Dalacin 2% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clindamycin phosphate

Available from:

Lexon (UK) 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

Patient Information leaflet

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.
Your medicine is called Dalacin Cream 2% but will
be referred to as Dalacin Cream throughout the
leaflet.
WHAT IS IN THIS LEAFLET
What Dalacin Cream is and what it is used for
What you need to know before you use
Dalacin Cream
How to use Dalacin Cream
Possible side effects
How to store Dalacin Cream
Contents of the pack and other information
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).
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 during
treatment with Dalacin Cream is not recommended.
Dalacin Cream may weaken condoms and
diaphragms. Do not rely on condoms or
contra

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.