PROTOPIC OINTMENT 0.1%

Land: Malaysia

Språk: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv ingrediens:

TACROLIMUS

Tilgjengelig fra:

DKSH MALAYSIA SDN BHD

INN (International Name):

TACROLIMUS

Enheter i pakken:

30gm mcg/mL; 10gm mcg/mL

Produsert av:

LEO Laboratories Ltd

Informasjon til brukeren

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
PROTOPIC® OINTMENT
Tacrolimus (0.03% w/w, 0.1% w/w)
WHAT IS IN THIS LEAFLET
1.
What Protopic® is used for
2.
How Protopic® works
3.
Before you use Protopic®
4.
How to use Protopic®
5.
While you are using it
Side effects
6.
Storage and Disposal of
Protopic®
7.
Product Description
8.
Manufacturer and Product
Registration Holder
10. Date of revision
WHAT PROTOPIC® IS USED FOR
Protopic® is used to treat moderate
to severe atopic dermatitis (eczema)
in adults who are not adequately
responsive to or are intolerant of
conventional therapies such as
topical corticosteroids.
Only Protopic® 0.03% is used to
treat children (2 years of age and
older) who failed to respond
adequately to conventional therapies
such as topical corticosteroids.
HOW PROTOPIC® WORKS
The active substance of Protopic®,
tacrolimus monohydrate, is an
immunomodulating agent.
In atopic dermatitis, an over-
reaction of the skin’s immune
system causes skin inflammation
(itchiness, redness, dryness).
Protopic® alters the abnormal
immune response and relieves the
skin inflammation and the itch.
BEFORE YOU USE PROTOPIC®
-
_When you must not use it _
If you are allergic to tacrolimus or
any of the other ingredients of this
medicine or to macrolide antibiotics
(e.g. azithromycin, clarithromycin,
erythromycin).
-
_Before you start to use it _
Talk to your doctor
•
If you have liver failure.
•
If you have any skin malignancies
(tumours) or if you have a
weakened immune system
(immuno-compromised) whatever
the cause.
•
If you have an inherited skin
barrier disease such as Netherton’s
syndrome, lamellar ichthyosis
(extensive scaling of the skin due to
a thickening of the outer layer of the
skin), or if you suffer from
generalised erythroderma
(inflammatory reddening and
scaling of the entire skin).
•
If you have a cutaneous Graft
Versus Host Disease (an immune
reaction of the skin which is a
common complication after
undergoing a bone marrow
transplant).
•
If you have swollen lymph nod

Preparatomtale

PROTOPIC
®
NAME OF THE MEDICINAL PRODUCT
PROTOPIC® ointment 0.03%
PROTOPIC® ointment 0.1%
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of PROTOPIC® 0.03% ointment contains 0.3 mg of tacrolimus as
tacrolimus
monohydrate (0.03%).
1 g of PROTOPIC® 0.1% ointment contains 1.0 mg of tacrolimus as
tacrolimus
monohydrate (0.1%).
For the full list of excipients, see List of Excipients.
PHARMACEUTICAL FORM
Ointment. A white to slightly yellowish ointment.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
PROTOPIC® 0.03% ointment is indicated in adults, adolescents and
children from
the age of 2 years.
PROTOPIC® 0.1 % ointment is indicated in adults and adolescents (16
years of
age and above)
_Adults and adolescents (16 years of age and above) _
Treatment of moderate to severe atopic dermatitis in adults who are
not
adequately responsive to or are intolerant of conventional therapies
such as
topical corticosteroids.
_Children (2 years of age and above) _
Treatment of moderate to severe atopic dermatitis in children who
failed to
respond adequately to conventional therapies such as
topicalcorticosteroids.
POSOLOGY AND METHOD OF ADMINISTRATION
PROTOPIC® treatment should be initiated by physicians with experience
in the
diagnosis and treatment of atopic dermatitis.
PROTOPIC® is available in two strengths, PROTOPIC® 0.03% and
PROTOPIC® 0.1%
ointment.
Posology
PROTOPIC® can be used for short-term and intermittent long-term
treatment.
Treatment should not be continuous on a long-term basis.
PROTOPIC® treatment should begin at the first appearance of signs and
symptoms. Each affected region of the skin should be treated with
PROTOPIC®
until lesion are cleared, almost cleared or mildly affected. At the
first signs of
recurrence (flares) of the disease symptoms, treatment should be
re-initiated.
_Adults and adolescents (16 years of age and above) _
Treatment should be started with PROTOPIC® 0.1% twice a day and
treatment
should be continued until clearance of the lesion. If symptoms recur,
twice daily
treatment with PROTOP