Pramipexole Teva

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 



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1.  NAME OF THE MEDICINAL PRODUCT  
 
Pramipexole Teva 0.088 mg tablets 
Pramipexole Teva 0.18 mg tablets 
Pramipexole Teva 0.35 mg tablets 
Pramipexole Teva 0.7 mg tablets 
 
 
2.  QUALITATIVE AND QUANTITATIVE COMPOSITION  
 
Pramipexole Teva 0.088 mg tablets 
Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg 
pramipexole.  
 
Pramipexole Teva 0.18 mg tablets 
Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg 
pramipexole. 
 
Pramipexole Teva 0.35 mg tablets 
Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg 
pramipexole.  
 
Pramipexole Teva 0.7 mg tablets 
Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 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 Teva 0.088 mg tablets 
White, round, flat face bevel edge tablet, 5.55 mm diameter, embossed with “93” on one side and “P1” 
on the other side.  
 
Pramipexole Teva 0.18 mg tablets 
White, round, flat face bevel edge tablet, 7.00 mm diameter, embossed with "P2" over "P2" on the 
scored side and "93" on the other side. The tablet can be divided into equal halves. 
 
Pramipexole Teva 0.35 mg tablets 
White to off-white, oval, biconvex tablets, engraved with 9 vertical scoreline 3 on the scored side, and 
8023 on the other side. The tablet can be divided into equal halves. 
 
Pramipexole Teva 0.7 mg tablets 
White, round, flat face bevel edge tablet, 8.82 mm diameter, embossed with "8024" over "8024" on the 
scored side and "93" on the other side. The tablet can be divided into equal halves.  
 
 



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4.  CLINICAL PARTICULARS  
 
4.1  Therapeutic indications  
 
Pramipexole Teva 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).  
 
Pramipexole Teva is indicated in adults for symptomatic treatment of moderate to severe idiopathic 
Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt) (see section 4.2). 
 
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 Teva    
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 
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 Teva, 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 or a dopamine agonist withdrawal 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). Dopamine agonist withdrawal syndrome could still appear while 
tapering and a temporary increase of the dose could be necessary before resuming tapering (see 
section 4.4). 



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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 
Teva 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 Teva 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 Teva 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 Teva 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 Teva pharmacokinetics has not been investigated.  
 
Paediatric population 
The safety and efficacy of Pramipexole Teva in children below 18 years has not been established. 
There is no relevant use of Pramipexole Teva in the paediatric population for the indication of 
Parkinson’s Disease. 
 
Restless Legs Syndrome 
 
The recommended starting dose of Pramipexole Teva is 0.088 mg of base (0.125 mg of salt) taken 
once daily 2-3 hours before bedtime. For patients requiring additional symptomatic relief, the dose 
may be increased every 4-7 days to a maximum of 0.54 mg of base (0.75 mg of salt) per day (as 
shown in the table below). 
 
Dose Schedule of Pramipexole Teva  
Titration Step  Once Daily Evening Dose 

(mg of base) 
Once Daily Evening Dose 
(mg of salt) 

1 0.088 0.125 
2* 0.18 0.25 
3* 0.35 0.50 
4* 0.54 0.75 
* if needed 
 
Patient’s response should be evaluated after 3 months treatment and the need for treatment 
continuation should be reconsidered. If treatment is interrupted for more than a few days it should be 
re-initiated by dose titration carried out as above. 
 
Treatment discontinuation 
Since the daily dose for the treatment of Restless Legs Syndrome will not exceed 0.54 mg of base 
(0.75 mg of salt) Pramipexole Teva can be discontinued without tapering off. In a 26 week placebo 
controlled trial, rebound of RLS symptoms (worsening of symptom severity as compared to baseline) 



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was observed in 10% of patients (14 out of 135) after abrupt discontinuation of treatment. This effect 
was found to be similar across all doses. 
 
Renal impairment 
The elimination of pramipexole is dependent on renal function. Patients with a creatinine clearance 
above 20 ml/min require no reduction in daily dose. 
The use of Pramipexole Teva has not been studied in haemodialysis patients, or in patients with severe 
renal impairment. 
 
Hepatic impairment 
Dose adjustment in patients with hepatic failure is not required, as approx. 90% of absorbed active 
substance is excreted through the kidneys. 
 
