Dovobet Ointment

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/08/18

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 4/3/2019

Click on this link to Download PDF directly

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
1 - 0 of 40 items.Total: Infinity pages

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 Month Year.

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 3 March 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 March 2016 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 27 January 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 27 January 2016 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • 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 6.1 the number 11 is removed from polyoxypropylene stearyl ether in line with an updated monograph
- The date of revision is updated
- Minor formatting corrections
- Correction of spelling error in 4.8

Updated on 25 January 2016 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 6 August 2015 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

- The rare side effect "pustular psoriasis" has been added to Section 4.8.  

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.

Skin exfoliation is a new common side effect.  Rash and Skin burning are moved from common to uncommon.  New uncommon side effects: Skin infection, skin atrophy, purpura or ecchymosis.  New rare side effects:     furuncle, hypersensitivity, hypercalcaemia, skin striae, photosensitivity reaction, acne, dry skin, 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 12 November 2013 SmPC

Reasons for updating

  • 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 statement regarding reporting of suspected adverse reactions has been added.
- In section 6.1 polyoxypropylene-15 stearyl ether has been renamed to polyoxypropylene-11 stearyl ether
- The date of revision has been updated

Updated on 7 November 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to further information section
  • Addition of information on reporting a side effect.

Updated on 5 July 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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

- In section 2 (qualitative and quantitative composition), butylhydroxytoluene has been added as an excipient with know effect
- In section 4.2 (posology and method of administration) information regarding adolescents has been added
- In section 4.8 (undesirable effects) information regarding adolescents has been added
- In section 5.1 (pharmacodynamic properties) information regarding adolescents has been added
- In section 10 the date of revision has been updated

Updated on 4 September 2012 PIL

Reasons for updating

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

Updated on 27 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 7 Marketing Authorisation Holder has been updated to reflect a change in the name of the manufacturer from LEO Pharmaceutical products to LEO Pharma A/S.

Updated on 29 December 2011 PIL

Reasons for updating

  • Change to date of revision

Updated on 29 November 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

The date of last renewal has been updated to reflect the approval of the renewal.
The date of revision of the text has been updated as a result.

Updated on 28 October 2011 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to date of revision
  • Change to warnings or special precautions for use

Updated on 30 September 2011 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Section 4.4 Special warnings and precautions for use

In this section, the following wording has been added:

'Dovobet® ointment contains butylhydroxytoluene (E321). This may cause local skin reactions (e.g. Contact dermatitis), or irritation to the eyes and mucous membranes.'

Section 6.1 List of Excipients

Butylhydroxytoluene (E321) is now listed as an excipient.

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 25 March 2011 PIL

Reasons for updating

  • Change to date of revision

Updated on 18 February 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • 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 2 Qualitative and Quantiative Composition
Editorial change: 'One gram of ointment contains' has been added before the quantiative composition

Editorial change: The previous SmPC stated 'For excipients, see section 6.1', the new SmPC states 'For a full list of excipients, see section 6.1'

Section 4 Clinical Particulars

4.1 Therapeutic particulars
The word 'in adults' has been added to the sentence 'Topical treatment of stable plaque psoriasis amenable to topical therapy in adults'.

The word 'in adults' has been added to the sentence 'Topical treatment of stable plaque psoriasis amenable to topical therapy in adults'.

4.2 Posology and method of administration

There has been an editorial change regarding repeated treatment with the product;

There has been an editorial change regarding repeated treatment with the product;

The wording is changing from "After this period, repeated treatment with Dovobet can be initiated under medical supervision" to "If it is necessary to continue or restart treatment after 4 weeks, treatment should be continued after medical review and under regular medical supervision".

The wording has changed from:

'The maximum daily dose should not exceed 15 g, the maximum weekly dose should not exceed 100 g, and the treated area should not be more than 30% of the body surface'

to:

'When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g. The body surface area treated with calcipotriol containing medicinal products should not exceed 30%.'

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.

 

Paediatric population

 

 

 

 

The safety and efficacy of Dovobet gel in children below 18 years have not been established. No data are available.

Method of administration

 

 

 

 

Dovobet ointment should be applied to the affected area. In order to achieve optimal effect, it is not recommended to take a shower or bath immediately after application of

Dovobet ointment.

4.3 Contraindications

The word 'known' has been removed from the sentence 'Known hypersensitivity to the active substances or to any of the excipients.'

'Guttate psoriasis' is no longer listed as a contraindicated condition, the new wording is as follows:

'Dovobet ointment is contraindicated in erythrodermic, exfoliative and pustular psoriasis'.

The following contraindication has been removed:

'Dovobet is contraindicated in patients with severe renal insufficiency or sever hepatic disorders.'

4.4 Special warning and precautions for use

The following wording has been removed:

'The patient must be instructed in correct use of the product to avoid application and accidental transfer to the scalp, face, mouth and eyes. Hands must be washed after each application.'

Under the subheading of 'Effects on endocrine system', 'adverse effects' are now known as 'adverse reactions'.

The reference to avoiding application under occlusive dressings due to increased absorption has been removed.

The following sentence regarding sensitive skin areas has been removed:

'These areas (i.e. Skin of the face and genitals) should only be treated with weaker corticosteroids'

A reference to the maximum weekly dose of 100g has been removed, and has been replaced with a reference to the maximum daily dose of 15 g.

