Protopic

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

tacrolimus

Available from:

LEO Pharma A/S

ATC code:

D11AH01

INN (International Name):

tacrolimus

Therapeutic group:

Other dermatological preparations

Therapeutic area:

Dermatitis, Atopic

Therapeutic indications:

Flare treatmentAdults 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.Children (two years of age and above)Treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.Maintenance treatmentMaintenance 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 four or more times per year) who have had an initial response to a maximum of six weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).

Product summary:

Revision: 26

Authorization status:

Authorised

Authorization date:

2002-02-27

Patient Information leaflet

39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROTOPIC 0.03% 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 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 Protopic is and what it is used for
2.
What you need to know before you use Protopic
3.
How to use Protopic
4.
Possible side effects
5.
How to store Protopic
6.
Contents of the pack and other information
1.
WHAT PROTOPIC IS AND WHAT IT IS USED FOR
The active substance of Protopic, tacrolimus monohydrate, is an
immunomodulating agent.
Protopic 0.03% 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 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 Protopic 0.03%
ointment twice weekly.
In atopic dermatitis, an over-reaction of the skin’s immune system
causes skin inflammation
(itchiness, redness, dryness). Protopic alters the abnormal immune
response and relieves the skin
inflammation and the itch.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PROTOPIC
DO NOT USE PROTOPIC
•
If you are allergic to tacrolimus or any of the other ingredi

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Protopic 0.03% ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of Protopic 0.03% ointment contains 0.3 mg of tacrolimus as
tacrolimus monohydrate (0.03%).
Excipient with known effect
Butylhydroxytoluene (E321) 15 micrograms/g ointment.
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
Protopic 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 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
Protopic treatment should be initiated by physicians with experience
in the diagnosis and treatment of
atopic dermatitis.
Protopic is available in two strengths, Protopic 0.03% and Protopic
0.1% ointment.
Posology
Flare treatment
Protopic can be used for short-term and intermittent long-term
treatment. Treatment should not be
continuous on a long-term basis.
Protopic treatment should begin at the first appearance of signs and
symptoms. Each affected region of
the skin should be treated with Protopic until lesions are cleared,
almost cleared or mildly a