Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Most of the adverse experiences observed during Salagen treatment were a consequence of exaggerated parasympathetic stimulation. These adverse experiences were dose-dependent and usually mild and self-limited. However, severe adverse experiences might occasionally occur and therefore careful monitoring of the patient is recommended.
In controlled clinical trials the following adverse reactions were observed: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, < 1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Nervous system disorders
Very common: headache
Common: dizziness
Eye disorders
Common: lacrimation; blurred vision; abnormal vision; conjunctivitis; eye pain Cardiac disorders
Common: flushing (vasodilatation); hypertension; palpitations
Respiratory, thoracic and mediastinal disorders
Common: rhinitis
Gastrointestinal disorders
Common: dyspepsia; diarrhea; abdominal pain; nausea, vomiting; constipation, increased salivation Uncommon: flatulence
Skin and subcutaneous tissue disorders
Very common: sweating
Common: allergic reactions, including rash, pruritus
Renal and urinary disorders
Very common: increased urinary frequency
Uncommon: urinary urgency
General disorders and administration site conditions
Very common: flu syndrome
Common: asthenia, chills
There is no indication of a difference between older and younger patients receiving Salagen as regards reporting adverse experiences, except for dizziness, which was reported significantly more often by patients aged over 65 years.
The following adverse effects, which are due to the intrinsic pharmacological properties of pilocarpine, have been published in the medical literature: respiratory distress, gastro-intestinal spasm, atrioventricular block, tachycardia, bradycardia, cardiac arrhythmia, hypotension, shock, tremors, and mental status changes including memory loss, hallucinations, lability of affect, confusion, agitation.
Reporting of suspected adverse reactions