Zindaclin 1% Gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLINDAMYCIN PHOSPHATE

Available from:

KCI Europe Holding B.V.

ATC code:

D10AF; D10AF01

INN (International Name):

CLINDAMYCIN PHOSPHATE

Dosage:

1 percent weight/weight

Pharmaceutical form:

Gel

Therapeutic area:

Antiinfectives for treatment of acne; clindamycin

Authorization status:

Marketed

Authorization date:

2002-11-22

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZINDACLIN® 1% GEL
Clindamycin Phosphate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE.
➢
Keep this leaflet. You may need to read it again.
➢
If you have any further questions, ask your doctor or pharmacist.
➢
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
➢
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Zindaclin is and what it is used for.
2. Before you use Zindaclin.
3. How to use Zindaclin.
4. Possible side effects.
5. How to store Zindaclin.
6. Further information.
1.
WHAT ZINDACLIN IS AND WHAT IT IS USED FOR
Zindaclin is used to treat mild to moderate acne (spots). Zindaclin
contains an antibiotic clindamycin
that reduces the number of bacteria and stops the skin pores becoming
blocked and new spots forming.
Zindaclin may also help to reduce the redness of the spots you already
have.
It will take some time once you have started using Zindaclin before
you see your acne improving.
WHAT IS ACNE?
Acne is an extremely common skin condition most common in adolescence,
but not restricted to this
stage of life. During adolescence, glands in the skin produce extra
grease in response to normal
amounts of sex hormones in the body, and this can cause blocked pores,
resulting in blackheads. When
this happens the pores are invaded by bacteria. The chemicals produced
by these bacteria go into
deeper layers of the skin and produce red spots filled with pus.
2.
BEFORE YOU USE ZINDACLIN
DO NOT USE ZINDACLIN
➢
If you are allergic (hypersensitive) to the active substance
clindamycin phosphate or any of the other
ingredients (See Section 6).
➢
If you are allergic (hypersensitive) to lincomycin another type of
antibiotic.
An allergic reaction may include a rash, red skin, itching, swelling
or breathing difficulties.
Zindaclin

Summary of Product characteristics

Health Products Regulatory Authority
06 November 2020
CRN009TLL
Page 1 of 4
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
Studies indicate a toxin(s) produced by _Clostridium difficile_ is the
major cause of antibiotic-associated colitis. Colitis is usually
characterised by severe persistent diarrhoea and abdominal cramps.
Should antibiotic associated colitis occur appropriate
diagnostic and therapeutic measures (such as stopping Zindaclin and,
if necessary, antibiotic treatment such as metronidazole
or vancomycin treatment) should be taken imme