FUCIDIN OINTMENT

Israel - English - Ministry of Health

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Active ingredient:
SODIUM FUSIDATE
Available from:
DEXCEL LTD, ISRAEL
ATC code:
D06AX
Pharmaceutical form:
OINTMENT
Composition:
SODIUM FUSIDATE 20 MG/G
Administration route:
DERMAL
Prescription type:
Required
Manufactured by:
LEO LABORATORIES LTD., IRELAND
Therapeutic group:
OTHER ANTIBIOTICS FOR TOPICAL USE
Therapeutic indications:
Local treatment of skin infection due to sensitive strains of staphylococos.
Authorization number:
056 28 26528 00
Authorization date:
2012-03-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

23-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

24-05-2018

Fucidin Cream

Fucidin Ointment

SUMMARY OF THE PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT

Fucidin cream

Fucidin ointment

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Fucidin cream

Each gram of cream contains 20 mg fusidic acid.

Excipients with known effect: Contains Butylhydroxyanisole 0.04 mg/g,

Potassium Sorbate 2.7 mg/g and cetyl alcohol 111 mg/g.

For a full list of excipients, see section 6.1.

Fucidin ointment

Each gram of ointment contains: 20 mg sodium fusidate.

Excipients with known effect: Contains cetyl alcohol 4 mg/g, wool fat

(lanolin) 46 mg/g and butylhydroxytoluene

For a full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Fucidin cream

Cream

A white cream.

Fucidin ointment

Ointment

Translucent, yellowish to white ointment

4.

CLINICAL PARTICULARS

4.1 Therapeutic indications

Local treatment of skin infections due to sensitive strains of

staphylococcus aureus.

4.2 Posology and method of administration

Apply three to four times daily or as required.

Less frequent application may be adequate for covered lesions.

Method of administration

Cutaneous use

4.3 Contraindications

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

excipients listed in section 6.1.

4.4 Specials 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 of fusidic acid may increase the risk of developing antibiotic

resistance.

Fucidin cream

Fucidin cream contains butylhydroxyanisole, potassium sorbate and cetyl

alcohol. These excipients may cause local skin reactions (e.g. contact

dermatitis). In addition, butylhydroxyanisole may also cause irritation to

the eyes and the mucous membranes. Fucidin

Cream should therefore be

used with care when applied in the proximity of the eyes.

Fucidin ointment

Fucidin

ointment contains cetyl alcohol and wool fat (lanolin). These

excipients may cause local skin reactions (e.g. contact dermatitis).

Fucidin

Ointment contains butylhydroxytoluene 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 may cause conjunctival irritation.

4.5 Interaction with other medicinal products and other forms of

interaction

No interaction studies have been performed. Interactions with systemically

administered medical products are considered minimal as the systemic

absorption of topical Fucidin

is negligible.

4.6 Fertility, pregnancy and lactation

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 breast-fed newborn/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 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 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 reactions during treatment are

various skin reactions such as pruritus and rash, followed by various

application site 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 the 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 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

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):

Dermatitis (including 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.

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 (including 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.

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.

Any suspected adverse events should be reported to the Ministry of Health

according to the National Regulation by using an online form

http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffec

tMedic@moh.gov.il

4.9 Overdose

Overdose is unlikely to occur.

5.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC code: D06AX01

Fucidin Cream & Fucidin Ointment contain fusidic acid/ sodium fusidate

respectively, potent topical antibacterials. Fusidic acid and its salts exhibit

fat and water solubility properties with strong surface activity, and show

unusual ability to penetrate intact skin. However, they are poorly

systemically absorbed after topical administration. Concentrations of 0.03

- 0.12 mcg/ml inhibit nearly all strains of Staphylococcus aureus. Topical

Fucidin® is also active against Streptococci, Corynebacteria, Neisseria

and certain Clostridia.

5.2 Pharmacokinetic properties

There are no data which define the pharmacokinetics of Fucidin® Cream

and Fucidin® Ointment, following topical administration in man.

However, in vitro studies show that fusidic acid and its salts can penetrate

intact human skin in concentrations well above the MIC-values of

susceptible organisms. The degree of penetration depends on factors

such as the duration of exposure to fusidic acid (or its salts) and the

condition of the skin. Fusidic acid and its salts are excreted mainly in the

bile with little excreted in the urine.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are

additional to that already included in other sections of the SPC.

6.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Fucidin cream

Cetyl alcohol, glycerol (85%), liquid paraffin, polysorbate 60, white soft

paraffin, potassium sorbate, butylhydroxyanisole, hydrochloric acid,

purified water, all-rac-α-tocopherol.

