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Dermovate Scalp Application 0.05%w/v Cutaneous Solution

*
Pharmacy Only: Prescription

  • Company:

    GlaxoSmithKline (Ireland) Ltd

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Clobetasol Propionate

    *Additional information is available within the SPC or upon request to the company

Updated on 30 July 2021

File name

ie-spc-dermovate-scalp-issue10draft1-master-meds.ie.pdf

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 28 April 2021

File name

ie-pl-dermovate-scalp-issue9draft1_clean_med.ie.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 28 April 2021

File name

ie-spc-dermovate-scalp-issue9draft1_clean_med.ie.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 25 October 2017

File name

PIL_8152_91.pdf

Reasons for updating

  • New PIL for new product

Updated on 25 October 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 25 October 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SPC Section 4.4 - warnings and precautions – addition of visual disturbances

SPC Section 4.8 - Undesirable effects – addition of blurred vision AE

Updated on 25 October 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 09 November 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 – Special warnings and precautions for use:   
• The removal of text under 'infection risk with occlusion' to bring in line with the GDS, this text is deemed redundant as it is already reflected earlier within the same section.

• The removal of information regarding 'chronic leg ulcers' as this is not applicable for the Scalp application.

Section 4.8 – Undesirable effects:
• The addition of acne as an adverse reaction in section.

Updated on 09 November 2016

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 06 May 2016

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

GDS consistency and editorial updates.

Updated on 06 May 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 09 October 2015

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 1: Change to product name (w/w to w/v)
Section 2:  Consequential change to active substance quantitative declaration expression (w/w to w/v)

Updated on 09 October 2015

Reasons for updating

  • Change of trade or active ingredient name
  • Change to date of revision

Updated on 17 July 2015

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to address of the MA Holder

Updated on 17 July 2015

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 03 June 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2 - Update to quantitative declaration
Section 4.3 - Administrative updates
Section 4.4 - Update to include ‘Paediatric population’ sub-heading & administrative updates
Section 4.6 - Administrative updates
Section 4.8 - Administrative updates including adverse event reporting statement
Section 6.1 - Administrative updates
Section 6.6 - Update to include disposal statement

Updated on 02 June 2015

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 21 May 2014

Reasons for updating

  • Change to date of revision

Updated on 19 May 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.2 - Addition of flammable warning
4.4 - Additional warning added
4.8 - AE reporting updated
5.1 - ATC code added
6.4 - Storage precautions updated

Updated on 07 May 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 08 October 2013

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications

Updated on 24 January 2013

Reasons for updating

  • Change of inactive ingredient

Updated on 17 September 2012

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



Section 4.6 Pregnancy and Lactation, 4.7 Effects on Ability to Drive and Use Machines and 4.9 Overdose have been updated to the format as per the QRD template. 

 

The rest of the sections have had the following changes:

 

Section 4.2 Posology and Method of Administration:

 

The following sections were added:

Application in Children

Children are more likely to develop local and systemic side effects of topical corticosteroids and, in general require shorter courses and less potent agents that adults.

 

Care should be taken when using Clobetasol Propionate to ensure the amount applied is the minimum that provides therapeutic benefit.

 

Application in the 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.

 

Application in Renal/Hepatic Impairment

In the 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.

 

Section 4.3 Contraindications

 

The contraindication for ‘Use in acne rosacea’ as been removed:

 

Section 4.4 Special Warnings and Special Precautions for Use

 

The following section has been updated with additional information:

Clobetasol should be used with caution in patients with a history of local hypersensitivity to corticosteroids or to any of the excipients in the preparation. Local hypersensitivity reactions (see Adverse Reactions) 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 Adverse Reactions). The risk with topical corticosteroids is reduced but potentially still exists.

 

Risk Factors for increased systemic effects are:

·         Potency and formulation of topical steroid

·         Duration of exposure

·         Application to a large surface area

·         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 such as the face

·         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.

