Pramipexole Accord

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
  



 

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1. NAME OF THE MEDICINAL PRODUCT   
 
Pramipexole Accord 0.088 mg tablets 
Pramipexole Accord 0.18 mg tablets 
Pramipexole Accord 0.35 mg tablets 
Pramipexole Accord 0.7 mg tablets 
Pramipexole Accord 1.1 mg tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Pramipexole Accord 0.088 mg tablet 
Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg 
pramipexole. 
 
Pramipexole Accord 0.18 mg tablet 
Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg 
pramipexole. 
 
Pramipexole Accord 0.35 mg tablet 
Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg 
pramipexole. 
 
Pramipexole Accord 0.7 mg tablet 
Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg 
pramipexole. 
 
Pramipexole Accord 1.1 mg tablet 
Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.1 mg 
pramipexole. 
 
Please note: 
Pramipexole doses as published in the literature refer to the salt form. 
Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in 
brackets). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM  
 
Tablet.   
 
Pramipexole Accord 0.088 mg tablet 
The tablets are white to off-white, round, flat faced, bevel edged, with inscription ‘I1’ on one side and 
plain on the other side. 
 
Pramipexole Accord 0.18 mg tablet 
The tablets are white to off-white, round, flat faced, bevel edged, with inscription ‘I’ and ‘2’ on either 
side of the breakline on one side and breakline on the other side. 
 
The tablet can be divided into two equal doses. 
 
Pramipexole Accord 0.35 mg tablet 
The tablets are white to off-white, round, flat faced, bevel edged, with inscription ‘I’ and ‘3’ on either 
side of the breakline on one side and breakline  on the other side. 
 



 

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The tablet can be divided into two equal doses. 
 
Pramipexole Accord 0.7 mg tablet 
The tablets are white to off-white, round, flat faced, bevel edged, with inscription ‘I’ and ‘4’ on either 
side of the breakline on one side and breakline  on the other side. 
 
The tablet can be divided into two equal doses. 
 
Pramipexole Accord 1.1 mg tablet 
The tablets are white to off-white, round, flat faced, bevel edged, with inscription ‘I’ and ‘5’ on either 
side of the breakline on one side and breakline on other side. 
 
The tablet can be divided into two equal doses. 
 
 
4. CLINICAL PARTICULARS   
 
4.1 Therapeutic indications 
 
Pramipexole Accord is indicated in adults for treatment of the signs and symptoms of idiopathic 
Parkinson’s disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of 
the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and 
fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations). 
 
 
4.2 Posology and method of administration  
 
Posology 
 
Parkinson’s disease 
 
The daily dose is administered in equally divided doses 3 times a day. 
 
Initial treatment 
Doses should be increased gradually from a starting dose of 0.264 mg of base (0.375 mg of salt) per 
day and then increased every 5-7 days. Providing patients do not experience intolerable undesirable 
effects, the dose should be titrated to achieve a maximal therapeutic effect. 
 
Ascending dose schedule of Pramipexole  Accord 
Week Dose (mg of 

base) 
Total Daily 
Dose (mg of 
base)  

Dose (mg of 
salt) 

Total Daily 
Dose (mg of 
salt) 

1 3 x 0.088 0.264 3 x 0.125 0.375 
2 3 x 0.18 0.54 3 x 0.25 0.75 
3 3 x 0.35 1.1 3 x 0.5 1.50 
 
If a further dose increase is necessary the daily dose should be increased by 0.54 mg of base (0.75 mg 
of salt) at weekly intervals up to a maximum dose of 3.3 mg of base (4.5 mg of salt) per day. 
However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg 
(of salt) per day (see section 4.8). 
 
Maintenance treatment 
The individual dose of pramipexole should be in the range of 0.264 mg of base (0.375 mg of salt) to a 
maximum of 3.3 mg of base (4.5 mg of salt) per day. During dose escalation in pivotal studies, 
efficacy was observed starting at a daily dose of 1.1 mg of base (1.5 mg of salt). Further dose 
adjustments should be done based on the clinical response and the occurrence of adverse reactions. In 



 

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clinical trials approximately 5% of patients were treated at doses below 1.1 mg of base (1.5 mg of 
salt). In advanced Parkinson’s disease, pramipexole doses higher than 1.1 mg of base (1.5 mg of salt) 
per day can be useful in patients where a reduction of the levodopa therapy is intended. It is 
recommended that the dose of levodopa is reduced during both the dose escalation and the 
maintenance treatment with Pramipexole Accord, depending on reactions in individual patients (see 
section 4.5). 
 
Treatment discontinuation 
Abrupt discontinuation of dopaminergic therapy can lead to the development of a neuroleptic 
malignant syndrome. Pramipexole should be tapered off at a rate of 0.54 mg of base (0.75 mg of salt) 
per day until the daily dose has been reduced to 0.54 mg of base (0.75 mg of salt). Thereafter the dose 
should be reduced by 0.264 mg of base (0.375 mg of salt) per day (see section 4.4). 
 
Renal impairment 
The elimination of pramipexole is dependent on renal function. The following dose schedule is 
suggested for initiation of therapy: 
 
Patients with a creatinine clearance above 50 ml/min require no reduction in daily dose or dosing 
frequency. 
 
In patients with a creatinine clearance between 20 and 50 ml/min, the initial daily dose of 
Pramipexole Accord should be administered in two divided doses, starting at 0.088 mg of base (0.125 
mg of salt) twice a day (0.176 mg of base/0.25 mg of salt daily). A maximum daily dose of 1.57 mg 
pramipexole base (2.25 mg of salt) should not be exceeded. 
 
In patients with a creatinine clearance less than 20 ml/min, the daily dose of Pramipexole Accord 
should be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily. A 
maximum daily dose of 1.1 mg pramipexole base (1.5 mg of salt) should not be exceeded. 
 
If renal function declines during maintenance therapy the Pramipexole Accord daily dose should be 
reduced by the same percentage as the decline in creatinine clearance, i.e. if creatinine clearance 
declines by 30%, then the Pramipexole Accord daily dose should be reduced by 30%. The daily dose 
can be administered in two divided doses if creatinine clearance is between 20 and 50 ml/min and as a 
single daily dose if creatinine clearance is less than 20 ml/min. 
 
