Zindaclin 1% Gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLINDAMYCIN PHOSPHATE

Available from:

Crawford Healthcare Limited

ATC code:

D10AF; D10AF01

INN (International Name):

CLINDAMYCIN PHOSPHATE

Dosage:

1 percent weight/weight

Pharmaceutical form:

Gel

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Antiinfectives for treatment of acne; clindamycin

Authorization status:

Marketed

Authorization date:

2002-11-22

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zindaclin 1% Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1g of gel contains 10mg clindamycin (1% w/w) equivalent to 11.88 mg
clindamycin phosphate. Zindaclin 1% Gel also
contains 40% w/w propylene glycol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel.
A white translucent gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zindaclin is indicated for the treatment of mild to moderate acne
vulgaris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and adolescents
Apply a thin film of Zindaclin once daily to the affected area.
Patient response should be reviewed after 6-8 weeks of
treatment and the duration of treatment should be limited to 12 weeks.
Children
Zindaclin is not indicated for use in children below the age of 12
years.
Cutaneous use.
4.3 CONTRAINDICATIONS
Zindaclin 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 should not be used in patients who have
demonstrated lincomycin sensitivity.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Oral and parenteral clindamycin, as well as most other antibiotics,
have been associated with severe
pseudomembranous colitis. Topical clindamycin has very rarely been
associated with pseudomembranous colitis;
however if diarrhoea occurs the product should be discontinued
immediately.
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