Last Updated on eMC 31-10-2014 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 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:28-10-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Addition of 3 month in-use shelf-life resulting in a change to sections 6.3 and 6.4.

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 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
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:16-07-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.3       Contraindications

            Known hHypersensitivity to fusidic acid/sodium fusidate, hydrocortisone acetate or to any of the excipients listed in section 6.1.

 

            As with other topical corticosteroid preparations, Fucidin® H cream is contraindicated in the following conditions: Primary skin Infections caused by bacteria, fungi or viruses (such as herpes or varicella), skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis and rosacea.

           

            Due to the content of corticosteroid, Fucidin® H is contraindicated in the following conditions:

 

            Primary skin infections caused by fungi, virus or bacteria, either untreated or uncontrolled by appropriate treatment (see section 4.4).

 

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

            Perioral dermatitis and rosacea.

4.4       Special warnings and precautions for use

Long term continuous topical therapy should be avoided. 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 topical steroids. Caution should be exercised, if Fucidin® H 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.  As with all antibiotics, extended or recurrent application may increase the risk of developing 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.

 

As Fucidin® H cream contains a corticosteroid it is not recommended in the

following conditions: atrophic skin, cutaneous ulcer, acne vulgaris, fragile skin veins and perianal and genital pruritus.  Contact with open wounds and mucous

            membranes should be avoided.  As with all corticosteroids, prolonged use on the

            face should be avoided.

 

Fucidin® H Cream contains butylhydroxyanisole, cetyl alcohol, and potassium sorbate which may cause local skin reactions (e.g. contact dermatitis). Butylhydroxyanisole may also cause irritation to the eyes and mucous membranes.

 

Long-term continuous topical therapy with Fucidin® H should be avoided.

 

Depending on the application site, possible systemic absorption of hydrocortisone acetate should always be considered during treatment with Fucidin® H.

 

Due to the content of corticosteroid, Fucidin® H should be used with care near the eyes. Avoid getting Fucidin® H into the eyes (see section 4.8).

 

Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur with or without occlusions following systemic absorption of topical corticosteroids.

 

Fucidin® H should be used with care in children as paediatric patients may be more susceptible to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than adult patients (see section 4.8).

 

 

Bacterial resistance has been reported to occur with the topical use of fusidic acid. As with all antibiotics, extended or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance. Limiting therapy with topical fusidic acid and hydrocortisone acetate 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. Steroid antibiotic combinations should not be continued for more than 7 days in the absence of any clinical improvement.

 

Due to the immunosuppressant effect of corticosteroids, Fucidin® H may be associated with increased susceptibility to infection, aggravation of existing infection, and activation of latent infection. It is advised to switch to systemic therapy if infection cannot be controlled with topical treatment (see section 4.3).

 

As Fucidin® H cream contains a corticosteroid it is not recommended in the

following conditions: atrophic skin, cutaneous ulcer, acne vulgaris, fragile skin veins and perianal and genital pruritus.  Contact with open wounds and mucous

            membranes should be avoided.  As with all corticosteroids, prolonged use on the

            face should be avoided.

 

Fucidin® H cream contains butyl hydroxyanisole, cetyl alcohol and potassium sorbate. These excipients may cause local skin reactions (e.g. contact dermatitis). Butyl hydroxyanisole may also cause irritation to the eyes and mucous membranes.

4.5       Interaction with other medicinal products and other forms of interaction

            None known

No interaction studies have been performed. Interactions with systemically administered medicinal products are considered minimal.

4.6       Fertility, pregnancy and lactation

            Pregnancy

            For fusidic acid no clinical data on exposed pregnancies are available. Animal studies do not indicate a direct or indirect harmful effect with respect to pregnancies, embryonal/foetal development, parturition or postnatal development. Absorption of hydrocortisone acetate following topical application is limited and data from exposed pregnancies indicate no adverse effects on the foetus/newborn child. Caution should be exercised when prescribing to pregnant women.

           

            Pregnancy:

            Fusidic acid:

            No effects during pregnancy are anticipated, since systemic exposure to fusidic acid is negligible.

