Canesten Thrush Cream 2% w/w

Country: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

CLOTRIMAZOLE

Disponibbli minn:

Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland

Kodiċi ATC:

G01AF02

INN (Isem Internazzjonali):

CLOTRIMAZOLE 2 % (W/W)

Għamla farmaċewtika:

VAGINAL CREAM

Kompożizzjoni:

CLOTRIMAZOLE 2 % (W/W)

Tip ta 'preskrizzjoni:

OTC

Żona terapewtika:

GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2015-05-07

Fuljett ta 'informazzjoni

BCH22024
PATIENT LEAFLET: INFORMATION FOR THE USER
CANESTEN THRUSH CREAM
Clotrimazole 2% w/w
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel
worse after seven days.
WHAT IS IN THIS LEAFLET
1. What is Canesten Thrush Cream and what is it used for
2. What you need to know before you use Canesten Thrush Cream
3. How to use Canesten Thrush Cream
4. Possible side effects
5. How to store Canesten Thrush Cream
6. Contents of the pack and other information
1. WHAT IS CANESTEN® THRUSH CREAM AND WHAT IS IT USED FOR
Canesten Thrush Cream relieves irritation of the vulva (vulvitis)
which is caused by vaginal
thrush (candidiasis). Although this cream provides relief from the
external irritation caused by
vaginal thrush, it cannot treat any internal (vaginal) cause of the
infection. Ask your doctor or
pharmacist to recommend a treatment for this.
Canesten Thrush Cream is used to treat adults and children aged 12
years and over.
ONLY USE THIS PRODUCT IF YOU HAVE BEEN PREVIOUSLY DIAGNOSED BY YOUR
DOCTOR AS HAVING
VAGINAL THRUSH.
Some women suffer from recurrent attacks of thrush.
To reduce the frequency of these attacks, the sexual partner’s penis
can be treated with this cream
to prevent reinfection, even if they have no symptoms of thrush.
The active substance in Canesten Thrush 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. WHAT YOU NEED TO KNOW BEFORE YOU USE CANESTEN® THRUSH CREAM
DO NOT USE C

Karatteristiċi tal-prodott

BCH22024
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Canesten Thrush Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 20mg Clotrimazole (2% w/w).
Excipients with known effect:
Cetostearyl alcohol 100mg in each gram of cream
Benzyl alcohol 20mg in each gram of cream
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Vaginal Cream
A white oil-in-water type cream.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Canesten Thrush Cream is recommended for the treatment of candidal
vulvitis. It should be
used as an adjunct to treatment of candidal vaginitis.
It can also be used for treatment of the sexual partner’s penis to
prevent re-infection.
4.2
Posology and method of administration
Canesten Thrush Cream should be applied to the vulva and surrounding
area.
It can also be applied to the sexual partner’s penis to prevent
re-infection.
Adults and children of 12 years of age and older:
The cream should be applied thinly two or three times daily and rubbed
in gently.
Treatment should be continued until symptoms of the infection
disappear.
If symptoms persist for more than 7 days the patient may have a
medical condition that
requires treatment by a doctor.
BCH22024
2
The treatment can be repeated if necessary, however, recurrent
infections may indicate an
underlying medical cause. Patients should seek medical advice if
symptoms return within 2
months.
If the cream is being used for treatment of the sexual partner’s
penis it should be applied two or
three times daily for up to two weeks.
Children under 12 years of age:
There is no clinical experience in the use of Canesten Thrush Cream in
children.
4.3
Contraindications
Hypersensitivity to the active substance or to any of the 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 Cream medical advice must be sought if
a