NERIDERM CREAM

Israel - English - Ministry of Health

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Active ingredient:
DIFLUCORTOLONE VALERATE
Available from:
PERRIGO ISRAEL PHARMACEUTICALS LTD
ATC code:
D07AC06
Pharmaceutical form:
CREAM
Composition:
DIFLUCORTOLONE VALERATE 0.1 G / 100 G
Administration route:
TOPICAL
Prescription type:
Required
Manufactured by:
PERRIGO ISRAEL PHARMACEUTICALS LTD
Therapeutic group:
DIFLUCORTOLONE
Therapeutic area:
DIFLUCORTOLONE
Therapeutic indications:
Corticoid responsive dermatoses in the absence of infection
Authorization number:
061 50 24636 00
Authorization date:
2013-09-30

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

18-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

12-06-2018

.תשפיחש המ תא ונאצמ אל הנוכנ תנזהש תבותכה םא קודבל יאדכ תבותכב עייסל חמשנ

info@gov.il

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Neriderm Cream

Neriderm Ointment

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Neriderm Cream: 100g cream contains 0.1g diflucortolone valerate

Neriderm Ointment: 100g ointment contains 0.1g diflucortolone valerate

3.

PHARMACEUTICAL FORM

Cream, Ointment

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Corticoid responsive dermatoses in the absence of infection.

4.2

Posology and method of administration

Adults: Initially, Neriderm should be applied thinly twice daily. When the condition

improves or when longer periods of treatment are required one application daily is

appropriate.

Long-term continuous therapy with topical corticosteroids should be avoided, with

a usual maximum duration of 4 weeks. If used on the face, courses should be

limited to 5 days and occlusion should not be used (see section 4.4).

Children 1-4years of age: Neriderm should be applied thinly twice daily. It should

be used with great care, for short periods and generally only on the advice of a

doctor specialising in dermatology. Courses should be limited to 5 days and

occlusion should not be used.

Children 5 years of age and over: Initially, Neriderm should be applied thinly twice

daily. When the condition improves one application daily is appropriate. Courses

should be limited to 1-2 weeks. If used on the face, courses should be limited to 5

days and occlusion should not be used.

Neriderm should not be used in children under 1 year of age.

Elderly: Natural thinning of the skin occurs in the elderly. No special precautions

are required, however, when Neriderm is used in this group of patients.

Occlusive dressings: An occlusive dressing may be called for in unusually

refractory cases and usually under specialist supervision. If an infection develops

under the dressing, occlusive treatment must be terminated.

Neriderm Cream is suitable for weeping skin conditions. Neriderm Cream has a

high water and low fat content. In weeping skin diseases it allows secretions to

drain away, thus providing for rapid reduction of swelling and drying up of the skin.

Neriderm Cream is also suitable for application to moist, exposed and hairy areas

of the body.

Neriderm Ointment is suitable in very dry skin conditions which need an anhydrous

fatty base. The occlusive effect of the Neriderm Ointment base promotes the healing

process.

If the skin dries out too much under protracted use of Neriderm Cream, the patient

should be switched to a form which contains more fat (Neriderm Ointment).

4.3

Contraindications

Hypersensitivity to the active subtance diflucortolone valtrate or to any of the

excipients listed in section 6.1.Rosacea and peri-oral dermatitis.

Acne vulgaris, undiagnosed perianal and genital pruritus, napkin eruptions,; viral

infections, primary bacterial or fungal infections of the skin. Secondary infections in

the absence of appropriate anti-infective therapy. Post vaccination skin reactions in

the area to be treated.

Neriderm is not suitable for the treatment of ophthalmic conditions.

4.4

Special warnings and precautions for use

Long-term continuous therapy with topical corticosteroids should be avoided, with a

usual maximum duration of 4 weeks irrespective of age. Adrenal suppression can

occur, even without occlusion. If used on children up to the age of 4 years or on the

face, courses should be limited to 5 days and occlusion should not be used.

