DUAC

Israel - English - Ministry of Health

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Active ingredient:
BENZOYL PEROXIDE AS HYDROUS; CLINDAMYCIN AS PHOSPHATE
Available from:
PERRIGO ISRAEL AGENCIES LTD
ATC code:
D10AF01
Pharmaceutical form:
GEL
Composition:
CLINDAMYCIN AS PHOSPHATE 1 %W/W; BENZOYL PEROXIDE AS HYDROUS 5 %W/W
Administration route:
TOPICAL
Prescription type:
Required
Manufactured by:
GLAXO OPERATIONS UK LIMITED (TRADING AS GLAXO WELLCOME OPERATIONS)
Therapeutic group:
CLINDAMYCIN
Therapeutic area:
CLINDAMYCIN
Therapeutic indications:
Mild to moderate acne vulgaris, particulary inflammatory lesions.
Authorization number:
140 92 31439 01
Authorization date:
2014-05-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Hebrew

17-08-2016

Prescribing Information

Duac Gel

1. NAME OF THE MEDICINAL PRODUCT

Duac® Gel

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 g of gel contains:

10 mg clindamycin as clindamycin phosphate

50 mg anhydrous benzoyl peroxide as hydrous benzoyl peroxide

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

White to slightly yellow homogeneous gel

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Mild to moderate acne vulgaris, particularly inflammatory lesions.

4.2 Posology and method of administration

For cutaneous use only.

Posology

Adults and Adolescents (aged 12 years and above)

Duac gel should be applied once daily in the evening, to the entire

affected area.

Patients should be advised that excessive application will not improve

efficacy, but may increase the risk of skin irritation. If excessive dryness or

peeling occurs, frequency of application should be reduced or application

temporarily interrupted (see section 4.4).

An effect on inflammatory and non-inflammatory lesions may be seen as

early as week 2-5 of treatment (see section 5.1).

The safety and efficacy of Duac Gel has not been studied beyond 12

weeks in acne vulgaris clinical trials.

Treatment with Duac Gel should not exceed more than 12 weeks of

continuous use.

Pediatric population

The safety and efficacy of Duac gel has not been established in children

under 12 years of age, therefore Duac gel is not recommended for use in

this population.

Elderly patients

No specific recommendations.

Method of administration

Duac Gel should be applied in a thin film after washing gently with a mild

cleanser and fully drying. If the gel does not rub into the skin easily, too

much is being applied.

Hands should be washed after application

4.3 Contraindications

Duac Gel must not be administered to patients with known hypersensitivity

- clindamycin

- lincomycin

- benzoyl peroxide

- any of the excipients in the formulation, listed in section 6.1.

4.4 Special warnings and precautions for use

Contact with the mouth, eyes, lips and mucous membranes or areas of

irritated or broken skin should be avoided. Application to sensitive areas of

skin should be made with caution. In case of accidental contact, rinse well

with water.

During the first weeks of treatment, an increase in peeling and reddening

will occur in most patients. Depending upon the severity of these side

effects, patients can use a non-comedogenic moisturiser, temporarily

reduce the frequency of application of Duac Gel or temporarily discontinue

use; however, efficacy has not been established for less than once daily

dosing frequencies.

Duac gel should be used with caution in patients with a history of regional

enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

Duac gel should be used with caution in atopic patients, in whom further

skin drying may occur.

Concomitant topical acne therapy should be used with caution because a

possible cumulative irritancy may occur, which sometimes may be severe,

especially with the use of peeling, desquamating, or abrasive agents.

If severe local irritancy (e.g. severe erythema, severe dryness and itching,

severe stinging/burning) occurs, Duac Gel should be discontinued.

As benzoyl peroxide may cause increased sensitivity to sunlight,

sunlamps should not be used and deliberate or prolonged exposure to sun

should be avoided or minimised. When exposure to strong sunlight cannot

be avoided, patients should be advised to use a sunscreen product and

wear protective clothing.

If a patient has sunburn, this should be resolved before using Duac Gel

If prolonged or significant diarrhoea occurs or the patient suffers from

abdominal cramps, treatment with Duac gel should be discontinued

immediately, as the symptoms may indicate antibiotic-associated colitis.

Suitable diagnostic methods, such as the determination of Clostridium

difficile and toxin and, if necessary, colonoscopy should be employed and

treatment options for colitis considered.

The product may bleach hair or coloured fabrics.

Avoid contact with hair,

fabrics, furniture or carpeting.