Hepatic impairment 
Dose adjustment in patients with hepatic failure is probably not necessary, as approx. 90% of 
absorbed active substance is excreted through the kidneys. However, the potential influence of hepatic 
insufficiency on Pramipexole Accord pharmacokinetics has not been investigated. 
 
Paediatric population 
The safety and efficacy of Pramipexole Accord in children below 18 years has not been established. 
There is no relevant use of Pramipexole Accord in the paediatric population for the children of 
Parkinson’s disease. 
 
Tourette Disorder 
 
Paediatric population 
Pramipexole Accord is not recommended for use in children and adolescents below 18 years since the 
efficacy and safety has not been established in this population. Pramipexole Accord should not be 
used in children or adolescents with Tourette Disorder because of a negative benefit-risk balance for 
this disorder (see section 5.1). 
 
Method of administration 
 
The tablets should be taken orally, swallowed with water, and can be taken either with or without 
food. 



 

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4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
When prescribing Pramipexole Accord in a patient with Parkinson’s disease with renal impairment a 
reduced dose is suggested in line with section 4.2. 
 
Hallucinations 
 
Hallucinations are known as a side effect of treatment with dopamine agonists and levodopa. Patients 
should be informed that (mostly visual) hallucinations can occur. 
 
Dyskinesia 
 
In advanced Parkinson’s disease, in combination treatment with levodopa, dyskinesia can occur 
during the initial titration of Pramipexole Accord. If they occur, the dose of levodopa should be 
decreased. 
 
Dystonia  

Axial dystonia including antecollis, camptocormia and pleurothotonus (Pisa Syndrome) has 
occasionally been reported in patients with Parkinson’s disease following initiation or incremental 
dose increase of pramipexole. Although dystonia may be a symptom of Parkinson’s disease, the 
symptoms in these patients have improved after reduction or withdrawal of pramipexole. If dystonia 
occurs, the dopaminergic medication regimen should be reviewed and an adjustment in the dose of 
pramipexole considered. 
 
Sudden onset of sleep and somnolence 
 
Pramipexole has been associated with somnolence and episodes of sudden sleep onset, particularly in 
patients with Parkinson’s disease. Sudden onset of sleep during daily activities, in some cases without 
awareness or warning signs, has been reported uncommonly. Patients must be informed of this and 
advised to exercise caution while driving or operating machines during treatment with Pramipexole 
Accord. Patients who have experienced somnolence and/or an episode of sudden sleep onset must 
refrain from driving or operating machines. Furthermore a reduction of the dose or termination of 
therapy may be considered. Because of possible additive effects, caution should be advised when 
patients are taking other sedating medicinal products or alcohol in combination with pramipexole (see 
sections 4.5, 4.7 and section 4.8). 
 
Impulse control disorders 
 
Patients should be regularly monitored for the development of impulse control disorders. Patients and 
carers should be made aware that behavioural symptoms of impulse control disorders including 
pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge 
eating and compulsive eating can occur in patients treated with dopamine agonists, including 
Pramipexole Accord. Dose reduction/tapered discontinuation should be considered if such symptoms 
develop. 
 
 
Mania and delirium 
 
Patients should be regularly monitored for the development of mania and delirium. Patients and carers 
should be made aware that mania and delirium can occur in patients treated with pramipexole. Dose 
reduction/tapered discontinuation should be considered if such symptoms develop. 



 

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Patients with psychotic disorders 
 
Patients with psychotic disorders should only be treated with dopamine agonists if the potential 
benefits outweigh the risks. Co-administration of antipsychotic medicinal products with pramipexole 
should be avoided (see section 4.5). 
 
Ophthalmologic monitoring 
 
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur. 
 
Severe cardiovascular disease 
 
In case of severe cardiovascular disease, care should be taken. It is recommended to monitor blood 
pressure, especially at the beginning of treatment, due to the general risk of postural hypotension 
associated with dopaminergic therapy. 
 
Neuroleptic malignant syndrome 
 
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal 
of dopaminergic therapy (see section 4.2). 
 
Dopamine agonist withdrawal syndrome 
To discontinue treatment in patients with Parkinson’s disease, pramipexole should be tapered off (see 
section 4.2). Non-motor adverse effects may occur when tapering or discontinuing dopamine agonists 
including pramipexole. Symptoms include apathy, anxiety, depression, fatigue, sweating and pain 
which may be severe. Patients should be informed about this before tapering the dopamine agonist, 
and monitored regularly thereafter. In case of persistent symptoms, it may be necessary to increase the 
pramipexole dose temporarily (see section 4.8). 
 
Augmentation 
 
Reports in the literature indicate that treatment of another indication  with dopaminergic medicinal 
products can result in augmentation. Augmentation refers to the earlier onset of symptoms in the 
evening (or even the afternoon), increase in symptoms, and spread of symptoms to involve other 
extremities. Augmentation was specifically investigated in a controlled clinical trial over 26 weeks. 
Augmentation was observed in 11.8% of patients in the pramipexole group (N = 152) and 9.4% of 
patients in the placebo group (N = 149). Kaplan-Meier analysis of time to augmentation showed no 
significant difference between pramipexole and placebo groups. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Plasma protein binding 
 
Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is 
seen in man. Therefore, interactions with other medicinal products affecting plasma protein binding or 
elimination by biotransformation are unlikely. As anticholinergics are mainly eliminated by 
biotransformation, the potential for an interaction is limited, although an interaction with 
anticholinergics has not been investigated. There is no pharmacokinetic interaction with selegiline and 
levodopa. 
 
Inhibitors/competitors of active renal elimination pathway 
 
Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by 
inhibition of the cationic secretory transport system of the renal tubules. Therefore, medicinal 
products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, 
such as cimetidine, amantadine, mexiletine, zidovudine, cisplatin, quinine, and procainamide, may 



 

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interact with pramipexole resulting in reduced clearance of pramipexole. Reduction of the 
pramipexole dose should be considered when these medicinal products are administered 
concomitantly with Pramipexole Accord. 
 
Combination with levodopa 
 
When Pramipexole Accord is given in combination with levodopa, it is recommended that the dose of 
levodopa is reduced and the dose of other anti-parkinsonian medicinal products is kept constant while 
increasing the dose of Pramipexole Accord. 
 
