Stalevo

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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS



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1. NAME OF THE MEDICINAL PRODUCT

Stalevo 50 mg/12.5 mg/200 mg film-coated tablets
Stalevo 75 mg/18.75 mg/200 mg film-coated tablets
Stalevo 100 mg/25 mg/200 mg film-coated tablets
Stalevo 125 mg/31.25 mg/200 mg film-coated tablets
Stalevo 150 mg/37.5 mg/200 mg film-coated tablets
Stalevo 175 mg/43.75 mg/200 mg film-coated tablets
Stalevo 200 mg/50 mg/200 mg film-coated tablets 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

50 mg/12.5 mg/200 mg
Each tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.

Excipient with known effect:
Each tablet contains 1.2 mg of sucrose.

75 mg/18.75 mg/200 mg
Each tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone.

Excipient with known effect: 
Each tablet contains 1.4 mg of sucrose.

100 mg/25 mg/200 mg 
Each tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.

Excipient with known effect: 
Each tablet contains 1.6 mg of sucrose.

125 mg/31.25 mg/200 mg
Each tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.

Excipient with known effect: 
Each tablet contains 1.6 mg of sucrose.

150 mg/37.5 mg/200 mg
Each tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.

Excipient with known effect: 
Each tablet contains 1.9 mg of sucrose.

175 mg/43.75 mg/200 mg
Each tablet contains 175 mg of levodopa, 43.75 mg of carbidopa and 200 mg of entacapone.

Excipient with known effect: 
Each tablet contains 1.89 mg of sucrose.

200 mg/50 mg/200 mg
Each tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.

Excipient with known effect: 
Each tablet contains 2.3 mg of sucrose.

For the full list of excipients, see section 6.1.



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3. PHARMACEUTICAL FORM

Film-coated tablet (tablet)

50 mg/12.5 mg/200 mg
Brownish or greyish red, round, convex, unscored film-coated tablets marked with ‘LCE 50’ on one 
side.

75 mg/18.75 mg/200 mg
Light brownish red, oval film-coated tablets marked with ‘LCE 75’ on one side.

100 mg/25 mg/200 mg
Brownish or greyish red, oval, unscored film-coated tablets marked with ‘LCE 100’ on one side.

125 mg/31.25 mg/200 mg
Light brownish red, oval film-coated tablets marked with ‘LCE 125’ on one side.

150 mg/37.5 mg/200 mg
Brownish or greyish red, elongated-ellipse shaped, unscored film-coated tablets marked with ‘LCE 
150’ on one side.

175 mg/43.75 mg/200 mg
Light brownish red, oval, unscored film-coated tablets marked with ‘LCE 175’ on one side.

200 mg/50 mg/200 mg
Dark brownish red, oval, unscored film-coated tablets marked with ‘LCE 200’ on one side.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Stalevo is indicated for the treatment of adult patients with Parkinson’s disease and end-of-dose motor 
fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.

4.2 Posology and method of administration

Posology

The optimum daily dose must be determined by careful titration of levodopa in each patient. The daily 
dose should be preferably optimised using one of the seven available tablet strengths 
(50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg,
150 mg/37.5 mg/200 mg, 175 mg/43.75 mg/200 mg or 200 mg/50 mg/200 mg 
levodopa/carbidopa/entacapone). 

Patients should be instructed to take only one Stalevo tablet per dose administration. Patients 
receiving less than 70-100 mg carbidopa a day are more likely to experience nausea and vomiting. 
While the experience with total daily dose greater than 200 mg carbidopa is limited, the maximum 
recommended daily dose of entacapone is 2,000 mg and therefore the maximum dose is 10 tablets per 
day for the Stalevo strengths of 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg 
100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg and 150 mg/37.5 mg/200 mg. Ten tablets of Stalevo 
150 mg/37.5 mg/200 mg equals 375 mg of carbidopa a day. According to this daily carbidopa dose, 
the maximum recommended daily dose of Stalevo 175 mg/43.75 mg/200 mg is 8 tablets per day and 
Stalevo 200 mg/50 mg/200 mg dose is 7 tablets per day.



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Usually Stalevo is to be used in patients who are currently treated with corresponding doses of 
standard release levodopa/DDC inhibitor and entacapone. 

How to transfer patients taking levodopa/DDC inhibitor (carbidopa or benserazide) preparations and 
entacapone tablets to Stalevo 

a. Patients who are currently treated with entacapone and with standard release levodopa/carbidopa in 
doses equal to Stalevo tablet strengths can be directly transferred to corresponding Stalevo tablets. 
For example, a patient taking one tablet of 50 mg/12.5 mg of levodopa/carbidopa with one tablet of 
entacapone 200 mg four times daily can take one 50 mg/12.5 mg/200 mg Stalevo tablet four times 
daily in place of their usual levodopa/carbidopa and entacapone doses. 

b. When initiating Stalevo therapy for patients currently treated with entacapone and 
levodopa/carbidopa in doses not equal to Stalevo tablets (50 mg/12.5 mg/200 mg or 
75 mg/18.75 mg/200 mg or 100 mg/25 mg/200 mg or 125 mg/31.25 mg/200 mg or 
150 mg/37.5 mg/200 mg or 175 mg/43.75 mg/200 mg or 200 mg/50 mg/200 mg), Stalevo dosing 
should be carefully titrated for optimal clinical response. At the initiation, Stalevo should be adjusted 
to correspond as closely as possible to the total daily dose of levodopa currently used. 

c. When initiating Stalevo in patients currently treated with entacapone and levodopa/benserazide in a 
standard release formulation, the dosing of levodopa/benserazide should be discontinued in the 
previous night, and Stalevo should be started in the next morning. The starting dose of Stalevo should
provide either the same amount of levodopa or slightly (5-10%) more. 

How to transfer patients not currently treated with entacapone to Stalevo

Initiation of Stalevo may be considered at corresponding doses to current treatment in some patients 
with Parkinson's disease and end-of-dose motor fluctuations, who are not stabilised on their current 
standard release levodopa/DDC inhibitor treatment. However, a direct switch from levodopa/DDC 
inhibitor to Stalevo is not recommended for patients who have dyskinesias or whose daily levodopa 
dose is above 800 mg. In such patients it is advisable to introduce entacapone treatment as a separate 
treatment (entacapone tablets) and adjust the levodopa dose if necessary, before switching to Stalevo.

Entacapone enhances the effects of levodopa. It may therefore be necessary, particularly in patients 
with dyskinesia, to reduce levodopa dose by 10-30% within the first days to first weeks after initiating 
Stalevo treatment. The daily dose of levodopa can be reduced by extending the dosing intervals and/or 
by reducing the amount of levodopa per dose, according to the clinical condition of the patient. 

Dose adjustment during the course of the treatment

When more levodopa is required, an increase in the frequency of doses and/or the use of an alternative 
strength of Stalevo should be considered, within the dose recommendations. 

When less levodopa is required, the total daily dose of Stalevo should be reduced either by decreasing 
the frequency of administration by extending the time between doses, or by decreasing the strength of 
Stalevo at an administration.

If other levodopa products are used concomitantly with a Stalevo tablet, the maximum dose 
recommendations should be followed.

Discontinuation of Stalevo therapy: If Stalevo treatment (levodopa/carbidopa/entacapone) is 
discontinued and the patient is transferred to levodopa/DDC inhibitor therapy without entacapone, it 
is necessary to adjust the dosing of other antiparkinsonian treatments, especially levodopa, to achieve 
a sufficient level of control of the parkinsonian symptoms.



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Paediatric population: The safety and efficacy of Stalevo in children aged below 18 years have not 
been established. No data are available.

Elderly: No dose adjustment of Stalevo is required for elderly.

Hepatic impairment: It is advised that Stalevo should be administered cautiously to patients with mild 
to moderate hepatic impairment. Dose reduction may be needed (see section 5.2). For severe hepatic 
impairment see section 4.3.

Renal impairment: Renal impairment does not affect the pharmacokinetics of entacapone. No 
particular studies are reported on the pharmacokinetics of levodopa and carbidopa in patients with 
renal insufficiency, therefore Stalevo therapy should be administered cautiously to patients in severe 
renal impairment including those receiving dialysis therapy (see section 5.2). 

Method of administration
Each tablet is to be taken orally either with or without food (see section 5.2). One tablet contains one 
treatment dose and the tablet may only be administered as whole tablets.

4.3 Contraindications

- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
- Severe hepatic impairment.
- Narrow-angle glaucoma.
- Pheochromocytoma.
- Coadministration of Stalevo with non-selective monoamine oxidase (MAO-A and MAO-B) 

inhibitors (e.g. phenelzine, tranylcypromine). 
- Coadministration with a selective MAO-A inhibitor and a selective MAO-B inhibitor (see 

section 4.5). 
- A previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic 

rhabdomyolysis.

4.4 Special warnings and precautions for use 

- Stalevo is not recommended for the treatment of drug-induced extrapyramidal reactions.
- Stalevo therapy should be administered cautiously to patients with ischemic heart disease, 

severe cardiovascular or pulmonary disease, bronchial asthma, renal or endocrine disease, 
history of peptic ulcer disease or history of convulsions. 

- In patients with a history of myocardial infarction who have residual atrial nodal or ventricular 
arrhythmias; cardiac function should be monitored with particular care during the period of 
initial dose adjustments.

- All patients treated with Stalevo should be monitored carefully for the development of mental 
changes, depression with suicidal tendencies, and other serious antisocial behaviour. Patients 
with past or current psychosis should be treated with caution.

- Concomitant administration of antipsychotics with dopamine receptor-blocking properties, 
particularly D2 receptor antagonists should be carried out with caution, and the patient carefully 
observed for loss of antiparkinsonian effect or worsening of parkinsonian symptoms.

- Patients with chronic wide-angle glaucoma may be treated with Stalevo with caution, provided 
the intra-ocular pressure is well controlled and the patient is monitored carefully for changes in 
intra-ocular pressure.

- Stalevo may induce orthostatic hypotension. Therefore Stalevo should be given cautiously to 
patients who are taking other medicinal products which may cause orthostatic hypotension.

- Entacapone in association with levodopa has been associated with somnolence and episodes of 
sudden sleep onset in patients with Parkinson’s disease and caution should therefore be 
exercised when driving or operating machines (see section 4.7).

- In clinical studies, dopaminergic adverse reactions, e.g. dyskinesia, were more common in 
patients who received entacapone and dopamine agonists (such as bromocriptine), selegiline or 



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amantadine compared to those who received placebo with this combination. The doses of other 
antiparkinsonian medicinal products may need to be adjusted when Stalevo treatment is 
substituted for a patient currently not treated with entacapone.

- Rhabdomyolysis secondary to severe dyskinesias or neuroleptic malignant syndrome (NMS) has 
been observed rarely in patients with Parkinson’s disease. Therefore, any abrupt dose reduction 
or withdrawal of levodopa should be carefully observed, particularly in patients who are also 
receiving neuroleptics. NMS, including rhabdomyolysis and hyperthermia, is characterised by 
motor symptoms (rigidity, myoclonus, tremor), mental status changes (e.g., agitation, 
confusion, coma), hyperthermia, autonomic dysfunction (tachycardia, labile blood pressure) 
and elevated serum creatine phosphokinase. In individual cases, only some of these symptoms 
and/or findings may be evident. The early diagnosis is important for the appropriate 
management of NMS. A syndrome resembling the neuroleptic malignant syndrome including 
muscular rigidity, elevated body temperature, mental changes and increased serum creatine 
phosphokinase has been reported with the abrupt withdrawal of antiparkinsonian agents. 
Neither NMS nor rhabdomyolysis have been reported in association with entacapone treatment 
from controlled trials in which entacapone was discontinued abruptly. Since the introduction of 
entacapone into the market, isolated cases of NMS have been reported, especially following 
abrupt reduction or discontinuation of entacapone and other concomitant dopaminergic 
medicinal products. When considered necessary, the replacement of Stalevo with levodopa and 
DDC inhibitor without entacapone or other dopaminergic treatment should proceed slowly and 
an increase in levodopa dose may be necessary.

- If general anaesthesia is required, therapy with Stalevo may be continued for as long as the 
patient is permitted to take fluids and medicinal products by mouth. If therapy has to be stopped 
temporarily, Stalevo may be restarted as soon as oral medicinal products can be taken at the 
same daily dose as before. 

- Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is 
recommended during extended therapy with Stalevo.

- For patients experiencing diarrhoea, a follow-up of weight is recommended in order to avoid 
potential excessive weight decrease. Prolonged or persistent diarrhoea appearing during use of
entacapone may be a sign of colitis. In the event of prolonged or persistent diarrhoea, the drug 
should be discontinued and appropriate medical therapy and investigations considered.

- Patients should be regularly monitored for the development of impulse control disorders. 
Patients and carers should be made aware that behavioural symptoms of impulse control 
disorders including pathological gambling, increased libido, hypersexuality, compulsive 
spending or buying, binge eating and compulsive eating can occur in patients treated with 
dopamine agonists and/or other dopaminergic treatments containing levodopa including
Stalevo. Review of treatment is recommended if such symptoms develop.

- Dopamine Dysregulation Syndrome (DDS) is an addictive disorder resulting in excessive use of 
the product seen in some patients treated with carbidopa/levodopa. Before initiation of 
treatment, patients and caregivers should be warned of the potential risk of developing DDS 
(see also section 4.8).

- For patients who experience progressive anorexia, asthenia and weight decrease within a 
relatively short period of time, a general medical evaluation including liver function should be 
considered.

- Levodopa/carbidopa may cause false positive result when a dipstick is used to test for urinary 
ketone and this reaction is not altered by boiling the urine sample. The use of glucose oxidase 
methods may give false negative results for glycosuria.

- Stalevo contains sucrose, and therefore patients with rare hereditary problems of fructose 
intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not 
take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction 

Other antiparkinsonian medicinal products: To date there has been no indication of interactions that 
would preclude concurrent use of standard antiparkinsonian medicinal products with Stalevo therapy. 
Entacapone in high doses may affect the absorption of carbidopa. However, no interaction with 



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carbidopa has been observed with the recommended treatment schedule (200 mg of entacapone up to 
10 times daily). Interactions between entacapone and selegiline have been investigated in repeated 
dose studies in Parkinson's disease patients treated with levodopa/DDC inhibitor and no interaction 
was observed. When used with Stalevo, the daily dose of selegiline should not exceed 10 mg.

Caution should be exercised when the following active substances are administered concomitantly 
with levodopa therapy.

Antihypertensives: Symptomatic postural hypotension may occur when levodopa is added to the 
treatment of patients already receiving antihypertensives. Dose adjustment of the antihypertensive 
agent may be required. 

Antidepressants: Rarely, reactions including hypertension and dyskinesia have been reported with the 
concomitant use of tricyclic antidepressants and levodopa/carbidopa. Interactions between entacapone 
and imipramine and between entacapone and moclobemide have been investigated in single dose 
studies in healthy volunteers. No pharmacodynamic interactions were observed. A significant number 
of Parkinson's disease patients have been treated with the combination of levodopa, carbidopa and 
entacapone with several active substances including MAO-A inhibitors, tricyclic antidepressants, 
noradrenaline reuptake inhibitors such as desipramine, maprotiline and venlafaxine and medicinal 
products that are metabolised by COMT (e.g. catechol-structured compounds, paroxetine). No 
pharmacodynamic interactions have been observed. However, caution should be exercised when these 
medicinal products are used concomitantly with Stalevo (see sections 4.3 and 4.4).

Other active substances: Dopamine receptor antagonists (e.g. some antipsychotics and antiemetics), 
phenytoin and papaverine may reduce the therapeutic effect of levodopa. Patients taking these 
medicinal products with Stalevo should be carefully observed for loss of therapeutic response.

Due to entacapone's affinity to cytochrome P450 2C9 in vitro (see section 5.2), Stalevo may 
potentially interfere with active substances whose metabolism is dependent on this isoenzyme, such as 
S-warfarin. However, in an interaction study with healthy volunteers, entacapone did not change the 
plasma levels of S-warfarin, while the AUC for R-warfarin increased on average by 18% [CI90 11-
26%]. The INR values increased on average by 13% [CI90 6-19%]. Thus, a control of INR is 
recommended when Stalevo is initiated for patients receiving warfarin.

Other forms of interactions: Since levodopa competes with certain amino acids, the absorption of 
Stalevo may be impaired in some patients on high protein diet.

Levodopa and entacapone may form chelates with iron in the gastrointestinal tract. Therefore, Stalevo 
and iron preparations should be taken at least 2-3 hours apart (see section 4.8).

In vitro data: Entacapone binds to human albumin binding site II which also binds several other 
medicinal products, including diazepam and ibuprofen. According to in vitro studies, significant 
displacement is not anticipated at therapeutic concentrations of the medicinal products. Accordingly, 
to date there has been no indication of such interactions.