Resistance to clindamycin

Patients with a recent history of systemic or topical clindamycin or

erythromycin use are more likely to have pre-existing anti-microbial

resistant Propionibacterium acnes and commensal flora (see section 5.1).

Cross-resistance

Cross-resistance may occur with other antibiotics such as lincomycin and

erythromycin when using antibiotic monotherapy (see section 4.5).

4.5 Interaction with other medicinal products and other forms of interaction

No formal drug-drug interaction studies have been performed with Duac

Gel.

Concomitant topical antibiotics, medicated or abrasive soaps and

cleansers, soaps and cosmetics that have a strong drying effect, and

products with high concentrations of alcohol and/or astringents, should be

used with caution as a cumulative irritant effect may occur.

Duac Gel should not be used in combination with erythromycin-containing

products due to possible antagonism to the clindamycin component.

Clindamycin has been shown to have neuromuscular blocking properties

that may enhance the action of other neuromuscular blocking agents.

Therefore caution should be exercised with concomitant use.

Concomitant application of Duac Gel with tretinoin, isotretinoin and

tazarotene should be avoided since benzoyl peroxide may reduce their

efficacy and increase irritation. If combination treatment is required, the

products should be applied at different times of the day (e.g. one in the

morning and the other in the evening).

Using topical benzoyl peroxide-containing preparations at the same time as

topical sulfonamide-containing products may cause skin and facial hair to

temporarily change colour (yellow/orange).

4.6 Fertility pregnancy and lactation

Pregnancy

There are no adequate data from the use of Duac gel in pregnant women.

Animal reproductive/developmental studies have not been conducted with

Duac gel or benzoyl peroxide. There are limited data on the use of

clindamycin and benzoyl peroxide alone in pregnant women

Data from a

limited number of pregnancies exposed in the first trimester to clindamycin

indicate no adverse effects of clindamycin on pregnancy or on the health

of the foetus/new-born child. Reproduction studies in rats and mice, using

subcutaneous and oral doses of clindamycin, revealed no evidence of

impaired fertility or harm to the foetus due to clindamycin.

The safety of Duac gel in human pregnancy is not established. Therefore,

Duac gel should only be prescribed to pregnant women after careful

risk/benefit assessment by the physician in charge.

Breastfeeding

Use of Duac Gel has not been studied during breastfeeding.

Percutaneous absorption of clindamycin and benzoyl peroxide is low

however; it is not known whether clindamycin or benzoyl peroxide is

excreted in human milk following the use of Duac gel, but oral and

parenteral administration of clindamycin has been reported to result in the

appearance of clindamycin in breast milk. For this reason, Duac gel

should be used during lactation only if the expected benefit justifies the

potential risk to the infant.

To avoid accidental ingestion by the infant if used during lactation, Duac Gel

should not be applied to the breast area.

Fertility

There are no data on the effect of Duac Gel on fertility in humans.

4.7 Effects on ability to drive and use machines

Not relevant

4.8 Undesirable effects

Adverse drug reactions (ADRs) are summarized below for Duac Gel as a

combination including any additional ADRs that have been reported for the single

topical active ingredients, benzoyl peroxide or clindamycin. Adverse drug reactions

are listed by MedDRA system organ class and by frequency. Frequencies are

defined as: 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) and not known (cannot be

estimated from the available data).

MedDRA SOC

Very

Common

Common

Uncommon

Not known**

Immune system

disorders

Allergic reactions

including

hypersensitivity and

anaphylaxis

Nervous

system

disorders

Paraesthesia

Gastrointestinal

disorders

Colitis (including

pseudomembranous

colitis), hemorrhagic

diarrhea, diarrhea,

abdominal pain

Skin and

subcutaneous

tissue

disorders*

Erythema,

peeling,

dryness

(Generally

reported

as ‘mild’ in

severity)

Burning

sensation

Dermatitis,

pruritus,

erythematous

rash,

worsening of

acne

Urticaria

General

disorders and

Application site

reactions including

Administration

site conditions

skin discoloration

*At site of application. **Based on post-marketing reports. Since these reports are

from a population of uncertain size and are subject to confounding factors, it is not

possible to reliably estimate their frequency however, systemic reactions are rarely

seen.

In addition to the ADRs reported in the table above, in the pivotal trial conducted

with topical clindamycin 1%/benzoyl peroxide 3% gel, application site

photosensitivity reaction was also reported commonly.

Also in addition to the ADRs reported above, in studies conducted with topical

clindamycin alone, headache and application site pain were reported commonly.