Paediatric population 
Pramipexole Teva is not recommended for use in children and adolescents below 18 years due to a 
lack of data on safety and efficacy. 
 
Tourette Disorder 
 
Paediatric population 
Pramipexole Teva 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 Teva 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. 
 
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 Teva 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 Teva. 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. 
 



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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 
Teva. 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 
Teva. 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. 
 
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 (DAWS) 
DAWS has been reported with dopamine agonists, including pramipexole (see section 4.8). To 
discontinue treatment in patients with Parkinson’s disease, pramipexole should be tapered off (see 
section 4.2). Limited data suggests that patients with impulse control disorders and those receiving 
high daily dose and/or high cumulative doses of dopamine agonists may be at higher risk for 
developing DAWS. Withdrawal symptoms may include apathy, anxiety, depression, fatigue, sweating 
and pain and do not respond to levodopa. Prior to tapering off and discontinuing pramipexole, patients 
should be informed about potential withdrawal 
symptoms. Patients should be closely monitored during tapering and discontinuation. In case 
of severe and/or persistent withdrawal symptoms, temporary re-administration of 
pramipexole at the lowest effective dose may be considered. 
 
Augmentation 
Reports in the literature indicate that treatment of Restless Legs Syndrome 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. 



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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. 
 
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-
free’. 
 
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 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 Teva.  
 
Combination with levodopa 
When Pramipexole Teva 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 Teva.  
 
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 Teva should not be used during pregnancy unless clearly necessary, i.e. if the potential 
benefit justifies the potential risk to the foetus.  
 
Breast-feeding 
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 Teva 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. 
 



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4.7  Effects on ability to drive and use machines  
 
Pramipexole Teva can have a major influence on the ability to drive and use machines.  
 
Hallucinations or somnolence can occur. 
 
Patients being treated with Pramipexole Teva 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 
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.  
 
Table 1: Parkinson’s disease 



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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   

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 weight increase   



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including 
decreased 
appetite 

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. 

 
Restless Legs Syndrome, most common adverse reactions 
The most commonly (≥ 5 %) reported adverse drug reactions in patients with Restless Legs Syndrome 
treated with pramipexole were nausea, headache, dizziness and fatigue. Nausea and fatigue were more 
often reported in female patients treated with pramipexole (20.8 % and 10.5 %, respectively) 
compared to males (6.7 % and 7.3 %, respectively).  
 
Table 2: Restless Legs Syndrome 
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 
behavioural symptoms of impulse 
control disorders and compulsions1 
(such as: compulsive shopping, 
pathological gambling, 
hypersexuality, binge eating) 

 

Nervous 
system 
disorders 

 headache 
dizziness 
somnolence 

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   hypersensitivity   



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subcutaneous 
tissue disorders 

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 Restless Legs Syndrome 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).  
 
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 
Teva (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 



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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.  
 
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.  
 
The mechanism of action of pramipexole as treatment for Restless Legs Syndrome is unknown. 
Neuropharmacological evidence suggests primary dopaminergic system involvement. 
 
Pharmacodynamic effects 
In human volunteers, a dose-dependent decrease in prolactin was observed. In a clinical trial with 
healthy volunteers, where pramipexole prolonged-release tablets were titrated faster (every 3 days) 
than recommended up to 3.15 mg pramipexole base (4.5 mg of salt) per day, an increase in blood 
pressure and heart rate was observed. Such effect was not observed in patient studies. 
 
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.  
 

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Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies with 
pramipexole 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 Restless Legs Syndrome 
The efficacy of pramipexole was evaluated in four placebo-controlled clinical trials in approximately 
1,000 patients with moderate to very severe idiopathic Restless Legs Syndrome. 
 
The mean change from baseline in the Restless Legs Syndrome Rating Scale (IRLS) and the Clinical 
Global Impression-Improvement (CGI-I) were the primary efficacy outcome measures. For both 
primary endpoints statistically significant differences have been observed for the pramipexole dose 
groups 0.25 mg, 0.5 mg and 0.75 mg pramipexole salt in comparison to placebo. After 12 weeks of 
treatment the baseline IRLS score improved from 23.5 to 14.1 points for placebo and from 23.4 to 9.4 
points for pramipexole (doses combined). The adjusted mean difference was -4.3 points (CI 95% -6.4; 
-2.1 points, p-value <0.0001). CGI-I responder rates (improved, very much improved) were 51.2% and 
72.0% for placebo and pramipexole, respectively (difference 20% CI 95%: 8.1%; 31.8%, p<0.0005). 
Efficacy was observed with 0.088 mg of base (0.125 mg of salt) per day after the first week of 
treatment. 
 
In a placebo-controlled polysomnography study over 3 weeks pramipexole significantly reduced the 
number of periodic limb movements during time in bed. 
 
Longer term efficacy was evaluated in a placebo-controlled clinical trial. After 26 weeks of treatment, 
there was an adjusted mean reduction in IRLS total score of 13.7 and 11.1 points in the pramipexole 
and placebo group, respectively, with a statistically significant (p = 0.008) mean treatment difference 
of -2.6. CGI-I responder rates (much improved, very much improved) were 50.3% (80/159) and 68.5% 
(111/162) for placebo and pramipexole, respectively (p = 0.001), corresponding to a number needed to 
treat (NNT) of 6 patients (95%CI: 3.5, 13.4). 
 
Paediatric population 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
pramipexole in one or more subsets of the paediatric population in Restless Legs Syndrome (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). 
 



14 

5.2  Pharmacokinetic properties  
 
Absorption 
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 
Microcrystalline cellulose 
Sodium starch glycolate 
Povidone K25 
Magnesium stearate 



15 

Sodium stearyl fumarate 
Colloidal silicon dioxide.  
 
6.2  Incompatibilities  
 
Not applicable  
 
6.3  Shelf life  
 
2 years  
 
6.4  Special precautions for storage  
 
Do not store above 25 °C. 
Store in the original package in order to protect from light and moisture. 
 
6.5  Nature and contents of container  
 
Aluminium/Aluminium Blister  
Pack sizes: 30, 30 x 1, 50 x 1, 100 x 1 and 100 tablets 
 
Polyethylene tablet container with CRC polypropylene cap. Pack sizes: 90 tablets. 
 
Not all pack sizes may be marketed 
 
6.6  Special precautions for disposal 
 
No special requirements. 
 
 
7.  MARKETING AUTHORISATION HOLDER  
 
Teva B.V. 
Swensweg 5, 2031GA Haarlem 
The Netherlands 
 
 
8.  MARKETING AUTHORISATION NUMBER(S)  
 
Pramipexole Teva 0.088 mg tablets 
EU/1/08/490/001 
EU/1/08/490/002 
EU/1/08/490/003 
EU/1/08/490/004 
EU/1/08/490/017 
EU/1/08/490/018 
 
Pramipexole Teva 0.18 mg tablets 
EU/1/08/490/005 
EU/1/08/490/006 
EU/1/08/490/007 
EU/1/08/490/008 
EU/1/08/490/019 
EU/1/08/490/020 
 



16 

Pramipexole Teva 0.35 mg tablets 
EU/1/08/490/009 
EU/1/08/490/010 
EU/1/08/490/011 
EU/1/08/490/012 
EU/1/08/490/021 
EU/1/08/490/022 
 
Pramipexole Teva 0.7 mg tablets 
EU/1/08/490/013 
EU/1/08/490/014 
EU/1/08/490/015 
EU/1/08/490/016 
EU/1/08/490/023 
EU/1/08/490/024 
 
 
9.  DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION  
 
Date of first authorisation: 18 December 2008 
Date of latest renewal: 26 August 2013 
 
 
10.  DATE OF REVISION OF THE TEXT  
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 
  

http://www.emea.europa.eu/


17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH 

RELEASE 
 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 
AND USE 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 
D.  CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 



18 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Teva Pharmaceutical Works Co. Ltd. 
Pallagi Street 13 
H-4042 Debrecen 
Hungary 
 
TEVA Pharmaceutical Works Private Limited Company 
H-2100 Gödöllő,  
Táncsics Mihály út 82 
Hungary  
 
TEVA UK Ltd  
Brampton Road,  
Hampden Park,  
Eastbourne,  
East Sussex,  
BN22 9AG  
United Kingdom 
 
Pharmachemie B.V.  
Swensweg 5,  
Postbus 552,  
2003 RN Haarlem  
The Netherlands   
 
GALIEN LPS 
98 rue Bellocier 
89100 Sens 
France 
 
Teva Czech Industries s.r.o. 
Ostravska 29, c.p. 305 
747 70 Opava-Komarov 
Czech Republic 
 
Merckle GmbH  
Ludwig-Merckle-Straße 3 
89143 Blaubeuren 
Germany 
 
Balkanpharma Dupnitsa AD 
3 Samokovsko Shosse Str., 
Dupnitsa 2600,  
Bulgaria 
 
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. 
 



