Donepezil 5 mg Tablets — Generic For Aricept — SOLCO

These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS.

DONEPEZIL HYDROCHLORIDE tablets, for oral use

Initial U.S. Approval: 1996

Indications And Usage

Donepezil hydrochloride is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease (1).

Dosage And Administration

Dosage Forms And Strengths

Tablets: 5 mg, 10 mg (3)

Contraindications

Known hypersensitivity to donepezil hydrochloride or to piperidine derivatives (4)

Warnings And Precautions

• Cholinesterase inhibitors are likely to exaggerate succinylcholine-type muscle relaxation during anesthesia (5.1).
• Cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block (5.2).
• Donepezil hydrochloride can cause vomiting. Patients should be observed closely at initiation of treatment and after dose increases (5.3).
• Patients should be monitored closely for symptoms of active or occult gastrointestinal (GI) bleeding, especially those at increased risk for developing ulcers (5.4).
• Cholinomimetics may cause bladder outflow obstructions (5.6).
• Cholinomimetics are believed to have some potential to cause generalized convulsions (5.7).
• Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease (5.8).

• Cholinesterase inhibitors are likely to exaggerate succinylcholine-type muscle relaxation during anesthesia (5.1).
• Cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block (5.2).
• Donepezil hydrochloride can cause vomiting. Patients should be observed closely at initiation of treatment and after dose increases (5.3).
• Patients should be monitored closely for symptoms of active or occult gastrointestinal (GI) bleeding, especially those at increased risk for developing ulcers (5.4).
• Cholinomimetics may cause bladder outflow obstructions (5.6).
• Cholinomimetics are believed to have some potential to cause generalized convulsions (5.7).
• Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease (5.8).

Adverse Reactions

Most common adverse reactions in clinical studies of donepezil hydrochloride are nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Use In Specific Populations

Pregnancy: Based on animal data, may cause fetal harm (8.1).

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 6/2025