Colobreathe 1662500IU inhalation powder, hard capsules

Country: European Union

Language: English

Source: myHealthbox

Active ingredient:

colistimethate sodium

Available from:

Forest Laboratories UK Ltd

ATC code:

J01XB01

INN (International Name):

colistimethate sodium

Dosage:

Each capsule contains 1662500IU (approximately equal to 125mg) of colistimethate sodium

Pharmaceutical form:

Inhalation powder, hard capsule

Administration route:

To inhale from the capsule through the inhaler

Units in package:

8,56 capsules + 1 Turbospin inhaler

Prescription type:

Medicinal product subject to medical prescription

Manufactured by:

Penn Pharmaceutical Services Ltd, Forest-Tosara Ltd

Therapeutic group:

antibacterials for systemic use

Therapeutic area:

Cystic Fibrosis

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

Authorization status:

Authorized

Authorization date:

2012-02-13

Patient Information leaflet

20

PACKAGE LEAFLET: INFORMATION FOR THE USER 

COLOBREATHE 1,662,500 IU INHALATION POWDER, HARD CAPSULES 
Colistimethate sodium 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU. 
- 
Keep this leaflet.  You may need to read it again. 
- 
If you have any further questions,
ask your doctor or pharmacist. 
- 
This medicine has been prescribed for you only.  Do not pass
it on to others.  It may harm them, 
even if their signs of illness are the same as yours.   
- 
If you get any side effects, talk to
your doctor or pharmacist. This includes any possible side 
effects not listed in this leaflet. 

WHAT IS IN THIS LEAFLET 
1. 
What Colobreathe is and what it is used for 
2. 
What you need to know before you take Colobreathe 
3. 
How to use Colobreathe 
4. 
Possible side effects 
5. 
How to store Colobreathe 
6. 
Contents of the pack and other information 

1. 
WHAT COLOBREATHE IS AND WHAT IT IS USED 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.  

2. 
WHAT YOU NEED TO KNOW BEFORE YOU USE COLOBREATHE 

DO NOT USE COLOBREATHE: 

  if you/your child are allergic to colistimethate
sodium (sometimes known as colistin), colistin 
sulphate or polymyxins: 

WARNINGS AND PRECAUTIONS 

TELL YOUR DOCTOR IF YOU/

Summary of Product characteristics

1 

ANNEX I 

SUMMARY OF PRODUCT CHARACTERISTICS 

2

1. 
NAME OF THE MEDICINAL PRODUCT 

Colobreathe 1,662,500 IU inhalation powder, hard capsules 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each capsule contains 1,662,500 IU, which is approximately equal to
125 mg of colistimethate 
sodium.  

For the list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Inhalation powder, hard capsule (inhalation powder) 
Hard transparent gelatin capsules containing a fine white powder. 

4. 
CLINICAL PARTICULARS 

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 agents. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
_ _
Posology 
To ensure proper administration of the drug, 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. 

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. 

_Adults _
One capsule to be inhaled twice daily. 
The dose interval should be as close as possible to 12 hours.  
_ _
_Paediatric population_ 
_ _
_Children of 6 years of age and older _
The same dose recommendations as for adults apply to children of 6 years of age and older. 

_Children below 6 years of age _
The safety and efficacy of Colobreathe in children under 6 years of age has not been established. No data 
are available.