Desamix Effе

Patient Information Leaflet

desamix effe 0.3% + 1% cream

dexamethasone + clotrimazole
Please read this leaflet carefully before using this medicine as 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 only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DESAMIX EFFE is and what it is used for

DESAMIX EFFE is a topical cream containing two active substances (dexamethasone and clotrimazole).
Dexamethasone is a corticosteroid with anti-inflammatory, antiallergic, and antiproliferative properties.
Clotrimazole is an imidazole antifungal agent active against fungi and bacteria.
It is indicated for preventive and curative treatment of superimposed skin infections (skin), for which a topical steroid therapy is appropriate.

It is indicated:

• in all fungal and yeast skin infections: these may occur between the fingers (interdigital intertrigo, athlete's foot - tinea pedis), in hairless areas (tinea corporis), in the groin area (tinea inguinalis - Hebra's marginated eczema, inguinal intertrigo), under the breasts or armpits (submammary, axillary intertrigo), at the corners of the mouth (angular cheilitis), or may present with irregular patches (pityriasis versicolor).
• in skin infections such as primary pyodermas (impetigo, ostiofolliculitis, intertrigo) and erythrasma (scaly pink-brown patches on the skin) affecting the groin, axillary, or interdigital areas.

2. What you need to know before using DESAMIX EFFE

Do not use DESAMIX EFFE

• if you are allergic to dexamethasone, clotrimazole, or any of the other ingredients of this medicine (listed in section 6).
• if you have any of the following skin disorders: acne (boils), rosacea (intense flushing or redness of the skin and face), perioral dermatitis (red skin rash around the mouth), syphilis (lues), cutaneous tuberculosis.
• if you have a viral skin infection such as herpes simplex or chickenpox.
• if you experience skin reactions following vaccinations.

Warnings and precautions
Talk to your doctor or pharmacist before using DESAMIX EFFE.
Application over large areas and for prolonged periods may allow corticosteroids (dexamethasone) to pass through the skin into the bloodstream. This is even more likely if the cream is applied under occlusive dressings (non-breathable) or under diapers in newborns.
If occlusive dressings are necessary and are used over large areas, the medicine should be applied to limited areas at different times to avoid interference with body temperature regulation and systemic absorption of the components through the skin.
Contact your doctor if you notice swelling and weight gain around the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Suppression of adrenal gland function may occur after stopping prolonged or intensive treatment with DESAMIX EFFE. Consult your doctor before stopping treatment on your own. These risks are particularly important in children and in patients treated with a medicine called ritonavir.
Contact your doctor if you experience blurred vision or other visual disturbances.
Use, especially if prolonged, of topical skin products may lead to sensitization (allergy to one or more components). If this occurs, stop treatment and consult your doctor, who will take appropriate measures (see section 4 “Possible side effects”).
The same approach should be followed if resistant microorganisms develop and secondary infections occur.

Children
In very early infancy, this product should be used only when strictly necessary and under direct medical supervision.
In newborns, diapers may act as occlusive dressings (see above “Warnings and precautions”).

Other medicines and DESAMIX EFFE
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Contact your doctor if you are taking ritonavir or cobicistat, as they may increase dexamethasone levels in the blood.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, use this medicine only when strictly necessary and under direct medical supervision.

Driving and using machines
DESAMIX EFFE does not affect the ability to drive vehicles or operate machinery.

DESAMIX EFFE contains cetyl alcohol, stearyl alcohol, and benzyl alcohol
Cetyl alcohol and stearyl alcohol may cause localized skin reactions (e.g., contact dermatitis).
This medicine contains 10 mg of benzyl alcohol per gram. Benzyl alcohol may cause allergic reactions and mild local irritation.

3. How to use DESAMIX EFFE

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
DESAMIX EFFE must not be taken by mouth and must not be applied to the eyes.
Apply DESAMIX EFFE 2-3 times a day to the affected areas, gently rubbing it in.
Continue treatment for at least 5 days after healing has occurred.
If you use more DESAMIX EFFE than you should
Prolonged application over large areas (more than 10% of body surface area), on damaged skin, or under occlusive dressing may result in absorption through the skin and passage of desamethasone into the bloodstream.
In such cases, effects similar to those of oral corticosteroids may occur, including impaired function of the adrenal glands (the adrenal glands are located near the kidneys and produce hormones) and the development of hypercorticism (an excess level of steroids in the body).
Cushing's syndrome (a condition in which the body produces too much cortisol, a type of steroid) and the very rare intracranial hypertension (increased pressure in the brain) are clinical manifestations of this.
These symptoms resolve after treatment is stopped, which should be done gradually.
In case of accidental ingestion/ingestion of DESAMIX EFFE, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

When corticosteroids are used on the skin, especially intensively and for long periods of time, some of the following side effects may occur:

• burning sensation, itching, irritation
• skin rashes with inflammation or swelling (allergic contact dermatitis)
• dryness of the skin
• thinning of the skin (cutaneous atrophy)
• excessive hair growth (hypertrichosis)
• appearance of blackheads and boils (acneiform eruption)
• loss of skin colour (hypopigmentation)
• thinning of the skin (atrophy) and stretch marks (striae) in skin folds (e.g. groin, armpits or under the breasts) treated for a long time with occlusive dressing
• hormonal problems (frequency not known): increased body hair growth (especially in women), weakness and muscle atrophy, purple stretch marks on the body, increased blood pressure, irregular or missed menstrual periods, changes in protein and calcium levels in the body, delayed growth in children and adolescents, and swelling and weight gain in the body and face (called “Cushing's syndrome”) (see section 2, “Warnings and precautions”).
• blurred vision (frequency not known). Following the instructions in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DESAMIX EFFE

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, correctly stored.
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 DESAMIX EFFE contains

• The active substances are: dexamethasone and clotrimazole. 100 g of cream contain 0.3 g of dexamethasone and 1.0 g of clotrimazole.
• The other components (excipients) are: cetyl alcohol, stearyl alcohol, liquid paraffin, polysorbate 60, sorbitan stearate, sorbitol 70% non-crystallizable, isopropyl myristate, benzyl alcohol, purified water.

Description of the appearance of DESAMIX EFFE and package contents
DESAMIX EFFE is a cream contained in a 30-gram tube.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Savoma Medicinali S.p.A. - Via Baganza, 2/A - 43125 Parma.
Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)