Last Updated on eMC 23-12-2015 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 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 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 1 - Name of the medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - Fertility, pregnancy and lactation

Date of revision of text on the SPC:02-12-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Changes to sections 1, 2, 3, 4.1, 4.2, 4.3, 4.4, 4.6, 4.8, 5.1, 5.2, 6.5 and 9 – Editorial amendments and updates in line with QRD template.

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:18-08-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Addition of 3 month in-use shelf life to section 6.3 of the SmPC and consequential update of section 6.4

Reasons for adding or updating:

  • Change to section 6.1 - List of excipients
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

Date of revision of text on the SPC:22-11-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



 

 

 

 

 

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Fucidin

 

® Ointment contains Sodium Fusidate Ph.Eur.2% .

 

Excipient: butylhydroxytoluene (E321)

 

 

 

 

Excipient: cetyl alcohol

Excipient: lanolin

 

(wool fat)

 

 

 

 

 

For

 

the full list of excipients, see section 6.1

 

 

4.4 Special warnings and precautions for use

 

 

Fucidin® ointment contains butylhydroxytoluene (E321) which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

 

6.1 List of excipients

 

 

Cetyl alcohol

,

 

lL

 

anolin (wool fat),

 

wW

 

hite soft paraffin,

 

lL

 

iquid paraffin,

 

All-

 

rac-α-tocopherol

 

Butylhydroxytoluene (E321)

 

 

 

8 MARKETING AUTHORISATION NUMBER(S)

PL
00043/5005R

 

10 DATE OF REVISION OF THE TEXT

10 July 2013

November 2013

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-01-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



 

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Fucidin

 

® Ointment contains Sodium Fusidate Ph.Eur.2% .

 

Excipient: butylhydroxytoluene (E321)

 

 

 

Excipient: cetyl alcohol

Excipient: lanolin

 

(wool fat)

 

For

 

the full list of excipients, see section 6.1

 

 

4.4 Special warnings and precautions for use

 

 

 

Bacterial resistance among

 

staphylococcus aureus has been reported to occur with the use of topical Fucidin®. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance.

 

Extended or recurrent use may increase the risk of developing contact sensitisation.

Fucidin

 

® Ointment contains cetyl alcohol and hydrous lanolin. These excipients may cause local skin reactions (e.g. contact dermatitis). Fucidin® ointment contains Fucidin® Ointment-Storage Conditions Update-Highlighted SPC 12.08.13

 

 

 

 

butylhydroxytoluene (E321) which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

 

 

 

 

When Fucidin

 

® ointment is used on the face; care should be taken to avoid the eyes as the excipients in the ointment may cause conjunctival irritation.

 

6.1 List of excipients

 

 

Cetyl alcohol

 

,

 

lL

 

 

anolin (wool fat),

 

wW

 

 

hite soft paraffin,

 

lL

 

 

iquid paraffin,

 

All-

 

 

rac-α-tocopherol

 

Butylhydroxytoluene (E321)

 

6.3 Shelf life

 

Unopened container:

 

 

3 years.

 

After first opening of container: 3 months

 

 

 

 

 

6.4 Special precautions for storage

 

 

None. This medicinal product does not require any special storage conditions.

For storage conditions after first opening of the medicinal product, see section 6.3.

 

 

 

 

 

 

8. MARKETING AUTHORISATION NUMBER(S)

 

 

 

PL 0

 

0043/5005R

 

 

 

 

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 4.7 - Effects on ability to drive and use machines
  • 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:10-07-2013

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 the active substance or to any of the excipients.

Infection caused by non-susceptible organisms, in particular, Pseudomonas aeruginosa.

4.4       Special warnings and precautions for use

The sodium salt of fusidic acid has been shown to cause conjunctival irritation.  The ointment should not be used in or near the eye.  Bacterial resistance has been reported to occur with the use of fusidic acid.  As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance.

Bacterial resistance among staphylococcus aureus has been reported to occur with the use of topical Fucidin®.  As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance.

Extended or recurrent use may increase the risk of developing contact sensitisation.

Fucidin® Ointment contains cetyl alcohol and hydrous lanolin, . These excipients may cause local skin reactions (e.g. contact dermatitis). which may cause allergic reactions (possibly delayed).

When Fucidin® ointment is used on the face; care should be taken to avoid the eyes as the excipients in the ointment may cause conjunctival irritation.

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 as the systemic absorption of topical Fucidin® is negligible.

4.6       Fertility, pregnancy and lactation

There is inadequate evidence of safety in human pregnancy.  Animal studies and many years of clinical experience have suggested that fusidic acid is devoid of teratogenic effects.

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.

Fertility

There are no clinical studies with topical Fucidin® regarding fertility. No effects in women of childbearing potential are anticipated, since systemic exposure following topically applied fusidic acid/sodium fusidate is negligible.

Pregnancy

No effects during pregnancy are anticipated, since systemic exposure to topically applied fusidic acid/sodium fusidate is negligible. Topical Fucidin® can be used during pregnancy.

Breast-feeding

No effects on the breastfed new-born/infant are anticipated since the systemic exposure of topically applied fusidic acid/sodium fusidate to the breast-feeding woman is negligible. Topical Fucidin® can be used during breast-feeding but it is recommended to avoid applying topical Fucidin® on the breast.

