Inbrija

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 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. 



3 

 
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. 

 
Detailed instructions for use for the patients are included in the package leaflet. 
 
4.3 Contraindications 
 
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
- Narrow-angle glaucoma. 
- Phaeochromocytoma. 
- Co-administration with non-selective monoamine oxidase (MAO) inhibitors. These inhibitors 

should already be discontinued for at least two weeks prior to initiating therapy due to the 
established underlying levodopa therapy (see section 4.5). 

- A previous history of neuroleptic malignant syndrome (NMS) and/or non-traumatic 
rhabdomyolysis. 

 
4.4 Special warnings and precautions for use 
 
Bronchospasm in patients with lung disease 
 
Because of the risk of bronchospasm, use of levodopa inhalation powder in patients with asthma, 
chronic obstructive pulmonary disease (COPD), or other chronic underlying lung disease is not 
recommended. There is limited data regarding chronic effect of Inbrija in respiratory compromised 
patients. 
 
Central Nervous System (CNS) effects and mental disturbances 
 
Somnolence and episodes of sudden sleep onset 
Levodopa has been associated with somnolence and episodes of sudden sleep onset (see section 4.7). 
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has 
been reported very rarely. Patients must be informed of this and advised to exercise caution while 



4 

driving or operating machines during treatment (see section 4.7). Patients who have experienced 
somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. 
Furthermore, a reduction of dose or termination of therapy may be considered. 
 
Withdrawal-emergent hyperpyrexia and confusion 
A symptom complex that resembles neuroleptic malignant syndrome (characterised by elevated 
temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other 
obvious aetiology, has been reported in association with rapid dose reduction, withdrawal of, or 
changes in the background dopaminergic therapy. Therefore, any abrupt dose reduction or withdrawal 
of any levodopa medicinal product should be carefully observed, particularly in patients who are also 
receiving neuroleptics. 
 
Mental disturbances 
Patients may experience new or worsening mental status and behavioural changes, which may be 
severe, including psychotic-like and suicidal behaviour during levodopa treatment or after starting or 
increasing the dose of levodopa. This abnormal thinking and behaviour can consist of one or more of a 
variety of manifestations including anxiety, depression, paranoid ideation, delusions, hallucinations, 
confusion, psychotic-like behaviour, disorientation, aggressive behaviour, agitation, and delirium. 
Patients with a major psychotic disorder or a history of psychotic disorder must be treated cautiously 
with a levodopa/dopa-decarboxylase inhibitor because of the risk of exacerbating psychosis. In 
addition, certain medicinal products used to treat psychosis may exacerbate the symptoms of 
Parkinson’s disease and may decrease the effectiveness of levodopa. Concomitant use of 
antipsychotics should be monitored carefully for worsening of Parkinson’s motor symptoms especially 
when D2-receptor antagonists are used (see section 4.5). 
 
Impulse control disorders 
Patients should be regularly monitored for the development of impulse control disorders. Patients and 
carers should be made aware that behavioural symptoms of impulse control disorders including 
pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating 
and compulsive eating can occur in patients treated with levodopa. Review of treatment is 
recommended if such symptoms develop. 
 
Dyskinesia 
Inbrija may cause dyskinesia. Adjustment of levodopa therapy or other medicinal products used for 
the treatment of Parkinson’s disease may be considered. 
 
Cardiovascular ischaemic events 
 
Inbrija should be administered with caution in patients with severe cardiovascular disease. Care should 
be exercised when Inbrija is administered to patients with a history of myocardial infarction who have 
residual atrial, nodal, or ventricular arrhythmias. Cardiac function should be monitored with particular 
care in such patients during the initiation of treatment with Inbrija. 
 
Peptic ulcer disease 
 
Levodopa should be administered cautiously to patients with a history of peptic ulcer disease (because 
of the possibility of upper gastro-intestinal haemorrhage). 
 
Glaucoma 
 
Levodopa may cause increased intraocular pressure in patients with glaucoma. Patients with chronic 
glaucoma may be treated cautiously with levodopa provided the intraocular pressure is well-controlled 
and the patient is monitored carefully for changes in intraocular pressure during therapy. 
 



5 

Melanoma 
 
Epidemiological studies have shown that patients with Parkinson’s disease have a higher risk (2- to 
approximately 6-fold higher) of developing melanoma than the general population. Whether the 
increased risk observed was due to Parkinson’s disease or other factors, such as medicinal products 
used to treat Parkinson’s disease, is unclear. 
Periodic skin examinations are recommended to monitor for melanoma in patients receiving Inbrija. 
 
Laboratory monitoring 
 
Abnormalities in laboratory tests may include elevations of liver function tests such as alkaline 
phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactic dehydrogenase 
(LDH), and bilirubin. Abnormalities in blood urea nitrogen (BUN) and positive Coombs test have also 
been reported. 
 
Interference with test 
 
Levodopa may cause a false-positive reaction for urinary ketone bodies when a test tape is used for 
determination of ketonuria. This reaction will not be altered by boiling the urine specimen. False-
negative tests may result with the use of glucose-oxidase methods of testing for glucosuria. 
Cases of falsely diagnosed pheochromocytoma in patients on levodopa/dopa-decarboxylase inhibitor 
therapy have been reported very rarely. Caution should be exercised when interpreting the plasma and 
urine levels of catecholamines and their metabolites in patients on levodopa or levodopa/dopa-
decarboxylase inhibitor therapy. 
 
Orthostatic hypotension 
 
Levodopa can cause orthostatic hypotension. Inbrija should be used with caution in case of 
concomitant use of medicinal products that may cause orthostatic hypotension, e.g. anti-hypertensive 
medicinal products. 
 
