Aureocort

Package leaflet: Information for the patient

AUREOCORT 3% + 0.1% cream

triamcinolone + chlortetracycline
Please read all of this leaflet carefully before you start using/giving your child this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and/or your child only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you and/or your child experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Aureocort is and what it is used for
2. What you need to know before using/giving your child Aureocort
3. How to use/give your child Aureocort
4. Possible side effects
5. How to store Aureocort
6. Contents of the pack and other information

1. What Aureocort is and what it is used for

Aureocort is a topical cream containing two active substances: triamcinolone and chlorotetracycline.
Triamcinolone is a corticosteroid used to reduce the symptoms of inflammation.
Chlorotetracycline is an antibiotic capable of inhibiting bacterial growth.
Aureocort is a medicine indicated in adults and children:

• for skin inflammations (dermatitis) in which corticosteroids (medicines such as triamcinolone) are effective, when accompanied by bacterial infection sensitive to chlorotetracycline;
• for skin inflammations (dermatitis) in which chlorotetracycline is effective, when accompanied by evident inflammatory reaction.

2. What you should know before using/giving Aureocort to your child

Do not use/give Aureocort to your child

• if you and/or your child are allergic to triamcinolone or chlortetracycline or to any of the other ingredients of this medicine (listed in section 6);
• if the area of skin to be treated is affected by tuberculosis (an infectious disease);
• if you and/or your child have viral infections (e.g. herpes);
• if you and/or your child have chickenpox;
• if you and/or your child have other fungal or viral skin diseases affecting the area to be treated;
• if you and/or your child have rosacea (facial redness and scaling affecting certain facial areas);
• if you/your child have skin lesions. Do not use/give Aureocort to your child with occlusive dressings (dressings with gauze or other material to locally retain medicines applied to the skin).

Do not use/give Aureocort to your child in the eyes.
Warnings and precautions
Talk to your doctor or pharmacist before using/giving Aureocort to your child.
Contact your doctor if:

• the condition does not improve quickly after treatment; in such cases, your doctor will stop the treatment and prescribe an appropriate alternative therapy for you and/or your child;
• blurred vision or other visual disturbances occur.

If you use/give Aureocort to your child for a prolonged period, repeatedly, or over large areas of the body, the following effects may occur:

• allergic reactions—in such cases, treatment must be stopped immediately and the doctor informed (see section 4 Possible Side Effects);
• bacterial (caused by bacteria) or fungal (caused by fungi) infections that are resistant to chlortetracycline—in such cases, treatment must be stopped and the doctor informed;
• systemic reactions due to absorption (Cushing's syndrome, suppression of the hypothalamic-pituitary-adrenal axis), especially in patients with impaired kidney function (renal insufficiency).

Children and adolescents
In early infancy (i.e., up to 2 years of age), use only when strictly necessary and under direct medical supervision.
Aureocort must not be used with diapers, as diapers may act as occlusive dressings.
Other medicines and Aureocort
Inform your doctor or pharmacist if you/your child are using, have recently used, or might use any other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Generally, use this medicine during pregnancy only when strictly necessary and under direct medical supervision.
Breastfeeding
It is not known whether topical administration of Aureocort leads to absorption of triamcinolone in amounts sufficient to result in detectable levels in breast milk.
For this reason, caution is advised if you use Aureocort while breastfeeding; in particular, do not apply Aureocort to the breast area.
Driving and using machines
Aureocort does not affect the ability to drive vehicles or operate machinery.
Aureocort cream contains lanolin
May cause local skin reactions (e.g. contact dermatitis).

3. How to use/give Aureocort to your child

Use/give this medicine to your child exactly as directed by the doctor or pharmacist. If you have any doubts, consult the doctor or pharmacist.
The recommended dose is one application 2 or 3 times daily to the affected area.
You may apply the cream directly to the skin or by using a sterile gauze.
Do not use/give Aureocort to your child for the eyes.
Use in children and adolescents
Aureocort must not be used under a diaper, as the diaper may act as an occlusive dressing (see section 2 Children and adolescents).
Duration of treatment
Do not use/give Aureocort to your child for longer than one consecutive week.
If you use/give your child more Aureocort than you should
In case of accidental ingestion/overdose of Aureocort, contact the doctor immediately or go to the nearest hospital.
If you use/give your child more Aureocort than you should, wash the affected part of the body with water and soap and consult the doctor.
If you forget to use/give your child Aureocort
Do not use/give your child a double dose to make up for a missed dose.
If you forget to apply the cream at the scheduled time, apply it as soon as possible.
If you stop treatment with Aureocort
If you have any doubts about using this medicine, consult the doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you and/or your child experience any of the following side effects during treatment with Aureocort, consult your doctor immediately, who will STOP treatment with
Aureocort:

• allergic reactions which may present with the following symptoms:
• increased blood flow to a part of the body (hyperemia)
• swelling
• itching
• desquamation
  Blurred vision may occur, with an unknown frequency (frequency cannot be determined from the available data).

For prolonged treatments, the following side effects may occur, for which the frequency cannot be established:
Effects related to the skin

• skin atrophy (skin becomes thin and less elastic),
• excessive hair growth (hypertrichosis),
• acneiform eruptions (acne, pus-filled boils),
• red spots on the skin (purpura)

Effects related to blood vessels

• capillary fragility

Other side effects reported following excessive use of corticosteroids (medicines such as triamcinolone), which therefore may also be potential side effects of Aureocort, include:
Effects related to the heart and blood vessels:

• high blood pressure (arterial hypertension)
• heart rhythm disturbances

Effects related to metabolism and nutrition:

• decreased potassium levels in the blood
• decreased acid levels in the blood (metabolic alkalosis)

Effects related to the whole body:

• weakness, sometimes severe (asthenia and adynamia)

Reporting of side effects
If you and/or your child experience any side effect, including those not listed in this leaflet, talk to your doctor. You may also report side effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aureocort

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month. The stated expiry date applies to the product in its original, undamaged packaging and properly stored.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Do not use this medicine if you notice that the tube is damaged.

6. Package contents and other information

What Aureocort contains
The active substances are: Chlortetracycline hydrochloride and Triamcinolone acetonide (100 g of cream contain 3.0 g of chlortetracycline hydrochloride and 0.1 g of triamcinolone acetonide, respectively).
The other components are: Anhydrous lanolin (see section 2, Aureocort contains lanolin),
white vaseline.
Description of the appearance of Aureocort and package contents
Aureocort is a yellow cream for topical use, supplied in a 30 g tube.
Marketing Authorization Holder
TEOFARMA S.r.l.
via F.lli Cervi, 8 – 27010 Valle Salimbene (PV)
Manufacturer
TEOFARMA S.r.l.
V.le Certosa 8/A – 27100 Pavia
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