Zindaclin 1% gel

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clindamycin phosphate

Available from:

Canute Pharma 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; GTIN: 5038903000181

Patient Information leaflet

03830700-0820 ZINDACLIN 1 % GEL, UK ❹ • 148 x 540 (270) mm •
Black • Code 0410
z x x z z x z z
• Permission to print at __.__.2021
_CC-2020-00215_
03830700-0820
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 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.
TAK

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
INDACLIN 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 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,
ulcerative colitis or Cro