Intercurrent respiratory infection 
 
There is limited data available on the use of Inbrija during a respiratory infection. Based on individual 
assessments of the severity of the intercurrent respiratory infection Inbrija may be continued or 
discontinued until the respiratory symptoms resolve (see section 4.2).  
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Non-selective Monoamine Oxidase (MAO) inhibitors 
 
The use of non-selective MAO inhibitors with levodopa is contraindicated (see section 4.3). Any non-
selective MAO inhibitors should be discontinued at least 14 days prior to initiating levodopa. 
 
Selective Monoamine Oxidase (MAO) inhibitors 
 
The use of selective MAO-B inhibitors (e.g. rasagiline, selegiline, and safinamide) with levodopa may 
be associated with orthostatic hypotension. Patients who are taking these medicinal products should be 
monitored closely. 
 
Dopamine D2 receptor antagonists and isoniazid 
 
Dopamine D2 receptor antagonists (e.g. phenothiazines, butyrophenones, risperidone, 
metoclopramide) and isoniazid may reduce the effectiveness of levodopa. Patients who are taking 
these medicinal products should be monitored for worsening Parkinson’s symptoms (see section 4.4). 
 
Antihypertensives 



6 

 
Symptomatic postural hypotension has occurred when combinations of levodopa and a dopa-
decarboxylase inhibitor are added to the treatment of patients already receiving certain 
antihypertensives. Dose adjustment of the antihypertensive medicinal products may be required during 
concomitant use of Inbrija. 
 
Anticholinergics 
 
Anticholinergic medicinal products can work synergistically with levodopa, in order to improve 
tremor. Concurrent use can, however, cause a worsening of involuntary motor disorders. 
Anticholinergic medicinal products may impair the effect of oral levodopa medicinal products, due to 
a delayed absorption. A dose adjustment of levodopa may be required.  
 
COMT inhibitors 
 
The addition of entacapone to a levodopa/dopa-decarboxylase inhibitor has been demonstrated to 
increase the levodopa bioavailability by 30%. A dose adjustment of levodopa may be required with 
concomitant use of COMT inhibitors. 
 
Tricyclic antidepressants 
 
There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting 
from the concomitant use of tricyclic antidepressants and a levodopa/dopa-decarboxylase inhibitor. 
 
Amantadine 
 
Concurrent administration of levodopa and amantadine may increase confusion, hallucinations, 
nightmares, gastro-intestinal disturbances, or other atropine-like side effects. Psychotic reactions have 
been observed in patients receiving amantadine and levodopa. 
 
Local or systemic pulmonary medicinal products 
 
Interactions of Inbrija with local or systemic pulmonary medicinal products were not investigated 
because Inbrija is not recommended in patients with asthma, chronic obstructive pulmonary disease 
(COPD), or other chronic underlying lung disease (see section 4.4). 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no or limited amount of data from the use of levodopa in pregnant women. Studies in 
animals have shown reproductive toxicity (see section 5.3). Inbrija is not recommended during 
pregnancy and in women of childbearing potential not using contraception. 
 
Breast-feeding 
 
Levodopa is excreted in human milk. There is insufficient information on the effects of levodopa in 
newborns/infants. Breast-feeding should be discontinued during treatment with Inbrija. 
 
Fertility 
 
There are no data on the effects of levodopa on human fertility. Animal studies indicated no effect on 
fertility (see section 5.3). 
 



7 

4.7 Effects on ability to drive and use machines 
 
Levodopa may have a major influence on the ability to drive and use machines. Certain side effects 
such as sleepiness and dizziness, that have been reported with other forms of levodopa medicinal 
products, may affect some patients’ ability to drive or use machines. 
 
Patients being treated with levodopa medicinal products and presenting with somnolence and/or 
sudden sleep episodes must be informed to refrain from driving or engaging in activities where 
impaired alertness may put themselves or others at risk of serious injury or death (e.g. use machines), 
until such recurrent episodes and somnolence have resolved (see also section 4.4). 
 
4.8 Undesirable effects 
 
Summary of safety profile  
 
The most frequent adverse reactions reported in the Inbrija clinical studies were cough (15.6%), fall 
(8.7%), upper respiratory tract infection (5.8%), dyskinesia (5.7%) and sputum discoloured (2.8%). 
Serious adverse reactions of allergic oedema have been reported with levodopa medicinal products but 
not in clinical studies with Inbrija. A symptom complex resembling neuroleptic malignant syndrome 
and rhabdomyolysis may occur with levodopa/dopa-decarboxylase inhibitor medicinal products, 
although no cases have been identified in clinical studies with Inbrija. Gastrointestinal haemorrhage 
has been reported with levodopa medicinal products and was observed once in Inbrija clinical studies. 
 
Tabulated list of adverse reactions 
 
Adverse reactions are presented by system organ class and frequency in Table 1 below. Frequency 
categories are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), not known 
(cannot be estimated from the available data). The not known column represents adverse reactions 
reported for other oral levodopa medicinal products. 
 
