Canesten Combi Soft Vaginal Capsule & Cream 500 mg Soft Vaginal Capsule and 2 % w/w Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clotrimazole; Clotrimazole

Available from:

Bayer Limited

ATC code:

G01AF; G01AF02

INN (International Name):

Clotrimazole; Clotrimazole

Dosage:

500 mg/2 percent weight/weight

Pharmaceutical form:

Cream + vaginal capsule, soft

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Imidazole derivatives; clotrimazole

Authorization status:

Marketed

Authorization date:

2016-03-24

Patient Information leaflet

BCH22013
PACKAGE LEAFLET – INFORMATION FOR THE USER
CANESTEN CREAM COMBI
INTERNAL AND EXTERNAL CREAMS
CLOTRIMAZOLE 10% W/W AND 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
you pharmacist has told you.
This medicine is available without prescription. However, you still
need to use CANESTEN® CREAM
COMBI 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.
• 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® CREAM COMBI and what is it used for
2.
What you need to know before you use CANESTEN® CREAM COMBI
3. How to use CANESTEN® CREAM COMBI
4. Possible side effects
5. How to store CANESTEN® CREAM COMBI
6. Contents of the pack and other information
1.
WHAT IS CANESTEN® CREAM COMBI AND WHAT IS IT USED FOR
This product is a complete treatment for vaginal thrush because it
treats both the internal cause
and external symptoms. It contains:
• an intravaginal cream in a pre-filled applicator, containing 500mg
(10% w/w) Clotrimazole as
the active ingredient, for treatment at the site of infection.
• a tube of soothing cream, containing 2% w/w Clotrimazole, to start
relieving the external itch
immediately.
Canesten Cream Combi 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 the external cream as
well, even if they have no
symptoms of thrush.
If you are unsure w

Summary of Product characteristics

Health Products Regulatory Authority
05 December 2022
CRN00CW79
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Canesten Combi Soft Vaginal Capsule & Cream 500 mg Soft Vaginal
Capsule and 2 % w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The soft vaginal capsule contains 500mg clotrimazole.
Each gram of cream contains 20mg clotrimazole (equivalent to 2% w/w).
Excipients with known effect:
Cetostearyl alcohol 100mg in each gram of cream
Benzyl alcohol 20mg in each gram of cream
Soya oil.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Vaginal capsule, soft and cream.
Yellow teardrop-shaped soft capsule.
A white oil-in-water type cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The soft vaginal capsule is recommended for the treatment of candidal
vaginitis.
The cream is recommended for the treatment of candidal vulvitis. It
should be used as an adjunct to treatment of candidal
vaginitis.
The cream can also be used for treatment of the sexual partner’s
penis to prevent re-infection.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
One 500mg soft vaginal capsule should be inserted at night, before
going to bed. A second treatment may be carried out if
necessary.
The cream should be applied thinly to the vulva and surrounding area
two or three times daily and rubbed in gently. Treatment
should be continued until symptoms of the infection disappear.
Patients should be advised to consult their physician if the symptoms
have not been relieved within one week of using
Canesten Combi. Canesten Combi 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.
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.
_Paediatric Population_
Not for use in children under 16.
Health Products Regulatory Authority
05 December 2022
CR