Dovobet Gel

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Summary of Product Characteristics last updated on medicines.ie: 4/3/2019

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LEO Pharma

LEO Pharma

Company Products

Medicine NameActive Ingredients
Medicine Name Dovobet Gel Active Ingredients Betamethasone dipropionate, Calcipotriol monohydrate
Medicine Name Dovobet Ointment Active Ingredients Betamethasone dipropionate, Calcipotriol monohydrate
Medicine Name Dovonex Cream Active Ingredients Calcipotriol hydrate
Medicine Name Dovonex Ointment Active Ingredients Calcipotriol
Medicine Name Dovonex Psoriasis 50 microgram/g ointment Active Ingredients Calcipotriol
Medicine Name Enstilar Cutaneous Foam Active Ingredients Betamethasone dipropionate, Calcipotriol monohydrate
Medicine Name Fucibet Cream Active Ingredients Betamethasone Valerate, Fusidic Acid
Medicine Name Fucibet Lipid Cream Active Ingredients Betamethasone Valerate, Fusidic Acid
Medicine Name Fucidin Cream Active Ingredients Fusidic Acid
Medicine Name Fucidin H Cream Active Ingredients Fusidic Acid Hemihydrate, Hydrocortisone Acetate
Medicine Name Fucidin Ointment Active Ingredients Sodium Fusidate
Medicine Name Fucidin Suspension Active Ingredients Fusidic Acid Hemihydrate
Medicine Name Fucidin Tablets Active Ingredients Sodium Fusidate
Medicine Name innohep 10,000 IU in 0.5 ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 10,000 IU/ml Solution for Injection (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name innohep 12,000 IU in 0.6ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 14,000 IU in 0.7 ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 16,000 IU in 0.8ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 18,000 IU in 0.9ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 2,500 IU syringe (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name Innohep 20,000 IU/ml Solution for Injection (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 3,500 IU syringe (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name innohep 4,500 IU syringe (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name innohep 8,000 IU in 0.4ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name Kyntheum 210 mg Solution for Injection Active Ingredients Brodalumab
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 4 March 2019 SmPC

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 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 21 August 2018 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 21 August 2018 SmPC

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 PIL

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 PIL

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 SmPC

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 SmPC

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 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 11 May 2018 PIL

Reasons for updating

  • Addition of joint PIL covering all presentations

Updated on 15 February 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 February 2017 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 6 January 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 6 January 2017 SmPC

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

In Section 4.8 a missing asterisk has been added to the tabulation

Updated on 22 December 2016 SmPC

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 4.8 (undesirable effects), hair colour changes added with frequency 'not known'
- In Section 2, minor typographical error corrected
- In Section 10, date of revision updated

Updated on 20 December 2016 PIL

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 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration
  • Introduction of new pack/pack size

Updated on 21 December 2015 SmPC

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 6.1 (list of excipients) the number "11" has been removed from the excipient polyoxypropylene stearyl ether
- 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 3 September 2015 SmPC

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

- In Sections 4.2, 6.3, 6.4 and 6.5 information on the Dovobet Gel Applicator is added.
- The date of revision is updated

Updated on 12 November 2014 SmPC

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 PIL

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 SmPC

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 4.2, 4.8 and 5.1 information regarding studies in adolescents is added
- 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 SmPC

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 2 and 4.4 butylated hydroxytoluene is renamed to butylhydroxytoluene
- 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 2 December 2013 PIL

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 3 July 2013 PIL

Reasons for updating

  • Change to date of revision
  • Introduction of new pack/pack size

Updated on 2 July 2013 SmPC

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

A pack size of 3 x 60 g has been registered.

Updated on 28 August 2012 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to name of manufacturer

Updated on 24 August 2012 SmPC

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

Section & Marketing Authorisation Holder:
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 PIL

Reasons for updating

  • Change to date of revision

Updated on 2 August 2011 SmPC

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

Section 9 - Inserted
Date of last renewal 7th January 2011
Section 10 - Text amened to read
Date of revision of the text July 2011

Updated on 5 July 2011 SmPC

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

Correction of spelling errors.

Updated on 11 February 2011 SmPC

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%.

     

     

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'.

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.

The date of revision of the text has changed from July 2009 to January 2011.

 

 

Updated on 11 February 2011 PIL

Reasons for updating

  • Change of contraindications
  • Change to side-effects

Updated on 22 September 2010 PIL

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 26 March 2010 PIL

Reasons for updating

  • New PIL for new product

Updated on 26 March 2010 SmPC

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

None provided