4.6 Fertility, pregnancy and lactation

Pregnancy
There are no adequate data from the use of the combination of levodopa/carbidopa/entacapone in 
pregnant women. Studies in animals have shown reproductive toxicity of the separate compounds (see 
section 5.3). The potential risk for humans is unknown. Stalevo should not be used during pregnancy 
unless the benefits for the mother outweigh the possible risks to the foetus.

Breast-feeding
Levodopa is excreted in human breast milk. There is evidence that breast-feeding is suppressed during 
treatment with levodopa. Carbidopa and entacapone were excreted in milk in animals but is not 



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known whether they are excreted in human breast milk. The safety of levodopa, carbidopa or 
entacapone in the infant is not known. Women should not breast-feed during treatment with Stalevo.

Fertility 
No adverse reactions on fertility were observed in preclinical studies with entacapone, carbidopa or 
levodopa alone. Fertility studies in animals have not been conducted with the combination of 
entacapone, levodopa and carbidopa.

4.7 Effects on ability to drive and use machines

Stalevo may have a major influence on the ability to drive and use machines. Levodopa, carbidopa 
and entacapone together may cause dizziness and symptomatic orthostatism. Therefore, caution 
should be exercised when driving or using machines.

Patients being treated with Stalevo and presenting with somnolence and/or sudden sleep onset 
episodes must be instructed 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 such 
recurrent episodes have resolved (see section 4.4).

4.8 Undesirable effects

a. Summary of the safety profile

The most frequently reported adverse reactions with Stalevo are dyskinesias occurring in 
approximately 19% of patients; gastrointestinal symptoms including nausea and diarrhoea occurring 
in approximately 15% and 12% of patients, respectively; muscle, musculoskeletal and connective 
tissue pain occurring in approximately 12% of patients; and harmless reddish-brown discolouration of 
urine (chromaturia) occurring in approximately 10% of patients. Serious events of gastrointestinal 
haemorrhage (uncommon) and angioedema (rare) have been identified from the clinical trials with 
Stalevo or entacapone combined with levodopa/DDC inhibitor. Serious hepatitis with mainly 
cholestatic features, rhabdomyolysis and neuroleptic malignant syndrome may occur with Stalevo 
although no cases have been identified from the clinical trial data. 

b. Tabulated list of adverse reactions

The following adverse reactions, listed in Table 1, have been accumulated both from a pooled data of 
eleven double-blind clinical trials consisting of 3230 patients (1810 treated with Stalevo or 
entacapone combined with levodopa/DDC inhibitor, and 1420 treated with placebo combined with 
levodopa/DDC inhibitor or cabergoline combined with levodopa/ DDC inhibitor), and from the post-
marketing data since the introduction of entacapone into the market for the combination use of 
entacapone with levodopa/DDC inhibitor. 

Adverse reactions are ranked under headings of frequency, the most frequent first, using the following 
convention: 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, since no valid estimate can be derived from clinical trials or epidemiological studies).

Table 1. Adverse reactions

Blood and lymphatic system disorders
Common: Anaemia
Uncommon: Thrombocytopenia

Metabolism and nutrition disorders
Common: Weight decreased*, decreased appetite*



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Psychiatric disorders
Common: Depression, hallucination, confusional state*, abnormal dreams*, anxiety, 

insomnia
Uncommon: Psychosis, agitation* 
Not known: Suicidal behaviour, Dopamine dysregulation syndrome

Nervous system disorders
Very common: Dyskinesia*
Common: Parkinsonism aggravated (e.g. bradykinesia)*, tremor, on and off phenomenon, 

dystonia, mental impairment (e.g. memory impairment, dementia), somnolence, 
dizziness*, headache

Not known: Neuroleptic malignant syndrome*

Eye disorders
Common: Blurred vision

Cardiac disorders
Common: Ischemic heart disease events other than myocardial infarction (e.g. angina

pectoris)**, irregular heart rhythm 
Uncommon: Myocardial infarction**

Vascular disorders
Common: Orthostatic hypotension, hypertension
Uncommon: Gastrointestinal haemorrhage

Respiratory, thoracic and mediastinal disorders
Common: Dyspnoea

Gastrointestinal disorders
Very common: Diarrhoea*, nausea*
Common:    Constipation*, vomiting*, dyspepsia, abdominal pain and discomfort*, dry mouth*
Uncommon: Colitis*, dysphagia

Hepatobiliary disorders
Uncommon: Hepatic function test abnormal*
Not known: Hepatitis with mainly cholestatic features (see section 4.4)*

Skin and subcutaneous tissue disorders
Common: Rash*, hyperhidrosis
Uncommon: Discolourations other than urine (e.g. skin, nail, hair, sweat)*
Rare: Angioedema
Not known: Urticaria*

Musculoskeletal and connective tissue disorders
Very common: Muscle, musculoskeletal and connective tissue pain*
Common: Muscle spasms, arthralgia
Not known: Rhabdomyolysis*

Renal and urinary disorders
Very common: Chromaturia*
Common: Urinary tract infection
Uncommon: Urinary retention

General disorders and administration site conditions
Common:      Chest pain, peripheral oedema, fall, gait disturbance, asthenia, fatigue
Uncommon: Malaise



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*Adverse reactions that are mainly attributable to entacapone or are more frequent (by the frequency
difference of at least 1% in the clinical trial data) with entacapone than levodopa/DDC inhibitor 
alone. See section c.

**The incidence rates of myocardial infarction and other ischemic heart disease events (0.43% and 
1.54%, respectively) are derived from an analysis of 13 double-blind studies involving 2082 patients 
with end-of-dose motor fluctuations receiving entacapone.

c. Description of selected adverse reactions

Adverse reactions that are mainly attributable to entacapone or are more frequent with entacapone 
than levodopa/DDC inhibitor alone are indicated with an asterisk in Table 1, section 4.8b. Some of 
these adverse reactions relate to the increased dopaminergic activity (e.g. dyskinesia, nausea and 
vomiting) and occur most commonly at the beginning of the treatment. Reduction of levodopa dose 
decreases the severity and frequency of these dopaminergic reactions. Few adverse reactions are 
known to be directly attributable to the active substance entacapone including diarrhoea and reddish-
brown discolouration of urine. Entacapone may in some cases cause also discolouration of e.g. skin, 
nail, hair and sweat. Other adverse reactions with an asterisk in Table 1, section 4.8b are marked 
based on either their more frequent occurring (by the frequency difference of at least 1%) in the 
clinical trial data with entacapone than levodopa/DDCI alone or the individual case safety reports
received after the introduction of entacapone into the market.

Convulsions have occurred rarely with levodopa/carbidopa; however a causal relationship to 
levodopa/carbidopa therapy has not been established.

Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive 
spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine 
agonists and/or other dopaminergic treatments containing levodopa including Stalevo (see section 
4.4).

Dopamine Dysregulation Syndrome (DDS) is an addictive disorder seen in some patients treated with 
carbidopa/levodopa. Affected patients show a compulsive pattern of dopaminergic drug misuse above
doses adequate to control motor symptoms, which may in some cases result in severe dyskinesias (see 
also section 4.4).

Entacapone in association with levodopa has been associated with isolated cases of excessive daytime 
somnolence and sudden sleep onset episodes.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V.

4.9 Overdose

The post-marketing data includes isolated cases of overdose in which the reported highest daily doses 
of levodopa and entacapone have been at least 10,000 mg and 40,000 mg, respectively. The acute 
symptoms and signs in these cases of overdose included agitation, confusional state, coma, 
bradycardia, ventricular tachycardia, Cheyne-Stokes respiration, discolourations of skin, tongue and 
conjunctiva, and chromaturia. Management of acute overdose with Stalevo therapy is similar to acute 
overdose with levodopa. Pyridoxine, however, is not effective in reversing the actions of Stalevo. 
Hospitalisation is advised and general supportive measures should be employed with immediate 
gastric lavage and repeated doses of charcoal over time. This may hasten the elimination of 
entacapone in particular by decreasing its absorption/reabsorption from the GI tract. The adequacy of 

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the respiratory, circulatory and renal systems should be carefully monitored and appropriate 
supportive measures employed. ECG monitoring should be started and the patient carefully monitored 
for the possible development of arrhythmias. If required, appropriate anti-arrhythmic therapy should 
be given. The possibility that the patient has taken other active substances in addition to Stalevo 
should be taken into consideration. The value of dialysis in the treatment of overdose is not known.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: anti-parkinson drugs, dopa and dopa derivatives, ATC code: N04BA03

According to the current understanding, the symptoms of Parkinson’s disease are related to depletion 
of dopamine in the corpus striatum. Dopamine does not cross the blood-brain barrier. Levodopa, the 
precursor of dopamine, crosses the blood brain barrier and relieves the symptoms of the disease. As 
levodopa is extensively metabolised in the periphery, only a small portion of a given dose reaches the 
central nervous system when levodopa is administered without metabolic enzyme inhibitors. 

Carbidopa and benserazide are peripheral DDC inhibitors which reduce the peripheral metabolism of 
levodopa to dopamine, and thus, more levodopa is available to the brain. When decarboxylation of 
levodopa is reduced with the co-administration of a DDC inhibitor, a lower dose of levodopa can be 
used and the incidence of adverse reactions such as nausea is reduced.

With inhibition of the decarboxylase by a DDC inhibitor, catechol-O-methyltransferase (COMT) 
becomes the major peripheral metabolic pathway catalyzing the conversion of levodopa to 3-O-
methyldopa (3-OMD), a potentially harmful metabolite of levodopa. Entacapone is a reversible, 
specific and mainly peripherally acting COMT inhibitor designed for concomitant administration with 
levodopa. Entacapone slows the clearance of levodopa from the bloodstream resulting in an increased 
area under the curve (AUC) in the pharmacokinetic profile of levodopa. Consequently the clinical 
response to each dose of levodopa is enhanced and prolonged.

The evidence of the therapeutic effects of Stalevo is based on two phase III double-blind studies, in 
which 376 Parkinson’s disease patients with end-of-dose motor fluctuations received either 
entacapone or placebo with each levodopa/DDC inhibitor dose. Daily ON time with and without 
entacapone was recorded in home-diaries by patients. In the first study, entacapone increased the 
mean daily ON time by 1 h 20 min (CI 95% 45 min, 1 h 56 min) from baseline. This corresponded to an 
8.3% increase in the proportion of daily ON time. Correspondingly, the decrease in daily OFF time 
was 24% in the entacapone group and 0% in the placebo group. In the second study, the mean 
proportion of daily ON time increased by 4.5% (CI95% 0.93%, 7.97%) from baseline. This is translated 
to a mean increase of 35 min in the daily ON time. Correspondingly, the daily OFF time decreased by 
18% on entacapone and by 5% on placebo. Because the effects of Stalevo tablets are equivalent with 
entacapone 200 mg tablet administered concomitantly with the commercially available standard 
release carbidopa/levodopa preparations in corresponding doses these results are applicable to 
describe the effects of Stalevo as well.

5.2 Pharmacokinetic properties

General characteristics of the active substances

Absorption/distribution: There are substantial inter- and intra-individual variations in the absorption 
of levodopa, carbidopa and entacapone. Both levodopa and entacapone are rapidly absorbed and 
eliminated. Carbidopa is absorbed and eliminated slightly slower compared with levodopa. When 
given separately without the two other active substances, the bioavailability for levodopa is 15-33%, 
for carbidopa 40-70% and for entacapone 35% after a 200 mg oral dose. Meals rich in large neutral 
amino acids may delay and reduce the absorption of levodopa. Food does not significantly affect the 



12

absorption of entacapone. The distribution volume of both levodopa (Vd 0.36-1.6 l/kg) and 
entacapone (Vdss 0.27 l/kg) is moderately small while no data for carbidopa are available.

Levodopa is bound to plasma protein only to a minor extent of about 10-30% and carbidopa is bound 
approximately 36%, while entacapone is extensively bound to plasma proteins (about 98%) –mainly to 
serum albumin. At therapeutic concentrations, entacapone does not displace other extensively bound 
active substances (e.g. warfarin, salicylic acid, phenylbutazone, or diazepam), nor is it displaced to any 
significant extent by any of these substances at therapeutic or higher concentrations.

Biotransformation and elimination: Levodopa is extensively metabolised to various metabolites: 
decarboxylation by dopa decarboxylase (DDC) and O-methylation by catechol-O-methyltransferase 
(COMT) being the most important pathways.

Carbidopa is metabolized to two main metabolites which are excreted in the urine as glucuronides and 
unconjugated compounds. Unchanged carbidopa accounts for 30% of the total urinary excretion.

Entacapone is almost completely metabolized prior to excretion via urine (10 to 20%) and bile/faeces
(80 to 90%). The main metabolic pathway is glucuronidation of entacapone and its active metabolite, 
the cis-isomer, which accounts for about 5% of plasma total amount.

Total clearance for levodopa is in the range of 0.55-1.38 l/kg/h and for entacapone is in the range of 
0.70 l/kg/h. The elimination-half life is (t1/2) is 0.6-1.3 hours for levodopa, 2-3 hours for carbidopa and
0.4-0.7 hours for entacapone, each given separately.

Due to short elimination half-lives, no true accumulation of levodopa or entacapone occurs on 
repeated administration.

Data from in vitro studies using human liver microsomal preparations indicate that entacapone 
inhibits cytochrome P450 2C9 (IC50 ~ 4 µM). Entacapone showed little or no inhibition of other 
types of P450 isoenzymes (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A and CYP2C19); see 
section 4.5.

Characteristics in patients

Elderly: When given without carbidopa and entacapone, the absorption of levodopa is greater and 
elimination is slower in elderly than in young people. However, after combination of carbidopa with 
levodopa, the absorption of levodopa is similar between the elderly and the young people, but the 
AUC is still 1.5 fold greater in the elderly due to decreased DDC activity and lower clearance by 
aging. There are no significant differences in the AUC of carbidopa or entacapone between younger 
(45–64 years) and elderly (65–75 years).

Gender: Bioavailability of levodopa is significantly higher in women than in men. In the 
pharmacokinetic studies with Stalevo the bioavailability of levodopa is higher in women than in men, 
primarily due to the difference in body weight, while there is no gender difference with carbidopa and 
entacapone.

Hepatic impairment: The metabolism of entacapone is slowed in patients with mild to moderate 
hepatic impairment (Child-Pugh Class A and B) leading to an increased plasma concentration of 
entacapone both in the absorption and elimination phases (see sections 4.2 and 4.3). No particular 
studies on the pharmacokinetics of carbidopa and levodopa in patients with hepatic impairment are 
reported, however, it is advised that Stalevo should be administered cautiously to patients with mild or 
moderate hepatic impairment. 

Renal impairment: Renal impairment does not affect the pharmacokinetics of entacapone. No 
particular studies are reported on the pharmacokinetics of levodopa and carbidopa in patients with 
renal impairment. However, a longer dosing interval of Stalevo may be considered for patients who 



13

are receiving dialysis therapy (see section 4.2).

5.3 Preclinical safety data

Preclinical data of levodopa, carbidopa and entacapone, tested alone or in combination, revealed no 
special hazard for humans based on conventional studies of safety pharmacology, repeated dose 
toxicity, genotoxicity, and carcinogenic potential. In repeated dose toxicity studies with entacapone, 
anaemia most likely due to iron chelating properties of entacapone was observed. Regarding 
reproduction toxicity of entacapone, decreased foetal weight and a slightly delayed bone development 
were noticed in rabbits treated at systemic exposure levels in the therapeutic range. Both levodopa and 
combinations of carbidopa and levodopa have caused visceral and skeletal malformations in rabbits. 

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet core:
Croscarmellose sodium
Magnesium stearate
Maize starch
Mannitol (E421)
Povidone K 30 (E1201) 

Film-coating of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg:
Glycerol (85 per cent) (E422)
Hypromellose
Magnesium stearate
Polysorbate 80
Red iron oxide (E172)
Sucrose
Titanium dioxide (E171)
Yellow iron oxide (E172)

Film-coating of 75/18.75/200 mg, 125/31.25/200 mg, 175/43.75/200 mg and 200/50/200 mg:
Glycerol (85 per cent) (E422)
Hypromellose
Magnesium stearate
Polysorbate 80
Red iron oxide (E172)
Sucrose
Titanium dioxide (E171)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container



14

HDPE bottle with a child resistant PP-closure.

Pack sizes of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg:
10, 30, 100, 130, 175 and 250 tablets.

Pack sizes of 75/18.75/200 mg, 125/31.25/200 mg, 175/43.75/200 mg and 200/50/200 mg:
10, 30, 100, 130 and 175 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

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

7. MARKETING AUTHORISATION HOLDER

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

8. MARKETING AUTHORISATION NUMBERS 

50 mg/12.5 mg/200 mg
EU/1/03/260/001-004
EU/1/03/260/013
EU/1/03/260/016

75 mg/18.75 mg/200 mg
EU/1/03/260/024-028

100 mg/25 mg/200 mg
EU/1/03/260/005-008
EU/1/03/260/014
EU/1/03/260/017

125 mg/31.25 mg/200 mg
EU/1/03/260/029-033

150 mg/37.5 mg/200 mg
EU/1/03/260/009-012
EU/1/03/260/015
EU/1/03/260/018

175 mg/43.75 mg/200 mg
EU/1/03/260/034-038

200 mg/50 mg/200 mg
EU/1/03/260/019-023

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION



15

Date of first authorisation: 17 October 2003
Date of latest renewal: 17 October 2008

10. DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of European Medicines 
Agency http://www.ema.europa.eu

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


16

ANNEX II

A. MANUFACTURER 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 



17

A MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Orion Corporation 
Orionintie 1 
FI-02200 Espoo
Finland

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)

Not applicable.



