Desamix effe - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Unwanted Effects Shelf Life and Storage Other Information

Active ingredients: Dexamethasone, Clotrimazole

Desamix effe 0.3% + 1% cream

Why is Desamix effe used? What is it for?

Pharmacotherapeutic group

DESAMIX EFFE is a preparation for dermatological use, containing dexamethasone and clotrimazole.

Dexamethasone exerts an anti-inflammatory, anti-allergic and antiproliferative action.

Clotrimazole is an imidazole derivative with antifungal and antibacterial activity.

Therapeutic indications

For preventive and curative purposes of overlapping infections, in all skin diseases, for which topical steroid therapy is indicated.

In all primitive or secondary superficial mycoses caused by Epidermophyton, Trichophyton, Microsporum, Candida and Malassezia furfur: tinea pedis (athlete's foot), tinea corporis, tinea inguinalis (eczema marginate of Hebra), candidiasis (inguinal, submammary, axillary intertrigines , interdigital, boccarola), pityriasis versicolor.

In primitive pyoderma (impetigo, ostiofolliculitis, intertrigo).

In the erythrasma (inguinal, axillary, interdigital).

Contraindications When Desamix effe should not be used

Hypersensitivity to the active substance or to any of the excipients.

Dermatological affections such as: acne, rosacea, perioral dermatitis, lue, cutaneous tuberculosis.

Viral diseases with skin localization (eg herpes simplex, chicken pox).

Skin reactions to vaccinations.

Precautions for use What you need to know before taking Desamix effe

In very early childhood, the product should be administered in cases of real need and under the direct supervision of the doctor.

The epicutaneous application of cortisone in the treatment of extensive dermatosis and for prolonged periods, can cause systemic absorption; this occurrence occurs more easily when an occlusive bandage is used. Where occlusive bandages are to be used for the treatment of extensive lesions, it is it is advisable to treat them in successive zones in order to avoid interference with thermal homeostasis and systemic effects of the components.

In infants, the diaper can act as an occlusive dressing.

The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case, suspend the treatment and institute a suitable therapy.

Similar behavior must be adopted in the case of the development of non-sensitive microorganisms and secondary infections.

Interactions Which drugs or foods can modify the effect of Desamix effe

Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.

No cases of interactions with other drugs have been reported in the common therapies of relevance.

Warnings It is important to know that:

DESAMIX EFFE is not for ophthalmic use.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

In pregnant women, the product should be administered in cases of real need and under direct medical supervision.

Important information about some of the excipients

This medicine contains cetyl alcohol. May cause local skin reactions (e.g. contact dermatitis).

Effects on ability to drive and use machines

DESAMIX EFFE does not affect the ability to drive or use machines.

Dose, Method and Time of Administration How to use Desamix effe: Posology

Apply the cream on the lesions 2-3 times a day, rubbing gently.

Duration of treatment

The treatment must be continued for at least 5 days, after the achievement of clinical recovery.

Overdose What to do if you have taken an overdose of Desamix effe

In the event of prolonged applications on large surfaces (more than 10% of the body surface), on injured skin or in the presence of an occlusive bandage, the characteristic effects of systemic corticotherapy may occur following systemic absorption of dexamethasone, with inhibition of the " pituitary adrenal axis and the appearance of hypercorticism.

Cushing's syndrome and the very rare intracranial hypertension are its clinical expression.

The disappearance of these symptoms occurs following discontinuation of the treatment which must be progressive.

In case of accidental ingestion / intake of DESAMIX EFFE, notify your doctor immediately or go to the nearest hospital.

IF YOU HAVE ANY DOUBTS ABOUT THE USE OF DESAMIX EFFE, ASK YOUR DOCTOR OR PHARMACIST.

Side Effects What are the side effects of Desamix effe

Like all medicines, DESAMIX EFFE can cause side effects, although not everybody gets them.

During epicutaneous cortisone therapy, especially for intense and prolonged treatments, some of the following side effects may occur: burning sensation, itching, irritation, allergic contact dermatitis, dry skin, skin atrophy, hypertrichosis, acne rash, hypopigmentation; atrophy and striae localized to the intertriginous areas treated for a long period of time with occlusive dressing.

