Decoderm

Package Leaflet: Information for the Patient

Decoderm 2% + 0.1% cream

miconazole nitrate, fluprednidene-21-acetate
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 using 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 substances:

• fluprednidene, which belongs to a class of medicines called "glucocorticosteroids", used against inflammations,
• 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,
• of inflammatory skin reactions (eczema) complicated by fungal infections.

Decoderm is indicated only during the initial phase of treatment. After the inflammatory symptoms have disappeared,
it is advisable to use only the antifungal (antimycotic) medicine.

2. What you need to know before using Decoderm

Do not use Decoderm

• if you are allergic to the active substances, to other antifungal medicines similar to Clotrimazole (imidazole derivatives), or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from specific skin disorders such as “tuberculosis” or “syphilis”;
• if you have viral infections (herpes simplex, herpes zoster, varicella);
• if you have reactions caused by vaccinations;
• if you suffer from skin disorders (dermatitis) localized 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 ophthalmic use. Do not administer Decoderm to very young children or newborns, as the medicine is contraindicated in this patient population.

Do not apply Decoderm:

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

Warnings and precautions
Talk to your doctor or pharmacist before using Decoderm.

• Avoid contact with mucous membranes.
• Avoid contact with the eyes.
• If you suffer from other medical conditions, bear in mind that medicines containing anti-inflammatory agents (corticosteroids) may alter the symptoms of certain diseases, thus interfering with accurate diagnosis by the physician.
• If you develop bacterial infections caused by resistant bacteria, your doctor will discontinue treatment and initiate appropriate therapy.
• Exercise particular caution when applying Decoderm to the face, as facial skin is especially sensitive and local adverse effects are more likely to occur. In particular, do not use Decoderm on the eyelids, as serious adverse effects such as increased intraocular pressure (glaucoma) may develop.
• Decoderm contains petroleum jelly (vaseline), therefore if you are using this medicine in the genital or anal areas, it may reduce the effectiveness and safety of latex-based products (e.g. condoms, diaphragms).

In general, to avoid skin damage, long-term treatment with topical anti-inflammatory medicines known as “corticosteroids” should be avoided.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children
This medicine should be used in children only when strictly necessary and under direct medical supervision. Decoderm is contraindicated in newborns and young children.
Other medicines and Decoderm
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between Decoderm and other medicines are currently known.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
There are no available data on the use of Decoderm in pregnant or breastfeeding women. Therefore, if you are pregnant or breastfeeding, use of this medicine is not recommended.
Driving and using machines
Decoderm does not affect the ability to drive or operate machinery.
Decoderm contains propylene glycol
Propylene glycol may cause skin irritation.
Decoderm contains stearic alcohol
Stearic alcohol may cause local skin reactions (e.g. contact dermatitis).

3. How to use Decoderm

Take this medicine exactly as directed by your doctor or pharmacist. If you are in doubt, consult your
doctor or pharmacist.
The recommended dose is:
a thin layer of Decoderm applied to the affected area of skin once or twice daily.
Do not use Decoderm for more than 7 days.
If you use more Decoderm than you should
If Decoderm is accidentally ingested, do not panic, as the amounts of the two active substances are low.
In case of accidental ingestion/overdose of Decoderm, contact your doctor immediately or go to the nearest hospital.
If you forget to use Decoderm
Do not apply a double dose to make up for the missed dose.
If you stop using Decoderm
If you stop treatment with Decoderm, you may experience a relapse.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Decoderm can cause side effects, although not everybody gets them.
Systemic (whole-body) side effects are rare.
Side effects with unknown frequency (frequency cannot be estimated from the available data)

• allergic reactions,
• irritation,
• red skin rash (exanthema),
• increased skin pigmentation (hyperpigmentation),
• thinning (atrophy) of the skin,
• dilation of superficial blood vessels (telangiectasia),
• streaks on the skin (striae distensae),
• drug-induced acne (caused by corticosteroids),
• dermatitis around the mouth (perioral dermatitis),
• excessive hair growth (hypertrichosis),
• loss of skin pigmentation (depigmentation),
• altered synthesis of certain hormones (hypothalamic-pituitary-adrenal axis suppression),
• blurred vision.

These effects may occur when using non-breathable dressings (occlusive bandages), or when large areas of the body are treated with high doses over 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, or breathing difficulties (angioedema, anaphylactic reactions).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report side effects directly via 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 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 "Exp.". The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, unopened packaging and stored correctly.
Usable for 6 months after opening
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Decoderm contains

• The active substances 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 components are: purified water, propylene glycol, cetyl alcohol, Ariacel 165, glycerol monostearate 40-50%, white soft paraffin, semi-synthetic solid glycerides, dimethicone.

Description of the appearance of Decoderm and contents of the pack
Decoderm is available as:

• Topical cream in a 20 g tube.

Marketing Authorisation Holder and Manufacturer
Almirall Hermal GmbH
Scholtzstrasse, 3
21465 Reinbek - Germany