Neriderm may be applied under an occlusive dressing. However, each dressing

should not be left on for more than 24 hours. Although occlusive dressings may be

used repeatedly, it should be noted that systemic corticoid absorption is likely to be

increased with a consequent increased risk of adrenal suppression. If occlusive

treatment is expected to be prolonged, it is advisable to change the dressing every

12 hours.

Neriderm should not be allowed to come into contact with the eyes.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons

including rebound relapses following development of tolerance, risk of generalised

pustular psoriasis, and local and systemic toxicity due to impaired barrier function

of the skin. Careful patient supervision is important in psoriasis.

Exacerbation of skin infections may occur. Infections or secondarily infected

dermatoses require additional therapy with antibiotics or chemotherapeutic agents.

This treatment can often be topical, but for heavy infections systemic antibacterial

therapy may be necessary. If fungal infections are present, a topically active

antimycotic should be applied.

If aggravation of skin irritation develops with the use of Neriderm, treatment

should be withdrawn and appropriate therapy installed.

Allergic contact dermatitis due to topical corticosteroids and excipients can occur.

In these cases eczema fails to improve or deteriorates with treatment.

Corticosteroid hypersensitivity occurs most frequently among patients with stasis

dermatitis and leg ulceration. Such an observation should be corroborated with

appropriate diagnostic patch testing. The appropriate corticosteroid concentration

and the choice of the vehicle is crucial in detecting corticosteroid hypersensitivity

in patch tests.

Patients with an allergy to corticosteroids may cross-react to several

corticosteroids to which they have not previously been exposed.

After topical application, allergies to cross-reacting systemically applied

corticosteroids may occur.

As known from systemic corticoids, glaucoma may also develop by using local

corticoids (e.g. after large dosed or extensive application over a prolonged period,

occlusive dressing technique or application to the skin around the eyes).

4.5

Interaction with other medicinal products and other forms of interaction

None stated.

4.6

Pregnancy and lactation

There is inadequate evidence of safety in human pregnancy. Topical

administration of corticosteroids to pregnant animals can cause abnormalities in

foetal development including cleft palate and intra-uterine growth retardation.

There may, therefore, be a very small risk of such effects on the human foetus

and, as a general rule, topical preparations containing corticoids should not be

applied during the first trimester of pregnancy. In particular, application to large

areas of the body or for prolonged periods must be avoided.

Side effects cannot be excluded in neonates whose mothers have been treated

extensively or for a prolonged period of time during pregnancy or while lactating

(for example, reduced adrenocortical function, when applied during the last

weeks of pregnancy).

Nursing mothers should not be treated on the breasts.

4.7

Effects on ability to drive and use machines

None stated.

4.8

Undesirable effects

Common local adverse reactions reported with Neriderm formulations in clinical

studies include burning, pruritus, erythema and irritations.

In common with all other topical corticoids, side-effects may occur when Neriderm is

applied to large areas of the body (10% or more) and for long periods of time (more

than four weeks), especially if the ointment or an occlusive dressing is being used.

There may be local signs such as atrophy of the skin, telangiectasia, striae, acneform

changes, perioral dermatitis and hypertrichosis, or systemic corticoid effects caused

by absorption. Systemic absorption can produce the features of hypercorticism.

Therefore, caution should be exercised when using occlusive dressings, as there is a

possibility that natural steroid production may be suppressed.

In rare cases, allergic skin reactions may occur.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the medicinal

product.

Any suspected adverse events should be reported to the Ministry of Health according

to the National Regulation by using an online form https://sideeffects.health.gov.il

Additionally, you can also report to www.perrigo-pharma.co.il.

4.9

Overdose

On the basis of results from acute toxicity studies with both diflucortolone

valerate and Neriderm preparations, no acute risk of intoxication is to be

expected either after a single dermal application of an overdose (application over

a large area under conditions favouring resorption) or even after inadvertent oral

intake of a whole tube.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties

Diflucortolone

valerate

topically

acting

fluoridated

corticosteroid

which

suppresses inflammation in inflammatory and allergic skin conditions and alleviates

the subjective complaints such as itching, burning and pain.