18

ANNEX III

LABELLING AND PACKAGE LEAFLET



19

A. LABELLING



20

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING

BOTTLE LABEL AND OUTER CARTON TEXT

1. NAME OF THE MEDICINAL PRODUCT

Stalevo 50 mg/12.5 mg/200 mg film-coated tablets 
levodopa/carbidopa/entacapone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.

3. LIST OF EXCIPIENTS

Contains sucrose. 

4. PHARMACEUTICAL FORM AND CONTENTS

Carton
10 film-coated tablets
30 film-coated tablets
100 film-coated tablets
130 film-coated tablets
175 film-coated tablets
250 film-coated tablets

Label
10 tablets
30 tablets
100 tablets
130 tablets
175 tablets
250 tablets

5. METHOD AND ROUTE(S) 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



21

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

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

Carton
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Label
Orion Corporation

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/260/001  10 film-coated tablets
EU/1/03/260/002  30 film-coated tablets
EU/1/03/260/003  100 film-coated tablets
EU/1/03/260/004  250 film-coated tablets
EU/1/03/260/013  175 film-coated tablets
EU/1/03/260/016  130 film-coated tablets

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

stalevo 50/12.5/200 mg [carton only]

17. UNIQUE IDENTIFIER – 2D BARCODE



22

2D barcode carrying the unique identifier included [carton only]

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

[carton only]:

PC: {number}
SN: {number}
< NN: {number} >



23

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING

BOTTLE LABEL AND OUTER CARTON TEXT

1. NAME OF THE MEDICINAL PRODUCT

Stalevo 75 mg/18.75 mg/200 mg film-coated tablets
levodopa/carbidopa/entacapone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of 
entacapone.

3. LIST OF EXCIPIENTS

Contains sucrose. 

4. PHARMACEUTICAL FORM AND CONTENTS

Carton
10 film-coated tablets
30 film-coated tablets
100 film-coated tablets
130 film-coated tablets
175 film-coated tablets

Label
10 tablets
30 tablets
100 tablets
130 tablets
175 tablets

5. METHOD AND ROUTE(S) 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



24

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

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

Carton
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Label
Orion Corporation

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/260/024  10 film-coated tablets
EU/1/03/260/025  30 film-coated tablets
EU/1/03/260/026  100 film-coated tablets
EU/1/03/260/027  130 film-coated tablets
EU/1/03/260/028  175 film-coated tablets

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

stalevo 75/18.75/200 mg [carton only]

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included [carton only]



25

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

[carton only]:

PC: {number}
SN: {number}
< NN: {number} >



26

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING

BOTTLE LABEL AND OUTER CARTON TEXT

1. NAME OF THE MEDICINAL PRODUCT

Stalevo 100 mg/25 mg/200 mg film-coated tablets 
levodopa/carbidopa/entacapone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.

3. LIST OF EXCIPIENTS

Contains sucrose.

4. PHARMACEUTICAL FORM AND CONTENTS

Carton
10 film-coated tablets
30 film-coated tablets
100 film-coated tablets
130 film-coated tablets
175 film-coated tablets
250 film-coated tablets

Label
10 tablets
30 tablets
100 tablets
130 tablets
175 tablets
250 tablets

5. METHOD AND ROUTE(S) 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



27

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

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

Carton
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Label
Orion Corporation

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/260/005  10 film-coated tablets
EU/1/03/260/006  30 film-coated tablets
EU/1/03/260/007  100 film-coated tablets
EU/1/03/260/008  250 film-coated tablets
EU/1/03/260/014  175 film-coated tablets
EU/1/03/260/017  130 film-coated tablets

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

stalevo 100/25/200 mg [carton only]

17. UNIQUE IDENTIFIER – 2D BARCODE



28

2D barcode carrying the unique identifier included [carton only]

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

[carton only]:

PC: {number}
SN: {number}
< NN: {number} >



29

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING

BOTTLE LABEL AND OUTER CARTON TEXT

1. NAME OF THE MEDICINAL PRODUCT

Stalevo 125 mg/31.25 mg/200 mg film-coated tablets
levodopa/carbidopa/entacapone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of 
entacapone.

3. LIST OF EXCIPIENTS

Contains sucrose.

4. PHARMACEUTICAL FORM AND CONTENTS

Carton
10 film-coated tablets
30 film-coated tablets
100 film-coated tablets
130 film-coated tablets
175 film-coated tablets

Label
10 tablets
30 tablets
100 tablets
130 tablets
175 tablets

5. METHOD AND ROUTE(S) 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



30

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

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

Carton
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Label
Orion Corporation

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/260/029 10 film-coated tablets
EU/1/03/260/030 30 film-coated tablets
EU/1/03/260/031 100 film-coated tablets
EU/1/03/260/032 130 film-coated tablets
EU/1/03/260/033 175 film-coated tablets

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

stalevo 125/31.25/200 mg [carton only]

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included [carton only]



31

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

[carton only]:

PC: {number}
SN: {number}
< NN: {number} >



32

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING

BOTTLE LABEL AND OUTER CARTON TEXT

1. NAME OF THE MEDICINAL PRODUCT

Stalevo 150 mg/37.5 mg/200 mg film-coated tablets 
levodopa/carbidopa/entacapone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of 
entacapone.

3. LIST OF EXCIPIENTS

Contains sucrose. 

4. PHARMACEUTICAL FORM AND CONTENTS

Carton
10 film-coated tablets
30 film-coated tablets
100 film-coated tablets
130 film-coated tablets
175 film-coated tablets
250 film-coated tablets

Label
10 tablets
30 tablets
100 tablets
130 tablets
175 tablets
250 tablets

5. METHOD AND ROUTE(S) 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.



33

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

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

Carton
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Label
Orion Corporation

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/260/009  10 film-coated tablets
EU/1/03/260/010  30 film-coated tablets
EU/1/03/260/011  100 film-coated tablets
EU/1/03/260/012  250 film-coated tablets
EU/1/03/260/015  175 film-coated tablets
EU/1/03/260/018  130 film-coated tablets

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

stalevo 150/37.5/200 mg [carton only]

17. UNIQUE IDENTIFIER – 2D BARCODE



34

2D barcode carrying the unique identifier included [carton only]

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

[carton only]:

PC: {number}
SN: {number}
< NN: {number} >



35

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING

BOTTLE LABEL AND OUTER CARTON TEXT

1. NAME OF THE MEDICINAL PRODUCT

Stalevo 175 mg/43.75 mg/200 mg film-coated tablets
levodopa/carbidopa/entacapone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 175 mg of levodopa, 43.75 mg of carbidopa and 200 mg of 
entacapone.

3. LIST OF EXCIPIENTS

Contains sucrose. 

4. PHARMACEUTICAL FORM AND CONTENTS

Carton
10 film-coated tablets
30 film-coated tablets
100 film-coated tablets
130 film-coated tablets
175 film-coated tablets

Label
10 tablets
30 tablets
100 tablets
130 tablets
175 tablets

5. METHOD AND ROUTE(S) 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



36

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

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

Carton
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Label
Orion Corporation

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/260/034 10 film-coated tablets
EU/1/03/260/035 30 film-coated tablets
EU/1/03/260/036 100 film-coated tablets
EU/1/03/260/037 130 film-coated tablets
EU/1/03/260/038 175 film-coated tablets

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

stalevo 175/43.75/200 mg [carton only]

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included [carton only]



37

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

[carton only]:

PC: {number}
SN: {number}
< NN: {number} >



38

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING

BOTTLE LABEL AND OUTER CARTON TEXT

1. NAME OF THE MEDICINAL PRODUCT

Stalevo 200 mg/50 mg/200 mg film-coated tablets
levodopa/carbidopa/entacapone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.

3. LIST OF EXCIPIENTS

Contains sucrose. 

4. PHARMACEUTICAL FORM AND CONTENTS

Carton
10 film-coated tablets
30 film-coated tablets
100 film-coated tablets
130 film-coated tablets
175 film-coated tablets

Label
10 tablets
30 tablets
100 tablets
130 tablets
175 tablets

5. METHOD AND ROUTE(S) 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



39

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

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

Carton
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Label
Orion Corporation

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/03/260/019  10 film-coated tablets
EU/1/03/260/020  30 film-coated tablets
EU/1/03/260/021  100 film-coated tablets
EU/1/03/260/022  130 film-coated tablets
EU/1/03/260/023  175 film-coated tablets

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

stalevo 200/50/200 mg [carton only]

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included [carton only]



40

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

[carton only]:

PC: {number}
SN: {number}
< NN: {number} >



41

B. PACKAGE LEAFLET



42

Package leaflet: Information for the user

Stalevo 50 mg/12.5 mg/200 mg film-coated tablets
Levodopa/carbidopa/entacapone

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 Stalevo is and what it is used for
2. What you need to know before you take Stalevo
3. How to take Stalevo
4. Possible side effects
5 How to store Stalevo
6. Contents of the pack and other information

1. What Stalevo is and what it is used for

Stalevo contains three active substances (levodopa, carbidopa and entacapone) in one film-coated 
tablet. Stalevo is used for the treatment of Parkinson’s disease. 

Parkinson’s disease is caused by low levels of a substance called dopamine in the brain. Levodopa 
increases the amount of dopamine and hence reduces the symptoms of Parkinson’s disease. Carbidopa 
and entacapone improve the antiparkinson effects of levodopa. 

2. What you need to know before you take Stalevo

Do not take Stalevo if you:

- are allergic to levodopa, carbidopa or entacapone, or any of the other ingredients of this 
medicine (listed in section 6)

- have narrow-angle glaucoma (an eye disorder)
- have a tumour of the adrenal gland
- are taking certain medicines for treating depression (combinations of selective MAO-A and 

MAO-B inhibitors, or non-selective MAO-inhibitors)
- have ever had neuroleptic malignant syndrome (NMS – this is a rare reaction to medicines used 

to treat severe mental disorders)
- have ever had non-traumatic rhabdomyolysis (a rare muscle disorder)
- have a severe liver disease. 

Warnings and precautions 

Talk to your doctor or pharmacist before taking Stalevo if you have or have ever had:
- a heart attack or any other diseases of the heart including cardiac arrhythmias, or of the blood 

vessels
- asthma or any other disease of the lungs
- a liver problem, because your dose may need to be adjusted
- kidney or hormone-related diseases



43

- stomach ulcers or convulsions
- if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation 

of the colon
- any form of severe mental disorder like psychosis
- chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in 

your eyes may need to be monitored.

Consult your doctor if you are currently taking:
- antipsychotics (medicines used to treat psychosis)
- a medicine which may cause low blood pressure when rising from a chair or bed. You should 

be aware that Stalevo may make these reactions worse.

Consult your doctor if during the treatment with Stalevo you:
- notice that your muscles get very rigid or jerk violently, or if you get tremors, agitation, 

confusion, fever, rapid pulse, or wide fluctuations in your blood pressure. If any of this 
happens, contact your doctor immediately

- feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour
- find yourself suddenly falling asleep, or if you feel very drowsy. If this happens, you should not 

drive or use any tools or machines (see also section 'Driving and using machines')
- notice that uncontrolled movements begin or get worse after you started to take Stalevo. If this 

happens, your doctor may need to change the dose of your antiparkinson medicine 
- experience diarrhoea: monitoring of your weight is recommended in order to avoid potentially 

excessive weight loss
- experience progressive anorexia, asthenia (weakness, exhaustion) and weight decrease within a 

relatively short period of time. If this happens, a general medical evaluation including liver 
function should be considered

- feel the need to stop using Stalevo, see section 'If you stop taking Stalevo'.

Tell your doctor if you or your family/carer notices you are developing addiction-like symptoms 
leading to craving for large doses of Stalevo and other medicines used to treat Parkinson’s disease.

Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in 
ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain 
activities that could harm yourself or others. These behaviours are called impulse control disorders 
and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or a 
preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to review your 
treatments.

Your doctor may take some regular laboratory tests during a long term treatment with Stalevo.

If you must undergo surgery, please tell your doctor that you are using Stalevo.

Stalevo is not recommended to be used for treatment of extrapyramidal symptoms (e.g. involuntary 
movements, shaking, muscle rigidity and muscle contractions) caused by other medicines.

Children and adolescents

Experience with Stalevo in patients under 18 years is limited. Therefore, the use of Stalevo in children
or adolescents is not recommended.

Other medicines and Stalevo

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



44

Do not take Stalevo if you are taking certain medicines for treating depression (combinations of 
selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).

Stalevo may increase the effects and side effects of certain medicines. These include: 
- medicines used to treat depression such as moclobemide, amitriptyline, desipramine, 

maprotiline, venlafaxine and paroxetine 
- rimiterole and isoprenaline, used to treat respiratory diseases
- adrenaline, used for severe allergic reactions
- noradrenaline, dopamine and dobutamine, used to treat heart diseases and low blood pressure
- alpha-methyldopa, used to treat high blood pressure 
- apomorphine, which is used to treat Parkinson’s disease.

The effects of Stalevo may be weakened by certain medicines. These include: 
- dopamine antagonists used to treat mental disorders, nausea and vomiting
- phenytoin, used to prevent convulsions 
- papaverine used to relax the muscles.

Stalevo may make it harder for you to digest iron. Therefore, do not take Stalevo and iron 
supplements at the same time. After taking one of them, wait at least 2 to 3 hours before taking the 
other.

Stalevo with food and drink

Stalevo may be taken with or without food. For some patients, Stalevo may not be well absorbed if it 
is taken with, or shortly after eating protein-rich food (such as meats, fish, dairy products, seeds and 
nuts). Consult your doctor if you think this applies to you.

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 not breast-feed during treatment with Stalevo.

Driving and using machines

Stalevo may lower your blood pressure, which may make you feel light-headed or dizzy. Therefore, 
be particularly careful when you drive or when you use any tools or machines.

If you feel very drowsy, or if you sometimes find yourself suddenly falling asleep, wait until you feel 
fully awake again before driving or doing anything else that requires you to be alert. Otherwise, you 
may put yourself and others at risk of serious injury or death.

Stalevo contains sucrose

Stalevo contains sucrose (1.2 mg/tablet). If you have been told by your doctor that you have 
intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Stalevo

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.

For adults and elderly:
- Your doctor will tell you exactly how many tablets of Stalevo to take each day. 



45

- The tablets are not intended to be split or broken into smaller pieces.
- You should take only one tablet each time.
- Depending on how you respond to treatment, your doctor may suggest a higher or lower dose. 
- If you are taking Stalevo 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 

100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg or 150 mg/37.5 mg/200 mg tablets, do not 
take more than 10 tablets per day.

Talk to your doctor or pharmacist if you think the effect of Stalevo is too strong or too weak, or if you 
experience possible side effects.

To open the bottle for the first time: open the closure, 
and then press with your thumb on the seal until it 
breaks. See picture 1.

Picture 1

If you take more Stalevo than you should

If you have accidentally taken more Stalevo tablets than you should, talk to your doctor or pharmacist 
immediately. In case of an overdose you may feel confused or agitated, your heart rate may be slower 
or faster than normal or the colour of your skin, tongue, eyes or urine may change.

If you forget to take Stalevo

Do not take a double dose to make up for a forgotten tablet.

If it is more than 1 hour until your next dose: 
Take one tablet as soon as you remember, and the next tablet at the normal time. 

If it is less than 1 hour until your next dose: 
Take a tablet as soon as you remember, wait 1 hour, then take another tablet. After that carry on as 
normal. 

Always leave at least an hour between Stalevo tablets, to avoid possible side effects.

If you stop taking Stalevo 

Do not stop taking Stalevo unless your doctor tells you to. In such a case your doctor may need to 
adjust your other antiparkinson medicines, especially levodopa, to give sufficient control of your 
symptoms. If you suddenly stop taking Stalevo and other antiparkinsonian medicines it may result in 
unwanted side effects. 

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. Many of 
the side effects can be relieved by adjusting the dose. 

If you during the treatment with Stalevo experience the following symptoms, contact your doctor 
immediately: 
- Your muscles get very rigid or jerk violently, you get tremors, agitation, confusion, fever, rapid 

pulse, or wide fluctuations in your blood pressure. These can be symptoms of neuroleptic 
malignant syndrome (NMS, a rare severe reaction to medicines used to treat disorders of the 
central nervous system) or rhabdomyolysis (a rare severe muscle disorder).



