Azilect

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



 

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1. NAME OF THE MEDICINAL PRODUCT 
 
AZILECT 1 mg tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains 1 mg rasagiline (as mesilate).  
 
For the full list of excipients, see section 6.1.  
 
 
3. PHARMACEUTICAL FORM 
 
Tablet 
 
White to off-white, round, flat, bevelled tablets, debossed with “GIL” and “1” underneath on one side 
and plain on the other side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
AZILECT is indicated in adults for the treatment of idiopathic Parkinson’s disease as monotherapy 
(without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations. 
 
4.2 Posology and method of administration 
 
Posology 
 
The recommended dose of rasagiline is 1 mg (one tablet of AZILECT) once daily, to be taken with or 
without levodopa. 
 
Elderly 
No change in dose is required for elderly patients (see section 5.2).  
 
Hepatic impairment 
Rasagiline is contraindicated in patients with severe hepatic impairment (see section 4.3). Rasagiline 
use in patients with moderate hepatic impairment should be avoided. Caution should be used when 
initiating treatment with rasagiline in patients with mild hepatic impairment. In case patients progress 
from mild to moderate hepatic impairment rasagiline should be stopped (see section 4.4 and 5.2). 
 
Renal impairment 
No special precautions are required in patients with renal impairment. 
 
Paediatric population 
The safety and efficacy of AZILECT in children and adolescents have not been established. There is 
no relevant use of AZILECT in the paediatric population in the indication Parkinson’s disease. 
 
Method of administration 
 
For oral use.  
AZILECT may be taken with or without food. 
 



 

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4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Concomitant treatment with other monoamine oxidase (MAO) inhibitors (including medicinal and 
natural products without prescription e.g. St. John's Wort) or pethidine (see section 4.5). At least 
14 days must elapse between discontinuation of rasagiline and initiation of treatment with MAO 
inhibitors or pethidine. 
 
Severe hepatic impairment. 
 
4.4 Special warnings and precautions for use 
 
Concomitant use of rasagiline with other medicinal products 
 
The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided (see section 4.5). 
At least five weeks should elapse between discontinuation of fluoxetine and initiation of treatment 
with rasagiline. At least 14 days should elapse between discontinuation of rasagiline and initiation of 
treatment with fluoxetine or fluvoxamine. 
 
The concomitant use of rasagiline and dextromethorphan or sympathomimetics such as those present 
in nasal and oral decongestants or cold medicinal product containing ephedrine or pseudoephedrine is 
not recommended (see section 4.5). 
 
Concomitant use of rasagiline and levodopa 
Since rasagiline potentiates the effects of levodopa, the adverse reactions of levodopa may be 
increased and pre-existing dyskinesia exacerbated. Decreasing the dose of levodopa may ameliorate 
this adverse reaction.  
 
There have been reports of hypotensive effects when rasagiline is taken concomitantly with levodopa. 
Patients with Parkinson’s disease are particularly vulnerable to the adverse reactions of hypotension 
due to existing gait issues. 
 
Dopaminergic effects 
 
Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes 
Rasagiline may cause daytime drowsiness, somnolence, and, occasionally, especially if used with 
other dopaminergic medicinal products - falling asleep during activities of daily living. Patients must 
be informed of this and advised to exercise caution while driving or operating machines during 
treatment with rasagiline. Patients who have experienced somnolence and/or an episode of sudden 
sleep onset must refrain from driving or operating machines (see section 4.7). 
 
Impulse control disorders (ICDs) 
ICDs can occur in patients treated with dopamine agonists and/or dopaminergic treatments. Similar 
reports of ICDs have also been received post-marketing with rasagiline. Patients should be regularly 
monitored for the development of impulse control disorders. Patients and carers should be made aware 
of the behavioural symptoms of impulse control disorders that were observed in patients treated with 
rasagiline, including cases of compulsions, obsessive thoughts, pathological gambling, increased 
libido, hypersexuality, impulsive behaviour and compulsive spending or buying. 
 
Melanoma 
 
During the clinical development program, the occurrence of cases of melanoma prompted the 
consideration of a possible association with rasagiline. The data collected suggests that Parkinson’s 
disease, and not any medicinal products in particular, is associated with a higher risk of skin cancer 
(not exclusively melanoma). Any suspicious skin lesion should be evaluated by a specialist. 
 



 

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Hepatic impairment 
 
Caution should be used when initiating treatment with rasagiline in patients with mild hepatic 
impairment. Rasagiline use in patients with moderate hepatic impairment should be avoided. In case 
patients progress from mild to moderate hepatic impairment, rasagiline should be stopped (see 
section 5.2). 
 
4.5 Interaction with other medicinal products and other forms of interaction  
 
MAO Inhibitors 
 
Rasagiline is contraindicated along with other MAO inhibitors (including medicinal and natural 
products without prescription e.g. St. John's Wort) as there may be a risk of non-selective MAO 
inhibition that may lead to hypertensive crises (see section 4.3). 
 