 

Chronic leg ulcers

Topical corticosteroids are sometimes used to treat the dermatitis around chronic leg ulcers. However, this use may be associated with a higher occurrence of local hypersensitivity reactions and an increased risk of local infection.

 

Patients should be advised to avoid:

·         Smoking whilst applying to the scalp

·         Fire, flame and heat including use of hair dryer after application

 

Section 4.8 Undesirable Effects

 

The additional side effects include Opportunistic infection, telangiectasias, skin wrinkling and skin dryness.

The layout of this section has been updated:

Current section

Present approved section

 

 

Immune system disorders

Very rare:        Hypersensitivity

 

Local hypersensitivity reactions such as erythema, rash, pruritus, urticaria, local skin burning and allergic contact dermatitis may occur at the site of application and may resemble symptoms of the condition under treatment.

If signs of hypersensitivity appear, application should be stopped immediately.

 

Endocrine disorders

Very rare:        Features of Hypercortisolism

 

As with other topical corticosteroids prolonged use of large amounts or treatment of extensive areas can result in sufficient systemic absorption to produce the features of hypercortisolism.  This effect is more likely to occur in infants and children, and if occlusive dressings are used.  In infants, the napkin may act as an occlusive dressing. 

 

Provided the weekly dosage is less than 50 grams in adults, any suppression of HPA axis is likely to be transient with a rapid return to normal values once the short course of steroid therapy has ceased.

 

Vascular disorders

Uncommon:    Dilatation of the superficial blood vessels

 

Prolonged and intensive treatment with highly-active corticosteroid preparations may cause dilatation of the superficial blood vessels particularly when occlusive dressings are used, or where skin folds are involved.

 

Skin and subcutaneous tissue disorders

Uncommon:    Local atrophy, striae

 

Very rare:        Thinning, pigmentation changes, hypertrichosis, exacerbation of underlying symptoms, pustular psoriasis.

 

Prolonged and intensive treatment with highly-active corticosteroid preparations may cause atrophic changes such as striae, (see also Vascular Disorder MedDRA System Organ Class subheading), particularly when occlusive dressings are used, or where skin folds are involved.

 

In very rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked the pustular form of the disease.

 

Infections and Infestations

 

Very rare:       Opportunistic infection

 

Immune System Disorders

 

Very rare        Local Hypersensitivity

 

 

 

 

 

 

 

 

 

 

Endocrine Disorders

 

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

 

*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

 

 

Updated on 13 September 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to dosage and administration

Updated on 23 July 2012

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 18 October 2011

Reasons for updating

  • Change of manufacturer

Updated on 24 August 2009

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



1.       NAME OF THE MEDICINAL PRODUCT

 

Dermovate Scalp Application 0.05% w/w Cutaneous Solution

 

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Clobetasol propionate BP 0.05%w/w.

 

For  a full list of excipients, see section 6.1

 

 

6.       PHARMACEUTICAL PARTICULARS

 

6.1     List of Excipients

 

Carbomer 980NF

Isopropyl Alcohol

Sodium Hydroxide ( for pH adjustment only)

Purified Water

6.5     Nature and Contents of Container

 

HDPE, squeeze bottle with an elongated nozzle containing a colourless, clear to slightly hazy, slightly viscous liquid.

 

Pack size: 100ml

 

Not All pack sizes may be marketed.

 

 

Updated on 26 June 2009

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



(New text highlighted in red)

 

 

1.         NAME OF THE MEDICINAL PRODUCT

 

Dermovate Scalp Application 0.05% w/w Cutaneous Solution

 

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Clobetasol propionate BP 0.05%w/w.

 

Updated on 17 June 2009

Reasons for updating

  • Change of trade or active ingredient name

Updated on 30 October 2008

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Addition of " February  2006"

Updated on 20 February 2006

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 25 January 2006

Reasons for updating

  • Improved electronic presentation

Updated on 26 August 2005

Reasons for updating

  • Change to side-effects

Updated on 10 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 03 July 2003

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 19 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)