Canesten Internal Cream

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Clotrimazole

Tersedia dari:

Bayer Limited

Kode ATC:

G01AF; G01AF02

INN (Nama Internasional):

Clotrimazole

Dosis:

10 percent weight/weight

Bentuk farmasi:

Vaginal cream

Jenis Resep:

Product not subject to medical prescription

Area terapi:

Imidazole derivatives; clotrimazole

Status otorisasi:

Not marketed

Tanggal Otorisasi:

1986-05-19

Selebaran informasi

BCH22054
PATIENT LEAFLET – INFORMATION FOR THE USER
CANESTEN INTERNAL CREAM
CLOTRIMAZOLE 10% 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 doctor, pharmacist or
nurse have told you.
This medicine is available without prescription. However, you still
need to use Canesten Internal
Cream 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 Internal Cream and what is it used for
2.
What you need to know before you use Canesten Internal Cream
3. How to use Canesten Internal Cream
4. Possible side effects
5. How to store Canesten Internal Cream
6. Contents of the pack and other information
1. WHAT IS CANESTEN® INTERNAL CREAM AND WHAT IS IT USED FOR?
Canesten Internal Cream is a single application, full course treatment
for vaginal thrush. It is a
soothing intravaginal cream in a prefilled applicator for treatment at
the site of infection.
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.
The active substance in Canesten Internal 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® INTERNAL CREAM
DO NOT USE CANESTEN® INTERNAL CREAM:
•
If you are allergic (hypersensitive) to clotrimazole or any of the
other ingredients including
cetostearyl alcohol or benzyl alcohol, of Caneste

Karakteristik produk

Health Products Regulatory Authority
10 July 2023
CRN00DC2T
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Canesten Internal Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 100mg clotrimazole equivalent to
clotrimazole 10% w/w
Excipients with known effect:
Cetostearyl alcohol 35mg in each gram of cream
Benzyl alcohol 10mg in each gram of cream
For the full list of excipients, see Section 6.1_._
3 PHARMACEUTICAL FORM
Vaginal cream.
A soft, white cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Canesten Internal Cream is recommended for the treatment of candidal
vaginitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Canesten Internal Cream should be administered intravaginally using
the applicator supplied.
Adults and children of 12 years of age and older:
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.
If the labia and adjacent areas are simultaneously infected, local
treatment with an external cream should also be given in
addition to the intravaginal treatment (combination treatment).
_ _
CHILDREN UNDER 12 YEARS OF AGE:
As the product is used with an applicator, paediatric usage is not
recommended.
Instructions for use:
1.
Remove applicator from package.Insert plunger into applicator.
2.
Remove cap by turning.
3.
Introduce applicator as deeply as possible into the vagina (this is
best done with the patient lying on her back with
the knees bent up) and empty its contents into the vagina by pushing
the plunger.
4.
Remove the applicator and dispose of it.
4.3 CONTRAINDICATIONS
Health Products Regulatory Authority
10 July 2023
CRN00DC2T
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