Servonex Adverse Reactions

The most common adverse events are diarrhoea, muscle cramps, fatigue, nausea, vomiting and insomnia. Adverse reactions reported as more than an isolated case are listed as follows, by system organ class and by frequency. Frequencies are defined as: very common (>1/10); common (>1/100, < 1/10); uncommon (>1/1,000, < 1/100); rare (>1/10,000, <1/1,000); very rare (<1/10000) and not known (cannot be estimated from available data).
Infections and infestations: Common: Common cold.
Metabolism and nutrition disorders: Common: Anorexia.
Psychiatric disorders: Common: Hallucinations**, Agitation**, Aggressive behaviour **, Abnormal dreams and Nightmares**.
Nervous system disorders: Common: Syncope*, Dizziness.
Uncommon: Seizure*.
Rare: Extra pyramidal symptoms.
Very rare: Neuroleptic malignant syndrome.
Cardiac disorders: Uncommon: Bradycardia.
Rare: Sino-atrial block, Atrioventricular block.
Gastrointestinal disorders: Very common: Diarrhoea, Nausea.
Common: Vomiting, Abdominal disturbance.
Uncommon: Gastrointestinal haemorrhage, Gastric, duodenal ulcers and Salivary hypersecretion.
Hepato-biliary disorders: Rare: Liver dysfunction including hepatitis***.
Skin and subcutaneous tissue disorders: Common: Rash, Pruritis.
Musculoskeletal, connective tissue and bone disorders: Common: Muscle cramps.
Very rare: Rhabdomyolysis****.
Renal and urinary disorders: Common: Urinary incontinence.
General disorders and administration site conditions: Very common: Headache.
Common: Fatigue, Pain.
Investigations: Uncommon: Minor increase in serum concentration of muscle creatine kinase.
Injury and poisoning: Common: Accident.
*In investigating patients for syncope or seizure the possibility of heart block or long sinusal pauses should be considered.
**Reports of hallucinations, agitation and aggressive behaviour have resolved on dose-reduction or discontinuation of treatment.
***In cases of unexplained liver dysfunction, withdrawal of Donepezil hydrochloride (Servonex) tablets should be considered.
****Rhabdomyolysis has been reported to occur independently of Neuroleptic Malignant syndrome and in close temporal association with donepezil initiation or dose increase.