Pethidine 
 
Serious adverse reactions have been reported with the concomitant use of pethidine and MAO 
inhibitors including another selective MAO-B inhibitor. The concomitant administration of rasagiline 
and pethidine is contraindicated (see section 4.3). 
 
Sympathomimetics 
 
With MAO inhibitors there have been reports of medicinal product interactions with the concomitant 
use of sympathomimetic medicinal products. Therefore, in view of the MAO inhibitory activity of 
rasagiline, concomitant administration of rasagiline and sympathomimetics such as those present in 
nasal and oral decongestants or cold medicinal products, containing ephedrine or pseudoephedrine, is 
not recommended (see section 4.4). 
 
Dextromethorphan 
 
There have been reports of medicinal product interactions with the concomitant use of 
dextromethorphan and non-selective MAO inhibitors. Therefore, in view of the MAO inhibitory 
activity of rasagiline, the concomitant administration of rasagiline and dextromethorphan is not 
recommended (see section 4.4). 
 
SNRI/SSRI/tri- and tetracyclic antidepressants 
 
The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided (see section 4.4). 
 
For concomitant use of rasagiline with selective serotonin reuptake inhibitors (SSRIs)/selective 
serotonin-norepinephrine reuptake inhibitors (SNRIs) in clinical trials, see section 4.8. 
 
Serious adverse reactions have been reported with the concomitant use of SSRIs, SNRIs, 
tricyclic/tetracyclic antidepressants and MAO inhibitors. Therefore, in view of the MAO inhibitory 
activity of rasagiline, antidepressants should be administered with caution.  
 
Agents that affect CYP1A2 activity 
 
In vitro metabolism studies have indicated that cytochrome P450 1A2 (CYP1A2) is the major enzyme 
responsible for the metabolism of rasagiline.  
 
CYP1A2 inhibitors 
Co-administration of rasagiline and ciprofloxacin (an inhibitor of CYP1A2) increased the AUC of 
rasagiline by 83%. Co-administration of rasagiline and theophylline (a substrate of CYP1A2) did not 
affect the pharmacokinetics of either product. Thus, potent CYP1A2 inhibitors may alter rasagiline 
plasma levels and should be administered with caution. 



 

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CYP1A2 inducers 
There is a risk that the plasma levels of rasagiline in smoking patients could be decreased, due to 
induction of the metabolising enzyme CYP1A2. 
 
Other cytochrome P450 isoenzymes 
 
In vitro studies showed that rasagiline at a concentration of 1 µg/ml (equivalent to a level that is 
160 times the average Cmax ~ 5.9-8.5 ng/ml in Parkinson’s disease patients after 1 mg rasagiline 
multiple dosing), did not inhibit cytochrome P450 isoenzymes, CYP1A2, CYP2A6, CYP2C9, 
CYP2C19, CYP2D6, CYP2E1, CYP3A4 and CYP4A. These results indicate that rasagiline’s 
therapeutic concentrations are unlikely to cause any clinically significant interference with substrates 
of these enzymes (see section 5.3). 
 
Levodopa and other Parkinson’s disease medicinal products  
 
In Parkinson’s disease patients receiving rasagiline as adjunct therapy to chronic levodopa treatment, 
there was no clinically significant effect of levodopa treatment on rasagiline clearance. 
 
Concomitant administration of rasagiline and entacapone increased rasagiline oral clearance by 28%.  
 
Tyramine/rasagiline interaction 
 
Results of five tyramine challenge studies (in volunteers and Parkinson’s disease patients), together 
with results of home monitoring of blood pressure after meals (of 464 patients treated with 0.5 or 
1 mg/day of rasagiline or placebo as adjunct therapy to levodopa for six months without tyramine 
restrictions), and the fact that there were no reports of tyramine/rasagiline interaction in clinical 
studies conducted without tyramine restriction, indicate that rasagiline can be used safely without 
dietary tyramine restrictions. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no data from the use of rasagiline in pregnant women. Animal studies do not indicate direct 
or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary 
measure, it is preferable to avoid the use of rasagiline during pregnancy. 
 
Breast-feeding 
 
Non-clinical data indicate that rasagiline inhibits prolactin secretion and thus, may inhibit lactation. 
It is not known whether rasagiline is excreted in human milk. Caution should be exercised when 
rasagiline is administered to a breast-feeding mother. 
 
Fertility 
 
No human data on the effect of rasagiline on fertility are available. Non-clinical data indicate that 
rasagiline has no effect on fertility. 
 
4.7 Effects on ability to drive and use machines 
 
In patients experiencing somnolence/sudden sleep episodes, rasagiline may have major influence on 
the ability to drive and use machines. 
Patients should be cautioned about operating hazardous machines, including motor vehicles, until they 
are reasonably certain that rasagiline does not affect them adversely. 
 



 

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Patients being treated with rasagiline 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. operating machines) until they have gained 
sufficient experience with rasagiline and other dopaminergic medications to gauge whether or not it 
affects their mental and/or motor performance adversely. 
 
