DERMAVAL 30 G Cream

Зміст інструкції

1. DERMAVAL 0,3% hydrophobic cream
2. DERMAVAL 0,1% cream

DERMAVAL 0,3% hydrophobic cream

Diflucortolone valerate
PHARMACOTHERAPEUTIC CATEGORY: D07AC06
Dermaval is a corticosteroid not associated with other active ingredients.

THERAPEUTIC INDICATIONS
Local treatment of chronic dermatoses, even of high severity. These include
psoriasis, neurodermatitis (endogenous eczema, atopic dermatitis), lichen ruber planus and verrucosus,
chronic lupus erythematosus (chronic discoid lupus erythematosus) and chronic eczema.

CONTRAINDICATIONS
Hypersensitivity to the active ingredient or to any of the excipients.
Dermaval 0.3% hydrophobic cream is contraindicated in the presence of tuberculous, mycotic, luetic and viral
processes (with particular regard to vaccinal pustules, varicella, herpes simplex, herpes zoster), rosacea, skin
ulcers, burns and frostbite equal to or greater than 2nd degree.
The preparation is not indicated for the treatment of infants and children under 4 years of age, due to the high
concentration of the active ingredient.
Due to the high concentration of the active ingredient, 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 available without a prescription.
None known.

SPECIAL WARNINGS
The use, especially if prolonged, of topical products can give rise to sensitization phenomena and produce
undesirable effects. In such cases, it is necessary to discontinue treatment
and consult your doctor.
Avoid contact of the preparation with the eyes.
Treatment of extensive skin surfaces or for prolonged periods may induce, particularly with
occlusive technique, increased systemic absorption, the excess of which could lead to
undesirable effects similar to those observed during treatment with systemic steroids.
The duration of therapy should therefore be limited to the minimum possible.
In case of extensive lesions, it is advisable to treat subsequently, one at a time, partial areas.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
The clinical indication for treatment with Dermaval 0.3% hydrophobic cream in pregnant and
breastfeeding women must be carefully examined and assessed whether the benefits justify
the potential risks to the fetus.
In particular, use on extensive areas or for a prolonged period should be avoided.
Some epidemiological studies suggest that there may be an increased risk of
cleft palate in newborns from women who have been treated with systemic corticosteroids during the
first trimester of pregnancy.
Adverse effects cannot be excluded in newborns whose mothers have been treated on
extensive areas or for prolonged periods during pregnancy or breastfeeding (for example, a
reduction in adrenal function may occur following application in the last weeks of
pregnancy).
Breastfeeding women should not be treated on the breast.

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

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Posology and method of administration
Unless otherwise prescribed by your doctor, it is advisable to start treatment by spreading the preparation in
a thin layer 2-3 times a day, for a period of 1-2 weeks.
Following improvement of the clinical picture, it is suggested to reduce the administrations to one
daily application or to switch to the analogous product with a lower concentration
(DERMAVAL 0.1% Cream).
DERMAVAL 0.3% hydrophobic cream is a water-in-oil emulsion and, as such, allows
very wide possibilities of use ranging from skin conditions not excessively secreting
to those not particularly dry.
The preparation ensures the skin an appropriate lipid supply without blocking transpiration and
heat exchange.

Overdose
In case of ingestion/accidental intake of an excessive dose of Dermaval, immediately notify
your doctor or go to the nearest hospital.
If you take more Dermaval hydrophobic cream than prescribed.
No side effects from overdose have been described.

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, ask your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, Dermaval can cause side effects, although not everyone will
experience them.
During treatment with Dermaval 0.3% hydrophobic cream, especially after prolonged use
(over 10 days), or on extensive skin areas (about 10% and more of the body surface), cannot
be excluded, as with other corticoids, the appearance of the following side effects: skin atrophies,
hypopigmentation, telangiectasias, striae, acneiform manifestations and systemic symptoms from
resorption of corticoid, skin redness, scaling, irritation, skin dryness, vesicles, folliculitis, local allergic reactions.
If any of these side effects worsen, inform your doctor or pharmacist.

Shelf life and storage
Expiry date: see the expiry date printed on the packaging.
The expiry date refers to the product in intact packaging, correctly stored.
Caution do not use the medicine after the expiry date printed on the packaging
Store at a temperature below 30°C.
Keep out of the sight and reach of children.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.
It is important to always have the information about the medicine available, therefore keep both the

Composition
100g of hydrophobic cream contains: diflucortolone valerate g 0.3.
Excipients: white beeswax, liquid paraffin, white petrolatum, aliphatic esters with high molecular weight,
purified water.

Pharmaceutical form and content
Hydrophobic cream 0.3% - Tube of 20 g

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

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

DERMAVAL 0,1% cream

Diflucortolone valerate
PHARMACOTHERAPEUTIC CATEGORY: D07AC06
Dermaval cream is an unassociated corticosteroid.