Fucidin ointment

White soft paraffin, liquid paraffin, Wool fat, Cetyl alcohol,

butylhydroxytoluene, all-rac-α-tocopherol.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

Fucidin cream

After first opening: 1 month

Fucidin ointment

After first opening: 3 months

6.4 Special precautions for storage

Do not store above 30°C

7. MARKETING AUTHORISATION HOLDER

Dexcel Ltd., 1 Dexcel street, Or-Akiva 3060000, Israel.

8. Manufacturer

Leo Laboratories Ltd., Ireland.

The format of this leaflet was determind by the Ministry of Health (MOH)

and its content was checked and approved by the MOH in March 2016.

לע העדוה ( הרמחה

עדימ ל ןולעב )תוחיטב אפור

ןכדועמ(

.102.50

רשוא

61.2

ךיראת

21.01.2016

:םושירה רפסמו תילגנאב רישכת םש

00)

-

26528

-

28

-

Fucidin Ointment (056

)

00

-

26521

-

29

-

056

(

Fucidin Cream

םושירה לעב םש

1

Dexcel Ltd

ה טורפל דעוימ הז ספוט דבלב תורמחה

תושקובמה תורמחהה

ןולעב קרפ

יחכונ טסקט

שדח טסקט

Indication

Contraindications

Posology, dosage

& administration

Special Warnings

and Special

Precautions for

Use

Fucidin cream

Fucidin cream contains

butylhydroxyanisole,

potassium sorbate and cetyl

alcohol which may cause local

allergic skin reactions (e.g.

contact dermatitis). In

addition, butylhydroxyanisole

may cause irritation to the

eyes and the mucous

membranes.

Fucidin ointment

When Fucidin® ointment is

used on the face; care should

be taken to avoid the eyes as

sodium fusidate may cause

conjunctival irritation.

Fucidin

ointment contains

butylhydroxytoluene, cetyl

alcohol and wool fat which

may cause local skin

reactions (e.g. contact

dermatitis).

Fucidin cream

Fucidin cream contains

butylhydroxyanisole, potassium

sorbate and cetyl alcohol. These

excipients may cause local skin

reactions (e.g. contact dermatitis). In

addition, butylhydroxyanisole may

also cause irritation to the eyes and

the mucous membranes. Fucidin

Cream should therefore be used with

care when applied in the proximity of

the eyes.

Fucidin ointment

Fucidin

ointment contains cetyl

alcohol and wool fat (lanolin). These

excipients may cause local skin

reactions (e.g. contact dermatitis).

Fucidin

Ointment contains

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 sodium fusidate the

excipients

may cause conjunctival

irritation.

Interaction with

Other

Medicaments and

Other Forms of

Interaction

None Known

None known. No interaction studies

have been performed. Interactions

with systemically administered

medical products are considered

minimal as the systemic absorption of

topical Fucidin

is negligible.

Pregnancy and

Fertility, Lactation

Pregnancy:

For fusidic acid/sodium

fusidate 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.

Caution should be exercised

when prescribing to pregnant

women.

Lactation:

No effects on the suckling

child are anticipated since the

systemic exposure of the

breast-feeding woman to

fusidic acid is negligible.

Fucidin cream and ointment

can be used during breast-

feeding.

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:

For fusidic acid/sodium fusidate 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.

Caution should be exercised when

prescribing to pregnant women.

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 breast-fed

newborn/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.

Adverse events

Based on combined clinical data

for Fucidin cream and Fucidin

ointment, approximately 5% of

patients can be expected to

Based on combined clinical data for

Fucidin cream and Fucidin ointment,

approximately 5% of patients can be

expected to experience an undesirable

experience an undesirable effect.

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.

Undesirable effects are listed

by MedDRA SOC and the

individual undesirable effects

are listed starting with the

most frequently reported.

Immune system disorders

Rare (≥1/10,000 and

<1/1,000):

Allergic reaction

Eye Disorders

Rare (≥1/10,000 and

<1/1,000):

Conjunctival irritation

Skin and subcutaneous

tissue disorders

Uncommon (≥1/1,000 and

<1/100):

Rash*

Irritation at site of application

(incl. pain, stinging, burning

and erythema)

Pruritus

Contact dermatitis

* Various types of rash

reactions such as

erythematous,

maculo-papular

and pustular have been

reported.

Frequency unknown:

Urticaria

Angioneurotic oedema

Eczema

Periorbital oedema

effect.

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 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

reactions during treatment are various

skin reactions such as pruritus and

rash, followed by various application

site conditions such as pain and

irritation, which all occurred in less

than 1% of patients.

Allergic reactions and contact dermatitis

have been reported.

Hypersensitivity and angioedema have

been reported.