If increased somnolence or new episodes of falling asleep during activities of daily living (e.g. 
watching television, passenger in a car, etc.) are experienced at any time during treatment, the patients 
should not drive or participate in potentially dangerous activities.  
Patients should not drive, operate machinery, or work at heights during treatment if they have 
previously experienced somnolence and/or have fallen asleep without warning prior to use of 
rasagiline.  
 
Patients should be cautioned about possible additive effects of sedating medicinal products, alcohol, or 
other central nervous system depressants (e.g. benzodiazepines, antipsychotics, antidepressants) in 
combination with rasagiline, or when taking concomitant medications that increase plasma levels of 
rasagiline (e.g. ciprofloxacin) (see section 4.4). 
 
4.8 Undesirable effects  
 
Summary of the safety profile 
 
In clinical studies in Parkinson's disease patients the most commonly reported adverse reactions were: 
headache, depression, vertigo, and flu (influenza and rhinitis) in monotherapy; dyskinesia, orthostatic 
hypotension, fall, abdominal pain, nausea and vomiting, and dry mouth in adjunct to levodopa therapy; 
musculoskeletal pain, as back and neck pain, and arthralgia in both regimens. These adverse reactions 
were not associated with an elevated rate of drug discontinuation.  
 
Tabulated list of adverse reactions 
 
Adverse reactions are listed below in Tables 1 and 2 by system organ class and frequency using the 
following conventions: very common (≥1/10), common (≥1/100 to <1/10), uncommon 
(≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be 
estimated from the available data). 
 
Monotherapy 
The tabulated list below includes adverse reactions which were reported with a higher incidence in 
placebo-controlled studies, in patients receiving 1 mg/day rasagiline. 
 
System Organ 
Class 

Very common Common Uncommon Not known 

Infections and 
infestations 

 Influenza   

Neoplasms 
benign, 
malignant and 
unspecified 
(including cysts 
and polyps) 

 Skin carcinoma   

Blood and 
lymphatic system 
disorders 

 Leucopenia   

Immune system 
disorders 

 Allergy   

Metabolism and 
nutrition 
disorders 

  Decreased appetite  



 

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System Organ 
Class 

Very common Common Uncommon Not known 

Psychiatric 
disorders 

 Depression, 
Hallucinations* 

 Impulse control 
disorders* 

Nervous system 
disorders 

Headache  Cerebrovascular 
accident 

Serotonin 
syndrome*, 
Excessive daytime 
sleepiness (EDS) 
and sudden sleep 
onset (SOS) 
episodes* 

Eye disorders  Conjunctivitis   
Ear and 
labyrinth 
disorders 

 Vertigo   

Cardiac 
disorders 

 Angina pectoris Myocardial 
infarction 

 

Vascular 
disorders 

   Hypertension* 

Respiratory, 
thoracic and 
mediastinal 
disorders 

 Rhinitis   

Gastrointestinal 
disorders 

 Flatulence   

Skin and 
subcutaneous 
tissue disorders 

 Dermatitis Vesiculobullous 
rash 

 

Musculoskeletal 
and connective 
tissue disorders 

 Musculoskeletal 
pain, 
Neck pain, 
Arthritis 

  

Renal and 
urinary disorders 

 Urinary urgency   

General 
disorders and 
administration 
site conditions 

 Fever, 
Malaise 

  

*See section description of selected adverse reactions 
 
Adjunct Therapy 
The tabulated list below includes adverse reactions which were reported with a higher incidence in 
placebo-controlled studies in patients receiving 1 mg/day rasagiline.  
 
System Organ 
Class 

Very common Common Uncommon Not known 

Neoplasms 
benign, 
malignant and 
unspecified 

  Skin melanoma* 
 

 

Metabolism and 
nutrition 
disorders 

 Decreased appetite   

Psychiatric 
disorders 

 Hallucinations*, 
Abnormal dreams 

Confusion 
 

Impulse control 
disorders* 

Nervous system Dyskinesia Dystonia, Cerebrovascular Serotonin 



 

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System Organ 
Class 

Very common Common Uncommon Not known 

disorders Carpal tunnel 
syndrome, 
Balance disorder 

accident syndrome*, 
Excessive daytime 
sleepiness (EDS) 
and sudden sleep 
onset (SOS) 
episodes* 

Cardiac 
disorders 

  Angina pectoris  

Vascular 
disorders 

 Orthostatic 
hypotension* 

 Hypertension* 

Gastrointestinal 
disorders 

 Abdominal pain, 
Constipation, 
Nausea and 
vomiting, 
Dry mouth 

  

Skin and 
subcutaneous 
tissue disorders 

 Rash   

Musculoskeletal 
and connective 
tissue disorders* 

 Arthralgia, 
Neck pain 

  

Investigations  Decreased weight   
Injury, poisoning 
and procedural 
complications 

 Fall   

*See section description of selected adverse reactions 
 
Description of selected adverse reactions 
 
Orthostatic hypotension 
In blinded placebo-controlled studies, severe orthostatic hypotension was reported in one subject 
(0.3%) in the rasagiline arm (adjunct studies), none in the placebo arm. Clinical trial data further 
suggest that orthostatic hypotension occurs most frequently in the first two months of rasagiline 
treatment and tends to decrease over time. 
 