Because of possible additive effects, caution should be advised when patients are taking other 
sedating medicinal products or alcohol in combination with pramipexole (see sections 4.4, 4.7 and 
4.8). 
 
Antipsychotic medicinal products 
 
Co-administration of antipsychotic medicinal products with pramipexole should be avoided (see 
section 4.4), e.g. if antagonistic effects can be expected. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
The effect on pregnancy and lactation has not been investigated in humans. Pramipexole was not 
teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section 5.3). 
Pramipexole Accord should not be used during pregnancy unless clearly necessary, i.e. if the potential 
benefit justifies the potential risk to the foetus. 
 
Breastfeeding 
 
As pramipexole treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected. 
The excretion of pramipexole into breast milk has not been studied in women. In rats, the 
concentration of active substance-related radioactivity was higher in breast milk than in plasma. 
In the absence of human data, Pramipexole Accord should not be used during breast-feeding. 
However, if its use is unavoidable, breast-feeding should be discontinued. 
 
Fertility 
 
No studies on the effect on human fertility have been conducted. In animal studies, pramipexole 
affected oestrous cycles and reduced female fertility as expected for a dopamine agonist. However, 
these studies did not indicate direct or indirect harmful effects with respect to male fertility. 
 
4.7 Effects on ability to drive and use machines 
 
Pramipexole Accord has major influence on the ability to drive and use machines. 
 
Hallucinations or somnolence can occur.  
 
Patients being treated with Pramipexole Accord and presenting with somnolence and/or sudden sleep 
episodes must be informed to refrain from driving or engaging in activities where impaired alertness 
may put themselves or others at risk of serious injury or death (e.g. operating machines) until such 
recurrent episodes and somnolence have resolved (see also sections 4.4, 4.5 and 4.8). 
 
4.8 Undesirable effects 
 
Based on the analysis of pooled placebo-controlled trials, comprising a total of 1,923 patients on 
pramipexole and 1,354 patients on placebo, adverse drug reactions were frequently reported for both 



 

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groups. 63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse 
drug reaction. 
 
The majority of adverse drug reactions usually start early in therapy and most tend to disappear even 
as therapy is continued. 
 
Within the system organ classes, adverse reactions are listed under headings of frequency (number of 
patients expected to experience the reaction), using the following categories: 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). 
 
Parkinson’s disease, most common adverse reactions 
 
The most commonly (≥ 5%) reported adverse drug reactions in patients with Parkinson’s disease more 
frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension, 
dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue. The incidence of 
somnolence is increased at doses higher than 1.5 mg pramipexole salt per day (see section 4.2). A 
more frequent adverse drug reaction in combination with levodopa was dyskinesia. Hypotension may 
occur at the beginning of treatment, especially if pramipexole is titrated too fast. 
 



 

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Table 1: Parkinson’s disease 
Body System 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) 

Not known 

Infections and 
infestations 

  pneumonia   

Endocrine 
disorders 

  inappropriate 
antidiuretic 
 hormone secretion1 

  

Psychiatric 
disorders 

 Insomnia 
hallucinations 
abnormal dreams  
confusion  
 
behavioural 
symptoms of 
impulse control 
disorders and 
compulsions  
 

compulsive 
shopping  
pathological 
gambling 
restlessness 
hypersexuality 
delusion 
libido disorder 
paranoia 
delirium 
binge eating1  
hyperphagia1  

mania  

Nervous 
system 
disorders 

somnolence 
dizziness  
dyskinesia  

headache sudden onset of 
sleep 
amnesia 
hyperkinesia 
syncope 

  

Eye disorders  visual 
impairment 
including 
diplopia vision 
blurred  
visual acuity 
reduced 

   

Cardiac 
disorders 

  cardiac failure1   

 



 

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Vascular 
disorders 

 hypotension    

Respiratory, 
thoracic, and 
mediastinal 
disorders 

  Dyspnoea 
hiccups 

  

Gastrointestinal 
disorders 

nausea constipation 
vomiting 

   

Skin and 
subcutaneous 
tissue disorders 

  hypersensitivity 
pruritus 
rash 

  

General 
disorders and 
administration 
site conditions 

 fatigue 
peripheral 
oedema 

  Dopamine 
agonist 
withdrawal 
syndrome 
including 
apathy, 
anxiety, 
depression, 
fatigue, 
sweating 
and pain. 

Investigations  weight decrease 
including 
decreased 
appetite 

weight increase   

1 This side effect has been observed in post-marketing experience. With 95 % certainty, the 
frequency category is not greater than uncommon, but might be lower. A precise frequency 
estimation is not possible as the side effect did not occur in a clinical trial database of 2,762 
patients with Parkinson’s Disease treated with pramipexole. 

 
Other indication, most common adverse reactions 
 
The most commonly (≥ 5%) reported adverse drug reactions in patients with  other indication treated 
with pramipexole were nausea, headache, dizziness and fatigue. Nausea and fatigue were more often 
reported in female patients treated with Pramipexole Accord (20.8% and 10.5%, respectively) 
compared to males (6.7% and 7.3%, respectively). 
 
Table 2: Other indication 
 
Body System Very 

common 
(≥1/10) 

Common 
(≥1/100 to 

<1/10) 

Uncommon 
(≥1/1,000 to 

< 1/100) 

Not known 
 

Infections and 
infestations 

  pneumonia1  

Endocrine 
disorders 

  inappropriate antidiuretic hormone 
secretion1 

 
 

Psychiatric 
disorders 

 insomnia 
abnormal 
dreams  

restlessness 
confusion  
hallucinations 
libido disorder 
delusion1 
hyperphagia1 
paranoia1 
mania1 
delirium1 

 



 

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behavioural symptoms of impulse 
control disorders and compulsions1 
(such as: 
compulsive shopping, 
pathological gambling, 
hypersexuality, binge eating) 

Nervous 
system 
disorders 

 headache 
dizziness 
somnolance 

sudden onset of sleep  
syncope 
dyskinesia 
amnesia1 
hyperkinesia1 

 
 
 
 
 

Eye disorders   visual impairment including  
visual acuity reduced 
diplopia  
vision blurred  

 
 
 
 

Cardiac 
disorders 

  cardiac failure1  

Vascular 
disorders 

  hypotension  

Respiratory, 
thoracic, and 
mediastinal 
disorders 

  dyspnoea 
hiccups 

 
 

Gastrointestinal 
disorders 

nausea constipation 
vomiting 

  

Skin and 
subcutaneous 
tissue disorders 

  hypersensitivity pruritus 
rash 

 
 

General 
disorders and 
administration 
site conditions 

 fatigue 
 

peripheral oedema Dopamine 
agonist 
withdrawal 
syndrome 
including 
apathy, anxiety, 
depression, 
fatigue, 
sweating and 
pain 

Investigations   weight decrease including 
decreased appetite 
weight increase 

 
 
 

1 This side effect has been observed in post-marketing experience. With 95 % certainty, the 
frequency category is not greater than uncommon, but might be lower. A precise frequency 
estimation is not possible as the side effect did not occur in a clinical trial database of 1,395 
patients with other indication treated with pramipexole. 

