May 17, 2023
To whom it may concern:

Company NameCorporate
Representative
Contact:

TOHO HOLDINGS CO., LTD.

Atsushi Udoh, Representative
Director, CEO(Prime Market of Tokyo Stock
Exchange Securities Code: 8129)
Makoto Kawamura, Corporate
Officer and General Manager,
Corporate Communications andInvestor Relations Division(TEL: 81-3-6838-2803)

Notice Regarding Approval of Partial Amendments to Dosage and Administration ofDonepezil Hydrochloride Tablets 3mg / 5mg / 10mg “FFP” and Donepezil Hydrochloride OD Tablets
3mg / 5mg / 10mg “FFP” for KYOSOMIRAI PHARMATOHO HOLDINGS CO., LTD. (Headquarters: Tokyo; Representative Director, CEO: Atsushi Udoh ) is
pleased to announce that KYOSOMIRAI PHARMA CO., LTD. (Headquarters:Tokyo; President andRepresentative Director: Nobuaki Hosaka), the wholly-owned subsidiary involved in pharmaceuticals
manufacture and sales business, received an approval of partial amendments to dosage and administration ofDonepezil Hydrochloride Tablets 3mg / 5mg / 10mg “FFP” and Donepezil Hydrochloride OD Tablets 3mg /5mg / 10mg “FFP” on May 17, 2023 as below.
Outline of Donepezil Hydrochloride Tablets 3mg / 5mg / 10mg “FFP” and Donepezil Hydrochloride OD
Tablets 3mg / 5mg / 10mg “FFP”
ClassProduct Name
Original Brand Name
Therapeutic agent for
Alzheimer's disease
Therapeutic agent for dementia
with Lewy bodies

Donepezil Hydrochloride Tablets
3mg / 5mg / 10mg “FFP”
Donepezil Hydrochloride OD Tablets
3mg / 5mg / 10mg “FFP”

Aricept® Tablets
3mg/ 5mg/ 10mg
Aricept® D Tablets
3mg/ 5mg/ 10mg

Outline of Amendments to Dosage and Administration of Donepezil Hydrochloride Tablets 3mg / 5mg / 10mg
“FFP” and Donepezil Hydrochloride OD Tablets 3mg / 5mg / 10mg “FFP”
Indications and Suppression of progression of dementia symptoms in Alzheimer's disease and dementia
Usagewith Lewy bodies
Suppression of progression of dementia symptoms in Alzheimer's disease
The usual initial adult dose for oral use is 3mg of donepezil hydrochloride once daily.
After 1 to 2weeks the dose is increased to 5mg. The dosage for patients with severe
Alzheimer's disease is increased to 10mg after dosing at 5mg for 4 or more weeks. The
dose can be reduced appropriately according to patients' symptoms.
Suppression of progression of dementia with Lewy bodies
The usual initial adult dose for oral use is 3mg of donepezil hydrochloride once daily.
After 1 to 2weeks the dose is increased to 5mg. The dosage for patients with severe
Alzheimer's disease is increased to 10mg after dosing at 5mg for 4 or more weeks.
Dosage andThe dose can be reduced to 5mg according to patients' symptoms. By approximately
Administration
12 weeks after the start of administration of the drug, perform an efficacy evaluation
based on a cognitive function test and a hearing with the patient and his/her family
and/or caregiver on the subjective/objective symptoms, and if the benefits shown inthe comprehensive evaluation of cognitive function, psychological symptoms,
behavior disturbance, activities on daily living, etc. are not considered to outweigh therisk, discontinue the administration. Even if the administration is continued based on
the result of efficacy evaluation by 12 weeks after the start of administration, regularly
perform an efficacy evaluation to determine whether or not to continue theadministration.
(Underlined parts are revised parts.)