Local Tolerability

During the five clinical trials with Duac Gel, all patients were graded for facial

erythema, peeling, burning, and dryness on the following scale: 0 = absent, 1 =

mild, 2 = moderate and 3 = severe. The percentage of patients that had symptoms

present before treatment (at baseline) and during treatment were as follows:

Local Tolerability Assessments for Subjects (N=397) in the Duac Gel Group

during the Phase 3 Studies

Before Treatment (Baseline)

During Treatment

Mild

Moderate

Severe

Mild

Moderate

Severe

Erythema

Peeling

<1%

Burning

<1%

<1%

Dryness

<1%

<1%

Reporting of suspected adverse reactions

Suspected adverse reactions should be reported by the physician or other

healthcare provider to the Ministry of Health according to the National

Regulation by using an online form

(

https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffe

ctMedic%40moh.gov.il

) or by email (

adr@MOH.HEALTH.GOV.IL

).

Additionally, you should also report to

www.perrigo-pharma.co.il

.

4.9 Overdose

Excessive application of Duac gel may result in severe irritation. In this

event, discontinue use and wait until the skin has recovered.

Topically applied benzoyl peroxide is not generally absorbed in sufficient

amounts to produce systemic effects.

Excessive application of topically applied clindamycin may result in

absorption of sufficient amounts to produce systemic effects.

In the event of accidental ingestion of Duac gel, gastrointestinal adverse

reactions similar to those seen with systemically administered clindamycin

may be seen.

Appropriate symptomatic measures should be taken to provide relief from

irritation due to excessive application.

Accidental ingestion should be managed clinically or as recommended by

the National Poisons Centre, where available.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Clindamycin, combinations

ATC Code: D10AF51

Clindamycin is a lincosamide antibiotic with bacteriostatic action against

Gram-positive aerobes and a wide range of anaerobic bacteria.

Lincosamides such as clindamycin bind to the 23S subunit of the bacterial

ribosome and inhibit the early stages of protein synthesis. The action of

clindamycin is predominantly bacteriostatic although high concentrations

may be slowly bactericidal against sensitive strains.

Although clindamycin phosphate is inactive in-vitro, rapid in-vivo

hydrolysis converts this compound to the antibacterial active clindamycin.

Clindamycin activity has been demonstrated clinically in comedones from

acne patients at sufficient levels to be active against most strains of

Propionibacterium acnes. Clindamycin in-vitro inhibits all

Propionibacterium acnes cultures tested (MIC 0.4mcg/ml). Free fatty acids

on the skin surface have been decreased from approximately 14% to 2%

following application of clindamycin.

Benzoyl peroxide is mildly keratolytic acting against comedones at all

stages of their development. It is an oxidising agent with bactericidal

activity against Propionibacterium acnes, the organism implicated in acne

vulgaris. Furthermore it is sebostatic, counteracting the excessive sebum

production associated with acne.

Duac gel has a combination of mild keratolytic and antibacterial properties

providing activity particularly against inflamed lesions of mild to moderate

acne vulgaris.

The prevalence of acquired resistance may vary geographically and with

time for selected species. Local information of resistance is desirable,

particularly when treating severe infections.

The inclusion of benzoyl peroxide reduces the potential for the emergence

of organisms resistant to Clindamycin.

The presentation of both active ingredients in one product is more

convenient and ensures patient compliance.

Clinical efficacy and safety

In five randomized double-blind clinical studies of 1318 patients with facial

acne vulgaris with both inflammatory and non-inflammatory lesions, 396

used Duac, 396 used benzoyl peroxide, 349 used clindamycin and 177

used vehicle. Treatment was applied once daily for 11 weeks and patients

were evaluated and lesions counted at 2, 5, 8 and 11 weeks.

The mean percentage reduction in the number of lesions after 11 weeks is

shown in the table.

Mean percent reduction in number of lesions from baseline after 11 weeks

Study

(n =

120)

Study

(n =

273)

Study

(n =

280)

Study

(n =

287)

Study

158*

(n =

358)

Inflammatory lesions

Duac

Benzoyl peroxide

36

37

41

Clindamycin

34

30

49

33

Vehicle

19

-0.4

29

Non-inflammatory lesions

Duac

Benzoyl peroxide

29

Clindamycin

-4

13

11

18

Vehicle

-9

-5

Total lesions (inflammatory plus non-inflammatory lesions)

Duac

Benzoyl peroxide

Clindamycin

11

22

22

33

26

Vehicle

1

-1

22

16

* Pivotal study. Statistically significant differences highlighted in bold.