Undesirable effects are listed by the

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 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

Rare (≥1/10,000 and <1/1,000):

Allergic reaction Hypersensitivity

Eye Disorders

Rare (≥1/10,000 and <1/1,000):

Conjunctivitis

Skin and subcutaneous tissue

disorders

Uncommon (≥1/1,000 and <1/100):

Dermatitis (including dermatitis

contact, eczema)

Rash*

Stinging

Pruritus

Erythema

* Various types of rash reactions such

as erythematous,

pustular, vesicular,

maculo-papular and papular have

been reported. Rash generalised has

also occurred.

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 (including 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.

Frequency unknown:

Urticaria

Angioneurotic oedema

Eczema

Periorbital oedema

לע העדוה ( הרמחה

עדימ ןכרצל ןולעב )תוחיטב

ןכדועמ(

.102.50

ךיראת

21.01.2016

םושירה רפסמו תילגנאב רישכת םש

00)

-

26528

-

28

-

Fucidin Ointment (056

00)

-

26521

-

29

-

Fucidin Cream (056

םושירה לעב םש

1

Dexcel Ltd

ה טורפל דעוימ הז ספוט דבלב תורמחה

תורמחהה תושקובמה

ןולעב קרפ

יחכונ טסקט

שדח טסקט

תויוותה

ןיא יתמ שמתשהל ?רישכתב

תורהזא תודחוימ תועגונה שומישל :הפורתב

:תורהזא םא

וא והשלכ ןוזמל שיגר ךניה ,יהשלכ הפורתל ךכ לע עידוהל ךילע שומישה ינפל אפורל הפורתב

.

ןידיסופ

:ליכמ םרק

Cetyl alcohol

potassium sorbate

לולעה םי

םורגל עגממ רוע תקלדל תשוחתב הוולמה רועב תדרגמ החירפ( שומיש השענ וב רוזאב תוחיפנו םוח ו )החשמב

butylhydroxyanisole

םורגל לולעה

עגממ רוע תקלד

יוריגלו םייניעב וא

)םיינזואו ףא ,הפ( תוירירב

ןידיסופ

:ליכמ החשמ

Cetyl alcohol

wool fat

לולעה םי

םורגל תדרגמ החירפ( עגממ רוע תקלדל תוחיפנו םוח תשוחתב הוולמה רועב ו )החשמב שומיש השענ וב רוזאב

butylhydroxyanisole

םורגל לולעה

עגממ רוע תקלד

םייניעב יוריגלו וא

)םיינזואו ףא ,הפ( תוירירב

רוזאב החשמ ןידיסופב שמתשהל ןיא .םייניעה

:תורהזא םא

ךניה

וא והשלכ ןוזמל שיגר ,יהשלכ הפורתל אפורל ךכ לע עידוהל ךילע שומישה ינפל הפורתב

.

םרק/החשמ ןידיסופב שמתשהל ןיא ןמזל ךשוממ ךשוממ שומישש ינפמ תולעהל לולע םיקדייחה תודימעל ןוכיסה תא הפורתה תוליעיב עוגפל ךכבו ,הקיטויביטנאל

ענמה ב םרק/החשמה לש עגממ םייניע :אמגודל( םא וא םיידיהמ רבע םא תועטב םייניעל בורק היה שומישה םורגל הלולעה ) .םייניעב )הבירצ( יוריגל

