Dalacin 2% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clindamycin phosphate

Available from:

Pilsco Ltd

ATC code:

G01AA10

INN (International Name):

Clindamycin phosphate

Dosage:

20mg/1gram

Pharmaceutical form:

Vaginal cream

Administration route:

Vaginal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07020200; GTIN: 05060669870333

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DALACIN
® 2% CREAM
(CLINDAMYCIN PHOSPHATE)
The name of this product is Dalacin® 2%Cream but will be referred
to as Dalacin Cream throughout this leaflet.
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 your
pharmacist.
•
This medicine has been prescribed for you. Do not pass it onto
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
your
pharmacist.
IN THIS LEAFLET:
1. What Dalacin Cream is and what it is used for
2. Before you use Dalacin Cream
3. How to use Dalacin Cream
4. Possible side effects
5. How to store Dalacin Cream
6. Further Information
1.
WHAT DALACIN CREAM IS AND WHAT IT IS
USED FOR
Dalacin Cream is a vaginal cream. It contains clindamycin
phosphate which is an antibiotic. It is used in the treatment of
bacterial vaginosis (a bacterial infection of the vagina).
2.
BEFORE YOU USE DALACIN CREAM
DO NOT USE DALACIN CREAM
If you are allergic (hypersensitive) to clindamycin, lincomycin or to
any of the other ingredients in this cream.
Do not use if you suffer with a history of inflammatory bowel
disease or antibiotic-associated colitis.
TAKE SPECIAL CARE WITH DALACIN CREAM
Before taking this medicine make sure that your doctor knows 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 Cream 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 cream is not recommended for use in children.
As with all vaginal infections, sexual intercourse during treatment
with Dalacin Cream is not recommended. Dalacin Cream m

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dalacin Cream 2%.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains clindamycin phosphate equivalent to 20 mg
or
2.0% w/w clindamycin. Each applicator full of 5 grams of vaginal cream
contains approximately 100 mg of clindamycin phosphate.
Excipients of known effect:
Cetostearyl alcohol, propylene glycol.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Vaginal Cream
White, semi-solid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Antibiotic for the treatment of bacterial vaginosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
One applicator full intravaginally at bedtime for 7 consecutive days.
In patients for whom a shorter treatment course is desirable, a 3 day
regimen
has been shown to be effective.
Paediatric population:
Safety and efficacy in paediatric patients have not been established
(see
section 4.4).
Elderly:
No clinical studies have been conducted in populations older than 60.
4.3
CONTRAINDICATIONS
Dalacin
Cream
is
contra-indicated
in
patients
previously
found
to
be
hypersensitive
to
preparations
containing
clindamycin
or
to
any
of
the
excipients listed in section 6.1.
Although cross-sensitisation to lincomycin has not been demonstrated,
it is
recommended that Dalacin Cream should not be used in patients who have
demonstrated
lincomycin
sensitivity.
Dalacin
Cream
2%
is
also
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
The use of clindamycin may result in the overgrowth of non-susceptible
organisms, particularly yeasts.
Virtually all antibiotics have been associated with diarrhoea and in
some cases
pseudomembranous colitis. Therefore, even though only a minimal amount
of
drug is absorbed, if significant diarrhoea occurs, the drug should be
discontinued and appropriate diagnostic procedures and treatment
provided as
necessary.
Dalacin Cream contains oil-based components.