Dermovate Ointment 0.05%
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 22 September 2023
File name
ie-pl-dermovate-oint-issue15draft1-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 07 July 2022
File name
uk-pl-dermovate-ointment-issue12draft1-clean eMC.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 01 September 2021
File name
ie-pl-dermovate-oint-issue13draft1_clean-meds.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 30 July 2021
File name
ie-spc-dermovate-ointment-issue9draft1-master-meds.ie.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
- 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-oint-issue12draft1_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 6 - manufacturer
- Change to section 6 - date of revision
Updated on 28 April 2021
File name
ie-spc-dermovate-ointment-issue8draft1_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 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 February 2021
File name
ie-pl-dermovate-oint-issue10draft1-clean-medie.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 04 February 2021
File name
ie-pl-dermovate-oint-issue9draft2-formedicines.ie.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 04 February 2021
File name
ie-spc-dermovate-ointment-issue6draft2-formedicines.ie.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 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 excipient wording for propylene glycol
Section 4.4 - update to excipient warning for propylene glycol and addition of paraffin flammability warning
Section 4.8 - update to HPRA reporting details
Section 10 - update to last revised date
Updated on 31 October 2019
File name
ie-pl-dermovate-oint-issue8draft1-clean-medicines.ie.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 19 March 2019
File name
ie-pl-dermovate-oint-issue7draft1 for meds.ie.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 25 October 2017
File name
PIL_9186_457.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 4.2 - 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 4.8 - 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
• Update information in line with the GDS and the other presentations of Dermovate.
Section 4.3 – Contraindications:
• Update information in line with the GDS and the other presentations of Dermovate.
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.
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 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 3 - use in children/adolescents
- 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
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 28 September 2015
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
- Change to improve clarity and readability
- Improved electronic presentation
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
Updated on 16 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 4.3 - 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 5.1 - Pharmacodynamic properties
- 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 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 5.1 - To add ATC code
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 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 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 and method of administration:
The following statement:
Therapy should be discontinued when control is achieved.
Was updated to add that it should be gradually discontinued:
Therapy with Clobetasol should be gradually discontinued once control is achieved and an emollient continued as maintenance therapy.
The following paragraphs were added:
Administration 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.
Administration 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.
Administration 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 ‘Primary cutaneous viral infections’ was updated to state ‘Unresloved cutaneous viral, bacterial or fungal infections
Section 4.4 Special warnings and precautions for use
This section was updated with subheadings and the following additional information was added:
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
Children
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. If clobetasol propionate is required for use in children, it is recommended that the treatment should be limited to only a few days and reviewed weekly.
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.
Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction
The interaction with Ritonavir and Itraconazole has been added.
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:
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Current section |
Present approved section |
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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.
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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
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Updated on 13 September 2012
Reasons for updating
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to dosage and administration
- Change to warnings or special precautions for use
Updated on 23 July 2012
Reasons for updating
- Change due to harmonisation of PIL
Updated on 20 August 2009
Reasons for updating
- 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
Dermovate 0.05% w/w Ointment
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Clobetasol propionate 0.05%w/w.
Excipients: Also contains Propylene Glycol
For a full list of excipients, see section 6.1
6.5 Nature and Contents of Container
Dermovate Ointment is supplied in 30g and 100g collapsible aluminium tubes.
Not All pack sizes may be marketed.
Updated on 26 June 2009
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
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)
Dermovate 0.05% w/w Ointment
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Clobetasol propionate 0.05%w/w.
Excipients: Also contains Propylene Glycol
For a full list of excipients, see section 6.1
6.5 Nature and Contents of Container
Dermovate Ointment is supplied in 30g and 100g collapsible aluminium tubes.
Not All pack sizes may be marketed.
Updated on 17 June 2009
Reasons for updating
- Change of trade or active ingredient name
Updated on 29 October 2008
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 September 2008
Reasons for updating
- 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
Updated on 21 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 11 August 2005
Reasons for updating
- Improved electronic presentation
Updated on 28 October 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 09 August 2004
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 3 - Pharmaceutical form
- Change to section 6.2 - Incompatibilities
- 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 27 June 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)