Dovobet Gel
*Company:
LEO PharmaStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 30 January 2023
File name
ie-spc-dovobet gel-069-201911.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Document format updated - pdf to html
Updated on 07 July 2020
File name
ie-mockup-pl-dovobet gel paraffin.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 18 November 2019
File name
ukie-mockup-pl-dovobet gel.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 18 November 2019
File name
ie-spc-dovobet gel.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 Undesirable Effects
- New statement:
“No clinically relevant differences between the safety profiles in adult and adolescent populations have been observed. A total of 216 adolescent subjects were treated in three open label clinical trials. See section 5.1 for further details regarding the trials.”
(This replaces the previous statement referring to 109 adolescents)
- Administrative corrections to the tabulation and footnotes
Section 5.1 Pharmacodynamic Properties
Paediatric population sub-section
- Subtitle ‘Scalp’ added above statement relating to 109 adolescents
- New section ‘Scalp and body’ with results of new adolescent trials
Updated on 04 March 2019
File name
spc-IE-dovobet gel-084-20180817-PRAC.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to date format to state as Month Year.
Updated on 25 October 2018
File name
Pil-UKIE-dovobet gel-084+066-prac+shelf life tr.pdf
Reasons for updating
- Change to other sources of information section
Updated on 21 August 2018
File name
ins-UKIE-Dovobet Gel bottle -084-PRAC.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
Updated on 21 August 2018
File name
Dovobet gel spc-ie-gel-084-20180810-PRAC update cl.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 6.3 the shelf life extension as previously approved in June 2018 was inadvertently omitted from this new version of the SmPC. This has been corrected.
Updated on 20 August 2018
File name
Package leaflet-UK IE-CLEAN-Dovobet Gel -PRAC update.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 17 August 2018
File name
Package leaflet-UK IE-CLEAN-Dovobet Gel -PRAC update.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 17 August 2018
File name
spc-dovobet-gel-2205109-WS084-prac-cl.pdf
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 not be renewed (A)
Updated on 15 June 2018
File name
Dovobet gel-2205926-20180613-shelf life extn cl.docx
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- In Section 6.3 the shelf life has been changed from 2 to 3 years. The in-use shelf life of the bottle has been changed from 3 to 6 months.
- In Section 10 the date of revision has been updated.
Updated on 15 June 2018
File name
pil-gel-066-20180613-shelf life extn.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 11 May 2018
File name
Dovobet gel ins 054747 054758 - joint ukie pack.pdf
Reasons for updating
- Addition of joint PIL covering all presentations
Updated on 15 February 2017
File name
PIL_14617_266.pdf
Reasons for updating
- New PIL for new product
Updated on 15 February 2017
Reasons for updating
- Improved presentation of PIL
Updated on 06 January 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 January 2017
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 22 December 2016
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- In Section 2, minor typographical error corrected
- In Section 10, date of revision updated
Updated on 20 December 2016
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to other sources of information section
- Correction of spelling/typing errors
Updated on 21 December 2015
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- In Section 6.5 (nature and contents of container), new pack sizes 80 g and 2 x 80 g have been added
- The date of revision has been updated
Updated on 21 December 2015
Reasons for updating
- Change to date of revision
- Change to dosage and administration
- Introduction of new pack/pack size
Updated on 03 September 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- The date of revision is updated
Updated on 12 November 2014
Reasons for updating
- 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 4.9 - Overdose
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.3 - contraindications in syphilis, perianal and genital pruritus are removed (but warning about use on genitals remains)
Section 4.4 - local adverse reactions in relation to accidental administration to the eye have been removed (they are included in section 4.8). No experience of concurrent use with other antipsoriatic drugs amended to "limited experience". No experience of use of ointment on the scalp amended to "limited experience"
Section 4.6 - new statement that "less than 300 pregnancy outcomes" have been studied
Section 4.8 - section fully revised in line with study/post marketing data and new table of adverse events included. Number of patients treated and % experiencing an AE is no longer included (not required in SmPC guideline). Adverse event are grouped under new subheadings in the tables.
New uncommon side effect: Skin infection. New rare side effects: hypersensitivity, skin striae, skin exfoliation, rebound effect.
