Tacrolimus 0.1 % ointment

국가: 몰타

언어: 영어

출처: Medicines Authority

유효 성분:

TACROLIMUS

제공처:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC 코드:

D11AH01

INN (국제 이름):

TACROLIMUS 0.1 % (W/W)

약제 형태:

OINTMENT

구성:

TACROLIMUS 0.1 % (W/W)

처방전 유형:

POM

치료 영역:

OTHER DERMATOLOGICAL PREPARATIONS

승인 상태:

Withdrawn

승인 날짜:

2018-01-04

환자 정보 전단

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TACROLIMUS 0.1% OINTMENT
Tacrolimus
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Tacrolimus ointment is and what it is used for
2.
What you need to know before you use Tacrolimus ointment
3.
How to use Tacrolimus ointment
4.
Possible side effects
5.
How to store Tacrolimus ointment
6.
Contents of the pack and other information
1.
WHAT TACROLIMUS OINTMENT IS AND WHAT IT IS USED FOR
The active substance of Tacrolimus ointment, tacrolimus monohydrate,
is an immunomodulating
agent.
Tacrolimus 0.1% ointment 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.
Once moderate to severe atopic dermatitis is cleared or almost cleared
after up to 6 weeks treatment
of a flare, and if you are experiencing frequent flares (i.e. 4 or
more per year), it may be possible to
prevent flares coming back or prolong the time you are free from
flares by using Tacrolimus 0.1%
ointment twice weekly.
In atopic dermatitis, an over-reaction of the skin’s immune system
causes skin inflammation
(itchiness, redness, dryness).
Tacrolimus ointment alters the abnormal immune response and
relieves the skin inflammation and the itch.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TACROLIMUS OINTMENT
DO NOT USE TACROLIMUS OINTMENT
-
If you are allergic (hypersensitive) to tacrolimus or any of the other
ingredients of Tacrolimus
ointment (listed in secti

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Tacrolimus 0.1 % ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g ointment contains tacrolimus monohydrate corresponding to 1.0 mg
tacrolimus.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ointment
A white to slightly yellowish ointment.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tacrolimus 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.
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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Tacrolimus treatment should be initiated by physicians with experience
in the diagnosis and treatment
of atopic dermatitis.
Tacrolimus is available in two strengths, tacrolimus 0.03 % and
tacrolimus 0.1 % ointment.
_Posology _
Flare treatment
Tacrolimus can be used for short-term and intermittent long-term
treatment. Treatment should not be
continuous on a long-term basis.
Tacrolimus treatment should begin at the first appearance of signs and
symptoms. Each affected region
of the skin should be treated with Tacrolimus ointment until lesions
are cleared, almost cleared or
mildly affected. Thereafter, patients are considered suitable for
maintenance treatment (see below). At
the first signs of recurrence (flares) of the disease symptoms,
treatment should be re-initiated.
_ _
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_ _
_Adults and adolescents (16 years of age and above)_
Treatmen