Protopy
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
29-10-2008
Summary of Product characteristics
(SPC)
29-10-2008
Public Assessment Report
(PAR)
29-10-2008
Active ingredient:
tacrolimus
Available from:
Astellas Pharma GmbH
ATC code:
D11AX14
INN (International Name):
tacrolimus
Therapeutic group:
Other dermatological preparations
Therapeutic area:
Dermatitis, Atopic
Therapeutic indications:
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. Treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.Maintenance 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).
Product summary:
Revision: 10
Authorization status:
Withdrawn
Authorization date:
2002-02-28
Patient Information leaflet
Medicinal product no longer authorised
34
B. PACKAGE LEAFLET
Medicinal product no longer authorised
35
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROTOPY 0.03% OINTMENT
Tacrolimus monohydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Protopy is and what it is used for
2.
Before you use Protopy
3.
How to use Protopy
4.
Possible side effects
5.
How to store Protopy
6.
Further information
1.
WHAT PROTOPY IS AND WHAT IT IS USED FOR
The active substance of Protopy, tacrolimus monohydrate, is an
immunomodulating agent.
Protopy 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. In atopic
dermatitis, an over-reaction of the
skin’s immune system causes skin inflammation (itchiness, redness,
dryness). Protopy alters the
abnormal immune response and relieves the skin inflammation and the
itch.
2.
BEFORE YOU USE PROTOPY
DO NOT USE PROTOPY
-
If you are allergic (hypersensitive) to tacrolimus or any of the other
ingredients of Protopy or to
macrolide antibiotics (e.g. azithromycin, clarithromycin,
erythromycin).
TAKE SPECIAL CARE WITH PROTOPY
-
Protopy ointment is not approved for children younger than 2 years of
age. Therefore it should
not be used in this age group. Please consult your doctor.
-
The effect of treatment with Protopy on the developing immune system
in children, especially
the you
Read the complete document
Summary of Product characteristics
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Protopy 0.03% ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of Protopy 0.03% ointment contains 0.3 mg of tacrolimus as
tacrolimus monohydrate (0.03%).
For a 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
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. Treatment of moderate to
severe atopic dermatitis in children (2 years of age and above) who
failed to respond adequately to
conventional therapies such as topical corticosteroids.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Protopy should be initiated by physicians with experience in the
diagnosis and treatment of atopic
dermatitis.
Treatment should be intermittent and not continuous.
Protopy ointment should be applied as a thin layer to affected areas
of the skin. Protopy ointment may
be used on any part of the body, including face, neck and flexure
areas, except on mucous membranes.
Protopy ointment should not be applied under occlusion (see section
4.4).
Each affected region of the skin should be treated with Protopy until
clearance occurs and then
treatment should be discontinued. Generally, improvement is seen
within one week of starting
treatment. If no signs of improvement are seen after two weeks of
treatment, further treatment options
should be considered. Protopy can be used for short term and
intermittent long term treatment. At the
first signs of recurrence (flares) of the disease symptoms, treatment
should be re-initiated.
Protopy is not recommended for use in children below age of 2 years
until further data are available.
Use in children (2 years of age and above)
Treatment should be started twice a day for up to three weeks.
Afterwards the fr
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