Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Side effects that occur frequently with Dopicar are those due to the central neuropharmacological activity of dopamine. These reactions can usually be diminished by dosage reduction. The most common are dyskinesias including choreiform, dystonic and other involuntary movements and nausea. Muscle twitching and blepharospasm may be taken as early signs to consider dosage reduction.
Other side effects reported in clinical trials or in post-marketing experience include: Infections and infestations: urinary tract infections (frequency: very common) Body as a whole: syncope, chest pain, anorexia.
Cardiovascular: cardiac irregularities and/or palpitations, orthostatic effects including hypotensive episodes, hypertension, phlebitis.
Gastrointestinal: vomiting, gastrointestinal bleeding, development of duodenal ulcer, diarrhoea, dark saliva.
Haemotologic: leucopenia, haemolytic and non-haemolytic anaemia, thrombocytopenia, agranulocytosis.
Hypersensitivity: angioedema, urticaria, pruritus, Henoch-Schonlein purpura.
Nervous System/Psychiatric: neuroleptic malignant syndrome (see section 4.3 ‘Contraindications’), bradykinetic episodes (the “on-off” phenomenon), dizziness, paraesthesia, psychotic episodes including delusions, hallucinations and paranoid ideation, depression with or without development of suicidal tendencies, dementia, dream abnormalities, agitation, confusion, increased libido. Levodopa is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes.
Respiratory: dyspnoea.
Skin: alopecia, rash, dark sweat.
Urogenital: dark urine.
Rarely convulsions have occurred; however, a causal relationship with Dopicar has not been established.
Other side effects that have been reported with levodopa or levodopa/carbidopa combinations and may be potential side effects with Dopicar include:
Gastrointestinal: dyspepsia, dry mouth, bitter taste, sialorrhoea, dysphagia, bruxism, hiccups, abdominal pain and distress, constipation, flatulence, burning sensation of the tongue.
Metabolic: weight gain or loss, oedema.
Nervous System/Psychiatric: asthenia, decreased mental acuity, disorientation, ataxia, numbness, increased hand tremor, muscle cramp, trismus, activation of latent Horner’s syndrome, insomnia, anxiety, euphoria, falling, gait abnormalities and Dopamine Dysregulation Syndrome.
Description of selected adverse reactions
Dopamine Dysregulation Syndrome (DDS) is an addictive disorder seen in some patients treated with carbidopa/ levodopa. Affected patients show a compulsive pattern of dopaminergic drug misuse above doses adequate to control motor symptoms, which may in some cases result in severe dyskinesias (see also section 4.4).
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 and/or other dopaminergic treatments containing levodopa including Dopicar (see section 4.4. ‘Special warnings and precautions for use’)
Skin: flushing, increased sweating.
Special senses: diplopia, blurred vision, dilated pupils, oculogyric crises.
Urogenital: urinary retention, urinary incontinence, priapism.
Miscellaneous: weakness, faintness, fatigue, headache, hoarseness, malaise, hot flushes, sense of stimulation, bizarre breathing patterns, malignant melanoma (see section 4.3 ‘Contraindications’).
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