Hypertension 
Rasagiline selectively inhibits MAO-B and is not associated with increased tyramine sensitivity at the 
indicated dose (1 mg/day). In blinded placebo-controlled studies (monotherapy and adjunct) severe 
hypertension was not reported in any subjects in the rasagiline arm. In the post-marketing period, 
cases of elevated blood pressure, including rare serious cases of hypertensive crisis associated with 
ingestion of unknown amounts of tyramine-rich foods, have been reported in patients taking 
rasagiline. In post-marketing period, there was one case of elevated blood pressure in a patient using 
the ophthalmic vasoconstrictor tetrahydrozoline hydrochloride while taking rasagiline. 
 
Impulse control disorders 
One case of hypersexuality was reported in monotherapy placebo-controlled study. The following 
were reported during post-marketing exposure with unknown frequency: compulsions, compulsive 
shopping, dermatillomania, dopamine dysregulation syndrome, impulse-control disorder, impulsive 
behaviour, kleptomania, theft, obsessive thoughts, obsessive-compulsive disorder, stereotypy, 
gambling, pathological gambling, libido increased, hypersexuality, psychosexual disorder, sexually 
inappropriate behaviour. Half of the reported ICD cases were assessed as serious. Only single cases of 
reported cases had not recovered at the time they were reported. 
 



 

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Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes 
Excessive daily sleepiness (hypersomnia, lethargy, sedation, sleep attacks, somnolence, sudden onset 
of sleep) can occur in patients treated with dopamine agonists and/or other dopaminergic treatments. A 
similar pattern of excessive daily sleepiness has been reported post-marketing with rasagiline. 
Cases of patients, treated with rasagiline and other dopaminergic medicinal products, falling asleep 
while engaged in activities of daily living have been reported. Although many of these patients 
reported somnolence while on rasagiline with other dopaminergic medicinal products, some perceived 
that they had no warning signs, such as excessive drowsiness, and believed that they were alert 
immediately prior to the event. Some of these events have been reported more than 1-year after 
initiation of treatment. 
 
Hallucinations 
Parkinson’s disease is associated with symptoms of hallucinations and confusion. In post-marketing 
experience, these symptoms have also been observed in Parkinson’s disease patients treated with 
rasagiline. 
 
Serotonin syndrome 
Rasagiline clinical trials did not allow concomitant use of fluoxetine or fluvoxamine with rasagiline, 
but the following antidepressants and doses were allowed in the rasagiline trials: amitriptyline 
≤ 50 mg/daily, trazodone ≤ 100 mg/daily, citalopram ≤ 20 mg/daily, sertraline ≤ 100 mg/daily, and 
paroxetine ≤ 30 mg/daily (see section 4.5). 
 
In the post-marketing period, cases of potentially life-threating serotonin syndrome associated with 
agitation, confusion, rigidity, pyrexia and myoclonus have been reported by patients treated with 
antidepressants, meperidine, tramadol, methadone, or propoxyphene concomitantly with rasagiline. 
 
Malignant melanoma 
Incidence of skin melanoma in placebo-controlled clinical studies was 2/380 (0.5%) in rasagiline 1 mg 
as adjacent to levodopa therapy group vs. 1/388 (0.3%) incidence in placebo group. Additional cases 
of malignant melanoma were reported during post-marketing period. These cases were considered 
serious in all reports. 
 
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  
 
Symptoms 
 
Symptoms reported following overdose of rasagiline in doses ranging from 3 mg to 100 mg included 
hypomania, hypertensive crisis and serotonin syndrome. 
 
Overdose can be associated with significant inhibition of both MAO-A and MAO-B. In a single-dose 
study healthy volunteers received 20 mg/day and in a ten-day study healthy volunteers received 
10 mg/day. Adverse reactions were mild or moderate and not related to rasagiline treatment. In a dose 
escalation study in patients on chronic levodopa therapy treated with 10 mg/day of rasagiline, there 
were reports of cardiovascular adverse reactions (including hypertension and postural hypotension) 
which resolved following treatment discontinuation. These symptoms may resemble those observed 
with non-selective MAO inhibitors. 
 
Management 
 

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There is no specific antidote. In case of overdose, patients should be monitored and the appropriate 
symptomatic and supportive therapy instituted. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Anti-Parkinson-Drugs, monoamine oxidase -B inhibitors, ATC code: 
N04BD02 
 
Mechanism of action 
 
Rasagiline was shown to be a potent, irreversible MAO-B selective inhibitor, which may cause an 
increase in extracellular levels of dopamine in the striatum. The elevated dopamine level and 
subsequent increased dopaminergic activity are likely to mediate rasagiline's beneficial effects seen in 
models of dopaminergic motor dysfunction. 
 
1-Aminoindan is an active major metabolite and it is not a MAO-B inhibitor.  
 
Clinical efficacy and safety 
 
The efficacy of rasagiline was established in three studies: as monotherapy treatment in study I and as 
adjunct therapy to levodopa in the studies II and III. 
 
