Protopic 0.1% ointment

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Tacrolimus monohydrate

Verfügbar ab:

LEO Pharma

ATC-Code:

D11HA01

INN (Internationale Bezeichnung):

Tacrolimus monohydrate

Dosierung:

1mg/1gram

Darreichungsform:

Ointment

Verabreichungsweg:

Cutaneous

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 13050300; GTIN: 5390332111181 5390332111198

Gebrauchsinformation

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range - 10 g, 15 g, 30 g, 60 g
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®
range - 15 g, 30 g, 60 g
Fucicort
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range - 15 g, 30 g, 60 g
FRONT OF LEAFLET
Creation Date:
Revision Date:
Sign:
Sign:
Scale:
OMA
24/08/2015
OMA
06/07/2018
Ref. No.:
Size:
Material:
Type:
100%
IIE042-03
610 x 350 mm
Insert
PACKAGING COMPONENT SPECIFICATION
LEO Pharma
Internal Market Access
Industriparken 55
2750 Ballerup
Denmark
610x350_105x28_mF_154_AK2_Rev 4
Folded to 105 x 28 mm
Comments:
IIE042-00 - 13/09/2016 - OMA: New leaflet based on trial 99991530 with
new supplier drawing
IIE042-01 - 06/11/2017 - JUG: Material number Font and size defind and
info added on drawing
IIE042-02 - 16/05/2018 - OMA: Updated with drawing from Essentra
containing new folding pattern
IIE042-03 - 06/07/2018 - OMA: Updated with drawing from Essentra
containing new folding pattern and i-mark position
Revision info:
Used for:
IIE042-03 - 610 x 350 mm - page 1 of 2
Only to be used together with CIE093 37 x 32 x 120 mm, CIE094 44 x 32
x 140 mm, CIE095 47 x 38 x 160 mm,
610 mm
350 mm
105 mm
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105 mm
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105 mm
85 mm
8 mm
10
26 mm
24 mm
28 mm
28 mm
28 mm
28 mm
28 mm
28 mm
28 mm
28 mm
23 mm
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5 mm
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PACKAGE LEAFLET: INFORMATION FOR THE USER
PROTOPIC® 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 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. Con

Fachinformation

OBJECT 1
PROTOPIC 0.1% OINTMENT
Summary of Product Characteristics Updated 17-Jul-2018 | Leo
Laboratories Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Protopic 0.1% ointment
2. Qualitative and quantitative composition
1 g of Protopic 0.1% ointment contains 1.0 mg of tacrolimus as
tacrolimus monohydrate (0.1%).
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 0.1 % 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 f