Tacrolimus 0.03% ointment

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Tacrolimus

Dostupné s:

Accord Healthcare Ireland Ltd.

ATC kód:

D11A; D11AH01

INN (Mezinárodní Name):

Tacrolimus

Léková forma:

Ointment

Terapeutické oblasti:

OTHER DERMATOLOGICAL PREPARATIONS; tacrolimus

Stav Autorizace:

Not marketed

Datum autorizace:

2022-11-11

Informace pro uživatele

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
TACROLIMUS 0.03% 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 any 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 is and what it is used for
2.
What you need to know before you use Tacrolimus
3.
How to use Tacrolimus
4.
Possible side effects
5.
How to store Tacrolimus
6.
Contents of the pack and other information
1.
WHAT TACROLIMUS IS AND WHAT IT IS USED FOR
The active substance of Tacrolimus, tacrolimus, is an immunomodulating
agent.
Tacrolimus 0.03% ointment is used to treat moderate to severe atopic
dermatitis (eczema) in adults and
adolescents who are not adequately responsive to or are intolerant of
conventional therapies such as
topical corticosteroids and in children (2 years of age and older) who
failed to respond adequately to
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 0.03%
ointment twice weekly.
In atopic dermatitis, an over-reaction of the skin’s immune system
causes skin inflammation (itchiness,
redness, dryness). Tacrolimus alters the abnormal immune response and
relieves the skin inflammation
and the itch.
2.
WHAT YOU NEED TO KNOW BEFORE YOU
USE TACROLIMUS
DO NOT
USE TACROLIMUS
-
If you are allergic (hypersensitive) to tacrolimus or any

Charakteristika produktu

Health Products Regulatory Authority
16 November 2022
CRN008LJS
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tacrolimus 0.03% ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains 0.3 mg of tacrolimus, as monohydrate.
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 0.03% ointment is indicated in adults, adolescents and
children from the age of 2 years.
Flare treatment
_Adults and adolescents (16 years of age and above) _
Treatment of moderate to severe atopic dermatitis in adults AND
ADOLESCENTS 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).
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% ointment
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 until lesions are cleared, almost cleared or
mildly affected. Thereaft