Canesten Combi Pessary & Cream
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
05-12-2022
Summary of Product characteristics
(SPC)
05-12-2022
Active ingredient:
Clotrimazole; Clotrimazole
Available from:
Bayer Limited
ATC code:
G01AF; G01AF02
INN (International Name):
Clotrimazole; Clotrimazole
Dosage:
500mg/2 percent weight/weight
Pharmaceutical form:
Cream + pessary
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Imidazole derivatives; clotrimazole
Authorization status:
Marketed
Authorization date:
2001-08-24
Patient Information leaflet
BCH220241038
PACKAGE LEAFLET: INFORMATION FOR THE USER
CANESTEN® COMBI PESSARY & CREAM
clotrimazole
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 contact a doctor if your symptoms worsen or do not improve in
7 days.
WHAT IS IN THIS LEAFLET
1. What is Canesten Combi and what is it used for
2. What you need to know before you use Canesten Combi
3. How to use Canesten Combi
4. Possible side effects
5. How to store Canesten Combi
6. Contents of the pack and other information
1. WHAT IS CANESTEN® COMBI AND WHAT IS IT USED FOR
Canesten Combi Pessary & Cream is a complete treatment for vaginal
thrush because it treats
both the internal cause and external symptoms.
ONLY USE THIS PRODUCT IF YOU HAVE BEEN PREVIOUSLY DIAGNOSED BY YOUR
DOCTOR AS HAVING
VAGINAL THRUSH.
The active substance in Canesten Combi Pessary & 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.
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CANESTEN® COMBI
DO NOT USE CANESTEN® COMBI PESSARY & CREAM:
•
If you are allergic (hypersensitive) to clotrimazole or any of the
other ingredients, including
cetostearyl alcohol or benzyl alcohol, of Canesten Combi Pessary &
Cream (listed in section
6).
•
During your period as it may be less effective.
WARNINGS AND PRECAUTIONS:
Talk to
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
05 December 2022
CRN00D655
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Canesten Combi Pessary & Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The pessary contains clotrimazole 500 mg
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
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pessary and vaginal cream.
White, convex pessary marked “Bayer” on one side and “MU” on
the other side.
A white oil-in-water type cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The pessary 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
The pessary should be inserted intravaginally, as high as possible,
using the applicator provided.
Adults and children of 12 years of age and older:
Insert one pessary, 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 pessaries need moisture in the vagina in order to dissolve
completely, otherwise undissolved pieces of the pessary
might crumble out of the vagina. Pieces of undissolved pessary may be
noticed by women who experience vaginal dryness. To
help prevent this it is important that the pessary is inserted as high
as possible into the vagina at bedtime.
To insert the pessary:
1.
Pull out plunger until it stops. Place the pessary into the
applicator.
Health Products Reg
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