ןידיסופ

:ליכמ םרק

Cetyl alcohol

potassium sorbate

לולעה םי

םורגל

החירפ המודא

רועב תדרגמ וב רוזאב תוחיפנו םוח תשוחתב הוולמה םרקב שומיש השענ

ןוג

.)עגממ רוע תקלד

butylhydroxyanisole

םורגל לולעה

תדרגמו המודא החירפל רועב הוולמה תשוחתב תוחיפנו םוח השענ וב רוזאב םרקב שומיש

ןוגכ

עגממ רוע תקלד

יוריגלו םייניעב

( תוירירב ןוגכ

)םיינזואו ףא ,הפ

ןידיסופ

:ליכמ החשמ

Cetyl alcohol

Wool fat

לולעה םי םורגל

החירפ המודא

הוולמה רועב תדרגמ השענ וב רוזאב תוחיפנו םוח תשוחתב ומיש

החשמב

ןוגכ

.)עגממ רוע תקלד

butylhydroxytoluene

םורגל לולעה

החירפ המודא

תדרגמ

הוולמה רועב השענ וב רוזאב תוחיפנו םוח תשוחתב שומיש החשמב

ןוגכ

)עגממ רוע תקלד םייניעב יוריגלו

( תוירירב ןוגכ

ףא ,הפ .)םיינזואו

רוזאב החשמ ןידיסופב שמתשהל ןיא .םייניעה

שמתשהל ןיא ילבמ הפורתב אפורב ץעוויהל תלחתה ינפל :לופיטה

ןיב תובוגת :תויתופורת

שומיש הפורתב תכירצו :לוהוכלא

:הקנהו ןוירה

ןיא ץעוויהל ילבמ הפורתב שמתשהל לופיטה תלחתה ינפל אפורב

םא

ניה

ןויריהב ךניהש תדשוח ,ןוירהב

.הקינמ וא

ןיא אפורב ץעוויהל ילבמ הפורתב שמתשהל לופיטה תלחתה ינפל

םא

,ןוירהב ךניה תבשוח ןויריהב ךניהש

נכיהל תננכתמ

ןוירה

.הקינמ וא

ךניה םא םרק/החשמ ןידיסופב שמתשהל ןתינ .ןוירהב ךניהש תבשוח וא ןוירהב

מ ןידיסופב שמתשהל ןתינ תא םא םרק/החש םרקה/החשמה תא חורמל ןיא ךא ,הקינמ .הזחה רוזאב

שמתשת דציכ :הפורתב

יאוול תועפות

תונפל שי

אפורל דימ

לבוס ךניה םא

תיגרלא הבוגת

:הינמיסש

,המישנב ישוק תוחיפנ ,הפבו םייתפשב תוחיפנ וא ץוצקע .רועה לע הרומח החירפ ,ןורגב וא םינפב

תועפות תופסונ יאוול

תועיפומ

:תובורק םיתיעל

תבוגת

תחירמ רוזאב רקיעב ,רוע ;םרקה וא החשמה

תונפל שי

אפורל דימ

לבוס ךניה םא

:תואבה תועפותהמ

תיגרלא הבוגת

העפות העיפומ( הרידנ

ךותמ דחא שמתשמ

0111

םייתפשב תוחיפנ וא ץוצקע ,המישנב ישוק הרומח החירפ ,ןורגב וא םינפב תוחיפנ ,הפבו .רועה לע

תועפות

תופסונ יאוול

םא

תופסונ יאוול תועפות תועיפו תוחפ

החירפ

דוריג

עגממ רוע תקלד וא המודא החירפ( םוח תשוחתב הוולמה רועב תדרגמו שומיש השענ וב רוזאב תוחיפנו )םרק/החשמב

ץוצקע ,באכ תשוחת

השענ וב רוזאב תוימומדא וא/ו הבירצ כתב שומיש ריש

תועיפומ

:תוקוחר םיתיעל

תודרגמ םייניע וא

;תועמוד

תועפות :העודי הניא ןתוחיכשש יאוול

המזקא ;רועב תוימומדא;

תוחיפנ ;תלרח פעה לש םייפע

.ףוגב םירחא םיקלח וא

וא הרימחמ יאוולה תועפותמ תחא םא רשאכ ךניה

לבוס ת/

אלש יאוול תעפותמ הרכזוה

הל ךילע ,ןולעב ווי םע ץע

.אפורה

.םדקהב אפורל תונפל שי תורומח

תועפות ,תוחיכש ןניאש יאוול תועפות ב תועיפומש

0-01

ךותמ םישמתשמ

תבוגת

וא החשמה תחירמ רוזאב רקיעב ,רוע ;םרקה

חירפ

וא דוריג

רועה לש תוימומדא

עגממ רוע תקלד וא המזקא

המודא החירפ( תוחיפנו םוח תשוחתב הוולמה רועב תדרגמו אב שענ וב רוז )םרק/החשמב שומיש ה

,באכ תשוחת ( יוריג ץוצקע

וא

הביר

רוזאב שומיש השענ וב

הפורתב

ב תועיפומש תועפות ,תורידנ יאוול תועפות

ךותמ םישמתשמ

01,11

תודרגמ םייניע

;תועמוד

,םינפה לש תוחיפנ

,םייתפש

,הפ

וא ןורג יישקל םורגל הלולע רשא ןושלה העילב וא .המישנ

וא תלרח

.תויחופלש

תועפות :העודי הניא ןתוחיכשש יאוול

המזקא ;רועב תוימומדא;

תלרח לש תוחיפנ ; פעה םייפע

.ףוגב םירחא םיקלח וא

תועפות

םידליב םג שחרתהל תולולע ולא .הפורתב םישמתשמה

םא תועפותמ תחא םא ,יאוול תעפות העיפוה לבוס התא רשאכ וא הרימחמ יאוולה תעפותמ םע ץעייתהל ךילע ,ןולעב הניוצ אלש יאוול .אפורה

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