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Expiry and Retention

Expiry: see the expiry date printed on the package.

The expiry date refers to the product in intact packaging, correctly stored.

Warning: do not use the medicine after the expiry date shown on the package.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN.

Deadline "> Other information

Composition

100 g of cream contain:

Active ingredients: DESAMETHASONE 0.3 g, CLOTRIMAZOLE 1.0 g.

Excipients: cetyl alcohol, stearyl alcohol, liquid paraffin, polysorbate 60, sorbitan stearate, non crystallizable 70% sorbitol, isopropyl myristate, benzyl alcohol, purified water.

Pharmaceutical form and content

Cream. Tube 30 g.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Desamix effe is available in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT - 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION - 03.0 PHARMACEUTICAL FORM - 04.0 CLINICAL PARTICULARS - 04.1 Therapeutic indications - 04.2 Posology and method of administration - 04.3 Contraindications - 04.4 Special warnings and appropriate precautions for use - 04.5 Interactions with other medicinal products and other forms of interaction - 04.6 Pregnancy and lactation - 04.7 Effects on the ability to drive and use machines - 04.8 Undesirable effects - 04.9 Overdose - 05.0 PHARMACOLOGICAL PROPERTIES - 05.1 "Pharmacodynamic properties - 05.2 Pharmacokinetic properties" - 05.3 Preclinical safety data - 06.0 PHARMACEUTICAL PARTICULARS - 06.1 Excipients - 06.2 Incompatibility "- 06.3 Shelf life" - 06.4 Special precautions for storage - 06.5 Nature of the primary packaging and contents of the package - 06.6 Instructions for use and handling - 07.0 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 08.0 MARKETING AUTHORIZATION NUMBER - 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION - 10.0 DATE OF REVISION OF THE TEXT - 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY - 12.0 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

DESAMIX EFFE 0.3% + 1% CREAM

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

100 g of cream contain:

Active principles: dexamethasone 0.3 g, clotrimazole 1.0 g.

Excipients: contains cetyl alcohol.

03.0 PHARMACEUTICAL FORM -

Cream.

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

For preventive and curative purposes of overlapping infections, in all skin diseases, for which topical steroid therapy is indicated.

In all primitive or secondary superficial mycoses, caused by Epidermophyton, Trichophyton, Microsporum, Candida and Malassezia furfur: tinea pedis (athlete's foot), tinea corporis, tinea inguinalis (eczema marginal of Hebra), candidiasis (inguinal, submammary, axillary, interdigital, bush), pityriasis versicolor.

In primitive pyoderma (impetigo, ostiofolliculitis, intertrigo).

In the erythrasma (inguinal, axillary, interdigital).

04.2 Posology and method of administration -

Apply the cream on the lesions 2-3 times a day, rubbing gently.

The treatment must be continued for at least 5 days after the achievement of clinical recovery.

04.3 Contraindications -

Hypersensitivity to the active substance or to any of the excipients.

Dermatological affections such as: acne, rosacea, perioral dermatitis, lue, cutaneous tuberculosis.

Viral diseases with skin localization (eg herpes simplex, chicken pox).

Skin reactions to vaccinations.

04.4 Special warnings and appropriate precautions for use -

In very early childhood, the product should be administered in cases of real need and under the direct supervision of the doctor.

The epicutaneous application of cortisone in the treatment of extended dermatoses and for prolonged periods, can determine a systemic absorption; this occurrence occurs more easily when the occlusive bandage is used.

In infants, the diaper can act as an occlusive dressing.

The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute a suitable therapy.

Similar behavior must be adopted in the case of the development of non-sensitive microorganisms and secondary infections.

Where extensive lesions are to be treated with the occlusive bandage, it is advisable to treat them in subsequent areas in order to avoid interference with thermal homeostasis and systemic effects of the components.

DESAMIX EFFE is not for ophthalmic use.

This medicine contains cetyl alcohol. May cause local skin reactions (e.g. contact dermatitis).

