PROTOPIC OINTMENT 0.03%

Země: Malajsie

Jazyk: angličtina

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

Aktivní složka:

TACROLIMUS

Dostupné s:

DKSH MALAYSIA SDN BHD

INN (Mezinárodní Name):

TACROLIMUS

Jednotky v balení:

10gm mcg/mL; 30gm mcg/mL

Výrobce:

LEO Laboratories Ltd

Informace pro uživatele

_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.
Protopic® is also used to treat
moderate to severe atopic dermatitis
(eczema) for the prevention of flares
and prolongation of flare-free
intervals in patients experiencing a
high frequency of disease
exacerbations (i.e. occurring 4 or
more times per year) who have had
an initial response to maximum 6
weeks treatment of twice daily
Protopic® ointment.
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 sca

Charakteristika produktu

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)
Flare treatment
_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 topical corticosteroids.
Maintenance treatment
Treatment of moderate to severe atopic dermatitis for the prevention
of flares and the
prolongation of flare-free intervals in patients experiencing a high
frequency of disease
exacerbations (i.e. occurring 4 or more times per year) who have had
an initial response to a
maximum of 6 weeks treatment of twice daily tacrolimus ointment
(lesions cleared, almost
cleared or mildly affected).
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
Flare treatment
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