LOCATOP 0.1 %

1986-ו"משתה(םירישכת)םיחקורהתונקתיפלןכרצלןולע

.אפורםשרמבתב

ייחוזהפורת :הפורתבשמתשתםרטבופוסדעןולעהתאןויעבארק ̯˜†∞Ʊ†Ù¢ÂÏ

∫·Î¯‰ Desonide 0.1%

:וזוכירוליעפהרמוחה :םיליעפיתלבםיב

Purified W

ater

aseline, Emulgade 1000 NI, Liquid Paraf

Acid, Disodium Edetate, Propyl Gallate.

Topical corticosteroids

,סיטיטמרד

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םיבצמב

לופיטל

ידיאורטס

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יכרממדחאלתושיגרהעודיםאשמתשהלןיא ˙ÏÁ˙‰†

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רצקןמזךותללכ–ךרדבתופלוח

atient pac

kage inser

t in accordance with the phar

regulations (prepar

ations – 1986) The dispensing of this medicine requires a doctor’

s prescr

Read the entire leaflet carefully bef

ore commencing treatment: Locatop 0.1% Cream Composition: Activ

e ing

redient:

Desonide 0.1% Inactive ingredients: Pur

ified

ater

,V

aseline

, Em

ulgade 1000 NI, Liquid P

Acid, Disodium Edetate

, Prop

yl Gallate

Therapeutic gr

oup:

T

opical cor

ticosteroids

Therapeutic action:

T

reatment of der

treatment with topical cor

ticosteroids e

psor

iasis

atopic der

matitis

, contact der

matitis

When should this preparation not be used?

Do not use this medicine if y

ou suff

er from acne or rosacea.

not use this medicine in case of bacter

ial, vir

ection, elementar

y or secondar

y,e

ven in case the inf

includes inflammation

.

Do not apply this medicine to hemorrhagic area. Do not use this medicine if y

u are sensitiv

e to an

redients

This medicine should not be used without consulting a ph

ysician prior to commencing treatment:

If y

or breastf

eeding. If the ph

ysician appro

ved use of this medicine in breastf

omen – do not apply the medicine on breast bef

ore breast-f

W

arnings: Do not apply this medicine to wide skin areas or to open w

ounds

Special caution is required when treating children. Usage of this medicine in children and adolescents m

accompanied b

medical super

vision. Av

oid contact of this medicine with e

ash e

yes thoroughly with w

ater

.If y

ou are sensitiv

e to an

of f

ood or medicine

, inf

our ph

ysician pr

treatment. Drug interactions: If y

ou tak

e another medicine concomitantly or if y

ou ha

finished treatment with another medicine

, inf

in order to pre

vent hazards or lac

k of efficacy ar

ising from dr

inter

actions

Side eff

ects: In addition to the desired eff

ect of the medicine

, some side eff

y occur dur

ing treatment with this medicine such as:

irr

and itching, dr

yness of skin, skin r

ash, redness

eeling of w

and stinging.

These side eff

ects gener

ally disappear within a shor

time f

ollo

wing a per

iod of adaptation to the medicine

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Purified W

ater

aseline, Emulgade 1000 NI, Liquid Paraf

Acid, Disodium Edetate, Propyl Gallate.

Topical corticosteroids

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לכב .הזיראהתואבתונושתופורתןסחאלןיא 130833030700

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.הילצרה22ןוירוגןב,מ"עבןיילידמ

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לע

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Side eff

ects whic

h require special attention: In case the side eff

ects mentioned abo

are not tr

another w

orsening in skin condition occurs

, stop treatment and ref

to the ph

ysician. In case y

ou notice side eff

ects not mentioned in this leaflet or if there has been an

y change in y

our gener

al health, consult y

our ph

immediately

Dosa

g

e

and direction f

or use: Dosage is according to ph

ysician’

s instr

uction only

Do not e

xceed the recommended dosage

Apply a thin la

yer to the aff

ected area 2-3 times a da

y.Clar

your ph

ysician the dur

ation of treatment.

Do not use the cream f

longer per

iod. This medicine is usually not designated f

or inf

ants (saf

efficiency ha

not been pro

ven). Av

oid using of sealed dressing on aff

ected area unless instr

the ph

ysician. If no impro

vement is noted, or if y

ur condition w

orsens within f

, ref

er to the ph

ysician. Attention: Do not s

allo

w!

This medicine is intended f

or e

xter

nal use only

Av

oid poisoning! This medicine and an

y other medicine m

ust be k

out of the reach of children and/or inf

ants

, in order to a

If y

u ha

tak

en an o

erdose

, or if a child has accidentally sw

allo

ed the medicine

, proceed to the hospital’

immediately and br

ing the pac

kage of the medicine with y

n

tin

v

itin

g unless e

xplicitly instr

ucted to do so b

doctor! This medicine has been prescr

ibed specifically f

of y

our ailment.

