ZETIN acitretin 25mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

acitretin, Quantity: 25 mg

Available from:

Douglas Pharmaceuticals Australia Pty Ltd

INN (International Name):

Acitretin

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: titanium dioxide; microcrystalline cellulose; purified water; iron oxide red; sodium ascorbate; iron oxide yellow; Gelatin; maltodextrin; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid

Administration route:

Oral

Units in package:

100 Capsules, 60 Capsules

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Acitretin may be used for the treatment of:,? 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

Product summary:

Visual Identification: 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; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-05-23

Patient Information leaflet

1
ZETIN CAPSULES
ZETIN
®
_Acitretin 10 mg and 25 mg capsules _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about ZETIN. It does not
contain all the available information. It
does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was last
updated on the date listed on the last
page. More recent information on this
medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you using this medicine against the
benefits they expect it will have for
you.
Pharmaceutical companies cannot give
you medical advice or an individual
diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is ZETIN. It
contains the active ingredient acitretin.
It is used to treat:
•
psoriasis
•
keratinisation disorders
Ask your doctor if you have any
questions about why this medicine has
been prescribed for you. Your doctor
may have prescribed this medicine for
another reason.
This medicine is available only with a
doctor's prescription.
_HOW IT WORKS _
Acitretin, the active ingredient of
ZETIN, belongs to a group of medicines
called retinoids.
It is very similar to Vitamin A which is
obtained from our diet and is vital for
the normal growth and development
of the body, especially the skin.
Psoriasis is a skin disease with
thickened patches of red skin, often
with silvery scales. ZETIN is used to
treat severe psoriasis and other severe
skin disorders.
ZETIN works to return skin to normal
when problems with the normal
development of the skin are present,
as in the case of severe psoriasis and
some other skin disorders.
There is no evidence that this medicine
is addictive.
_USE

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – ZETIN (ACITRETIN) CAPSULES
1
NAME OF THE MEDICINE
Acitretin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZETIN (acitretin) is a retinoid for the oral treatment of severe cases
of psoriasis and disorders of
keratinisation. It is available in 10 and 25 mg capsules.
For full list of excipients, see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
ZETIN hard gelatin capsule is intended for oral administration.
ZETIN 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.
ZETIN 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
T
HERAPEUTIC INDICATIONS
ZETIN (acitretin) may be used for the treatment of:
•
Severe intractable psoriasis in all its forms
•
Severe forms of disorders of keratinisation such as:
o
hyperkeratosis palmaris et plantaris
o
pustulosis palmaris et plantaris
o
ichthyosis
o
keratosis follicularis (Darier's disease)
o
lichen planus affecting the skin or the mucosae
o
pityriasis rubra pilaris
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
ZETIN 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