 2: COLICYM 1 MIU: Add the solvent (3 mL of isotonic saline solution) to the corresponding vial to dissolve the powder.
COLICYM 2 MIU: Add the solvent (4 mL of isotonic saline solution) to the corresponding vial to dissolve the powder.
In order to avoid foaming, shake the vial gently until all powder is dissolved. Pour the solution into the nebuliser. Do not use COLICYM if you notice visible particles in the solution after dissolution.
Once prepared COLICYM should be used immediately. Any unused solution should be disposed of.
Using your COLICYM
COLICYM is for inhalation use with an appropriate nebuliser (such as PARI LC PLUS, PARI LC SPRINT or eFlow rapid). For more detailed information on correct use of the selected nebuliser follow the instruction manual of the nebuliser. Inhalation should take place in a well ventilated room.
After inhalation of COLICYM
Please refer to the manufacturer’s instructions for use of the nebuliser for cleaning and disinfecting instructions.
IMPORTANT: Do not mix COLICYM with any other product for nebulisation at the same time.
Duration of treatment
For nebulised use your doctor will advise on the course of the treatment.
If you use more COLICYM than you should
If you think that you have given yourself too much COLICYM, you should contact your doctor or nurse immediately for advice or, if they are not available, contact or go to your nearest hospital accident and emergency department.
If too much COLICYM is accidentally given, the side effects can be serious and can include kidney problems, muscle weakness and difficulty (or even stopping) breathing.
Arial 11 pt 160 x 840 mm If you forget to use COLICYM
If you are treating yourself and have missed any doses, you should give the missed dose as soon as you remember and then give the next dose 8 hours later if using COLICYM three times a day, or 12 hours later if using COLICYM twice a day. Carry on from there as instructed. Do not take a double dose to make up forgotten dose.
If you stop using COLICYM
Do not stop your treatment early unless your doctor says you can. Your doctor will decide how long your treatment should last.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
When COLICYM is given by inhalation, an allergic reaction is possible. Serious allergic reactions can happen even with the very first dose and can include rapid development of rashes, swelling of the face, tongue and neck, inability to breathe due to narrowing of the airways and loss of consciousness.
If you experience signs of an allergic reaction you should stop taking COLICYM and seek urgent medical attention.
Less severe allergic reactions include skin rashes that appear later during treatment. If this happens, you should stop taking COLICYM and tell your doctor.
Breathing in COLICYM 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.
Very common (may affect more than 1 in 10 people):
A feeling of tightness in the chest
due to narrowing of the airways (may not always be a true allergic reaction)
Not known (frequency cannot be estimated from the available data):
Patients with severe kidney
impairment and higher dosages may experience side effects known for intravenous administration
- Confusion
- Psychotic disorder
- Visual disturbance
- Dizziness
If you experience any of these, tell your doctor straight away.
Other possible side effects: Very common (may affect more than 1 in 10 people):
- Mouth or throat sore
- Coughing
- Shortness of breath
- Wheezing
Worsening of lung function test
results
Transient absence of spontaneous
respiration
If any of these affects you severely, tell your doctor.
Not known (frequency cannot be estimated from the available data):
- Subjective skin sensations
- Speech disorder
- Vertigo
- Renal failure
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 via Yellow Card Scheme, Website: www.mhra.gov.uk/ yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store COLICYM
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial and carton after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Reconstituted solutions:
Hydrolysis of colistimethate is significantly increased when reconstituted below its critical micelle concentration of about 80,000 IU per mL.
Solutions below this concentration should be used immediately.
For solutions for nebulisation, the chemical and physical in-use stability of reconstituted solution in the original vial, with a concentration ≥ 80,000 IU/ mL, has been demonstrated for:
1 MIU for 12 hours at 2-8°C when
dissolved in 3 mL of Sodium chloride 0.9% or Water for injection
2 MIU for 24 hours at 2-8°C when
dissolved in 4 mL of Sodium chloride 0.9% or Water for injection.
From a microbiological point of view, unless the method of opening/ reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of user.
Any remaining solution should be discarded.
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 protect the environment.
6. Contents of the pack and other information
What COLICYM contains
The active substance is colistimethate sodium.
Each vial contains colistimethate sodium (also called colistin) as an amount of powder equivalent to one million or two million units.
There are no other ingredients.
What COLICYM looks like and contents of the pack
COLICYM powder for nebuliser solution, is supplied as a white to off-white powder in single dose vials of either:
- 1 million units of colistimethate sodium per vial
- 2 million units of colistimethate sodium per vial
Clear type I glass vials closed with bromobutyl closures 20 mm and sealed with 20 mm aluminum pull-off or tear-off caps.
Each box contains 1, 10 or 30 vials.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Noridem Enterprises Limited Evagorou and Makariou,
Mitsi Building 3, Office 115, 1065 Nicosia, Cyprus
Manufacturer
DEMO S.A. PHARMACEUTICAL INDUSTRY
21st Km National Road Athens–Lamia, 14568 Krioneri, Attiki, Greece
This leaflet was last revised in 01/2023
38000847-1