 
Description of selected adverse reactions 
 
Somnolence 
 
Pramipexole is commonly associated with somnolence and has been associated uncommonly with 
excessive daytime somnolence and sudden sleep onset episodes (see also section 4.4). 
 
Libido disorders 
 
Pramipexole may uncommonly be associated with libido disorders (increased or decreased). 



 

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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 including 
Pramipexole Accord. (see section 4.4). 
 
In a cross-sectional, retrospective screening and case-control study including 3,090 Parkinson’s 
disease patients, 13.6% of all patients receiving dopaminergic or non-dopaminergic treatment had 
symptoms of an impulse control disorder during the past six months. Manifestations observed include 
pathological gambling, compulsive shopping, binge eating, and compulsive sexual behaviour 
(hypersexuality). Possible independent risk factors for impulse control disorders included 
dopaminergic treatments and higher doses of dopaminergic treatment, younger age ( ≤ 65 years), not 
being married and self-reported family history of gambling behaviours. 
 
Dopamine agonist withdrawal syndrome 
Non-motor adverse effects may occur when tapering or discontinuing dopamine agonists including 
pramipexole. Symptoms include apathy, anxiety, depression, fatigue, sweating and pain (see section 
4.4). 
 
Cardiac failure 
 
In clinical studies and post-marketing experience cardiac failure has been reported in patients with 
pramipexole. In a pharmacoepidemiological study pramipexole use was associated with an increased 
risk of cardiac failure compared with non-use of pramipexole (observed risk ratio 1.86; 95% CI, 1.21-
2.85). 
 
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 
 
There is no clinical experience with massive overdose. The expected adverse reactions would be those 
related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, 
hyperkinesia, hallucinations, agitation and hypotension. There is no established antidote for overdose 
of a dopamine agonist. If signs of central nervous system stimulation are present, a neuroleptic agent 
may be indicated. Management of the overdose may require general supportive measures, along with 
gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram 
monitoring. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: anti-Parkinson drugs, dopamine agonists, ATC code: N04BC05. 
 
Mechanism of action 
 
Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the D2 subfamily 
of dopamine receptors of which it has a preferential affinity to D3 receptors, and has full intrinsic 
activity.  



 

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Pramipexole alleviates parkinsonian motor deficits by stimulation of dopamine receptors in the 
striatum. Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and 
turnover. 
 
Pharmacodynamic effects 
 
In human volunteers, a dose-dependent decrease in prolactin was observed.  
 
Clinical efficacy and safety in Parkinson’s disease 
 
In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson’s disease. Placebo-
controlled clinical trials included approximately 1,800 patients of Hoehn and Yahr stages I – V treated 
with pramipexole. Out of these, approximately 1,000 were in more advanced stages, received 
concomitant levodopa therapy, and suffered from motor complications. 
In early and advanced Parkinson’s disease, efficacy of pramipexole in controlled clinical trials was 
maintained for approximately six months. In open continuation trials lasting for more than three years 
there were no signs of decreasing efficacy. 
 
In a controlled double blind clinical trial of 2 year duration, initial treatment with pramipexole 
significantly delayed the onset of motor complications, and reduced their occurrence compared to 
initial treatment with levodopa. This delay in motor complications with pramipexole should be 
balanced against a greater improvement in motor function with levodopa (as measured by the mean 
change in UPDRS-score). The overall incidence of hallucinations and somnolence was generally 
higher in the escalation phase with the pramipexole group. However, there was no significant 
difference during the maintenance phase. These points should be considered when initiating 
pramipexole treatment in patients with Parkinson’s disease. 
 
Paediatric population 
 
The European Medicines Agency has waived the obligation to submit the results of studies with 
Pramipexole Accord in all subsets of the paediatric population in Parkinson’s Disease (see section 4.2 
for information on paediatric use). 
 
Clinical efficacy and safety in Tourette Disorder 
 
The efficacy of pramipexole (0.0625-0.5 mg/day) with paediatric patients aged 6-17 years with 
Tourette Disorder was evaluated in a 6-week, double-blind, randomised, placebo-controlled flexible 
dose study. A total of 63 patients were randomised (43 on pramipexole, 20 on placebo). The primary 
endpoint was change from baseline on the Total Tic Score (TTS) of the Yale Global Tic Severity 
Scale (YGTSS). No difference was observed for pramipexole as compared to placebo for either the 
primary endpoint or for any of the secondary efficacy endpoints including YGTSS total score, Patient 
Global Impression of Improvement (PGI-I), Clinical Global Impression of Improvement (CGI-I), or 
Clinical Global Impressions of Severity of Illness (CGI-S). Adverse events occurring in at least 5% of 
patients in the pramipexole group and more common in the pramipexole-treated patients than in 
patients on placebo were: headache (27.9%, placebo 25.0%), somnolence (7.0%, placebo 5.0%), 
nausea (18.6%, placebo 10.0%), vomiting (11.6%, placebo 0.0%), upper abdominal pain (7.0%, 
placebo 5.0%), orthostatic hypotension (9.3%, placebo 5.0%), myalgia (9.3%, placebo 5.0%), sleep 
disorder (7.0%, placebo 0.0%), dyspnoea (7.0%, placebo 0.0%) and upper respiratory tract infection 
(7.0%, placebo 5.0%). Other significant adverse events leading to discontinuation of study medication 
for patients receiving pramipexole were confusional state, speech disorder and aggravated condition 
(see section 4.2). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 



 

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Pramipexole is rapidly and completely absorbed following oral administration. The absolute 
bioavailability is greater than 90% and the maximum plasma concentrations occur between 1 and 3 
hours. Concomitant administration with food did not reduce the extent of pramipexole absorption, but 
the rate of absorption was reduced. Pramipexole shows linear kinetics and a small inter-patient 
variation of plasma levels. 
 
