Novatin acitretin 25mg capsule blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

acitretin

제공처:

Apotex Pty Ltd

INN (국제 이름):

Acitretin

수업:

Medicine Registered

승인 상태:

Registered

환자 정보 전단

NOVATIN
_Acitretin_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Novatin capsules.
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 Novatin
Capsules 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 IS NOVATIN USED
FOR
Novatin contains the active
ingredient acitretin.
Novatin is used to treat severe
psoriasis (skin disease with thickened
patches of red skin, often with silvery
scales) and other severe disorders of
the skin.
Novatin belongs to a group of
medicines called retinoids, which are
very similar to Vitamin A. Vitamin
A, which we obtain from food, is
important for the normal growth and
development of the body, especially
the skin.
In severe psoriasis and some other
skin disorders, where there is
problem with the normal
development of the skin,
Novatin helps return the skin to
normal.
There are many different types of
medicines used to treat skin
conditions.
Your doctor may have prescribed
Novatin for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY NOVATIN HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
NOVATIN
_DO NOT TAKE NOVATIN IF:_
•
YOU ARE PREGNANT, OR INTEND TO
BECOME PREGNANT DURING
TREATMENT OR IN THE 3 YEARS AFTER
STOPPING TREATMENT.
THE POSSIBILITY THAT YOU MAY BE
PREGNANT MUST BE RULED OUT BY YOU
AND YOUR DOCTOR BEFORE YOU START
TAKING NOVATIN.
A PREGNANCY TEST MUST BE NEGATIVE
WHEN PERFORMED WITHIN ONE WEEK
BEFORE BEGINNING OF TREATMENT.
NOVATIN IS HIGHLY TERATOGENIC AND
THERE IS AN EXTREMELY HIGH RISK THAT
A SEVERELY DEFORMED BABY WILL
RESULT IF TAKEN BEFORE OR DURING
PREGNANCY, NO MATTER FOR

제품 특성 요약

1
AUSTRALIAN PRODUCT INFORMATION
NOVATIN™ (ACITRETIN) CAPSULES
1
NAME OF THE MEDICINE
Acitretin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gelatin capsule contains 10 mg or 25 mg of acitretin as the
active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Gelatin
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
Novatin acitretin capsules are available in 10 and 25 mg capsules.
10 MG CAPSULE:
Hard gelatin capsule containing a yellow powder with a white to
off-white body and a brown
cap printed in black with “A10” on the capsule body.
25 MG CAPSULE:
Hard gelatin capsule containing a yellow powder with a yellow to light
yellow body and a brown
cap printed in black with “A25” on the capsule body.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

Severe intractable psoriasis in all its forms

Severe forms of disorders of keratinisation such as

hyperkeratosis palmaris et plantaris

pustulosis palmaris et plantaris

ichthyosis

keratosis follicularis (Darier's disease)

lichen planus affecting the skin or the mucosae

pityriasis rubra pilaris
2
4.2
DOSE AND METHOD OF ADMINISTRATION
Novatin hard gelatin capsule is intended for oral administration.
DOSAGE
Acitretin should only be prescribed by physicians who are experienced
in the use of systemic
retinoids and understand the risk of teratogenicity associated with
acitretin therapy.
ADULTS
Because there are differences in the absorption and rate of metabolism
of acitretin, the dosage
must be individually adjusted. The capsules should be taken preferably
once daily with meals,
or with milk.
An initial dosage of 25 mg or 30 mg for about two to four weeks may
give satisfactory
therapeutic results.
The maintenance dose must be based on clinical efficacy and tolerance.
In general, a daily
dosage of 25 - 50 mg taken for a further six to eight weeks achieves
optimal therapeutic results.
Therapy can be terminated in patients with psoriasis whose lesions
have resolved sufficiently.
Relapses should be trea