Core Safety Profile

M0B

Active substance:
Pharmaceutical form(s)/strength:

P-RMS:
Date of FAR:

Clindamycin
300mg/2 ml Ampulle, 600 mg/4 ml
Ampulle, 900 mg/6 ml Ampulle, 75 mg/5
ml Granulat fr orale Lsung, 150 mg
Kapselnn, 300 mg Kapseln, Lsung zur
uerlichen Anwendung, Lotion.
Vaginalcreme
AT/H/PSUR/0035/001
25.11.2013

EU Core Safety Profile

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Active Substance: Clindamycin Phosphate (Topical Preparations)

Brand Names: CELOCIN T, DALACIN C, DALACIN T,
DALACINE, DALACINE T, DALACIN
EMULSION, DALACIN TOPICO, DALACIN
GEL, DALACIN TOPICAL LOTION,
DALACIN LOTION, DALACIN TOPICAL
SOLUTION
Pharmaceutical form(s)/strength: 1% and 10mg/ml Cutaneous Emulsion, 1%
Topical Gel, 1% Cutaneous Lotion, 1%
Topical Lotion, 1% and 10mg/ml Cutaneous
Solution, 1% and 10mg/ml Topical Solution,
P-RMS: Austria
Date: 13 December 2012
Supersedes:

4.3

Contraindications
Topical clindamycin is contraindicated in individuals with a history of
hypersensitivity to clindamycin, lincomycin, or to any excipient listed in Section
6.1 (List of excipients). Clindamycin topical is contraindicated in individuals with
a history of antibiotic-associated colitis.

4.4

Special warnings and precautions for use

Oral and parenteral clindamycin, as well as most other antibiotics, have been
associated with severe diarrhea and pseudomembranous colitis (see Section 4.8),.
Use of the topical formulation of clindamycin results in absorption of the
antibiotic from the skin surface. Diarrhea and colitis have been reported
infrequently with topical clindamycin. Therefore, the physician should be alert to
the possible development of antibiotic-associated diarrhea or colitis. If significant
or prolonged diarrhea occurs, the drug should be discontinued and appropriate
diagnostic procedures and treatment provided as necessary.
Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up
to several weeks following cessation of oral and parental therapy with
clindamycin.
Topical clindamycin solution contains an alcohol base and can cause burning and
irritation of eyes, mucous membranes and abraded skin.

4.5

Interaction with other medicinal products and other forms of interaction

Systemic clindamycin has been shown to have neuromuscular blocking properties
that may enhance the action of other neuromuscular blocking agents. Therefore, it
should be used with caution in patients receiving such agents.

4.6

Fertility, pregnancy and lactation

Pregnancy
Oral and subcutaneous reproductive toxicity studies in rats and rabbits revealed
no evidence of impaired fertility or harm to the fetus due to clindamycin, except
at doses that caused maternal toxicity. Animal reproduction studies are not always
predictive of human response.

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In clinical trials with pregnant women, the systemic administration of clindamycin

during the second and third trimesters, has not been associated with an increased
frequency of congenital abnormalities.
Clindamycin should be used during the first trimester of pregnancy only if clearly
needed. There are no adequate and well-controlled studies in pregnant women
during the first trimester of pregnancy.
Lactation
It is not known whether clindamycin is excreted in human milk following use of
topical clindamycin. However, orally and parenterally administered clindamycin
has been reported to appear in breast milk. Because of the potential for serious
adverse reactions in nursing infants, a decision should be made whether to
discontinue nursing or to discontinue the drug, taking into account the importance
of the drug to the mother.
Fertility
Fertility studies in rats treated orally with clindamycin revealed no effects on
fertility or mating ability.
4.7

Effects on ability to drive and use machines

Clindamycin has no or negligible influence on the ability to drive and use
machines.

4.8

Undesirable effects
The table below lists the adverse reactions identified through clinical trial
experience and post-marketing surveillance by system organ class and frequency.
Adverse reactions identified from post-marketing experience are included in

italics. The frequency grouping is defined using the following convention: Very
common (1/10); Common ( 1/100 to <1/10); Uncommon (1/1,000 to <1/100);
Rare ( 1/10,000 to <1/1,000); Very Rare (< 1/10,000); and Not known (cannot
be estimated from the available data). Within each frequency grouping,
undesirable effects are presented in order of decreasing seriousness.
Clindamycin Topical Gel

System Organ
Class

Very
Common
1/10

Common
1/100
to < 1/10

Uncommon
1/1 000
to <1/100

Rare
1/10
000 to
<1/1
000

Very
Rare
< 1/10
000

Folliculitis

Infections and
Infestations
Eye Disorders

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Eye pain
Abdominal pain
Pseudomembranous
colitis (see section 4.4)

Gastrointestin
al disorder

Gastrointestinal
Disorders
Skin and
Subcutaneous Tissue
Disorders

Not Known
(cannot be estimated
from available data)

Skin
irritation
Seborrhoea

Urticaria
Dermatitis contact

Clindamycin Topical Solution

System Organ
Class

Very
Common
1/10

Common
1/100
to < 1/10

Uncommon
1/1 000
to <1/100

Very
Rare
<
1/10
000

Not Known
(cannot be estimated
from available data)

Folliculitis

Infections and
Infestations
Eye Disorders
Gastrointestina
l disorder

Gastrointestinal
Disorders
Skin and
Subcutaneous Tissue
Disorders

Rare
1/10
000 to
<1/1 000

Dry skin
Skin
irritation
Urticaria

Seborrhoea

Eye pain
Abdominal pain
Pseudomembranous
colitis (see section 4.4)
Dermatitis contact

Clindamycin Topical Lotion

System Organ
Class

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Common
1/100
to < 1/10

Uncommo
n
1/1 000
to <1/100

Rare
1/10
000 to
<1/1 000

Very
Rare
< 1/10
000

Not Known
(cannot be estimated
from available data)

Infections and
Infestations
Eye Disorders

Folliculitis

Gastrointestinal
Disorders

Abdominal pain
Gastrointestinal
disorder
Pseudomembranous
colitis (see section 4.4)
Dermatitis contact

Skin and Subcutaneous

Tissue Disorders

4.9

Very
Common
1/10

Eye pain

Skin
irritation
Urticaria

Seborrhoea

Overdose
Topically applied clindamycin can be absorbed in sufficient amounts to produce
systemic effects.
In the event of overdosage, general symptomatic and supportive measures are
indicated as required.