ARAZIL donepezil hydrochloride 5 mg tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

donepezil hydrochloride, Quantity: 5 mg

제공처:

Alphapharm Pty Ltd

INN (국제 이름):

Donepezil hydrochloride

약제 형태:

Tablet, film coated

구성:

Excipient Ingredients: hyprolose; lactose monohydrate; microcrystalline cellulose; magnesium stearate; maize starch; hypromellose; macrogol 400; titanium dioxide

관리 경로:

Oral

패키지 단위:

98, 120, 60, 7, 14, 84, 28, 56, 30, 50

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

ARAZIL (donepezil hydrochloride) is indicated for the treatment of mild, moderate and severe Alzheimer?s disease.

제품 요약:

Visual Identification: 7 mm white, film coated round tablet, embossed with "DL"over "5" on one side and "G" on the reverse.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

승인 상태:

Licence status A

승인 날짜:

2012-10-03

환자 정보 전단

ARAZIL
®
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ARAZIL?
ARAZIL contains the active ingredient donepezil hydrochloride. ARAZIL
is used to treat mild, moderate and severe Alzheimer’s
disease, also called dementia of the Alzheimer’s type.
For more information, see Section 1. Why am I using ARAZIL? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ARAZIL?
Do not use if you have ever had an allergic reaction to donepezil
hydrochloride or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
ARAZIL? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ARAZIL and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ARAZIL?
•
The usual starting dose for ARAZIL is one 5 mg tablet each day.
•
After one month, your doctor will assess your response and may
increase your dose to one ARAZIL 10 mg tablet a day.
More instructions can be found in Section 4. How do I use ARAZIL? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ARAZIL?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
ARAZIL.
•
Keep all of your doctor's appointments so that your progress can be
checked.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking your medicine or change the dosage without checking
with your doctor first.
DRIVING
OR USING
MACHINES
•
ARAZIL may cause fatigue, dizziness and muscle cramps, especially at
the start of treatment.
•
Be careful driving or operating machinery until you know how ARAZIL
affects you.
•
Alzheimer’s disease may affect your ability to drive or operate
machinery.
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제품 특성 요약

AUSTRALIAN PRODUCT INFORMATION
ARAZIL
®
_Donepezil hydrochloride _
1
NAME OF THE MEDICINE
Donepezil hydrochloride
_ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ARAZIL film coated tablets for oral administration are supplied
containing 5 mg or 10 mg donepezil
hydrochloride equivalent to 4.56 mg or 9.12 mg donepezil free base,
respectively.
Excipients with known effect: sugars as lactose and traces of
sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ARAZIL tablets containing either 5 mg or 10 mg donepezil
hydrochloride.
ARAZIL 5 mg tablets – 7 mm white, film coated, round tablets
embossed with “DL” over “5” on one
side and “G” on the reverse.
ARAZIL10 mg tablets – 9 mm white, film coated, round tablets
embossed with “DL” over “10” on one
side and “G” on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ARAZIL (donepezil hydrochloride) is indicated for the treatment of
mild, moderate and severe
Alzheimer’s disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS/ELDERLY:
Treatment should be initiated and supervised by a doctor experienced
in the diagnosis and treatment of
Alzheimer’s Dementia. Individual response to donepezil cannot be
predicted. Treatment should be
continued for as long as a therapeutic benefit for the patient exists.
Discontinuation of therapy should
be considered where there is no longer evidence of a therapeutic
effect, which should be assessed by
periodic evaluations by the physician using input from the patient and
caregiver.
The dosages of donepezil hydrochloride shown to be effective in
controlled clinical trials are 5 mg and
10 mg administered once daily. Although there is no statistically
significant evidence that a greater
treatment effect is obtained from the use of the 10 mg dose, there is
a suggestion, based on analysis of
group data, that some additional benefits may accrue to some patients
from the use of the higher dose.
Treatment is initiated at 5 mg/day (once-a-day dosing). Donepezil
h