Canesten Thrush Internal 10% vaginal cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clotrimazole

Available from:

Bayer 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; GTIN: 5010605054099

Patient Information leaflet

10/01/17
TL017668
8092739-14
04384044
A
TR1209604
JAMES CLAYTON
G=1; O=0; R=1; - JC - 10/01/17 08:30:03
N/A
N/A
10001(48)
N/A
N/A
Kern Pharma
Generic Bayer
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READ ALL OF THIS LEAFLET CAREFULLY 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. Do not give it
to anyone else under any circumstances.
•
If you have any unusual effects after using this product,
tell your doctor.
IN THIS LEAFLET
1.
What is Canesten Vaginal Cream and what is it used for?
2.
Before you use Canesten Vaginal Cream
3.
How to use Canesten Vaginal Cream
4.
Possible side effects
5.
How to store Canesten Vaginal Cream
6.
Further information
1. WHAT IS CANESTEN® VAGINAL
CREAM AND WHAT IS IT USED
FOR?
Canesten Vaginal Cream is a single application, full course
treatment for vaginal thrush (candidiasis). It is a soothing
intravaginal cream in a pre-filled applicator for treatment at the
site of infection.
The active substance in Canesten Vaginal 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®
VAGINAL CREAM
DO NOT USE CANESTEN® VAGINAL CREAM:
•
If you are allergic (hypersensitive) to clotrimazole or any of
the other ingredients, including cetostearyl alcohol, of
Canesten Vaginal Cream_ (see Section 6. Further_
_Information)._
•
During your period as it may be less effective.
IMPORTANT INFORMATION ABOUT SOME OF THE
INGREDIENTS:
This product contains cetostearyl alcohol which may cause
local skin irritation (e.g. rash, itching or redness).
SPECIAL PRECAUTIONS:
As with other creams, this product may reduce the
effectiveness of rubber contraceptives, such as condoms or
diaphragms. Consequently, you should use alternative
precautions for at leas

Summary of Product characteristics

OBJECT 1
CANESTEN 10% W/W VAGINAL CREAM
Summary of Product Characteristics Updated 16-Jan-2018 | Bayer plc
1. Name of the medicinal product
Canesten 10% w/w Vaginal Cream
2. Qualitative and quantitative composition
Clotrimazole 10% w/w
For excipients, see 6.1
3. Pharmaceutical form
Vaginal cream.
4. Clinical particulars
4.1 Therapeutic indications
Canesten vaginal cream is recommended 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
Patients should be advised to consult their physician if the symptoms
have not been relieved within one
week of using Canesten Vaginal Cream. Canesten Vaginal Cream can be
used again if the candidal
infection returns after 7 days. However, if the candidal infection
recurs more than twice within six
months, patients should be advised to consult their physician.
This product contains cetostearyl alcohol, which may cause local skin
reactions (e.g. contact dermatitis).
4.5 Interaction with other medicinal products and other forms of
interaction
Laboratory tests have suggested that, when used together, this product
may cause damage to latex
contraceptives. Consequ