Distribution 
 
In humans, the protein binding of pramipexole is very low (< 20%) and the volume of distribution is 
large (400 l). High brain tissue concentrations were observed in the rat (approx. 8-fold compared to 
plasma). 
 
Biotransformation 
 
Pramipexole is metabolised in man only to a small extent. 
 
Elimination 
 
Renal excretion of unchanged pramipexole is the major route of elimination. Approximately 90% of 
14C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces. The total 
clearance of pramipexole is approximately 500 ml/min and the renal clearance is approximately 400 
ml/min. The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly. 
 
5.3 Preclinical safety data 
 
Repeated dose toxicity studies showed that pramipexole exerted functional effects, mainly involving 
the CNS and female reproductive system, and probably resulting from an exaggerated 
pharmacodynamic effect of pramipexole. 
 
Decreases in diastolic and systolic pressure and heart rate were noted in the minipig, and a tendency 
to a hypotensive effect was discerned in the monkey. 
 
The potential effects of pramipexole on reproductive function have been investigated in rats and 
rabbits. Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at 
maternally toxic doses. Due to the selection of animal species and the limited parameters investigated, 
the adverse effects of pramipexole on pregnancy and male fertility have not been fully elucidated. 
 
A delay in sexual development (i.e., preputial separation and vaginal opening) was observed in rats. 
The relevance for humans is unknown. 
 
Pramipexole was not genotoxic. In a carcinogenicity study, male rats developed Leydig cell 
hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole. This finding is 
not clinically relevant to man. The same study also showed that, at doses of 2 mg/kg (of salt) and 
higher, pramipexole was associated with retinal degeneration in albino rats. The latter finding was not 
observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species 
investigated. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1  List of excipients 
 
Mannitol 
Cellulose, microcrystalline 
Maize starch  
Silica, colloidal anhydrous  
Povidone  



 

15 

Magnesium stearate 
 
6.2  Incompatibilities 
 
Not applicable. 
 
6.3  Shelf life 
 
2 years 
 
6.4  Special precautions for storage 
 
Store below 30°C. Store in the original package in order to protect from light. 
 
6.5  Nature and contents of container 
 
Pramipexole Accord tablets are packed in alu-alu blisters. 
 
Each blister strip contains 10 tablets.   
Pack-sizes of 30 or 100 tablets 
 
Not all pack sizes may be marketed. 
 
6.6  Special precautions for disposal 
 
Any unused product or waste material should be disposed of in accordance with local requirement. 
 
 
7.  MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U.  
World Trade Center, Moll de Barcelona, s/n,  
Edifici Est 6ª planta,  
08039 Barcelona,  
Spain 
 
 
8.  MARKETING AUTHORISATION NUMBER(S) 
 
Pramipexole Accord 0.088 mg tablet 
EU/1/11/728/001-002 (30/100 tablets in alu/alu blister) 
 
Pramipexole Accord 0.18 mg tablet 
EU/1/11/728/003-004 (30/100 tablets in alu/alu blister) 
 
Pramipexole Accord 0.35 mg tablet 
EU/1/11/728/005-006 (30/100 tablets in alu/alu blister) 
 
Pramipexole Accord 0.7 mg tablet 
EU/1/11/728/007-008 (30/100 tablets in alu/alu blister) 
 
Pramipexole Accord 1.1 mg tablet 
EU/1/11/728/009-010 (30/100 tablets in alu/alu blister) 
 
 
9.  DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 



 

16 

Date of first authorisation: 30 September 2011 
Date of latest renewal: 15th July 2016 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu/. 
  



 

17 

 
 

 
 

 
 
 

 
 

 
 
 

 
 

 
 
 

ANNEX II 

A.  MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

B.  CONSITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION 

D.  CONDISTIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 
 
 
  



 

18 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE  
 
Name and address of the manufacturer responsible for batch release 
 
Accord Healthcare Ltd. 
Sage House 
319 Pinner road  
North Harrow, Middx HA1 4HF 
United Kingdom 
 
Accord Healthcare Polska Sp.z o.o., 
ul. Lutomierska 50,95-200 Pabianice, Poland 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to medical prescription 

 
C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION  



 Periodic Safety Update Reports  
 

The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 

 

D.  CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT 



 Risk Management Plan (RMP) 
  

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 
updates of the RMP. 

An updated RMP should be submitted:  

 At the request of the European Medicines Agency;  

 Whenever the risk management system is modified, especially as the result of new 
information being received that may lead to a significant change to the benefit/risk profile or 
as the result of an important (pharmacovigilance or risk minimisation) milestone being 
reached.  

 
 
 



 

19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
ANNEX III 

 
LABELLING AND PACKAGE LEAFLET 

  



 

20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 
  



 

21 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton for blisters 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pramipexole Accord 0.088 mg tablets 
Pramipexole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg 
pramipexole. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 tablets 
100 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION: 
 
Read the package leaflet before use. 
For oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7 OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9.  SPECIAL STORAGE CONDITIONS 
 
Store below 30°C. Store in the original package in order to protect from light. 
 
  



 

22 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused product or waste material should be disposed of in accordance with local requirement 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U.  
World Trade Center, Moll de Barcelona, s/n,  
Edifici Est 6ª planta,  
08039 Barcelona,  
Spain 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/728/001-002 (30/100 tablets in alu/alu blister) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pramipexole Accord 0.088 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC:  
SN:  
NN: 



 

23 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister-alu/alu  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pramipexole Accord 0.088 mg tablets 
Pramipexole 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Accord 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



 

24 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton for blisters 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pramipexole Accord 0.18 mg tablets 
Pramipexole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg 
pramipexole. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 tablets 
100 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION: 
 
Read the package leaflet before use. 
For oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7 OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9.  SPECIAL STORAGE CONDITIONS 
 
Store below 30°C. Store in the original package in order to protect from light. 
 