The reduction in total lesions was significantly greater with Duac gel than

clindamycin or vehicle in all five studies. The improvement was

consistently greater with Duac gel than benzoyl peroxide, but the

difference did not achieve statistical significance in individual studies.

Against inflammatory lesions, Duac gel was significantly superior to

clindamycin alone in four of five studies and to benzoyl peroxide alone in

three of five studies. Against non-inflammatory lesions, Duac gel was

significantly better than clindamycin in four of five studies, and tended to

be better than benzoyl peroxide alone.

Overall improvement in acne was assessed by the physician and was

significantly better with Duac gel than with either benzoyl peroxide or

clindamycin alone in three of five studies.

An effect on inflammatory lesions was apparent from week 2 of treatment.

The effect on non-inflammatory lesions was more variable, with efficacy

generally apparent after 2-5 weeks of treatment.

5.2 Pharmacokinetic properties

In a maximized percutaneous absorption study the mean plasma

clindamycin levels during a four-week dosing period for Duac gel were

negligible (0.043% of applied dose).

The presence of benzoyl peroxide in the formulation did not have an effect

on the percutaneous absorption of clindamycin.

Radio-label studies have shown that absorption of benzoyl peroxide

through the skin can only occur following its conversion to benzoic acid.

Benzoic acid is mostly conjugated to form hippuric acid, which is excreted

via the kidneys.

5.3 Preclinical safety data

Duac gel

a two year carcinogenicity study in mice, topical administration of

Duac gel showed no evidence of increased carcinogenic risk,

compared with controls.

a photococarcinogenicity study in mice, a slight reduction in the

median time to tumour formation was observed relative to controls

following concurrent exposure to Duac gel and simulated sunlight. The

clinical relevance of the findings in this study is unknown.

Repeat-dose dermal toxicity studies conducted on Duac gel, in two

species, for up to 90 days, revealed no toxic effects, apart from minor local

irritation.

An ocular irritation study found Duac gel to be only very slightly irritant.

Benzoyl peroxide

In animal toxicity studies, benzoyl peroxide was well tolerated when

applied topically.

Although high doses of benzoyl peroxide have been shown to induce DNA

strand breaks, the available data from other mutagenicity studies,

carcinogenicity studies and a photo co-carcinogenicity study indicate that

benzoyl peroxide is not a carcinogen or a photocarcinogen.

No reproductive toxicity data are available.

Clindamycin

In-vitro and in-vivo studies did not reveal any mutagenic potential of

clindamycin. No long-term animal studies investigating the tumorigenic

potential of clindamycin have been conducted. Otherwise, preclinical data

reveal no special hazard for humans based on conventional studies of

single and repeat-dose toxicity and toxicity to reproduction.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Carbomer (50000mPa.s)

Dimeticone (100mm

Disodium Lauryl Sulfosuccinate

Edetate Disodium

Glycerol

Silica, Colloidal Hydrated

Poloxamer 182

Purified Water

Sodium Hydroxide

6.2 Incompatibilities

Not applicable

6.3 Shelf life

Shelf life of medicinal product as packaged for sale:

18 months

Shelf life of medicinal product after first opening:

2 months

6.4 Special precautions for storage

Unopened: Store in a refrigerator (2°C-8°C). Do not freeze.

Storage conditions after first opening:

Store below 25°C.

6.5 Nature and contents of container

Internally lacquered membrane-sealed aluminium tubes fitted with a

polyethylene screw-cap, packed into a carton.

Pack sizes: 6 or 25 grams

6.6 Special precautions for disposal and other handling

No special requirements.

7. MANUFACTURER

Glaxo Operations UK Limited, Barnard Castle, UK.

8. REGISTRATION HOLDER AND IMPORTER

Perrigo Israel Agencies Ltd. Bnei –Brak, Israel.

9. REGISTRATION AUTHORISATION NUMBER

140-92-31439-01

The content of this leaflet was checked and approved by the Ministry of

Health in July 2013.

