Hydrocortisone 1% ointment

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Δραστική ουσία:

Hydrocortisone

Διαθέσιμο από:

Sovereign Medical Ltd

Φαρμακολογική κατηγορία (ATC):

D07AA02

INN (Διεθνής Όνομα):

Hydrocortisone

Δοσολογία:

10mg/1gram

Φαρμακοτεχνική μορφή:

Cutaneous ointment

Οδός χορήγησης:

Cutaneous

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 13040000; GTIN: 05021730031022 05021730031039 05021730031046

Φύλλο οδηγιών χρήσης

                                PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GB
674-9964-APIL
HYDROCORTISONE OINTMENT 1%
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Please 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 Hydrocortisone Ointment 1% is and what it
is used for
2. What you need to know before you use
Hydrocortisone Ointment 1%
3. How to use Hydrocortisone Ointment 1%
4. Possible side effects
5. How to store Hydrocortisone Ointment 1%
6. Contents of the pack and other information
1. WHAT HYDROCORTISONE OINTMENT 1% IS AND WHAT IT IS USED FOR
The name of your medicine is Hydrocortisone
Ointment 1%.
Hydrocortisone Ointment 1% contains the active
ingredient hydrocortisone which belongs to a group
of medicines called corticosteroids or ‘steroids’.
Steroids like hydrocortisone are applied to the skin
to reduce inflammation.
Hydrocortisone Ointment 1% is used to treat all
types of eczema and dermatitis and insect bite
reactions.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HYDROCORTISONE OINTMENT 1%
DO NOT USE HYDROCORTISONE OINTMENT 1%:
•
if you are allergic to hydrocortisone or any of the
other ingredients of this medicine (listed in
section 6) (allergic reactions include mild
symptoms such as itching and/or rash. More
severe symptoms include swelling of the face,
lips, tongue and/or throat with difficulty in
swallowing or breathing).
•
If you have an infection of the skin which has not
been treated;
•
If you have pale or reddened patches of skin –
(usually as a result of an allergy; this is a
condition known as urticaria);
•
If you have a facial skin cond
                                
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Αρχείο Π.Χ.Π.

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone Ointment 1%
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone EP 1% w/w
3
PHARMACEUTICAL FORM
A smooth, white to off-white ointment
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hydrocortisone Ointment is indicated for the treatment of eczema and
dermatitis of
all types, including atopic eczema, photodermatitis, otitis externa,
primary irritant and
allergic dermatitis, intertrigo, prurigo nodularis, seborrhoeic
dermatitis and insect bite
reactions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children: To be applied sparingly to the affected skin two
or three times
daily after gently cleansing the area. Courses of treatment in
children should
generally be limited to not more than seven to ten days.
4.3
CONTRAINDICATIONS
Hydrocortisone Ointment is contra-indicated in patients with
bacterial, viral or fungal
infections of the skin. Urticaria, rosacea, ulcers and local infection
are also contra-
indications.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Prolonged use in infants and children and on the face should be
avoided.
Hydrocortisone Ointment is for symptomatic relief and is not curative.
For this
reason, there is a possibility of rebound of symptoms.
Hydrocortisone Ointment is not recommended for pruritis.
Topical corticosteroids may be hazardous in patients with psoriasis
and should
therefore be avoided.
Long term use in patients with diabetes or tuberculosis is not
recommended.
I
nstruct patients not to smoke or go near naked flames - risk of severe
burns.
Fabric (clothing, bedding, dressings etc) that has been in contact
with this
product burns more easily and is a serious fire hazard. Washing
clothing and
bedding may reduce product build-up but not totally remove it.
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
                                
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