Rasagiline Mylan

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ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 

 

Rasagiline Mylan 1 mg tablets 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Each tablet contains rasagiline tartrate corresponding to 1 mg rasagiline. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Tablet 

 

White to off-white, oblong (approximately 11.5 mm x 6 mm) biconvex tablets, debossed with ‘R9SE’ 

on one side and ‘1’ on the other side.  

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

Rasagiline Mylan is indicated for the treatment of idiopathic Parkinson’s disease (PD) 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 

 

Rasagiline is administered orally, at a dose of 1 mg once daily with or without levodopa. 

 

Elderly 

No change in dose is required for elderly patients. 

 

Hepatic impairment  

Rasagiline use in patients with severe hepatic impairment is contraindicated (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). 

 

Renal impairment 

No change in dose is required for renal impairment. 

 

Paediatric population 

Rasagiline is not recommended for use in children and adolescents due to lack of data on safety and 

efficacy. 

 

Method of administration 

 

For oral use. 

 

Rasagiline 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 

 

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. 

 

Impulse control disorders (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. 

 

Since rasagiline potentiates the effects of levodopa, the adverse effects of levodopa may be increased 

and pre-existing dyskinesia exacerbated. Decreasing the dose of levodopa may ameliorate this side 

effect. 

 

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 effects of hypotension due 

to existing gait issues. 

 

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). 

 

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. 

 

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 

 

There are a number of known interactions between non-selective MAO inhibitors and other medicinal 

products. 

 

Rasagiline must not be administered 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). 

 



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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). 

 

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). 

 

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). 

 

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. 

 

In Parkinson's disease patients receiving chronic levodopa treatment as adjunct therapy, there was no 

clinically significant effect of levodopa treatment on rasagiline clearance. 

 

In vitro metabolism studies have indicated that cytochrome P450 1A2 (CYP1A2) is the major enzyme 

responsible for the metabolism of rasagiline. 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. 

 

There is a risk that the plasma levels of rasagiline in smoking patients could be decreased, due to 

induction of the metabolising enzyme CYP1A2. 

 

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. 

 

Concomitant administration of rasagiline and entacapone increased rasagiline oral clearance by 28%. 

 

Tyramine/rasagiline interaction: Results of five tyramine challenge studies (in volunteers and PD 

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 

 



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For rasagiline no clinical data on exposed pregnancies is available. Animals studies do not indicate 

direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition 

or postnatal development (see section 5.3). Caution should be exercised when prescribing to pregnant 

women. 

 

Breast-feeding 

 

Experimental data indicated 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. 

 

4.7 Effects on ability to drive and use machines 

 

No studies on the effects on the ability to drive and use machines have been performed. 

 

Patients should be cautioned about operating hazardous machines, including motor vehicles, until they 

are reasonably certain that Rasagiline does not affect them adversely. 

 

4.8 Undesirable effects 

 

Summary of the safety profile 

 

In the rasagiline clinical program overall, 1,361 patients were treated with rasagiline for 

3,076.4 patient years. In the double blind placebo-controlled studies, 529 patients were treated with 

rasagiline 1 mg/day for 212 patient years and 539 patients received placebo for 213 patient years. 

 

Monotherapy 

The list below includes adverse reactions which were reported with a higher incidence in placebo 

controlled studies, in patients receiving 1 mg/day rasagiline (rasagiline group n=149, placebo group 

n=151). 

 

Tabulated list of adverse reactions 

 

Adverse reactions with at least 2% difference over placebo are marked in italics.  

In parentheses is the adverse reaction incidence (% of patients) in rasagiline vs. placebo, respectively. 

 

Adverse reactions are ranked under headings of 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). 