03.2015

העדוה

לע

הרמחה

(

עדימ

ןולעב )תוחיטב

ל

ןכרצ :ךיראת

29.4.2013

םושירה רפסמו תילגנאב רישכת םש

:

140-92-31439-00

Duac Gel

מ"עב תויונכוס לארשי וגירפ : םושירה לעב םש :ןולע דוק

29.04.2013

! דבלב תורמחהה טורפל דעוימ הז ספוט תורמחהה

תושקובמה קרפ

ןולעב טסקט

יחכונ טסקט

שדח שומיש ינפל הפורתב ?הפורתב שמתשהל ןיא יתמ דחאל תושיגר ךל העודי םא שמתשהל ןיא .ןיצימוקנילל וא הפורתה יביכרממ אפורב ץעוויהל ילבמ הפורתב שמתשהל ןיא :םיאבה םירקמב לופיטה תלחתה ינפל .הקינמ וא ןוירהב ךניה םא :תורהזא םע הפורתה עגממ רהזיהל שי שומישה תעב םע ןכו תויריר תומקר וא הפה ,םייניעה שי .םיקלדומ וא םיחותפ םירחא םיעצפ םילפוטמב הפורתה םע תוריהזב שמתשהל תקלד ,םייעמ תקלד לש הירוטסיה ילעב תובקעב סגה יעמב תקלד ,סגה יעמב תיביכ רוע ילעב םילפוטמבו הקיטויביטנא תליטנ םורגל לולע לופיטה םהב יגרלא וא שיגר םיחתפתמש הדימב .רועה לש רתי שובייל תיחפהל שי ,םימזגומ תוימומדא וא יוריג הלולע הפורתה .הפורתב שומישה תורידתב תפוקתב .רעיש וא םיינועבצ םיגירא ןיבלהל הפישחמ ענמיהל ץלמומ הפורתה םע לופיטה .שמשל הפורתל וא והשלכ ןוזמל ה/שיגר ךניה םא ינפל אפורל ךכ-לע עידוהל ךילע ,יהשלכ .הפורתב שומישה :הפורתב שמתשהל ןיא

םא )יגרלא( שיגר התא ,ןיצימדנילק דיסקוריפ ליאוזנב ,ןיצימוקניל

דחא לכל וא הפורתה הליכמ רשא םיפסונה םיביכרמהמ ףיעס האר(

)

דחי םיליכמה םירישכת םע .ןיצימורתירא תודחוימ תורהזא

שומישל תועגונה הפורתב

רועה לע ל'ג קאודב שמתשהל שי .דבלב ,םייניעה :ןוגכ םירוזאמ קחרה ףאה לש ימינפה קלחה וא הפה ,םייתפשה .ךלש

ןיא ל'גב שמתשהל לע

םירוזא

םירוגמ ךרועב

,

ומכ תיווכ ,תוטירש ,םיכתח : .םוגפ רוע וא שמש

הרקמב

לש , הפה ,םייניעה םע עגמ ףאה לש ימינפה קלחה וא םייתפשה ,ךלש שי

ףוטשל .םימ הברה םע בטיה

ל'ג קאוד ידמ רתויב שמתשהל ןיא .רועה לש םישיגרה םירוזיאב

רועב והשלכ םדוא ווחי םילפוטמה בור םינושארה תועובשה ךלהמב ףוליקו קקדזתו ןכתיי ,הרוגמ ךרוע םא .לופיטל שי ,הז הרקמב .ןמוש אלל תוחל םרקל תוקוחר םיתיעל ל'ג קאודב שמתשהל רצק ןמזל שומישה תא קיספהל וא רתוי ןכמ רחאלו םילחהל רועל רשפאל ידכ .לופיטה תא שדחמ לחתה

אפורל תונפלו לופיטה תא קיספהל שי םדואב אטבתמ( רומח רועה יוריג םא וא )הבירצ וא ץוצקע ,דורג ,שבוי ,רומח .יוריגה בצמב רופיש ןיא םא

םידב םע קאוד לש עגמ רשפאל ןיא ,םיעצמ ,תובגמ ,םידגב ללוכ םיינועבצ .םיחיטש וא טוהיר ןיבלהל לולע קאוד :תויתפורת ןיב תובוגת תרמג םא וא תפסונ הפורת ת/לטונ ךניה םא חוודל ךילע ,תרחא הפורתב לופיט התע הז וא םינוכיס עונמל ידכ לפטמה אפורל ,תויתפורת-ןיב תובוגתמ םיעבונה תוליעי-יא רישכת :םע בלושמ לופיטב דחוימב וא םינובס ,ינוציח שומישל רחא יטויביטנא ,רועה תא םיקחושה םייאופר יוקינ ירמוח שבייל םילולעש םייטמסוק םירצומ וא םינובס לש הובג זוכיר םיליכמה םירישכת ,רועה תא שי .םד ילכ םיצווכמ םיביכרמ וא לוהוכלא םע ל'ג קאוד לש ינמז וב שומישמ ענמיהל ןימטיו םיליכמה םירחא םירישכת

