2% of patients on placebo reported at least one adverse reaction. At the beginning of therapy dopaminergic adverse reactions such as nausea and vomiting may occur. These are usually mild or moderate in intensity and transient even if treatment is continued.
Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Neupro are nausea, application site reactions, asthenic conditions and headache. 2% of 748 patients using Neupro, experienced application site reactions.
2% of subjects. Discontinuation rate The discontinuation rate was studied in 3 clinical trials ranging up to 3 years in duration. The percentage of subjects discontinuing was 25-38% over the first year, 10% in the second year, and 11% in the third year.
Periodic assessment of efficacy should be performed, along with evaluation of safety, including augmentation. Tabulated list of adverse reactions The following table covers adverse drug reactions from the pooled studies mentioned above in patients with Restless Legs Syndrome and from post-marketing experience.
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).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. System/organ classes acc. to MedDRA Very common Common Uncommon Rare Not known Immune system disorders Hypersensitivity, which may include angioedema, tongue oedema and lip oedema Psychiatric disorders Sleep attacks/sudden onset of sleep, sexual desire disordersa (incl.
hypersexuality, libido increased), insomnia, sleep disorder, abnormal dreams, impulse-control disordersa,d (incl. pathological gambling, stereotypy/ punding, binge eating/eating disorderb, compulsive shoppingc) Obsessive- compulsive disorder, agitationd Aggressive behaviour/ aggressionb, disorientationd Dopamine dysregulation syndromec, perception disturbancese (incl.
hallucination, hallucination visual, hallucination auditory, illusion), nightmaree, paranoiae, confusional statee, psychotic disordere, delusione, deliriume Nervous system disorders Headache Somnolence Dizzinesse, disturbances in consciousness 8 NECe (incl.
syncope, syncope vasovagal, loss of consciousness), dyskinesiae, dizziness posturale, lethargye, convulsione Eye disorders Vision blurrede, visual impairmente, photopsiae Ear and labyrinth disorders Vertigoe Cardiac disorders Palpitationse, atrial fibrillatione, supraventricular tachycardiae Vascular disorders Hypertension Orthostatic hypotension Hypotensione Respiratory, thoracic and mediastinal disorders Hiccupse Gastrointestinal disorders Nausea Vomiting, dyspepsia Constipatione, dry mouthe, abdominal paine, diarrhoeac Skin and subcutaneous tissue disorders Pruritus Erythemae, hyperhidrosise, pruritus generalisede, skin irritatione, dermatitis contacte, rash generalisede Reproductive system and breast disorder Erectile dysfunctione General disorders and administration site conditions Application and instillation site reactionsa (incl.
erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation, swelling, discolouration, papules, Irritability, oedema peripheral 9 exfoliation, urticaria, hypersensitivity), asthenic conditionsa (incl. fatigue, asthenia, malaise) Investigations Weight decreasede, hepatic enzyme increasede (incl.
AST, ALT, GGT), weight increasede, heart rate increasede, CPK increasedd,e Injury, poisoning and procedural complications Falle Musculoskeletal and connective tissue disorders Rhabdomyolysisc a High Level Term b Observed in open-label studies c Observed during post-marketing d Observed in 2011 data pool of double-blind placebo-controlled studies e Observed in studies performed in patients with Parkinson’s disease Description of selected adverse reactions Sudden onset of sleep and somnolence Rotigotine has been associated with somnolence including excessive daytime somnolence and sudden sleep onset episodes.
7). 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.