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AUREOCORT 3.09% W/W/ 0.1% W/W OINTMENT

Active substance(s): CHLORTETRACYCLINE HYDROCHLORIDE / TRIAMCINOLONE ACETONIDE / CHLORTETRACYCLINE HYDROCHLORIDE / TRIAMCINOLONE ACETONIDE / CHLORTETRACYCLINE HYDROCHLORIDE / TRIAMCINOLONE ACETONIDE

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Package leaflet: Information for the patient

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 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass this medicine 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, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
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.
What is in this leaflet:
1. What Aureocort Ointment is and what it is used for
2. What you need to know before you use Aureocort Ointment
3. How to use Aureocort Ointment
4. Possible side effects
5. How to store Aureocort Ointment
6. Contents of the pack and other 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. WHAT YOU NEED TO KNOW BEFORE YOU USE
AUREOCORT OINTMENT
Do not use Aureocort Ointment:
• if you are allergic to any tetracycline antibiotic (including chlortetracycline
hydrochloride), corticosteroids (including triamcinolone acetonide) or to any of the
other ingredients of this medicine (listed in section 6)
• if you have a skin problem caused by a bacterial ( e.g. impetigo), viral (e.g. cold
sores, herpes, chicken pox), fungal (e.g. athlete’s foot) infection. This medicine
may mask the seriousness of these conditions or make them worse
• if you have a skin condition from the bacteria that causes tuberculosis
• if you have a skin condition called psoriasis, on most parts of your body
• if you have a skin condition (rosacea/acne vulgaris/perioral dermatitis)
characterized by red rash on your face.
Warnings and precautions:
Talk to your doctor, pharmacist or nurse before using Aurecort ointment:
• On the area of skin surrounding the eyes, mouth and nose. Accidental administration
to the eyes can lead to cataract, raised pressure in the eye, damage to the front of
the eye, and increased possibility of bacterial or fungal infection or worsening of any
existing viral infection. Avoid prolonged use on the face (and keep away from eyes)
• There is a risk of absorption of the ointment in the blood stream, particularly in
children, if applied to large areas of skin, to broken skin or under certain dressings.
This can cause Cushing’s syndrome (a hormonal disorder caused by prolonged
exposure of the body’s tissues to high levels of the hormone cortisol), high blood
pressure and raised sugar in the blood and urine
• If it is used for psoriasis. The condition may relapse or significantly worsen on
stopping treatment and there is a risk of widespread pustular psoriasis. This is a
condition where the psoriasis spreads and becomes very inflamed. In order to
minimise side effects, this ointment should only be used on small areas of
psoriasis (e.g. scalp, hands and feet). If your doctor has prescribed this product to
treat psoriasis, you should let your doctor review your progress regularly as such
treatment needs careful supervision
• Protect treated areas from sources of UV light, such as sun beds and natural
sunlight, to avoid any sensitivity reaction, e.g. a rash. At first signs of redness to the
skin, treatment should be stopped and you should see your doctor or pharmacist
• Continued use of this medicine can lead to a risk of discolouration and/or
permanent damage to the teeth, especially in children
• Particular care should be taken if you are elderly or if the person using the
ointment is under 8 years old
• Avoid prolong use of this product in children and use under specialist supervision.
If any of the above applies to you, please tell your doctor or pharmacist.
Contact your doctor if you experience blurred vision or other visual disturbances.
Other medicines and Aurecort Ointment:
Tell your doctor or pharmacist if you are using, have recently used or might use any
other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding:
The possibility of a very small risk to the development of a baby in pregnant women
treated with this product at usual doses, cannot be entirely ruled out.
However, if a doctor prescribes this medicine to you it should not be used on large
areas of the skin.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
Breast-feeding:
Patients who are breast-feeding should not use Aureocort Ointment.
Driving and using machines:
Using this ointment should not affect the ability to drive or use machines.
Aureocort Ointment contains wool fat
Wool fat-may cause local skin reactions (e.g. contact dermatitis) (see section 4,
Possible side effects).

3. HOW TO USE AUREOCORT OINTMENT
Always use this medicine exactly as your doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
The recommended dose is:
1

Continued overleaf

100114/LF/057/04

Version No:
Product Name:
Pack Size:
Component:
SKU:
Market:
Production Site:
Revision No.:
Revision Date:
Revised by:
CRF:

Aureocort Ointment
15 g
Leaflet
100114
UK
Haupt Pharma
2
03/05/2017
PAT
PR 11954

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
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Print Colours:

