PHARMACOR ISOTRETINOIN isotretinoin 20mg capsule blister pack

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

isotretinoin, Quantity: 20 mg

Sẵn có từ:

Southern Cross Pharma Pty Ltd

INN (Tên quốc tế):

Isotretinoin

Dạng dược phẩm:

Capsule, soft

Thành phần:

Excipient Ingredients: Soya Oil; yellow beeswax; hydrogenated soya oil; partially hydrogenated soya oil; Gelatin; glycerol; titanium dioxide; iron oxide red; iron oxide yellow; propylene glycol; brilliant blue FCF; ethanol; purified water; Shellac; strong ammonia solution

Tuyến hành chính:

Oral

Các đơn vị trong gói:

60 capsule

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

Treatment of severe cystic acne. A single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. If a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. Because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

Tóm tắt sản phẩm:

Visual Identification: red-orange, size 6, oval, soft gelatin capsules, marked 'P20'; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Tình trạng ủy quyền:

Licence status A

Ngày ủy quyền:

2010-12-06

Tờ rơi thông tin

CONSUMER MEDICINE INFORMATION
PHARMACOR ISOTRETINOIN
(ISOTRETINOIN) CAPSULES
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
PHARMACOR ISOTRETINOIN.
It does not contain all the
available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
PHARMACOR ISOTRETINOIN
against the benefits they expect
it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to
read it again.
WHAT PHARMACOR
ISOTRETINOIN IS USED
FOR
PHARMACOR ISOTRETINOIN
contains the active ingredient
isotretinoin.
PHARMACOR ISOTRETINOIN
is used to treat acne.
PHARMACOR ISOTRETINOIN
belongs to a group of medicines
called retinoids, which are
similar to vitamin A.
The retinoids work by reducing
the amount of the oily substance
(ie. sebum) made by glands in
your skin, reducing bacteria,
reducing inflammation and
opening clogged pores.
There are many different types
of medicines used to treat acne.
PHARMACOR ISOTRETINOIN
is used for more severe cases.
YOUR DOCTOR, HOWEVER, MAY
HAVE PRESCRIBED
PHARMACOR ISOTRETINOIN
FOR ANOTHER PURPOSE.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
PHARMACOR ISOTRETINOIN
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only
with a doctor's prescription.
PHARMACOR ISOTRETINOIN
is not addictive.
BEFORE YOU TAKE
PHARMACOR
ISOTRETINOIN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PHARMACOR
ISOTRETINOIN IF:
1. YOU ARE PREGNANT, OR FOR
AT LEAST ONE MONTH
BEFORE YOU PLAN TO FALL
PREGNANT.
If you fall pregnant while
taking PHARMACOR
ISOTRETINOIN there is
an extremely high risk of
having a baby that is
severely deformed. You
must use effective
contraception for one
month before, during and
one month after treatment.
2. YOU ARE BREASTFEEDING.
Breastfeeding must stop
before treatment begins.
Do not breastfeed while
taking PHARMACOR
ISOTRETINOIN.
3. YOU HAVE HAD AN ALLERGIC
REACTION TO PHARMAC

Đặc tính sản phẩm

AUSTRALIAN PRODUCT INFORMATION
PHARMACOR ISOTRETINOIN, (ISOTRETINOIN) CAPSULES
_ _
1. NAME OF THE MEDICINE
Isotretinoin
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
PHARMACOR ISOTRETINOIN 20 mg capsules contain 20 mg Isotretinoin.
Excipients with known effect:
PHARMACOR ISOTRETINOIN contains Soya oil, hydrogenated soya oil and
partially hydrogenated soya oil,
gelatin, for the full list of excipients, see Section 6.1 LIST OF
EXCIPIENTS.
3. PHARMACEUTICAL FORM
PHARMACOR ISOTRETINOIN 20 mg Capsules is a soft gelatin, oval
(red-orange, size 6) marked P20
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Treatment of severe cystic acne: A single course of therapy has been
shown to result in complete and
prolonged remission of disease in many patients. If a second course of
therapy is needed, it should not be
initiated until at least eight weeks after completion of the first
course, since experience has shown that
patients may continue to improve while off the drug.
Because of significant adverse effects associated with its use,
isotretinoin should be reserved for patients with
severe cystic acne who are unresponsive to conventional therapy,
including systemic antibiotics.
4.2. DOSE AND METHOD OF ADMINISTRATION
The therapeutic response to isotretinoin is dose related and varies
between patients. This necessitates
individual adjustment of dosage according to the response of the
condition and the patient's tolerance of the
drug. In most cases complete or near complete suppression of acne is
achieved with a 16 week course of
treatment.
All patients should initially receive PHARMACOR ISOTRETINOIN at doses
up to 0.5 mg/kg/day bodyweight daily
for a period of two to four weeks, when their responsiveness to the
drug will usually be apparent. It should
be noted that transient exacerbation of acne is occasionally seen
during this initial period. Satisfactory initial
responses have been reported from 0.05 mg/kg/day. Relapse rates on the
lower doses are higher (a second
course may be required in about two-thirds of patients on