19 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION 

 
• Periodic safety update reports (PSURs) 

 
At the time of granting the marketing authorisation, the submission of PSURs is not required for this 
medicinal product. However, the marketing authorisation holder (MAH) shall submit PSURs for this 
medicinal product if the product is included in the list of Union reference dates (EURD list) provided 
for under Article 107c(7) of Directive 2001/83/EC and 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. 
 
 
 
 
 
 
 
 
 
 



 
 

20 

 
 

 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



 
 

21 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 

A. LABELLING 
  



 
 

22 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
Carton – Pramipexole Teva 0.088 mg Tablets  
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pramipexole Teva 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 
 
Tablets 
 
Blisters: 
30 tablets 
50 x 1 tablets 
100 tablets 
30 x 1 tablets 
100 x 1 tablets 
 
Tablet container: 
90 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. Read the package leaflet before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



 
 

23 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25 °C. 
Store in the original package in order to protect from light and moisture.  
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5, 2031GA Haarlem 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/08/490/001 
EU/1/08/490/002 
EU/1/08/490/003 
EU/1/08/490/004 
EU/1/08/490/017 
EU/1/08/490/018 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pramipexole Teva 0.088 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN  



 
 

24 

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



 
 

25 

PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS 
 
Self-adhesive, paper label -Pramipexole Teva 0.088 mg Tablets 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pramipexole Teva 0.088 mg tablets 
pramipexole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole.  
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablets 
 
90 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. Read the package leaflet before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25 °C. 
Store in the original package in order to protect from light and moisture.  
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 



 
 

26 

 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5, 2031GA Haarlem 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/08/490/004 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 
  



 
 

27 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
Carton – Pramipexole Teva 0.18 mg tablets 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pramipexole Teva 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 
 
Tablets 
 
Blisters: 
30 tablets 
50 x 1 tablets 
100 tablets 
30 x 1 tablets 
100 x 1 tablets 
 
Tablet container: 
90 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. Read the package leaflet before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



 
 

28 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25 °C. 
Store in the original package in order to protect from light and moisture 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5, 2031GA Haarlem 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/08/490/005 
EU/1/08/490/006 
EU/1/08/490/007 
EU/1/08/490/008 
EU/1/08/490/019 
EU/1/08/490/020 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pramipexole Teva 0.18 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 – Pramipexole Teva 0.18 mg tablets 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pramipexole Teva 0.18 mg tablets 
pramipexole  
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
 



 
 

30 

PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS 
 
self-adhesive, paper label - Pramipexole Teva 0.18 mg tablets 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pramipexole Teva 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 
 
Tablets 
 
90 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. Read the package leaflet before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25 °C. 
Store in the original package in order to protect from light and moisture 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 



 
 

31 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5, 2031GA Haarlem 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/08/490/008 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 



 
 

32 

  
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton – Pramipexole Teva 0.35 mg Tablets 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pramipexole Teva 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 
 
Tablets 
 
Blisters: 
30 tablets 
50 x 1 tablets 
100 tablets 
30 x 1 tablets 
100 x 1 tablets 
 
Tablet container: 
90 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. Read the package leaflet before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



 
 

33 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 
Store in the original package in order to protect from light and moisture.  
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5, 2031GA Haarlem 
The Netherlands  
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/08/490/009 
EU/1/08/490/010 
EU/1/08/490/011 
EU/1/08/490/012 
EU/1/08/490/021 
EU/1/08/490/022 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Pramipexole Teva 0.35 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN  



 
 

34 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
  
Blister – Pramipexole Teva 0.35 mg Tablets 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pramipexole Teva 0.35 mg tablets 
pramipexole  
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
 
 



 
 

35 

PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS 
 
Self-adhesive, paper label – Pramipexole Teva 0.35 mg Tablets 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pramipexole Teva 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 
 
Tablets 
 
90 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. Read the package leaflet before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25 °C. 
Store in the original package in order to protect from light and moisture.  
 