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

CONTRAINDICATIONS
Hypersensitivity to the active ingredient or to any of the excipients.
Dermaval is contraindicated in cases where, in the area to be treated, there are skin conditions of
tuberculous or luetic origin; viral pathologies (e.g. varicella, 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, even
those without a prescription.

SPECIAL WARNINGS
Infants, children and adults should not be treated for periods longer than 3 weeks,
In particular, in infants and children, it is advisable not to prolong therapy beyond 5-7 days, if
the areas to be treated are covered by diapers or plastic pants. In case of extensive lesions it is
advisable to treat in succession, one at a time, partial areas.
In inflammatory and allergic dermatoses, caused or complicated by a bacterial component, it is
advisable to associate a treatment with topical chemotherapeutic agents; in case of mycoses, local
antimycotics are necessary.
Percutaneous application of corticosteroids in the treatment of extensive and/or long-lasting
dermatoses, may determine secondary systemic absorption phenomena (Cushing's syndrome, inhibition of the
hypothalamo-pituitary axis). This event is more frequent in children and in case of occlusive bandaging.
In pediatric use, skin folds and diapers can act as an occlusive bandage. Therefore, in the treatment of
chronic conditions requiring prolonged therapies, once a favorable therapeutic effect has been achieved, it
will be appropriate to reduce the dosage and frequency of applications to the minimum necessary to control
the symptoms and avoid relapses, suspending the use of the preparation as soon as possible and instituting
adequate therapy.
In case of application to the face, avoid contact of the preparation with the eyes.
In the presence of rosacea or perioral dermatitis, Dermaval should not be applied to the face.
The use, especially if prolonged, of topical products can give rise to sensitization phenomena and produce
undesirable effects. In this case it is necessary to interrupt the treatment and consult your doctor.
In case of application to the face, avoid contact of the preparation with the eyes.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
The clinical indication for treatment with Dermaval in pregnant and breastfeeding women
must be carefully examined and evaluated whether the benefits justify the potential risks to the fetus.
In particular, use on extensive areas or for a prolonged period should be avoided.
Some epidemiological studies suggest that there may be an increased risk of
cleft palate in newborns from women who have been treated with systemic corticosteroids during
the first trimester of pregnancy.
Adverse effects cannot be excluded in newborns whose mothers have been treated on
extensive areas or for prolonged periods during pregnancy or breastfeeding (for example, a reduction in
adrenal function may occur following application in the last weeks of pregnancy).
Breastfeeding women should not be treated on the breast.

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

Important information about some excipients
Dermaval cream contains stearyl alcohol: it may cause localized skin reactions (e.g.
contact dermatitis).
Dermaval cream contains methyl parahydroxybenzoate and propyl parahydroxybenzoate: they may
cause allergic reactions (even delayed ones).

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Warning: do not exceed the indicated doses.
Unless otherwise prescribed by your doctor, it is advisable to start treatment by spreading the preparation in
a thin layer 2-3 times a day. The duration of treatment is related to the nature and severity of the
pathology.
Following improvement of the clinical picture, a single daily application is sufficient.
For infants and children under 4 years of age, a treatment not exceeding 3 weeks is recommended,
especially in case of application to areas covered by diapers.
In case of extensive lesions, it is advisable to treat, one at a time, partial areas.
Due to its particular excipient (oil-in-water emulsion with low fat content), Dermaval cream is
particularly indicated in the treatment of weeping lesions and humid skin areas, such as the
anal region and the armpits where a base with a high water content should be used.
Dermaval cream allows the secretion to flow and induces a rapid exudation and drying
of the skin.
The preparation does not leave a greasy trace on the skin and is therefore also suitable for application on
the face, on uncovered skin areas and on those covered with hair.

Overdose
In case of ingestion/accidental intake of an excessive dose of Dermaval, immediately notify
your doctor or go to the nearest hospital.

If you take more Dermaval cream than prescribed.
No side effects from overdose have been described.

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, ask your doctor or pharmacist.
SIDE EFFECTS
Like all medicines, Dermaval can cause side effects, although not everyone will experience them.
During treatment with Dermaval of large skin areas (about 10% and more of the body surface
area) and/or of a prolonged therapy, more than 4 weeks, especially under occlusive bandaging (not
longer than one day to avoid possible disturbances of homeostasis), it cannot be excluded, as for
other corticoids, the appearance of concomitant effects, such as skin atrophy, hypopigmentation,
telangiectasias, striae, acneiform manifestations and systemic symptoms from reabsorption of
corticoid.
Application for prolonged periods of Dermaval cream may induce dryness of the skin and in such
event it is appropriate to switch to a pharmaceutical form with excipients with a higher fat content.
If any of these side effects worsen, or if you notice any other side effect

Shelf life and storage
Shelf life: see the expiry date printed on the packaging.
The expiry date refers to the product in intact packaging, correctly stored.
Caution do not use the medicine after the expiry date printed on the packaging
Store at a temperature below 25°C.
Keep out of the sight and reach of children.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
It is important to always have the information about the medicine available, therefore keep both

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

Pharmaceutical form
Cream 0.1% - Tube of 30 g

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

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