AUREOCORT 3 %/0,1 % Крем

Содержание инструкции

1. AUREOCORT 3% + 0.1% cream
   1. What Aureocort is and what it is used for
   2. What you need to know before using/giving Aureocort to your child
   3. How to use/give Aureocort to your child
   4. Possible side effects
   5. How to store Aureocort
   6. Contents of the pack and other information

AUREOCORT 3% + 0.1% cream

triamcinolone + chlortetracycline

Read this leaflet carefully before using/giving this medicine to your child as it
contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you and/or your child. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If you and/or your child experience any side effects, including those not listed in this leaflet, tell 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 Aureocort to your child
• 3. How to use/give Aureocort to your child
• 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 cream for topical use containing two active ingredients: triamcinolone and chlortetracycline.
Triamcinolone is a corticosteroid used to reduce the symptoms of inflammation.
Chlortetracycline is an antibiotic capable of blocking the growth of bacteria.
Aureocort is a medicine indicated in adultsand children:

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

2. What you need to 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 chlorotetracycline 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 (caused by fungi) and viral diseases affecting the skin to be treated,
• if you and/or your child have rosacea (redness and scaling that characterize certain areas of the face)
• if you/your child have skin lesions. Do notuse/give Aureocort to your child with an occlusive dressing (dressing with gauze or other material to keep medicines applied to the skin locally).

Do notuse/give Aureocort to your child for the eyes.

Warnings and precautions
Consult your doctor or pharmacist before using/giving Aureocort to your child.
Consult your doctor if:

• the condition does not improve quickly after treatment, in these cases the doctor will interrupt the treatment and prescribe you and/or your child an adequate alternative therapy.
• you experience blurred vision or other visual disturbances.

If you use/give Aureocort to your child for a long period of time, if you use it repeatedly or if you

use it on large areas of the body, the following effects may occur:

• allergic reactions in this case it is necessary to stop treatment immediately and inform the doctor (see section 4 Possible Side Effects)
• bacterial (caused by bacteria) or fungal (caused by fungi) infections that do not respond to chlorotetracycline (resistant infections), in this case it is necessary to stop treatment and inform the doctor
• reactions affecting the whole body following absorption (Cushing's syndrome, inhibition of the pituitary-adrenal axis), especially in subjects with reduced kidney function (renal insufficiency).

Children and adolescents
In early infancy (i.e. up to 2 years of age) use only if absolutely necessary and under
direct medical supervision.
Aureocort must notbe used with a diaper as the diaper can act as an occlusive
dressing.

Other medicines and Aureocort
Tell your doctor or pharmacist if you/your child are taking, have recently taken or
might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Generally, if you are pregnant, use this medicine only if absolutely
necessary and under direct medical supervision.

Breastfeeding
It is not known whether local administration of Aureocort leads to absorption of triamcinolone such
that detectable amounts are present in breast milk.
For this reason, you should be careful if you use Aureocort and are breastfeeding, in particular
do not use Aureocort on the breast.

Driving and using machines
Aureocort does not impair the ability to drive vehicles or use machines.

Aureocort cream contains lanolin
It 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 following the instructions of the doctor or pharmacist exactly as given. If you have any doubts, consult your doctor or pharmacist.
The recommended doseis to apply it 2 or 3 times a day to the affected area.
You can apply the cream directly to the skin or using a sterile gauze.

Do notuse/give Aureocort to your child for the eyes.

Use in children and adolescents
Aureocort must notbe used with a diaper as the diaper can act as an occlusive dressing (see section 2 Children and adolescents)

Duration of treatment
Do notuse/give Aureocort to your child for more than one consecutive week.

If you use/give your child more Aureocort than you should
In case of accidental ingestion/intake of an excessive dose of Aureocort, immediately inform your doctor or go to the nearest hospital.
If you use/give your child more Aureocort than you should, wash the body part with soap and water and consult your doctor.

If you forget to use/give Aureocort to your child
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, you can apply it as soon as possible.

If you stop treatment with Aureocort
If you have any doubts about the use of this medicine, consult your 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 the following side effects during treatment with Aureocort, contact your doctor immediatelywho will STOPtreatment with
Aureocort:

• allergic reactions that may manifest with the following symptoms:
• increased blood in a part of the body (hyperemia)
• swelling
• itching
• scaling. Blurred vision may occur with an unknown frequency (frequency cannot be established based on available data).

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

Effects concerning the skin

• atrophy of the skin (the skin becomes thin and inelastic),
• increased hair growth (hypertrichosis),
• acneiform eruptions (acne, boils with pus),
• red spots on the skin (purpura)

Effects concerning blood vessels

• fragility of capillaries

Other side effects that have been reported following excessive use of corticosteroids
(medicines such as triamcinolone), which therefore may also be potential side effects of
Aureocort, are :

Effects concerning the heart and blood vessels:

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

Effects concerning metabolism and nutrition:

• decrease in potassium levels in the blood
• decrease in acids in the blood (metabolic alkalosis)

Effects concerning the whole body:

• weakness, even 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, tell your doctor. You can also report side effects directly
through the national reporting system at 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 particular storage conditions.
Do not use this medicine after the expiry date which is reported on the packaging after Scad.
The expiry date refers to the last day of that month. The indicated expiry date refers
to the product in intact packaging, correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that are no longer used. This will help protect the environment.
Do not use this medicine if you notice that the tube is not intact.

6. Contents of the pack and other information

What Aureocort contains
The active ingredients are: Tetracycline hydrochloride and Triamcinolone acetonide (100 g of cream
contain respectively 3.0 g of tetracycline hydrochloride and 0.1 g of triamcinolone acetonide).
The other ingredients are: Anhydrous Lanolin(see section 2 Aureocort contains lanolin),
white petrolatum

Description of the appearance of Aureocort and contents of the pack
Aureocort is presented as a yellow cream for local use packaged in a 30 g tube.

Marketing Authorisation 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

This leaflet was last updated on: