ENDEP 25 amitriptyline hydrochloride 25mg tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

amitriptyline hydrochloride, Quantity: 25 mg

제공처:

Alphapharm Pty Ltd

약제 형태:

Tablet, film coated

구성:

Excipient Ingredients: pregelatinised maize starch; sodium starch glycollate; colloidal anhydrous silica; microcrystalline cellulose; disodium edetate; magnesium stearate; lactose monohydrate; titanium dioxide; hypromellose; indigo carmine; sunset yellow FCF; quinoline yellow; macrogol 4000

관리 경로:

Oral

패키지 단위:

50, 10 (sample), 90, 1000

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

For the treatment of major depression. Nocturnal enuresis where organic pathology has been excluded.

제품 요약:

Visual Identification: 7mm yellow film coated normal convex tablet marked AP/25 on one side, alpha symbol on reverse.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

승인 상태:

Registered

승인 날짜:

1997-05-02

환자 정보 전단

ENDEP
®
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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 ENDEP?
ENDEP contains the active ingredient amitriptyline hydrochloride.
ENDEP is used to treat depression. It can also be used to treat
bedwetting, provided that there is no physical cause for the problem
(eg. problems with the bladder).
For more information, see Section 1. Why am I using ENDEP? in the full
CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ENDEP?
Do not use if you have ever had an allergic reaction to ENDEP 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
ENDEP? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ENDEP 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 ENDEP?
•
For depression, the usual starting dose is 75 mg to 150 mg per day in
divided doses.
•
The doses recommended for bedwetting are lower than the doses used to
treat depression and usually depend on the person's
age and weight.
•
More instructions can be found in Section 4. How do I use ENDEP? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ENDEP?
THINGS YOU
SHOULD DO
•
Tell your doctor immediately if you have any suicidal thoughts or
other mental/mood changes.
•
Keep all of your appointments with your doctor so that your progress
can be checked.
•
Remind any doctor, dentist or pharmacist you visit that you are using
ENDEP.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking ENDEP, or lower the dose, without checking with
your doctor.
•
Do not use ENDEP to treat any other conditions unless your doctor
tells you to.
DRIVING
OR USING
MACHINES
•
ENDEP may reduce yo

제품 특성 요약

AUSTRALIAN PRODUCT INFORMATION
ENDEP
®
_Amitriptyline hydrochloride tablet _
1
NAME OF THE MEDICINE
Amitriptyline hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ENDEP 10 tablets contains 10 mg of amitriptyline hydrochloride as
the active ingredient.
Each ENDEP 25 tablets contains 25 mg of amitriptyline hydrochloride as
the active ingredient.
Each ENDEP 50 tablets contains 50 mg of amitriptyline hydrochloride as
the active ingredient.
Excipients with known effect in 10 mg tablet: Sugars as lactose, soya
bean products and traces of sulfites..
Excipients with known effect in 25 mg and 50 mg: tablets: Sugars as
lactose and traces of sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
_ENDEP 10,_
10 mg tablet: 7mm, normal convex, blue film coated tablet debossed
with ‘AP 10’ on one side
and α on the other.
_ENDEP 25,_
25 mg tablet: 7 mm yellow, film coated, normal convex tablet marked
AP/25 on one side, α on
reverse.
_ENDEP 50,_
50 mg tablet: 8 mm hexagonal, tan film coated tablet marked AP 50 on
one side, α on reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of major depression. ENDEP 50 mg tablets are
indicated only for the maintenance treatment
of major depression (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS
FOR USE).
Nocturnal enuresis where organic pathology has been excluded.
4.2
DOSE AND METHOD OF ADMINISTRATION
DEPRESSION
_Dosage considerations._
Dosage should be initiated at a low level and increased gradually,
noting carefully
the clinical response and any evidence of intolerance.
_Initial dosage for outpatient adults._
75 mg a day in divided doses is usually satisfactory. If necessary,
this
may be increased to a total of 150 mg a day. Increases are made
preferably in the late afternoon and/or bedtime
doses. The sedative effect is usually rapidly apparent. The
antidepressant activity may be evident within three
or four days or may take up to 30 days to develop adequately.
Alternative methods for initiati