Canesten Cream Combi Internal & External Creams
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
10-07-2023
Summary of Product characteristics
(SPC)
10-07-2023
Active ingredient:
Clotrimazole; Clotrimazole
Available from:
Bayer Limited
ATC code:
G01AF; G01AF02
INN (International Name):
Clotrimazole; Clotrimazole
Dosage:
2 percent weight/weight
Pharmaceutical form:
Vaginal cream
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Imidazole derivatives; clotrimazole
Authorization status:
Not marketed
Authorization date:
2006-07-28
Patient Information leaflet
BCH22054
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
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
10 July 2023
CRN00DC2T
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Canesten Cream Combi Internal & External Creams
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Canesten Combi 10 % Internal Cream contains Clotrimazole 100 mg/g
Canesten Combi 2% External Cream contains Clotrimazole 20 mg/g
Excipients with known effect:
The 10% cream contains Cetostearyl alcohol 35mg in each gram of cream
and
Benzyl alcohol 10mg in each gram of cream
The 2% cream also contains Cetostearyl alcohol 100mg in each gram of
cream and
Benzyl alcohol 20mg in each gram of cream
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Vaginal Cream.
Canesten 10 % Internal Cream contains a soft, white cream in a
prefilled applicator
Canesten 2% External Cream contains white oil in water type cream
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The internal cream is recommended for the treatment of candidal
vaginitis.
The external 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
Adults and children of 12 years of age and older:
Canesten Internal Cream should be administered intravaginally using
the applicator supplied. The contents of the filled
applicator (5g) should be inserted as deeply as possible into the
vagina, preferably at night, before going to bed.
If symptoms persist for more than 7 days the patient may have a
medical condition that requires treatment by a doctor.
The treatment can be repeated if necessary, however, recurrent
infections may indicate an underlying medical cause. Patient
should seek medical advice if symptoms return within 2 months.
_ _
Canesten External Cream should be applied thinly to the vulva and
surrounding area, two or three times daily and rubbed in
gently.
If the cream is being used for treatment of the sexual pa
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