Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
colobreathe 1,662,500 IU Inhalation Powder, Hard Capsules
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Colistimethate sodium may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Colobreathe contains colistimethate sodium, a type of antibiotic called a polymyxin. Colobreathe is used to control persistent lung infections caused by the bacterium Pseudomonas aeruginosa in adult patients and children aged 6 years and older with cystic fibrosis. Pseudomonas aeruginosa is a very common bacterium that infects nearly all cystic fibrosis patients at some time during their lives. Some people will get this infection whilst very young but for others it will be much later. If this infection is not properly controlled it will cause damage to the lungs. How it works Colobreathe works by destroying the bacterial cell membrane, having a lethal effect on them.
2.
What you need to know before you take it
e Colobreathe
Do not use Colobreathe:
- if you/your child are allergic to colistimethate sodium, colistin sulphate or polymyxins. Warnings and precautions Talk to your doctor or pharmacist before using Colobreathe. Tell your doctor if you/your child has ever had any of the following conditions:
- have reacted badly to inhaled dry powder medicines previously unless this has already been discussed with your doctor
- already have a muscle condition known as myasthenia gravis or the inherited condition, porphyria
- blood in your sputum (the substance you cough up).
1
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After each inhalation of Colobreathe, the mouth should be rinsed with water. The rinse should not be swallowed. Rinsing may reduce the risk of developing oral fungal super-infection during treatment and may also reduce the unpleasant taste associated with colistimethate sodium. When you/your child start using Colobreathe, you/your child may find they have cough, breathlessness, tightness of chest or wheezing. The number of these side-effects may reduce as you continue to use the inhaler or your doctor may prescribe a bronchodilator to use before or after taking Colobreathe. If any of these effects become a problem, please contact your doctor who may change your treatment. If you/your child has any problems with your kidneys or nerves, care should be taken when administering Colobreathe but your doctor should be aware of this. If you/your child needs to have other forms of colistimethate either by injection or nebulisation caution should be used but your doctor should be aware of this. Children Do not give Colobreathe to children under the age of 6 years as it is not suitable for them. Other medicines and Colobreathe Tell your doctor if you/your child are taking, have recently taken or might take any other medicines, and in particular if you/your child: • • • •
are taking aminoglycoside antibiotics used to treat infections caution must be taken suffer from myasthenia gravis and are taking macrolide type antibiotics such as azithromycin and clarithromycin, or fluoroquinolones such as norfloxacin and ciprofloxacin. Taking these at the same time as Colobreathe may cause problems with muscle weakness. are taking colistimethate by injection or nebulisation caution must be taken need to have a general anaesthetic caution must be taken.
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 using this medicine. There is no information about the safety of Colobreathe in pregnant women. Your doctor should advise you before using Colobreathe whether the benefits of the medicine exceed the risks. Colistimethate sodium may be secreted in the breast milk. Please discuss the use of Colobreathe with your doctor. Driving and using machines It is possible while using Colobreathe that you may experience dizziness, confusion or have problems with your sight. Do not drive or use any machines until the symptoms have gone away. Colobreathe contains sodium This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.
3.
How to take it
Colobreathe
Always use this medicine exactly as your doctor has told you. Check with your doctor if you/your child are not sure. The first dose should be given under medical supervision.
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The recommended dose is Adults and children 6 years of age and older
- The contents of one Colobreathe capsule should be inhaled twice a day using the Turbospin inhaler.
- There should be a 12 hour gap between doses. The order in which other treatments should be taken or carried out If you/your child are taking other treatments for cystic fibrosis you/your child should take them in the following order:
- inhaled bronchodilators
- chest physiotherapy
- other inhaled medicines
- then Colobreathe. You/your child should confirm the order of your treatments with your doctor.
Method of administration Colobreathe is inhaled into the lungs as a powder from the capsule using the hand-held inhaler called the Turbospin. Colobreathe can only be administered using this device. Do not swallow Colobreathe capsules. To inhale Colobreathe from the capsule through the Turbospin inhaler follow the procedure described below. Your doctor, pharmacist or nurse should show you/your child how to inhale the medicine when you/your child first start treatment: Taking Colobreathe using the Turbospin inhaler Preparing the Turbospin
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1. Remove the cap. It comes away with a gentle pull.