  



 

25 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused product or waste material should be disposed of in accordance with local requirement 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U.  
World Trade Center, Moll de Barcelona, s/n,  
Edifici Est 6ª planta,  
08039 Barcelona,  
Spain 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/728/003-004 (30/100 tablets in alu/alu blister) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pramipexole Accord 0.18 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC:  
SN:  
NN: 



 

26 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister-alu/alu  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pramipexole Accord 0.18 mg tablets 
Pramipexole 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Accord 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



 

27 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton for blisters 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pramipexole Accord 0.35 mg tablets 
Pramipexole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg 
pramipexole. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 tablets 
100 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION: 
 
Read the package leaflet before use. 
For oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7 OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9.  SPECIAL STORAGE CONDITIONS 
 
Store below 30°C. Store in the original package in order to protect from light. 
 
  



 

28 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused product or waste material should be disposed of in accordance with local requirement 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U.  
World Trade Center, Moll de Barcelona, s/n,  
Edifici Est 6ª planta,  
08039 Barcelona,  
Spain 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/728/005-006 (30/100 tablets in alu/alu blister) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pramipexole Accord 0.35 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC:  
SN:  
NN: 



 

29 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister-alu/alu  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pramipexole Accord 0.35 mg tablets 
Pramipexole 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Accord 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



 

30 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton for blisters 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pramipexole Accord 0.7 mg tablets 
Pramipexole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg 
pramipexole. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 tablets 
100 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION: 
 
Read the package leaflet before use. 
For oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7 OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9.  SPECIAL STORAGE CONDITIONS 
 
Store below 30°C. Store in the original package in order to protect from light. 
 
  



 

31 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused product or waste material should be disposed of in accordance with local requirement 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U.  
World Trade Center, Moll de Barcelona, s/n,  
Edifici Est 6ª planta,  
08039 Barcelona,  
Spain 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/728/007-008 (30/100 tablets in alu/alu blister) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pramipexole Accord 0.7 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC:  
SN:  
NN: 



 

32 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister-alu/alu  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pramipexole Accord 0.7 mg tablets 
Pramipexole 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Accord 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



 

33 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton for blisters 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pramipexole Accord 1.1 mg tablets 
Pramipexole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.1 mg 
pramipexole. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 tablets 
100 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION: 
 
Read the package leaflet before use. 
For oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED 

OUT OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7 OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9.  SPECIAL STORAGE CONDITIONS 
 
Store below 30°C. Store in the original package in order to protect from light. 
 
  



 

34 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused product or waste material should be disposed of in accordance with local requirement 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U.  
World Trade Center, Moll de Barcelona, s/n,  
Edifici Est 6ª planta,  
08039 Barcelona,  
Spain 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/11/728/009-010 (30/100 tablets in alu/alu blister) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pramipexole Accord 1.1 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC:  
SN:  
NN: 
 



 

35 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister-alu/alu  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pramipexole Accord 1.1 mg tablets 
Pramipexole 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Accord 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



 

36 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
B. PACKAGE LEAFLET 

 



 

37 

 Package leaflet: Information for the user 
 
 

Pramipexole Accord 0.088 mg tablets 
Pramipexole Accord 0.18 mg tablets 
Pramipexole Accord 0.35 mg tablets 
Pramipexole Accord 0.7 mg tablets 
Pramipexole Accord 1.1 mg tablets 

 
Pramipexole 

 
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 of the 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 Pramipexole Accord is and what it is used for 
2. What you need to know before you take Pramipexole Accord  
3. How to take Pramipexole Accord  
4. Possible side effects 
5. How to store Pramipexole Accord  
6. Contents of the pack and other information 
 
 
1. What Pramipexole Accord is and what it is used for 
 
Pramipexole Accord contains the active substance pramipexole and belongs to a group of medicines 
known as dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of the 
dopamine receptors triggers nerve impulses in the brain that help to control body movements. 
 
Pramipexole Accord is used to: 
 treat the symptoms of primary Parkinson’s disease in adults. It can be used alone or in 

combination with levodopa (another medicine for Parkinson’s disease). 
 
 
2.  What you need to know before you take Pramipexole Accord  
 
Do not take Pramipexole Accord: 
 if you are allergic to pramipexole or to any of the other ingredients of this medicine (listed in 

section 6). 
 
Warnings and precautions: 
Talk to your doctor before taking Pramipexole Accord. Tell your doctor if you have (had) or develop 
any medical conditions or symptoms, especially any of the following: 
 Kidney disease. 
 Hallucinations (seeing, hearing or feeling things that are not there). Most hallucinations are 

visual. 
 Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs). If you have advanced 

Parkinson’s disease and are also taking levodopa, you might develop dyskinesia during the up-
titration of Pramipexole Accord. 

 Dystonia 



 

38 

 Inability of keeping your body and neck straight and upright (axial dystonia). In particular, you 
may experience forward flexion of the head and neck (also called antecollis), forward bending 
of the lower back (also called camptocormia) or sidewards bending of the back (also called 
pleurothotonus or Pisa Syndrome). If this happens, your doctor may want to change your 
medication. 

 Sleepiness and episodes of suddenly falling asleep. 
 Psychosis (e.g. comparable with symptoms of schizophrenia). 
 Vision impairment. You should have regular eye examinations during treatment with 

Pramipexole Accord. 
 Severe heart or blood vessels disease. You will need to have your blood pressure checked 

regularly, especially at the beginning of treatment. This is to avoid postural hypotension (a fall 
in blood pressure on standing up). 

 Augmentation. You may experience that symptoms start earlier than usual, be more intense and 
involve other limbs. 

 
Tell your doctor if you or your family/carer notices that you are developing urges or cravings to 
behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry 
out certain activities that could harm yourself or others. These are called impulse control disorders 
and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally 
high sex drive or preoccupation with an increase in sexual thoughts or feelings. Your doctor may need 
to adjust or stop your dose. 
 
Tell your doctor if you or your family/carer notices that you are developing mania (agitation, feeling 
elated or over-excited) or delirium (decreased awareness, confusion or loss of reality). Your doctor 
may need to adjust or stop your dose. 
 
Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or 
pain after stopping or reducing your Pramipexole Accord treatment. If the problems persist more than 
a few weeks, your doctor may need to adjust your treatment. 
 
