DESAMIX 0.3% + 1% Cream

Зміст інструкції

1. desamix effe 0,3% +1% crema
   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

desamix effe 0,3% +1% crema

desametasone + clotrimazolo

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, 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 may 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 DESAMIX EFFE is and what it is used for
• 2. What you need to know before you use 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 cream for topical application that contains two active ingredients (desamethasone and
clotrimazole).
Desamethasone is a corticosteroid with anti-inflammatory, anti-allergic and anti-proliferative action.
Clotrimazole is an imidazole antifungal active against fungi and bacteria.
Its use is indicated for the prevention and treatment of superimposed skin infections (skin), for which a topical steroid therapy is indicated.
It is indicated:

• in all skin infections caused by fungi and yeasts: these can be located between the fingers (digital 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) in the groin, axillary, interdigital areas.

2. What you need to know before using DESAMIX EFFE

Do not use DESAMIX EFFE

• if you are allergic to desamethasone, clotrimazole or any of the other ingredients of this medicine (listed in section 6).
• if you have one of the following skin conditions: acne (pimples), rosacea (severe flushing or redness of the skin and face), perioral dermatitis (red rashes around the mouth), syphilis, cutaneous tuberculosis.
• if you have a viral skin infection such as herpes simplex and varicella.
• if you suffer from skin reactions to vaccinations.

Warnings and precautions
Consult your doctor or pharmacist before using DESAMIX EFFE.
Application to large areas and for long periods may result in the passage of corticosteroids (desamethasone) into the bloodstream through the skin. This is even more likely to occur if the cream is applied under an occlusive (non-breathable) bandage or under diapers in infants.
If an occlusive bandage is necessary and is used on large surfaces, the medicine should be applied to limited areas and at different times to avoid interference with body temperature regulation and the passage of components through the skin.
Consult your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first signs of a syndrome called Cushing's syndrome. Suppression of adrenal gland function may develop after discontinuation of prolonged or intensive treatment with DESAMIX EFFE. Consult your doctor before stopping treatment on your own. These risks are particularly important in children and patients treated with a medicine called ritonavir.
Contact your doctor if you experience blurred vision or other visual disturbances.
The use, especially if prolonged, of products to be applied to the skin can give rise to sensitization phenomena (allergy to one or more components). In this case, discontinue treatment and consult your doctor, who will take appropriate therapy (see section 4 “Possible side effects”).
The same approach should be adopted if microorganisms insensitive to the medicine develop and secondary infections appear.

Children
In early infancy, the product should be administered only when absolutely necessary and under the direct supervision of a doctor.
In newborns, the diaper can act as an occlusive bandage (see above “Warnings and precautions”).

Other medicines and DESAMIX EFFE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Consult your doctor if you are taking ritonavir or cobicistat, as they may increase the level of desamethasone in the blood.

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 taking this medicine.
If you are pregnant, use this medicine only if absolutely necessary and under the direct supervision of your doctor.

Driving and operating machinery
DESAMIX EFFE does not impair the ability to drive vehicles or operate machinery.

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

3. How to use DESAMIX EFFE

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.

DESAMIX EFFE must not be taken orally and must not be applied to the eyes.
Apply DESAMIX EFFE 2-3 times a day to the lesions, rubbing gently.
Continue treatment for at least 5 days after achieving healing.

If you use more DESAMIX EFFE than you should
In the event of prolonged applications on extensive surfaces (more than 10% of the body surface), on
damaged skin or in the presence of an occlusive dressing, absorption through the skin with
passage into the bloodstream of desamethasone may occur.
In this case, effects similar to those of corticosteroids taken orally may manifest with
dysfunction of the adrenal glands (the adrenal glands are located near the kidneys and produce
hormones) and the appearance of hypercortisolism (an excess of steroid levels in the body).
Cushing's syndrome (a condition in which the body produces too much cortisol, which is a type of
steroid) and the very rare intracranial hypertension (an increase in pressure in the brain) are
its clinical expression.
The disappearance of these symptoms occurs after discontinuation of treatment, which must be
gradual.
In case of accidental ingestion/intake of DESAMIX EFFE, immediately inform your doctor or
go to the nearest hospital.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist .

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During the use of corticosteroids on the skin, especially if intensely and for long periods of time,
some of the following side effects may appear:

• burning sensation, itching, irritation
• skin rashes with inflammation or swelling (allergic contact dermatitis)
• dryness of the skin
• thinning of the skin (skin atrophy)
• excessive hair growth (hypertrichosis)
• appearance of blackheads and boils (acneiform eruption)
• decrease in skin color (hypopigmentation)
• thinning of the skin (atrophy) and stretch marks (striae) in skin folds (example: groin, armpits or under the breasts) treated for a long period of time with occlusive dressing
• hormonal problems (frequency not known): increased hair growth on the body (especially in women), weakness and muscle atrophy, purple stretch marks on the skin of the body, increased blood pressure, irregular or absent menstrual cycle, changes in protein and calcium levels in the body, delayed growth in children and adolescents and swelling and weight gain of the body and face (called “Cushing’s syndrome”) (see section 2, “Warnings and precautions”).
• blurred vision (frequency not known).

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/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 that is reported on the packaging after Exp. The expiry
date refers to the last day of that month.
The 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 you no longer use. This will help protect the environment .

6. Contents of the pack and other information

What DESAMIX EFFE contains

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

Description of the appearance of DESAMIX EFFE and contents of the pack
DESAMIX EFFE is a cream contained in a tube of 30 grams.

Marketing authorisation holder and manufacturer
Marketing authorisation 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)