Boots Derma Care Hydrocortisone 1% ointment

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Descarcare Prospect (PIL)
06-04-2023

Ingredient activ:

Hydrocortisone

Disponibil de la:

The Boots Company Plc

Codul ATC:

D07AA02

INN (nume internaţional):

Hydrocortisone

Dozare:

10mg/1gram

Forma farmaceutică:

Cutaneous ointment

Calea de administrare:

Cutaneous

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 13040000; GTIN: 5000167082401

Prospect

                                UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE
ALTERED WITHOUT PRIOR PERMISSION FROM WK360.
TECHNICAL INFORMATION, PRINTER PLEASE NOTE:
WK360 HAVE CREATED THIS ARTWORK TO A GENERIC PRINT
PROCESS SPECIFICATION AND REPRO HAS NOT BEEN APPLIED.
PLEASE CALL YOUR CLIENT CONTACT TO DISCUSS ANY AMENDS
OR IF ANYTHING FALLS BENEATH YOUR PRINT TOLERANCES
Applescan House, Latimer Road, Luton, Beds, LU1 3XE
TEL: 01582 487580 / 01582 456082 WEB: wk360.com
BRANDING
16/11/2021
Martyn Price
PRINTING COLOURS
PMS
280 C
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Guides
TECHNICAL & NON-PRINTING
SPECIAL FINISHES & FOILS
5481.004
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BRAILLE:
Health
Boots Own Brand
Healthy Skin
45-89-327
N/A
00110010 (305)
NENN9
3
Leaflet
Paper
White
1
WBA-2001-Boots Derma Care 1pc w_w Ointment Leaflet
PACK MOCK UP
ARTWORK TEXT SIZE
MAIN HEADINGS:
11pt
SUB HEADINGS:
9pt
BODY HEADINGS:
8pt
VERSION
NO.
DATE
ISSUED
REASON FOR CHANGE
1
08/10/2021
Introduction of leaflet
00014/0364
N/A
Internally approved
15g
Boots Derma Care 1% w/w
Ointment
PRODUCT NAME:
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ARTWORK
Always use this medicine exactly as
described in this leaflet or as your doctor,
pharmacist or nurse have told you.
• Keep this leaflet. You may need to read it
again.
• Ask your pharmacist if you need more
information or advice.
• If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.
• You must talk to a doctor if you do not feel
better or if you feel worse after 7 days.
WHAT IS IN THIS LEAFLET
1. What Boots Derma Care Ointment is and
what it is us
                                
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Caracteristicilor produsului

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone Ointment
Boots Derma Care Hydrocortisone 1% Ointment
Almus Hydrocortisone 1% Ointment
Boots Derma Care 1% w/w Ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient %w/w
Hydrocortisone Ph Eur 1.0
3.
PHARMACEUTICAL FORM
Ointment
4.1
THERAPEUTIC INDICATIONS
For the relief of irritant contact dermatitis, allergic contact
dermatitis,
insect bite reactions and mild to moderate eczema.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For adults, the elderly and children over 10 years of age: Apply
sparingly
to a small area, once or twice a day, for a maximum of 7 days.
Children under 10 years of age: Not recommended except under medical
supervision.
For topical application.
4.3
CONTRAINDICATIONS
The product should not be used if allergic to any of the ingredients
or on
the eyes or face, the ano-genital area or on broken or infected skin
including impetigo, cold sores, acne or athlete's foot.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Medical advice should be sought if the condition does not improve.
Visual impairment:
Visual impairment may be reported with systemic and topical use of
corticosteroids. If patients develop symptoms such as blurred vision
or
other visual disturbances, consideration should be given to referring
the
patient to an ophthalmologist to establish the possible cause which
may
include cataract, glaucoma or rare conditions such as central serous
chorioretinopathy (CSCR) which have been reported after use of
systemic
and topical corticosteroids.
Long term continuous or inappropriate use of topical steroids can
result in
the
development
of
rebound
flares
after
stopping
treatment
(topical
steroid
withdrawal
syndrome).
A
severe
form
of
rebound
flare
can
develop
which
takes
the
form
of
a
dermatitis
with
intense
redness,
stinging and burning that can spread beyond the initial treatment
area. It is
more likely to occur when delicate skin sites such as the face and
flexures
are treated. Should there be a reoccurrenc
                                
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