ZINDACLIN 1 % GEL

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

CLINDAMYCIN PHOSPHATE

제공처:

TARO INTERNATIONAL LTD, ISRAEL

ATC 코드:

D10AF01

약제 형태:

GEL

구성:

CLINDAMYCIN PHOSPHATE 1 %W/W

관리 경로:

DERMAL

처방전 유형:

Required

Manufactured by:

DR. AUGUST WOLFF GMBH & CO., GERMANY

치료 그룹:

CLINDAMYCIN

치료 영역:

CLINDAMYCIN

치료 징후:

Zindaclin is indicated for the treatment of acne vulgaris.

승인 날짜:

2023-06-30

환자 정보 전단

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s
prescription only
ZINDACLIN 1% GEL
COMPOSITION:
Each gram of gel contains 10 mg clindamycin (1% w/w)
equivalent to 11.88 mg clindamycin phosphate.
For a list of inactive ingredients and allergens in the
preparation - see section 6 “Further Information”.
READ THE PACKAGE INSERT CAREFULLY IN ITS ENTIRETY
BEFORE USING THIS MEDICINE. This leaflet contains
concise information about the medicine. If you have
further questions, refer to the doctor or pharmacist.
This medicine has been prescribed for you. Do not
pass it on to others. It may harm them even if it seems
to you that their medical condition is similar.
The medicine is not intended for infants and children
under the age of 12.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the treatment of acne
vulgaris.
THERAPEUTIC GROUP:
Clindamycin is a lincosamide antibiotic.
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF:
• You are breastfeeding.
• You are sensitive (allergic) to the active ingredient
or to any of the other ingredients contained in the
medicine.
For the list of inactive ingredients - see section 6
“Further Information”.
• You are sensitive (allergic) to lincomycin - another
type of antibiotic.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE: BEFORE USING ZINDACLIN 1% GEL, TELL THE DOCTOR IF:
• You are pregnant, think that you might be pregnant
or are trying to become pregnant.
• You suffer, or have suffered in the past, from
impaired function of the digestive system (e.g.,
ulcer), inflammation of the colon.
• You suffered from diarrhea while taking an
antibiotic.
• You are sensitive to any food or medicine.
IF YOU ARE TAKING, OR HAVE RECENTLY TAKEN, OTHER
MEDICINES, INCLUDING NON-PRESCRIPTION MEDICINES
AND NUTRITIONAL SUPPLEMENTS, TELL YOUR DOCTOR OR
PHARMACIST. PREGNANCY AND BREASTFEEDING
• If you are pregnant, think that you might be pregnant
or are trying to become

제품 특성 요약

1
Zindaclin 1% Gel- SPC – 06.2023
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zindaclin 1% Gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The gel contains clindamycin phosphate equivalent to clindamycin 1%
w/w.
3.
PHARMACEUTICAL FORM
Gel
A white translucent gel.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Zindaclin 1% Gel is indicated for the treatment of mild to moderate
acne vulgaris.
4.2
Posology and method of administration
Cutaneous use.
Adults and adolescents
Apply a thin film of Zindaclin 1% Gel once daily to the affected area.
Patient
response should be reviewed periodically.
Children
Zindaclin 1% Gel is not indicated for use in children below the age of
12 years.
4.3
Contraindications
Zindaclin 1% Gel is contra-indicated in patients with a
hypersensitivity to the active
substance clindamycin or to any of the excipients in the medicinal
product. Although
cross-sensitisation to lincomycin has not been demonstrated, it is
recommended that
Zindaclin 1% Gel should not be used in patients who have demonstrated
lincomycin
sensitivity.
4.4
Special warnings and precautions for use
The product contains approximately 20% ethanol. Each gram contains
approximately
0.2 gram alcohol.
Do not light a cigarette or come in contact with an open flame until
the product has
been completely dried off.
Oral and parenteral clindamycin, as well as most other antibiotics,
have been
associated with severe pseudomembranous colitis. Topical clindamycin
has very
2
Zindaclin 1% Gel- SPC – 06.2023
_ _
rarely been associated with pseudomembranous colitis; however if
diarrhea occurs the
product should be discontinued immediately.
Studies indicate a toxin(s) produced by
_Clostridium difficile_
is the major cause of
antibiotic-associated colitis. Colitis is usually characterized by
severe persistent
diarrhea and abdominal cramps. Should antibiotic associated colitis
occur, appropriate
diagnostic and therapeutics measures (Such as vancomycin treatment)
should be taken
immediately. Responses may not be