Capillary dilatation, intercellular oedema and tissue infiltration regress; capillary

proliferation is suppressed. This leads to fading of inflamed skin surfaces.

5.2.

Pharmacokinetic Properties

In order to exert its antiproliferative and anti-inflammatory effects, diflucortolone

valerate has to diffuse from the preparation into the living epidermis and into the

upper

dermis.

In

vitro

penetration

studies

showed

that

diflucortolone

valerate

penetrates human skin rapidly. After application to damaged skin - as a model for

diseased skin - the local corticosteroid levels were distinctly higher than in the intact

skin.

Once in the skin diflucortolone valerate is partly hydrolysed into the similarly effective

diflucortolone.

Part

corticosteroid

applied

skin

percutaneously

absorbed, distributed into organs and tissues, metabolised and finally excreted. The

extent of percutaneous absorption and the resulting systemic load depend on a

series of factors: the vehicle, the exposure conditions (skin area dose, treatment

area, duration of treatment), condition of treatment (open/occlusive), the status of the

penetration barrier and the localisation of the treated area on the body.

After application of the radiolabelled ointment onto an intact and a “stripped” area of

skin on the back of 3 volunteers, 0.7% of the dose was percutaneously absorbed

during a 7 hour exposure period.

Following percutaneous absorption diflucortolone valerate is hydrolysed very rapidly

into diflucortolone and the respective fatty acid. 11-ketodiflucortolone and two further

metabolites have been found in the plasma in addition to diflucortolone.

Diflucortolone is eliminated from the plasma with a half-life of approximately 4-5

hours, all metabolites together with a half-life of approximately 9 hours (results after

i.v. administration). The metabolites are excreted with urine and faeces in a ratio of

75:25.

5.3.

Pre-clinical Safety Data

There are no preclinical safety data which could be of relevance to the prescriber and

which are not already included in other relevant sections of the SPC.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients

Neriderm Cream:

Purified Water, Vaselin-White, Paraffin Liquid Heavy, Stearyl

Alcohol, Polyoxyl 40 Stearate, , Carbopol 980, Edetate

Disodium Dihydrate, Sodium Hydroxide, Methyl

Parahydroxy Benzoate, Propyl Parahydroxy Benzoate.

Neriderm Ointment:

Bees wax, Paraffin Liquid Heavy, Vaseline white,

Dehymuls® E, Purified Water.

6.2.

Incompatibilities

None stated.

6.3.

Shelf Life

The expiry date of the product is indicated on the packaging materials

6.4.

Special Precautions for Storage

Store in a cold place, below 25°C.

6.5.

Nature and Contents of Container

Aluminium tubes containing 30g cream or ointment.

6.6.

Instructions for Use/Handling

Keep out of reach of children

7.

MANUFACTURER AND MARKETING AUTHORISATION HOLDER

Perrigo Israel Pharmaceuticals, Ltd., Yerucham

8.

MARKETING AUTHORISATION NUMBER(S)

Neriderm Cream:

24636

Neriderm Ointment:

24637

Revised on August 2020

העדוה העדוה

לע לע

הרמחה הרמחה

(

(

עדימ עדימ

ןולעב )תוחיטב ןולעב )תוחיטב

ןכרצל ןכרצל

ןכדועמ( ןכדועמ(

05.2013

05.2013

ךיראת

25.8.2013

םש

רישכת

תילגנאב

רפסמו

םושירה

061-50-24636-00

Neriderm cream

061-51-24637-00

Neriderm ointment

םש

לעב

םושירה

Perrigo Israel Pharmaceuticals, Ltd., Yerucham

ספוט

הז

דעוימ

טורפל

תורמחהה

דבלב

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תושקובמה

קרפ

ןולעב טסקט

יחכונ טסקט

שדח תויוותה

הפורתה הניא

ליגל תחתמ םידליל תדעוימ

ב לופיטלו הנש

םילותיח תחרפת

ןיא יתמ שמתשהל

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רוע יחטש לע וז הפורתב שמתשהל ןיא

םיחותפ םיעצפ וא םיבחרנ

וא םרדירנ לש רתוי הלודג תומכ חורמל ןיא

תצלמהמ רתוי תכשוממ הפוקתל שמתשהל

אפורה

םייניעה םע עגמב אובל הפורתל רוסא

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הוולמ תויהל בייח םירגבתמבו םידליב שומיש

יאופר בקעמב

וז הפורתב ןמז ךרואל ףיצר שומישמ ענמה

לש תוליעפה תא דירוהל הלולע םרדירנ

םורגל ךכבו לנרדא הילכה תרתוי תטולב

תומוד תועפות תולחמל תודימעב הדיריל

שומיש רחאל קוניתה לצא עיפוהל תולולע

תועובשה ךלהמב ומא ידי לע םרדירנב בחרנ

הקנהה ןמזב וא ןוירהל םינורחאה

רוזא לש השיבח

:

לופיטה

רועב םיעוגנה םירוזאה יכ ץילמה אפורה םא

השיבח ורבעי םרדירנב םילפוטמה ךלש

תורידת יבגל ויתוארוה תא עצבל ךילע

םרדירנב שומישה תומכו תושובחתה תפלחה

ךשמל תשובחת לכ ריאשהל ןיא יללכ ןפואב

מ רתוי לש

םימייוסמ םירקמב תועש

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תוריהזב קודב דימת ץלמומה ןמזה ךשמל

השיבחה תא ףילחמ התא רשאכ רועה תא םא

רועה

ךלש

הארנ

קלדומ רתוי

רשאמ םדוק

וא

םא

ועיפוה

םינועצפ

םיליכמה

הלגומ

אפורל הנפו תושובחתב שמתשהל קספה

ירשפאה םדקהב

הקנהו ןוירה

ןיטולחל לולשל ןתינ אל ליגרה ןונימב וליפא

תוחתפתהב דואמ ןטק ןוכיסל תורשפאה תא

םרדירנב ולפוטש תורה םישנב קוניתה ןכל

,

ןוירהב ךניה םא הפורתב שמתשהל ןיא

,

,

םא אלא הקינמ וא ןוירהל סנכהל הסנמ

אפורה ידי לע ינויחל בשחנ לופיטה ןכ

.