In another patient it ma

y cause har

Do not giv

this medicine to y

our relativ

, neighbors or acquaintances

n

tt

m

in

th

d

!Chec

tim

e y

ou tak

e the medicine

.W

ear glasses if y

Stora

g

e

:In a cool dr

y place

en if k

ept in their or

iginal containers and stored as recommended, medicines ma

y be k

ept f

or a limited per

iod only

xpir

y date of the medicine! In case of doubt, consult the phar

macist who dispensed the medicine to y

Do not store Diff

erent medications in the same pac

kage

Registration n

umber:

130 83 30307 00 Man

ufacturer:

Pierre F

abre Medicaments

rance

Man

ufacturer’

s a

g

ent:

Mediline Ltd, 22 Ben Gur

Impor

ter:

Mediline Ltd, P

x 531

The Ministr

y of health had deter

mined the f

its content had been e

xamined and appro

I1250509

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«

√

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ÔŠ ÆUNK³ s

Locatop Cream leaflet Siz

200 x 155 Te

190 x 145 Meged, 27/5/2009

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT

LOCATOP® 0.1

°/o,

cream

2

QUALITATIVE AND QUANTITATIVE

COMPOSITION

Desonide

.........................................................................0.100

for 100

of cream

Excipient with specific effect: sorbic acid.

For a full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Cream

4. CLINICAL PARTICULARS

4.1.

T

herapeutic indication

Treatment of dermatoses which require treatment with topical

corticosteroids

e.g. psoriasis,

lichenipication,

atopic dermatitis, contact dermatitis

4.2.

P

OSOLOGY AND METHOD OF ADMINISTRATION

LOCATOP®

Cream should be applied to the affected areas as a thin film limited to two times daily,

each

rubbed in gently.

An excessive increase in the number of applications per day risks aggravating the adverse effects without improving the

therapeutic effects.

Treatment of large areas required monitoring of the number of tubes used.

For rational use, it is advisable to apply the product as small amounts spaced out, then spread with a plastic glove until fully

absorbed.

Gradual withdrawal is advisable in some dermatoses (psoriasis, atopic dermatitis, etc.). This may be done by reducing the

frequency of applications and/or by using a less potent or less concentrated corticoid.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement

seen within 2 weeks, reassessment of diagnosis may be necessary.

LOCATOP®

Cream should not be used with occlusive dressings.

4.3 CONTRAINDICATIONS:

Hypersensitivity to any of the ingredient contained in this medicinal product.

Primary bacterial, viral or fungal infections or parasitical infections even if they include an inflammatory component.

Ulcerated lesions.

Acne.

Rosacea.

4.4 Special warning and precautions for use

Special warnings

Prolonged use of highly active corticoids on the face leads to a risk of corticoid-induced and paradoxically corticoid-sensitive

dermatitis with rebound after each withdrawal. Gradual weaning, although particularly difficult, is then necessary.

Systemic absorption of topical corticosteroids can produce reversible

hypothalamic-pituitary-adrenal

(HPA) axis

suppression with the potential for

glucocorticosteroid

insufficiency

after withdrawal of treatment.

S

S

Manifestations

of Cushing's

syndrome and slowing of growth, hyperglycemia,

and glucosuria

can also be produced in some

patients

systemic

absorption

of topical corticosteroids

while

treatment.

These effects disappear when

treatment is withdrawn, but sudden withdrawal may be followed by acute adrenal insufficiency.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be

evaluated

periodically

for evidence of HPA axis

suppression.

This may be done by using the ACTH stimulation, A.M.

plasma cortisol, and urinary free cortisol tests. Patients receiving superpotent corticosteroids should not

treated for more than 2 weeks at a time and only small areas should be treated at any one time due to

increased risk of HPA axis

suppression.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the

frequency

of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally

prompt

and complete upon

discontinuation

topical

corticosteroids.

Infrequently,

signs and

symptoms

of glucocorticosteroid

insufficiency

may occur

requiring supplemental

systemic

corticosteroids.

information

systemic

supplementation,

see prescribing information for those

products.

Pediatric patients

may be more susceptible

to systemic toxicity from equivalent

doses due to their larger

skin surface to body mass ratios. (See PRECAUTIONS FOR USE- Pediatric

use).

Allergic

contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting

clinical exacerbation as with most topical products not containing

corticosteroids.

Such an observation

should

be corroborated with appropriate diagnostic patch

testing.

Precautions for use

In the event of bacterial or mycotic infection of a cortico-sensitive dermatosis, administer specific treatment before

using corticoids. It is nevertheless possible, but only in certain cases, to use a combination of corticoid + specific

treatment.

If local intolerance appears, the treatment must be stopped and the cause must be investigated

In the case of application to the eyebrows, the duration of treatment must be limited. Prolonged application leads

to a risk of ptosis (due to an adverse effect on the eyelid levator muscle), glaucoma and a rebound effect.

