SCHEDULING STATUS
S1
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
CANESTEN® Vaginal Cream 1 %
WHAT CANESTEN® VAGINAL CREAM CONTAINS
The active ingredient is clotrimazole 10 mg/g. The other ingredients include benzyl alcohol 2 %, cetostearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, sorbitan monostearate and purified water.
WHAT CANESTEN® VAGINAL CREAM IS USED FOR
For the relief of vaginal itching, burning and discharge associated with vaginal yeast infections (Vaginal thrush).
BEFORE YOU USE CANESTEN® VAGINAL CREAM
Do not use CANESTEN® Vaginal Cream
Do not use the cream if you are allergic to clotrimazole or any of the other ingredients, if you are under 12 years of age, or if you are having your menstrual period.
Take special care with CANESTEN® Vaginal Cream
Special care is required if symptoms such as fever, lower abdominal pain, back pain, foul smelling vaginal discharge, nausea, vaginal bleeding, or associated shoulder pain occur. Vaginal intercourse should be avoided during treatment, and additional contraceptive measures may be needed because CANESTEN® Vaginal Cream may reduce the effectiveness and safety of latex products such as condoms and diaphragms.
Pregnancy and Breastfeeding
If you are pregnant or breastfeeding, consult your doctor, pharmacist or other healthcare professional before using this medicine. Safety and efficacy have not been established in pregnancy, and breastfeeding should be discontinued during treatment.
Driving and using machinery
CANESTEN® Vaginal Cream has no or negligible influence on the ability to drive or use machinery.
Important information about some of the ingredients
Cetostearyl alcohol may cause local skin reactions, for example rash.
USING OTHER MEDICINES WITH CANESTEN® VAGINAL CREAM
Always tell your healthcare professional if you are taking any other medicine, including complementary and traditional medicines. The use of CANESTEN® Vaginal Cream with oral tacrolimus or sirolimus may lead to increased plasma levels, and monitoring may be required.
HOW TO USE CANESTEN® VAGINAL CREAM
CANESTEN® Vaginal Cream should be used exactly as instructed by a doctor or pharmacist. The usual dose is one applicator inserted deeply into the vagina every evening before going to bed for six successive days.
If you use more CANESTEN® Vaginal Cream than you should
In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.
If you forget to use a dose of CANESTEN® Vaginal Cream
Do not use a double dose to make up for forgotten individual doses.
POSSIBLE SIDE EFFECTS
| Action required | Side effects |
|---|---|
| Stop taking CANESTEN® Vaginal Cream and tell your doctor immediately or go to the casualty department at your nearest hospital | Hives or skin rash; temporary loss of consciousness; itching; vaginal oedema (swelling) |
| Tell your doctor immediately or go to the casualty department at your nearest hospital | Pelvic pain; shortness of breath; vaginal bleeding |
| Tell your doctor if you notice any of the following | Abnormal low blood pressure; genital peeling; redness of the skin; discomfort; burning; irritation; abdominal pain |
If you notice any side effects not mentioned in the leaflet, inform your doctor or pharmacist.
STORING AND DISPOSING OF CANESTEN® VAGINAL CREAM
Store all medicines out of reach of children. Store at or below 25 ºC. Protect from light. Do not use after the expiry date on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewage systems.
PRESENTATION OF CANESTEN® VAGINAL CREAM
CANESTEN® Vaginal Cream is presented in 35 g or 50 g collapsible aluminium tubes with six applicators placed into an outer carton.
IDENTIFICATION OF CANESTEN® VAGINAL CREAM
A soft, white cream.
REGISTRATION NUMBER
K/20.2.2/187
DIRECTIONS FOR USING THE APPLICATOR
Wash your hands thoroughly. Pull out the plunger of the disposable applicator until it stops. Attach the applicator to the tube, fill it by squeezing the tube carefully, then insert the applicator as deeply as possible into the vagina and empty it by pressing the plunger. Each applicator is for use once only.