2. Unscrew the mouthpiece, exposing the chamber of the Turbospin inhaler.
3. Remove a single capsule from the blister. Once you have removed the capsule it must be used immediately.
4. Gently insert the capsule into the chamber with the widest end first. No force is required.
5. Now replace the mouthpiece by screwing it back into place.
Piercing the capsule and inhaling the medicine ColInh-PL-UK-2a
6. To pierce the capsule:
- Hold the inhaler with the mouthpiece upright, gently push the piston upwards until the visible line is reached – you will feel resistance at this point and this will lock the capsule in place ready for piercing. Hold that position before continuing to follow through with the piercing.
- Now, with the capsule locked in place, continue pushing the piston as far as it will go and then release.
- The capsule is now pierced and the contents can be inhaled.
- Do not pierce the capsule more than once. You may see a small amount of powder released from the capsule chamber after the capsule is pierced, this is normal.
7. Breathe out slowly. Place the mouthpiece between your lips and teeth. Ensure there is a seal between your lips and the mouthpiece. Take care not to cover the air slits with your fingers or mouth during inhalation. 8. Then, breathe in slowly and deeply through your mouth at a rate sufficient for you to hear or feel the capsule spinning. 9. Remove the Turbospin inhaler from your mouth and hold your breath for about 10 seconds or for as long as is comfortable, then breathe out slowly. 10. If you do not hear the capsule spinning, the capsule may be stuck in the compartment. If this occurs, you can loosen the capsule by gently tapping the chamber of the inhaler. Do not try to loosen the capsule by repeatedly pressing the piston. If the capsule cannot be loosened and the powder cannot be inhaled, dispose of the broken capsule and any powder remaining in it and use another. 11. Inhale the medicine again by repeating Steps 7 and 8 to ensure you have emptied the capsule. 12. You can check whether the capsule is empty by unscrewing the mouthpiece and checking the capsule. If it is not empty, repeat steps 7, 8 and 9 until you have inhaled all of the contents. 13. Once all the contents have been inhaled, rinse your mouth out well with water and spit out. Removing the empty capsule from the Turbospin 14. When the capsule is empty, unscrew the mouthpiece, then remove and discard the empty capsule. Additional information
ColInh-PL-UK-2a
As you breathe in slowly, you suck air through the body of the Turbospin inhaler into the capsule chamber. The tiny particles of medication in the capsule are picked up by the airflow and carried down your airway into your lungs. Occasionally, very small pieces of the capsule shell can get into your mouth or airways.
- If this happens, you may be able to feel these pieces on your tongue or in your airways.
- The capsule shell is made of gelatin, which is harmless to humans if swallowed or inhaled.
- The chances of the capsule breaking into pieces are increased if the capsule is pierced more than once during Step 6. Cleaning the Turbospin device Clean the Turbospin inhaler after each dose using the following procedure: 1. Deeply press the piston a few times whilst keeping the chamber turned upside down. 2. Clean the chamber using a tissue or cotton bud. Do not use water. 3. Screw the mouthpiece firmly back into place, put the cap back on and the inhaler is ready to be used for your next dose. If you/your child use more Colobreathe than you/your child should, or have accidentally swallowed the capsule, contact your doctor immediately for advice. If you/your child forget to use Colobreathe If you/your child forget to take a dose of Colobreathe then you/your child should take your missed dose as soon as you/your child remember. You/your child must not take 2 doses within 12 hours. Carry on from there as instructed. If you/your child stop using Colobreathe Do not stop your treatment early unless your doctor says you can. Your doctor will decide how long you/your child's treatment should last. If you/your child have any further questions on the use of this medicine, ask your doctor.
4.