Table 1: Adverse reactions 

 Adverse reactions in clinical trials with 
Inbrija 

Adverse reactions reported 
with oral levodopa 

System Organ 
Class 

Very common Common Not known 

Neoplasm benign, 
malignant and 
unspecified (incl. 
cysts and polyps) 

  Malignant melanoma 

Blood and 
lymphatic system 
disorders 

  Anaemia, 
Agranulocytosis, 
Thrombocytopenia, 
Leukopenia 

Immune system 
disorder 

  Allergic oedema 

Metabolism and 
nutrition disorders 

  Decreased appetite 

Psychiatric 
disorders 

  Confusional state, 
Hallucination, 
Depression, 
Anxiety, 
Abnormal dreams, 
Insomnia, 
Psychotic disorder, 
Impulse-control disorder (see 
section 4.4), 
Agitation, 



8 

 Adverse reactions in clinical trials with 
Inbrija 

Adverse reactions reported 
with oral levodopa 

System Organ 
Class 

Very common Common Not known 

Suicide attempt (see 
section 4.4), 
Disorientation, 
Dopamine dysregulation 
syndrome, 
Euphoric mood, 
Libido increased, 
Bruxism, 
Paranoia, 
Delusion 

Nervous system 
disorders 

 Dyskinesia Dystonia, 
On and off phenomenon, 
Somnolence, 
Dizziness, 
Worsening of Parkinson’s 
disease, 
Paraesthesia, 
Headache, 
Tremor, 
Seizure, 
Sudden onset of sleep (see 
section 4.4), 
Restless legs syndrome, 
Neuroleptic malignant 
syndrome (see section 4.4), 
Ataxia, 
Dysgeusia, 
Cognitive disorder, 
Horner's syndrome, 
Dementia 

Eye disorders   Vision blurred, 
Diplopia, 
Mydriasis, 
Oculogyric crisis, 
Blepharospasm 

Cardiac disorders   Cardiac rhythm disordersa (see 
section 4.4), 
Palpitations 

Vascular disorders   Orthostatic hypotension (see 
section 4.4), 
Hypertension, 
Syncope, 
Thrombophlebitis, 
Hot flush 

Respiratory, 
thoracic and 
mediastinal 
disorders 

Cough Upper respiratory tract 
infection, 
Sputum discoloured, 
Nasal discharge 
discolouration, 
Throat irritation 

Dyspnoea, 
Respiration abnormal, 
Dysphonia, 
Hiccups 

Gastrointestinal 
disorders 

 Nausea, 
Vomiting 

Abdominal pain, 
Constipation, 
Diarrhoea, 



9 

 Adverse reactions in clinical trials with 
Inbrija 

Adverse reactions reported 
with oral levodopa 

System Organ 
Class 

Very common Common Not known 

Dry mouth, 
Gastrointestinal haemorrhage, 
Peptic ulcer (see section 4.4), 
Dysphagia, 
Dyspepsia, 
Glossodynia, 
Flatulence, 
Saliva discolouration, 
Salivary hypersecretion 

Skin and 
subcutaneous 
tissue disorders 

  Angioedema, 
Hyperhidrosis, 
Rash, 
Pruritus, 
Henoch-Schonlein purpura, 
Urticaria, 
Alopecia, 
Sweat discolouration 

Musculoskeletal 
and connective 
tissue disorders 

  Muscle spasms, 
Trismus 

Renal and urinary 
disorders 

  Urinary retention, 
Chromaturia, 
Urinary incontinence 

Reproductive 
system and breast 
disorders 

  Priapism 

General disorders 
and administration 
site conditions 

  Oedema peripheral, 
Asthenia, 
Fatigue, 
Malaise, 
Gait disturbance, 
Chest pain 

Investigations   Aspartate aminotransferase 
increased, 
Alanine aminotransferase 
increased, 
Blood lactate dehydrogenase 
increased, 
Blood bilirubin increased, 
Blood glucose increased, 
Blood creatinine increased, 
Blood uric acid increased, 
Haemoglobin decreased, 
Haematocrit decreased, 
Blood urine present, 
Blood urea increased, 
Blood alkaline phosphatase 
increased, 
Coombs test positive, 
White blood cells urine 
positive, 
Bacterial test positive, 
Weight decreased, 



10 

 Adverse reactions in clinical trials with 
Inbrija 

Adverse reactions reported 
with oral levodopa 

System Organ 
Class 

Very common Common Not known 

Weight increased 
Injury, poisoning 
and procedural 
complications 

 Fall  

a  Cardiac rhythm disorder here is a combined term representing atrial fibrillation, atrial flutter, atrioventricular 
block, bundle branch block, sick sinus syndrome, bradycardia, and tachycardia. 

 
Description of selected adverse reactions 
 
Sudden sleep onset 
Levodopa is associated with somnolence and has been associated very rarely with excessive daytime 
somnolence and sudden sleep onset episodes. 
 
Impulse control disorders 
Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating 
and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic 
treatments containing levodopa (see section 4.4). 
 
Coughing 
Most cough reported in the clinical studies with Inbrija were mild to moderate in intensity, and usually 
reported within the first 30 days of the treatment. Due to cough, 2% of subjects withdrew from the 
clinical studies with Inbrija. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
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. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Anti-Parkinson drugs, dopaminergic agents, ATC code: N04BA01 
 
Mechanism of action 
 
Levodopa is a precursor of dopamine, and is given as dopamine replacement therapy in Parkinson’s 
disease. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


11 

Clinical efficacy and safety 
 
The effectiveness of Inbrija for the treatment of OFF episodes in patients with Parkinson’s disease 
given on top of background dopaminergic treatment was evaluated in a 12-week, randomised, 
placebo-controlled, double-blind study. Subjects had to be able to recognise OFF periods and to 
handle the device. 
 
A total of 114 patients were randomised and treated with Inbrija 66 mg (two 33 mg capsules) and 
112 patients received placebo. When experiencing an OFF period, subjects could use inhaled levodopa 
on demand up to five times a day. Apomorphine was not allowed as background medicinal product. At 
baseline, patients had at least 2 hours of OFF time per day, and the levodopa/dopa-decarboxylase 
inhibitor medicines did not exceed 1,600 mg levodopa per day. 
 
