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

Logo CANESTEN® Solution, Topical Cream

C 5369-1196

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

CANESTEN® Solution, Topical Cream

COMPOSITION:
Solution: Clotrimazole 200 mg, Inert solvent to 20 mL
Cream: Clotrimazole 200 mg, Benzyl alcohol 1% (as preservative), Inert ointment base (o/w) to 20 g.

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.2 Fungicides

PHARMACOLOGICAL ACTION:
A broad spectrum antimycotic acting as fungicide.

INDICATIONS:
The range of indications is:
1. All dermatomycoses due to dermatophytes (e.g. Trichophyton species).
2. All dermatomycoses due to yeasts (e.g. Candida species).
3. Dermatomycoses due to moulds and other fungi.
4. Skin diseases with secondary infection by these fungi.
The dermatomycoses mentioned under 1-4 include among others:
1. Mycoses of the skin and skin folds, (e.g. fungal infections of the groin, perineum, axillae, Dhobies’or jock itch and barber’s itch.)
2. Ringworm.
3. Interdigital mycoses e.g. athlete's foot.
4. Candida vulvitis (vulval thrush).
5. Candida balanitis, (thrush of the glans penis).
6. Pityriasis(Tinea) versicolor.
7. Erythrasma.
8. Paronychias,associated with nail mycoses, (fungal infections of the tissues adjacent to the nail of a finger or toe).

CONTRA-INDICATIONS:
Possible hypersensitivity to clotrimazole and / or cetostearyl alcohol (cream).

WARNING:
Solution is inflammable. Keep away from open flame. For external use only.
Direct contact with Canesten® 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:
Apply thinly to the affected areas 2-3 times daily and rub in. A small amount of cream or a few drops of solution is usually sufficient for an area about the size of the palm. Successful treatment demands that CANESTEN be applied correctly and over a sufficiently long period of time.
The duration of treatment varies. In general, it is 3-4 weeks in the case of dermatomycoses due to dermatophytes and yeasts; in Candida vulvitis and Candida balanitis, 1-2 weeks; and approximately 2-4 weeks in Erythrasma and 1-3 weeks in Pityriasis versicolor.
TREATMENT OF FUNGAL INFECTION SHOULD BE CONTINUED FOR APPROXIMATELY 2 WEEKS AFTER THE DISAPPEARANCE OF ALL SYMPTOMS DESPITE A RAPID, SUBJECTIVE IMPROVEMENT, IN ORDER TO PREVENT RELAPSE.
Athlete's foot: Always dry the feet carefully, especially between the toes.
CANESTEN preparations are odourless, can be washed off and do not stain. Cosmetically well accepted.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Not intended for ophthalmic use. Local reactions including skin irritation and burning may occur. Contact allergic dermatitis has been reported. In cases of systemic absorption, lower abdominal cramps, increase in urinary frequency or skin rash may occur.

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:
Solution: A clear to pale yellow liquid
Cream: A soft, white cream.

PRESENTATION:
CANESTEN Solution: Bottle of 20 mL.
CANESTEN Cream: Tube of 20 g.

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

REGISTRATION NO:
Solution:         E/20.2.2/48
Cream:         E/20.2.2/49

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

® = Registered trade mark of Bayer Germany.         C 5369-1196

ZIMBABWE: PID 74/14.1.3/242 CREAM ONLY

PATIENT INFORMATION LEAFLET

COMPOSITION:
Canesten Cream
contains clotrimazole 10 mg/g as the active ingredient and 1% benzyl alcohol as preservative. Canesten Cream also contains octyldodecanol, cetyl esters wax, cetostearyl alcohol, sorbitan monostearate, polysorbate 60 and purified water.
Canesten solution contains clotrimazole 10 mg/mL. Canesten Solution also contains isopropanol, polyethylene glycol and propylene glycol.

INDICATIONS:
Canesten
is indicated for all fungal infections of the skin caused by moulds, yeasts and fungi and also for skin diseases with secondary infections of these fungi.
These fungal infections may include among others:
1. Fungal infections of the skin and skin folds, (e.g. fungal infections of the groin, perineum, arm pits, Dhobies’or jock itch and barber’s itch.)
2. Ringworm.
3. Fungal infections inbetween toes or fingers e.g. athlete's foot.
4. Candida vulvitis (vulval thrush).
5. Candida balanitis, (thrush of the glans penis).
6. Pityriasis(Tinea) versicolor.
7. Erythrasma.
8. Paronychias, associated with nail mycoses, (fungal infections of the tissues adjacent to the nail of a finger or toe).
BEFORE USING THIS MEDICINE:
Canesten cream
should not be used by persons allergic to clotrimazole and/or cetostearyl alcohol.
If your skin problem does not improve within 1 week, check with your doctor or pharmacist.
If you are taking other medicines on a regular basis, concomitant use of this medicine may cause undesirable interactions. Please consult your doctor or pharmacist.
If you are pregnant or breast feeding your baby while using this medicine please consult your doctor, pharmacist or other health care professional for advice.
Direct contact with Canesten® Cream may reduce the effectiveness and safety of latex products such as condoms and diaphragms. The effect is temporary and occurs only during treatment.

HOW TO USE THIS MEDICINE:
Canesten Cream
should be applied thinly to the affected areas two to three times a day and rubbed in.
Canesten Solution should be applied three times a day.
Successful treatment demands that Canesten Cream be applied correctly and over a sufficiently long period of time. The duration of treatment is generally three to four weeks.
TREATMENT OF FUNGAL INFECTIONS OF THE SKIN SHOULD BE CONTINUED FOR APPROXIMATELY 2 WEEKS AFTER THE DISAPPEARANCE OF SYMPTOMS DESPITE A RAPID, SUBJECTIVE IMPROVEMENT, IN ORDER TO PREVENT RELAPSE.
For the treatment of athlete’s foot and other fungal infections in skin folds it is important to dry the area carefully.
Keep this medicine away from the eyes.
Do not place an occlusive dressing (airtight covering such as kitchen plastic wrap) over the medicine.

SIDE-EFFECTS
Check with your doctor or pharmacist if any of the following side-effects occur:
Skin rash, hives, blistering, burning, itching, peeling, redness, stinging, swelling, or other signs of skin irritation not present before the use of this medicine.
Not all side effects reported for this medicine are included in this leaflet. If your general state of health worsens while using this medicine, please consult your doctor.

STORAGE AND DISPOSAL INFORMATION
Store below 25°C. Store all medicines out of reach of children. Any unused medicine should be returned to your pharmacist, doctor or health care provider for proper disposal.
Do not share medicines prescribed for you with others.
64095 AA 902

Updated on this site: March 2003
Source: Pharmaceutical Industry

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