 



 
 

36 

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

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5, 2031GA Haarlem 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/08/490/012 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
Not applicable 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 



 
 

37 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
Carton – Pramipexole Teva 0.7 mg tablets  
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pramipexole Teva 0.7 mg tablets 
pramipexole  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg 
pramipexole.  
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablets 
 
Blisters: 
30 tablets 
50 x 1 tablets 
100 tablets 
30 x 1 
100 x 1 
 
Tablet container: 
90 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. Read the package leaflet before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



 
 

38 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25 °C. 
Store in the original package in order to protect from light and moisture.  
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
  
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5, 2031GA Haarlem 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/08/490/013 
EU/1/08/490/014 
EU/1/08/490/015 
EU/1/08/490/016 
EU/1/08/490/023 
EU/1/08/490/024 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
Not applicable 
 
 
16. INFORMATION IN BRAILLE 
 
Pramipexole Teva 0.7 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



 
 

39 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
  



 
 

40 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister – Pramipexole Teva 0.7 mg tablets 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pramipexole Teva 0.7 mg tablets 
pramipexole  
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Not applicable 
 
 
 



 
 

41 

PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS 
 
self-adhesive, paper label - Pramipexole Teva 0.7 mg tablets 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pramipexole Teva 0.7 mg tablets 
pramipexole  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg 
pramipexole.  
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Tablets 
 
90 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. Read the package leaflet before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25 °C. 
Store in the original package in order to protect from light and moisture 
 
 



 
 

42 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5, 2031GA Haarlem 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/08/490/016 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
Not applicable 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 
  



 
 

43 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 

B. PACKAGE LEAFLET 



 
 

44 

Package leaflet: Information for the user 
 

Pramipexole Teva 0.088 mg tablets 
Pramipexole Teva 0.18 mg tablets 
Pramipexole Teva 0.35 mg tablets 
Pramipexole Teva 0.7 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 Teva is and what it is used for 
2. What you need to know before you take Pramipexole Teva  
3. How to take Pramipexole Teva 
4. Possible side effects 
5. How to store Pramipexole Teva 
6. Contents of the pack and other information 
 
1. What Pramipexole Teva is and what it is used for 
 
Pramipexole Teva 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 Teva 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). 
• treat the symptoms of moderate to severe primary Restless Legs Syndrome in adults. 
 
2. What you need to know before you take Pramipexole Teva 
 
Do not take Pramipexole Teva 
• 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 Teva. 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 Teva. 

• Dystonia (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).  



 
 

45 

• 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 Teva. 
• 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 Teva treatment. If the problems persist more than a 
few weeks, your doctor may need to adjust your treatment. 
 
Tell your doctor if you are developing an inability of keeping your body and neck straight and upright 
(axial dystonia). If this happens, your doctor may want to adjust or change your medication. 
 
Children and adolescents 
Pramipexole Teva is not recommended for use in children or adolescents under 18 years. 
 
Other medicines and Pramipexole Teva 
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 Teva 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 Teva. 
 
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 Teva may affect your ability to drive and operate 
machinery. 
 



 
 

46 

Pramipexole Teva with food, drink and alcohol 
You should be cautious while drinking alcohol during treatment with Pramipexole Teva. 
Pramipexole Teva 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 Teva.  
 
The effect of Pramipexole Teva on the unborn child is not known. Therefore, do not take Pramipexole 
Teva if you are pregnant unless your doctor tells you to do so. 
 
Pramipexole Teva should not be used during breast-feeding. Pramipexole Teva can reduce the 
production of breast milk. Also, it can pass into the breast milk and can reach your baby. If use of 
Pramipexole Teva is unavoidable, breast-feeding should be stopped. 
 
Ask your doctor or pharmacist for advice before taking any medicine. 
 
Driving and using machines 
Pramipexole Teva can cause hallucinations (seeing, hearing or feeling things that are not there). If 
affected, do not drive or use machines. 
 
Pramipexole Teva 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. 
 
Pramipexole Teva contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-
free’. 
 
3. How to take Pramipexole Teva 
 
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 Teva 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 Teva 0.088 mg three times a day 
(equivalent to 0.264 mg daily): 
 
 1st week 
Number of tablets 1 tablet Pramipexole Teva 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 tablet Pramipexole Teva 

0.18 mg three times a day 
OR 
2 tablets Pramipexole Teva 
0.088 mg three times a day 

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



 
 

47 

Total daily dose (mg) 0.54 1.1 
  
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 Teva 0.088 mg tablets a day is 
also possible. 
 
