DOSULEPIN VIATRIS 75 dosulepin (dothiepin) hydrochloride 75 mg film coated tablet blister pack

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

dosulepin (dothiepin) hydrochloride, Quantity: 75 mg

متاح من:

Alphapharm Pty Ltd

INN (الاسم الدولي):

dosulepin (dothiepin) hydrochloride

الشكل الصيدلاني:

Tablet, film coated

تركيب:

Excipient Ingredients: povidone; maize starch; sodium starch glycollate; lactose monohydrate; purified talc; magnesium stearate; titanium dioxide; xanthan gum; polyvinyl alcohol; brilliant scarlet 4R; lecithin

طريقة التعاطي:

Oral

الوحدات في الحزمة:

30

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

The 75mg tablets are indicated only for the maintenance treatment of major depression. (see Precautions).

ملخص المنتج:

Visual Identification: Red film coated, (scored) normal convex tablets marked DT breakline 75 on one side and with the greek alphabet symbol for alpha on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

الوضع إذن:

Licence status A

تاريخ الترخيص:

2017-08-23

نشرة المعلومات

DOSULEPIN VIATRIS
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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 DOSULEPIN VIATRIS?
DOSULEPIN VIATRIS contains the active ingredient dosulepin. DOSULEPIN
VIATRIS is used to treat depression. For more
information, see Section 1. Why am I using DOSULEPIN VIATRIS? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DOSULEPIN VIATRIS?
Do not use if you have ever had an allergic reaction to DOSULEPIN
VIATRIS 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 DOSULEPIN VIATRIS? in
the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DOSULEPIN VIATRIS 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 DOSULEPIN VIATRIS?
•
Your doctor will tell you how much DOSULEPIN VIATRIS you need to take
each day and when to take it.
•
This depends how well you respond to DOSULEPIN VIATRIS and whether or
not you are taking any other medicines.
More instructions can be found in Section 4. How do I use DOSULEPIN
VIATRIS? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DOSULEPIN VIATRIS?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
DOSULEPIN VIATRIS.
•
Tell your doctor immediately if you have any suicidal thoughts or
other mental/mood changes.
•
Tell your doctor immediately if you become pregnant while taking
DOSULEPIN VIATRIS.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly or lower the dose, without
checking with your doctor.
•
Do not use DOSULEPIN VIATRIS to treat any other conditions unless your
doctor tells you to.
•
Do not give DOSUL

خصائص المنتج

AUSTRALIAN PRODUCT INFORMATION
DOSULEPIN VIATRIS
_dosulepin (dothiepin) hydrochloride tablet and capsules _
1
NAME OF THE MEDICINE
Dosulepin (dothiepin) hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 25 mg of dosulepin (dothiepin) hydrochloride as
the active ingredient. Each tablet
contains 75 mg of dosulepin (dothiepin) hydrochloride as the active
ingredient.
DOSULEPIN VIATRIS 25 capsules contain sugars as lactose and sulfites
(sulfites are present in trace
amounts).
DOSULEPIN VIATRIS 75 tablets contain sugars as lactose, sulfites and
soya bean products (sulfites and soya
bean are present in trace amounts).
3
PHARMACEUTICAL FORM
DOSULEPIN VIATRIS 25: 25 mg capsule: Size 4 hard gelatin capsule with
a red cap and green body.
DOSULEPIN VIATRIS 75: 75 mg tablet: Red film coated, (scored) normal
convex tablets marked DT
breakline 75 on one side and with “α”on the other
.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of major depression.
The 75 mg tablet is indicated only for the maintenance treatment of
major depression (see
SECTION 4.4 SPECIAL
WARNING AND PRECAUTIONS FOR USE).
4.2
DOSE AND METHOD OF ADMINISTRATION
The main dose should be taken at night as it may produce drowsiness.
_NOTE._
Dosage should be reduced to the smallest amount necessary to maintain
relief of the symptoms of
depression, once a satisfactory response has been obtained. Plasma
levels will reach a new steady state 10 to
14 days after each up or down adjustment.
ADULTS
Begin with 25 mg three times daily for one to two weeks. The daily
dosage should be increased by 25 to 50
mg at intervals of one to two weeks if the response is inadequate.
The daily dose should not exceed 200 mg.
Up to 150 mg of the daily dose may be given as a single night time
dose once an effective dose has been
established.
USE IN CHILDREN AND ADOLESCENTS (<18 YEARS)
The safety and efficacy of DOSULEPIN VIATRIS for the treatment of
depression or other psychiatric
disorders in children and adolescents aged less than 1