Last Updated on eMC 20-10-2015 View medicine  | Leo Laboratories Limited Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:30-09-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 2, Qualitative and Quantitative Composition:  Update in line with QRD template.

Section 3, Pharmaceutical Form:  Update in line with QRD template.

Section 4.2, Posology:  Update in line with QRD template.

Section4.3, Contraindications:  Update of wording, and rewording of existing text, in line with current CCSI:

Systemic fungal infections.

Primary skin infections caused by fungi, virus or bacteria, either untreated or uncontrolled by appropriate treatment.

Skin manifestations in relation to tuberculosis or syphilis, either untreated or uncontrolled by appropriate therapy.

Perioral dermatitis and rosacea.

Section 4.4, Special Warnings and Precautions for Use:  Update of wording, and rewording of existing text, in line with CCSI, plus update in line with QRD template:

Depending on the application site, possible systemic absorption of betamethasone valerate should always be considered during treatment with Fucibet.

Due to the content of corticosteroid, Fucibet should be used with care near the eyes.

Reversible HPA axis suppression may occur following systemic absorption of topical corticosteroids.

Use with care in children as paediatric patients may demonstrate greater susceptibility to topical corticosteroids-induced HPA axis suppression and Cushing’s syndrome than adult patients.  Avoid large amounts, occlusion and prolonged treatment.

Prolonged topical use of Fucibet may cause skin atrophy.

Limiting therapy with topical fusidic acid and betamethasone valerate to no more than 14 days at a time will minimise the risk of developing resistance. This also prevents the risk that the immunosuppressive action of corticosteroid might mask any potential symptoms of infections due to antibiotic-resistant bacteria.

Fucibet may be associated with increased susceptibility to infection, aggravation of existing infection, and activation of latent infection. It is advised to switch to systemic treatment if infection cannot be controlled with topical treatment.

Section 4.5, Interaction with other medicinal products and other forms of interaction:  Update in line with QRD template.

Section 4.6, Fertility, Pregnancy and Lactation:  Updated in line with current CCSI and QRD template.

Section 4.8, Undesirable effects:  Updated in line with the current CCSI; addition of frequency table.

Section 4.9, Overdose:  Updated in line with the current CCSI, ‘For topically applied fusidic acid, no information concerning potential symptoms and signs due to overdose administration is available. Cushing's syndrome and adrenocortical insufficiency may develop following topical application of corticosteroids in large amounts and for more than 3 weeks.

Systemic consequences of an overdose of the active substances after accidental oral intake are unlikely to occur.  The amount of fusidic acid in one tube of Fucibet does not exceed the oral daily dose of systemic treatment.  A single oral overdose of corticosteroids is rarely a clinical problem.’

Section 5.1, Pharmacodynamic properties:  Addition of ATC code and pharmacotherapeutic group.

Section 5.3, Pharmacokinetic properties:  Additional of wording in line with the CCSI, ‘Studies of corticosteroids in animals have shown reproductive toxicity (e.g. cleft palate, skeletal malformations, low birth weight).’

Section 6.4, Special precautions for storage: Updated in line with QRD template.

Section 6.5, Nature and contents of container:  Updated in line with QRD template.

Section 6.6, Special precautions for disposal:  Updated in line with QRD template.

Section 9, Date of Authorisation/Renewal of Authorisation:  Both dates added.

Section 10, Date of Revision of the Text:  Updated to September 2015.

Reasons for adding or updating:

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

Date of revision of text on the SPC:01-10-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 7 Marketing Authorisation Holder

LEO Laboratories Limited

Princes Risborough

Bucks

HP27 9RR

Horizon

Honey Lane

Hurley

Maidenhead

Berkshire

SL6 6RJ

UK

Reasons for adding or updating:

  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:29-03-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



6.1       List of excipients

Steareth-21

Cetostearyl alcohol

White soft paraffin

Liquid paraffin

Hypromellose

Citric acid monohydrate

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Potassium sorbate

All-rac-α-tocopherol

Purified water


10      DATE OF REVISION OF THE TEXT

4 May 2010

29 March 2012

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC:04-05-2010

Legal Category:POM

Black Triangle (CHM): NO

Reasons for adding or updating:

  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:28-04-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



6.1       List of excipients

 

Steareth-21

Cetostearyl alcohol

White soft paraffin

Liquid paraffin

Hypromellose

Citric acid monohydrate

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Potassium sorbate

All-rac-α-tocopherol

Purified water

 

10.       DATE OF REVISION OF THE TEXT

 

            4 May 2010

 

            28 April 2011

 

Reasons for adding or 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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:04-05-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.3                 Contraindications

Known hypersensitivity to fusidic acid/sodium fusidate, betamethasone valerate the drug substances or to any of the excipients ingredients.