 

            Hydrocortisone acetate:

            A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicates no malformative nor feto/neonatal toxicity of corticosteroids.

 

            Fucidin® H can be used during pregnancy if clinically needed. However, based on a general knowledge about systemic corticosteroids, caution should be exercised when using Fucidin® H during pregnancy.

 

 

            Lactation

            No effects on the infant are anticipated since the systemic exposure of the breast feeding woman to fusidic acid and hydrocortisone acetate is negligible following topical application. Fucidin® H can be used when breast-feeding. If used on the nipples, any cream on the nipples should be cleaned off before breast-feeding.

 

            Breastfeeding

            No effects on the breastfed new-born/infant are anticipated since the systemic exposure of topically applied fusidic acid/hydrocortisone acetate to a limited area of skin of the breastfeeding woman is negligible.

 

            Fucidin® H can be used during breastfeeding but it is recommended to avoid applying Fucidin® H on the breast.

 

            Fertility

            There are no clinical studies with Fucidin® H regarding fertility. 

4.8       Undesirable effects

            Based on clinical data for Fucidin® H approximately 5% of patients can be expected to experience an undesirable effect.

           

            The estimation of the frequency of adverse reactions is based on a pooled analysis of data from clinical studies and spontaneous reporting.

 

            The most frequently reported adverse drug reactions during treatment are various skin application site reactions and in particular application site reactions. Allergic reactions and contact dermatitis have been reported including pruritus, burning and irritation.

            The undesirable effects Adverse reactions are listed by MedDRA system organ class (SOC) and the individual undesirable effects adverse reactions are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.

 

            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

 

Uncommon

(≥1/1,000 and <1/100)

            Allergic reaction

            Hypersensitivity

 

            Skin and subcutaneous tissue disorders

Uncommon

(≥1/1,000 and <1/100)

      Skin irritation

      Skin burning sensation

      Skin stinging sensation

      Pruritus

      Eczema aggravated

      Dermatitis contact

      Eczema (condition aggravated)

      Rash

 

      Not known

            Rash

            Allergic contact dermatitis

            Depigmentation

 

            General disorders and administration site conditions

 

            Common

            (≥1/100 and <1/10)

 

            Application site reaction (incl. pruritus, burning and irritation)

 

           

Immune system disorders

Uncommon

 (≥1/1,000 and <1/100)

Hypersensitivity

Skin and subcutaneous tissue disorders

Uncommon:

 (≥1/1,000 and <1/100)

Dermatitis contact

Eczema (condition aggravated)

Rash

General disorders and administration site conditions

Common:

 (≥1/1,00 and <1/10)

Application site reaction

(incl. pruritus, burning and irritation)

 

 

            Systemic undesirable effects

 

            Systemic undesirable class effects of mild corticosteroids, like hydrocortisone, include adrenal suppression especially during prolonged topical administration (see section 4.4).

 

            Raised intra-ocular pressure and glaucoma may also occur after topical use of corticosteroids near the eyes, particularly with prolonged use and in patients predisposed to developing glaucoma (see section 4.4).

 

            Dermatological undesirable class effects of mild corticosteroids like hydrocortisone include: Atrophy, dermatitis (incl. dermatitis contact, dermatitis acneiform and perioral dermatitis), skin striae, telangiectasia, rosacea, erythema, depigmentation, hypertrichosis and hyperhidrosis. Ecchymosis may also occur with prolonged use of topical corticosteroids.

 

            Class effects for corticosteroids have been uncommonly reported for Fucidin® H as described in the frequency table above.

 

            Paediatric population

            The observed safety profile is similar in children and adults (see section 4.4).

 

            Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

 

            Class effect

 

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

4.9       Overdose

            Acute overdosage is very unlikely to occur.  However, chronic overdosage or misuse may result in increased risk of topical or systemic side effects.

 

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 three 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 Fucidin® H does not exceed the oral daily dose of systemic treatment. A single oral overdose of corticosteroids is rarely a clinical problem.