46

- Allergic reaction, the signs may include hives (nettle rash), itching, rash, swelling of your face, 
lips, tongue or throat. This may cause difficulties in breathing or swallowing.

Very common (may affect more than 1 in 10 people)
- uncontrolled movements (dyskinesias)
- feeling sick (nausea)
- harmless reddish-brown discolouration of urine
- muscle pain
- diarrhoea

Common (may affect up to 1 in 10 people)
- light-headedness or fainting due to low blood pressure, high blood pressure
- worsening of Parkinson`s symptoms, dizziness, drowsiness
- vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation
- inability to sleep, hallucinations, confusion, abnormal dreams (including nightmares), tiredness
- mental changes – including problems with memory, anxiety and depression (possibly with 

thoughts of suicide) 
- heart or artery disease events (e.g. chest pain), irregular heart rate or rhythm
- more frequent falling 
- shortness of breath 
- increased sweating, rashes
- muscle cramps, swelling of legs
- blurred vision  
- anaemia
- decreased appetite, decreased weight
- headache, joint pain
- urinary tract infection

Uncommon (may affect up to 1 in 100 people)
- heart attack
- bleeding in the gut
- changes in the blood cell count which may result in bleeding, abnormal liver function tests
- convulsions
- feeling agitated
- psychotic symptoms 
- colitis (inflammation of the colon) 
- discolourations other than urine (e.g. skin, nail, hair, sweat)
- swallowing difficulties
- inability to urinate

Not known (cannot be estimated from the available data)
Craving for large doses of Stalevo in excess of that required to control motor symptoms, known as 
dopamine dysregulation syndrome. Some patients experience severe abnormal involuntary movements 
(dyskinesias), mood swings or other side effects after taking large doses of Stalevo.

The following side effects have also been reported:
- hepatitis (inflammation of the liver)
- itching

You may experience the following side effects: 
- Inability to resist the impulse to perform an action that could be harmful, which may include:

- strong impulse to gamble excessively despite serious personal or family consequences
- 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
- binge eating (eating large amounts of food in a short time period) or compulsive eating 



47

(eating more food than normal and more than is needed to satisfy your hunger).

Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or 
reducing the symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety 
of this medicine.

5. How to store Stalevo

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 bottle and the carton after EXP. 
The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 to protect the environment.

6. Contents of the pack and other information

What Stalevo contains

- The active substances of Stalevo are levodopa, carbidopa and entacapone.
- Each Stalevo 50 mg/12.5 mg/200 mg tablet contains 50 mg of levodopa, 12.5 mg of carbidopa 

and 200 mg of entacapone.
- The other ingredients in the tablet core are croscarmellose sodium, magnesium stearate, maize 

starch, mannitol (E421) and povidone (E1201)
- The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium 

stearate, polysorbate 80, red iron oxide (E172), sucrose, titanium dioxide (E171), and yellow 
iron oxide (E172).

What Stalevo looks like and contents of the pack

Stalevo 50 mg/12.5 mg/200 mg: brownish or greyish red, round, convex unscored film-coated tablets 
marked with ‘LCE 50’ on one side.

Stalevo comes in six different pack sizes (10, 30, 100, 130, 175 or 250 tablets). Not all pack sizes may 
be marketed.

Marketing Authorisation Holder and Manufacturer

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

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

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


48

Belgique/België/Belgien
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Lietuva
UAB Orion Pharma
Tel. +370 5 276 9499

България
Orion Pharma Poland Sp z.o.o.
Tel.: + 48 22 8333177

Luxembourg/Luxemburg
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Česká republika
Orion Pharma s.r.o.
Tel: +420 234 703 305

Magyarország
Orion Pharma Kft.
Tel.: +36 1 239 9095

Danmark
Orion Pharma A/S
Tlf: +45 8614 0000

Malta
Salomone Pharma
Tel: +356 21220174

Deutschland
Orion Pharma GmbH
Tel: +49 40 899 6890

Nederland
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Eesti
Orion Pharma Eesti OÜ
Tel: +372 66 44 550

Norge
Orion Pharma AS
Tlf: +47 40 00 42 10

Ελλάδα
Orion Pharma Hellas M.E.Π.E
Τηλ: + 30 210 980 3355

Österreich
Orion Pharma GmbH
Tel: +49 40 899 6890

España
Orion Pharma S.L.
Tel: + 34 91 599 86 01

Polska
Orion Pharma Poland Sp z.o.o.
Tel.: + 48 22 8333177

France
Centre Spécialités Pharmaceutiques
Tel: + 33 (0) 1 47 04 80 46

Portugal
Orionfin Unipessoal Lda
Tel: + 351 21 154 68 20

Hrvatska
Orion Pharma d.o.o.
Tel: +386 (0) 1 600 8015

România
Orion Corporation
Tel: +358 10 4261

Ireland
Orion Pharma (Ireland) Ltd.
c/o Allphar Services Ltd.
Tel: +353 1 428 7777

Slovenija
Orion Pharma d.o.o.
Tel: +386 (0) 1 600 8015

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Orion Pharma s.r.o
Tel: +420 234 703 305

Italia
Orion Pharma S.r.l.
Tel: + 39 02 67876111

Suomi/Finland
Orion Corporation
Puh./Tel: +358 10 4261



49

Κύπρος
Lifepharma (ZAM) Ltd
Τηλ.: +357 22056300

Sverige
Orion Pharma AB
Tel: +46 8 623 6440

Latvija
Orion Corporation
Orion Pharma pārstāvniecība
Tel: +371 20028332

United Kingdom
Orion Pharma (UK) Ltd.
Tel: +44 1635 520 300

This leaflet was last revised in.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.

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


50

Package leaflet: Information for the user
Stalevo 75 mg/18.75 mg/200 mg film-coated tablets

Levodopa/carbidopa/entacapone

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 Stalevo is and what it is used for
2. What you need to know before you take Stalevo
3. How to take Stalevo
4. Possible side effects
5 How to store Stalevo
6. Contents of the pack and other information

1. What Stalevo is and what it is used for

Stalevo contains three active substances (levodopa, carbidopa and entacapone) in one film-coated 
tablet. Stalevo is used for the treatment of Parkinson’s disease. 

Parkinson’s disease is caused by low levels of a substance called dopamine in the brain. Levodopa 
increases the amount of dopamine and hence reduces the symptoms of Parkinson’s disease. Carbidopa 
and entacapone improve the antiparkinson effects of levodopa. 

2. What you need to know before you take Stalevo

Do not take Stalevo if you:

- are allergic to levodopa, carbidopa or entacapone, or any of the other ingredients of this 
medicine (listed in section 6)

- have narrow-angle glaucoma (an eye disorder)
- have a tumour of the adrenal gland
- are taking certain medicines for treating depression (combinations of selective MAO-A and 

MAO-B inhibitors, or non-selective MAO-inhibitors)
- have ever had neuroleptic malignant syndrome (NMS – this is a rare reaction to medicines used 

to treat severe mental disorders)
- have ever had non-traumatic rhabdomyolysis (a rare muscle disorder)
- have a severe liver disease. 

Warnings and precautions 

Talk to your doctor or pharmacist before taking Stalevo if you have or have ever had:
- a heart attack or any other diseases of the heart including cardiac arrhythmias, or of the blood 

vessels
- asthma or any other disease of the lungs
- a liver problem, because your dose may need to be adjusted
- kidney or hormone-related diseases



51

- stomach ulcers or convulsions
- if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation 

of the colon
- any form of severe mental disorder like psychosis
- chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in 

your eyes may need to be monitored.

Consult your doctor if you are currently taking:
- antipsychotics (medicines used to treat psychosis)
- a medicine which may cause low blood pressure when rising from a chair or bed. You should 

be aware that Stalevo may make these reactions worse.

Consult your doctor if during the treatment with Stalevo you:
- notice that your muscles get very rigid or jerk violently, or if you get tremors, agitation, 

confusion, fever, rapid pulse, or wide fluctuations in your blood pressure. If any of this 
happens, contact your doctor immediately

- feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour
- find yourself suddenly falling asleep, or if you feel very drowsy. If this happens, you should not 

drive or use any tools or machines (see also section 'Driving and using machines')
- notice that uncontrolled movements begin or get worse after you started to take Stalevo. If this 

happens, your doctor may need to change the dose of your antiparkinson medicine 
- experience diarrhoea: monitoring of your weight is recommended in order to avoid potentially 

excessive weight loss
- experience progressive anorexia, asthenia (weakness, exhaustion) and weight decrease within a 

relatively short period of time. If this happens, a general medical evaluation including liver 
function should be considered

- feel the need to stop using Stalevo, see section 'If you stop taking Stalevo'.

Tell your doctor if you or your family/carer notices you are developing addiction-like symptoms 
leading to craving for large doses of Stalevo and other medicines used to treat Parkinson’s disease.

Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in
ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain 
activities that could harm yourself or others. These behaviours are called impulse control disorders 
and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or a 
preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to review your 
treatments.

Your doctor may take some regular laboratory tests during a long term treatment with Stalevo.

If you must undergo surgery, please tell your doctor that you are using Stalevo.

Stalevo is not recommended to be used for treatment of extrapyramidal symptoms (e.g. involuntary 
movements, shaking, muscle rigidity and muscle contractions) caused by other medicines.

Children and adolescents

Experience with Stalevo in patients under 18 years is limited. Therefore, the use of Stalevo in children
or adolescents is not recommended.

Other medicines and Stalevo

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



52

Do not take Stalevo if you are taking certain medicines for treating depression (combinations of 
selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).

Stalevo may increase the effects and side effects of certain medicines. These include: 
- medicines used to treat depression such as moclobemide, amitriptyline, desipramine, 

maprotiline, venlafaxine and paroxetine 
- rimiterole and isoprenaline, used to treat respiratory diseases
- adrenaline, used for severe allergic reactions
- noradrenaline, dopamine and dobutamine, used to treat heart diseases and low blood pressure
- alpha-methyldopa, used to treat high blood pressure 
- apomorphine, which is used to treat Parkinson’s disease.

The effects of Stalevo may be weakened by certain medicines. These include: 
- dopamine antagonists used to treat mental disorders, nausea and vomiting
- phenytoin, used to prevent convulsions 
- papaverine used to relax the muscles.

Stalevo may make it harder for you to digest iron. Therefore, do not take Stalevo and iron 
supplements at the same time. After taking one of them, wait at least 2 to 3 hours before taking the 
other.

Stalevo with food and drink

Stalevo may be taken with or without food. For some patients, Stalevo may not be well absorbed if it 
is taken with, or shortly after eating protein-rich food (such as meats, fish, dairy products, seeds and 
nuts). Consult your doctor if you think this applies to you.

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 not breast-feed during treatment with Stalevo.

Driving and using machines

Stalevo may lower your blood pressure, which may make you feel light-headed or dizzy. Therefore, 
be particularly careful when you drive or when you use any tools or machines.

If you feel very drowsy, or if you sometimes find yourself suddenly falling asleep, wait until you feel 
fully awake again before driving or doing anything else that requires you to be alert. Otherwise, you 
may put yourself and others at risk of serious injury or death.

Stalevo contains sucrose

Stalevo contains sucrose (1.4 mg/tablet). If you have been told by your doctor that you have 
intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Stalevo

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.

For adults and elderly:
- Your doctor will tell you exactly how many tablets of Stalevo to take each day. 



53

- The tablets are not intended to be split or broken into smaller pieces.
- You should take only one tablet each time.
- Depending on how you respond to treatment, your doctor may suggest a higher or lower dose. 
- If you are taking Stalevo 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 

100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg or 150 mg/37.5 mg/200 mg tablets, do not 
take more than 10 tablets per day.

Talk to your doctor or pharmacist if you think the effect of Stalevo is too strong or too weak, or if you 
experience possible side effects.

To open the bottle for the first time: open the closure, 
and then press with your thumb on the seal until it 
breaks. See picture 1.

Picture 1

If you take more Stalevo than you should

If you have accidentally taken more Stalevo tablets than you should, talk to your doctor or pharmacist 
immediately. In case of an overdose you may feel confused or agitated, your heart rate may be slower 
or faster than normal or the colour of your skin, tongue, eyes or urine may change.

If you forget to take Stalevo

Do not take a double dose to make up for a forgotten tablet.

If it is more than 1 hour until your next dose: 
Take one tablet as soon as you remember, and the next tablet at the normal time. 

If it is less than 1 hour until your next dose: 
Take a tablet as soon as you remember, wait 1 hour, then take another tablet. After that carry on as 
normal. 

Always leave at least an hour between Stalevo tablets, to avoid possible side effects.

If you stop taking Stalevo 

Do not stop taking Stalevo unless your doctor tells you to. In such a case your doctor may need to 
adjust your other antiparkinson medicines, especially levodopa, to give sufficient control of your 
symptoms. If you suddenly stop taking Stalevo and other antiparkinsonian medicines it may result in 
unwanted side effects. 

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. Many of 
the side effects can be relieved by adjusting the dose. 

If you during the treatment with Stalevo experience the following symptoms, contact your doctor 
immediately: 
- Your muscles get very rigid or jerk violently, you get tremors, agitation, confusion, fever, rapid 

pulse, or wide fluctuations in your blood pressure. These can be symptoms of neuroleptic 
malignant syndrome (NMS, a rare severe reaction to medicines used to treat disorders of the 
central nervous system) or rhabdomyolysis (a rare severe muscle disorder).



54

- Allergic reaction, the signs may include hives (nettle rash), itching, rash, swelling of your face, 
lips, tongue or throat. This may cause difficulties in breathing or swallowing.

Very common (may affect more than 1 in 10 people)
- uncontrolled movements (dyskinesias)
- feeling sick (nausea)
- harmless reddish-brown discolouration of urine
- muscle pain
- diarrhoea

Common (may affect up to 1 in 10 people)
- light-headedness or fainting due to low blood pressure, high blood pressure
- worsening of Parkinson’s symptoms, dizziness, drowsiness
- vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation
- inability to sleep, hallucinations, confusion abnormal dreams (including nightmares), tiredness
- mental changes – including problems with memory, anxiety and depression (possibly with 

thoughts of suicide) 
- heart or artery disease events (e.g. chest pain), irregular heart rate or rhythm
- more frequent falling 
- shortness of breath 
- increased sweating, rashes
- muscle cramps, swelling of legs
- blurred vision
- anaemia
- decreased appetite, decreased weight
- headache, joint pain
- urinary tract infection

Uncommon (may affect up to 1 in 100 people)
- heart attack
- bleeding in the gut
- changes in the blood cell count which may result in bleeding, abnormal liver function tests
- convulsions
- feeling agitated
- psychotic symptoms
- colitis (inflammation of the colon)
- discolourations other than urine (e.g. skin, nail, hair, sweat)
- swallowing difficulties
- inability to urinate

Not known (cannot be estimated from the available data)
Craving for large doses of Stalevo in excess of that required to control motor symptoms, known as 
dopamine dysregulation syndrome. Some patients experience severe abnormal involuntary movements 
(dyskinesias), mood swings or other side effects after taking large doses of Stalevo.

The following side effects have also been reported:
- hepatitis (inflammation of the liver)
- itching

You may experience the following side effects: 
- Inability to resist the impulse to perform an action that could be harmful, which may include:

- strong impulse to gamble excessively despite serious personal or family consequences
- 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
- binge eating (eating large amounts of food in a short time period) or compulsive eating 



55

(eating more food than normal and more than is needed to satisfy your hunger).

Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or 
reducing the symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety 
of this medicine.

5. How to store Stalevo

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 bottle and the carton after EXP. 
The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 to protect the environment.

6. Contents of the pack and other information

What Stalevo contains

- The active substances of Stalevo are levodopa, carbidopa and entacapone.
- Each Stalevo 75 mg/18.75 mg/200 mg tablet contains 75 mg of levodopa, 18.75 mg of 

carbidopa and 200 mg of entacapone.
- The other ingredients in the tablet core are croscarmellose sodium, magnesium stearate, maize 

starch, mannitol (E421) and povidone (E1201)
- The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium 

stearate, polysorbate 80, red iron oxide (E172), sucrose, and titanium dioxide (E171).

What Stalevo looks like and contents of the pack

Stalevo 75 mg/18.75 mg/200 mg: light brownish red, oval film-coated tablets marked with ‘LCE 75’ 
on one side.