          Acne rosacea and perioral dermatitis. Skin lesions of viral, fungal or bacterial origin.  

As with other topical corticosteroid preparations, Fucibet® Lipid Cream is contraindicated in the following conditions: Skin lesions of viral, fungal or bacterial origin (such as herpes or varicella), skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis and rosacea.



4.4                 Special warnings and precautions for use

            Long-term continuous topical therapy should be avoided, particularly in children. Adrenal suppression can occur even without occlusion. Atrophic changes may occur on the face and to a lesser degree in other parts of the body, after prolonged treatment with potent topical steroids. Caution should be exercised if Fucibet® Lipid cream is used near the eye.  Glaucoma might result if the preparation enters the eye. Systemic chemotherapy is required if bacterial infection persists.

 

            Bacterial resistance has been reported to occur with the use of fusidic acid applied topically. As with all topical antibiotics, extended or recurrent application may increase the risk of developing contact sensitisation and the development of antibiotic resistance.

            Steroid-antibiotic combinations should not be continued for more than 7 days in the absence of any clinical improvement since in this situation occult extension of the infection may occur due to the masking of the steroid. Similarly, steroids may also mask hypersensitivity reactions.

            Fucibet® Lipid Cream contains methyl and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). It also contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).


4.6                 Pregnancy and lactation

            Topical administration of any corticosteroid to pregnant animals can cause abnormalities of foetal development.  The relevance of this finding to human beings has not been established; however, topical steroids should not be used extensively in pregnancy, i.e. in large amounts or for prolonged periods.

            Pregnancy

            Safety for use of Fucibet® Lipid Cream during pregnancy has not been established. Studies in animals have not shown teratogenic effects with fusidic acid but studies with corticosteroids have shown teratogenic effects. The potential risk for humans is unknown. Fucibet® Lipid Cream should not be used during pregnancy unless clearly necessary.

            Lactation

            No effects on the infant are anticipated since the systemic exposure of the breast-feeding woman to fusidic acid and betamethasone valerate is negligible. Fucibet® Lipid Cream can be used when breast-feeding but should not be used on the breast.



4.7                 Effects on ability to drive and use machines

Not applicable

Fucibet® Lipid Cream has no or negligible influence on the ability to drive or to use machines.



4.9                 Overdose

Not applicable

Excessive prolonged use of topical corticosteroids may suppress the pituitary-adrenal functions resulting in secondary adrenal insufficiency which is usually reversible. In such cases symptomatic treatment is indicated.



10             DATE OF REVISION OF THE TEXT

06/02/2007 4 May 2010

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:26-02-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.8                 Undesirable effects

            Prolonged and intensive treatment with potent corticosteroids may cause local atrophic changes in the skin, including striae, thinning and dilation of superficial blood vessels, particularly when applied to the flexures or when occlusion is employed.  As with other topical corticosteroids sufficient systemic absorption to produce hypercorticism can occur with prolonged or extensive use.  Children are at particular risk. Hypersensitivity reactions to fusidic acid are rare and Fucibet® Lipid cream does not contain lanolin.  However, if signs of hypersensitivity occur, treatment should be withdrawn.

            Based on combined clinical data for Fucibet® approximately 3% of patients can be expected to experience an undesirable effect.

            The most frequently reported undesirable effects are various transient symptoms of application site irritation. Allergic reactions have been reported.

            Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.

            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

 

            Immune system disorders

            Not known

            Allergic reaction

 

            Skin and subcutaneous tissue disorders

            Uncommon

            Skin irritation

            Skin burning sensation

            Pruritus

            Eczema aggravated

            Skin stinging sensation

            Erythema

 

            Rare

            Urticaria

            Dry skin

 

            Not known

            Contact dermatitis

            Rash

            Telangiectasia

 

            Class effect

                      Undesirable effects observed for corticosteroids include: Skin atrophy, telangiectasia and skin striae, especially during prolonged application, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation, glaucoma and adrenocortical suppression.

Reasons for adding or updating:

  • New SPC for new product