Possible side effects
Like all medicines this medicine can cause side effects, although not everyone gets them. Allergic reactions An allergic reaction with Colobreathe is possible (typically serious allergic reactions may cause rashes, swelling of the face, tongue and neck, inability to breathe due to narrowing of the airways and loss of consciousness). If you/your child experience signs of an allergic reaction you should seek urgent medical attention. Other possible side effects You/your child may get an unpleasant taste in your mouth after inhaling Colobreathe. Very common: may affect more than 1 in 10 people
- difficulty in breathing
- cough, throat irritation
- hoarse or weak, or even loss of the voice
- unpleasant taste. Common: may affect up to 1 in 10 people
- headache
- ringing or buzzing noises in the ear, problems with balance
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• • • • • •
coughing up blood, wheezing, chest discomfort, asthma, productive cough (a cough which brings up mucus), infection of the lungs, lung crackles (your doctor would hear this when listening to your lungs using a stethoscope) vomiting, nausea changes in how your lungs function (found by testing) joint pains lack of energy, tiredness raised temperature.
Uncommon: may affect up to 1 in 100 people
- allergic (hypersensitivity) reactions, the signs may include rash and itching
- weight fluctuations, decreased appetite
- anxiety
- fits
- sleepiness
- blockage in the ears
- chest pain
- shortness of breath
- nose bleeds, catarrh (mucus in your nose, which may make you feel blocked up), coughing up thick green mucus, pain in the throat and sinuses
- unusual noises in the chest (your doctor would hear this when listening to your lungs with a stethoscope)
- diarrhoea, wind
- excessive production of saliva
- toothache
- protein in the urine (found by testing)
- thirst. The above side effects have been seen in people of all ages with similar frequency. 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 it
Colobreathe
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 outer carton and blister after EXP. The expiry date refers to the last date of that month. Do not store above 25oC. Store in the original package until immediately before use in order to protect from moisture. If you/your child accidentally peel back the foil, and any capsules become exposed, please discard these capsules. Discard the Turbospin inhaler after the completion of a treatment pack.
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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 Colobreathe contains The active substance is colistimethate sodium. Each capsule contains 1,662,500 IU (approximately equivalent to 125 mg) of colistimethate sodium. The other ingredients are: Capsule Shell gelatin, polyethylene glycol, sodium lauryl sulfate, purified water. What Colobreathe looks like and contents of the pack Colobreathe inhalation powder, hard capsule (inhalation powder) is supplied as small, hard, transparent gelatin capsules containing a fine white powder. The Turbospin is an inspiratory flow driven dry powder inhaler made of polypropylene and stainless steel. The capsules are packed in blister packs supplied in cartons containing:
- 56 hard capsules and one Turbospin powder inhaler device sufficient for 4 weeks use.
- 8 hard capsules and one Turbospin inhaler device sufficient for 4 days use. Not all pack sizes may be marketed. Marketing Authorisation Holder Essential Pharma Limited, 8a Crabtree Road, Egham, Surrey, TW20 8RN, UK Manufacturer Penn Pharmaceutical Services Limited Tafarnaubach Industrial Estate Tredegar Gwent NP22 3AA United Kingdom Teva Pharmaceuticals Europe BV Swensweg 5 2031 GA Haarlem The Netherlands Millmount Healthcare Limited Block 7, City North Business Campus Stamullen Co Meath K32 YD60 Ireland Merckle GmbH Ludwig-Merckle-Str-3 89143 Blaubeuren Germany ColInh-PL-UK-2a
Laboratorios Liconsa S.A Avda. Miralcampo, 7, Pol. Ind. Miralcampo, Azuqueca de Henares, 19200, Guadalajara, Spain This leaflet was last revised in April 2025. PLGB 41871/0023
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Frequently asked questions about colobreathe 1,662,500 IU Inhalation Powder, Hard Capsules
How do I take colobreathe 1,662,500 IU Inhalation Powder, Hard Capsules?
colobreathe 1,662,500 IU Inhalation Powder, Hard Capsules comes as capsule containing 662.5iu. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in colobreathe 1,662,500 IU Inhalation Powder, Hard Capsules?
The active substance in colobreathe 1,662,500 IU Inhalation Powder, Hard Capsules is colistimethate sodium.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for colobreathe 1,662,500 IU Inhalation Powder, Hard Capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get colobreathe 1,662,500 IU Inhalation Powder, Hard Capsules without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: colistimethate sodium
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Colobreathe is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older (see section 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial active substances.
4.2. Posology and method of administration
Posology
Adults and children of 6 years of age and older
One capsule to be inhaled twice daily.
The dose interval should be as close as possible to 12 hours.
