DERMOVATE SCALP APPLICATION

Page

1

8

The format of this leaflet was determined by the Ministry of Health and its content was checked and approved in January 2017

, was updated according to the

guidelines of the Ministry of Health in December 2017

Dermovate Scalp Application

1.

Name of the Medicinal Product

Dermovate

Scalp Application

2.

Qualitative and Quantitative Composition

Each 1 g contains 0.5 mg of clobetasol propionate (0.05% w/w)

3.

Pharmaceutical Form

Scalp application

Clinical Particulars

4.1.

Therapeutic Indications

For the topical treatment of inflammatory conditions of the scalp responsive only to corticosteroids.

4.2.

Posology and Method of Administration

Route of administration: Topical, on the scalp.

Owing to the flammable nature of the product, Dermovate Scalp Application should be kept away from

open fire and flames and all sources of ignition, including smoking, during and immediately after use.

Adults, Elderly and Children over 1 year

A small quantity of clobetasol should be applied to the scalp night and morning until improvement is

noticeable. It may then be possible to sustain improvement by applying once a day, or less frequently.

Paediatric population

Children are more likely to develop local and systemic side effects of topical corticosteroids and, in

general, require shorter courses and less potent agents than adults.

Care should be taken when using clobetasol propionate to ensure the amount applied is the minimum

that provides therapeutic benefit.

Duration of treatment for children and infants

Courses should be limited if possible to a few days and reviewed weekly.

Page

2

8

Elderly

Clinical studies have not identified differences in responses between the elderly and younger patients.

The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if

systemic absorption occurs. Therefore the minimum quantity should be used for the shortest duration to

achieve the desired clinical benefit.

Renal / Hepatic Impairment

In case of systemic absorption (when application is over a large surface area for a prolonged period)

metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore

the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

4.3.

ContraIndications

Infections of the scalp.

Hypersensitivity to the active substance or any of the excipients listed in section 6.1.

Dermatoses in children under one year of age, including dermatitis.

4.4.

Special Warnings and Precautions for Use

Care must be taken to keep the preparation away from the eyes.

Patients should be advised to avoid:

smoking whilst applying to the scalp

fire, flame and heat including use of hair dryer after application

Clobetasol should be used with caution in patients with a history of local hypersensitivity to other

corticosteroids or to any of the excipients in the preparation. Local hypersensitivity reactions (see

section 4.8) may resemble symptoms of the condition under treatment.

Manifestations of hypercortisolism (Cushing’s syndrome) and reversible hypothalamic-pituitary-adrenal

(HPA) axis suppression, leading to glucocorticosteroid insufficiency, can occur in some individuals as a

result of increased systemic absorption of topical steroids. If either of the above are observed, withdraw

the drug gradually by reducing the frequency of application, or by substituting a less potent

corticosteroid. Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency (see

section 4.8).

Risk factors for increased systemic effects are:

Potency and formulation of topical steroid

Duration of exposure

Application to a large surface area

Page

3

8

Use on occluded areas of skin (e.g. on intertriginous areas or under occlusive dressings)

Increasing hydration of the stratum corneum

Use on thin skin areas

Use on broken skin or other conditions where the skin barrier may be impaired

In comparison with adults, children and infants may absorb proportionally larger amounts of topical

corticosteroids and thus be more susceptible to systemic adverse effects. This is because children

have an immature skin barrier and a greater surface area to body weight ratio compared with adults.

Paediatric population

In infants and children under 12 years of age, Long-term continuous topical corticosteroid therapy

should be avoided, where possible, as adrenal suppression can occur.

Children are more susceptible to develop atrophic changes with the use of topical corticosteroids.

Duration of treatment for children and infants

Courses should be limited if possible to a few days and reviewed weekly.

Infection risk with occlusion

Bacterial infection is encouraged by the warm, moist conditions within skin folds or caused by occlusive

dressings. When using occlusive dressings, the skin should be cleansed before a fresh dressing is

applied.