 

Infections and infestations 

Common: influenza (4.7% vs. 0.7%) 

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

Common: skin carcinoma (1.3% vs. 0.7%) 

Blood and lymphatic system disorders 

Common: leucopenia (1.3% vs. 0%) 

Immune system disorders 

Common: allergy (1.3% vs. 0.7%) 

Metabolism and nutrition disorders 

Uncommon: decreased appetite (0.7% vs. 0%) 

Psychiatric disorders 

Common: depression (5.4% vs. 2%), hallucinations (1.3% vs. 0.7%) 

Nervous system disorders 

Very common: headache (14.1% vs. 11.9%) 

Uncommon: cerebrovascular accident (0.7% vs. 0%) 



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Eye disorders 

Common: conjunctivitis (2.7% vs. 0.7%) 

Ear and labyrinth disorders 

Common: vertigo (2.7% vs. 1.3%) 

Cardiac disorders 

Common: angina pectoris (1.3% vs. 0%); 

Uncommon: myocardial infarction (0.7% vs. 0%) 

Respiratory, thoracic and mediastinal disorders 

Common: rhinitis (3.4% vs. 0.7%) 

Gastrointestinal disorders 

Common: flatulence (1.3% vs.0%) 

Skin and subcutaneous tissue disorders 

Common: dermatitis (2.0% vs. 0%) 

Uncommon: vesiculobullous rash (0.7% vs. 0%) 

Musculoskeletal and connective tissue disorders 

Common: musculoskeletal pain (6.7% vs. 2.6%), neck pain (2.7% vs. 0%), arthritis (1.3% vs.0.7%) 

Renal and urinary disorders 

Common: urinary urgency (1.3% vs. 0.7%). 

General disorders and administration site conditions 

Common: fever (2.7% vs. 1.3%), malaise (2% vs. 0%) 

 

Adjunct therapy 

The list below includes adverse reactions which were reported with a higher incidence in placebo 

controlled studies in patients receiving 1 mg/day rasagiline (rasagiline group n=380, placebo group 

n=388). In parentheses is the adverse reaction incidence (% of patients) in rasagiline vs. placebo, 

respectively. 

 

Adverse reactions with at least 2% difference over placebo are in italics. 

 

Adverse reactions are ranked under headings of 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). 

 

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

Uncommon: skin melanoma (0.5% vs. 0.3%) 

Metabolism and nutrition disorders 

Common: decreased appetite (2.4% vs. 0.8%) 

Psychiatric disorders 

Common: hallucinations (2.9% vs. 2.1%), abnormal dreams (2.1% vs. 0.8%) 

Uncommon: confusion (0.8% vs. 0.5%) 

Nervous system disorders 

Very common: dyskinesia (10.5% vs. 6.2%) 

Common: dystonia (2.4% vs. 0.8%), carpal tunnel syndrome (1.3% vs. 0%), balance disorder 

(1.6% vs. 0.3%) 

Uncommon: cerebrovascular accident (0.5% vs. 0.3%) 

Cardiac disorders 

Uncommon: angina pectoris (0.5% vs. 0%) 

Vascular disorders 

Common: orthostatic hypotension (3.9% vs. 0.8%) 

Gastrointestinal disorders 

Common: abdominal pain (4.2% vs. 1.3%), constipation (4.2% vs. 2.1%), nausea and vomiting 

(8.4% vs. 6.2%), dry mouth (3.4% vs. 1.8%) 

Skin and subcutaneous tissue disorders 

Common: rash (1.1% vs. 0.3%) 

Musculoskeletal and connective tissue disorders 

Common: arthralgia (2.4% vs. 2.1%), neck pain (1.3% vs. 0.5%) 



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Investigations 

Common: decreased weight (4.5% vs. 1.5%) 

Injury, poisoning and procedural complications 

Common: fall (4.7% vs. 3.4%) 

 

Description of selected adverse reactions 

 

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. 

 

Serious adverse reactions are known to occur with the concomitant use of SSRIs, SNRIs, 

tricyclic/tetracyclic antidepressants and MAO inhibitors. In the post-marketing period, cases of 

serotonin syndrome associated with agitation, confusion, rigidity, pyrexia and myoclonus have been 

reported by patients treated with antidepressants/SNRI concomitantly with rasagiline. 

