DONEPEZIL 5 MG
DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE) : 5 MG · DIN 02416417 · PRO DOC LIMITEE
Health Canada status: MARKETED
What is DONEPEZIL?
DONEPEZIL 5 MG contains DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE) : 5 MG. It is listed in the Health Canada Drug Product Database under DIN 02416417, held by PRO DOC LIMITEE, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 02-Oct-2025. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is DONEPEZIL used for?
Symptomatic treatment of patients with mild, moderate and severe dementia of the Alzheimer’s type.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02416417 |
|---|---|
| Brand name | DONEPEZIL |
| Generic / active ingredient | DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE) : 5 MG |
| Manufacturer | PRO DOC LIMITEE |
| Strength | 5 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | N06DA02 DONEPEZIL |
| AHFS class | 12:04.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 02-Oct-2025 |
| Original market date | 2013-12-30 00:00:00 |
How is it administered?
Initial: 5 mg once daily. Maintain for 4-6 weeks before considering increase to 10 mg once daily. Max: 10 mg/day. Take with or without food. Swallow whole. Morning intake if sleep disturbed.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly stated in provided text (Section 11 not included in full), though typically 15-30°C for such forms. Refer to full monograph.
How is it supplied?
High-density polyethylene (HDPE) bottles of 100 tablets.
Contraindications
Hypersensitivity to donepezil, piperidine derivatives, or any ingredient; history of QT prolongation and/or torsade de pointes, congenital long QT syndromes, or history of cardiac arrhythmias.
Warnings and precautions
Cholinesterase inhibitors may have vagotonic effects (bradycardia); risk of QTc prolongation, GI bleeding, rhabdomyolysis, Neuroleptic Malignant Syndrome (NMS), and seizures.
Is DONEPEZIL in shortage in Canada?
A Canadian shortage report is on file for this molecule: Resolved — reported by SANIS HEALTH INC, last seen 20 Apr 2026. A shortage on one presentation does not always affect every DIN of the molecule — the alternatives below list what else is marketed in Canada. Nexara can confirm current availability and identify substitutions or import options where permitted.
What can be used instead?
Other Canadian products sharing ATC code N06DA02 DONEPEZIL. 37 of 76 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| ACH-DONEPEZIL | 10 MG | TABLET | ACCORD HEALTHCARE INC | MARKETED | DIN 02402653 |
| ACH-DONEPEZIL | 5 MG | TABLET | ACCORD HEALTHCARE INC | MARKETED | DIN 02402645 |
| AG-DONEPEZIL | 10 MG | TABLET | ANGITA PHARMA INC. | MARKETED | DIN 02432692 |
| AG-DONEPEZIL | 5 MG | TABLET | ANGITA PHARMA INC. | MARKETED | DIN 02432684 |
| APO-DONEPEZIL | 10 MG | TABLET | APOTEX INC | MARKETED | DIN 02362279 |
| APO-DONEPEZIL | 5 MG | TABLET | APOTEX INC | MARKETED | DIN 02362260 |
| ARICEPT | 10 MG | TABLET | PFIZER CANADA ULC | MARKETED | DIN 02232044 |
| ARICEPT | 5 MG | TABLET | PFIZER CANADA ULC | MARKETED | DIN 02232043 |
| AURO-DONEPEZIL | 10 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02400588 |
| AURO-DONEPEZIL | 5 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02400561 |
Who else supplies DONEPEZIL worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. DONEPEZIL appears in 512 registered pack listings across 14 markets, published on 11 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.