10      DATE OF REVISION OF THE TEXT

13 April 2011

December 2012

16 July 2013

 

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:13-04-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Within Section 6.1 (List of excipients) the excipient all-rac-α-tocopherol has been added to the list of excipients within section 6.1 of the SPC.

Section 10 has been updated with the revised revision date of 13 April 2011.

These are the only changes to the SPC in this instance.

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 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

            Hypersensitivity to fusidic acid and its salts. 

            Known hypersensitivity to fusidic acid/sodium fusidate, hydrocortisone acetate or any of the excipients.

            As with other topical corticosteroid preparations, Fucidin® H cream is contraindicated in the following conditions: Primary skin Infections primarily caused by in primary bacterial, fungi or viruses (such as herpes or varicella) viral and fungal skin infections, skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis and rosacea.

 


4.4                 Special warnings and precautions for use

Fusidic acid does not appear to cause conjunctival irritation in experimental animals. Caution should still be exercised, however, when Fucidin® H cream is used near the eyes.

Long term continuous topical therapy should be avoided. 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 still be exercised, however, when if Fucidin® H cream is used near the eyes. 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.

          As Fucidin® H cream contains a corticosteroid it is not recommended in the

following conditions: atrophic skin, cutaneous ulcer, acne vulgaris, fragile skin veins and perianal and genital pruritis.  Contact with open wounds and mucous membranes should be avoided.  As with all corticosteroids, prolonged use on the face should be avoided.

In infants and children, long-term continuous topical therapy with corticosteroids should be avoided.  Adrenal suppression can occur even without occlusion.

Fucidin® H Cream contains butylhydroxyanisole, cetyl alcohol, and potassium sorbate which may cause local skin reactions (e.g. contact dermatitis). Butylhydroxyanisole may also cause irritation to the eyes and mucous membranes.

4.6                 Pregnancy and lactation

            There is inadequate evidence of safety in human pregnancy.  Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation.  There may, therefore, be a very small risk of such effects in the human foetus.  Animal studies and many years of clinical experience have suggested that fusidic acid is devoid of teratogenic effect.  There is evidence to suggest that when given systemically, fusidic acid can penetrate the placental barrier.  The use of topical Fucidin® in pregnancy requires that the potential benefits be weighed against the possible hazards to the foetus. 

            Safety in nursing mothers has not been established.

 

            When fusidic acid (as the sodium salt) has been given systemically, levels have been detected in breast milk, but with topical use the possible amount of drug present is unlikely to affect the infant.

            Pregnancy

            For fusidic acid no clinical data on exposed pregnancies are available. Animal studies do not indicate a direct or indirect harmful effect with respect to pregnancies, embryonal/foetal development, parturition or postnatal development. Absorption of hydrocortisone acetate following topical application is limited and data from exposed pregnancies indicate no adverse effects on the foetus/newborn child. Caution should be exercised when prescribing to pregnant women.

            Lactation

            No effects on the infant are anticipated since the systemic exposure of the breast feeding woman to fusidic acid and hydrocortisone acetate is negligible following topical application. Fucidin® H can be used when breast-feeding. If used on the nipples, any cream on the nipples should be cleaned off before breast-feeding.

 


4.7                 Effects on ability to drive and use machines

            Not known

            Fucidin® H has no or negligible influence on the ability to drive or to use machines.

10             DATE OF REVISION OF THE TEXT

03/01/2007  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:01-12-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:




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

            Based on combined clinical data for Fucidin® H approximately 5% of patients can be expected to experience an undesirable effect.

            The most frequently reported undesirable effects for Fucidin® H are various symptoms of application site irritation. Pruritus, skin irritation, skin rash, worsening of eczema, transient stinging and burning sensation were uncommon.   Allergic reactions have been reported.

            Undesirable effects, starting with the most frequently reported, are:

·         Skin and subcutaneous tissue disorders

                                      Pruritus

                                      Skin irritation

                                      Skin burning sensation

                                      Skin stinging sensation

                                      Rash

                                      Eczema aggravated

 

·         Immune system disorders

                      Allergic reaction

 

            The most frequently reported adverse drug reactions are various skin reactions and in particular application site reactions. Allergic reactions and contact dermatitis have been reported.

