Canesten Thrush Internal 10% vaginal cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clotrimazole

Available from:

Sigma Pharmaceuticals Plc

ATC code:

G01AF02

INN (International Name):

Clotrimazole

Dosage:

100mg/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 BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use Canesten Thrush Internal Cream carefully to get the
best results from it.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
You must contact a doctor if your symptoms worsen or do not
impro
ve in 7
days.
•
If you have any unusual effects after using this product, tell
your doctor or pharmacist.
IN THIS LEAFLET
1.
What is Canesten Thrush Internal Cream and what is it
used for?
2.
Before you use Canesten Thrush Internal Cream
3.
How to use Canesten Thrush Internal Cream
4.
Possible side effects
5.
How to store Canesten Thrush Internal Cream
6.
Further information
1. WHAT IS CANESTEN® THRUSH
INTERNAL CREAM AND WHAT IS
IT USED FOR?
Canesten Thrush Internal Cream is a single application, full course
treatment for vaginal thrush. It is a soothing intravaginal cream in
a prefilled applicator for treatment at the site of infection.
ONLY USE THIS PRODUCT IF YOU HAVE BEEN PREVIOUSLY DIAGNOSED
BY YOUR DOCTOR AS HAVING VAGINAL THRUSH.
The active substance in Canesten Thrush Internal Cream is
clotrimazole. Clotrimazole belongs to a group of medicines
called azoles and is an antifungal agent which fights the cause of
infections such as vaginal thrush.
2. BEFORE YOU USE CANESTEN®
THRUSH INTERNAL CREAM
DO NOT USE CANESTEN® THRUSH INTERNAL CREAM:
•
If you are allergic (hypersensitive) to clotrimazole or any of
the other ingredients, including cetostearyl alcohol,
of Canesten Thrush Internal Cream (
_see Section 6. Further_
_Information_).
•
During your period as it may be less effective.
BEFORE USING CANESTEN® THRUSH INTERNAL CREAM, YOU
SHOULD SEE YOUR DOCTOR IF:
•
You are unsure whether you have thrush or this is the first
time you have had these symptoms.
•
You have had more than two infections of thrush in the last six
months.
•
You or your partner have ever had a sexually tran

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Canesten Thrush Internal Cream 10% w/w vaginal cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 10% w/w
Excipients with known effects: cetostearyl alcohol
For the full list of excipients, see 6.1.
3
PHARMACEUTICAL FORM
Vaginal cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Canesten Thrush Internal Cream is indicated for the treatment of
candidal
vaginitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The cream should be administered intravaginally using the applicator
supplied.
_ _
_ADULTS:_
The contents of the filled applicator (5g) should be inserted as
deeply as possible
into the vagina, preferably at night. A second treatment may be
carried out if
necessary.
Generally:
treatment during the menstrual period should not be performed due to
the risk of
the cream being washed out by the menstrual flow. The treatment should
be
finished before the onset of menstruation.
Do not use tampons, intravaginal douches, spermicides or other vaginal
products while using this product.
Vaginal intercourse should be avoided in case of vaginal infection and
while
using this product because the partner could become infected.
_ _
_CHILDREN:_
Not for use in children under 16.
4.3
CONTRAINDICATIONS
Hypersensitivity to clotrimazole or any other excipients listed in
section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Medical advice should be sought if this is the first time the patient
has
experienced symptoms of candidal vaginitis.
Before using Canesten Thrush Internal Cream, medical advice must be
sought if
any of the following are applicable:
•
more than two infections of candidal vaginitis in the last 6 months.
•
previous history of a sexually transmitted disease or exposure to
partner
with sexually transmitted disease
•
pregnancy or suspected pregnancy
•
aged under 16 or over 60 years
•
known hypersensitivity to imidazoles or other vaginal antifungal
products
Canesten Thrush Internal Cream should not be used if the patient has
a