The following wording is being removed: 'There is no experience with concurrent use of other anti-psoriatic products administered locally or systemically or with phototherapy', and has been replaced with:

'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 anti-psoriatic medicinal products administered systemically or with phototherapy.'

The following wording has been removed:

'There may be a risk of rebound when discontinuing a long term treatment with corticosteroids.'

Section 4.5 Interaction with other medicinal products and other forms of interaction

'None known' has been replaced with 'No interaction studies have been performed.'

The heading 'Lactation' has been replaced with 'Breastfeeding'.

The following text 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 classification frequencies have changed, they are now as follows:

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

Very rare <1/10,000

Not known (cannot be estimated from the available data)

The following undesirable effect has been added:

General disorders and administration site conditions

Not known: Rebound effect - included in section 4.4

Under the heading of 'Calcipotriol', 'undesirable effects' are now described as 'Adverse reactions'.

Under the heading of 'Bethamethasone (as diproprionate)', 'systemic effects' are now listed as 'systemic reactions'

The following sentence has been removed: 'This product contains a potent corticosteroid.'

The following wording has been removed:

'The undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported'

and has been replaced with

'The adverse reactions are listed by MedDRA System Organ Class and the individual adverse reactions are listed starting with the most frequently reported. Within each frequency grouping, the adverse reactions are listed in order of decreasing seriousness.'

4.9 Overdose

In this section which describes a case of misuse, the quantities which were used by this patient are now listed as a corresponding daily dose used and this is contrasted with the maximum daily dose.

Section 5 Pharmacological Properties

5.1 Pharmacodynamic properties

The following wording has been added: 'Pharmacotherapeutic group: Antipsoriatics. Other antipsoriatics for topical use, Calcipotriol combinations'

The ATC Code has been added: 'ATC Code: D05 AX52'.

A reference has been removed 'by a factor of 10', referencing penetrating through the stratum corneum from the following sentence:

'Through occlusion, the effect can be enhanced due to increased penetration of the stratum corneum'.

The following wording has been added:

'Adrenal response to ACTH was determined by measuring serum cortisol levels in patients with both extensive scalp and body psoriasis, using up to 106 g per week combined Dovobet gel and Dovobet ointment. A borderline decrease in cortisol response at 30 minutes post ACTH challenge was seen in 5 of 32 patients (15.6%) after 4 weeks of treatment and 2 of 11 patients (18.2%) who continued treatment until 8 weeks. In all cases, serum cortisol levels were normal at 60 minutes post ACTH challenge.

There was no evidence of change of calcium metabolism observed in these patients. With regard to HPA suppression, therefore, this study shows some evidence tht very high doses of Dovobet gel and ointment may have a weak effect on the HPA axis'.

5.2 Pharmacokinetic properties

The following sentence has been added:

'Following systemic exposure, both active ingredients - calcipotriol and bethamethasone diproprionate are rapidly and extensively metabolised.'

The following sentence with regard to excretion has been removed:

'Excretion takes palce by urine and faeces'

and has been replaced with:

'The main route of excretion of calcipotriol is via faeces (rats and minipigs) and for bethamethasone diproprionate it is via urine (rats and mice). In rats, tisue distribution studies with radiolabelled calcipotriol and bethamethasone diproprionate, respectively, showed that kidney and liver had the highest levels of radioactivity.'

 

The following sentence has been added:

'Calcipotriol and bethamethasone diproprionate were below the lower limit of quantification in all blood samples of 34 patients treated, for 4 or 8 weeks with both Dovobet gel and Dovobet ointment, for extensive posriasis invloving the body and scalp. One metabolite of calcipotriol and one metabolite of bethamethasone diproprionate were quantifiable in some of the patients.'

5.3 Preclinical safety data

The wording regarding the study carried out on the UV exposure of albino hairless mice has been removed.

The following wording has been added:

'Photo(co)carcinogenicity studies in mice suggest that calcipotriol may enhnace the effect of UVR to induce skin tumours.

6.1 List of Excipients

á-tocopherol is now listed as all-rac-á-tocopherol

6.2 Incompatabilities

The following sentence has been removed:

'Not to be mixed with other medicinal products.'

and has been replaced with:

'In the absence of compatability studies, this medicinal product must not be mixed with other medicinal products.'

10. Date of Revision of Text

The date has been update to February 2011.

Updated on 27 August 2007 PIL

Reasons for updating

  • Change to improve clarity and readability
  • Change due to user-testing of patient information

Updated on 23 January 2007 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 22 January 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 11 January 2007 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Updates to Section 4.4 and 5.3 have been made in relation to clinical data on carcinogenicity and photocarcinogenicity  

Updated on 16 June 2006 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 16 May 2006 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 7 - Marketing authorisation holder
  • 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)

Updated on 16 August 2005 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Updated on 16 June 2005 SmPC

Reasons for updating

  • Change to section 4.9 - Overdose

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

Updated on 8 March 2005 PIL

Reasons for updating

  • Change to storage instructions

Updated on 7 March 2005 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Updated on 29 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 9 August 2004 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 14 November 2003 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 26 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 26 June 2003 SmPC

Reasons for updating

  • Addition of legal category

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