Stalevo 75 mg/18.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 
tablets). Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

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

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


56

Belgique/België/Belgien
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Lietuva
UAB Orion Pharma
Tel. +370 5 276 9499

България
Orion Pharma Poland Sp z.o.o.
Tel.: + 48 22 833317

Luxembourg/Luxemburg
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Česká republika
Orion Pharma s.r.o.
Tel: +420 234 703 305

Magyarország
Orion Pharma Kft.
Tel.: +36 1 239 9095

Danmark
Orion Pharma A/S
Tlf: +45 8614 0000

Malta
Salomone Pharma
Tel: +356 21220174

Deutschland
Orion Pharma GmbH
Tel: +49 40 899 6890

Nederland
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Eesti
Orion Pharma Eesti OÜ
Tel: +372 66 44 550

Norge
Orion Pharma AS
Tlf: +47 40 00 42 10

Ελλάδα
Orion Pharma Hellas M.E.Π.E
Τηλ: + 30 210 980 3355

Österreich
Orion Pharma GmbH
Tel: +49 40 899 6890

España
Orion Pharma S.L.
Tel: + 34 91 599 86 01

Polska
Orion Pharma Poland Sp z.o.o.
Tel.: + 48 22 8333177

France
Centre Spécialités Pharmaceutiques
Tel: + 33 (0) 1 47 04 80 46

Portugal
Orionfin Unipessoal Lda
Tel: + 351 21 154 68 20

Hrvatska
Orion Pharma d.o.o.
Tel: +386 (0) 1 600 8015

România
Orion Corporation
Tel: +358 10 4261

Ireland
Orion Pharma (Ireland) Ltd.
c/o Allphar Services Ltd.
Tel: +353 1 428 7777

Slovenija
Orion Pharma d.o.o.
Tel: +386 (0) 1 600 8015

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Orion Pharma s.r.o
Tel: +420 234 703 305

Italia
Orion Pharma S.r.l.
Tel: + 39 02 67876111

Suomi/Finland
Orion Corporation
Puh./Tel: +358 10 4261

Κύπρος
Lifepharma (ZAM) Ltd
Τηλ.: +357 22056300

Sverige
Orion Pharma AB
Tel: +46 8 623 6440



57

Latvija
Orion Corporation
Orion Pharma pārstāvniecība
Tel: +371 20028332

United Kingdom
Orion Pharma (UK) Ltd.
Tel: +44 1635 520 300

This leaflet was last revised in.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.

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


58

Package leaflet: Information for the user

Stalevo 100 mg/25 mg/200 mg film-coated tablets
Levodopa/carbidopa/entacapone

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 Stalevo is and what it is used for
2. What you need to know before you take Stalevo
3. How to take Stalevo
4. Possible side effects
5 How to store Stalevo
6. Contents of the pack and other information

1. What Stalevo is and what it is used for

Stalevo contains three active substances (levodopa, carbidopa and entacapone) in one film-coated 
tablet. Stalevo is used for the treatment of Parkinson’s disease. 

Parkinson’s disease is caused by low levels of a substance called dopamine in the brain. Levodopa 
increases the amount of dopamine and hence reduces the symptoms of Parkinson’s disease. Carbidopa 
and entacapone improve the antiparkinson effects of levodopa. 

2. What you need to know before you take Stalevo

Do not take Stalevo if you:

- are allergic to levodopa, carbidopa or entacapone, or any of the other ingredients of this 
medicine (listed in section 6)

- have narrow-angle glaucoma (an eye disorder)
- have a tumour of the adrenal gland
- are taking certain medicines for treating depression (combinations of selective MAO-A and 

MAO-B inhibitors, or non-selective MAO-inhibitors)
- have ever had neuroleptic malignant syndrome (NMS – this is a rare reaction to medicines used 

to treat severe mental disorders)
- have ever had non-traumatic rhabdomyolysis (a rare muscle disorder)
- have a severe liver disease. 

Warnings and precautions

Talk to your doctor or pharmacist before taking Stalevo if you have or have ever had:
- a heart attack or any other diseases of the heart including cardiac arrhythmias, or of the blood 

vessels
- asthma or any other disease of the lungs
- a liver problem, because your dose may need to be adjusted
- kidney or hormone-related diseases



59

- stomach ulcers or convulsions
- if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation 

of the colon
- any form of severe mental disorder like psychosis
- chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in 

your eyes may need to be monitored.

Consult your doctor if you are currently taking:
- antipsychotics (medicines used to treat psychosis)
- a medicine which may cause low blood pressure when rising from a chair or bed. You should 

be aware that Stalevo may make these reactions worse.

Consult your doctor if during the treatment with Stalevo you:
- notice that your muscles get very rigid or jerk violently, or if you get tremors, agitation, 

confusion, fever, rapid pulse, or wide fluctuations in your blood pressure. If any of this 
happens, contact your doctor immediately

- feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour
- find yourself suddenly falling asleep, or if you feel very drowsy. If this happens, you should not 

drive or use any tools or machines (see also section 'Driving and using machines')
- notice that uncontrolled movements begin or get worse after you started to take Stalevo. If this 

happens, your doctor may need to change the dose of your antiparkinson medicine 
- experience diarrhoea: monitoring of your weight is recommended in order to avoid potentially 

excessive weight loss
- experience progressive anorexia, asthenia (weakness, exhaustion) and weight decrease within a 

relatively short period of time. If this happens, a general medical evaluation including liver 
function should be considered

- feel the need to stop using Stalevo, see section 'If you stop taking Stalevo'.

Tell your doctor if you or your family/carer notices you are developing addiction-like symptoms 
leading to craving for large doses of Stalevo and other medicines used to treat Parkinson’s disease.

Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in 
ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain 
activities that could harm yourself or others. These behaviours are called impulse control disorders 
and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or a 
preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to review your 
treatments.

Your doctor may take some regular laboratory tests during a long term treatment with Stalevo.

If you must undergo surgery, please tell your doctor that you are using Stalevo.

Stalevo is not recommended to be used for treatment of extrapyramidal symptoms (e.g. involuntary 
movements, shaking, muscle rigidity and muscle contractions) caused by other medicines.

Children and adolescents

Experience with Stalevo in patients under 18 years is limited. Therefore, the use of Stalevo in children
or adolescents is not recommended.

Other medicines and Stalevo

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



60

Do not take Stalevo if you are taking certain medicines for treating depression (combinations of 
selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).

Stalevo may increase the effects and side effects of certain medicines. These include: 
- medicines used to treat depression such as moclobemide, amitriptyline, desipramine, 

maprotiline, venlafaxine and paroxetine
- rimiterole and isoprenaline, used to treat respiratory diseases
- adrenaline, used for severe allergic reactions
- noradrenaline, dopamine and dobutamine, used to treat heart diseases and low blood pressure
- alpha-methyldopa, used to treat high blood pressure 
- apomorphine, which is used to treat Parkinson’s disease.

The effects of Stalevo may be weakened by certain medicines. These include: 
- dopamine antagonists used to treat mental disorders, nausea and vomiting
- phenytoin, used to prevent convulsions
- papaverine used to relax the muscles.

Stalevo may make it harder for you to digest iron. Therefore, do not take Stalevo and iron 
supplements at the same time. After taking one of them, wait at least 2 to 3 hours before taking the 
other.

Stalevo with food and drink

Stalevo may be taken with or without food. For some patients, Stalevo may not be well absorbed if it 
is taken with, or shortly after eating protein-rich food (such as meats, fish, dairy products, seeds and 
nuts). Consult your doctor if you think this applies to you.

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 not breast-feed during treatment with Stalevo.

Driving and using machines

Stalevo may lower your blood pressure, which may make you feel light-headed or dizzy. Therefore, 
be particularly careful when you drive or when you use any tools or machines.

If you feel very drowsy, or if you sometimes find yourself suddenly falling asleep, wait until you feel 
fully awake again before driving or doing anything else that requires you to be alert. Otherwise, you 
may put yourself and others at risk of serious injury or death.

Stalevo contains sucrose

Stalevo contains sucrose (1.6 mg/tablet). If you have been told by your doctor that you have 
intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Stalevo

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.

For adults and elderly:
- Your doctor will tell you exactly how many tablets of Stalevo to take each day. 



61

- The tablets are not intended to be split or broken into smaller pieces.
- You should take only one tablet each time.
- Depending on how you respond to treatment, your doctor may suggest a higher or lower dose. 
- If you are taking Stalevo 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 

100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg or 150 mg/37.5 mg/200 mg tablets, do not 
take more than 10 tablets per day.

Talk to your doctor or pharmacist if you think the effect of Stalevo is too strong or too weak, or if you 
experience possible side effects.

To open the bottle for the first time: open the closure, 
and then press with your thumb on the seal until it 
breaks. See picture 1.

Picture 1

If you take more Stalevo than you should

If you have accidentally taken more Stalevo tablets than you should, talk to your doctor or pharmacist 
immediately. In case of an overdose you may feel confused or agitated, your heart rate may be slower 
or faster than normal or the colour of your skin, tongue, eyes or urine may change.

If you forget to take Stalevo

Do not take a double dose to make up for a forgotten tablet.

If it is more than 1 hour until your next dose: 
Take one tablet as soon as you remember, and the next tablet at the normal time. 

If it is less than 1 hour until your next dose: 
Take a tablet as soon as you remember, wait 1 hour, then take another tablet. After that carry on as 
normal.

Always leave at least an hour between Stalevo tablets, to avoid possible side effects.

If you stop taking Stalevo 

Do not stop taking Stalevo unless your doctor tells you to. In such a case your doctor may need to 
adjust your other antiparkinson medicines, especially levodopa, to give sufficient control of your 
symptoms. If you suddenly stop taking Stalevo and other antiparkinsonian medicines it may result in 
unwanted side effects. 

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. Many of 
the side effects can be relieved by adjusting the dose. 

If you during the treatment with Stalevo experience the following symptoms, contact your doctor 
immediately: 
- Your muscles get very rigid or jerk violently, you get tremors, agitation, confusion, fever, rapid 

pulse, or wide fluctuations in your blood pressure. These can be symptoms of neuroleptic 
malignant syndrome (NMS, a rare severe reaction to medicines used to treat disorders of the 
central nervous system) or rhabdomyolysis (a rare severe muscle disorder).



62

- Allergic reaction, the signs may include hives (nettle rash), itching, rash, swelling of your face, 
lips, tongue or throat. This may cause difficulties in breathing or swallowing.

Very common (may affect more than 1 in 10 people)
- uncontrolled movements (dyskinesias)
- feeling sick (nausea)
- harmless reddish-brown discolouration of urine
- muscle pain
- diarrhoea

Common (may affect up to 1 in 10 people)
- light-headedness or fainting due to low blood pressure, high blood pressure
- worsening of Parkinson’s symptoms, dizziness, drowsiness
- vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation
- inability to sleep, hallucinations, confusion abnormal dreams (including nightmares), tiredness
- mental changes – including problems with memory, anxiety and depression (possibly with 

thoughts of suicide) 
- heart or artery disease events (e.g. chest pain), irregular heart rate or rhythm 
- more frequent falling 
- shortness of breath 
- increased sweating, rashes
- muscle cramps, swelling of legs
- blurred vision
- anaemia
- decreased appetite, decreased weight
- headache, joint pain
- urinary tract infection

Uncommon (may affect up to 1 in 100 people)
- heart attack
- bleeding in the gut
- changes in the blood cell count which may result in bleeding, abnormal liver function tests
- convulsions
- feeling agitated
- psychotic symptoms
- colitis (inflammation of the colon)
- discolourations other than urine (e.g. skin, nail, hair, sweat)
- swallowing difficulties
- inability to urinate

Not known (cannot be estimated from the available data)
Craving for large doses of Stalevo in excess of that required to control motor symptoms, known as 
dopamine dysregulation syndrome. Some patients experience severe abnormal involuntary movements 
(dyskinesias), mood swings or other side effects after taking large doses of Stalevo.

The following side effects have also been reported: 
- hepatitis (inflammation of the liver)
- itching

You may experience the following side effects: 
- Inability to resist the impulse to perform an action that could be harmful, which may include:

- strong impulse to gamble excessively despite serious personal or family consequences
- 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
- binge eating (eating large amounts of food in a short time period) or compulsive eating 



63

(eating more food than normal and more than is needed to satisfy your hunger).

Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or 
reducing the symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety 
of this medicine.

5. How to store Stalevo

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 bottle and the carton after EXP. 
The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Stalevo contains

- The active substances of Stalevo are levodopa, carbidopa and entacapone.
- Each Stalevo 100 mg/25 mg/200 mg tablet contains 100 mg of levodopa, 25 mg of carbidopa 

and 200 mg of entacapone.
- The other ingredients in the tablet core are croscarmellose sodium, magnesium stearate, maize 

starch, mannitol (E421) and povidone (E1201)
- The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium 

stearate, polysorbate 80, red iron oxide (E172), sucrose, titanium dioxide (E171), and yellow 
iron oxide (E172).

What Stalevo looks like and contents of the pack

Stalevo 100 mg/25 mg/200 mg: brownish or greyish red, oval, unscored film-coated tablets marked 
with ‘LCE 100’ on one side.

Stalevo comes in six different pack sizes (10, 30, 100, 130, 175 or 250 tablets). Not all pack sizes may 
be marketed.

Marketing Authorisation Holder and Manufacturer

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

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

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


64

Belgique/België/Belgien
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Lietuva
UAB Orion Pharma
Tel. +370 5 276 9499

България
Orion Pharma Poland Sp z.o.o.
Tel.: + 48 22 8333177

Luxembourg/Luxemburg
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Česká republika
Orion Pharma s.r.o.
Tel: +420 234 703 305

Magyarország
Orion Pharma Kft.
Tel.: +36 1 239 9095

Danmark
Orion Pharma A/S
Tlf: +45 8614 0000

Malta
Salomone Pharma
Tel: +356 21220174

Deutschland
Orion Pharma GmbH
Tel: +49 40 899 6890

Nederland
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Eesti
Orion Pharma Eesti OÜ
Tel: +372 66 44 550

Norge
Orion Pharma AS
Tlf: +47 40 00 42 10

Ελλάδα
Orion Pharma Hellas M.E.Π.E
Τηλ: + 30 210 980 3355

Österreich
Orion Pharma GmbH
Tel: +49 40 899 6890

España
Orion Pharma S.L.
Tel: + 34 91 599 86 01

Polska
Orion Pharma Poland Sp z.o.o.
Tel.: + 48 22 8333177

France
Centre Spécialités Pharmaceutiques
Tel: + 33 (0) 1 47 04 80 46

Portugal
Orionfin Unipessoal Lda
Tel: + 351 21 154 68 20

Hrvatska
Orion Pharma d.o.o.
Tel: +386 (0) 1 600 8015

România
Orion Corporation
Tel: +358 10 4261

Ireland
Orion Pharma (Ireland) Ltd.
c/o Allphar Services Ltd.
Tel: +353 1 428 7777

Slovenija
Orion Pharma d.o.o.
Tel: +386 (0) 1 600 8015

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Orion Pharma s.r.o
Tel: +420 234 703 305

Italia
Orion Pharma S.r.l.
Tel: + 39 02 67876111

Suomi/Finland
Orion Corporation
Puh./Tel: +358 10 4261

Κύπρος
Lifepharma (ZAM) Ltd
Τηλ.: +357 22056300

Sverige
Orion Pharma AB
Tel: +46 8 623 6440



65

Latvija
Orion Corporation
Orion Pharma pārstāvniecība
Tel: +371 20028332

United Kingdom
Orion Pharma (UK) Ltd.
Tel: +44 1635 520 300

This leaflet was last revised in.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.

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


66

Package leaflet: Information for the user

Stalevo 125 mg/31.25 mg/200 mg film-coated tablets
Levodopa/carbidopa/entacapone

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 Stalevo is and what it is used for
2. What you need to know before you take Stalevo
3. How to take Stalevo
4. Possible side effects
5 How to store Stalevo
6. Contents of the pack and other information

1. What Stalevo is and what it is used for

Stalevo contains three active substances (levodopa, carbidopa and entacapone) in one film-coated 
tablet. Stalevo is used for the treatment of Parkinson’s disease. 

Parkinson’s disease is caused by low levels of a substance called dopamine in the brain. Levodopa 
increases the amount of dopamine and hence reduces the symptoms of Parkinson’s disease. Carbidopa
and entacapone improve the antiparkinson effects of levodopa. 

2. What you need to know before you take Stalevo

Do not take Stalevo if you:

- are allergic to levodopa, carbidopa or entacapone, or any of the other ingredients of this 
medicine (listed in section 6)

- have narrow-angle glaucoma (an eye disorder)
- have a tumour of the adrenal gland
- are taking certain medicines for treating depression (combinations of selective MAO-A and 

MAO-B inhibitors, or non-selective MAO-inhibitors)
- have ever had neuroleptic malignant syndrome (NMS – this is a rare reaction to medicines used 

to treat severe mental disorders)
- have ever had non-traumatic rhabdomyolysis (a rare muscle disorder)
- have a severe liver disease. 

Warnings and precautions

Talk to your doctor or pharmacist before taking Stalevo if you have or have ever had:
- a heart attack or any other diseases of the heart including cardiac arrhythmias, or of the blood 

vessels
- asthma or any other disease of the lungs
- a liver problem, because your dose may need to be adjusted
- kidney or hormone-related diseases



67

- stomach ulcers or convulsions
- if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation 

of the colon
- any form of severe mental disorder like psychosis
- chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in 

your eyes may need to be monitored.

