Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000) very rare (<1/10,000), not known (cannot be estimated from the available data).


In monotherapy                              In adjunct therapy
Immune system disorders
Not known                           Hypersensitivity reactions (including urticaria, angioedema, rash, pruritus).
Psychiatric disorders
Common                              hallucinations                              Confusion Uncommon                            Psychotic reactions (other than             Psychotic reactions (other than hallucinations) including delirium,         hallucinations) including delirium, delusion, paranoia.                         delusion, paranoia.
Not known                           Aggression*
Dopamine dysregulation syndrome
Not known                           Impulse control disorders including pathological gambling, compulsive shopping, binge eating and hypersexuality and increased libido, have been reported in post marketing reports (see section 4.4)
Nervous system disorders
Very common                        Syncope , Somnolence                    Somnolence, dyskinesia. In patients with advanced Parkinson's disease,
dyskinesias can occur during the initial titration of ropinirole. In clinical trials it was shown that a reduction of the levodopa dose may ameliorate dyskinesia (see section 4.2) common                             dizziness (including vertigo)           dizziness (including vertigo).
Uncommon                           Sudden onset of sleep, excessive        Sudden onset of sleep, excessive daytime somnolence                      daytime somnolence
Ropinirole is associated with somnolence and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes.
Vascular disorders
Uncommon                           Postural hypotension or hypotension is rarely severe Gastrointestinal disorders
Very common                                                                Nausea Common                             Vomiting, abdominal pain                Heartburn Hepatobiliary disorders
Not known                          Hepatic reactions, mainly increased liver enzymes General disorders and administrative site condiions
Common                           oedema peripheral (including leg oedema).
* Aggression has been associated with psychotic reactions as well as compulsive symptoms 
Additional adverse events observed during clinical trial with Ropinirole film-coated (immediate-release) tablets in patients in early stage Parkinson‟s disease: dyskinesia, dizziness, hallucinations, headache and increased sweating.
Additional adverse events observed during clinical trial with Ropinirole film-coated (immediate-release) tablets in patients in advanced stage Parkinson‟s disease: dizziness, asthenic condition and viral infection.
Other adverse events were reported but their frequency is not known (see section 4.4. „Special warnings and precautions for use‟):

Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including ROPINIROLE TEVA® (see section 4.4.).

-emergent Hyperpyrexia and Confusion.


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.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il