DECODERM <2% + 0,1% Cream

Зміст інструкції

1. Decoderm 2% + 0,1% cream
   1. What Decoderm is and what it is used for
   2. What you need to know before using Decoderm
   3. How to use Decoderm
   4. Possible side effects
   5. How to store Decoderm
   6. Contents of the pack and other information

Decoderm 2% + 0,1% cream

miconazole nitrate, fluprednidene-21-acetate

Read this leaflet carefully before you start to use this medicine 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 for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Decoderm is and what it is used for
• 2. What you need to know before you use Decoderm
• 3. How to use Decoderm
• 4. Possible side effects
• 5. How to store Decoderm
• 6. Contents of the pack and other information

1. What Decoderm is and what it is used for

Decoderm contains two active ingredients:

• fluprednidene, which belongs to a class of medicines called “glucocorticosteroids”, used against inflammation,
• miconazole nitrate, which belongs to a class of medicines called “antifungals” used against infections caused by fungi.

Decoderm is indicated for local (topical) use in the treatment of:

• inflammatory skin diseases (inflammatory dermatomycoses) caused by dermatophytes (organisms that feed on dead skin cells), yeasts and/or fungi,
• skin inflammatory reactions (eczema) aggravated by fungal infections.

Decoderm is indicated only in the initial phase of treatment. After the disappearance of the symptoms
of inflammation, it is appropriate to use only the medicine with antifungal (antimycotic) action.

2. What you need to know before using Decoderm

Do not use Decoderm

• if you are allergic to the active ingredients, to other antifungal medicines similar to Clotrimazole (imidazole derivatives) or to any of the other components of this medicine (listed in section 6);
• if you suffer from specific skin conditions such as “tuberculosis” and “syphilis”;
• if you suffer from infections caused by viruses (herpes simplex, herpes zoster, chickenpox);
• if you have reactions caused by vaccinations;
• if you suffer from skin alterations (dermatitis) located around the lips (perioral);
• if you suffer from a skin condition called “rosacea”;
• if you have acne;
• if you have skin inflammations with pus formation (suppurative infections).
• for the eyes (ophthalmic use). Do not administer Decoderm to very small children or newborns, as the medicine is contraindicated in this population of patients

Do not apply Decoderm:

• to areas of thinned skin;
• on wounds;
• on skin lesions (ulcers);
• for prolonged periods of time;
• to extensive areas of the skin;
• under non-breathable (occlusive) dressings such as plasters, etc., especially in children.

Warnings and precautions
Consult your doctor or pharmacist before using Decoderm.

• Avoid contact with mucous membranes.
• Avoid contact with the eyes.
• If you suffer from other diseases, you should consider that medicines based on anti-inflammatory drugs (corticosteroids) can alter the symptoms of some diseases, preventing a perfect diagnosis by the doctor.
• If you should have infections caused by resistant bacteria, the doctor will make you suspend the treatment and establish adequate therapy.
• Pay particular attention when applying Decoderm to the face, because the skin of the face is particularly sensitive and it is more likely that local adverse effects occur. In particular, do not use Decoderm on the eyelids because serious adverse effects such as increased pressure inside the eye (glaucoma) may develop.
• Decoderm contains petrolatum, so if you are using this medicine in the genital and anal areas, it may reduce the effectiveness and safety of latex products (e.g. condoms, diaphragms).

In general, to avoid alterations of the skin, long-term treatment with medicines used for local inflammation called “corticosteroids” should be avoided.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
The medicine should be used in children only in case of actual need and under the direct control of the doctor. Decoderm is contraindicated in newborns and young children.

Other medicines and Decoderm
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Currently, no interactions are known between other medicines and Decoderm.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
No data are available regarding the use of Decoderm in pregnant and breastfeeding women. Therefore, if you are pregnant or breastfeeding, the use of the medicine is not recommended.

Driving and using machines
Decoderm does not impair the ability to drive or operate machinery.

Decoderm contains propylene glycol
Propylene glycol can cause skin irritation.

Decoderm contains stearyl alcohol
Stearyl alcohol can cause local skin reactions (e.g. contact dermatitis).

3. How to use Decoderm

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is:
a thin layer of Decoderm to be applied to the affected skin area one or two times a day.
Do not use Decoderm for more than 7 days.

If you use more Decoderm than you should
If you accidentally ingest Decoderm, do not worry because the quantities of the two active ingredients are low.
In case of accidental ingestion/intake of an excessive dose of Decoderm, immediately notify your doctor or go to the nearest hospital.

If you forget to use Decoderm
Do not use a double dose to make up for a missed dose.

If you stop using Decoderm
If you stop treatment with Decoderm, you may experience a relapse.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Decoderm can cause side effects, although not everybody gets them.
Systemic side effects are rare.

Side effects with unknown frequency(frequency cannot be estimated from available data)

• allergic reactions,
• irritation,
• red spots on the skin (rash),
• increased skin pigmentation (hyperpigmentation),
• thinning (atrophy) of the skin,
• dilatation of superficial blood vessels (telangiectasia),
• stretch marks on the skin (striae distensae),
• acne induced by medicines used for inflammation (steroids),
• dermatitis around the mouth (perioral dermatitis),
• increased hair growth (hypertrichosis),
• loss of skin pigmentation (depigmentation),
• alteration of the synthesis of some hormones (suppression of the hypothalamus-pituitary-adrenal axis)
• blurred vision.

This effect can occur with the use of non-breathable dressings (occlusive bandages) or when
large areas of the body are treated with high doses for prolonged periods; children are more susceptible to
these effects.
If you experience any of the following side effects, stop using Decoderm and contact your
doctor immediately:

• swelling of the face, tongue or throat; difficulty swallowing, hives and difficulty breathing (angioedema, anaphylactic reactions)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Decoderm

Do not store at a temperature above 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Scad.”. The expiry date
refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.

Shelf life after opening: 6 months
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Decoderm contains

• The active ingredients are:
• miconazole nitrate. 1 g of cream contains 20 mg of miconazole nitrate;
• fluprednidene-21-acetate. 1 g of cream contains 1 mg of fluprednidene-21-acetate.
• The other ingredients are: purified water, propylene glycol, stearyl alcohol, Ariacel 165, glycerol monostearate 40-50%, white petrolatum, solid semi-synthetic glycerides, dimethicone.

Description of the appearance of Decoderm and contents of the pack
Decoderm is presented in the form of:

• Cream for external use in a 20 g tube.

Marketing authorisation holder and manufacturer
Almirall Hermal GmbH
Scholtzstrasse, 3
21465 Reinbek - Germany