ךלש

םיידשה לע םרדירנ חורמל ןיא הקינמ תא םא

לע בושח עדימ קלח

לש םיביכרמהמ הפורתה

ליכמ םרק םרדירנ

stearyl alcohol

לולעו

תקלד ןוגכ רועב תוימוקמ תובוגתל םורגל

םג הליכמ הפורתה עגממ רוע

Methyl

Parahydroxy Benzoate

Propyl

Parahydroxy Benzoate

םורגל םילולע רשא

תורחואמ תובוגת ללוכ תויגרלא תובוגתל

יאוול תועפות תולולע

עיפוהל

תועפשה יוריג :ןוגכ ,יאוול

,דוריגו שבוי

החירפ ,רועב תשגרה ,תוימומדאו

םוח תועפות .ץוצקעו

ולא תופלוח

ללכ-ךרדב

ךות

ןמז רצק

רחאל

תפוקת תולגתסהה

.רישכתל םיתעל

תורידנ

הלולע

שחרתהל הבוגת תיגרלא

םרדירנל

םא

התא

התא יכ שיגרמ הווח

הבוגת

תיגרלא

קספה

שמתשהל

חקורל וא אפורל דימ הנפו וז הפורתב םיתיעל

רחאל

םרדירנב שומיש

התא

לולע שיגרהל

הבירצ

דרג

וא

רועב יוריג

רועה

ךלש יושע

םג

קומס וא ימומדא תויהל

םא ירשפאה םדקהב אפורל תונפל שי התא

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הפורתב

וא לפוטמה רוזאב רועה

קיקדל ךפוה וביבסמ

הנקא ייומד םיעצפ

החיתמ ינמיס

הפה ביבס רוע תקלד

הפה רוזיאב רוע תלחמ

םינטק םד ילכ תוצבקתה

רועל תחתמ םיטלובה

היסטקאיגנלט

תחימצ

רעיש

תרבגומ

רועיש

סיזוכירטרפיה רתי

המוקואלג

ץחל

יניע ךות הובג

רשאכ תרבוג יאוול תועפות תעפוהל תוריבסה

םיבחרנ םירוזא לע השענ םרדירנב לופיטה

ףוגב

יקרפ ךשמלו ףוגה חטש לש רתויו

תועובש העבראל לעמ םיכשוממ ןמז

תודימע תושובחתב שומיש םייק םא דחוימב

ןוכיסה םימל תוריבס

םא הלוע המוקואלגל

ןיעה ביבסמש רועב םרדירנב שומיש השענ

םורגל לוכי םרדירנ דואמ תורידנ םיתיעל

םינומרוהה רוצייב הדירי ןוגכ יאוול תועפותל

רשא הילכה תרתוי תטולב ידי לע םייעבטה

תמגודכ הלחמל ליבוהל הלוכי תנומסת

םזילוזיטרוקרפיה גנישוק

ב"צמ

ובש ,ןולעה

תונמוסמ

תורמחהה

תושקובמה

לע

עקר

בוהצ

םייוניש

םניאש

רדגב

תורמחה

ונמוס

ןולעב עבצב )

שי .הנוש

ןמסל

קר

ןכות

יתוהמ

אלו

םייוניש םוקימב

.טסקטה העדוה העדוה

לע לע

הרמחה הרמחה

(

(

עדימ עדימ

ןולעב )תוחיטב ןולעב )תוחיטב

ל

ל

אפור אפור

ןכדועמ( ןכדועמ(

05.2013

05.2013

ךיראת

25.8.2013

םש

רישכת

תילגנאב

רפסמו

םושירה

061-50-24636-00

Neriderm cream

061-51-24637-00

Neriderm ointment

םש

לעב

םושירה

Perrigo Israel Pharmaceuticals, Ltd., Yerucham

ספוט

הז

דעוימ

טורפל

תורמחהה

דבלב

תורמחהה

תושקובמה קרפ

ןולעב טסקט

יחכונ טסקט

שדח

Posology and method of

administration

At the beginning of

treatment, Neriderm is

applied thinly twice, or

perhaps three times per

day. Once the clinical

picture has improved, one

application per day usually

suffices.

Babies children and adults

should not be treated with

Neriderm for longer than

three weeks.

Adults: Initially, Neriderm should

be applied thinly twice daily. When

the condition improves or when

longer periods of treatment are

required, one application daily is

appropriate.

Long-term continuous therapy with

topical corticosteroids should be

avoided, with a usual maximum

duration of 4 weeks. If used on the

face, courses should be limited to 5

days and occlusion should not be

used (see section 4.4).

Children 1-4years of age: Neriderm

should be applied thinly twice daily.

It should be used with great care,

for short periods and generally only

on the advice of a doctor

specialising in dermatology.

Courses should be limited to 5 days

and occlusion should not be used.

Children 5 years of age and over:

Initially, Neriderm should be

applied thinly twice daily. When the

condition improves, one application

daily is appropriate. Courses should

be limited to 1-2 weeks. If used on

the face, courses should be limited

to 5 days and occlusion should not

be used.

Neriderm should not be used in

children under 1 year of age.

Occlusive dressings: An occlusive

dressing may be called for in

unusually refractory cases and

usually under specialist supervision.

If an infection develops under the

dressing, occlusive treatment must

be terminated.

contraindications

Tuberculous or syphilitic

processes in the area to be

treated; virus diseases (e.g.

varicella,

herpes

zoster)

rosacea, perioral dermatitis

and postvaccination skin

reactions in the area to be

treated. Hypersensitivity to

the active substances or to

any of the excipients

Rosacea and peri-oral dermatitis.

