Adverse reactions : תופעות לוואי

4.8     Undesirable effects

Assessment of undesirable effects is based on the following frequencies: Very common:        (≥10%)
Common:             (≥1%, <10%)
Uncommon:           (≥0.1%, <1%)
Rare:               (≥0.01%, <0.1%)
Very rare:          Frequency cannot be estimated from the available data) 

Nervous system disorders:
Common:       Dizziness
Very rare:    Epileptic fits, usually after treatment in excess of the recommended dose; myoclonus, symptoms of peripheral neuropathy

Psychiatric disorders:
Common:          Sleep disturbances, motor and psychiatric agitation. Particularly in predisposed elderly patients, paranoid exogenous psychoses accompanied by visual hallucinations may be triggered. Adverse reactions of this type may occur with greater frequency when PK- Merz infusion is given in combination with other antiparkinsonian drugs (e.g. levodopa, bromocriptine) or memantine.

Renal and urinary disorders:
Common:         Urinary retention in case of prostatic hypertrophy.

Skin and subcutaneous tissue disorders:
Common:        Livedo reticularis (marble skin), sometimes associated with lower-leg and ankle oedema

Gastrointestinal disorders:
Common:         Nausea, dry mouth

Cardiac disorders:
Very rare:      Cardiac arrhythmias such as ventricular tachycardia, ventricular fibrillation, torsade de pointes and QT prolongation. Most of these cases occurred after overdose or in association with certain drugs or other risk factors for cardiac arrhythmias (see sections 4.3 and 4.5). Cardiac arrhythmias with tachycardia.

Vascular disorders:
Common:         Orthostatic dysregulation

Eye disorders:
Rare:             Blurred vision*
Very rare:        Temporary loss of vision*, increased photosensitivity Not known:        Corneal oedema, reversible after discontinuation
* The patient should be examined by an ophthalmologist as soon as loss of visual acuity or blurred vision occur, in order to rule out corneal oedema as a possible cause (see section 4.4).

Blood and lymphatic system disorders:
Very rare:     Haematological side-effects such as leukopenia and thrombocytopenia 
Yellow orange lacquer (E 110) may trigger allergic reactions.