Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Assessment of undesirable effects is based on the following frequencies: 
Very common:               (≥1/10)
Common:                    (≥1/100, <1/10)
Uncommon:                  (≥1/1000, <1/100)
Rare:                      (≥1/10000, <1/1000)
Very rare:                 (<1/10000), not known (cannot be estimated from the available data)

Blood and lymphatic system disorders
Very rarely during treatment with amantadine, haematological side effects, such as leukopenia and thrombocytopenia, have been reported.

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 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 are 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 and dry mouth.

Cardiac disorders:
Very rare reports of 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.

Blood and lymphatic system disorders:
Very rare: Haematological side effects such as leukopenia and thrombocytopenia 
The above undesirable effects have been reported less frequently following infusion therapy.

Immune system disorders:
Very rare: Anaphylactic reactions after infusion therapy have been reported.