Dalacin T 1% topical solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clindamycin phosphate

Available from:

Pfizer Ltd

ATC code:

D10AF01

INN (International Name):

Clindamycin phosphate

Dosage:

10mg/1ml

Pharmaceutical form:

Cutaneous solution

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13060100; GTIN: 5012882001216 5012882002374

Patient Information leaflet

Dalacin
®
T
Topical Solution/Topical Lotion
Clindamycin phosphate
Read all of this leaflet
carefully before you
start using this medicine
because it contains
important information for
you.
•
Keep this leaflet. You may
need to read it again.
•
If you have any further
questions, ask your doctor or
your pharmacist.
•
This medicine has been
prescribed for you only. Do
not pass it on to others. It
may harm them, even if their
signs of illness are the same
as yours.
•
If you get any side effects,
talk to your doctor or
pharmacist. This includes
any possible side effects
not listed in this leaflet. See
section 4.
What is in this leaflet
1. What Dalacin T is and what
it is used for
2. What you need to know
before you use Dalacin T
3. How to use Dalacin T
4. Possible side effects
5. How to store Dalacin T
6. Contents of the pack and
other information
1. What Dalacin T
is and what it is
used for
Dalacin T contains an antibiotic
called clindamycin phosphate
and comes as either a solution
or lotion. The solution and the
lotion are used on the skin to
treat acne.
2. What you need to
know before you
use Dalacin T
Do not use Dalacin T:
•
if you are hypersensitive
(allergic) to clindamycin,
lincomycin or to any of the
other ingredients of this
medicine (listed in section 6).
•
If you have a history of
inflammatory bowel disease
or antibiotic‑associated
colitis.
Warnings and precautions
Talk to your doctor or
pharmacist before using
Dalacin T if you have diarrhoea
or usually get diarrhoea when
you take antibiotics.
If you develop severe or
prolonged or bloody diarrhoea
during or after using Dalacin
tell your doctor immediately
since it may be necessary to
interrupt the treatment. This may
be a sign of bowel inflammation
_(pseudomembranous colitis)_
which can occur following
treatment with antibiotics.
Dalacin T Topical Solution
contains alcohol, which can
cause burning or irritation of
your eyes. Keep it away from
your eyes, mouth, and cuts or
grazes on your skin. If you get
any of these sensitive areas,
wash it aw

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dalacin
®
T Topical Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of Dalacin T Topical Solution contains the equivalent of 10 mg
Clindamycin.
Excipients with known effect:
Propylene glycol 50 mg/ml.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Topical solution.
Colourless aqueous solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dalacin T Topical Solution is indicated in the treatment of acne
vulgaris
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Apply a thin film of Dalacin T Topical Solution twice daily to the
affected
area.
Shake well before use.
4.3
CONTRAINDICATIONS
Topical clindamycin is contraindicated in individuals with a history
of
hypersensitivity to clindamycin, lincomycin or to any of the
excipients listed
in section 6.1. Clindamycin topical is contraindicated in individuals
with a
history of inflammatory bowel disease or a history of
antibiotic-associated
colitis.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Products containing benzoyl peroxide should not be used concurrently
with
Dalacin T Topical Solution.
Oral and parenteral clindamycin, as well as most other antibiotics,
have been
associated with severe pseudomembranous colitis. Post-marketing
studies,
however, have indicated a very low incidence of colitis with Dalacin T
Topical
Solution. The physician should, nonetheless, be alert to the
development of
antibiotic associated diarrhoea or colitis. If significant or
prolonged diarrhoea
occurs, the product should be discontinued immediately.
Diarrhoea, colitis, and pseudomembranous colitis have been observed to
begin
up to several weeks following cessation of oral and parenteral therapy
with
clindamycin.
Studies indicate a toxin(s) produced by _Clostridium difficile_ is the
major cause
of antibiotic associated colitis. Colitis is usually characterised by
persistent,
severe diarrhoea and abdominal cramps. Endoscopic examination may
reveal
pseudomembranous colitis. Stool culture for _C.