Zindaclin 1% gel

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clindamycin phosphate

Available from:

Lexon (UK) Ltd

ATC code:

D10AF01

INN (International Name):

Clindamycin phosphate

Dosage:

10mg/1gram

Pharmaceutical form:

Cutaneous gel

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13060100

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 acne (spots). Zindaclin is an antibiotic
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.
Zindaclin should NOT be used by children under the age of 12 years.
TAKE SPECIAL CARE WITH ZINDACLIN
•
Before you use Zindaclin consult your doctor if you suffer from a
condition known as inflammatory bowel disease or you
have had diarrhoea when you have taken antibiotics. If you do get
diarrhoea, when using Zindaclin, you must stop using
it straight away and tell your doctor IMMEDIATELY.
TAKING OTHER MEDICINES
Please tell your doctor or pharmacist if you are taking or recently
taken or used any other medicines, including medicines you
have bought without a prescription.
PREGNANCY AND BREAST-FEEDING
Ask your doctor or pharmacist for advice before taking or using any
medicin

Summary of Product characteristics

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. For
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.
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 SPECIAL 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 vancomycin
treatment)
should be taken immediately.
Responses may not be seen for 4-6 weeks.
Although the risk of systemic absorption following the administration
of ZINDACLIN
is low, the potential for the development of gastrointestinal adverse
effects should be
taken into account when considering treatment in patients with a
previous history of
antibiotic-associated colitis, enteritis, ulcerat