Dalacin T Topical 10 mg/ml Cutaneous Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLINDAMYCIN PHOSPHATE

Available from:

Pfizer Healthcare Ireland

ATC code:

D10AF; D10AF01

INN (International Name):

CLINDAMYCIN PHOSPHATE

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Cutaneous solution

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Antiinfectives for treatment of acne; clindamycin

Authorization status:

Not marketed

Authorization date:

1989-04-12

Patient Information leaflet

Page 1 of 4
2018-0036675
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DALACIN
®
T TOPICAL 10 MG/ML CUTANEOUS SOLUTION
clindamycin (as 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 onto
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 a solution. It is 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 allergic (hypersensitive) to clindamycin, lincomycin or to
any of the other
ingredients of this medicine (listed in section 6).

If you have or have suffered from inflammatory bowel disease including
bowel inflammation
following treatment with antibiotics (antibiotic-associated colitis).

If you are taking an antibiotic to treat an infection.
WARNINGS AND PRECAUTIONS
If you develop severe or prolonged or bloody diarrhoea when using
Dalacin T stop using the
solution and TELL YOUR DOCTOR IMMEDIATELY. This may be a sign of bowel
inflammation
(_pseudomembranous colitis_) which can occur following treatment with
antibiotics.
Dalacin T 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 Dalacin T Solution on
any of these sensitive ar

Summary of Product characteristics

Health Products Regulatory Authority
17 November 2019
CRN008N80
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dalacin T Topical 10 mg/ml Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains clindamycin phosphate equivalent to 10 mg
of clindamycin.
Excipients with known effect:
Propylene glycol 50 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution.
A clear, colourless solution with characteristic isopropyl alcohol
odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of acne vulgaris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Apply a thin film of Dalacin T Topical Solution twice daily to the
affected area after thorough cleansing.
Method of administration
Topical.
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. This is also contraindicated in
patients with a history of inflammatory bowel disease or a
history of antibiotic-associated colitis.
Dalacin T should not be used in patients with systemic infections for
which antimicrobials are being used.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If there is no response within a few weeks, alternative therapy should
be considered, but a response may not be seen for 4‑6
weeks.
_ _
_Clostridium difficile _associated diarrhoea(CDAD)
Oral and parenteral clindamycin, as well as most other antibiotics,
have been associated with severe diarrhoea and
pseudomembranous colitis (see section 4.8). Use of the topical
formulation of clindamycin results in absorption of the
antibiotic from the skin surface. Diarrhoea and colitis have been
reported infrequently with topical clindamycin. Therefore, the
physician should, nonetheless, be alert to the possible development of
antibiotic‑associated diarrhoea or colitis. If significant
or prolonged diarrhoea occurs, the drug product should be discontinued
immedia