The primary efficacy endpoint was the mean change from baseline in Unified Parkinson’s Disease 
Rating Scale (UPDRS) part III score 30 minutes post dose at week 12. The UPDRS part III is designed 
to assess the severity of the cardinal motor findings (e.g. tremor, rigidity, bradykinesia, postural 
instability) in patients with Parkinson’s disease. This endpoint was assessed in a clinical setting, i.e. 
patients had to take their regular morning oral levodopa/dopa-decarboxylase inhibitor dose and then 
visit the clinic 2-5 hours post dose. If an OFF period emerged subjects received placebo or inhaled 
levodopa. UPDRS-III was assessed before and 30 minutes post dose administration. Reduction in 
mean daily OFF time and improvement on the Patient Global Impression of Change (PGI-C) scale, a 
patient reported outcome of the overall improvement and satisfaction with Inbrija treatment, and 
Responders ON were the main secondary endpoints. Results are presented in Table 2. 
 



12 

Table 2: Baseline features and results of the efficacy endpoints  

Parameters Placebo n = 112 

Inbrija 
66 mg 

n = 114 
Subject features   
Age 63 years 64 years 
Duration PD 97 months 96 months 
Baseline Levodopa dose 841 mg 819 mg 
UPDRS-III score during OFF 
period n = 95

a n = 94a 

Pre-dose score 32.1 29.0 
Change at 30 min -5.91 -9.83 
Diff. (95% CI) - -3.92 (-6.84; -1.00) 
p-value - 0.009 
Responders ONb n = 97a n = 97a 
% (n) 36.1% (35) 57.7% (56) 
Diff. - 21.6% 
p-value - 0.003 
PGI-C n = 97a n = 98a 
Much improved % (n) 7.2% (7) 11.2% (11) 
Improved % (n) 7.2% (7) 26.5% (26) 
Little improved % (n) 32.0% (31) 33.7% (33) 
Not improved % (n) 53.6% (52) 28.6% (28) 
p-value - < 0.001c 

Daily OFF-time (h) n = 97a n = 95a 
Baseline mean (SD) 5.59 (2.25) 5.35 (2.26) 
LS mean change 
Mean diff. (95% CI) 
p-value 
 

-0.48 
 
 
 

-0.47 
-0.01 (-0.55; 0.56) 

0.975 
 Daily doses (median) 2 doses 2 doses 

a  Observed cases. 
b  A responder was defined as a subject that changed from OFF to ON within 60 minutes post dose and 

who remained ON at 60 minutes post dose. 
c  p-value for PGI-C is nominal. 
 
Pulmonary safety 
In a subpopulation of the 12-week study, serial spirometry measurements were performed at 15, 30 
and 60 minutes following the first dose of Inbrija 66 mg or placebo. No notable differences between 
placebo and Inbrija were observed in forced expiratory volume in 1 second (FEV1) following the first 
dose. 
 
The effect of Inbrija on pulmonary function was also evaluated in patients with Parkinson’s disease 
treated with an oral levodopa/dopa-decarboxylase inhibitor in a 12-month, randomised, controlled, 
open-labeled study. A total of 271 patients were treated with Inbrija 66 mg (two 33 mg capsules), and 
127 patients in an observational control group were observed on their regular oral medication regimen 
for the treatment of Parkinson’s disease. Pulmonary function was assessed by spirometry and carbon 
monoxide diffusing capacity (DLCO) every 3 months in both groups. After 12 months, the average 
reduction in FEV1 from baseline was the same in both groups (-0.1 L). The change from baseline for 
DLCO was compared between the Inbrija treatment group and the observational cohort; at the end of 
12 months, there was no significant difference in the change from baseline between Inbrija group and 
the observational cohort in DLCO. 
 



13 

Paediatric population 
 
The European Medicines Agency has waived the obligation to submit the results of studies with 
Inbrija in all subsets of the paediatric population in the treatment of idiopathic Parkinson’s disease (see 
section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
The pharmacokinetics of Inbrija 66 mg (2 x 33 mg capsules) and carbidopa/levodopa 25 mg/100 mg 
immediate release tablets was evaluated in 24 healthy volunteers in a fasted state receiving a total of 
50 mg carbidopa every 8 hours. 
 
The median time to maximal plasma concentration of levodopa was 30 minutes after a dose of Inbrija 
66 mg (2 x 33 mg capsules) compared to 45 minutes after a dose of carbidopa/levodopa 25 mg/100 mg 
immediate release tablets. The dose-normalised relative bioavailability of a single 66 mg emitted dose 
of Inbrija was 88.0% (90% CI: 80.3, 96.4) when compared to a single oral carbidopa/levodopa 
25 mg/100 mg dose. 
 
The mean maximal plasma concentration at 10 minutes (C10min) and at peak concentration (Cmax) of 
levodopa following administration of Inbrija 66 mg (2 x 33 mg capsules) was 418 ng/mL and 
696 ng/mL, respectively, with exposure over 4 hours (AUC0-4 h) of 1,280 ng●h/mL. 
 
Distribution 
 
Apparent volume of distribution (Vz/F) was 168 L for Inbrija 66 mg (2 x 33 mg capsules). 
 
Biotransformation 
 
Levodopa is extensively metabolised to various metabolites. The two major metabolic pathways are 
decarboxylation by L-aromatic amino acid decarboxylase and O-methylation by catechol-O-
methyltransferase (COMT). 
 