Consult your doctor if you are currently taking:
- antipsychotics (medicines used to treat psychosis)
- a medicine which may cause low blood pressure when rising from a chair or bed. You should 

be aware that Stalevo may make these reactions worse.

Consult your doctor if during the treatment with Stalevo you:
- notice that your muscles get very rigid or jerk violently, or if you get tremors, agitation, 

confusion, fever, rapid pulse, or wide fluctuations in your blood pressure. If any of this 
happens, contact your doctor immediately

- feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour
- find yourself suddenly falling asleep, or if you feel very drowsy. If this happens, you should not 

drive or use any tools or machines (see also section 'Driving and using machines')
- notice that uncontrolled movements begin or get worse after you started to take Stalevo. If this 

happens, your doctor may need to change the dose of your antiparkinson medicine 
- experience diarrhoea: monitoring of your weight is recommended in order to avoid potentially 

excessive weight loss
- experience progressive anorexia, asthenia (weakness, exhaustion) and weight decrease within a 

relatively short period of time. If this happens, a general medical evaluation including liver 
function should be considered

- feel the need to stop using Stalevo, see section 'If you stop taking Stalevo'.

Tell your doctor if you or your family/carer notices you are developing addiction-like symptoms 
leading to craving for large doses of Stalevo and other medicines used to treat Parkinson’s disease.

Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in
ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain 
activities that could harm yourself or others. These behaviours are called impulse control disorders 
and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or a 
preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to review your 
treatments.

Your doctor may take some regular laboratory tests during a long term treatment with Stalevo.

If you must undergo surgery, please tell your doctor that you are using Stalevo.

Stalevo is not recommended to be used for treatment of extrapyramidal symptoms (e.g. involuntary 
movements, shaking, muscle rigidity and muscle contractions) caused by other medicines.

Children and adolescents

Experience with Stalevo in patients under 18 years is limited. Therefore, the use of Stalevo in children
or adolescents is not recommended.

Other medicines and Stalevo

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



68

Do not take Stalevo if you are taking certain medicines for treating depression (combinations of 
selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).

Stalevo may increase the effects and side effects of certain medicines. These include: 
- medicines used to treat depression such as moclobemide, amitriptyline, desipramine, 

maprotiline, venlafaxine and paroxetine 
- rimiterole and isoprenaline, used to treat respiratory diseases
- adrenaline, used for severe allergic reactions
- noradrenaline, dopamine and dobutamine, used to treat heart diseases and low blood pressure
- alpha-methyldopa, used to treat high blood pressure 
- apomorphine, which is used to treat Parkinson’s disease.

The effects of Stalevo may be weakened by certain medicines. These include: 
- dopamine antagonists used to treat mental disorders, nausea and vomiting
- phenytoin, used to prevent convulsions 
- papaverine used to relax the muscles.

Stalevo may make it harder for you to digest iron. Therefore, do not take Stalevo and iron 
supplements at the same time. After taking one of them, wait at least 2 to 3 hours before taking the 
other.

Stalevo with food and drink

Stalevo may be taken with or without food. For some patients, Stalevo may not be well absorbed if it 
is taken with, or shortly after eating protein-rich food (such as meats, fish, dairy products, seeds and 
nuts). Consult your doctor if you think this applies to you.

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 not breast-feed during treatment with Stalevo.

Driving and using machines

Stalevo may lower your blood pressure, which may make you feel light-headed or dizzy. Therefore, 
be particularly careful when you drive or when you use any tools or machines.

If you feel very drowsy, or if you sometimes find yourself suddenly falling asleep, wait until you feel 
fully awake again before driving or doing anything else that requires you to be alert. Otherwise, you 
may put yourself and others at risk of serious injury or death.

Stalevo contains sucrose

Stalevo contains sucrose (1.6 mg/tablet). If you have been told by your doctor that you have 
intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Stalevo

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.

For adults and elderly:
- Your doctor will tell you exactly how many tablets of Stalevo to take each day. 



69

- The tablets are not intended to be split or broken into smaller pieces.
- You should take only one tablet each time.
- Depending on how you respond to treatment, your doctor may suggest a higher or lower dose. 
- If you are taking Stalevo 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 

100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg or 150 mg/37.5 mg/200 mg tablets, do not 
take more than 10 tablets per day.

Talk to your doctor or pharmacist if you think the effect of Stalevo is too strong or too weak, or if you 
experience possible side effects.

To open the bottle for the first time: open the closure, 
and then press with your thumb on the seal until it 
breaks. See picture 1.

Picture 1

If you take more Stalevo than you should

If you have accidentally taken more Stalevo tablets than you should, talk to your doctor or pharmacist 
immediately. In case of an overdose you may feel confused or agitated, your heart rate may be slower 
or faster than normal or the colour of your skin, tongue, eyes or urine may change.

If you forget to take Stalevo

Do not take a double dose to make up for a forgotten tablet.

If it is more than 1 hour until your next dose: 
Take one tablet as soon as you remember, and the next tablet at the normal time. 

If it is less than 1 hour until your next dose: 
Take a tablet as soon as you remember, wait 1 hour, then take another tablet. After that carry on as 
normal. 

Always leave at least an hour between Stalevo tablets, to avoid possible side effects.

If you stop taking Stalevo 

Do not stop taking Stalevo unless your doctor tells you to. In such a case your doctor may need to 
adjust your other antiparkinson medicines, especially levodopa, to give sufficient control of your 
symptoms. If you suddenly stop taking Stalevo and other antiparkinsonian medicines it may result in 
unwanted side effects. 

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. Many of 
the side effects can be relieved by adjusting the dose. 

If you during the treatment with Stalevo experience the following symptoms, contact your doctor 
immediately: 
- Your muscles get very rigid or jerk violently, you get tremors, agitation, confusion, fever, rapid 

pulse, or wide fluctuations in your blood pressure. These can be symptoms of neuroleptic 
malignant syndrome (NMS, a rare severe reaction to medicines used to treat disorders of the 
central nervous system) or rhabdomyolysis (a rare severe muscle disorder).



70

- Allergic reaction, the signs may include hives (nettle rash), itching, rash, swelling of your face, 
lips, tongue or throat. This may cause difficulties in breathing or swallowing.

Very common (may affect more than 1 in 10 people)
- uncontrolled movements (dyskinesias)
- feeling sick (nausea)
- harmless reddish-brown discolouration of urine
- muscle pain
- diarrhoea

Common (may affect up to 1 in 10 people)
- light-headedness or fainting due to low blood pressure, high blood pressure
- worsening of Parkinson’s symptoms, dizziness, drowsiness
- vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation
- inability to sleep, hallucinations, confusion abnormal dreams (including nightmares), tiredness
- mental changes – including problems with memory, anxiety and depression (possibly with 

thoughts of suicide) 
- heart or artery disease events (e.g. chest pain), irregular heart rate or rhythm 
- more frequent falling 
- shortness of breath 
- increased sweating, rashes
- muscle cramps, swelling of legs
- blurred vision 
- anaemia
- decreased appetite, decreased weight
- headache, joint pain
- urinary tract infection

Uncommon (may affect up to 1 in 100 people)
- heart attack
- bleeding in the gut
- changes in the blood cell count which may result in bleeding, abnormal liver function tests
- convulsions
- feeling agitated
- psychotic symptoms
- colitis (inflammation of the colon)
- discolourations other than urine (e.g. skin, nail, hair, sweat)
- swallowing difficulties
- inability to urinate

Not known (cannot be estimated from the available data)
Craving for large doses of Stalevo in excess of that required to control motor symptoms, known as 
dopamine dysregulation syndrome. Some patients experience severe abnormal involuntary movements 
(dyskinesias), mood swings or other side effects after taking large doses of Stalevo.

The following side effects have also been reported: 
- hepatitis (inflammation of the liver)
- itching

You may experience the following side effects: 
- Inability to resist the impulse to perform an action that could be harmful, which may include:

- strong impulse to gamble excessively despite serious personal or family consequences
- 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
- binge eating (eating large amounts of food in a short time period) or compulsive eating 



71

(eating more food than normal and more than is needed to satisfy your hunger).

Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or 
reducing the symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety 
of this medicine.

5. How to store Stalevo

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 bottle and the carton after EXP. 
The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 to protect the environment.

6. Contents of the pack and other information

What Stalevo contains

- The active substances of Stalevo are levodopa, carbidopa and entacapone.
- Each Stalevo 125 mg/31.25 mg/200 mg tablet contains 125 mg of levodopa, 31.25 mg of 

carbidopa and 200 mg of entacapone.
- The other ingredients in the tablet core are croscarmellose sodium, magnesium stearate, maize 

starch, mannitol (E421) and povidone (E1201)
- The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium 

stearate, polysorbate 80, red iron oxide (E172), sucrose, and titanium dioxide (E171).

What Stalevo looks like and contents of the pack

Stalevo 125 mg/31.25 mg/200 mg: light brownish red, oval film-coated tablets marked with ‘LCE 
125’ on one side.

Stalevo 125 mg/31.25 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 
tablets). Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

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

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


72

Belgique/België/Belgien
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Lietuva
UAB Orion Pharma
Tel. +370 5 276 9499

България
Orion Pharma Poland Sp z.o.o.
Tel.: + 48 22 8333177

Luxembourg/Luxemburg
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Česká republika
Orion Pharma s.r.o.
Tel: +420 234 703 305

Magyarország
Orion Pharma Kft.
Tel.: +36 1 239 9095

Danmark
Orion Pharma A/S
Tlf: +45 8614 0000

Malta
Salomone Pharma
Tel: +356 21220174

Deutschland
Orion Pharma GmbH
Tel: +49 40 899 6890

Nederland
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Eesti
Orion Pharma Eesti OÜ
Tel: +372 66 44 550

Norge
Orion Pharma AS
Tlf: +47 40 00 42 10

Ελλάδα
Orion Pharma Hellas M.E.Π.E
Τηλ: + 30 210 980 3355

Österreich
Orion Pharma GmbH
Tel: +49 40 899 6890

España
Orion Pharma S.L.
Tel: + 34 91 599 86 01

Polska
Orion Pharma Poland Sp z.o.o.
Tel.: + 48 22 8333177

France
Centre Spécialités Pharmaceutiques
Tel: + 33 (0) 1 47 04 80 46

Portugal
Orionfin Unipessoal Lda
Tel: + 351 21 154 68 20

Hrvatska
Orion Pharma d.o.o.
Tel: +386 (0) 1 600 8015

România
Orion Corporation
Tel: +358 10 4261

Ireland
Orion Pharma (Ireland) Ltd.
c/o Allphar Services Ltd.
Tel: +353 1 428 7777

Slovenija
Orion Pharma d.o.o.
Tel: +386 (0) 1 600 8015

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Orion Pharma s.r.o
Tel: +420 234 703 305

Italia
Orion Pharma S.r.l.
Tel: + 39 02 67876111

Suomi/Finland
Orion Corporation
Puh./Tel: +358 10 4261

Κύπρος
Lifepharma (ZAM) Ltd
Τηλ.: +357 22056300

Sverige
Orion Pharma AB
Tel: +46 8 623 6440



73

Latvija
Orion Corporation
Orion Pharma pārstāvniecība
Tel: +371 20028332

United Kingdom
Orion Pharma (UK) Ltd.
Tel: +44 1635 520 300

This leaflet was last revised in.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.

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


74

Package leaflet: Information for the user

Stalevo 150 mg/37.5 mg/200 mg film-coated tablets
Levodopa/carbidopa/entacapone

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 Stalevo is and what it is used for
2. What you need to know before you take Stalevo
3. How to take Stalevo
4. Possible side effects
5 How to store Stalevo
6. Contents of the pack and other information

1. What Stalevo is and what it is used for

Stalevo contains three active substances (levodopa, carbidopa and entacapone) in one film-coated 
tablet. Stalevo is used for the treatment of Parkinson’s disease. 

Parkinson’s disease is caused by low levels of a substance called dopamine in the brain. Levodopa 
increases the amount of dopamine and hence reduces the symptoms of Parkinson’s disease. Carbidopa
and entacapone improve the antiparkinson effects of levodopa. 

2. What you need to know before you take Stalevo

Do not take Stalevo if you:

- are allergic to levodopa, carbidopa or entacapone, or any of the other ingredients of this 
medicine (listed in section 6)

- have narrow-angle glaucoma (an eye disorder)
- have a tumour of the adrenal gland
- are taking certain medicines for treating depression (combinations of selective MAO-A and 

MAO-B inhibitors, or non-selective MAO-inhibitors)
- have ever had neuroleptic malignant syndrome (NMS – this is a rare reaction to medicines used 

to treat severe mental disorders)
- have ever had non-traumatic rhabdomyolysis (a rare muscle disorder)
- have a severe liver disease. 

Warnings and precautions

Talk to your doctor or pharmacist before taking Stalevo if you have or have ever had:
- a heart attack or any other diseases of the heart including cardiac arrhythmias, or of the blood 

vessels
- asthma or any other disease of the lungs
- a liver problem, because your dose may need to be adjusted
- kidney or hormone-related diseases



75

- stomach ulcers or convulsions
- if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation 

of the colon
- any form of severe mental disorder like psychosis
- chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in 

your eyes may need to be monitored.

Consult your doctor if you are currently taking:
- antipsychotics (medicines used to treat psychosis)
- a medicine which may cause low blood pressure when rising from a chair or bed. You should 

be aware that Stalevo may make these reactions worse.

Consult your doctor if during the treatment with Stalevo you:
- notice that your muscles get very rigid or jerk violently, or if you get tremors, agitation, 

confusion, fever, rapid pulse, or wide fluctuations in your blood pressure. If any of this 
happens, contact your doctor immediately

- feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour
- find yourself suddenly falling asleep, or if you feel very drowsy. If this happens, you should not 

drive or use any tools or machines (see also section 'Driving and using machines')
- notice that uncontrolled movements begin or get worse after you started to take Stalevo. If this 

happens, your doctor may need to change the dose of your antiparkinson medicine 
- experience diarrhoea: monitoring of your weight is recommended in order to avoid potentially 

excessive weight loss
- experience progressive anorexia, asthenia (weakness, exhaustion) and weight decrease within a 

relatively short period of time. If this happens, a general medical evaluation including liver 
function should be considered

- feel the need to stop using Stalevo, see section 'If you stop taking Stalevo'.

Tell your doctor if you or your family/carer notices you are developing addiction-like symptoms 
leading to craving for large doses of Stalevo and other medicines used to treat Parkinson’s disease.

Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in
ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain 
activities that could harm yourself or others. These behaviours are called impulse control disorders 
and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or a 
preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to review your 
treatments.

Your doctor may take some regular laboratory tests during a long term treatment with Stalevo.

If you must undergo surgery, please tell your doctor that you are using Stalevo.

Stalevo is not recommended to be used for treatment of extrapyramidal symptoms (e.g. involuntary 
movements, shaking, muscle rigidity and muscle contractions) caused by other medicines.

Children and adolescents

Experience with Stalevo in patients under 18 years is limited. Therefore, the use of Stalevo in children
or adolescents is not recommended.

Other medicines and Stalevo

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



76

Do not take Stalevo if you are taking certain medicines for treating depression (combinations of 
selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).

Stalevo may increase the effects and side effects of certain medicines. These include:
- medicines used to treat depression such as moclobemide, amitriptyline, desipramine, 

maprotiline, venlafaxine and paroxetine 
- rimiterole and isoprenaline, used to treat respiratory diseases
- adrenaline, used for severe allergic reactions
- noradrenaline, dopamine and dobutamine, used to treat heart diseases and low blood pressure
- alpha-methyldopa, used to treat high blood pressure
- apomorphine, which is used to treat Parkinson’s disease. 

The effects of Stalevo may be weakened by certain medicines. These include: 
- dopamine antagonists used to treat mental disorders, nausea and vomiting
- phenytoin, used to prevent convulsions 
- papaverine used to relax the muscles.

Stalevo may make it harder for you to digest iron. Therefore, do not take Stalevo and iron 
supplements at the same time. After taking one of them, wait at least 2 to 3 hours before taking the 
other.

Stalevo with food and drink

Stalevo may be taken with or without food. For some patients, Stalevo may not be well absorbed if it 
is taken with, or shortly after eating protein-rich food (such as meats, fish, dairy products, seeds and 
nuts). Consult your doctor if you think this applies to you.

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 not breast-feed during treatment with Stalevo.

Driving and using machines

Stalevo may lower your blood pressure, which may make you feel light-headed or dizzy. Therefore, 
be particularly careful when you drive or when you use any tools or machines.

If you feel very drowsy, or if you sometimes find yourself suddenly falling asleep, wait until you feel 
fully awake again before driving or doing anything else that requires you to be alert. Otherwise, you 
may put yourself and others at risk of serious injury or death.

Stalevo contains sucrose

Stalevo contains sucrose (1.9 mg/tablet). If you have been told by your doctor that you have 
intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Stalevo

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.

For adults and elderly:
- Your doctor will tell you exactly how many tablets of Stalevo to take each day. 



