Tacrolimus 0.1% Ointment

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tacrolimus

Available from:

Accord Healthcare Limited

ATC code:

D11A

INN (International Name):

Tacrolimus

Dosage:

0.1 percent

Pharmaceutical form:

Ointment

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

OTHER DERMATOLOGICAL PREPARATIONS

Authorization status:

Marketed

Authorization date:

2017-11-24

Patient Information leaflet

Artwork No.
Customer
Description
Market
Language
Size
Min. Font Size
Version No.
Date
-
Accord
Tacrolimus Ointment
UK-IE-MT
English
450 x 450 mm (Final Fold size - 38 x 35 mm)
10
2 (Page 1 of 2)
01/11/17 (Tacrolimus Ointment (ACC-UK-IE-MT)OS-PIL)
Colours Used
Pantone Black
Keyline
ADVERTISING & COMMUNICATION SERVICES LTD.
Prepared By
Regulatory Affairs
Checked By
Regulatory Affairs
Approved By
Quality Assurance
70 MM
35 MM
35 MM
10 0000 0 000000
Tacrolimus 0.1%
Ointment
10 0000 0 000000
Tacrolimus 0.1%
Ointment
186 MM
186 MM
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

Summary of Product characteristics

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.
_Adults and adolescents (16 years of age and above)_
Treatment should be started with Tacroli