The pharmacokinetics of the major levodopa metabolites 3-O-methyldopa (3-OMD), 3,4-
dihydroxyphenylacetic acid (DOPAC) and homovanillic acid (HVA) were studied following 
administration of a single inhaled dose of Inbrija and a single oral carbidopa/levodopa 25 mg/100 mg 
immediate release tablet. The metabolite profile following Inbrija inhalation was not substantially 
different than that observed following oral carbidopa/levodopa administration. The peak metabolite 
concentrations and total exposure achieved after Inbrija administration did not exceed those observed 
following an oral carbidopa/levodopa dose. 
 
The impact of the amount of circulating dopa-decarboxylase at the end of an oral carbidopa/levodopa 
dosing interval on the efficacy of Inbrija was not studied. 
 
Elimination 
 
In the presence of carbidopa, the apparent terminal elimination half-life (t1/2) of levodopa following a 
single administration of Inbrija 66 mg (2 x 33 mg capsules) was 2.3 hours and comparable to that 
following an oral dose of carbidopa/levodopa 25 mg/100 mg immediate release tablets of 1.9 hours. 
 
Linearity/non-linearity 
 
Inbrija shows dose proportional pharmacokinetics of levodopa from 13 mg to 122 mg. 
 



14 

Renal impairment 
 
Inbrija has not specifically been studied in patients with renal impairment. It is recommended to 
administer this medicinal product cautiously to patients with severe renal disease (see section 4.2). 
 
Hepatic impairment 
 
Inbrija has not specifically been studied in patients with hepatic impairment. It is recommended to 
administer this medicinal product cautiously to patients with severe hepatic impairment (see 
section 4.2). 
 
Gender 
 
A clinical study was performed with Inbrija 66 mg (2 x 33 mg capsules) in 24 healthy subjects 
(13 men and 11 women). After administration of Inbrija the Cmax and AUC0-24 h for women were 42.2% 
higher and 48.8% higher than for men, respectively. After correcting the parameters for body weight, 
the gender difference after each treatment was no longer significant: the body-weight adjusted Cmax 
and AUC0-24 h after a dose of Inbrija in women were 9.7% and 15.1% higher than men. Most of the 
gender difference is accounted for by differences in body weight. No dose adjustment is required 
based on gender. 
 
Smoking 
 
A clinical study was performed with Inbrija 66 mg (2 x 33 mg capsules) administered to 56 healthy 
subjects (31 non-smokers and 25 smokers). After administration of Inbrija the Cmax and AUC0-24 h was 
11% to 12% higher for smokers than for non-smokers. No dose adjustment is required based on 
smoking status. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. 
 
Reproductive toxicity 
 
Levodopa has caused visceral and skeletal malformations in rabbits. 
No effects were seen on male or female reproductive organs in repeat dose toxicology studies in mice, 
rats or monkeys with levodopa alone. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Capsule content 
 
Colfosceril palmitate (DPPC) 
Sodium chloride 
 
Capsule shell 
 
Hypromellose 
Titanium dioxide (E 171) 
Carrageenan 
Potassium chloride 
Carnauba wax 
Maize starch 



15 

 
Ink 
 
Shellac 
Black iron oxide (E 172) 
Propylene glycol 
Potassium hydroxide 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
Store below 25°C. Store in the original package in order to protect from light and moisture and remove 
immediately before use. 
 
6.5 Nature and contents of container  
 
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 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. 
 
6.6 Special precautions for disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Acorda Therapeutics Ireland Limited 
10 Earlsfort Terrace 
Dublin 2, D02 T380  
Ireland 
Tel: +353 (0)1 231 4609 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/19/1390/001 
EU/1/19/1390/002 
 
 



16 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
  

http://www.ema.europa.eu/


17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH 
RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 
 



18 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
ADOH B.V. 
Godfried Bomansstraat 31 
6543 JA Nijmegen 
Netherlands 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to medical prescription. 
 
 
C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of 
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC 
and any subsequent updates published on the European medicines web-portal. 
 
The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 
6 months following authorisation. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   
 
• Risk management plan (RMP) 
 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance 
activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the 
marketing authorisation and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 
• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

  



19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



21 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Inbrija 33 mg inhalation powder, hard capsules 
levodopa 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 42 mg levodopa. 
Each delivered dose contains 33 mg levodopa. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains colfosceril palmitate (DPPC), sodium chloride, hypromellose, titanium dioxide (E 171), 
carrageenan, potassium chloride, carnauba wax, maize starch, shellac, black iron oxide (E 172), 
propylene glycol, potassium hydroxide. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Inhalation powder, hard capsules 
 
60 hard capsules + 1 inhaler 
92 hard capsules + 1 inhaler 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For inhalation use only. Do not swallow Inbrija capsules. 
For use only with the inhaler provided in the pack. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



22 

9. SPECIAL STORAGE CONDITIONS 
 
Store below 25°C. Store in the original package in order to protect from light and moisture and only 
remove immediately before use. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Acorda Therapeutics Ireland Limited 
10 Earlsfort Terrace 
Dublin 2, D02 T380 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/19/1390/001 60 hard capsules 
 EU/1/19/1390/002 92 hard capsules 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Inbrija 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN  



23 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Inbrija 33 mg inhalation powder, hard capsules 
levodopa 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Acorda Therapeutics Ireland Limited 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Do not swallow capsules. Inhalation only. 
 
 
  



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 tumour of the adrenal gland called phaeochromocytoma. 
- if you are taking certain antidepressant medicines called non-selective MAO inhibitors (e.g. 

isocarboxazid and phenelzine). You must stop taking these medicines at least 14 days before 
starting treatment with Inbrija. See also under “Other medicines and Inbrija”. 

