DermaVal

Package leaflet

DERMAVAL 0.3% hydrophobic cream

Diflucortolone valerate
PHARMACOTHERAPEUTIC CATEGORY: D07AC06
Dermaval is a non-combination corticosteroid.
THERAPEUTIC INDICATIONS
Local treatment of chronic dermatoses, including those of high severity. These include
psoriasis, neurodermatitis (endogenous eczema, atopic dermatitis), lichen ruber planus and verrucosus,
chronic lupus erythematosus (chronic discoid erythematosus), and chronic eczema.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Dermaval 0.3% hydrophobic cream is contraindicated in the presence of tuberculous, fungal, syphilitic, and viral
processes (particularly vaccinia, varicella, herpes simplex, herpes zoster), rosacea, cutaneous ulcers, burns, and
frostbite of grade 2 or higher severity.
The product is not indicated for use in infants and children under 4 years of age due to the high
concentration of the active substance.
Due to the high concentration of active substance, it should not be applied to the face.
PRECAUTIONS FOR USE
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including
those without a prescription.
None known.
SPECIAL WARNINGS
The use, especially if prolonged, of topical products may lead to sensitization reactions and
produce undesirable effects. In such cases, treatment must be discontinued and medical advice sought.
Avoid contact of the product with the eyes.
Treatment of extensive skin areas or for prolonged periods may lead, particularly when using occlusive
techniques, to increased systemic absorption, the excess of which could result in adverse effects similar
to those observed during systemic steroid therapy.
Therefore, treatment duration should be limited to the shortest possible time.
In cases of extensive lesions, it is advisable to treat partial areas sequentially, one at a time.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
The clinical indication for treatment with Dermaval 0.3% hydrophobic cream in pregnant and
breastfeeding women must be carefully evaluated, weighing whether the benefits justify the potential
risks to the fetus.
In particular, use on extensive areas or for prolonged periods should be avoided.
Some epidemiological studies suggest there may be an increased risk of cleft palate in newborns
from women treated with systemic corticosteroids during the first trimester of pregnancy.
Adverse effects cannot be ruled out in newborns whose mothers were treated on extensive areas or
for prolonged periods during pregnancy or breastfeeding (for example, adrenal suppression may occur
following application in the last weeks of pregnancy).
Breastfeeding women should not apply the cream to the breast area.
Effects on ability to drive and use machines
Dermaval does not impair the ability to drive vehicles or operate machinery.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Dosage and method of administration
Unless otherwise prescribed by a physician, treatment should begin with a thin layer of the cream
applied 2–3 times daily for a period of 1–2 weeks.
Following clinical improvement, administration frequency should be reduced to once daily, or
switching to the analogous product with lower concentration should be considered
(DERMAVAL 0.1% Cream).
DERMAVAL 0.3% hydrophobic cream is a water-in-oil emulsion and, as such, allows broad application
possibilities ranging from cutaneous conditions that are not excessively exudative to those that are not
particularly dry.
The product provides the skin with an appropriate lipid supply without blocking perspiration and
heat exchange.
Overdose
In case of accidental ingestion/overdose of Dermaval, contact your doctor immediately or go to the
nearest hospital.
If you use more Dermaval hydrophobic cream than prescribed.
No adverse effects from overdose have been reported.
If you forget to apply Dermaval hydrophobic cream
Do not apply a double dose. Apply a normal dose as soon as possible.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, Dermaval can cause adverse effects, although not everyone will experience them.
During treatment with Dermaval 0.3% hydrophobic cream, especially after prolonged use (more than
10 days), or on extensive skin areas (approximately 10% or more of body surface area), the following
adverse effects—similar to those of other corticosteroids—cannot be excluded: cutaneous atrophy,
hypopigmentation, telangiectasia, striae, acneiform eruptions, systemic symptoms due to corticosteroid
absorption, skin redness, desquamation, irritation, dryness of the skin, vesicles, folliculitis, and local
allergic reactions.
If you notice any adverse effect not listed in this leaflet, or if any of the listed adverse effects worsen,
inform your doctor or pharmacist.
Expiry and Storage
Expiry date: see the date printed on the packaging.
The expiry date refers to the product in its original, undamaged packaging, correctly stored.
Do not use the medicine after the expiry date stated on the packaging.
Store below 30°C.
Keep out of the sight and reach of children.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use. This will help protect
the environment.
It is important to always keep the medicine information available; therefore, retain both the
packaging and the package leaflet.
Composition
100 g of hydrophobic cream contain: diflucortolone valerate 0.3 g.
Excipients: white beeswax, liquid paraffin, white vaseline, high molecular weight aliphatic esters, purified water.
Pharmaceutical form and contents
Hydrophobic cream 0.3% – Tube of 20 g
MARKETING AUTHORISATION HOLDER
MORGAN Srl
Via Divisione Folgore 46 - 36100 VICENZA
MANUFACTURER AND BATCH RELEASE RESPONSIBLE
INTENDIS MANUFACTURING SPA - Via E. Schering 21 - Segrate, Milan.

Package leaflet

DERMAVAL 0.1% cream

Diflucortolone valerate
THERAPEUTIC CATEGORY: D07AC06
Dermaval cream is a non-combination corticosteroid.

THERAPEUTIC INDICATIONS
Contact eczema, contact dermatitis (of allergic or toxic origin, such as hypersensitivity to detergents or other chemical agents), common eczema, microbial eczema, dermoepidermitis, seborrheic eczema, varicose eczema (however not directly on the ulcer), infantile eczema, anal eczema, rosacea.

CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Dermaval is contraindicated when cutaneous tuberculosis or syphilitic skin lesions are present in the area to be treated.
Viral skin infections (e.g. chickenpox, herpes zoster), rosacea, perioral dermatitis, and post-vaccination skin reactions.

PRECAUTIONS FOR USE

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those not requiring a prescription.

SPECIAL WARNINGS
Infants, children and adults should not be treated for longer than 3 weeks.
In particular, in infants and children, treatment should not exceed 5–7 days when the treated areas are covered by diapers or plastic pants. In cases of extensive lesions, it is advisable to treat partial areas sequentially, one at a time.
In inflammatory and allergic skin disorders complicated or associated with bacterial components, concomitant topical antimicrobial therapy is recommended; in case of fungal infections, topical antifungals are required.
Topical application of corticosteroids in the treatment of extensive dermatoses and/or for prolonged periods may lead to systemic absorption and secondary effects (Cushing's syndrome, hypothalamic-pituitary axis suppression). This is more likely in children and when occlusive dressings are used. In pediatric use, skin folds and diapers may act as occlusive dressings. Therefore, in the treatment of chronic conditions requiring prolonged therapy, once a favorable therapeutic response has been achieved, the dosage and frequency of application should be reduced to the minimum necessary to control symptoms and prevent relapses, and treatment should be discontinued as soon as possible, followed by appropriate alternative therapy.
When applying to the face, avoid contact with the eyes.
Dermaval must not be applied to the face in cases of rosacea or perioral dermatitis.
The use, especially prolonged, of topical products may lead to sensitization reactions and undesirable effects. In such cases, treatment must be discontinued and medical advice sought.
When applying to the face, avoid contact with the eyes.

Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
The clinical indication for treatment with Dermaval in pregnant or breastfeeding women must be carefully evaluated, weighing whether the benefits justify the potential risks to the fetus.
In particular, use over large areas or for prolonged periods should be avoided.
Some epidemiological studies suggest a possible increased risk of cleft palate in newborns whose mothers were treated with systemic corticosteroids during the first trimester of pregnancy.
Adverse effects cannot be ruled out in newborns whose mothers were treated over large areas or for prolonged periods during pregnancy or breastfeeding (for example, adrenal suppression may occur following application in the last weeks of pregnancy).
Breastfeeding women must not apply the product on the breast area.

Effects on ability to drive and use machines
Dermaval does not impair the ability to drive vehicles or operate machinery.

Important information on certain excipients
Dermaval cream contains cetyl alcohol: may cause local skin reactions (e.g. contact dermatitis).
Dermaval cream contains methyl parahydroxybenzoate and propyl parahydroxybenzoate: may cause allergic reactions (including delayed reactions).

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Caution: do not exceed the recommended doses.
Unless otherwise prescribed by a physician, treatment should begin with the application of a thin layer of the cream 2–3 times daily. The duration of treatment depends on the nature and severity of the condition.
After clinical improvement, once-daily application is sufficient.
For infants and children under 4 years of age, treatment should not exceed 3 weeks, especially when applied to diaper-covered areas.
In cases of extensive lesions, it is recommended to treat partial areas sequentially, one at a time.
Due to its specific excipient (a low-fat oil-in-water emulsion), Dermaval cream is particularly suitable for treating exudative lesions and moist skin areas, such as the anal region and axillae, where a water-rich base is appropriate.
Dermaval cream allows drainage of exudate and promotes rapid drying of the skin.
The product leaves no greasy residue on the skin and is therefore suitable for application on the face, exposed skin areas, and hairy regions.

Overdose
In case of accidental ingestion/overdose of Dermaval, contact your doctor immediately or go to the nearest hospital.
If you use more Dermaval cream than prescribed:
No adverse effects from overdose have been reported.

If you forget to apply Dermaval cream
Do not apply a double dose. Apply a normal dose as soon as possible.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

UNDESIRABLE EFFECTS
Like all medicines, Dermaval can cause side effects, although not everybody experiences them.
During treatment of large skin areas (approximately 10% or more of body surface area) and/or prolonged therapy exceeding 4 weeks, especially under occlusive dressing (not exceeding one day to avoid possible disturbances in homeostasis), the occurrence of concomitant effects cannot be excluded, as with other corticosteroids, such as cutaneous atrophy, hypopigmentation, telangiectasias, striae, acneiform eruptions, and systemic symptoms due to corticosteroid absorption.
Prolonged use of Dermaval cream may cause skin dryness; in such cases, switching to a pharmaceutical form with excipients of higher fat content is advisable.
Following the instructions in the package leaflet reduces the risk of undesirable effects.
If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Expiry and storage
Expiry date: see the date on the packaging.
The expiry date refers to the product stored in its original, unopened packaging under recommended conditions.
Do not use the medicine after the expiry date stated on the packaging.
Store below 25°C.
Keep out of sight and reach of children.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.
It is important to always keep the package and the package leaflet available for reference.

COMPOSITION
100 g of cream contain: diflucortolone valerate 0.1 g.
Excipients: macrogol stearate, cetyl alcohol, liquid paraffin, white soft paraffin, disodium edetate, carbomer, sodium hydroxide, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

Pharmaceutical form
0.1% cream – 30 g tube

MARKETING AUTHORIZATION HOLDER
MORGAN Srl
Via Divisione Folgore 46 - 36100 VICENZA

MANUFACTURER AND BATCH RELEASE RESPONSIBLE
INTENDIS MANUFACTURING SPA - Via E. Schering 21 - Segrate, Milan.