 

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. There were no cases of serotonin syndrome in the rasagiline clinical 

program in which 115 patients were exposed concomitantly to rasagiline and tricyclics and 

141 patients were exposed to rasagiline and SSRIs/ SNRIs. 

 

In the post-marketing period, cases of elevated blood pressure, including rare cases of hypertensive 

crisis associated with ingestion of unknown amounts of tyramine-rich foods, have been reported in 

patients taking rasagiline. 

 

With MAO inhibitors, there have been reports of drug interactions with the concomitant use of 

sympathomimetic medicinal products. 

 

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 

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. A similar pattern of impulse control disorders has been reported post-marketing with 

rasagiline, which also included compulsions, obsessive thoughts and impulsive behaviour (see 

section 4.4). 

 

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 

dysphoria, 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 events were mild or moderate and not related to rasagiline treatment. In a dose 

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


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escalation study in patients on chronic levodopa therapy treated with 10 mg/day of rasagiline, there 

were reports of cardiovascular undesirable reactions (including hypertension and postural 

hypotension) which resolved following treatment discontinuation. These symptoms may resemble 

those observed with non-selective MAO inhibitors. 

 

Management 

 

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. 

 



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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 

for the primary efficacy end point, 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. 

 

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 are linear with dose over the range of 0.5-2 mg. Its terminal half-life is 

0.6-2 hours. 

 

Characteristics in patients 



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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. 

 

5.3 Preclinical safety data 

 

Preclinical data reveal no special hazard for humans based on conventional studies of safety 

pharmacology, repeated-dose toxicity and reproduction toxicity. 

 

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 

 

Cellulose, microcrystalline  

Tartaric acid 

Maize starch 

Starch, pregelatinised maize 

Talc 

Stearic acid 

 

6.2 Incompatibilities 

 

Not applicable. 

 

6.3 Shelf life 

 

30 months 

 

6.4 Special precautions for storage 

 

Do not store above 25ºC. 

 

6.5 Nature and contents of container 

 

oPA/Al/PVC/Al. Blister packs of 7, 10, 28, 30, 100 or 112 tablets 

PVC/PVDC/Al. Blister packs of 7, 10, 28, 30, 100 or 112 tablets 

PVC/PVDC/Al. Perforated unit dose blister packs of 7 x 1, 10 x 1, 28 x 1, 30 x 1, 100 x 1 or 112 x 1. 

 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal 

 



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No special requirements for disposal. 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

117, Allée des Parcs, 

69800 Saint-Priest 

France 

 

 

8. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/16/1090/001 (7 tablets - oPA/alu/PVC/alu)  

EU/1/16/1090/002 (10 tablets - oPA/alu/PVC/alu) 

EU/1/16/1090/003 (28 tablets - oPA/alu/PVC/alu) 

EU/1/16/1090/004 (30 tablets - oPA/alu/PVC/alu) 

EU/1/16/1090/005 (100 tablets - oPA/alu/PVC/alu) 

EU/1/16/1090/006 (112 tablets - oPA/alu/PVC/alu) 

EU/1/16/1090/007 (7 tablets - PVC/PVDC/alu) 

EU/1/16/1090/008 (10 tablets - PVC/PVDC/alu) 

EU/1/16/1090/009 (28 tablets - PVC/PVDC/alu) 

EU/1/16/1090/010 (30 tablets - PVC/PVDC/alu) 

EU/1/16/1090/011 (100 tablets - PVC/PVDC/alu) 

EU/1/16/1090/012 (112 tablets - PVC/PVDC/alu) 

EU/1/16/1090/013 (7 tablets - PVC/PVDC/alu) 

EU/1/16/1090/014 (10 tablets - PVC/PVDC/alu) 

EU/1/16/1090/015 (28 tablets - PVC/PVDC/alu) 

EU/1/16/1090/016 (30 tablets - PVC/PVDC/alu) 

EU/1/16/1090/017 (100 tablets - PVC/PVDC/alu) 

EU/1/16/1090/018 (112 tablets - PVC/PVDC/alu) 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 4 April 2016 

Date of latest renewal: 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

 

  



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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 

 

Mylan Hungary Kft 

Mylan utca 1 

H-2900 Komárom 

Hungary 

 

Synthon Hispania S.L. 