- if you have previously suffered from neuroleptic malignant syndrome, a life-threatening 
reaction to certain medicines used to treat severe mental disorders or if you have suffered from 
non-traumatic rhabdomyolysis, a rare muscle disorder in which damaged muscle breaks down 
rapidly. 

 
Warnings and precautions 
Get urgent medical help if you have tremors, agitation, confusion, fever, rapid pulse, or dizziness 



26 

and fainting upon standing up, or you notice that your muscles get very rigid or jerk violently. These 
may be symptoms of “withdrawal-emergent hyperpyrexia”. For more information see section 4. 
 
Talk to your doctor or pharmacist before using Inbrija if you have, or have ever had, or you 
develop: 
- asthma, breathing difficulties like chronic obstructive pulmonary disease (COPD) or other long-

term lung diseases or breathing problems; 
- any form of severe mental disorder like psychosis; 
- a heart attack, or heart beat problems. Your doctor will monitor you closely during start of 

treatment; 
- an ulcer in your stomach or intestines; 
- an eye condition called glaucoma, because the pressure in your eyes may need to be monitored; 
- severe problems with your kidneys; 
- severe problems with your liver. 
 
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using 
Inbrija. 
 
Talk to your doctor or pharmacist if you develop any of the symptoms below whilst using Inbrija: 
- sudden sleep attacks or sometimes feeling very sleepy; 
- changes in or worsening of your mental state, which may be severe such as psychotic and 

suicidal behaviour; 
- hallucinations, along with being confused, unable to sleep and excessive dreaming. Abnormal 

thinking including anxiety, depression, being agitated, being paranoid, delusional, or 
disorientated, aggressive behaviour and delirious; 

- worsening of any breathing symptoms or having a respiratory infection; 
- urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, 

drive or temptation to carry out certain activities that could harm yourself or others. These 
behaviours are called impulse control disorders and can include addictive gambling, excessive 
eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings. 
Your doctor may need to review your treatments. 

- new or increased abnormal body movements (dyskinesia); 
- feeling dizzy when getting up (low blood pressure); 
- melanoma (a type of skin cancer) or suspicious skin growths or marks. 
 
If you need to have surgery, tell your doctor that you are using Inbrija. 
 
Tests 
You may need to have tests on your heart, liver, kidney, and blood cell tests during long-term 
treatment with your medicines. If you need to have tests on your blood or urine, tell your doctor or 
nurse that you are taking Inbrija. This is because the medicine may affect the results of some tests. 
 
Children and adolescents 
The use of Inbrija is not recommended in patients under 18 years of age. 
 
Other medicines and Inbrija 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. This is because other medicines can affect the way Inbrija works. 
 
Do not use Inbrija if you have taken medicines called non-selective MAO inhibitors for treating 
depression in the last 14 days. These medicines include isocarboxazid and phenelzine. If this applies to 
you, do not take Inbrija and ask your doctor or pharmacist for advice. 
 
Tell your doctor or pharmacist if you are taking: 
- medicines for your Parkinson’s disease called selective MAO inhibitors such as rasagiline, 

selegiline and safinamide, COMT inhibitors such as entacapone, tolcapone and opicapone, or 
anticholinergics such as orphenadrine and trihexyphenidyl; 



27 

- medicines for mental conditions including schizophrenia, such as benperidol, haloperidol, 
risperidone, chlorpromazine, fluphenazine decanoate, phenotiazine, butyrophenone, or 
trifluoperazine; 

- metoclopramide to treat nausea; 
- isoniazid, an antibiotic to treat tuberculosis; 
- medicines for high blood pressure, as the dose may need to be adjusted; 
- medicines for depression called tricyclic antidepressants such as clomipramin, desipramin, or 

doxepin; 
- amantadine to treat flu or your Parkinson’s disease. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
Treatment with Inbrija is not recommended during pregnancy and in women of childbearing age who 
do not use contraception. 
 
Women should not breast-feed during treatment with Inbrija. 
 
Driving and using machines 
Inbrija can cause excessive drowsiness, dizziness and sudden sleep attacks. If this happens to you, 
do not drive or use tools or machines. You must be sure that you do not get sudden sleep attacks, 
dizziness and drowsiness before you drive again or use machines. You could put yourself or others at 
risk of serious injury or death. 
 
 
3. How to use Inbrija 
 
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
Before starting Inbrija, you must be taking regular treatment for Parkinson’s disease combining a so-
called dopa-decarboxylase inhibitor with levodopa. 
 
The recommended dose of Inbrija is 2 capsules to treat each off period. Do not use more than 
2 capsules for each off period. You can use 2 capsules up to five times a day. 
 
The maximum dose of Inbrija is 10 capsules per day. 
 
Important information before you use Inbrija: 
- Inbrija capsules must not be swallowed. 
- This medicine is for use by inhalation only. 
- The capsules must only be removed from the blister pack immediately before use. 
- Two capsules of medicine should be inhaled to get the full dose. 
- The medicine must be used only with the Inbrija inhaler device. 
- When you open a new carton, always use the new inhaler supplied. 
- Your doctor or pharmacist will show you how to use your medicine correctly. 
 
Please see the “Instructions for use” at the end of this leaflet on how to use your medicine with the 
provided inhaler. 
 
If you use more Inbrija than you should 
If you use more Inbrija than you should (or someone accidentally swallows Inbrija) get medical help 
immediately. You may feel confused or agitated, and your heart rate may be slower or faster than 
normal. 
 



28 

If you forget to use Inbrija 
Use Inbrija only during an off period. If the off period has passed, do not use Inbrija until the next off 
period. 
 