.ולא םידב

.רעיש ןיבלהל לולע קאוד

שיגר תויהל ךרועל םורגל לולע קאוד שי .שמשה לש תועגופה תועפשהל רתוי ענמיהל

שומישמ

תוטימב

תורונמ

ףוזיש ךילע .שמשל הפישחה ןמז תא ןיטקהלו שמתשהל

ןנסמב

הנירק

שובללו

דוגיב ןגמ

תעב

שומישה

קאודב .ל'ג ךילע

תונפל

אפורל

וא

חקורל

ינפל שומישה

הפורתב

וז

םא

:

:ןוגכ יעמב היעב לכ רבעב ךל התייה ( םייעמ תקלד

regional enteritis

( סגה יעמב תיביכ תקלד

ulcerative

colitis

תובקעב סגה יעמב תקלד וא ) ( הקיטויביטנא תליטנ

antibiotic

associated colitis

לושלש וא ןטבב תותיווע חתפמ התא קיספהל שי ,רפתשמ וניאש וא רומח .אפורל תונפלו שומישה תא דיימ בצמל םורגל תולולע תוקיטויביטנא .ןטבב תותיווע וא רומח לושלשל ליבומה םע הרקי רבדהש ריבס אלש תורמל .רועה לע החירמל הקיטויביטנא

תופורתב הנורחאל תשמתשה םא וא ןיצימדנילק תוליכמה תורחא קאודש רבגומ יוכיס ונשי ,ןיצימורתירא .שרדנכ ךילע לעפי אל ל'ג רפסל ךילע חקורל וא אפורל תשמתשה םא הליכמה תרחא הפורת לכב הנורחאב .ןיצימורתירא וא ןיצימדנילק ,הנורחאל תחקל םא וא ,חקול התא םא םשרמ אלל תופורת ללוכ תורחא תופורת וא אפורל ךכ לע רפס ,הנוזת יפסותו .חקורל וא אפורה תא עדייל שי דחוימב חקורה

:חקול התא םא

יטויביטנא לופיט לכ .ךרוע לע שומישל הנקאל רחא

יוקינ ירמוח וא םינובס .רועה תא םיקחושה םייאופר

םירצומ וא םינובס לש רתי שובייל םימרוגה םייטמסוק .רועה

תומכ םיליכמה םירצומ .יוטיח ירמוח וא לוהוכלא לש ההובג םע בולישב ולא םירישכתב שומישש ןוויכ יוריגל ןמזה ךשמב םורגל לולע ל'ג קאוד .רועב לש ןתוליעיב הדיריל םורגל לולע ל'ג קאוד רועב לופיטל תוחקלנה תורחא תופורת :ללוכ ןמזה ותואב לופיטל תומייוסמ תופורת תוליכמה הנקאב ןיאוניטרטוזיא ,ןיאוניטרט .ןיטורזט וא תופורת לטונ התא םא אפורל רפסל ךילע םירצומה ינשב שמתשהל ךרטצתו ןכתיי ,ולא רקובב דחא :לשמל( םויב םינוש םינמזב .)הלילב ינשהו לופיטל דחי םירצומ רפסמ לש שומיש .רועה יוריגל ןוכיסה תא הלעמ הנקאב ןוספד ומכ תופורת םע דחי ל'ג קאודב שומיש עבצב ינמז יונישל םורגל לוכי ,דימאטפלוסו .רעישה וא/ו םינפה רובעל דמוע התא םא אפורב ץעוויהל שי לע עיפשהל לוכי ל'ג קאוד ןוויכמ ,חותינ .תומיוסמ המדרה תופורת תוליעפ

יאוול תועפות

:יאוול תועפות

ןמזב ,הפורתה לש היוצרה תוליעפל ףסונ עיפוהל תולולע הב שומישה ות יאוול תועפ :ןוגכ ,ימוקמ יוריג ,ימוקמ ףוליקו שבוי ,תוימומדא .דרגו הבירצ תשוחת רצק ןמז ךות ללכ ךרדב תופלוח ולא תועפות רתל תולגתסהה תפוקת רחאל הפו

תועפות יאוול :תדחוימ תוסחייתה תובייחמה ןטב יבאכ ,ךשוממו יתועמשמ לושלש :)רידנ( קספה י/