77

- The tablets are not intended to be split or broken into smaller pieces.
- You should take only one tablet each time.
- Depending on how you respond to treatment, your doctor may suggest a higher or lower dose. 
- If you are taking Stalevo 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 

100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg or 150 mg/37.5 mg/200 mg tablets, do not
take more than 10 tablets each day.

Talk to your doctor or pharmacist if you think the effect of Stalevo is too strong or too weak, or if you 
experience possible side effects.

To open the bottle for the first time: open the closure, 
and then press with your thumb on the seal until it 
breaks. See picture 1.

Picture 1

If you take more Stalevo than you should

If you have accidentally taken more Stalevo tablets than you should, talk to your doctor or pharmacist 
immediately. In case of an overdose you may feel confused or agitated, your heart rate may be slower 
or faster than normal or the colour of your skin, tongue, eyes or urine may change.

If you forget to take Stalevo

Do not take a double dose to make up for a forgotten tablet.

If it is more than 1 hour until your next dose: 
Take one tablet as soon as you remember, and the next tablet at the normal time. 

If it is less than 1 hour until your next dose: 
Take a tablet as soon as you remember, wait 1 hour, then take another tablet. After that carry on as 
normal. 

Always leave at least an hour between Stalevo tablets, to avoid possible side effects.

If you stop taking Stalevo 

Do not stop taking Stalevo unless your doctor tells you to. In such a case your doctor may need to 
adjust your other antiparkinson medicines, especially levodopa, to give sufficient control of your 
symptoms. If you suddenly stop taking of Stalevo and other antiparkinsonian medicines it may result 
in unwanted side effects. 

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. Many of 
the side effects can be relieved by adjusting the dose. 

If you during the treatment with Stalevo experience the following symptoms, contact your doctor 
immediately: 
- Your muscles get very rigid or jerk violently, you get tremors, agitation, confusion, fever, rapid 

pulse, or wide fluctuations in your blood pressure. These can be symptoms of neuroleptic 
malignant syndrome (NMS, a rare severe reaction to medicines used to treat disorders of the 
central nervous system) or rhabdomyolysis (a rare severe muscle disorder).



78

- Allergic reaction, the signs may include hives (nettle rash), itching, rash, swelling of your face, 
lips, tongue or throat. This may cause difficulties in breathing or swallowing.

Very common (may affect more than 1 in 10 people)
- uncontrolled movements (dyskinesias)
- feeling sick (nausea)
- harmless reddish-brown discolouration of urine
- muscle pain
- diarrhoea

Common (may affect up to 1 in 10 people)
- light-headedness or fainting due to low blood pressure, high blood pressure
- worsening of Parkinson’s symptoms, dizziness, drowsiness
- vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation
- inability to sleep, hallucinations, confusion abnormal dreams (including nightmares), tiredness
- mental changes – including problems with memory, anxiety and depression (possibly with 

thoughts of suicide) 
- heart or artery disease events (e.g. chest pain), irregular heart rate or rhythm 
- more frequent falling 
- shortness of breath 
- increased sweating, rashes
- muscle cramps, swelling of legs
- blurred vision
- anaemia
- decreased appetite, decreased weight
- headache, joint pain
- urinary tract infection

Uncommon (may affect up to 1 in 100 people)
- heart attack
- bleeding in the gut
- changes in the blood cell count which may result in bleeding, abnormal liver function tests
- convulsions
- feeling agitated
- psychotic symptoms
- colitis (inflammation of the colon)
- discolourations other than urine (e.g. skin, nail, hair, sweat)
- swallowing difficulties
- inability to urinate

Not known (cannot be estimated from the available data)
Craving for large doses of Stalevo in excess of that required to control motor symptoms, known as 
dopamine dysregulation syndrome. Some patients experience severe abnormal involuntary movements 
(dyskinesias), mood swings or other side effects after taking large doses of Stalevo.

The following side effects have also been reported: 
- hepatitis (inflammation of the liver)
- itching

You may experience the following side effects: 
- Inability to resist the impulse to perform an action that could be harmful, which may include:

- strong impulse to gamble excessively despite serious personal or family consequences
- 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
- binge eating (eating large amounts of food in a short time period) or compulsive eating 



79

(eating more food than normal and more than is needed to satisfy your hunger).

Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or 
reducing the symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety 
of this medicine.

5. How to store Stalevo

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 bottle and the carton after EXP. 
The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Stalevo contains

- The active substances of Stalevo are levodopa, carbidopa and entacapone.
- Each Stalevo 150 mg/37.5 mg/200 mg tablet contains 150 mg of levodopa, 37.5 mg of 

carbidopa and 200 mg of entacapone.
- The other ingredients in the tablet core are croscarmellose sodium, magnesium stearate, maize 

starch, mannitol (E421) and povidone (E1201).
- The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium 

stearate, polysorbate 80, red iron oxide (E172), sucrose, titanium dioxide (E171), and yellow 
iron oxide (E172).

What Stalevo looks like and contents of the pack

Stalevo 150 mg/37.5 mg/200 mg: brownish or greyish red, elongated-ellipse shaped, unscored film-
coated tablets marked with ‘LCE 150’ on one side.

Stalevo comes in six different pack sizes (10, 30, 100, 130, 175 or 250 tablets). Not all pack sizes may 
be marketed.

Marketing Authorisation Holder and Manufacturer

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

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

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


80

Belgique/België/Belgien
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Lietuva
UAB Orion Pharma
Tel. +370 5 276 9499

България
Orion Pharma Poland Sp z.o.o.
Tel.: + 48 22 8333177

Luxembourg/Luxemburg
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Česká republika
Orion Pharma s.r.o.
Tel: +420 234 703 305

Magyarország
Orion Pharma Kft.
Tel.: +36 1 239 9095

Danmark
Orion Pharma A/S
Tlf: +45 8614 0000

Malta
Salomone Pharma
Tel: +356 21220174

Deutschland
Orion Pharma GmbH
Tel: +49 40 899 6890

Nederland
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Eesti
Orion Pharma Eesti OÜ
Tel: +372 66 44 550

Norge
Orion Pharma AS
Tlf: +47 40 00 42 10

Ελλάδα
Orion Pharma Hellas M.E.Π.E
Τηλ: + 30 210 980 3355

Österreich
Orion Pharma GmbH
Tel: +49 40 899 6890

España
Orion Pharma S.L.
Tel: + 34 91 599 86 01

Polska
Orion Pharma Poland Sp z.o.o.
Tel.: + 48 22 8333177

France
Centre Spécialités Pharmaceutiques
Tel: + 33 (0) 1 47 04 80 46

Portugal
Orionfin Unipessoal Lda
Tel: + 351 21 154 68 20

Hrvatska
Orion Pharma d.o.o.
Tel: +386 (0) 1 600 8015

România
Orion Corporation
Tel: +358 10 4261

Ireland
Orion Pharma (Ireland) Ltd.
c/o Allphar Services Ltd.
Tel: +353 1 428 7777

Slovenija
Orion Pharma d.o.o.
Tel: +386 (0) 1 600 8015

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Orion Pharma s.r.o
Tel: +420 234 703 305

Italia
Orion Pharma S.r.l.
Tel: + 39 02 67876111

Suomi/Finland
Orion Corporation
Puh./Tel: +358 10 4261



81

Κύπρος
Lifepharma (ZAM) Ltd
Τηλ.: +357 22056300

Sverige
Orion Pharma AB
Tel: +46 8 623 6440

Latvija
Orion Corporation
Orion Pharma pārstāvniecība
Tel: +371 20028332

United Kingdom
Orion Pharma (UK) Ltd.
Tel: +44 1635 520 300

This leaflet was last revised in.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.

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


82

Package leaflet: Information for the user

Stalevo 175 mg/43.75 mg/200 mg film-coated tablets
Levodopa/carbidopa/entacapone

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 Stalevo is and what it is used for
2. What you need to know before you take Stalevo
3. How to take Stalevo
4. Possible side effects
5 How to store Stalevo
6. Contents of the pack and other information

1. What Stalevo is and what it is used for

Stalevo contains three active substances (levodopa, carbidopa and entacapone) in one film-coated 
tablet. Stalevo is used for the treatment of Parkinson’s disease. 

Parkinson’s disease is caused by low levels of a substance called dopamine in the brain. Levodopa 
increases the amount of dopamine and hence reduces the symptoms of Parkinson’s disease. Carbidopa 
and entacapone improve the antiparkinson effects of levodopa. 

2. What you need to know before you take Stalevo

Do not take Stalevo if you:

- are allergic to levodopa, carbidopa or entacapone, or any of the other ingredients of this 
medicine (listed in section 6)

- have narrow-angle glaucoma (an eye disorder)
- have a tumour of the adrenal gland
- are taking certain medicines for treating depression (combinations of selective MAO-A and 

MAO-B inhibitors, or non-selective MAO-inhibitors)
- have ever had neuroleptic malignant syndrome (NMS – this is a rare reaction to medicines used 

to treat severe mental disorders)
- have ever had non-traumatic rhabdomyolysis (a rare muscle disorder)
- have a severe liver disease. 

Warnings and precautions

Talk to your doctor or pharmacist before taking Stalevo if you have or have ever had:
- a heart attack or any other diseases of the heart including cardiac arrhythmias, or of the blood 

vessels
- asthma or any other disease of the lungs
- a liver problem, because your dose may need to be adjusted
- kidney or hormone-related diseases



83

- stomach ulcers or convulsions
- if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation 

of the colon
- any form of severe mental disorder like psychosis
- chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in 

your eyes may need to be monitored.

Consult your doctor if you are currently taking:
- antipsychotics (medicines used to treat psychosis)
- a medicine which may cause low blood pressure when rising from a chair or bed. You should 

be aware that Stalevo may make these reactions worse.

Consult your doctor if during the treatment with Stalevo you:
- notice that your muscles get very rigid or jerk violently, or if you get tremors, agitation, 

confusion, fever, rapid pulse, or wide fluctuations in your blood pressure. If any of this 
happens, contact your doctor immediately

- feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour
- find yourself suddenly falling asleep, or if you feel very drowsy. If this happens, you should not 

drive or use any tools or machines (see also section 'Driving and using machines')
- notice that uncontrolled movements begin or get worse after you started to take Stalevo. If this 

happens, your doctor may need to change the dose of your antiparkinson medicine 
- experience diarrhoea: monitoring of your weight is recommended in order to avoid potentially 

excessive weight loss
- experience progressive anorexia, asthenia (weakness, exhaustion) and weight decrease within a 

relatively short period of time. If this happens, a general medical evaluation including liver 
function should be considered

- feel the need to stop using Stalevo, see section 'If you stop taking Stalevo'.

Tell your doctor if you or your family/carer notices you are developing addiction-like symptoms 
leading to craving for large doses of Stalevo and other medicines used to treat Parkinson’s disease.

Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in 
ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain 
activities that could harm yourself or others. These behaviours are called impulse control disorders 
and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or a 
preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to review your 
treatments.

Your doctor may take some regular laboratory tests during a long term treatment with Stalevo.

If you must undergo surgery, please tell your doctor that you are using Stalevo.

Stalevo is not recommended to be used for treatment of extrapyramidal symptoms (e.g. involuntary 
movements, shaking, muscle rigidity and muscle contractions) caused by other medicines.

Children and adolescents

Experience with Stalevo in patients under 18 years is limited. Therefore, the use of Stalevo in children
or adolescents is not recommended.

Other medicines and Stalevo

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



84

Do not take Stalevo if you are taking certain medicines for treating depression (combinations of 
selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).

Stalevo may increase the effects and side effects of certain medicines. These include: 
- medicines used to treat depression such as moclobemide, amitriptyline, desipramine, 

maprotiline, venlafaxine and paroxetine 
- rimiterole and isoprenaline, used to treat respiratory diseases
- adrenaline, used for severe allergic reactions
- noradrenaline, dopamine and dobutamine, used to treat heart diseases and low blood pressure
- alpha-methyldopa, used to treat high blood pressure 
- apomorphine, which is used to treat Parkinson’s disease.

The effects of Stalevo may be weakened by certain medicines. These include: 
- dopamine antagonists used to treat mental disorders, nausea and vomiting
- phenytoin, used to prevent convulsions 
- papaverine used to relax the muscles.

Stalevo may make it harder for you to digest iron. Therefore, do not take Stalevo and iron 
supplements at the same time. After taking one of them, wait at least 2 to 3 hours before taking the 
other.

Stalevo with food and drink

Stalevo may be taken with or without food. For some patients, Stalevo may not be well absorbed if it 
is taken with, or shortly after eating protein-rich food (such as meats, fish, dairy products, seeds and 
nuts). Consult your doctor if you think this applies to you.

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 not breast-feed during treatment with Stalevo.

Driving and using machines

Stalevo may lower your blood pressure, which may make you feel light-headed or dizzy. Therefore, 
be particularly careful when you drive or when you use any tools or machines.

If you feel very drowsy, or if you sometimes find yourself suddenly falling asleep, wait until you feel 
fully awake again before driving or doing anything else that requires you to be alert. Otherwise, you 
may put yourself and others at risk of serious injury or death.

Stalevo contains sucrose

Stalevo contains sucrose (1.89 mg/tablet). If you have been told by your doctor that you have 
intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Stalevo

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.

For adults and elderly:
- Your doctor will tell you exactly how many tablets of Stalevo to take each day. 



85

- The tablets are not intended to be split or broken into smaller pieces.
- You should take only one tablet each time.
- Depending on how you respond to treatment, your doctor may suggest a higher or lower dose. 
- If you are taking Stalevo 175 mg/43.75 mg/200 mg tablets, do not take more than 8 tablets of 

this strength per day.

Talk to your doctor or pharmacist if you think the effect of Stalevo is too strong or too weak, or if you 
experience possible side effects.

To open the bottle for the first time: open the closure, 
and then press with your thumb on the seal until it 
breaks. See picture 1.

Picture 1

If you take more Stalevo than you should

If you have accidentally taken more Stalevo tablets than you should, talk to your doctor or pharmacist 
immediately. In case of an overdose you may feel confused or agitated, your heart rate may be slower 
or faster than normal or the colour of your skin, tongue, eyes or urine may change.

If you forget to take Stalevo

Do not take a double dose to make up for a forgotten tablet.

If it is more than 1 hour until your next dose: 
Take one tablet as soon as you remember, and the next tablet at the normal time. 

If it is less than 1 hour until your next dose: 
Take a tablet as soon as you remember, wait 1 hour, then take another tablet. After that carry on as 
normal. 

Always leave at least an hour between Stalevo tablets, to avoid possible side effects.

If you stop taking Stalevo 

Do not stop taking Stalevo unless your doctor tells you to. In such a case your doctor may need to 
adjust your other antiparkinson medicines, especially levodopa, to give sufficient control of your 
symptoms. If you suddenly stop taking Stalevo and other antiparkinsonian medicines it may result in 
unwanted side effects. 

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. Many of 
the side effects can be relieved by adjusting the dose. 

If you during the treatment with Stalevo experience the following symptoms, contact your doctor 
immediately: 
- Your muscles get very rigid or jerk violently, you get tremors, agitation, confusion, fever, rapid 

pulse, or wide fluctuations in your blood pressure. These can be symptoms of neuroleptic 
malignant syndrome (NMS, a rare severe reaction to medicines used to treat disorders of the 
central nervous system) or rhabdomyolysis (a rare severe muscle disorder).



86

- Allergic reaction, the signs may include hives (nettle rash), itching, rash, swelling of your face, 
lips, tongue or throat. This may cause difficulties in breathing or swallowing.

Very common (may affect more than 1 in 10 people)
- uncontrolled movements (dyskinesias)
- feeling sick (nausea)
- harmless reddish-brown discolouration of urine
- muscle pain
- diarrhoea

Common (may affect up to 1 in 10 people)
- light-headedness or fainting due to low blood pressure, high blood pressure
- worsening of Parkinson’s symptoms, dizziness, drowsiness
- vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation
- inability to sleep, hallucinations, confusion abnormal dreams (including nightmares), tiredness
- mental changes – including problems with memory, anxiety and depression (possibly with 

thoughts of suicide) 
- heart or artery disease events (e.g. chest pain), irregular heart rate or rhythm 
- more frequent falling 
- shortness of breath 
- increased sweating, rashes
- muscle cramps, swelling of legs
- blurred vision
- anaemia
- decreased appetite, decreased weight
- headache, joint pain
- urinary tract infection

Uncommon (may affect up to 1 in 100 people)
- heart attack
- bleeding in the gut
- changes in the blood cell count which may result in bleeding, abnormal liver function tests
- convulsions
- feeling agitated
- psychotic symptoms
- colitis (inflammation of the colon)
- discolourations other than urine (e.g. skin, nail, hair, sweat)
- swallowing difficulties
- inability to urinate

Not known (cannot be estimated from the available data)
Craving for large doses of Stalevo in excess of that required to control motor symptoms, known as 
dopamine dysregulation syndrome. Some patients experience severe abnormal involuntary movements 
(dyskinesias), mood swings or other side effects after taking large doses of Stalevo.