If you stop using Inbrija 
Do not stop using Inbrija without checking with your doctor. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Get urgent medical help if you have an allergic oedema with symptoms including hives (nettle rash), 
itching, rash, swelling of your face, lips, tongue, or throat. This may cause difficulties in breathing or 
swallowing. 
 
Get urgent medical help if your muscles get very rigid or jerk violently, you get tremors, agitation, 
confusion, fever, rapid pulse, or wide fluctuations in your blood pressure. These can be symptoms of 
neuroleptic malignant syndrome (NMS, a rare severe reaction to medicines used to treat disorders of 
the central nervous system) or rhabdomyolisis (a rare severe muscle disorder). 
 
Get urgent medical help if you have bleeding in your stomach or intestines which may be seen as 
blood in your faeces or darkened faeces. 
 
The following side effects may happen with this medicine: 
Very common (may affect more than 1 in 10 people): 
- cough 
 
Common (may affect up to 1 in 10 people): 
- new or increased abnormal body movements (dyskinesia); 
- infections of nose, sinuses, throat or lungs; 
- change in colour of your mucus; 
- discoloured (i.e. not clear) nasal mucus; 
- irritation in throat or itchy throat; 
- feeling sick (nausea); vomiting; 
- being prone to falls. 
 
Other side effects you may experience of which the frequency is not known include: 
 
- skin cancer; 
- lack of red blood cells so you are pale and feel tired; being more prone to infections because of a 

lack of white blood cells; lack of blood platelets which can lead to bruising and a tendency to 
bleed; 

- decreased appetite; 
- confusion; hallucinations; depression; anxiety; bad dreams; unable to sleep; abnormal thinking 

and perceptions, losing touch with reality; feeling agitated; suicidal; being disorientated; 
exaggerated feeling of happiness; increased sex drive; grinding of teeth; feeling paranoid and 
delusional; 

- movement disorder in which a person's muscles contract uncontrollably; sudden, sometimes 
unpredictable changes in symptoms, due to the return of Parkinson’s disease symptoms; 
sleepiness; dizziness; worsening of Parkinson’s disease; pins and needles; headache; tremors; 
seizure; sudden onset of sleep; restless legs syndrome; ataxia (disorder affecting co-ordination, 
balance and speech); distorted sense of taste; mental health disorders that affecting learning, 
memory, perception, and problem solving; Horner’s syndrome (an eye disorder); dementia; 



29 

- blurred vision; double vision; widening pupil; prolonged rolling eyes upwards; involuntary tight 
closure of the eyelids; 

- heart problems, a noticeably rapid, strong, or irregular heartbeat; 
- low blood pressure soon after standing up; high blood pressure; fainting; blood clot in a vein; 

hot flushes; 
- shortness of breath; difficulty in breathing; difficulty in speaking; hiccups; 
- stomach pains; constipation; diarrhoea; dry mouth; stomach and intestinal bleeding; stomach 

ulcer; difficulty in swallowing; indigestion; burning sensation in the mouth; passing wind; 
change in colour of saliva; more saliva than normal; 

- swelling of face, lips, tongue, limbs and genitals; excessive sweating; rash; severe itching of the 
skin; condition called Henoch-Schoenlein purpura, the symptoms of which include a purple 
spotted skin rash; allergic reaction causing a rash of round, red welts on the skin that itch 
intensely; hair loss; discoloured sweat; 

- muscle spasms; lockjaw; 
- difficulty in emptying the bladder; abnormal urine colour; loss of bladder control; 
- painful, abnormally long-lasting erection; 
- swelling of lower legs or hands; feeling weak and having no energy; feeling tired; lack of 

energy; difficulty in walking; chest pain; 
- abnormal blood investigation results; weight loss; weight gain. 
 
You may experience the following side effects: 
 
- inability to resist the impulse to perform an action that could be harmful, which may include: 

- strong impulse to gamble excessively despite serious personal or family consequences; 
- altersed or increased sexual interest and behaviour of significant concern to you or to others, 

for example, an increased sexual drive; 
- uncontrollable excessive shopping or spending; 
- binge eating (eating large amounts of food in a short time period) or compulsive eating 

(eating more food than normal and more than is needed to satisfy your hunger). 
 
Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or 
reducing the symptoms. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Inbrija 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the blisters and carton after EXP. The 
expiry date refers to the last day of that month. 
 
Store below 25°C. Store in the original package in order to protect from light and moisture and only 
remove immediately before use. 
 
Do not use any capsule that looks crushed, damaged or wet. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


30 

6. Contents of the pack and other information 
 
What Inbrija contains  
- The active substance is levodopa. Each hard capsule contains 42 mg levodopa. The dose that 

leaves the mouthpiece of the inhaler (delivered dose) is 33 mg of levodopa. 
- The other ingredients comprising the powder and capsule are colfosceril palmitate (DPPC), 

sodium chloride, hypromellose, titanium dioxide (E 171), carrageenan, potassium chloride, 
carnauba wax, maize starch, shellac, black iron oxide (E 172), propylene glycol and potassium 
hydroxide. 

 
What Inbrija looks like and contents of the pack 
Inbrija inhalation powder, hard capsules consist of a white powder for inhalation filled into white 
opaque hard capsules with “A42” printed in black on the cap of the caspule and two black bands 
printed on the body of the capsule. 
 
In this pack, you will find an inhaler together with peel-off blisters containing 4 hard capsules each. 
 