148 x 420mm
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the appropriate market authority (if applicable, e.g.
MHRA, HPRA, etc ) and that Mercury Pharma have
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Adults and (children over 8 years):
The ointment is usually used twice or three times each day. You should wash and dry
the area of the skin which is affected and apply enough ointment to just cover the area.
Do not get the ointment in your eyes, nose or mouth. If the ointment does get in your
eyes, you should wash them immediately with plenty of cool water. If your eyes feel
sore or painful go and see your doctor. Wash your hands after applying the ointment.
This product should not be used for more than 7 days or at regularly repeated intervals.
If your skin becomes worse while using this ointment, stop using it and tell your doctor.
Using occlusive dressings over the treatment area:
If your doctor has recommended that the affected areas of your skin on which the
ointment is used are also covered with a dressing, you must follow his/her instructions on
how often the dressing needs to be changed and how much ointment you should use. Do
not leave the dressing for longer that you have been told to. Always look carefully at the
skin when you change the dressing. If your skin looks more inflamed than before or if any
pimples containing pus have appeared, stop using the dressing and contact your doctor
as soon as possible. You should not use dressings on your face.
Method of administration: This ointment is designed for topical (on the skin)
application only.
If you use more Aurecort ointment than you should:
Only use the ointment as your doctor has told you to. Do not use more ointment as it
will not help you to get better any faster and may be harmful. If you use too much
ointment or you find that a child has used or swallowed any of the ointment, contact
your doctor or pharmacist immediately.
If you forget to use Aurecort ointment:
It is important that you use the ointment regularly. If you do forget to apply it at the
right time, you should use it as soon as you remember.
If you stop using Aurecort ointment:
You should keep using the ointment for as long as your doctor has told you to. Your
skin may look better before the infection has fully gone and if you stop using the
ointment too soon, it may come back. However, if your condition has not improved
within 7 days of starting treatment, then the treatment should be stopped.
If you have any further questions on the use of this medicine, ask your doctor,
pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets
them, but some people may be allergic to the antibiotic in the ointment.
Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or
itching (especially affecting your whole body) should be reported to a doctor immediately.
Most of the side effects that may occur are mild and listed under below frequencies:
Not known: frequency cannot be estimated from the available data
• skin reactions including:
– rashes which may be red, raised, scaly or pustular
– thinning and breaking of the skin
– small red or purple blood spots under the skin
– stretch marks
– burning sensation
– pale patches
– worsening of any pre-existing bacterial or fungal skin infections
– sensitivity to sunlight and itch.
• increased body hair
• delayed wound healing
• a risk of discolouration and/or permanent damage to the teeth with continued use
of this product, especially in children
• if this product accidentally gets in the eyes it may lead to cataract, raised pressure
in the eye, damage to the front of the eye, and increased possibility of bacterial or
fungal infection or worsening of any existing viral infection
• if this product is used over large areas of the body, then some of the drug may
enter the bloodstream. This may cause side effects such as acne and hypertension
(raised blood pressure)
• if you have an underlying fungal infection, this may at first seem to improve with
treatment, although it may worsen when treatment finishes
• if the medicine is stopped abruptly after a long period of treatment it may affect the
adrenal glands causing sudden tiredness, vomiting, low blood pressure and collapse
• blurred vision.
If any of the side effects become serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.

5. HOW TO STORE AUREOCORT OINTMENT
• Keep this medicine out of the sight and reach of children.
• Do not store above 25˚C (room temperature). Keep the tube in the outer carton in
order to protect from light.
• Do not use this medicine after the expiry date which is stated on the tube and
carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Aureocort Ointment contains:
The active substances are chlortetracycline hydrochloride and triamcinolone
acetonide. Each 1g of this ointment contains 30.9mg of chlortetracycline
hydrochloride and 1mg of triamcinolone acetonide.
The other ingredients are: wool fat and paraffin white soft.
What Aureocort Ointment looks like and contents of the pack:
Aureocort Ointment is a yellow, opaque and smooth ointment. It is supplied in
aluminium tubes containing 15g ointment.
Marketing Authorisation Holder:
Mercury Pharmaceuticals Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK
Manufacturer:
Haupt Pharma Wolfratshausen GmbH,
Pfaffenrieder Strasse 5, 82515 Wolfratshausen, Germany
This leaflet was last revised in April 2017.
Aureocort is the registered trademark of Mercury Pharma Group Limited.
100114/LF/057/04
722169 GB3
2

100114/LF/057/04

Version No:
Product Name:
Pack Size:
Component:
SKU:
Market:
Production Site:
Revision No.:
Revision Date:
Revised by:
CRF:

Aureocort Ointment
15 g
Leaflet
100114
UK
Haupt Pharma
2
03/05/2017
PAT
PR 11954

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
DCMF:
Print Colours:

148 x 420mm
722169 GB3
N/A
N/A
N/A
Black

Non-Print Colours: Cutter
Tech App. Date:
Min. Font Size:

No
9.5 pt

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, HPRA, etc ) and that Mercury Pharma have
license approval to distribute this component for
sale in the relevant market.

Accept Artwork / Reject Artwork
(Please strike off whichever NOT applicable)

Signature .......................................................................
Name .............................................................................
Date ...............................................................................

PAGE 2 OF 2

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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