Aureocort 3.09% W/W/ 0.1% W/W Ointment
e
MercuryPharma
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 (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
• you have a skin condition from the bacteria that causes tuberculosis
• you have a skin condition called psoriasis, on most parts of your body
• you have a skin condition (rosacea/acne vulgaris/perioral dermatitis) characterized by red rash on your face.
Take special care with Aureocort Ointment:
• Care should be taken when using this medicine 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.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or having recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding:
Even at the usual dose, the possibility of a very small risk to the development of a baby in pregnant women treated with this product cannot be entirely ruled out. Therefore, this medicine should not be used if you are pregnant or trying to become pregnant unless considered essential by your doctor. If a doctor prescribes this medicine to you it should not be used on large areas of the skin.
Patients who are breast-feeding should not use Aureocort Ointment.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines:
Using this ointment should not affect the ability to drive or use machines.
Important information about some of the ingredients of Aureocort Ointment:
This product contains wool fat which may cause local skin reactions (see section 4, Possible side effects).
3. HOW TO USE AUREOCORT OINTMENT
This ointment is designed for topical (on the skin) application only. Always use it exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.
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.
If you use more 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 your 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 your 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.
4. POSSIBLE SIDE EFFECTS
Usually this medicine does not cause any side effects 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 include:
• 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 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
• 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.
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.
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 after the expiry date. This date is printed on the tube. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. FURTHER 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 active 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 December 2013.
Aureocort is the registered trademark of Mercury Pharma Group Limited.
100114/LF/3 722169 GB3