Tacrolimus 0.1% Ointment

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tacrolimus

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

D11A

INN (International Name):

Tacrolimus

Dosage:

0.1 percent

Pharmaceutical form:

Ointment

Therapeutic area:

OTHER DERMATOLOGICAL PREPARATIONS

Authorization status:

Marketed

Authorization date:

2017-11-24

Patient Information leaflet

NL-H-4570-001-IA-018, version 01, Jan 2024
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 Tacro

Summary of Product characteristics

Health Products Regulatory Authority
20 March 2024
CRN00F5FZ
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tacrolimus 0.1% Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1g 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 mildl affected. There after, 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.
_Adults and adolesc