Monotherapy 
In study I, 404 patients were randomly assigned to receive placebo (138 patients), rasagiline 1 mg/day 
(134 patients) or rasagiline 2 mg/day (132 patients) and were treated for 26 weeks, there was no active 
comparator. 
In this study, the primary measure of efficacy was the change from baseline in the total score of the 
Unified Parkinson’s Disease Rating Scale (UPDRS, parts I-III). The difference between the mean 
change from baseline to week 26/termination (LOCF, Last Observation Carried Forward) was 
statistically significant (UPDRS, parts I-III: for rasagiline 1 mg compared to placebo -4.2, 95% CI  
[-5.7, -2.7]; p<0.0001; for rasagiline 2 mg compared to placebo -3.6, 95% CI [-5.0, -2.1]; p<0.0001, 
UPDRS Motor, part II: for rasagiline 1 mg compared to placebo -2.7, 95% CI [-3.87, -1.55], p<0.0001; 
for rasagiline 2 mg compared to placebo -1.68, 95% CI [-2.85, -0.51], p=0.0050). The effect was 
evident, although its magnitude was modest in this patient population with mild disease. There was a 
significant and beneficial effect in quality of life (as assessed by PD-QUALIF scale). 
 
Adjunct therapy 
In study II, patients were randomly assigned to receive placebo (229 patients), or rasagiline 1 mg/day 
(231 patients) or the catechol-O–methyl transferase (COMT) inhibitor, entacapone, 200 mg taken 
along with scheduled doses of levodopa (LD)/decarboxylase inhibitor (227 patients), and were treated 
for 18 weeks. In study III, patients were randomly assigned to receive placebo (159 patients), 
rasagiline 0.5 mg/day (164 patients), or rasagiline 1 mg/day (149 patients), and were treated for 
26 weeks.  
In both studies, the primary measure of efficacy was the change from baseline to treatment period in 
the mean number of hours that were spent in the “OFF” state during the day (determined from 
“24-hour” home diaries completed for 3 days prior to each of the assessment visits). 
 
In study II, the mean difference in the number of hours spent in the “OFF” state compared to placebo 
was -0.78h, 95% CI [-1.18, -0.39], p=0.0001. The mean total daily decrease in the OFF time was 
similar in the entacapone group (-0.80h, 95% CI [-1.20, -0.41], p<0.0001) to that observed in the 
rasagiline 1 mg group. In study III, the mean difference compared to placebo was -0.94h, 95% CI 
[-1.36, -0.51], p<0.0001. There was also a statistically significant improvement over placebo with the 
rasagiline 0.5 mg group, yet the magnitude of improvement was lower. The robustness of the results 

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for the primary efficacy endpoint, was confirmed in a battery of additional statistical models and was 
demonstrated in three cohorts (ITT, per protocol and completers). 
The secondary measures of efficacy included global assessments of improvement by the examiner, 
Activities of Daily Living (ADL) subscale scores when OFF and UPDRS motor while ON. Rasagiline 
produced statistically significant benefit compared to placebo.  
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Rasagiline is rapidly absorbed, reaching peak plasma concentration (Cmax) in approximately 0.5 hours. 
The absolute bioavailability of a single rasagiline dose is about 36%.  
Food does not affect the Tmax of rasagiline, although Cmax and exposure (AUC) are decreased by 
approximately 60% and 20%, respectively, when the medicinal product is taken with a high fat meal. 
Because AUC is not substantially affected, rasagiline can be administered with or without food. 
 
Distribution 
 
The mean volume of distribution following a single intravenous dose of rasagiline is 243 l. Plasma 
protein binding following a single oral dose of 14C-labelled rasagiline is approximately 60 to 70%. 
 
Biotransformation 
 
Rasagiline undergoes almost complete biotransformation in the liver prior to excretion. The 
metabolism of rasagiline proceeds through two main pathways: N-dealkylation and/or hydroxylation 
to yield: 1-aminoindan, 3-hydroxy-N-propargyl-1 aminoindan and 3-hydroxy-1-aminoindan. In vitro 
experiments indicate that both routes of rasagiline metabolism are dependent on cytochrome P450 
system, with CYP1A2 being the major iso-enzyme involved in rasagiline metabolism. Conjugation of 
rasagiline and its metabolites was also found to be a major elimination pathway to yield glucuronides. 
Ex vivo and in vitro experiments demonstrate that rasagiline is neither inhibitor nor inducer of major 
CYP450 enzymes (see section 4.5). 
 
Elimination 
 
After oral administration of 14C-labelled rasagiline, elimination occurred primarily via urine (62.6%) 
and secondarily via faeces (21.8%), with a total recovery of 84.4% of the dose over a period of 
38 days. Less than 1% of rasagiline is excreted as unchanged product in urine. 
 
Linearity/non-linearity 
 
Rasagiline pharmacokinetics is linear with dose over the range of 0.5-2 mg in Parkinson’s disease 
patients. Its terminal half-life is 0.6-2 hours. 
 
Hepatic impairment 
 
In subjects with mild hepatic impairment, AUC and Cmax were increased by 80% and 38%, 
respectively. In subjects with moderate hepatic impairment, AUC and Cmax were increased by 568% 
and 83%, respectively (see section 4.4).  
 