Children and adolescents 
Pramipexole Accord is not recommended for use in children or adolescents under 18 years. 
 
Other medicines and Pramipexole Accord 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. This includes medicines, herbal remedies, health foods or supplements that you have 
obtained without a prescription. 
 
You should avoid taking Pramipexole Accord together with antipsychotic medicines. 
 
Take care if you are taking the following medicines: 
 cimetidine (to treat excess stomach acid and stomach ulcers) 
 amantadine (which can be used to treat Parkinson’s disease) 
 mexiletine (to treat irregular heartbeats, a condition known as ventricular arrhythmia) 
 zidovudine (which can be used to treat the acquired immune deficiency syndrome (AIDS), a 

disease of the human immune system) 
 cisplatin (to treat various types of cancers) 
 quinine (which can be used for the prevention of painful night-time leg cramps and for the 

treatment of a type of malaria known as falciparum malaria (malignant malaria)) 
 procainamide (to treat irregular heart beat) 
If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start 
treatment with Pramipexole Accord. 
 
Take care if you are using any medicines that calm you down (have a sedative effect) or if you are 
drinking alcohol. In these cases Pramipexole Accord may affect your ability to drive and operate 
machinery. 



 

39 

 
Pramipexole Accord with food, drink and alcohol 
You should be cautious while drinking alcohol during treatment with Pramipexole Accord. 
Pramipexole Accord can be taken with or without food. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before taking this medicine. Your doctor will then discuss with you if you 
should continue to take Pramipexole Accord. 
 
The effect of Pramipexole Accord on the unborn child is not known. Therefore, do not take 
Pramipexole Accord if you are pregnant unless your doctor tells you to do so. 
 
Pramipexole Accord should not be used during breast-feeding. Pramipexole Accord can reduce the 
production of breast milk. Also, it can pass into the breast milk and can reach your baby. If use of 
Pramipexole Accord is unavoidable, breast-feeding should be stopped. 
 
Ask your doctor or pharmacist for advice before taking any medicine. 
 
Driving and using machines 
Pramipexole Accord can cause hallucinations (seeing, hearing or feeling things that are not there). If 
affected, do not drive or use machines. 
 
Pramipexole Accord has been associated with sleepiness and episodes of suddenly falling asleep, 
particularly in patients with Parkinson’s disease. If you experience these side effects, you must not 
drive or operate machinery. You should tell your doctor if this occurs. 
 
 
3.   How to take Pramipexole Accord  
 
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not 
sure. The doctor will advise you on the right dosing. 
 
You can take Pramipexole Accord with or without food. Swallow the tablets with water. 
 
Parkinson’s disease 
The daily dose is to be taken divided into 3 equal doses. 
 
During the first week, the usual dose is 1 tablet Pramipexole Accord 0.088 mg three times a day 
(equivalent to 0.264 mg daily): 
 
 1st week 
Number of tablets 1 Pramipexole Accord tablet 0.088 mg three times a day 
Total daily dose (mg) 0.264 
 
This will be increased every 5-7 days as directed by your doctor until your symptoms are controlled 
(maintenance dose). 
 
 2nd week 3rd week 
Number of tablets 1 Pramipexole Accord tablet 0.18 

mg three times a day 
OR 
2 Pramipexole Accord tablets 
0.088 mg three times a day 

1 Pramipexole Accord tablet 0.35 
mg three times a day 
OR 
2 Pramipexole Accord tablets 
0.18 mg three times a day 

Total daily dose (mg) 0.54 1.1 
 



 

40 

The usual maintenance dose is 1.1 mg per day. However, your dose may have to be increased even 
further. If necessary, your doctor may increase your tablet dose up to a maximum of 3.3 mg of 
pramipexole a day. A lower maintenance dose of three Pramipexole Accord 0.088 mg tablets a day is 
also possible. 
 
 Lowest maintenance dose Highest maintenance dose 
Number of tablets 1 Pramipexole Accord tablet 

0.088 mg three times a day 
1 Pramipexole Accord tablet 1.1 
mg three times a day 

Total daily dose (mg) 0.264 3.3 
 
Patients with kidney disease 
If you have moderate or severe kidney disease, your doctor will prescribe a lower dose. In this case, 
you will have to take the tablets only once or twice a day. If you have moderate kidney disease, the 
usual starting dose is 1 Pramipexole Accord tablet 0.088 mg twice a day. In severe kidney disease, the 
usual starting dose is just 1 Pramipexole Accord tablet 0.088 mg a day. 
 
If you take more Pramipexole Accord than you should 
If you accidentally take too many tablets, 
 Contact your doctor or nearest hospital casualty department immediately for advice. 
 You may experience vomiting, restlessness, or any of the side effects as described in chapter 4 

“Possible side effects”. 
 
If you forget to take Pramipexole Accord 
Do not worry. Simply leave out that dose completely and then take your next dose at the right time. 
Do not try to make up for the missed dose. 
 
If you stop taking Pramipexole Accord 
Do not stop taking Pramipexole Accord without first talking to your doctor. If you have to stop taking 
this medicine, your doctor will reduce the dose gradually. This reduces the risk of worsening 
symptoms. 
 
If you suffer from Parkinson’s disease you should not stop treatment with Pramipexole Accord 
abruptly. A sudden stop could cause you to develop a medical condition called neuroleptic malignant 
syndrome which may represent a major health risk. The symptoms include: 
 akinesia (loss of muscle movement) 
 rigid muscles 
 fever 
 unstable blood pressure 
 tachycardia (increased heart rate) 
 confusion 
 depressed level of consciousness (e.g. coma) 
 
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. 
Evaluation of these side effects is based on the following frequencies: 
 
Very common may affect more than 1 in 10 people 
Common may affect up to 1 in 10 people 
Uncommon may affect up to 1 in 100 people 
Rare may affect up to 1 in 1,000 people 
Very rare may affect up to 1 in 10,000 people 
Not known Frequency cannot be estimated from the available data 



 

41 

 
If you suffer from Parkinson’s disease, you may experience the following side effects: 
 
Very common: 
 Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs) 
 Sleepiness 
 Dizziness 
 Nausea (sickness) 
  