Use in Psoriasis

Topical corticosteroids should be used with caution in psoriasis as rebound relapses, development of

tolerances, risk of generalised pustular psoriasis and development of local or systemic toxicity due to

impaired barrier function of the skin have been reported in some cases. If used in psoriasis careful

patient supervision is important.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents

with symptoms such as blurred vision or other visual disturbances, the patient should be considered for

referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or

rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of

systemic and topical corticosteroids.

Concomitant infection

Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have

become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and

administration of appropriate antimicrobial therapy.

4.5.

Interactions with other Medicaments and other forms of Interaction

Co-administered drugs that can inhibit CYP3A4 (eg ritonavir and itraconazole) have been shown to

inhibit the metabolism of corticosteroids leading to increased systemic exposure. The extent to which

this interaction is clinically relevant depends on the dose and route of administration of the

corticosteroids and the potency of the CYP3A4 inhibitor.

4.6.

Fertility, pregnancy and lactation

Page

4

8

Pregnancy

There are limited data from the use of clobetasol in pregnant women.

Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal

development (see section 5.3)

The relevance of this finding to humans has not been established. Administration of clobetasol during

pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the

foetus. The minimum quantity should be used for the minimum duration.

Breast-feeding

The safe use of topical corticosteroids during lactation has not been established.

It is not known whether the topical administration of corticosteroids could result in sufficient systemic

absorption to produce detectable amounts in breast milk. Administration of clobetasol during lactation

should only be considered if the expected benefit to the mother outweighs the risk to the infant.

If used during lactation clobetasol should not be applied to the breasts to avoid accidental ingestion by

the infant.

Fertility

There are no data in humans to evaluate the effect of topical corticosteroids on fertility.

Clobetasol administered subcutaneously to rats had no effect upon mating performance; however,

fertility was decreased at the highest dose (

see

section 5.3

4.7.

Effects on Ability to Drive and Use Machines

There have been no studies to investigate the effect of clobetasol on driving performance or the ability to

operate machinery. A detrimental effect on such activities would not be anticipated from the adverse

reaction profile of topical clobetasol.

4.8.

Undesirable Effects

Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency.

Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000

and <1/100), rare (≥1/10,000 and <1/1,000) and very rare (<1/10,000), including isolated reports.

Post-marketing data

Infections and Infestations

Very rare

Opportunistic infection

Immune System Disorders

Very rare

Hypersensitivity, generalised rash

Endocrine Disorders

Page

5

8

Very rare

Hypothalamic-pituitary adrenal (HPA) axis suppression:

Cushingoid features: (e.g. moon face, central obesity), delayed weight

gain/growth retardation in children, osteoporosis, glaucoma,

hyperglycaemia/glucosuria, cataract, hypertension, increased weight/obesity,

decreased endogenous cortisol levels, alopecia, trichorrhexis

Skin and Subcutaneous Tissue Disorders

Common

Pruritus, local skin burning/skin pain

Uncommon

Skin atrophy*, striae*, telangiectasias*

Very rare

Skin thinning*, skin wrinkling*, skin dryness*, pigmentation changes*,

hypertrichosis, exacerbation of underlying symptoms, allergic contact

dermatitis/dermatitis, pustular psoriasis, erythema, rash, urticaria, acne

*Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis

suppression.

General Disorders and Administration Site Conditions

Very rare

Application site irritation/pain

Eye disorders

Not known:

Vision, blurred (see also section 4.4)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows

continued monitoring of the risk/benefit balance of the medicinal product. Healthcare professionals are

asked to report any suspected adverse reactions 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). Additionally, you should also report to GSK Israel (il.safety@gsk.com).

4.9.

Overdose

Symptoms

Topically applied clobetasol may be absorbed in sufficient amounts to produce systemic effects. Acute

overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the features

of hypercortisolism may occur (

see section 4.8

ManagementIn the event of overdose, clobetasol should be withdrawn gradually, by reducing the

frequency of application or by substituting a less potent corticosteroid because of the risk of

glucocorticosteroid insufficiency.