The efficacy of Colobreathe has been demonstrated in a study of 24-weeks duration. Treatment may be continued for as long as the physician considers that the patient is obtaining clinical benefit.
Renal impairment
No dose adjustment is considered to be necessary (see section 5.2).
Hepatic impairment
No dose adjustment is considered to be necessary (see section 5.2).
Paediatric population
The safety and efficacy of Colobreathe in children under 6 years of age have not been established. No data are available.
Method of administration
For inhalation use only.
Colobreathe capsules are to be used only with the Turbospin powder inhaler.
The capsules must not be swallowed.
To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler by a physician or other health professional, with the first dose being given under medical supervision.
If other treatments are being taken, they should be taken in the following order:
Inhaled bronchodilators
Chest physiotherapy
Other inhaled medicinal products
Colobreathe
4.3. Contraindications
Hypersensitivity to the active substance, colistin sulphate or polymyxin B.
4.4. Special warnings and precautions for use
Bronchospasm and coughing
Bronchospasm or coughing may occur on inhalation. These reactions usually disappear or significantly diminish with continued use and may be ameliorated by appropriate treatment with beta2-agonists prior to or following dry powder colistimethate sodium inhalation. If bronchospasm or coughing remain problematic, withdrawal of treatment should be considered.
Haemoptysis
Haemoptysis is a complication in cystic fibrosis and is more frequent in adults. The use of colistimethate sodium in patients with clinically significant haemoptysis should be undertaken or continued only if the benefits of treatment are considered to outweigh the risks of inducing further haemorrhage.
Acute respiratory exacerbation
If acute respiratory exacerbations develop additional intravenous or oral antibacterial agent therapy should be considered.
Oral fungal super-infection
After each inhalation of Colobreathe, the mouth should be rinsed with water. The rinse should not be swallowed. Rinsing may reduce the risk of developing oral fungal super-infection during treatment and may also reduce the unpleasant taste associated with colistimethate sodium.
Nephrotoxicity/neurotoxicity
There is very low transpulmonary absorption of colistimethate after inhalation of Colobreathe (see section 5.2). Care should still be taken in administering Colobreathe to patients who are known to have a propensity for nephrotoxic or neurotoxic events.
Caution should be taken with concomitant use of Colobreathe and parenteral or nebulised colistimethate sodium.
Caution should be taken with concomitant use of colistimethate sodium and potential nephrotoxic or neurotoxic medicinal products, including non-depolarising muscle relaxants (see section 4.5).
Other
Colobreathe should be used with extreme caution in patients with myasthenia gravis because of potential for drug induced neuromuscular blockade.
Colistimethate sodium should be used with extreme caution in patients with porphyria.
Safety and efficacy have been assessed in controlled studies for up to 24 weeks. (see section 5.1).
Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
There is no experience of using Colobreathe concurrently with other inhaled antibacterial agents.
Caution should be taken with concomitant use with other formulations of colistimethate sodium as there is little experience and there is a possibility of summative toxicity.
No in-vivo interaction studies have been performed.
Colistimethate sodium and colistin have been investigated in vitro to determine the effects on the expression of cytochrome P450 (CYP) enzymes on treating primary cultures of fresh human hepatocytes. Treatment with colistimethate sodium or colistin did not induce the activity of any enzyme tested (CYP1A2, 2B6, 2C8, 2C9, 2C19 and 3A4/5).
Concomitant use of inhaled colistimethate sodium with other medicinal products that are potentially nephrotoxic or neurotoxic, such as aminoglycosides, or neuromuscular blocking products, such as curariform agents should be undertaken with caution.
Co-treatment with colistimethate sodium and macrolides such as azithromycin and clarithromycin, or fluoroquinolones such as norfloxacin and ciprofloxacin should be undertaken with caution in patients with myasthenia gravis (see section 4.4).
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of inhaled colistimethate sodium in pregnant women. Studies in animals using parenteral administration have shown reproductive toxicity (see section 5.3). Single dose intravenous studies in human pregnancy show that colistimethate sodium crosses the placenta and consequently there is potential for foetal toxicity if administered during pregnancy.
Colistimethate sodium is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding
Physico-chemical data suggest excretion of colistimethate sodium in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from colistimethate sodium therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility
Colistimethate sodium has no notable effects on fertility in male or female rats or mice.
