Inbrija

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

levodopa

Available from:

Acorda Therapeutics Ireland Limited

ATC code:

N04BA01

INN (International Name):

levodopa

Therapeutic group:

Anti-Parkinson drugs

Therapeutic area:

Parkinson Disease

Therapeutic indications:

Inbrija is indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor.

Product summary:

Revision: 5

Authorization status:

Authorised

Authorization date:

2019-09-19

Patient Information leaflet

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
INBRIJA 33 MG INHALATION POWDER, HARD CAPSULES
levodopa
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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Inbrija is and what it is used for
2.
What you need to know before you use Inbrija
3.
How to use Inbrija
4.
Possible side effects
5.
How to store Inbrija
6.
Contents of the pack and other information
1.
WHAT INBRIJA IS AND WHAT IT IS USED FOR
The active substance in Inbrija is levodopa. Inbrija is a medicine
used by inhalation for treating the
worsening of your symptoms during the “off periods” of
Parkinson’s disease.
Parkinson’s disease affects your movement and it is treated with a
medicine that you take regularly.
During off periods your usual medicine does not control the condition
well enough and movement is
likely to be more difficult.
You should continue taking your main medicine for Parkinson’s
disease and use Inbrija to control
worsening of symptoms (such as inability to move) during off periods.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE INBRIJA
DO NOT USE INBRIJA:
-
if you are
ALLERGIC
TO LEVODOPA
or any of the other ingredients of this medicine (listed in
section 6).
-
if you get blurred vision, red eyes, severe eye and head pain, halos
around lights, pupils of your
eyes that are larger than normal size and feel sick. If you have any
of these symptoms, you may
have a eye condition called
NARROW ANGLE GLAUCOMA,
which occurs suddenly:
DO NOT
take
Inbrija and
GET URGENT MEDICAL ATTENTION
.
-
if you have a
RARE

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Inbrija 33 mg inhalation powder, hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 42 mg levodopa.
Each delivered dose contains 33 mg levodopa.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule.
White opaque capsules containing white powder, with “A42” printed
in black on the cap of the
capsule and two black bands printed on the body of the capsule.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Inbrija is indicated for the intermittent treatment of episodic motor
fluctuations (OFF episodes) in
adult patients with Parkinson’s disease (PD) treated with a
levodopa/dopa-decarboxylase inhibitor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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 impai