BRONCHITOL Inhalation powder, hard capsule Ref.[8203] Active ingredients: Mannitol

Posology

Initiation dose assessment

Before commencing treatment with Bronchitol all patients should be assessed for bronchial hyperresponsiveness to inhaled mannitol during administration of their initiation dose (see sections 4.4 and 5.1).

The patient’s initiation dose of Bronchitol must be used under the supervision and monitoring of an experienced physician or another health care professional appropriately trained and equipped to perform spirometry, monitor oxygen saturation (SpO₂), and manage acute bronchospasm (see sections 4.4 and 4.8) including appropriate use of resuscitation equipment.

The patient should be pre-medicated with a bronchodilator 5-15 minutes prior to the initiation dose but after the baseline FEV₁ and SpO₂ (Oxygen saturation in the blood) measurement. All FEV₁ measurements and SpO₂ monitoring should be performed 60 seconds after dose inhalation.

Training the patient to practice correct inhaler technique during the initiation dose assessment is important.

The initiation dose assessment must be performed according to the following steps:

Step 1: Patients baseline FEV₁ and SpO₂ is measured prior to the initiation dose.

Step 2: Patient inhales 40 mg (1x40 mg capsules) and SpO₂ is monitored.

Step 3: Patient inhales 80 mg (2x40 mg capsules) and SpO₂ is monitored.

Step 4: Patient inhales 120 mg (3x40 mg capsules), FEV₁ is measured and SpO₂ is monitored.

Step 5: Patient inhales 160 mg (4x40 mg capsules), FEV₁ is measured and SpO₂ is monitored.

Step 6: Patients FEV₁ is measured 15 minutes post initiation dose.

Patients with asthma may experience reversible temporary mild bronchospasm after passing the initiation dose assessment and therefore all patients should be monitored until their FEV₁ has returned to baseline levels.

Therapeutic dose regimen

The therapeutic dose regimen should not be prescribed until the initiation dose assessment has been performed. The patient must complete and pass the initiation dose assessment before starting treatment with Bronchitol.

A bronchodilator must be administered 5-15 minutes before each dose of Bronchitol.

The recommended dose of Bronchitol is 400 mg twice a day. This requires the inhalation of the contents of ten capsules via the inhaler device twice a day. The doses should be taken morning and night with the evening dose taken 2-3 hours before bedtime.

For patients receiving several respiratory therapies, the recommended order is:

1. Bronchodilator
2. Bronchitol
3. Physiotherapy/exercise
4. Dornase alfa (if applicable)
5. Inhaled antibiotics (if applicable)

Special populations

Elderly patients (≥65 years)

There are insufficient data in this population to support a recommendation for or against dose adjustment.

Renal or hepatic impairment

Bronchitol has not formally been studied in patients with impaired renal and hepatic function. Available data from studies DPM-CF-301 and 302 suggest that no dose adjustments are required for these patient populations.

Paediatric population

The safety and efficacy of Bronchitol in children and adolescents aged 6 to 18 years has not yet been established. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.

The safety and efficacy of Bronchitol in children aged less than 6 years has not been established. No data are available.

Method of administration

Bronchitol is for inhalation use, using the inhaler provided in the pack. It must not be administered by any other route or using any other inhaler. The capsules must not be swallowed.

Each of the capsules is loaded into the device separately. The contents of the capsules are inhaled via the inhaler device with one or two breaths. After inhalation, each empty capsule is discarded before inserting the next capsule into the inhaler device with as little delay as possible between capsules.

The inhaler device is to be replaced after one week of use. If the inhaler does require cleaning, it must be ensured that the device is empty, then it should be washed in warm water and before re-use,the inhaler should be allowed to thoroughly air dry.

Detailed instructions on how to use the inhaler can be found in the patient information leaflet. Patients should be advised to carefully read them.

Susceptible persons may suffer bronchoconstriction in the event of an inhaled overdose. If excessive coughing and bronchoconstriction occurs, a beta₂ agonist should be given, and oxygen if necessary.

3 years.

Discard the inhaler and its cap 1 week after first use.

Store below 30°C.

Store in the original blister in order to protect from moisture. The capsules must only be removed immediately before use.

Aluminium/polyamide/PVC/aluminium blisters. Cartons containing 10 or 280 capsules for initial dose and treatment use respectively.

The initiation dose carton contains 1 blister (of 10 capsules) and one inhaler device.

The 2-week carton contains 28 blisters (of 10 capsules each) and two inhaler devices.

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.