The following side effects have also been reported:
- hepatitis (inflammation of the liver)
- itching

You may experience the following side effects:
- Inability to resist the impulse to perform an action that could be harmful, which may include:

- strong impulse to gamble excessively despite serious personal or family consequences
- 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
- binge eating (eating large amounts of food in a short time period) or compulsive eating 



87

(eating more food than normal and more than is needed to satisfy your hunger).

Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or 
reducing the symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety 
of this medicine.

5. How to store Stalevo

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 bottle and the carton after EXP. 
The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Stalevo contains

- The active substances of Stalevo are levodopa, carbidopa and entacapone.
- Each Stalevo 175 mg/43.75 mg/200 mg tablet contains 175 mg of levodopa, 43.75 mg of 

carbidopa and 200 mg of entacapone.
- The other ingredients in the tablet core are croscarmellose sodium, magnesium stearate, maize 

starch, mannitol (E421) and povidone (E1201)
- The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium 

stearate, polysorbate 80, red iron oxide (E172), sucrose, and titanium dioxide (E171).

What Stalevo looks like and contents of the pack

Stalevo 175 mg/43.75 mg/200 mg: light brownish red, oval, unscored film-coated tablets marked with 
‘LCE 175’ on one side.

Stalevo 175 mg/43.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 
tablets). Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

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

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


88

Belgique/België/Belgien
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Lietuva
UAB Orion Pharma
Tel. +370 5 276 9499

България
Orion Pharma Poland Sp z.o.o.
Tel.: + 48 22 8333177

Luxembourg/Luxemburg
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Česká republika
Orion Pharma s.r.o.
Tel: +420 234 703 305

Magyarország
Orion Pharma Kft.
Tel.: +36 1 239 9095

Danmark
Orion Pharma A/S
Tlf: +45 8614 0000

Malta
Salomone Pharma
Tel: +356 21220174

Deutschland
Orion Pharma GmbH
Tel: +49 40 899 6890

Nederland
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Eesti
Orion Pharma Eesti OÜ
Tel: +372 66 44 550

Norge
Orion Pharma AS
Tlf: +47 40 00 42 10

Ελλάδα
Orion Pharma Hellas M.E.Π.E
Τηλ: + 30 210 980 3355

Österreich
Orion Pharma GmbH
Tel: +49 40 899 6890

España
Orion Pharma S.L.
Tel: + 34 91 599 86 01

Polska
Orion Pharma Poland Sp z.o.o.
Tel.: + 48 22 8333177

France
Centre Spécialités Pharmaceutiques
Tel: + 33 (0) 1 47 04 80 46

Portugal
Orionfin Unipessoal Lda
Tel: + 351 21 154 68 20

Hrvatska
Orion Pharma d.o.o.
Tel: +386 (0) 1 600 8015

România
Orion Corporation
Tel: +358 10 4261

Ireland
Orion Pharma (Ireland) Ltd.
c/o Allphar Services Ltd.
Tel: +353 1 428 7777

Slovenija
Orion Pharma d.o.o.
Tel: +386 (0) 1 600 8015

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Orion Pharma s.r.o
Tel: +420 234 703 305

Italia
Orion Pharma S.r.l.
Tel: + 39 02 67876111

Suomi/Finland
Orion Corporation
Puh./Tel: +358 10 4261

Κύπρος
Lifepharma (ZAM) Ltd
Τηλ.: +357 22056300

Sverige
Orion Pharma AB
Tel: +46 8 623 6440



89

Latvija
Orion Corporation
Orion Pharma pārstāvniecība
Tel: +371 20028332

United Kingdom
Orion Pharma (UK) Ltd.
Tel: +44 1635 520 300

This leaflet was last revised in.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.

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


90

Package leaflet: Information for the user

Stalevo 200 mg/50 mg/200 mg film-coated tablets
Levodopa/carbidopa/entacapone

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 Stalevo is and what it is used for
2. What you need to know before you take Stalevo
3. How to take Stalevo
4. Possible side effects
5 How to store Stalevo
6. Contents of the pack and other information

1. What Stalevo is and what it is used for

Stalevo contains three active substances (levodopa, carbidopa and entacapone) in one film-coated 
tablet. Stalevo is used for the treatment of Parkinson’s disease. 

Parkinson’s disease is caused by low levels of a substance called dopamine in the brain. Levodopa 
increases the amount of dopamine and hence reduces the symptoms of Parkinson’s disease. Carbidopa 
and entacapone improve the antiparkinson effects of levodopa. 

2. What you need to know before you take Stalevo

Do not take Stalevo if you:

- are allergic to levodopa, carbidopa or entacapone, or any of the other ingredients of this 
medicine (listed in section 6)

- have narrow-angle glaucoma (an eye disorder)
- have a tumour of the adrenal gland
- are taking certain medicines for treating depression (combinations of selective MAO-A and 

MAO-B inhibitors, or non-selective MAO-inhibitors)
- have ever had neuroleptic malignant syndrome (NMS – this is a rare reaction to medicines used 

to treat severe mental disorders)
- have ever had non-traumatic rhabdomyolysis (a rare muscle disorder)
- have a severe liver disease. 

Warnings and precautions

Talk to your doctor or pharmacist before taking Stalevoif you have or have ever had:
- a heart attack or any other diseases of the heart including cardiac arrhythmias, or of the blood 

vessels
- asthma or any other disease of the lungs
- a liver problem, because your dose may need to be adjusted
- kidney or hormone-related diseases



91

- stomach ulcers or convulsions
- if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation 

of the colon
- any form of severe mental disorder like psychosis
- chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in 

your eyes may need to be monitored.

Consult your doctor if you are currently taking:
- antipsychotics (medicines used to treat psychosis)
- a medicine which may cause low blood pressure when rising from a chair or bed. You should 

be aware that Stalevo may make these reactions worse.

Consult your doctor if during the treatment with Stalevo you:
- notice that your muscles get very rigid or jerk violently, or if you get tremors, agitation, 

confusion, fever, rapid pulse, or wide fluctuations in your blood pressure. If any of this 
happens, contact your doctor immediately

- feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour
- find yourself suddenly falling asleep, or if you feel very drowsy. If this happens, you should not 

drive or use any tools or machines (see also section 'Driving and using machines')
- notice that uncontrolled movements begin or get worse after you started to take Stalevo. If this 

happens, your doctor may need to change the dose of your antiparkinson medicine 
- experience diarrhoea: monitoring of your weight is recommended in order to avoid potentially 

excessive weight loss
- experience progressive anorexia, asthenia (weakness, exhaustion) and weight decrease within a 

relatively short period of time. If this happens, a general medical evaluation including liver 
function should be considered

- feel the need to stop using Stalevo, see section 'If you stop taking Stalevo'.

Tell your doctor if you or your family/carer notices you are developing addiction-like symptoms 
leading to craving for large doses of Stalevo and other medicines used to treat Parkinson’s disease.

Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in 
ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain 
activities that could harm yourself or others. These behaviours are called impulse control disorders 
and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or a 
preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to review your 
treatments.

Your doctor may take some regular laboratory tests during a long term treatment with Stalevo.

If you must undergo surgery, please tell your doctor that you are using Stalevo.

Stalevo is not recommended to be used for treatment of extrapyramidal symptoms (e.g. involuntary 
movements, shaking, muscle rigidity and muscle contractions) caused by other medicines.

Children and adolescents

Experience with Stalevo in patients under 18 years is limited. Therefore, the use of Stalevo in children
or adolescents is not recommended.

Other medicines and Stalevo

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



92

Do not take Stalevo if you are taking certain medicines for treating depression (combinations of 
selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).

Stalevo may increase the effects and side effects of certain medicines. These include: 
- medicines used to treat depression such as moclobemide, amitriptyline, desipramine, 

maprotiline, venlafaxine and paroxetine 
- rimiterole and isoprenaline, used to treat respiratory diseases 
- adrenaline, used for severe allergic reactions
- noradrenaline, dopamine and dobutamine, used to treat heart diseases and low blood pressure
- alpha-methyldopa, used to treat high blood pressure 
- apomorphine, which is used to treat Parkinson’s disease.

The effects of Stalevo may be weakened by certain medicines. These include: 
- dopamine antagonists used to treat mental disorders, nausea and vomiting
- phenytoin, used to prevent convulsions 
- papaverine used to relax the muscles.

Stalevo may make it harder for you to digest iron. Therefore, do not take Stalevo and iron 
supplements at the same time. After taking one of them, wait at least 2 to 3 hours before taking the 
other.

Stalevo with food and drink

Stalevo may be taken with or without food. For some patients, Stalevo may not be well absorbed if it 
is taken with, or shortly after eating protein-rich food (such as meats, fish, dairy products, seeds and 
nuts). Consult your doctor if you think this applies to you.

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 not breast-feed during treatment with Stalevo.

Driving and using machines

Stalevo may lower your blood pressure, which may make you feel light-headed or dizzy. Therefore, 
be particularly careful when you drive or when you use any tools or machines.

If you feel very drowsy, or if you sometimes find yourself suddenly falling asleep, wait until you feel 
fully awake again before driving or doing anything else that requires you to be alert. Otherwise, you 
may put yourself and others at risk of serious injury or death.

Stalevo contains sucrose

Stalevo contains sucrose (2.3 mg/tablet). If you have been told by your doctor that you have 
intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Stalevo

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.

For adults and elderly:
- Your doctor will tell you exactly how many tablets of Stalevo to take each day. 



93

- The tablets are not intended to be split or broken into smaller pieces.
- You should take only one tablet each time.
- Depending on how you respond to treatment, your doctor may suggest a higher or lower dose. 
- If you are taking Stalevo 200 mg/50 mg/200 mg, do not take more than 7 tablets of this strength 

per day.

Talk to your doctor or pharmacist if you think the effect of Stalevo is too strong or too weak, or if you 
experience possible side effects.

To open the bottle for the first time: open the closure, 
and then press with your thumb on the seal until it 
breaks. See picture 1.

Picture 1

If you take more Stalevo than you should

If you have accidentally taken more Stalevo tablets than you should, talk to your doctor or pharmacist 
immediately. In case of an overdose you may feel confused or agitated, your heart rate may be slower 
or faster than normal or the colour of your skin, tongue, eyes or urine may change.

If you forget to take Stalevo

Do not take a double dose to make up for a forgotten tablet.

If it is more than 1 hour until your next dose: 
Take one tablet as soon as you remember, and the next tablet at the normal time. 

If it is less than 1 hour until your next dose: 
Take a tablet as soon as you remember, wait 1 hour, then take another tablet. After that carry on as 
normal.

Always leave at least an hour between Stalevo tablets, to avoid possible side effects.

If you stop taking Stalevo 

Do not stop taking Stalevo unless your doctor tells you to. In such a case your doctor may need to 
adjust your other antiparkinson medicines, especially levodopa, to give sufficient control of your 
symptoms. If you suddenly stop taking of Stalevo and other antiparkinsonian medicines it may result 
in unwanted side effects. 

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. Many of 
the side effects can be relieved by adjusting the dose. 

If you during the treatment with Stalevo experience the following symptoms, contact your doctor 
immediately: 
- Your muscles get very rigid or jerk violently, you get tremors, agitation, confusion, fever, rapid 

pulse, or wide fluctuations in your blood pressure. These can be symptoms of neuroleptic 
malignant syndrome (NMS, a rare severe reaction to medicines used to treat disorders of the 
central nervous system) or rhabdomyolysis (a rare severe muscle disorder).



94

- Allergic reaction, the signs may include hives (nettle rash), itching, rash, swelling of your face, 
lips, tongue or throat. This may cause difficulties in breathing or swallowing.

Very common (may affect more than 1 in 10 people)
- uncontrolled movements (dyskinesias)
- feeling sick (nausea)
- harmless reddish-brown discolouration of urine
- muscle pain
- diarrhoea

Common (may affect up to 1 in 10 people)
- light-headedness or fainting due to low blood pressure, high blood pressure
- worsening of Parkinson’s symptoms, dizziness, drowsiness
- vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation
- inability to sleep, hallucinations, confusion abnormal dreams (including nightmares), tiredness
- mental changes – including problems with memory, anxiety and depression (possibly with 

thoughts of suicide) 
- heart or artery disease events (e.g. chest pain), irregular heart rate or rhythm 
- more frequent falling 
- shortness of breath 
- increased sweating, rashes
- muscle cramps, swelling of legs
- blurred vision
- anaemia
- decreased appetite, decreased weight
- headache, joint pain
- urinary tract infection

Uncommon (may affect up to 1 in 100 people)
- heart attack
- bleeding in the gut
- changes in the blood cell count which may result in bleeding, abnormal liver function tests
- convulsions
- feeling agitated
- psychotic symptoms
- colitis (inflammation of the colon)
- discolourations other than urine (e.g. skin, nail, hair, sweat)
- swallowing difficulties
- inability to urinate

Not known (cannot be estimated from the available data)
Craving for large doses of Stalevo in excess of that required to control motor symptoms, known as 
dopamine dysregulation syndrome. Some patients experience severe abnormal involuntary movements 
(dyskinesias), mood swings or other side effects after taking large doses of Stalevo.

The following side effects have also been reported: 
- hepatitis (inflammation of the liver)
- itching

You may experience the following side effects: 
- Inability to resist the impulse to perform an action that could be harmful, which may include:

- strong impulse to gamble excessively despite serious personal or family consequences
- 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
- binge eating (eating large amounts of food in a short time period) or compulsive eating 



95

(eating more food than normal and more than is needed to satisfy your hunger).

Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or 
reducing the symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety 
of this medicine.

5. How to store Stalevo

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 bottle and the carton after EXP. 
The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Stalevo contains

- The active substances of Stalevo are levodopa, carbidopa and entacapone.
- Each Stalevo 200 mg/50 mg/200 mg tablet contains 200 mg of levodopa, 50 mg of carbidopa 

and 200 mg of entacapone.
- The other ingredients in the tablet core are croscarmellose sodium, magnesium stearate, maize 

starch, mannitol (E421) and povidone (E1201).
- The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium 

stearate, polysorbate 80, red iron oxide (E172), sucrose and titanium dioxide (E171).

What Stalevo looks like and contents of the pack

Stalevo 200 mg/50 mg/200 mg: dark brownish red, oval, unscored film-coated tablets marked with 
‘LCE 200’ on one side.

Stalevo 200 mg/50 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175). Not 
all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

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

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


96

Belgique/België/Belgien
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Lietuva
UAB Orion Pharma
Tel. +370 5 276 9499

България
Orion Pharma Poland Sp z.o.o.
Tel.: + 48 22 8333177

Luxembourg/Luxemburg
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Česká republika
Orion Pharma s.r.o.
Tel: +420 234 703 305

Magyarország
Orion Pharma Kft.
Tel.: +36 1 239 9095

Danmark
Orion Pharma A/S
Tlf: +45 8614 0000

Malta
Salomone Pharma
Tel: +356 21220174

Deutschland
Orion Pharma GmbH
Tel: +49 40 899 6890

Nederland
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20

Eesti
Orion Pharma Eesti OÜ
Tel: +372 66 44 550

Norge
Orion Pharma AS
Tlf: +47 40 00 42 10

Ελλάδα
Orion Pharma Hellas M.E.Π.E
Τηλ: + 30 210 980 3355

Österreich
Orion Pharma GmbH
Tel: +49 40 899 6890

España
Orion Pharma S.L.
Tel: + 34 91 599 86 01

Polska
Orion Pharma Poland Sp z.o.o.
Tel.: + 48 22 8333177

France
Centre Spécialités Pharmaceutiques
Tel: + 33 (0) 1 47 04 80 46

Portugal
Orionfin Unipessoal Lda
Tel: + 351 21 154 68 20

Hrvatska
Orion Pharma d.o.o.
Tel: +386 (0) 1 600 8015

România
Orion Corporation
Tel: +358 10 4261

Ireland
Orion Pharma (Ireland) Ltd.
c/o Allphar Services Ltd.
Tel: +353 1 428 7777

Slovenija
Orion Pharma d.o.o.
Tel: +386 (0) 1 600 8015

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Orion Pharma s.r.o
Tel: +420 234 703 305

Italia
Orion Pharma S.r.l.
Tel: + 39 02 67876111

Suomi/Finland
Orion Corporation
Puh./Tel: +358 10 4261

Κύπρος
Lifepharma (ZAM) Ltd
Τηλ.: +357 22056300

Sverige
Orion Pharma AB
Tel: +46 8 623 6440



97

Latvija
Orion Corporation
Orion Pharma pārstāvniecība
Tel: +371 20028332

United Kingdom
Orion Pharma (UK) Ltd.
Tel: +44 1635 520 300

This leaflet was last revised in.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.

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

	SUMMARY OF PRODUCT CHARACTERISTICS
	A MANUFACTURER 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