Further management should be as clinically indicated or as recommended by the national poisons centre,

where available.

Page

6

8

Pharmacological Properties

5.1.

Pharmacodynamic Properties

Pharmacotherapeutic group:

Corticosteroids, very potent (group IV)

ATC code

:

D07AD

Mechanism of action

Topical corticosteroids act as anti-inflammatory agents via multiple mechanisms to inhibit late phase

allergic reactions including decreasing the density of mast cells, decreasing chemotaxis and activation of

eosinophils, decreasing cytokine production by lymphocytes, monocytes, mast cells and eosinophils, and

inhibiting the metabolism of arachidonic acid.

Pharmacodynamic effects

Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties.

5.2.

Pharmacokinetic Properties

Absorption

Topical corticosteroids can be systemically absorbed from intact healthy skin. The extent of

percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle

and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the

skin may also increase percutaneous absorption.

Distribution

The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is

necessary due to the fact that circulating levels are well below the level of detection.

Metabolism

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways

similar to systemically administered corticosteroids. They are metabolised primarily in the liver.

Elimination

Topical corticosteroids are excreted by the kidneys. In addition, some corticosteroids and their

metabolites are also excreted in the bile.

5.3.

Preclinical Safety Data

Carcinogenesis / Mutagenesis

Carcinogenesis

Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol

propionate.

Genotoxicity

Clobetasol propionate was not mutagenic in a range of

in vitro

bacterial cell assays.

Reproductive Toxicology

Fertility

Page

7

8

In fertility studies, subcutaneous administration of clobetasol propionate to rats at doses of 6.25 to

50 micrograms/kg/day produced no effects on mating, and fertility was only decreased at

50 micrograms/kg/day.

Pregnancy

Subcutaneous administration of clobetaol propionate to mice (

100 micrograms/kg/day), rats (400

micrograms/kg/day) or rabbits (1 to 10 micrograms/kg/day) during pregnancy produced foetal

abnormalities including cleft palate and intrauterine growth retardation.

In the rat study, where some animals were allowed to litter, developmental delay was observed in the F1

generation at

100 micrograms/kg/day and survival was reduced at 400 micrograms/kg/day. No

treatment-related effects were observed in F1 reproductive performance or in the F2 generation.

Pharmaceutical Particulars

6.1.

List of excipients

Isopropyl Alcohol

Carbomer

Sodium Hydroxide

Purified Water

6.2.

Incompatibilities

None known.

6.3.

Shelf Life

The expiry date of the product is indicated on the label and packaging.

6.4.

Special Precautions for Storage

Do not Store above 25

Use within 3 months after opening.

Keep container tightly closed when not in use. Contents are flammable. Keep away from fire, flame or

heat. Do not leave Dermovate Scalp Application in direct sunlight.

6.5.

Nature and Contents of Container

White High Density Polyethylene (HDPE) container with a white low density polyethylene (LDPE)

nozzle and a white HDPE screw cap.

Pack size: 25ml, 100ml.

Not all pack sizes may be marketed.

6.6.

Special precautions for disposal and other handling

Page

8

8

Patients should be advised to wash their hands after applying Dermovate Scalp Application.

For detailed instructions for use refer to the Patient Information Leaflet in every pack.

Do not use near a naked flame.

Administrative Data

7.

MANUFACTURER

Aspen Bad Oldesloe GmbH, Bad Oldesloe, Germany.

8.

LICENSE HOLDER AND IMPORTER

GlaxoSmithKline (Israel) Ltd., 25 Basel St., Petach Tikva.

9.

LICENSE NUMBER

046-92-23798

Der SA DR v5

©2017 GSK group of companies or its licensor

Trade marks are owned by or licensed to the GSK group of companies.