 Lowest maintenance dose Highest maintenance dose 
Number of tablets 1 tablet Pramipexole Teva 

0.088 mg three times a day 
1 tablet containing 1.1 mg 
pramipexole 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 tablet Pramipexole Teva 0.088 mg twice a day. In severe kidney disease, the 
usual starting dose is just 1 tablet Pramipexole Teva 0.088 mg a day. 
 
Restless Legs Syndrome 
The dose is usually taken once a day, in the evening, 2-3 hours before bedtime. 
 
During the first week, the usual dose is 1 tablet Pramipexole Teva 0.088 mg once a day (equivalent to 
0.088 mg daily): 
 
 1st week 
Number of tablets 1 tablet Pramipexole Teva 0.088 mg 
Total daily dose (mg) 0.088 

 
This will be increased every 4-7 days as directed by your doctor until your symptoms are controlled 
(maintenance dose). 
 
 2nd week 3rd week 4th week 
Number of 
tablets 

1 tablet Pramipexole Teva 
0.18 mg 
OR 
2 tablets Pramipexole Teva 
0.088 mg 

1 tablet Pramipexole Teva 
0.35 mg 
OR 
2 tablets Pramipexole Teva 
0.18 mg 
OR 
4 tablets Pramipexole Teva 
0.088 mg 

1 tablet Pramipexole 
Teva 0.35 mg and 1 tablet 
Pramipexole Teva 
0.18 mg 
OR 
3 tablets Pramipexole Teva 
0.18 mg 
OR 
6 tablets Pramipexole Teva 
0.088 mg 

Total daily 
dose (mg) 

0.18 0.35 0.54 

 
The daily dose should not exceed 6 tablets Pramipexole Teva 0.088 mg or a dose of 0.54 mg (0.75 mg 
pramipexole salt). 
 
If you stop taking your tablets for more than a few days and want to restart the treatment, you must 
start again at the lowest dose. You can then build up the dose again, as you did the first time. Ask your 
doctor for advice. 
 
Your doctor will review your treatment after 3 months to decide whether or not to continue the 
treatment. 



 
 

48 

 
Patients with kidney disease 
If you have severe kidney disease, Pramipexole Teva may not be a suitable treatment for you. 
 
If you take more Pramipexole Teva 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 Teva  
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 Teva 
Do not stop taking Pramipexole Teva 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 Teva 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 stop or reduce Pramipexole Teva you may also develop a medical condition called dopamine 
agonist withdrawal syndrome. The symptoms include depression, apathy, anxiety, fatigue, sweating or 
pain. If you experience these symptoms you should contact your physician. 
 
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 
 
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) 
 



 
 

49 

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 Teva 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 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”. 
 



 
 

50 

If you suffer from Restless Legs Syndrome, 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)* 
 
Not known: 
• After stopping or reducing your Pramipexole Teva 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. 



 
 

51 

 
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 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 Pramipexole Teva 
 
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, blister or bottle label after 
EXP. The expiry date refers to the last day of that month.  
 
Do not store above 25 ºC. 
Store in the original package in order to protect from light and moisture.  
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
6. Contents of the pack and other information 

 
What Pramipexole Teva contains 
 
The active substance is pramipexole. 
 
Each tablet contains 0.088 mg, 0.18 mg, 0.35 mg, or 0.7 mg pramipexole as 0.125 mg, 0.25 mg, 
0.5 mg, or 1 mg pramipexole dihydrochloride monohydrate, respectively. 
 
The other ingredients are mannitol, microcrystalline cellulose, sodium starch glycolate, povidone, 
magnesium stearate, sodium stearyl fumarate, colloidal silicon dioxide. 
 
What Pramipexole Teva looks like and contents of the pack 
• Pramipexole Teva 0.088 mg tablets are white, round tablets, embossed with "93" on one side 

and "P1" on the other side.  
• Pramipexole Teva 0.18 mg tablets are white round, scored tablets embossed with "P2" over 

"P2" on the scored side and "93" on the other side. The tablet can be divided into equal halves. 
• Pramipexole Teva 0.35 mg tablets are white, oval, biconvex tablets, engraved with 9 vertical 

scoreline 3 on the scored side, and 8023 on the other side. The tablet can be divided into equal 
halves. 

