Adverse reactions : תופעות לוואי

4.8.           Undesirable effects

Undesirable effects reported are listed below by system organ class and frequency. It is noted if these undesirable effects were reported in clinical trials as monotherapy or adjunct therapy to levodopa.

Frequencies are defined as: 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).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

The following adverse drug reactions have been reported in either Parkinson’s disease clinical trials with Requip Modotab prolonged-release or film-coated (immediate-release) tablets at doses up to 24 mg/day, or from post-marketing reports:

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 hallucinations) including delirium, delusion, paranoia.
Not known                      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 Requip Modutab (see section 4.4.).
Mania (see section 4.4.)
Aggression*
Dopamine dysregulation syndrome
Nervous system disorders
Very common                     Somnolence                         Somnolence** 
Syncope                           Dyskinesia***

Common                        Dizziness (including vertigo), sudden onset of sleep Uncommon                      excessive daytime somnolence
Vascular disorders
Common                                                          Postural hypotension, hypotension
Uncommon                      Postural hypotension,
hypotension
Respiratory, thoracic and mediastinal disorders
Uncommon                      Hiccups
Gastrointestinal disorders
Very common                   Nausea                            Nausea**** Common                        Constipation, heartburn
Vomiting, abdominal pain
Hepatobiliary disorders
Not known                     Hepatic reactions, mainly increased liver enzymes Reproductive system and breast disorders
Not known                     Spontaneous penile erection
General disorders and administrative site conditions
Common                        Oedema peripheral
Leg oedema
Not known                     Dopamine agonist withdrawal syndrome (including apathy, anxiety, depression, fatigue, sweating and pain) *****

*Aggression has been associated with psychotic reactions as well as compulsive symptoms.

** Somnolence has been reported very commonly in the adjunct therapy immediate- release clinical trials, and commonly in the adjunct therapy prolonged-release clinical trials.

*** 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).

****Nausea has been reported very commonly in the adjunct therapy immediate- release clinical trials, and commonly in the adjunct therapy prolonged-release clinical trials.

***** Non-motor adverse effects may occur when tapering or discontinuing dopamine agonists including ropinirole (see section 4.4).

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il/
Additionally, you should also report to GSK Israel (il.safety@gsk.com).