INBRIJA Inhalation powder, hard capsule Ref.[116049] Active ingredients: Levodopa

Posology

Patients should be on a stable levodopa/dopa-decarboxylase inhibitor (e.g. carbidopa or benserazide) regimen before starting Inbrija.

Patients selected for treatment with Inbrija should be able to recognize the onset of their 'OFF' symptoms and be capable of preparing the inhaler or else have a responsible care giver able to prepare the inhaler for them when required.

Inbrija should be inhaled when symptoms, motor or non-motor, of an OFF period start to return.

The recommended dose of Inbrija is 2 hard capsules up to 5 times per day each delivering 33 mg levodopa. The maximum daily dose of Inbrija should not exceed 10 capsules (330 mg). It is not recommended to take more than 2 capsules per OFF period. Exceeding the recommended dose may lead to increased levodopa associated adverse reactions.

Abrupt dose reduction or withdrawal of any levodopa medicinal product should be carefully observed, particularly in patients who are also receiving neuroleptics. See section 4.4 regarding withdrawal emergent hyperpyrexia and confusion.

Elderly

No dose adjustment of Inbrija is required for elderly patients (≥65 years). There is only limited data available in very elderly patients (≥75 years).

Renal impairment

Inbrija has not been studied in patients with renal impairment. It is recommended to administer this medicinal product cautiously to patients with severe renal disease.

Hepatic impairment

Inbrija has not been studied in patients with hepatic impairment. It is recommended to administer this medicinal product cautiously to patients with severe hepatic impairment.

Paediatric population

The safety and efficacy of Inbrija in children under 18 years of age have not been established. No data are available.

Method of administration

For inhalation use only. Inbrija hard capsules must not be swallowed.

The Inbrija inhaler is to be thrown away after all the capsules have been used.

The capsules must only be removed from the blister immediately before use.

The physician or other healthcare professional should instruct the patient how to administer the product correctly. A summary of how to use Inbrija is provided below.

• A complete dose is 2 capsules taken one right after the other.
• The patient should load 1 capsule into the Inbrija inhaler, breathe in and hold their breath for 5 seconds. The patient should hear the capsule "whirl".
• The used capsule should be removed from the Inbrija inhaler and the second capsule loaded into the inhaler. The maximum time between inhalation of the powder from the first and second capsules should not exceed 10 minutes.
• It is important to advise the patient that if they do not hear or feel the capsule "whirl" while inhaling they may need to take a deeper, longer breath, breathing in again using the same capsule or they may need to clean the mouthpiece.

Detailed instructions for use for the patients are included in the package leaflet.

The acute symptoms of levodopa overdose can be expected to arise from dopaminergic overstimulation. Using more than one dose of Inbrija (2 capsules) to treat the same OFF period may result in CNS disturbances, with an increasing likelihood of cardiovascular disturbance (e.g. hypotension, tachycardia) and more severe psychiatric problems at higher doses.

Patients should be monitored and supportive care should be provided. Patients should receive electrocardiographic monitoring for the development of arrhythmias; if needed, appropriate antiarrhythmic therapy should be given.

3 years.

Store below 25°C. Store in the original package in order to protect from light and moisture and remove immediately before use.

The hard capsules are supplied in Aluminium/PVC/Aluminium peel-off blisters. Each perforated unit-dose blister strip contains 4 hard capsules.

The Inbrija inhaler is made of polybutylene terephthalate (PBT), polycarbonate (PC) and polypropylene (PP). Puncturing tines and springs are made from stainless steel.

Carton containing 16 hard capsules (4 blister strips) and one inhaler.

Carton containing 32 hard capsules (8 blister strips) and one inhaler.

Carton containing 60 hard capsules (15 blister strips) and one inhaler.

Carton containing 92 hard capsules (23 blister strips) and one inhaler.

Not all pack sizes may be marketed.

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