Acne vulgaris, undiagnosed perianal

and genital pruritus, napkin

eruptions, Tuberculous or syphilitic

processes in the area to be treated,

viral infections, primary bacterial or

fungal infections of the skin.

Secondary infections in the absence

of appropriate anti-infective therapy.

Post vaccination skin reactions in

the area to be treated.

Neriderm is not suitable for the

treatment of ophthalmic conditions.

Hypersensitivity to the active

substances or to any of the excipients.

OverDose

Special Warnings and

Precautions

Additional,

specific

therapy

required

bacterially

infected

skin

diseases and/or in fungus

infections

If the skin dries out too

much under protracted use

of Neriderm cream, the

patient should be switched

to a form which contains

more

(Neriderm

ointment or Neriderm fatty

ointment)

Neriderm should not be

allowed

come

into

contact with the eyes when

being applied to the face

Extensive application of

topical corticosteroids to

large areas of the body or

for prolonged periods of

time, in particular under

occlusion,

significantly

increases the risk of side

effects

As known from systemic

corticoids, glaucoma may

also develop from using

...Long-term continuous therapy

with topical corticosteroids should

be avoided, with a usual maximum

duration of 4 weeks irrespective of

age. Adrenal suppression can occur,

even without occlusion.

If used on

children up to the age of 4 years or

on the face, courses should be

limited to 5 days and occlusion

should not be used

Neriderm may be applied under an

occlusive dressing. However, each

dressing should not be left on for

more than 24 hours. Although

occlusive dressings may be used

repeatedly, it should be noted that

systemic corticoid absorption is

likely to be increased with a

consequent increased risk of adrenal

suppression. If occlusive treatment

is expected to be prolonged, it is

advisable to change the dressing

every 12 hours.

Neriderm should not be allowed to

come into contact with the eyes.

Topical corticosteroids may be

hazardous in psoriasis for a number

of reasons including rebound

local corticoids (e.g. after

large-dose

extensive

application

over

prolonged

period,

occlusive

dressing

techniques, or application

to the skin around the

eyes)

relapses following development of

tolerance, risk of generalised

pustular psoriasis, and local and

systemic toxicity due to impaired

barrier function of the skin. Careful

patient supervision is important in

psoriasis.

Exacerbation of skin infections

may occur. Infections or

secondarily infected dermatoses

require additional therapy with

antibiotics or chemotherapeutic

agents. This treatment can often be

topical, but for heavy infections

systemic antibacterial therapy may

be necessary. If fungal infections

are present, a topically active

antimycotic should be applied.

If aggravation of skin

irritation develops with the

use of Neriderm, treatment

should be withdrawn and

appropriate therapy installed.

Allergic contact dermatitis due to

topical corticosteroids and

excipients can occur. In these cases

eczema fails to improve or

deteriorates with treatment.

Corticosteroid hypersensitivity

occurs most frequently among

patients with stasis dermatitis and

leg ulceration. Such an observation

should be corroborated with

appropriate diagnostic patch

testing. The appropriate

corticosteroid concentration and the

choice of the vehicle is crucial in

detecting corticosteroid

hypersensitivity in patch tests.

Patients with an allergy to

corticosteroids may cross-react

to several corticosteroids to

which they have not previously

been exposed.

After topical application,

allergies to cross-reacting

systemically applied

corticosteroids may occur.

As known from systemic corticoids,

glaucoma may also develop by using

local corticoids (e.g. after large dosed

or extensive application over a

prolonged period, occlusive dressing

technique or application to the skin

around the eyes)

Pregnancy and

lactation

Animal experimental

studies with

glucocorticosteroids have

shown reproductive

toxicity (cf. section

"Preclinical safety data").

A number of

epidemiological studies

suggest that there could

possibly be an increase

risk of oral clefts among

newborns of women who

were treated with systemic

glucocorticosteroids

during the first trimester of

pregnancy. Oral clefts are

a rare disorder and if

systemic

glucocorticosteroids are

teratogenic, these amy

account for an increase of

only one or two cases per

1000 women treated while

pregnant. Data concerning

topical glucocorticosteroid

use during pregnancy are

insufficient, however, a

lower risk might be

expected since systemic

availability of topically

applied glucocrticosteroids

is very low.