This medicinal product contains sorbic acid or one of its salts and can cause local skin reactions (for example:

eczema).

Pediatric

Use:

Safety and effectiveness in pediatric patients have not been established.

It is best to avoid potent corticoids (classes I and II) in babies. There is particular need to be on guard against

the spontaneous occlusion which can arise in skin creases and under nappies.

Because of a higher ratio of

skin

surface area to body mass, pediatric patients are at a greater risk

than adults of HPA axis suppression

when

they

treated with

topical

corticosteroids.

They

therefore also at greater risk of

glucocorticosteroid

insufficiency after withdrawal of treatment and of

Cushing's

syndrome while

on treatment.

Adverse

effects

including striae

have been

reported

with

inappropriate

use of topical corticosteroids in infants and

children.

HPA axis suppression, Cushing's

syndrome,

linear growth retardation,

delayed

weight gain and

intracranial

hypertension

have

been

reported in children receiving topical

corticosteroids.

Manifestations of

adrenal suppression

in children

include low plasma

cortisol levels, and absence of response

to ACTH

stimulation.

Manifestations

intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

4.5.

I

NTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

At the recommended doses, desonide for topical use is not likely to cause significant drug interactions from a

medical viewpoint

4.6.

P

REGNANCY AND LACTATION

Pregnancy

There have been no teratogenicity studies with topical corticoids.

Nevertheless, studies concerning oral corticoid medication have not revealed a risk of malformations greater than

that observed in the general population.

Lactation

Breast-feeding is to be avoided in patients receiving treatment with oral corticoids since they are excreted in breast

milk.

When used topically, the transdermal passage of corticoids and thus the slowing of metabolism in the newborn will depend on

the area treated, the degree of epidermal alteration and the duration of treatment.

4.7.

E

FFECTS ON ABILITY TO DRIVE AND USE MACHINES

Not applicable

4.8.

U

NDESIRABLE EFFECTS

Prolonged use may lead to cutaneous atrophy, telangiectasis (particularly to be feared on the face), striations (particularly

on the proximal parts of the limbs, and occurring more readily in adolescents), ecchymotic purpura secondary to atrophy,

and cutaneous fragility.

On the face, corticoids may create peri-oral dermatitis or even create or aggravate rosacea (see sections 4.3 and 4.4).

Delay of healing of atonic wounds, bed-sores and leg ulcers may be observed (see section 4.3 ).

Possibility of systemic effects (see section 4.4).

following

have

been

reported:

burning

dryness/scaliness,

acneiform

pustulous

eruptions,

hypertrichosis, depigmentation, folliculitis, miliaria.

Secondary infections, particularly under occlusive dressings or in skin creases, and allergic contact dermatoses have also

been reported during the use of topical corticoids.

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

Regulation by using an online form

http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@

moh.health.gov.il ) or by email (adr@MOH.HEALTH.GOV.IL ).

4.9 OVERDOSAGE:

In the event of excessive or prolonged use of local corticosteroids, there is a possible risk of exacerbated adverse

events and systemic effects. In the event of a systemic overdose, signs of hypercorticism may appear and the

treatment should be stopped progressively. The symptoms should be treated appropriately. However, due to the

risk of acute adrenal suppression, this should be done under medical supervision.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties

Potent topical glucocorticoid

Active

certain

inflammatory

processes

(e.g.:

contact

hypersensitivity)

pruritus

associated

with

them.

Vasoconstrictor. Inhibits cell multiplication.

5.2.

P

HARMACOKINETIC PROPERTIES

The degree of transdermal passage and of systemic effects depends on the area treated, the degree of

epidermal alteration, and the duration of treatment. These effects are to be feared all the more as the

treatment is more prolonged

5.3.

P

RECLINICAL SAFETY DATA

Not stated.

6.

PHARMACEUTICAL

PARTICULARS

6.1

L

IST OF EXCIPIENTS

white soft paraffin

, cetomacragol emulsifying wax,liquid paraffin, sorbic acid, sodium edetate, propyl

gallate, purified water.

6.2 Incompatibilities

applicable

6.3 Shelf-life

3 years.

6.4 Special precautions for storage

Store below 30°

.Use within 1 month after first opening

6.5 Nature and contents of container:

30 g in tube (PE)

6.6.

S

PECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING

No special requirements.

7. MARKETING AUTHORISATION

HOLDER & MANUFACTURER

PIERRE FABRE MEDICAMENT PRODUCTION

45, Place Abel Gance, 92100 Boulogne, France.

Registration holder

:

Perrigo Israel Agencies Ltd.,29 Lehi St.,Bnei-Brak

The Ministry of health had determined the format of this leaflet and its content had been examined and approved

on October 20,2015.