Renal impairment 
 
Rasagiline's pharmacokinetics characteristics in subjects with mild (CLcr 50-80 ml/min) and moderate 
(CLcr 30-49 ml/min) renal impairment were similar to healthy subjects. 
 
Elderly 
 
Age has little influence on rasagiline pharmacokinetics in the elderly (> 65 years) (see section 4.2) 



 

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5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on the standard studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity, reproduction and development. 
 
Rasagiline did not present genotoxic potential in vivo and in several in vitro systems using bacteria or 
hepatocytes. In the presence of metabolite activation rasagiline induced an increase of chromosomal 
aberrations at concentrations with excessive cytotoxicity which are unattainable at the clinical 
conditions of use. 
 
Rasagiline was not carcinogenic in rats at systemic exposure, 84 – 339 times the expected plasma 
exposures in humans at 1 mg/day. In mice, increased incidences of combined bronchiolar/alveolar 
adenoma and/or carcinoma were observed at systemic exposures, 144 – 213 times the expected plasma 
exposure in humans at 1 mg/day. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Mannitol 
Maize starch 
Pregelatinised maize starch 
Colloidal anhydrous silica 
Stearic acid 
Talc 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
Blisters: 3 years 
Bottles: 3 years 
 
6.4 Special precautions for storage 
 
Do not store above 30ºC.  
 
6.5 Nature and contents of container 
 
Blisters 
 
Aluminium/aluminium blister packs of 7, 10, 28, 30, 100 or 112 tablets. 
 
Bottles 
 
White, high-density polyethylene bottle with or without a child-resistant cap containing 30 tablets.  
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements for disposal.  
 



 

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7. MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/04/304/001-07 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE 

AUTHORISATION 
 
Date of first authorisation: 21 February 2005 
Date of latest renewal:  21 September 2009 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this product is available on the website of the European Medicines Agency 
http://www.ema.europa.eu 

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


 

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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  

 
 



 

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A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Teva Pharmaceuticals Europe B.V.  
Swensweg 5 
2031 GA Haarlem 
The Netherlands 
 
Pliva Croatia Ltd. 
Prilaz baruna Filipovica 25 
10000 Zagreb 
Croatia 
 
Teva Operations Poland Sp.z o.o. 
ul. Mogilska 80 
31-546 Krakow  
Poland 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
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 
 
The requirements for submission of periodic safety update reports 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. 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE 

AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 
 
The 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. 

 
 



 

16 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 



 

17 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



 

18 
 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR BLISTER PACK 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
AZILECT 1 mg tablets 
rasagiline  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 1 mg of rasagiline (as mesilate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablet 
 
7 tablets 
10 tablets 
28 tablets 
30 tablets 
100 tablets 
112 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
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  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
 



 

19 
 

 
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 
 
Teva B.V. 
2031 GA Haarlem 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/04/304/001  
EU/1/04/304/002 
EU/1/04/304/003 
EU/1/04/304/004 
EU/1/04/304/005 
EU/1/04/304/006 
 
13. BATCH NUMBER 
 
Lot  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
AZILECT 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



 

20 
 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
AZILECT 1 mg tablets 
rasagiline  
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot  
 
 
5. OTHER 
 



 

21 
 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTON FOR BOTTLE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
AZILECT 1 mg tablets 
rasagiline  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 1 mg of rasagiline (as mesilate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablet 
 
30 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
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  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 



 

22 
 

 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
2031 GA Haarlem 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/04/304/007  
 
 
13. BATCH NUMBER 
 
Lot  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription.  
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
AZILECT 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



 

23 
 

 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING  
 
BOTTLE LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
AZILECT 1 mg tablets 
rasagiline  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 1 mg of rasagiline (as mesilate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablet 
 
30 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before use. 
 
 
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  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 



 

24 
 

 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
2031 GA Haarlem 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/04/304/007  
 
 
13. BATCH NUMBER 
 
Lot  
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
 
 



 

25 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
 
 

 



 

26 
 

 
Package leaflet: Information for the user 

 
AZILECT 1 mg tablets 

rasagiline 
 
Read all of this leaflet carefully before you start taking 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 AZILECT is and what it is used for 
2. What you need to know before you take AZILECT 
3. How to take AZILECT 
4. Possible side effects 
5. How to store AZILECT 
6. Contents of the pack and other information 
 
 
1. What AZILECT is and what it is used for 
 
AZILECT contains the active substance rasagiline and it is used for the treatment of Parkinson’s 
disease in adults. It can be used together with or without Levodopa (another medicine that is used to 
treat Parkinson’s disease). 
 
With Parkinson’s disease, there is a loss of cells that produce dopamine in the brain. Dopamine is a 
chemical in the brain involved in movement control. AZILECT helps to increase and sustain levels of 
dopamine in the brain. 
 
 
2. What you need to know before you take AZILECT 
 
Do not take AZILECT 
- If you are allergic to rasagiline or any of the other ingredients of this medicine (listed in 

section 6). 
- If you have severe liver problems.  
 
