Patient Information leaflet
(PIL) 24-05-2018
Summary of Product characteristics
(SPC) 17-08-2016
Public Assessment Report
(PAR) 17-08-2016
- 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
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