The pack sizes are 
- a carton containing 60 hard capsules (15 blister strips) and one inhaler 
- a carton containing 92 hard capsules (23 blister strips) and one inhaler 

 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Acorda Therapeutics Ireland Limited 
10 Earlsfort Terrace 
Dublin 2, D02 T380 
Ireland 
Tel: +353 (0)1 231 4609 
 
Manufacturer 
ADOH B.V. 
Godfried Bomansstraat 31 
6543 JA Nijmegen 
Netherlands 
 
 
This leaflet was last revised in 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
------------------------------------------------------------------------------------------------------------------------ 



31 

Instructions for use: 
 

Read these instructions before you start using Inbrija. 

Overview 

• Make sure your hands are clean and dry when using the inhaler and capsules. 

• Only remove the capsules from the blister immediately before use. 

• A complete dose is 2 capsules used one after the other. 

• Load 1 capsule into the Inbrija inhaler, close your lips firmly around the mouthpiece, then 
breathe in (inhale) and hold that breath for 5 seconds. You should hear the capsule “whirl”. 
Then, remove the used capsule and load a second capsule into the inhaler. Close your lips 
firmly around the mouthpiece and breathe in, again holding your breath for 5 seconds. 

• You should inhale the contents of the second capsule within 10 minutes of the first one. 

• Do not load 2 capsules at the same time. 

• Dispose of all used capsules immediately after use. 

• Dispose of the inhaler after you are finished all of the capsules in the carton. 

Parts of your Inbrija inhaler 

 Alignment Arrows 

 
 Blue Handle Capsule Chamber White Mouthpiece Blue Cap 

Capsules 

Each carton includes blisters of 
4 capsules. 

 

Prepare and use a total of 
2 capsules. 

Use one capsule at a time. 

 

Full dose = 2 capsules. 

 

 

 

Prepare your dose 



32 

Step 1: Gather supplies  

 

Find a clean and dry surface. 

Make sure your hands are clean and dry. 

Get inhaler and strip of capsules. 

Tear off package of 2 capsules. 

 

A full dose is 2 capsules. 

Step 2: Remove blue cap from inhaler 

 

Pull the cap straight off. 

Place the cap to the side. You will need it later to 
store the inhaler. 

Step 3: Twist and pull off white mouthpiece 

 

Twist and pull off the mouthpiece to separate it 
from the handle. 

Place the mouthpiece and inhaler on a clean and dry 
surface. 

Step 4: Remove 1 capsule from package 

 

Carefully peel back the foil and take out 1 capsule. 

Only remove 1 capsule at a time, and just before 
use. 

Do not use any capsule that looks crushed, damaged 
or wet. Dispose of it and get a new capsule. 

Step 5: Load capsule 

 

Hold the inhaler upright using the handle. 

Drop 1 capsule into the opening of the capsule 
chamber. 

Do not load 2 capsules at the same time. 



33 

Step 6: Attach white mouthpiece 

Align arrows on mouthpiece and handle 

 

Line up the white arrows on the handle and 
mouthpiece. 

Compress mouthpiece only once 

 

Firmly push the mouthpiece and handle together 
until you hear a click. This punctures the capsule. 

 

Do not push the handle and mouthpiece together 
more than once. 

Release mouthpiece 

 

Release the mouthpiece. The mouthpiece will 
spring back and stay attached.  

Your inhaler is now ready to use. 

Do not push the handle and mouthpiece together more than once. This may damage the capsule, and 
you may not get your full dose. If this happens start again at Step 4 using a new capsule. 

Make sure the mouthpiece is securely attached and will not fall off before moving to Step 7. 

Take your dose 

Step 7: Hold inhaler away and breathe out 

 

Stand or sit with your head and chest upright. 

Hold the inhaler level and away from your mouth. 

Breathe out completely. 

Do not breathe into mouthpiece. 



34 

Step 8: Breathe in deeply to inhale powder 

 

While keeping the inhaler level, close your lips 
firmly around the mouthpiece. 

 

Take in a deep, comfortable breath until your 
lungs feel full. This normally takes several 
seconds. 

 

As you breathe in, you will hear and feel the 
capsule “whirl” (spin). The whirl means the inhaler 
is working and you are getting your medicine. 

If you cough or stop your dose, start again from the 
beginning of Step 7 using the same capsule. 

 

Important: If you did not hear or feel the 
capsule “whirl” while inhaling you may need to 
take a deeper, longer breath. Start again from 
the beginning of Step 7 using the same capsule. 

Step 9: Hold breath for 5 seconds, then 
breathe out 

 

Take the inhaler out of your mouth and hold your 
breath for 5 seconds. 

Then breathe out. 

Step 10: Remove capsule from inhaler 

Twist and pull off the mouthpiece 

 

Twist and pull off the mouthpiece. 



35 

Remove used capsule 

 

Take out the used capsule. 

Step 11: Dose with 2nd capsule 

 

Repeat Steps 4 to 10 with the second capsule to 
finish the full dose. 

 

 

You should inhale the contents of the second 
capsule within 10 minutes of the first one.  

Dispose and store 

Step 12: Dispose of used capsules 

 

Dispose of used capsules in accordance with local 
requirements. 

Step 13: Store inhaler 

Make sure there are no capsules in the 
inhaler 

 

Make sure there are no capsules in the inhaler 
before you store it. 

Attach mouthpiece 

 

Attach the mouthpiece to the handle by pushing 
until you hear a click. 



36 

Attach cap 

 

Attach the cap over the mouthpiece. 

Ready for storage 

 

Your inhaler is now ready to store.  

Cleaning the inhaler 

• It is normal for some powder to remain on the inhaler. 

• You do not need to clean the inhaler. You can use a dry cotton swab or tissue to wipe the 
outside of the inhaler. 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
	C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT  
	A. LABELLING
	B. PACKAGE LEAFLET