Do not take the following medicines while taking AZILECT: 
- Monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression or Parkinson’s disease, 

or used for any other indication), including medicinal and natural products without prescription 
e.g. St. John's Wort. 

- Pethidine (a strong pain killer). 
You must wait at least 14 days after stopping AZILECT treatment and starting treatment with MAO 
inhibitors or pethidine. 
 
Warnings and precautions 
Talk to your doctor before taking AZILECT 
- If you have any liver problems 
- You should speak with your doctor about any suspicious skin changes. 
 
Tell your doctor if you or your family/carer notices that you are developing unusual behaviours where 
you cannot resist the impulse, urges or cravings to carry out certain harmful or detrimental activities to 



 

27 
 

yourself or others. These are called impulse control disorders. In patients taking AZILECT and/or 
other medicines used to treat Parkinson’s disease, behaviours such as compulsions, obsessive 
thoughts, addictive gambling, excessive spending, impulsive behaviour and an abnormally high sex 
drive or an increase in sexual thoughts or feelings have been observed. Your doctor may need to adjust 
or stop your dose (see section 4). 
 
AZILECT may cause drowsiness and may cause you to suddenly fall asleep during day 
time activities, especially if you are taking other dopaminergic medicinal products (used 
for the treatment of Parkinson’s disease). For further information please refer to section 
driving and using machines. 
 
Children and adolescents 
There is no relevant use of AZILECT in children and adolescents. Therefore, AZILECT is not 
recommended for use under the age of 18. 
 
Other medicines and AZILECT 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Especially tell your doctor if you are taking any of the following medicines: 
- Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin-

norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants)  
- The antibiotic ciprofloxacin used against infections 
- The cough suppressant dextromethorphan 
- Sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold 

medicine containing ephedrine or pseudoephedrine 
The use of AZILECT together with the antidepressants containing fluoxetine or fluvoxamine should 
be avoided. 
If you are starting treatment with AZILECT, you should wait at least 5 weeks after stopping fluoxetine 
treatment. 
If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after 
stopping AZILECT treatment. 
 
Tell your doctor or pharmacist if you are smoking or intend to stop smoking. Smoking could decrease 
the amount of AZILECT in the blood. 
 
Pregnancy, breast-feeding and fertility 
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.  
 
You should avoid taking AZILECT if you are pregnant, as the effects of AZILECT on pregnancy and 
the unborn child are not known. 
 
Driving and using machines 
Ask your doctor for advice before you drive and operate machines, since Parkinson’s disease itself as 
well as the treatment with AZILECT may influence your ability to do so. AZILECT can make you feel 
dizzy or drowsy; it can also cause episodes of sudden sleep onset. 
This might be enhanced if you take other medicines to treat the symptoms of your Parkinson’s disease, 
or if you take medicines which can make you feel drowsy, or if you drink alcohol while taking 
AZILECT. If you have experienced somnolence and/or episodes of sudden sleep onset before, or 
while taking AZILECT do not drive or operate machinery (see section 2). 
 
 
3. How to take AZILECT 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 



 

28 
 

 
The recommended dose of AZILECT is 1 tablet of 1 mg taken by mouth once daily. AZILECT may 
be taken with or without food.  
 
If you take more AZILECT than you should 
If you think that you may have taken too many AZILECT tablets, contact your doctor or pharmacist 
immediately. Take the AZILECT carton/ blister or bottle with you to show the doctor or pharmacist. 
 
Symptoms reported following overdose of AZILECT included slightly euphoric mood (light form of 
mania), extremely high blood pressure and serotonin syndrome (see section 4). 
 
If you forget to take AZILECT 
Do not take a double dose to make up for a forgotten dose. Take the next dose normally, when it is 
time to take it. 
 
If you stop taking AZILECT 
Do not stop taking AZILECT without first talking to 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. 
 
Contact you doctor right away if you notice any of the following symptoms. You may need urgent 
medical advice or treatment: 

- If you develop unusual behaviours such as compulsions, obsessive thoughts, addictive 
gambling, excessive shopping or spending, impulsive behaviour and an abnormally high sex 
drive or an increase in sexual thoughts (impulse control disorders) (see section 2). 

- If you see or hear things which are not there (hallucinations). 
- Any combination of hallucinations, fever, restlessness, tremor and sweating (serotonin 

syndrome) 
- If you notice any suspicious skin changes because there is a higher risk of skin cancer (not 

exclusively melanoma) in patients with Parkinson’s disease (see section 2). 
 