As a general rule, topical

preparations containing

corticoids should not be

applied during the first

trimester of pregnancy.

The clinical indication for

treatment with Neriderm

must be carefully reviewed

and the benefits weighed

against the risks in

pregnant and lactating

women. In particular, large

area or prolonged use must

be avoided.

Nursing mothers should

not be treated on the

There is inadequate evidence of

safety in human pregnancy.

Topical administration of

corticosteroids to pregnant animals

can cause abnormalities in foetal

development including cleft palate

and intra-uterine growth

retardation. There may, therefore,

be a very small risk of such effects

on the human foetus and, as a

general rule, topical preparations

containing corticoids should not

be applied during the first

trimester of pregnancy. In

particular, application to large

areas of the body or for prolonged

periods must be avoided.

Side effects cannot be excluded in

neonates whose mothers have

been treated extensively or for a

prolonged period of time during

pregnancy or while lactating (for

example, reduced adrenocortical

function, when applied during the

last weeks of pregnancy).

Nursing mothers should not be treated

on the breasts.

breasts.

Undesirable Effects

Local symptoms such as

itching, burning, erythema

or vesiculation may occur

in isolated cases under

treatment with Neriderm.

The following reactions

may occur when topical

preparations are applied to

large areas of the body

(about 10% and more) or

for prolonged periods of

time (more than 4 weeks):

local symptoms such as

atrophy of the skin,

telangiectasia, striae,

acneform changes of the

skin, and systemic effects

of the corticoid due to

absorption.

As with other

corticosteroids for topical

application, the following

side-effects may occur in

rare cases: Folliculitis,

hypertrichosis, perioral

dermatitis, skin

discoloration, allergic skin

reactions to any of the

ingredients of the

formulation.

Side effects cannot be

excluded in neonates

whose mothers have been

treated extensively or for a

prolonged period of time

during pregnancy or while

lactating (for example,

reduced adrenocortical

function, when applied

during the last weeks of

pregnancy).

Common local adverse reactions

reported with Neriderm

formulations in clinical studies

include burning, pruritus,

erythema, itching, vesiculation

and irritations.

In common with all other topical

corticoids, side-effects may occur

when Neriderm is applied to large

areas of the body (10% or more)

and for long periods of time (more

than four weeks), especially if the

ointment or an occlusive dressing

is being used. There may be local

signs such as atrophy of the skin,

telangiectasia, striae, acneform

changes, perioral dermatitis and

hypertrichosis, or systemic

corticoid effects caused by

absorption. Systemic absorption

can produce the features of

hypercorticism. Therefore, caution

should be exercised when using

occlusive dressings, as there is a

possibility that natural steroid

production may be suppressed.

As with other corticosteroids for

topical application, the following

side-effects may occur in rare

cases: Folliculitis and skin

discoloration.

In rare cases, allergic skin reactions to

any of the ingredients of the

formulation may occur.

Overdose

Results from acute toxicity

studies do not indicate that

any risk of acute

intoxication is to be

expected following a

single dermal application

of an overdose (application

over a large area under

On the basis of results from acute

toxicity studies with both

diflucortolone valerate and

Neriderm preparations, no acute

risk of intoxication is to be

expected either after a single

dermal application of an overdose

(application over a large area

conditions favorable to

absorption) or inadvertent

oral ingestion.

under conditions favouring

resorption) or even after

inadvertent oral intake of a whole

tube.

ב"צמ

ובש ,ןולעה

נמוסמ תו

תורמחהה

שקובמה תו

לע

עקר

בוהצ

.

םייוניש

םניאש

רדגב

תורמחה

ונמוס

)ןולעב( עבצב

שי .הנוש

ןמסל

קר

ןכות

יתוהמ

אלו

םייוניש םוקימב

.טסקטה

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