Section 4.9 - symptoms of hypercalcaemia revised
Section 5.3 - statements regarding new non-clinical carcinogenicity studies (showing no special risk to humans) added
Updated on 10 November 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to date of revision
Updated on 22 August 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- In Section 4.8 the new HPRA contact details are added to the Reporting of Suspected Adverse Reactions statement
- In Section 10 the date of revision is updated
Updated on 10 December 2013
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 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- In section 4.8 a reporting of suspected adverse reactions statement is added
- In section 6.1 polyoxypropylene-15 is renamed to polyoxypropylene-11
- In section 10 the date of revision is updated
Updated on 02 December 2013
Reasons for updating
- Change to further information section
- Change to date of revision
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
Updated on 03 July 2013
Reasons for updating
- Change to date of revision
- Introduction of new pack/pack size
Updated on 02 July 2013
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 28 August 2012
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
- Change to name of manufacturer
Updated on 24 August 2012
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
The name of the MAH has changed from LEO Pharmaceutical Products (LEO Pharma A/S) to LEO Pharma A/S
Updated on 15 September 2011
Reasons for updating
- Change to date of revision
Updated on 02 August 2011
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Date of last renewal 7th January 2011
Section 10 - Text amened to read
Date of revision of the text July 2011
Updated on 05 July 2011
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 11 February 2011
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- 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 4.8 - 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 1 Name of the Medicinal Product:
Editorial change only, 'micrograms' instead of 'microgram'
Section 2 Qualitative and Quantitative Composition: Editorial change only, 'micrograms' instead of 'microgram'
Editorial change only, 'micrograms' instead of 'microgram'
Section 4.2 Posology and method of administration:
- A heading called 'Posology', positioned over the relevant text has been added.
- There has been an editorial change regarding repeated treatment with the product: "After this period, repeated treatment with Dovobet gel can be initiated under medical supervision" to "If it is necessary to continue or restart after this period, treatment should be continued after medical review and under regular medical supervision".
- The following statement has been removed 'The maximum weekly dose should not exceed 100 g'
- The following wording has been added:
Special Populations
Renal and Hepatic Impairment
The safety and efficacy of Dovobet gel in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated
- There has been an editorial change for wording on paediatric populations.
- A heading of 'Method of Administration' has been positioned over the relevant text.
- The following sentence has been added under the heading of 'Method of Administration'; 'The bottle should be shaken before use and Dovobet gel applied to the affected area'. This wording represents an editorial change with the exception of 'Dovobet gel applied to the affected area'.
Section 4.3 Contraindications
Guttate psoriasis has been removed as a contraindication
Section 4.4 Special warnings and Precautions for Use
- A reference to the maximum weekly dose of 100g has been removed, and has been replaced with a reference to the maximum daily dose
-
The following sentence regarding sensitive skin areas has been removed: 'These areas should only be treated with weaker corticosteroids'.
- The headings of 'Effects on calcium metabolism', 'Local Adverse reactions', 'Concomitant skin infections', 'Discontinuation of treatment', 'Long term use' has been added to the appropriate sections of the text.
- The following wording has been added:
Unevaluated uses
There is no experience for the use of Dovobet gel in guttate psoriasis
- The following wording has been removed:
'There is no experience with concurrent use of other anti-psoriatics products administered systemically or with phototherapy'
and has been replaced with:
Concurrent treatment and UV exposure
Dovobet ointment for body psoriasis lesions has been used in combination with Dovobet gel for scalp psoriasis lesions, but there is no experience of combination of Dovobet with other topical anti-psoriatic products at the same treatment area, other ant-psoriatic medicinal products administered systemcially or with phototherapy'.
Section 4.6 Fertility, pregnancy and lactation
- The following has been added:
Fertility
Studies in rats with oral doses of calcipotriol or bethamethasone diproprionate demonstrated no impairment of male and female fertility.
Section 4.8 Undesirable effects
- The following sentence, which refers to undesirable effects has been added:
'These reactions are usually mild and cover mainly various skin reactions with pruritus being the most common'.
- A reference has been added to include postmarket use in the following sentence 'Based on data from clinical trials and postmarket use the following adverse reactions are listed for Dovobet gel'.
- 'Impact on the metabolic control of diabetes mellitus' has been added as an effect of long term use of bethamethasone (as diproprionate).
Section 4.9 Overdose
- A reference to the maximum weekly dose of 100g has been removed, and has been replaced with a reference to the maximum daily dose
Section 5.1 Pharmacological properties
- The following sentence has been added to the section: 'With regard to HPA suppression, therefore, this study shows some evidence that very high doses of Dovobet® gel and ointment may have a weak effect on the HPA axis'.
The percentage of patients with controlled disease at week 8, using the gel vehicle (n = 35) has changed from 2.9% to 0%.
Section 5.2 Pharmacokinetic properties
- The following statement has been added 'Absorption through damaged skin is approximately 24%.'
- The following text has been added:
'Protein binding is approximately 64%. Plasma elimination half life after intravenous application is 5-6 hours. Due to formation of a depot in the skin, elimination after dermal application is in the order of days. Bethamethasone is metabolised especially in the liver, but also in the kidneys to glucuronide and sulphate esters.'
Section 10 Date of Revision of the Text:
The date of revision of the text has changed from July 2009 to January 2011.
Updated on 11 February 2011
Reasons for updating
- Change of contraindications
- Change to side-effects
Updated on 22 September 2010
Reasons for updating
- Change to date of revision
- Addition of manufacturer
Updated on 26 March 2010
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 26 March 2010
Reasons for updating
- New PIL for new product