COLOBREATHE Inhalation powder, hard capsule Ref.[7193] Active ingredients: Colistimethate

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

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.

Shelf life: 3 years.

Do not store above 25°C.

Store in the original package until immediately before use in order to protect from moisture.

The capsules are contained in oPA/aluminium/pvc blisters with a peelable lidding foil composed of polyester/aluminium of either 8 or 14 hard capsules in each blister.

Colobreathe is available in packs containing either 8 or 56 hard capsules.

Each 56 capsule pack contains one Turbospin powder inhaler device and 7 blisters of 8 capsules or one Turbospin powder inhaler device and 4 blisters of 14 capsules (56 hard capsules) sufficient for 4 weeks use.

Each 8 capsule pack contains one Turbospin powder inhaler device and 1 blister of 8 hard capsules sufficient for 4 days use.

Not all pack sizes may be marketed.

Capsules: no special requirements for disposal. The Turbospin device should be discarded after completion of the treatment pack.

Colobreathe capsules should only be administered using the Turbospin inhaler device.

Taking Colobreathe using the Turbospin inhaler

The following instructions should be adhered to by the patient when taking Colobreathe:

Preparing the Turbospin:

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 pack. 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

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

As you breathe in slowly, you suck air through the body of the Turbospin inhaler into the capsule chamber. The tiny particles of medicine 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.