Candaspor® 10 mg Cream

The active substance in CANDASPOR® CREAM is clotrimazole. Antifungals for topical use – imidazole and triazole derivatives.

CANDASPOR® CREAM is used to treat 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, Dhobie itch or jock itch and barber’s itch.)
2. Ringworm.
3. Fungal infections in - between 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).

Do not use CANDASPOR® CREAM

• If you are allergic to clotrimazole or any of the other ingredients in CANDASPOR® CREAM (listed in section 6).

Warnings and precautions

Take special care with CANDASPOR® CREAM

• Direct contact with CANDASPOR® CREAM may reduce the effectiveness and safety of latex products such as condoms and diaphragms. The effect is temporary and occurs only during treatment.
• Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis)
• Not intended for ophthalmic use.

Other medicines and CANDASPOR® CREAM

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding your baby, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine.

Safety and efficacy of CANDASPOR® CREAM has not been established in pregnancy.

CANDASPOR® CREAM during pregnancy but only under the supervision of a physician or midwife.

Breastfeeding should be discontinued during treatment with CANDASPOR® CREAM.

Driving and using machines

CANDASPOR® CREAM has no or negligible influence on the ability to drive or use machinery.

Do not share medicines prescribed for you with any other person. CANDASPOR® CREAM should be applied thinly to the affected areas 2 - 3 times a day and rubbed in. A small amount of cream is usually sufficient for an area about the size of a palm.

Successful treatment demands that CANDASPOR® CREAM be applied correctly and over a sufficiently long period of time. The normal period of treatment is 3 - 4 weeks.

Topical treatment of fungal infections should be continued for approximately 2 weeks after the disappearance of all 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.

If you use more CANDASPOR® 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. In case of accidental ingestion, gastro-intestinal disturbances and central nervous system depression may occur. Treatment is symptomatic and supportive.

If you forget to use CANDASPOR® CREAM

Apply the cream as soon as possible and then continue the rest of your treatment as usual.

CANDASPOR® CREAM can have side effects. Not all side effects reported for CANDASPOR® CREAM are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using CANDASPOR® CREAM, please consult your health care provider for advice.

If any of the following happens, using CANDASPOR® CREAM and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Rash.
• Swallowing or breathing problems.
• Swelling of your lips, face, throat or tongue.
• Weakness, feeling dizzy or faint.
• Nausea.

These are all very serious side effects. If you have them, you may have had a serious reaction to CANDASPOR® CREAM. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following: Itching, rash, blisters, burning, discomfort, swelling, irritation, redness or peeling of skin. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• 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.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8.

By reporting side effects, you can help provide more information on the safety of CANDASPOR® 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 (e.g. toilets).