Tacrolimus 0.1% ointment

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Tacrolimus monohydrate

Fáanlegur frá:

DE Pharmaceuticals

ATC númer:

D11AH01

INN (Alþjóðlegt nafn):

Tacrolimus monohydrate

Skammtar:

1mg/1gram

Lyfjaform:

Cutaneous ointment

Stjórnsýsluleið:

Cutaneous

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 13050300

Upplýsingar fylgiseðill

TACROLIMUS 0.1% OINTMENT
tacrolimus monohydrate
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.
1. WHAT TACROLIMUS 0.1% OINTMENT IS AND WHAT IT IS USED
FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE TACROLIMUS
0.1% OINTMENT
3. HOW TO USE TACROLIMUS 0.1% OINTMENT
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE TACROLIMUS 0.1% OINTMENT
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT TACROLIMUS 0.1% OINTMENT IS AND WHAT IT
IS USED FOR
The active substance of Tacrolimus 0.1 % 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 0.1 % Ointment alters the abnormal
immune response and relieves the skin inflammation and
the itch.
WHAT YOU NEED TO KNOW BEFORE YOU USE
TACROLIMUS 0.1% OINTMENT
DO NOT USE TACROLIMUS 0.1 % OINTMENT
•
If you are allergic (hypersensitive) to tacrolimus or any
of the other ingredients of Tacrolimus 0.1% Ointment
(listed in section 6) or to

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tacrolimus Teva 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 Teva 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 Teva 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 Teva can be used for short-term and intermittent long-term
treatment. Treatment should not be continuous on a long-term basis.
Tacrolimus Teva treatment should begin at the first appearance of
signs and
symptoms. Each affected region of the skin should be treated with
Tacrolimus
Teva 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)_
Treatme