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Tell the doctor or pharmacist before starting to take Donepezil HCL Genepharm Orodispersible Tablets if the patient has or has had: Stomach or duodenal ulcers.
Seizures (fits) or convulsions.
A heart condition (irregular or very slow heart beat).
Asthma or other long term lung disease.
Liver problems or hepatitis.
Difficulty passing urine or mild kidney disease.
Also tell the doctor if the patient is pregnant or thinks she might be pregnant.
Neuroleptic Malignant Syndrome (NMS): There have been very rare post-marketing reports of NMS in patients treated with donepezil with or without concomitant antipsychotic medication. NMS is a potentially life-threatening condition characterized by hyperthermia, muscle rigidity, autonomic instability (e.g., irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia), altered consciousness and elevated serum creatine phosphokinase (CPK) levels. If a patient develops symptoms indicative of NMS, or presents with unexplained high fever in the absence of additional clinical manifestations of NMS, donepezil therapy should be discontinued.
Rhabdomyolysis (Muscle Effects): Rare cases of rhabdomyolysis (including acute renal failure) have been reported in patients treated with donepezil, particularly in the days following dose initiation and dose increase. Majority of these cases occurred independently of the occurrence of NMS. Patients should be carefully monitored for muscle pain, tenderness or weakness and darkened urine, particularly if accompanied by malaise or fever. Blood creatine phosphokinase (CPK) levels should be assessed in patients experiencing these symptoms.
Donepezil therapy should be discontinued if markedly elevated CPK levels are measured and/or if the patient develops symptoms indicative of rhabdomyolysis. Caution should be particularly exercised in prescribing donepezil to patients with risk factors such as prior history of muscular disorders, uncontrolled hypothyroidism, hepatic or renal impairment, and in patients who are receiving concomitant medications that can cause rhabdomyolysis (e.g., statins, antipsychotics, selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor).
Driving and using machines: Alzheimer's disease may impair the ability to drive or operate machinery and the patient must not perform these activities unless the doctor tells that it is safe to do so. Also, the medicine can cause tiredness, dizziness and muscle cramp. If any of these effects were experienced, the patient must not drive or operate machinery.
Use in Children and adolescents: Donepezil HCL Genepharm Orodispersible Tablets is not recommended for use in children and adolescents (younger than 18 years of age).
