Zematane

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Alitretinoin 10mg

Available from:

Douglas Pharmaceuticals Limited

Dosage:

10 mg

Pharmaceutical form:

Liquid filled capsule

Composition:

Active: Alitretinoin 10mg Excipient: dl-Alpha tocopherol Gelatin Glycerol Glyceryl 1-monostearate Hydrogenated vegetable oil Iron oxide black Iron oxide red Iron oxide yellow Medium-chain triglycerides Purified water Sorbitol Soya bean oil, hydrogenated Soya oil Titanium dioxide

Prescription type:

Prescription

Therapeutic indications:

Zematane is indicated for use in adults who have severe chronic hand eczema that is unresponsive to treatment with potent topical corticosteroids. Patients in whom the eczema has predominantly hyperkeratotic features are more likely to respond to treatment than in those in whom the eczema predominantly presents as pompholyx.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 30 capsules - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2020-07-15

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
ZEMATANE*
_alitretinoin _
10 mg and 30 mg capsules
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING ZEMATANE.
THIS LEAFLET ANSWERS SOME COMMON QUESTIONS
ABOUT
ZEMATANE.
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 Zematane
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 ZEMATANE IS USED FOR
Zematane
is
used
to
treat
adults
with
severe
chronic hand eczema that has not got better after
topical treatments with steroids.
The active substance in Zematane is alitretinoin. It
belongs
to
a
group
of
medicines
known
as
retinoids which are related to Vitamin A.
This medicine is available only with a doctor's
prescription.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT
WHY ZEMATANE HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU TAKE ZEMATANE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ZEMATANE IF YOU HAVE AN ALLERGY TO:
•
any medicine containing alitretinoin or a class
of medicines called retinoids.
•
any of the ingredients listed at the end of this
leaflet
Some of the symptoms of an allergic reaction may
include:
•
difficulty in breathing or wheezing
•
shortness of breath
•
swelling of the face, tongue, lips, or other parts
of the body
•
hives on the skin, rash, or itching.
DO NOT TAKE ZEMATANE:
•
if you have liver disease
•
if you have severe kidney disease
•
if
you
have
high
blood
fats
(such
as
high
cholesterol or raised triglycerides).
•
if you have uncontrolled thyroid disease.
•
if you have very high levels of vitamin A in your
body (hypervitaminosis A)
•
if
you
are
allergic
to
alitretinoin,
to
other
retinoids (such as isotretinoin) or any of the
other ingredients of this medicine.
•
if you are allergic to peanut, soya o

Summary of Product characteristics

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Zematane* 10 mg capsules
Zematane* 30 mg capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Zematane 10 mg capsule contains 10 mg of alitretinoin.
Each Zematane 30 mg capsule contains 30 mg of alitretinoin.
EXCIPIENT(S) WITH KNOWN EFFECT
Zematane capsules contain soya-bean products. Sulfur
dioxide is present as a residue in gelatin. For the full list
of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Zematane 10 mg: light brown, oval, soft gelatin capsule.
Zematane 30 mg: yellow, oval, soft gelatin capsule.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Zematane is indicated for use in adults who have severe chronic hand
eczema that is
unresponsive to treatment with potent topical corticosteroids.
Patients in whom the eczema has predominantly hyperkeratotic features
are more likely to
respond to treatment than in those in whom the eczema predominantly
presents as pompholyx
(see section 5.1).
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSE
_ADULTS _
_ _
Zematane should only be prescribed by dermatologists, or physicians
with experience in the use
of systemic retinoids who have full understanding of the risks of
systemic retinoid therapy and
monitoring requirements. Prescriptions of Zematane for women of
childbearing potential should
be limited to 30 days of treatment and continuation of treatment
requires a new prescription.
Ideally, pregnancy testing, issuing a prescription and dispensing of
Zematane should occur on
the same day.
The recommended dose for Zematane is 10 mg or 30 mg once daily.
The recommended starting dose for Zematane is 30 mg once daily. A dose
reduction to 10 mg
once daily may be considered in patients with unacceptable adverse
reactions to the 30 mg
dose. In studies investigating 10 mg and 30 mg daily doses, both doses
resulted in clearing of the
2 | P a g e
disease. The 30 mg dose provided a more rapid response and a higher
response rate. The 10 mg
daily dose was associated with fewer adverse events (see section 5.1).
Duration of