4.7. Effects on ability to drive and use machines
Based on the safety profile of colistimethate sodium, neurotoxity may occur with the possibility of dizziness, confusion or visual disturbances. Patients should be warned not to drive or operate machines if this occurs.
4.8. Undesirable effects
Summary of the safety profile
The safety of Colobreathe has been assessed in a total of 237 subjects (225 cystic fibrosis patients and 12 healthy volunteers). Of these, 187 patients aged 6 years and above were exposed to Colobreathe one capsule twice daily in a 24-week, phase 3 comparative study. There were 32 patients aged 6-12 years, 41 patients aged 13-17 years and 114 patients aged 18 years and older. The most commonly reported adverse reactions as a percent of all Colobreathe treated patients were: unpleasant taste (62%), cough (59.4%), throat irritation (43.9%), dyspnoea (16.6%) and dysphonia (10.7%). Inhalation may induce coughing or bronchospasm which may be controlled by pre-treatment with inhaled beta2 agonists.
Sore throat or mouth has been reported with nebulised colistimethate sodium and may occur with Colobreathe. This may be related to Candida albicans infection or hypersensitivity. Skin rash may also indicate hypersensitivity and if this occurs treatment should be withdrawn.
Tabulated list of adverse reactions
In the 24 week clinical study, the following adverse reactions were observed across all ages.
Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare ((≥1/10,000 to <1/1,000), very rare <1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
System Organ Class
Very Common
Common
Uncommon
Immune system disorders
Drug hypersensitivity
Metabolism and nutrition disorders
Weight fluctuation, decreased appetite
Psychiatric disorders
Anxiety
Nervous system disorders
Balance disorder, headache
Convulsions, somnolence
Ear and labyrinth disorders
Tinnitus
Ear congestion
Respiratory, thoracic and mediastinal disorders
Dyspnoea, cough, dysphonia, throat irritation
Haemoptysis, bronchospasm, asthma, wheezing, chest discomfort, lower respiratory tract infection, productive cough, crackles lung
Chest pain, dyspnoea exacerbated, pharyngolaryngeal pain, epistaxis, sputum purulent, abnormal chest sound, increased upper airway secretion
Gastrointestinal disorders
Dysgeusia
Vomiting, nausea
Diarrhoea, toothache, salivary hypersecretion, flatulence
Musculoskeletal and connective tissue disorders
Arthralgia
Renal and urinary disorders
Proteinuria
General disorders and administration site conditions
Pyrexia, asthenia, fatigue
Thirst
Investigations
Forced expiratory volume decreased
Injury, poisoning and procedural complications
Medication error
Paediatric population
In the 24-week clinical study, where Colobreathe was administered twice daily to adults and children aged 6-17, the adverse reactions identified in the paediatric population were similar to that for the overall population. The most commonly reported adverse reactions as a percent of Colobreathe treated patients were: cough (55%), unpleasant taste (51%), throat irritation (34%), dyspnoea (10%) and dysphonia (10%).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms
Currently there is no experience of overdose with the use of Colobreathe. However, overdose may possibly result in higher systemic exposure.
Overdose is unlikely by the inhaled route but has been recognised after systemic use. More common signs and symptoms of intravenous overdose include unsteadiness, paraesthesia and dizziness. It can also result in neuromuscular blockade that can lead to muscular weakness, apnoea and possible respiratory arrest. Overdose can also cause acute renal failure characterised by decreased urine output and increased serum concentrations of BUN and creatinine.
Management
There is no specific antidote, therefore management should be done by supportive treatment. Measures to increase the rate of elimination of colistimethate sodium e.g. mannitol diuresis, prolonged haemodialysis or peritoneal dialysis may be tried, but effectiveness is unknown.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- COLOBREATHE prescriptionCOLISTIMETHATUM NATRICUM · inhaler / nebuliser
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- Colistin TZFColistimethatum natricum · inhaler / nebuliser
- ColobreatheColistimethatum natricum · inhaler / nebuliser
- Colistimethatum natricum NoridemColistimethatum natricum · inhaler / nebuliser
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about colobreathe 1,662,500 IU Inhalation Powder, Hard Capsules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.