Other side effects 
 
Very common (may affect more than 1 in 10 people) 
- Involuntary movements (dyskinesia) 
- Headache 
 
Common (may affect up to 1 in 10 people) 
- Abdominal pain 
- Fall 
- Allergy 
- Fever 
- Flu (influenza) 
- General feeling of being unwell (malaise) 
- Neck pain 
- Chest pain (angina pectoris) 
- Low blood pressure when rising to a standing position with symptoms like dizziness/light-

headedness (orthostatic hypotension) 
- Decreased appetite  
- Constipation 
- Dry mouth 
- Nausea and vomiting 



 

29 
 

- Flatulence 
- Abnormal results of blood tests (leucopenia) 
- Joint pain (arthralgia) 
- Musculoskeletal pain 
- Joint inflammation (arthritis) 
- Numbness and muscle weakness of the hand (carpal tunnel syndrome) 
- Decreased weight  
- Abnormal dreams 
- Difficulty in muscular coordination (balance disorder) 
- Depression 
- Dizziness (vertigo) 
- Prolonged muscle contractions (dystonia) 
- Runny nose (rhinitis) 
- Irritation of the skin (dermatitis)  
- Rash 
- Bloodshot eyes (conjunctivitis) 
- Urinary urgency 
 
Uncommon (may affect up to 1 in 100 people) 
- Stroke (cerebrovascular accident) 
- Heart attack (myocardial infarction) 
- Blistering rash (vesiculobullous rash) 
 
Not known: frequency cannot be estimated from the available data  
- Elevated blood pressure 
- Excessive drowsiness 
- Sudden onset of sleep 
 
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 AZILECT 
 
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 carton, bottle or blister after EXP. 
The expiry date refers to the last day of that month.  
 
Do not store above 30oC. 
 
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. 
 
 
6. Contents of the pack and other information 
 
What AZILECT contains 
- The active substance is rasagiline. Each tablet contains 1 mg rasagiline (as mesilate). 
- The other ingredients are mannitol, colloidal anhydrous silica, maize starch, pregelatinised 

maize starch, stearic acid, talc. 
 
What AZILECT looks like and contents of the pack 

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


 

30 
 

AZILECT tablets are presented as white to off-white, round, flat, bevelled tablets, debossed with 
“GIL” and “1” underneath on one side and plain on the other side. 
 
The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets or in a bottle containing 
30 tablets. 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
 
Teva B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands 
 
Manufacturers 
 
Teva Pharmaceuticals Europe B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands 
 
Pliva Croatia Ltd. 
Prilaz baruna Filipovica 25 
10000 Zagreb 
Croatia 
 
Teva Operations Poland Sp.z o.o. 
ul. Mogilska 80 
31-546 Krakow 
Poland 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder:  
 
België/Belgique/Belgien 
Teva Pharma Belgium N.V./S.A./AG 
Tél/Tel: +32 3 820 73 73 

Lietuva 
UAB "Sicor Biotech" 
Tel: +370 5 266 0203 
 

България 
Тева Фармасютикълс България ЕООД  
Teл: +359 2 489 95 82 
 

Luxembourg/Luxemburg 
Teva Pharma Belgium N.V./S.A./AG, 
Belgique/Belgien 
Tél/Tel: +32 3 820 73 73 
 

Česká republika  
Teva Pharmaceuticals CR, s.r.o.  
Tel: +420 251 007 111  
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel.: +36 1 288 6400 

Danmark 
Teva Denmark A/S 
Tlf: +45 4498 5511 
 

Malta 
Teva Pharmaceuticals Ireland 
L-Irlanda 
Tel: +353 51 321 740 
 

Deutschland 
Teva GmbH 
Tel: +800 53 23 66 48 
 

Nederland 
Teva Nederland B.V. 
Tel: +31 (0) 800 0228400 
 



 

31 
 

Eesti 
Teva Eesti esindus  
UAB Sicor Biotech Eesti filiaal 
Tel: +372 6610801 
 

Norge 
Teva Norway AS  
Tlf: +47 66775590 

Ελλάδα 
Teva Ελλάς Α.Ε. 
Τηλ: +30 210 72 79 099 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel.: +43 (0)1 97007 
 

 
España 
Teva Pharma, S.L.U. 
Tel: +34 91 387 32 80 

 
Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel.: +48 22 345 93 00 
 

France  
Teva Santé  
Tél: +33 1 55 91 7800  

Portugal 
Teva Pharma - Produtos 
Farmacêuticos Lda 
Tel: +351 21 476 75 50 
 

Hrvatska 
Pliva Hrvatska d.o.o. 
Tel.: + 385 1 37 20 000 
 

România 
Teva Pharmaceuticals S.R.L 
Tel: +4021 230 65 24 

Ireland 
Teva Pharmaceuticals Ireland 
Tel: +353 51 321 740 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 1 58 90 390 
 
 

Ísland 
Actavis Pharmaceuticals Iceland ehf. 
Sími: +354 550 3300 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 2 572 679 11 
 

Italia 
Teva Italia S.r.l. 
Tel: +39 028917981 

Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 20 180 5900 
 

Κύπρος 
Teva Ελλάς Α.Ε., Ελλάδα 
Τηλ: +30 210 72 79 099 

Sverige 
Teva Sweden AB 
Tel: + 46 42 12 11 00 
 

Latvija 
UAB "Sicor Biotech" filiāle Latvijā  
Tel: +371 67 323 666 

United Kingdom 
Teva UK Limited 
Tel:  +44(0) 1977 628500 

 
This leaflet was last revised in {month YYYY}. 
 


	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