• Pramipexole Teva 0.7 mg tablets are white, round, scored tablets embossed with "8024" over 
"8024" on the scored side and "93" on the other side. The tablet can be divided into equal 
halves.  

• Pramipexole Teva tablets are available in blister packs of 30, 30 x 1, 50 x 1, 100 x 1 and 100 
tablets and bottles containing 90 tablets. 

 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Teva B.V. 
Swensweg 5, 2031GA Haarlem 
The Netherlands 

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


 
 

52 

 
Manufacturer 
TEVA Pharmaceutical Works Private Limited Company  
Pallagi út 13,  
4042 Debrecen, 
Hungary 
 
TEVA Pharmaceutical Works Private Limited Company 
H-2100 Gödöllő,  
Táncsics Mihály út 82 
Hungary  
 
TEVA UK Ltd  
Brampton Road,  
Hampden Park,  
Eastbourne,  
East Sussex,  
BN22 9AG  
United Kingdom 
 
Pharmachemie B.V.  
Swensweg 5,  
Postbus 552,  
2003 RN Haarlem  
The Netherlands  
 
GALIEN LPS 
98 rue Bellocier 
89100 Sens 
France 
 
Teva Czech Industries s.r.o  
Ostravska 29, c.p. 305 
747 70 Opava-Komarov 
Czech Republic 
 
Merckle GmbH  
Ludwig-Merckle-Straße 3 
89143 Blaubeuren 
Germany 
 
Balkanpharma Dupnitsa AD 
3 Samokovsko Shosse Str., 
Dupnitsa 2600,  
Bulgaria 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 

België/Belgique/Belgien  
Teva Pharma Belgium N.V./S.A./AG  
Tél/Tel: +32 38207373  

Lietuva 
UAB Teva Baltics 
Tel: +370 52660203 



 
 

53 

 
България  
Актавис ЕАД 
Teл: +359 24899585  

 
Luxembourg/Luxemburg  
ratiopharm GmbH 
Allemagne/Deutschland 
Tél/Tel: +49 73140202 

 
Česká republika  
Teva Pharmaceuticals CR, s.r.o.  
Tel: +420 251007111 

 
Magyarország  
Teva Gyógyszergyár Zrt. 
Tel: +36 12886400  

 
Danmark  
Teva Denmark A/S  
Tlf: +45 44985511  

 
Malta  
Teva Pharmaceuticals Ireland 
L-Irlanda 
Tel: +353 19127700 
 

Deutschland 
TEVA GmbH 
Tel: +49 73140208 

Nederland  
Teva Nederland B.V. 
Tel: +31 8000228400  

 
Eesti 
UAB Teva Baltics Eesti filiaal 
Tel: +372 6610801 

 
Norge 
Teva Norway AS 
Tlf: +47 66775590 

 
Ελλάδα 
Specifar ΑΒΕΕ 
Τηλ: +30 2118805000 

 
Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43 1970070 

 
España 
Teva Pharma, S.L.U. 
Tel: +34 913873280 

 
Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel: +48 223459300 

 
France 
Teva Santé 
Tél: +33 155917800 

 
Portugal 
Teva Pharma - Produtos Farmacêuticos, 
Lda. 
Tel: +351 214767550 

 
Hrvatska 
Pliva Hrvatska d.o.o. 
Tel: +385 13720000 

 
România 
Teva Pharmaceuticals S.R.L. 
Tel: +40 212306524 

 
Ireland 
Teva Pharmaceuticals Ireland 
Tel: +353 19127700 

 
Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 15890390 

 
Ísland 
Teva Finland Oy 
Finnland 
Sími: +358 201805900 

 
Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 257267911 

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

 
Suomi/Finland 
Teva Finland Oy 
Puh/Tel: +358 201805900 



 
 

54 

 
Κύπρος 
Specifar ΑΒΕΕ, Ελλάδα 
Τηλ: +30 2118805000 

 
Sverige 
Teva Sweden AB 
Tel: +46 42121100 

 
Latvija  
UAB Teva Baltics filiāle Latvijā  
Tel: +371 67323666  

 
United Kingdom 
Teva UK Limited 
Tel: +44 1977628500 

 
This 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 


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