Common: 
 Urge to behave in an unusual way 
 Hallucinations (seeing, hearing or feeling things that are not there) 
 Confusion 
 Tiredness (fatigue) 
 Sleeplessness (insomnia) 
 Excess of fluid, usually in the legs (peripheral oedema) 
 Headache 
 Hypotension (low blood pressure) 
 Abnormal dreams 
 Constipation 
 Visual impairment 
 Vomiting (being sick) 
 Weight loss including decreased appetite 
 
Uncommon: 
 Paranoia (e.g. excessive fear for one’s own well-being) 
 Delusion 
 Excessive daytime sleepiness and suddenly falling asleep 
 Amnesia (memory disturbance) 
 Hyperkinesia (increased movements and inability to keep still) 
 Weight increase 
 Allergic reactions (e.g. rash, itching, hypersensitivity) 
 Fainting 
 Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)* 
 Inappropriate antidiuretic hormone secretion* 
 Restlessness 
 Dyspnoea (difficulties to breathe) 
 Hiccups 
 Pneumonia (infection of the lungs) 
 Inability to resist the impulse, drive or temptation to perform an action that could be harmful to 

you or others, 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 

(eating more food than normal and more than is needed to satisfy your hunger)* 
 Delirium (decreased awareness, confusion, loss of reality) 
 
Rare: 
 Mania (agitation, feeling elated or over excited) 
 
Not known: 
- After stopping or reducing your Pramipexole Accord treatment: Depression, apathy, anxiety, 

fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).  



 

42 

 
Tell your doctor if you experience any of these behaviours; he will discuss ways of managing or 
reducing the symptoms. 
For the side effects marked with * a precise frequency estimation is not possible, since these side 
effects were not observed in clinical studies among 2,762 patients treated with pramipexole. The 
frequency category is probably not greater than “uncommon”. 
 
If you suffer from other indication, you may experience the following side effects: 
 
Very common: 
 Nausea (sickness) 
 
Common: 
 Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness 
 Tiredness (fatigue) 
 Headache 
 Abnormal dreams 
 Constipation 
 Dizziness 
 Vomiting (being sick) 
 
Uncommon: 
 Urge to behave in an unusual way* 
 Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)* 
 Inappropriate antidiuretic hormone secretion* 
 Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs) 
 Hyperkinesia (increased movements and inability to keep still)* 
 Paranoia (e.g. excessive fear for one’s own well-being)* 
 Delusion* 
 Amnesia (memory disturbance)* 
 Hallucinations (seeing, hearing or feeling things that are not there) 
 Confusion 
 Excessive daytime sleepiness and suddenly falling asleep 
 Weight increase 
 Hypotension (low blood pressure) 
 Excess of fluid, usually in the legs (peripheral oedema) 
 Allergic reactions (e.g. rash, itching, hypersensitivity) 
 Fainting 
 Restlessness 
 Visual impairment 
 Weight loss including decreased appetite 
 Dyspnoea (difficulties to breathe) 
 Hiccups 
 Pneumonia (infection of the lungs)* 
 Inability to resist the impulse, drive or temptation to perform an action that could be harmful to 

you or others, 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 

(eating more food than normal and more than is needed to satisfy your hunger)* 
 Mania (agitation, feeling elated or over excited)* 
 Delirium (decreased awareness, confusion, loss of reality)* 
 



 

43 

Not known: 
- After stopping or reducing your Pramipexole Accord treatment: Depression, apathy, anxiety, 

fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).  
 
Tell your doctor if you experience any of these behaviors; he will discuss ways of managing or 
reducing the symptoms. 
For the side effects marked with * a precise frequency estimation is not possible, since these side 
effects were not observed in clinical studies among 1,395 patients treated with pramipexole. The 
frequency category is probably not greater than “uncommon”. 
 
Reporting of side effects  
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Pramipexole Accord 
  
 Keep this medicine out of the sight and reach of children. 
 Do not use this medicine after the expiry date which is stated on the carton after EXP. The 

expiry date refers to the last day of that month. 
 Store below 30°C. Store in the original package in order to protect from light. 
 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 Pramipexole Accord tablet contains: 
 
The active ingredient is pramipexole. 
 
Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg 
pramipexole. 
Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg 
pramipexole. 
Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg 
pramipexole. 
Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg 
pramipexole. 
Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.1 mg 
pramipexole. 
 
The other ingredients are mannitol, cellulose microcrystalline, maize starch, silica colloidal 
anhydrous, povidone K 30 and magnesium stearate. 
 
What Pramipexole Accord tablet looks like and contents of the pack 
 
Pramipexole Accord 0.088 mg tablets are white to off-white, round, flat faced, bevel edged, with 
inscription ‘I1’ on one side and plain on the other side. 
 
Pramipexole Accord 0.18 mg tablets are white to off-white, round, flat faced, bevel edged, with 
inscription ‘I’ and ‘2’ on either side of the breakline on one side and breakline on the other side. 
 



 

44 

Pramipexole Accord 0.35 mg tablets are white to off-white, round, flat faced, bevel edged, with 
inscription ‘I’ and ‘3’ on either side of the breakline on one side and breakline  on the other side. 
 
Pramipexole Accord 0.7 mg tablets are white to off-white, round, flat faced, bevel edged, with 
inscription ‘I’ and ‘4’ on either side of the breakline on one side and breakline  on the other side.. 
 
Pramipexole Accord 1.1 mg tablets are white to off-white, round, flat faced, bevel edged, with 
inscription ‘I’ and ‘5’ on either side of the breakline on one side and breakline on other side. 
 
All the strengths of Pramipexole Accord tablets are available in alu-alu blisters of 10 tablets per strip, 
in cartons containing 3 or 10 blister strips (30 or 100 tablets).  
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
Marketing Authorisation Holder 
Accord Healthcare S.L.U.  
World Trade Center, Moll de Barcelona, s/n,  
Edifici Est 6ª planta,  
08039 Barcelona,  
Spain 
 
Manufacturer 
Accord Healthcare Limited,  
Sage house, 319 Pinner road,  
North Harrow  
HA1 4HF, Middlesex,  
United Kingdom 
 
Accord Healthcare Polska Sp.z o.o., 
ul. Lutomierska 50,95-200 Pabianice, Poland 
 
 
The leaflet was last revised in {MM/YYYY}. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
 


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