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CANALBA VAGINAL CREAM
SCHEDULING STATUS: S2
CANALBA VAGINAL CREAM
COMPOSITION:
Each 1 g of cream contains:
Clotrimazole | 10 mg |
Preservative: Nipastat | 0,275% m/m |
PHARMACOLOGICAL CLASSIFICATION:
CANALBA VAGINAL CREAM is a broad spectrum antimycotic with fungicidal properties.
INDICATIONS:
For the relief of vaginal itching, burning and discharge associated with recurrent vaginal yeast infections. (Vaginal candidiasis).
CONTRA-INDICATION:
Possible sensitivity to clotrimazole. The possibility of absorption of clotrimazole when administered vaginally cannot be excluded. The safety in pregnancy has not been established.
WARNINGS:
1. | Use only if you have already had a vaginal yeast infection diagnosed by a medical practitioner and you have the same symptoms now, otherwise consult your doctor. These symptoms include itching and burning of the vagina and sometimes a white discharge. |
2. | If there is no improvement in 3 days or if symptoms have not disappeared within seven days, then consult a medical practitioner as not all vaginal infections are caused by yeasts. |
3. | Consult a medical practitioner if you have abdominal pain, fever or a foulsmelling vaginal discharge before or during use of this medication. |
4. | If symptoms recur within 2 months, consult a medical practitioner. |
5. | If you are pregnant or think you may be pregnant or are nursing, do not use this medication except on the advice of a medical practitioner. |
6. | Do not use in girls under 12 years of age, except on the advice of a medical practitioner. |
7. | If skin rash or new irritation occurs, discontinue use. |
DOSAGE AND DIRECTIONS FOR USE:
Fill enclosed vaginal applicator to the top (i.e. 5 g CANALBA VAGINAL CREAM). Insert deeply into the vagina every night on retiring for six consecutive days. This is best achieved when lying on the back with the legs pulled in a little towards the body. If individual cases should require it, two applications of 5 g vaginal cream can be used daily, i.e. one in the morning and one in the evening, for 6-12 days. Treatment should be carried out during menstruation and even if symptoms disappear. For Candida vulvitis or vulvo-vaginitis the vaginal cream should be applied thinly to the external genitalia 2 or 3 times a day for 1-2 weeks.
For the prevention of re-infection the partner should be treated locally with CANALBA CREAM at the same time. This preparation does not stain the underwear.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Local reactions including irritation and burning may occur. Contact allergic dermatitis has been reported. In case of systemic absorption, lower abdominal cramps, increase in urinary frequency or skin rash may occur. CANALBA VAGINAL CREAM can only be used with doctor's advice for pregnant women especially in the early stages of pregnancy.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See Side-effects and Special Precautions. In case of accidental ingestion, gastrointestinal disturbances and central nervous system depression may occur. Treatment is symptomatic and supportive.
IDENTIFICATION:
Soft, white cream.
PRESENTATION:
Tube of 50 g with 8 vaginal applicators.
STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.
Directions for using the applicator:
Preparation of the applicator: {illustrated}
1. | Wash your hands thoroughly. |
2. | Screw the open end of one of the applicators over the opening of the tube of cream. The plunger of the applicator should be pushed in at this stage. |
3. | Gently squeeze the bottom of the tube so that the cream fills the applicator to the top, pushing the plunger out to almost its full extent. |
4. | Unscrew the tube of cream and replace its cap. |
Inserting the applicator:
5. | Carefully insert the end of the applicator as deeply as possible into the vagina. (Making sure the plunger does not fall out). This is best achieved when on the back with the legs pulled in a little towards the body. |
6. | Slowly push the plunger with the forefinger until it stops. |
7. | Remove the applicator from the vagina and discard it. |
Each applicator is for use once only:
The surplus cream may be used to treat any inflammation of the vulva (outer vaginal area) and nearby areas. The cream should be applied thinly and rubbed in gently 2-3 times a day.