4.7       Effects on ability to drive and use machines

Fucidin® administered topically has no or negligible influence on the ability to drive and or to use machines.

4.8       Undesirable effects

The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and from spontaneous reporting.

 

Based on combined clinical data for Fucidin® cream and Fucidin® ointment, less than 5% of patients can be expected to experience an undesirable effect.

            Based on pooled data from clinical studies including 4724 patients who received Fucidin® cream or Fucidin® ointment, the frequency of undesirable effects is 2.3%.

The most frequently reported adverse drug reactions during treatment are various skin reactions such as pruritus and rash, followed by various and in particular application site reactions conditions such as pain and irritation, which all occurred in less than 1% of patients.

Hypersensitivity and angioedema have been reported.

Undesirable effects are listed by MedDRA System Organ Class (SOC) and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in 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

Not known (cannot be estimated from the available data)

 

Immune system disorders

Rare

(≥1/10,000 and <1/1,000)

Hypersensitivity

 

Eye disorders

Rare

(≥1/10,000 and <1/1,000)

Conjunctivitis

 

Skin and subcutaneous tissue disorders

Uncommon

(≥1/1,000 and <1/100)

Pruritus

Rash including erythematous, maculo-papular and pustular reactions

Contact Dermatitis

Irritation at site of application (including pain, stinging, burning and erythema)

            Dermatitis (incl. dermatitis contact, eczema)

            Rash*

            Pruritus

            Erythema

*Various types of rash reactions such as erythematous, pustular, vesicular, maculo-papular and papular have been reported. Rash generalised has also occurred.

 

Not known

Urticaria

Angioedema

Eczema

Periorbital oedema

            Rare

            (≥1/10,000 and <1/1,000)

            Angioedema

            Urticaria

            Blister

 

            General disorders and administration site conditions

            Uncommon

            (≥1/1,000 and <1/100)

            Application site pain (incl. skin burning sensation)

            Application site irritation

 

            Paediatric population

            Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.

10      DATE OF REVISION OF THE TEXT

5 August 2010

10 July 2013

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.7 - Effects on Ability to Drive and Use Machines
  • 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:05-08-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



2               QUALITATIVE AND QUANTITATIVE COMPOSITION

            Fucidin® Ointment contains Sodium Fusidate Ph.Eur.2% .

Excipient: cetyl alcohol

Excipient: lanolin

For full list of excipients, see section 6.1


4.3              Contraindications

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

            Infection caused by non-susceptible organisms, in particular, Pseudomonas aeruginosa.

            Fucidin ointment is contra-indicated in patients with hypersensitivity to fusidic acid and its salts.


4.4                 Special warnings and precautions for use

The sodium salt of fusidic acid has been shown to cause conjunctival irritation.  The ointment should not be used in or near the eye.  Bacterial resistance has been reported to occur with the use of fusidic acid applied topically.  As with all topical antibiotics, extended or recurrent use application may increase the risk of developing contact sensitisation and the development of antibiotic resistance.

Extended or recurrent use may increase the risk of developing contact sensitisation.

Fucidin® Ointment contains cetyl alcohol and lanolin, which may cause allergic reactions (possibly delayed).


4.5                 Interaction with other medicinal products and other forms of interaction

                Not applicable.

            None known.


4.7                 Effects on ability to drive and use machines

            Not applicable.

            Fucidin® administered topically has no or negligible influence on the ability to drive and to use machines.


4.8                 Undesirable effects

            Hypersensitivity reactions to the active ingredient in the form of skin rashes, mild stinging and irritation on application have been reported rarely.

            Based on combined clinical data for Fucidin® cream and Fucidin® ointment, less than 5% of patients can be expected to experience an undesirable effect.

            The most frequently reported adverse drug reactions are various skin reactions and in particular application site reactions.

            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

            Not known (cannot be estimated from the available data)

 

                      Immune system disorders

                      Rare

            Hypersensitivity

 

                      Eye disorders

                      Rare

            Conjunctivitis

 

            Skin and subcutaneous tissue disorders

            Uncommon

                      Pruritus

                      Rash including erythematous, maculo-papular and pustular reactions

                      Contact Dermatitis

                      Irritation at site of application (including pain, stinging, burning and erythema)

 

                      Not known

                      Urticaria

                      Angioedema

                      Eczema

                      Periorbital oedema



4.9                 Overdose

            Not applicable.

            Overdose is unlikely to occur.

            Unless hypersensitivity to Fusidic acid or any of the excipients exists, accidental ingestion of Fucidin® ointment is unlikely to cause any harm. The total quantity of fusidic acid (30g Fucidin® ointment contains 576mg fusidic acid) will usually not exceed the approved total daily oral dose of fusidic acid containing products except in children aged less than 1 year and weighing ≤ 10kg. Although in this instance a child of this particular age group is unlikely to ingest a whole tube of Fucidin® ointment. The concentration of the excipients is too low to constitute a safety risk.


10             DATE OF REVISION OF THE TEXT

May 1998   5 August 2010

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • Change to section 2 - qualitative and quantitative composition

Reasons for adding or updating:

  • Transferred from eMC version 1

Reasons for adding or updating:

  • Transferred from eMC version 1

Reasons for adding or updating:

  • No reasons supplied