C/ Castelló no1, Pol. Las Salinas 

08830, Sant Boi de Llobregat, Barcelona 

Spain 

 

Synthon s.r.o 

Brněnská 32/čp. 597 

678 01 Blansko 

Czech Republic 

 

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 



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ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

  



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A. LABELLING 

  



16 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON FOR BLISTER PACK  

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Rasagiline Mylan 1 mg tablets 

rasagiline 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains rasagiline tartrate corresponding to 1 mg rasagiline. 

 

 

3. LIST OF EXCIPIENTS 

 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Tablet 

 

7 tablets 

10 tablets 

28 tablets  

30 tablets 

100 tablets 

112 tablets 

7 x 1 tablets 

10 x 1 tablets  

28 x 1 tablets  

30 x 1 tablets  

100 x 1 tablets  

112 x 1 tablets 

 

 

5. METHOD AND ROUTE OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral 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 



17 

 

EXP  

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 25°C 

 

 

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 

 

Mylan S.A.S. 

117, Allée des Parcs  

69800 Saint-Priest 

France 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/16/1090/001 (7 tablets - oPA/alu/PVC/alu)  

EU/1/16/1090/002 (10 tablets - oPA/alu/PVC/alu) 

EU/1/16/1090/003 (28 tablets - oPA/alu/PVC/alu) 

EU/1/16/1090/004 (30 tablets - oPA/alu/PVC/alu) 

EU/1/16/1090/005 (100 tablets - oPA/alu/PVC/alu) 

EU/1/16/1090/006 (112 tablets - oPA/alu/PVC/alu) 

EU/1/16/1090/007 (7 tablets - PVC/PVDC/alu) 

EU/1/16/1090/008 (10 tablets - PVC/PVDC/alu) 

EU/1/16/1090/009 (28 tablets - PVC/PVDC/alu) 

EU/1/16/1090/010 (30 tablets - PVC/PVDC/alu) 

EU/1/16/1090/011 (100 tablets - PVC/PVDC/alu) 

EU/1/16/1090/012 (112 tablets - PVC/PVDC/alu) 

EU/1/16/1090/013 (7 x 1 tablets - PVC/PVDC/alu) 

EU/1/16/1090/014 (10 x 1 tablets - PVC/PVDC/alu) 

EU/1/16/1090/015 (28 x 1 tablets - PVC/PVDC/alu) 

EU/1/16/1090/016 (30 x 1 tablets - PVC/PVDC/alu) 

EU/1/16/1090/017 (100 x 1 tablets - PVC/PVDC/alu) 

EU/1/16/1090/018 (112 x 1 tablets - PVC/PVDC/alu) 

 

 

13. BATCH NUMBER 

 

Lot  

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 



18 

 

 

 

16. INFORMATION IN BRAILLE 

 

Rasagiline Mylan 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC:  

SN:  

NN:  



19 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Rasagiline Mylan1 mg tablets 

rasagiline 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Mylan S.A.S. 

 

 

3. EXPIRY DATE 

 

EXP  

 

 

4. BATCH NUMBER 

 

Lot  

 

 

5. OTHER 

 

 

 

  



20 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



21 

Package leaflet: Information for the patient 

 

Rasagiline Mylan 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 Rasagiline Mylan is and what it is used for 

2. What you need to know before you take Rasagiline Mylan  

3. How to take Rasagiline Mylan 

4. Possible side effects  

5. How to store Rasagiline Mylan 

6. Contents of the pack and other information 

 

 

1. What Rasagiline Mylan is and what it is used for 

 

Rasagiline Mylan is used for the treatment of Parkinson’s disease. 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. Rasagiline Mylan helps to increase and sustain 

levels of dopamine in the brain. 

 

 

2. What you need to know before you take Rasagiline Mylan 

 

Do not take Rasagiline Mylan: 

- 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 Rasagaline Mylan:  

- 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 Rasagiline Mylan treatment and starting treatment with 

MAO inhibitors or pethidine. 

 

Warnings and precautions  

Talk to your doctor before taking Rasagiline Mylan. 

- if you have mild to moderate liver problems 
- if you have any suspicious skin changes. 
 

Children and adolescents 

Rasagiline Mylan is not recommended for use under the age of 18. 

 



22 

Other medicines and Rasagiline Mylan 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines, including medicines obtained without prescription or if you are smoking or intend to stop 

smoking. 

 

Ask your doctor for advice before taking any of the following medicines together with Rasagiline 

Mylan: 

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 Rasagiline Mylan together with the antidepressants containing fluoxetine or fluvoxamine 

should be avoided. 

 

If you are starting treatment with Rasagiline Mylan, 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 Rasagiline Mylan treatment. 

 

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 

yourself or others. These are called impulse control disorders. In patients taking Rasagiline Mylan 

and/or other medications 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. 

 

Rasagiline Mylan with food and drink 

Rasagiline Mylan may be taken with or without food. 

 

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 any medicine. 

 

Driving and using machines 

No studies on the effects on the ability to drive and use machines have been performed. Ask your 

doctor for advice prior to driving or using machines. 

 

 

3. How to take Rasagiline Mylan 

 

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 

if you are not sure. 

 

The recommended dose is 1 tablet of 1 mg taken by mouth once daily. Rasagiline Mylan may be taken 

with or without food. 

 

If you take more Rasagiline Mylan than you should 

If you think that you may have taken too many Rasagiline Mylan tablets, contact your doctor or 

pharmacist immediately. Take the Rasagiline Mylan carton with you to show the doctor or pharmacist. 

 

If you forget to take Rasagiline Mylan 



23 

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 Rasagiline Mylan 

Do not stop taking Rasagiline Mylan 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. 

 

The following side effects have been reported in placebo controlled clinical trials: 

 

The frequency of possible side effects listed below is defined using the following convention: 
• Very common (may affect more than 1 in 10 people) 
• Common (may affect up to 1 in 10 people) 
• Uncommon (may affect up to 1 in 100 people) 
• Rare (may affect up to 1 in 1,000 people) 
• Very rare (may affect up to 1 in 10,000 people) 
• Not known (frequency cannot be estimated from the available data) 

 
Very common  

• abnormal movements (dyskinesia) 
• headache 
 

Common  

• 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  
• 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)  



24 

• urinary urgency 
 

Uncommon  

• stroke (cerebrovascular accident)  
• heart attack (myocardial infarction)  
• blistering rash (vesiculobullous rash) 
 

In addition, skin cancer was reported in around 1% of patients in the placebo controlled clinical trials. 

Nevertheless, scientific evidence suggests that Parkinson’s disease, and not any medicine in particular, 

is associated with a higher risk of skin cancer (not exclusively melanoma). You should speak with 

your doctor about any suspicious skin changes. 

 

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. 

 

There have been cases of patients who, while taking one or more medications for the treatment of 

Parkinson’s disease, were unable to resist the impulse, drive or temptation to perform an action that 

could be harmful to themselves or others. These are called impulse control disorders. In patients taking 

rasagiline and/or other medications used to treat Parkinson’s disease, the following have been 

observed: 

- Obsessive thoughts or impulsive behaviour. 
- Strong impulse to gamble excessively despite serious personal or family consequences. 
- Altered 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. 
  

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 Rasagiline Mylan 

 

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 or blister after EXP. The 

expiry date refers to the last day of that month. 

 

Do not store above 25°C. 

 

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 Rasagiline Mylan contains  

- The active substance is rasagiline. Each tablet contains rasagiline tartrate corresponding to 1 mg 
rasagiline.  

- The other ingredients are microcrystalline cellulose, tartric acid, maize starch, pregelatinized 
maize starch, talc, stearic acid. 

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


25 

 

What Rasagiline Mylan looks like and contents of the pack 

Rasagiline tablets are presented as white to off-white, oblong (approximately 11.5 mm x 6 mm) 

biconvex tablets, debossed with ‘R9SE’ on one side and ‘1’ on the other side.  

 

The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets and in perforated blister 

packs containing 7 x 1, 10 x 1, 28 x 1, 30 x 1, 100 x 1 and 112 x 1 tablets.  

 

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder 

Mylan S.A.S. 

117, Allée des Parcs 

69800 Saint-Priest 

France 

 

Manufacturer 

Mylan Hungary Kft,  

Mylan utca 1  

H-2900 Komárom 

Hungary. 

 

Synthon Hispania S.L.,  

C/ Castelló no1, Pol. Las Salinas,  

08830, Sant Boi de Llobregat, Barcelona,  

Spain 

 

Synthon s.r.o,  

Brněnská 32/čp. 597 

678 01 Blansko 

Czech Republic 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 

Mylan bvba/sprl 

Tél/Tel: + 32 (0)2 658 61 00 

 

Lietuva 

BGP Products UAB  

Tel: +370 5 205 1288 

 

България 

Майлан ЕООД 

Тел: +359 2 44 55 400 

 

Luxembourg/Luxemburg 

Mylan bvba/sprl 

Tel: +32 (0)2 658 61 00 

(Belgique/Belgien) 

 

Česká republika 

Mylan Healthcare CZ s.r.o. 

Tel: +420 222 004 400 

Magyarország 

Mylan EPD Kft  

Tel: +36 1 465 2100 

 

Danmark 

Mylan Denmark ApS  

Tel: +45 28 11 69 32  

 

Malta 

V.J. Salomone Pharma Ltd 

Tel: + 356 21 22 01 74 

 

Deutschland 

Mylan Healthcare GmbH  
Tel: +49 800 0700 800 

 

Nederland 

Mylan BV 

Tel: +31 (0)20 426 3300 



26 

Eesti 

BGP Products Switzerland GmbH Eesti 

filiaal  

Tel: + 372 6363 052 

 

Norge 

Mylan Healthcare Norge AS 

Tel: + 47 66 75 33 00 

Ελλάδα  

Generics Pharma Hellas ΕΠΕ  

Τηλ: +30 210 993 6410  

 

Österreich 

Arcana Arzneimittel GmbH 

Tel: +43 1 416 2418 

 

España 

Mylan Pharmaceuticals, S.L 
Tel: + 34 900 102 712 

 

Polska 

Mylan Healthcare Sp. z o.o. 

Tel: + 48 22 546 64 00 

 

France 

Mylan S.A.S 

Tel: +33 4 37 25 75 00 
 

Portugal 

Mylan, Lda. 

Tel: + 351 21 412 72 26   

 

Hrvatska 

Mylan Hrvatska d.o.o.   

Tel: +385 1 23 50 599 

România 

BGP Products SRL 

Tel: +40 372 579 000 

 

Ireland 

Mylan Ireland Limited 

Tel:  +353 (0) 87 1694982 

  

 

Slovenija 

Mylan Healthcare d.o.o. 

Tel: + 386 1 23 63 180 

Ísland 

Icepharma hf 
Tel: +354 540 8000  
 

Slovenská republika 

Mylan s r.o.  

Tel: +421 2 32 199 100 

Italia 

Mylan Italia S.r.l 

Tel: + 39 02 612 46921 

 

Suomi/Finland 

Mylan Finland OY 

Puh/Tel: +358 20 720 9555 

 

Κύπρος 

Varnavas Hadjipanayis Ltd   

Τηλ: +357 2220 7700 

 

Sverige 

Mylan AB  

Tel: + 46 855 522 750 

 

Latvija 

Mylan Healthcare SIA  

Tel: +371 676 055 80 

 

United Kingdom 

Generics [UK] Ltd 

Tel: +44 1707 853000 

 

This leaflet was last revised in <{MM/YYYY}><{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