Dalacin T Topical Lotion 10 mg/ml Cutaneous Emulsion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clindamycin

Available from:

Pfizer Healthcare Ireland

ATC code:

D10AF; D10AF01

INN (International Name):

Clindamycin

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Cutaneous emulsion

Prescription type:

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

Therapeutic area:

Antiinfectives for treatment of acne; clindamycin

Authorization status:

Marketed

Authorization date:

1991-01-03

Patient Information leaflet

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2021-0073326
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DALACIN
® T TOPICAL LOTION 10 MG/ML CUTANEOUS EMULSION
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 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 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 lotion. 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
lotion and
TELL YOUR DOCTOR IMMEDIATELY.
This may be a sign of bowel inflammation
(
_pseudomembranous colitis_
) which can occur following treatment with antibiotics.
Take care when using the lotion around your mouth as it has an
unpleasant taste.
OTHER MEDICINES AND DALACIN T
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other
medicines, or i

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 Lotion 10 mg/ml Cutaneous Emulsion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of emulsion contains clindamycin phosphate equivalent to 10 mg
clindamycin.
Excipients with known effect:
Cetostearyl alcohol 25 mg/ml
Methyl parahydroxybenzoate (E218) 3 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous emulsion.
A smooth, white to off-white emulsion.
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 Lotion twice daily to the
affected area after thorough cleansing.
Method of administration
Topical.
4.3 CONTRAINDICATIONS
Topical clindamycin is contra-indicated in individuals with a history
of hypersensitivity to clindamycin, lincomycin or to any of
the excipients listed in section 6.1. This is also contra-indicated 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 diarrhoea and severe
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 should be discontinued
immediate