INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CANESTEN® Vaginal Cream
64105 AA 902

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

CANESTEN® Vaginal Cream

COMPOSITION:
Clotrimazole 10 mg
Benzyl Alcohol 1% (as preservative)
Inert Ointment base o/w to 1 g.

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.2 Fungicides

PHARMACOLOGICAL ACTION:
Clotrimazole 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-INDICATIONS:
Possible hypersensitivity to clotrimazole and / or cetostearyl alcohol.

WARNINGS:
i) 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.
ii) If there is no improvement in 3 days or if symptoms have not disappeared within 7 days, then consult a medical practitioner as not all vaginal infections are caused by yeasts.
iii) Consult a medical practitioner if you have abdominal pain, fever or a foul-smelling vaginal discharge before or during use of this medication.
iv) If symptoms recur within 2 months, consult a medical practitioner.
v) 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.
vi) Do not use in girls under 12 years of age, except on the advice of a medical practitioner.
vii) If skin rash or new irritation occurs, discontinue use.
viii) Direct contact with Canesten Vaginal Cream may reduce the effectiveness and safety of latex products such as condoms and diaphragms. The effect is temporary and occurs only during treatment.

DOSAGE AND DIRECTIONS FOR USE:
Fill enclosed vaginal applicator to the top (i.e. 5 g CANESTEN Vaginal Cream). Insert deeply into the vagina every night on retiring for six consecutive days even if symptoms disappear. 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. Use even during menstruation, although it is recommended that the treatment should not be carried out during menstruation but should be completed before this begins. 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 CANESTEN Cream at the same time in so far as symptoms (e.g. pruritus, inflammation, etc.) are present. CANESTEN preparations are colourless and do not stain the underwear.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Local reactions including irritation and burning may occur. Contact allergic dermatitis has been reported. In cases of systemic absorption, lower abdominal cramps, increase in urinary frequency and skin rash may occur.
CANESTEN Vaginal Cream may only be used during pregnancy on the advice of a medical doctor. CANESTEN Vaginal Cream should not be administered to pregnant women during the first trimester, since the safety in this regard has not been established. The possibility of absorption of clotrimazole when administered vaginally cannot be excluded.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects and special precautions. In case of accidental ingestion, gastro-intestinal disturbances and central nervous system depression may occur. Treatment is symptomatic and supportive.

IDENTIFICATION:
A white cream.

PRESENTATION:
CANESTEN Vaginal Cream: Tube of 35 g with 6 vaginal applicators.
  Tube of 50 g with 6 vaginal applicators.

STORAGE INSTRUCTIONS:
Store below 25°C. Keep out of reach of children.

REGISTRATION NUMBER:
K/20.2.2/187

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Bayer (Pty) Ltd
Wrench Road        Isando        1600
Reg No 68/11192/07

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
April 1995       

ZIMBABWE: PID 81/14.17/1395

® = Registered trade mark of Bayer Germany.

PATIENT INFORMATION
DIRECTIONS FOR USING THE APPLICATOR:
1. Wash your hands thoroughly.
2. Pull out plunger of disposable applicator until it stops.
3. Open tube. Attach disposable applicator to tube, hold it firmly pressed against tube and fill it by squeezing tube carefully.
4. Detach applicator from the tube, insert as deeply as possible into the vagina (best achieved when lying on your back) and empty by pressing the plunger.
5. Remove applicator and dispose of it.

Each applicator is for use once only.
The surplus cream in the 35 g or 50 g tube of CANESTEN Vaginal 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.

Follow your doctor's instructions.

NB        In case of hypersensitivity to cetostearyl alcohol, CANESTEN Vaginal Tablets should be used for the treatment.
64105 AA 902

Updated on this site: March 2003
Source: Pharmaceutical Industry

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