Dalacin 2% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clindamycin phosphate

Available from:

Pfizer 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: 5012882009205

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DALACIN
® 2% CREAM
(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
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, tell your doctor or pharmacist.
This includes any side effects not listed in this leaflet. See
section 4.
The name of your medicine is Dalacin 2% Cream but will be
referred to as Dalacin Cream throughout the remainder of this
leaflet.
WHAT IS IN THIS LEAFLET
1.
What Dalacin Cream is and what it is used for
2.
What you need to know before you use Dalacin Cream
3.
How to use Dalacin Cream
4.
Possible side effects
5.
How to store Dalacin Cream
6.
Contents of the pack and other 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.
WHAT YOU NEED TO KNOW BEFORE YOU USE DALACIN CREAM
DO NOT USE DALACIN CREAM
•
if you are allergic to clindamycin, lincomycin or any of the
other ingredients of this medicine (listed in section 6).
•
if you suffer with a history of inflammatory bowel disease
or antibiotic-associated colitis.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using this medicine if
you have diarrhoea or usually get diarrhoea when you take
antibiotics.
If you develop severe, 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.
As with all vaginal infections, sexual intercourse d

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
Dalacin Cream contains 160.5 mg cetostearyl alcohol in each 5 g
applicator
which is equivalent to 32.1 mg/g.
Dalacin Cream contains 250 mg propylene glycol in each 5 g applicator
which
is equivalent to 50 mg/g.
Dalacin Cream contains 50 mg benzyl alcohol in each 5 g applicator
which is
equivalent to 10 mg/g.
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
Posology
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