            The 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

                                      Skin stinging sensation

                                      Pruritus

                                      Eczema aggravated

                                      Rash

                                      Not known

                      Rash

                      Allergic contact dermatitis

                      Depigmentation

            Although it has not been observed in the clinical studies for Fucidin® H, topical use of steroids may result in skin atrophy, telangiectasia or skin striae, especially during prolonged application.

 

            As with all other corticosteroids folliculitis, hypertrichosis, perioral dermatitis, contact dermatitis, depigmentation and systemic activity, although rare, may occur.

 

 

            Class effect

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


10             DATE OF REVISION OF THE TEXT

03/01/2007  December 2009

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:01-12-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.8 has been updated to bring the section in line with the MedDRA format and to include incidence of adverse events, as a result of the Company Core Safety Information (CCSI) being recently updated.

4.8                 Undesirable effects

            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

            Based on combined clinical data for Fucidin® H approximately 5% of patients can be expected to experience an undesirable effect.

            The most frequently reported undesirable effects for Fucidin® H are various symptoms of application site irritation. Pruritus, skin irritation, skin rash, worsening of eczema, transient stinging and burning sensation were uncommon.   Allergic reactions have been reported.

            Undesirable effects, starting with the most frequently reported, are:

·         Skin and subcutaneous tissue disorders

                                      Pruritus

                                      Skin irritation

                                      Skin burning sensation

                                      Skin stinging sensation

                                      Rash

                                      Eczema aggravated

 

·         Immune system disorders

                      Allergic reaction

 

            The most frequently reported adverse drug reactions are various skin reactions and in particular application site reactions. Allergic reactions and contact dermatitis have been reported.

            The 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

                                      Skin stinging sensation

                                      Pruritus

                                      Eczema aggravated

                                      Rash

                                      Not known

                      Rash

                      Allergic contact dermatitis

                      Depigmentation

            Although it has not been observed in the clinical studies for Fucidin® H, topical use of steroids may result in skin atrophy, telangiectasia or skin striae, especially during prolonged application.

 

            As with all other corticosteroids folliculitis, hypertrichosis, perioral dermatitis, contact dermatitis, depigmentation and systemic activity, although rare, may occur.

            Class effect

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

Reasons for adding or updating:

  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-01-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.1: Butylated hydroxyanisole amended to Butylhydroxyanisole (E320), Cetanol amended to Cetyl alcohol.
Section 6.4: Storage conditions added - Do not store above 30 deg C.

Reasons for adding or updating:

  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 (date of (partial) revision of the text

Date of revision of text on the SPC:01-05-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.3: 'skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis and rosacea' added
Section 4.4: Paragraph '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.' moved here from section 4.5.
Paragraph 'As Fucidin H cream contains a corticosteroid it is not recommended in the following conditions: atrophic skin, cutaneous ulcer, acne vulgaris, fragile skin veins and perianal and genital pruritus. Contact with open wounds and mucous membranes should be avoided. As with all corticosteroids, prolonged use on the face should be avoided.' added.
Last sentence - 'and children' added to 'In infants and children, long-term continuous topical therapy with corticosteroids should be avoided. Adrenal suppression can occur even without occlusion.'
Section 4.5: Paragraph moved to Section 4.4 - see above.
Section 4.8: This section has been completely re-written and updated.
Section 4.9: Amended from 'Not applicable' to 'Acute overdosage is very unlikely to occur. However, chronic overdosage or misuse may result in increase risk of topical or sytemic side effects.'

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2 Posology and method of administration:
Amended from 'Uncovered lesions-apply gently three or four times daily' to 'Uncovered lesions-a small quantity should be applied to the affected area twice daily until a satisfactory response is obtained. A single treatment course should not normally exceed 2 weeks'. 

Reasons for adding or updating:

  • Transferred from eMC version 1

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied