Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
• Dopicar is not recommended for the treatment of drug-induced extrapyramidal reactions.
• 'Dopicar should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or history of peptic ulcer disease (because of the possibility of upper gastrointestinal haemorrhage).
• Care should be exercised when Dopicar is administered to patients with a history of myocardial infarction who have residual atrial nodal, or ventricular arrhythmias. Cardiac function should be monitored with particular care in such patients during the period of initial dosage adjustment.
• Levodopa has been associated with somnolence and episodes of sudden sleep onset. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with levodopa. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. Furthermore, a reduction of dosage or termination of therapy may be considered.
• All patients should be monitored carefully for the development of mental changes, depression with suicidal tendencies, and other serious antisocial behaviour. Patients with current psychoses should be treated with caution.
• Dyskinesias may occur in patients previously treated with levodopa alone because carbidopa permits more levodopa to reach the brain and, thus, more dopamine to be formed. The occurrence of dyskinesias may require dosage reduction.
• As with levodopa, Dopicar may cause involuntary movements and mental disturbances. Patients with a history of severe involuntary movements or psychotic episodes when treated with levodopa alone should be observed carefully when Dopicar is substituted. These reactions are thought to be due to increased brain dopamine following administration of levodopa, and use of Dopicar may cause a recurrence. A syndrome resembling the neuroleptic malignant syndrome including muscular rigidity, elevated body temperature, mental changes and increased serum creatine phosphokinase has been reported with the abrupt withdrawal of antiparkinsonian agents. Therefore, any abrupt dosage reduction or withdrawal of Dopicar should be carefully observed, particularly in patients who are also receiving neuroleptics.
• Concomitant administration of psycho-active drugs such as phenothiazines or butyrophenones should be carried out with caution, and the patient carefully observed for loss of antiparkinsonian effect.
Patients with a history of convulsions should be treated with caution.
• As with levodopa, periodic evaluation of hepatic, haematopoetic, cardiovascular and renal function are recommended during extended therapy.
• Patients with chronic wide-angle glaucoma may be treated cautiously with Dopicar, provided the intra- ocular pressure is well controlled and the patient monitored carefully for changes in intra-ocular pressure during therapy.
• If general anaesthesia is required, therapy with Dopicar may be continued for as long as the patient is permitted to take fluids and medication by mouth. If therapy has to be stopped temporarily, Dopicar may be restarted as soon as oral medication can be taken at the same daily dosage as before.
• Epidemiological studies have shown that patients with Parkinson's disease have a higher risk of developing melanoma than the general population (approximately 2-6 fold higher). It is unclear whether the increased risk observed was due to Parkinson's disease, or other factors such as drugs used to treat Parkinson's disease. Therefore, patients and providers are advised to monitor for melanomas on a regular basis when using Dopicar for any indication. Ideally, periodic skin examinations should be performed by appropriately qualified individuals (e.g., dermatologists).
Laboratory Tests
• Commonly, levels of blood urea nitrogen, creatinine, and uric acid are lower during administration of Dopicar than with levodopa. Transient abnormalities include elevated levels of blood urea, AST (SGOT), ALT (SGPT), LDH, bilirubin, and alkaline phosphatase.
• Decreased haemoglobin, haematocrit, elevated serum glucose and white blood cells, bacteria and blood in the urine have been reported.
• Positive Coombs’ tests have been reported, both with Dopicar and levodopa alone.
• 'Dopicar may cause a false positive result when a dipstick is used to test for urinary ketone; and this reaction is not altered by boiling the urine. The use of glucose oxidase methods may give false negative results for glycosuria.
Dopamine Dysregulation Syndrome (DDS) is an addictive disorder resulting in excessive use of the product seen in some patients treated with carbidopa/levodopa. Before initiation of treatment, patients and caregivers should be warned of the potential risk of developing DDS (see also 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 and/or other dopaminergic treatments containing levodopa including Dopicar. Review of treatment is recommended if such symptoms develop.

Effects on Driving

4.7 Effects on ability to drive and use machines
Individual responses to medication may vary and certain side effects that have been reported with Dopicar may affect some patients’ ability to drive or operate machinery. Patients treated with levodopa 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 section 4.4 ‘Special warnings and precautions for use’).