Aureocort ointment

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Triamcinolone acetonide; Chlortetracycline hydrochloride

Available from:

Advanz Pharma

ATC code:

D07CB01

INN (International Name):

Triamcinolone acetonide; Chlortetracycline hydrochloride

Dosage:

1mg/1gram ; 30.9mg/1gram

Pharmaceutical form:

Cutaneous ointment

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13040000; GTIN: 5021691164753

Patient Information leaflet

PATIENT INFORMATION LEAFLET
AUREOCORT
®
3.09%W/W / 0.1%W/W OINTMENT
CHLORTETRACYCLINE HYDROCHLORIDE / TRIAMCINOLONE ACETONIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 this
medicine on to others.
It may harm them, even if their symptoms are the same as yours.
• Tell your doctor 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.
The name of your medicine is Aureocort
®
3.09%w/w / 0.1%w/w Ointment. It will be
referred to as Aureocort Ointment for ease hereafter.
IN THIS LEAFLET:
1.
What Aureocort Ointment is and what it is used for
2.
Before you use Aureocort Ointment
3.
How to use Aureocort Ointment
4.
Possible side effects
5.
How to store Aureocort Ointment
6.
Further information
1. WHAT AUREOCORT OINTMENT IS AND WHAT IT IS USED FOR
Aureocort Ointment contains a mixture of two active substances:
triamcinolone
acetonide and chlortetracycline hydrochloride.
Chlortetracycline hydrochloride is one of a group of antibiotics
called the tetracyclines.
Triamcinolone acetonide is one of a group of medicines called
corticosteroids and will
reduce the inflammation caused by some types of dermatitis or eczema.
This product should be applied on the skin and is used to treat some
kinds of skin
problems, such as dermatitis and eczema that have become infected.
Your doctor may also prescribe this product if you have an infected
insect bite.
2. BEFORE YOU USE AUREOCORT OINTMENT
DO NOT USE AUREOCORT OINTMENT IF:
• you know that you are allergic to any tetracycline antibiotic
(including
chlortetracycline hydrochloride), corticosteroids (including
triamcinolone acetonide),
or to any of the other ingredients of this medicine (see section 6 of
this leaflet)
• you have a skin problem caused by a bacterial ( e.g. impetigo),
viral

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aureocort 3.09% w/w/ 0.1% w/w Ointment
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aureocort Ointment is a topical preparation containing the active
ingredients
chlortetracycline hydrochloride 3.09 % w/w and triamcinolone acetonide
0.1
% w/w.
Excipient(s) with known effect
Wool Fat 10.000 % w/w
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ointment for topical administration.
Yellow, opaque, smooth, homogeneous ointment
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Aureocort combines the anti-inflammatory action of triamcinolone
acetonide
with the anti-infective properties of chlortetracycline.
It is indicated in the treatment of secondarily infected atopic
dermatitis,
contact dermatitis, eczema, neurodermatitis, otitis externa,
seborrhoeic
dermatitis, varicose eczema, vesiculo-pustular dermatitis. It may also
be used
in the treatment of infected insect bites.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Adults, Paediatric population (children over 8 years) and the elderly
Aureocort Ointment should be applied sparingly to the affected area,
either
directly or on sterile gauze, two or three times daily.
Aureocort treatment should be limited to seven days. (see section 4.4)
_ _
Avoid contact with eyes (see section 4.4)
_ _
In general, dose selection for an elderly patient should be cautious,
taking into
account physiological changes in ageing skin (see section 4.4)
Method of administration:
Topical use
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in
section 6.1.
The use of Aureocort is contra-indicated in tuberculous, fungal or
viral lesions
of the skin (herpes simplex, vaccinia and varicella), and primary
bacterial
infections, e.g. impetigo, pyoderma, furunculosis_,_ in acne vulgaris
rosacea,
perioral dermatitis and widespread plaque psoriasis (see Section 4.4)
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
General Use
Corticosteroids, such as triamcinolon