תא הנפו לופיטה י/ אפורל !דימ תולולעה תויגרלא תובוגת לש םירקמ לע חווד .תורומחו תוימואתפ תויהל יאוול תועפות ה/שיגרמ ךניה ובש הרקמ לכב יוניש לח םא וא ,הז ןולעב ונייוצ אלש אפורה םע ץעייתהל ךילע תיללכה ךתשגרהב .דימ ומכ

ב שומישה ,הפורת לכב ל'ג קאוד לולע .םישמתשמהמ קלחב יאוול תועפותל םורגל .יאוולה תועפות תמישר ארקמל להבית לא ןהמ תחא ףאמ לובסת אלו ןכתיי

ךילע

לופיטה תא קיספהל ל'ג קאודב תונפלו אפורל

םא דימ :םיאבה םינמיסה םיעיפומ

םינמיס תוחיפנ ומכ( תיגרלא הבוגתל ,ןושל וא םייתפש ,םייניע ,םינפה לש תדפרס ,המישנב םיישק , תוטטומתה

לושלש

ךשוממ

וא

רומח

תותיווע

ןטבב

.םירומח דוריג וא הבירצ ,ףוליק

תובורק םיתיעל תועיפומ :דואמ ףוליק ,םדוא בורל הלא יאוול תועפות .ימוקמ שבויו .תונותמ תובורק םיתיעל תועיפומ

:

.שאר יבאכ

רוזאב ,הבירצ :לופיטה באכ

תושיגר

רואל

תוקוחר םיתיעל תועיפומ

,)היזתסרפ( ץוצקע ,הנקאה לש הרמחה ,דרגמו םודא רוע ( החירפ

dermatitis, erythematous

rash

.

תועיפומ :העודי הניאש תוריבסב

תובוגת יעמה לש תקלד ,תויגרלא ,לושלש , ללוכ ןטב יבאכ ,ימד לושלש

:לופיטה רוזאב ,רועה עבצב יוניש ,רועב תועפות החירפ תדרגמ

וא ,הרימחמ יאוולה תועפותמ תחא םא אלש יאוול תעפותמ לבוס התא רשאכ .אפורה םע ץעייתהל ךילע ,ןולעב הרכזוה העדוה

לע

הרמחה

(

עדימ

ןולעב )תוחיטב

ל

אפור :ךיראת

29.4.2013

םושירה רפסמו תילגנאב רישכת םש

:

140-92-31439-00

Duac Gel

מ"עב תויונכוס לארשי וגירפ : םושירה לעב םש :ןולע דוק

29.04.2013

! דבלב תורמחהה טורפל דעוימ הז ספוט תורמחהה

תושקובמה קרפ

ןולעב טסקט

יחכונ טסקט

שדח

4.4 Special

warnings and

special

precautions for

use

Contact with the mouth, eyes and mucous

membranes and with abraded or

eczematous skin should be avoided.

Application to sensitive areas of skin

should be made with caution. In the event

of accidental contact with the eyes, bathe

with copious amounts of water.

Duac gel should be used with caution in

patients with a history of regional enteritis

or ulcerative colitis, or a history of

antibiotic-associated colitis. It should also

be used with caution in atopic patients, in

whom further skin drying may occur.

The frequency of application should be

reduced if excessive irritation or dryness

develops.

If prolonged or significant diarrhoea

occurs or the patient suffers from

abdominal cramps, treatment with Duac

gel should be discontinued immediately,

as the symptoms may indicate antibiotic-

associated colitis. Suitable diagnostic

methods, such as the determination of

Clostridium difficile and toxin and, if

necessary, colonoscopy should be

employed and treatment options for colitis

considered.

The product may bleach hair or coloured

fabrics.

It is recommended that exposure to sun or

sunlamps should be minimised.

Patients should be advised that, in some

Contact with the mouth, eyes, lips and

mucous membranes and or areas of

with abraded irritated or broken

eczematous skin should be avoided.

Application to sensitive areas of skin

should be made with caution. In case

of accidental contact, rinse well with

water. In the event of accidental

contact with the eyes, bathe with

copious amounts of water.

During the first weeks of treatment, an

increase in peeling and reddening will

occur in most patients. Depending

upon the severity of these side effects,

patients can use a non-comedogenic

moisturiser, temporarily reduce the

frequency of application of Duac Once

Daily Gel or temporarily discontinue

use; however, efficacy has not been

established for less than once daily

dosing frequencies.