04.5 Interactions with other medicinal products and other forms of interaction -

Not reported in the common therapies of relevance.

04.6 Pregnancy and breastfeeding -

In pregnant women, the product should be administered in cases of real need and under direct medical supervision.

04.7 Effects on ability to drive and use machines -

DESAMIX EFFE does not affect the ability to drive or use machines.

04.8 Undesirable effects -

During epicutaneous cortisone therapy, especially for intense and prolonged treatments, some of the following side effects may occur: burning sensation, itching, irritation, allergic contact dermatitis, dry skin, skin atrophy, hypertrichosis, acne rash, hypopigmentation; atrophy and striae localized to the intertriginous areas treated for a long period of time with occlusive dressing.

04.9 Overdose -

In the event of prolonged applications on large surfaces (more than 10% of the body surface), on injured skin or in the presence of an occlusive bandage, the characteristic effects of systemic corticotherapy may occur following systemic absorption of dexamethasone, with inhibition of the " pituitary-adrenal axis and the appearance of hypercorticism.

Cushing's syndrome and the very rare intracranial hypertension are its clinical expression.

The disappearance of these symptoms occurs following discontinuation of the treatment which must be progressive.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

DESAMIX EFFE is constituted by the association of a synthetic corticosteroid: dexamethasone, with a broad spectrum antifungal also active against Gram positive bacteria: clotrimazole.

Dexamethasone has a high anti-allergic and anti-inflammatory activity, about 30 times higher than that of hydrocortisone and about 5 times higher than that of prednisolone.

Clotrimazole is an imidazole derivative for topical use that shows both in vitro and in vivo a high activity against a wide variety of fungi, yeasts and molds including pathogenic fungi belonging to the genera: Tricophyton, Ephydermophyton, Candida, Microsporum, Coccidioides Immitis, Histoplasma Capsulatum, Aspergillus, Malassezia furfur, etc.

It is also active against: Stafilococcus aureus and Streptococcus Piogenes and develops an inhibitory and fungicidal action on Trichomonas Vaginalis.

05.2 "Pharmacokinetic properties -

The active ingredients present in DESAMIX EFFE essentially exert a local effect at the level of the treated area and, under normal conditions of use, their absorption is limited at the level of the epidermis.

05.3 Preclinical safety data -

Dexamethasone

Acute toxicity: LD 50 (SC mouse) sup. to 700 mg / kg; LD 50 (SC rat) 120 mg / kg.

Clotrimazole

Acute toxicity: LD 50 (rat p.o.) 708 mg / kg; LD 50 (mouse p.o.) 903 mg / kg; LD 50 (rabbit p.o.) 1000 mg / kg.

Chronic toxicity: following prolonged topical administration, Clotrimazole has shown good tolerability both locally and systemically.

Teratogenesis

Dexamethasone

The local application of corticosteroids to pregnant laboratory animals can induce, following systemic absorption, the appearance of fetal malformations.

The transferability of the find to the human species is not proven.

Clotrimazole

Clotrimazole does not exhibit embryotoxic or teratogenic activities in common laboratory animals.

06.0 PHARMACEUTICAL INFORMATION -

06.1 Excipients -

Cetyl alcohol, stearyl alcohol, liquid paraffin, polysorbate 60, sorbitan stearate, non crystallizable 70% sorbitol, isopropyl myristate, benzyl alcohol, purified water.

06.2 Incompatibility "-

Not relevant.

06.3 Period of validity "-

Validity: 3 years.

06.4 Special precautions for storage -

This medicinal product does not require any special storage conditions.

06.5 Nature of the immediate packaging and contents of the package -

Aluminum tube.

Tube 30 g.

06.6 Instructions for use and handling -

No special instructions.

07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -

SAVOMA MEDICINALI S.p.A. - Via Baganza N. 2 / A - 43100 PARMA.

08.0 MARKETING AUTHORIZATION NUMBER -

AIC n. 022235042

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -

Renewal A.I.C. January 2011

10.0 DATE OF REVISION OF THE TEXT -

October 2010

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY -

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL -

none:  ice-cream blood-health non-alcoholic cocktails