Duac gel should be used with caution

in patients with a history of regional

enteritis or ulcerative colitis, or a history

of antibiotic-associated colitis.

Duac gel It should also be used with

caution in atopic patients, in whom

further skin drying may occur.

The frequency of application should be

reduced if excessive irritation or

dryness develops.

During the first weeks of treatment, an

increase in peeling and reddening will

occur in most patients. Depending

cases, 4-6 weeks of treatment may be

required before the full therapeutic effect

is observed.

Cross-resistance may occur with other

antibiotics such as lincomycin and

erythromycin when using antibiotic

monotherapy.

Local recommendations about

antibiotic use and prevalence of

acquired resistance should be taken

into consideration.

upon the severity of these side effects,

patients can use a non-comedogenic

moisturiser, temporarily reduce the

frequency of application of Duac Gel or

temporarily discontinue use; however,

efficacy has not been established for

less than once daily dosing

frequencies.

Concomitant topical acne

therapy should be used with

caution because a possible

cumulative irritancy may occur,

which sometimes may be

severe, especially with the use of

peeling, desquamating, or

abrasive agents.

If severe local irritancy )e.g.

severe erythema, severe

dryness and itching, severe

stinging/burning( occurs, Duac

Gel should be discontinued.

As benzoyl peroxide may cause

increased sensitivity to sunlight,

sunlamps should not be used

and deliberate or prolonged

exposure to sun should be

avoided or minimised. When

exposure to strong sunlight

cannot be avoided, patients

should be advised to use a

sunscreen product and wear

protective clothing.

If a patient has sunburn, this should be

resolved before using Duac Gel.

If prolonged or significant diarrhoea

occurs or the patient suffers from

abdominal cramps, treatment with

Duac gel should be discontinued

immediately, as the symptoms may

indicate antibiotic-associated colitis.

Suitable diagnostic methods, such as

the determination of Clostridium difficile

and toxin and, if necessary,

colonoscopy should be employed and

treatment options for colitis considered.

The product may bleach hair or

coloured fabrics. Avoid contact with

hair, fabrics, furniture or carpeting.

It is recommended that exposure to

sun or sunlamps should be minimised.

Patients should be advised that, in

some cases, 4-6 weeks of treatment

may be required before the full

therapeutic effect is observed.

Resistance to clindamycin

Patients with a recent history of

systemic or topical clindamycin

or erythromycin use are more

likely to have pre-existing anti-

microbial resistant

Propionibacterium acnes and

commensal flora )see section

5.1(.

Cross-resistance

Cross-resistance may occur with other

antibiotics such as lincomycin and

erythromycin when using antibiotic

monotherapy )see section 4.5(.

Local recommendations about

antibiotic use and prevalence of

acquired resistance should be taken

into consideration.

4.8 Undesirable

effects

Immune System Disorders

In the post-marketing environment there

have been instances of allergic reactions

which can be sudden and severe.

In a few susceptible individuals there have

been isolated reports of

pseudomembraneous colitis or diarrhoea

due to other topical treatments containing

clindamycin. This is unlikely to occur with

Duac gel, as plasma levels have been

determined and the percutaneous

absorption of clindamycin is clinically

negligible.

With long term use of Duac gel resistance

may occur.

Duac gel may cause:

Skin and Subcutaneous Tissue Disorders;

erythema, peeling, dryness, and pruritus

at the site of application

Skin and Subcutaneous Tissue Disorders;

Immune system disorders: Not

known: Allergic reactions including

hypersensitivity and anaphylaxis

Gastrointestinal disorders

:

Not known: Colitis )including

pseudomembranous colitis(,

haemorrhagic diarrhoea, diarrhoea,

abdominal pain

Skin and subcutaneous tissue

disorders*: Very common: Erythema,

peeling, dryness

(

Generally reported as ‘mild’ in severity

Common: Burning sensation.

Uncommon: Dermatitis, pruritus,

erythematous rash, worsening of acne.

Not Known: Urticaria

General disorders and Administration

site conditions

:

Not known: Application site reactions

including skin discoloration

worsening of acne and contact dermatitis

can occur.

These localised effects are typically mild

to moderate. Reported frequencies in

clinical trials are:

Very common )>1/10(

Skin and Subcutaneous Tissue Disorders;

Erythema, Peeling, Dryness

Common )>1/100, <1/10(

Skin and Subcutaneous Tissue Disorders;

Burning, Pruritus

Uncommon )>1/1000, <1/100(

Skin and Subcutaneous Tissue Disorders;

Worsening of acne

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