Candacide Oral 000 iu Oral Suspension

CANDACIDE ORAL SUSPENSION contains NYSTATIN and is an antibiotic with antifungal activity against a wide variety of yeasts and yeast like fungi especially the Candida genus. It can be used to:

• Treatment of candidal (monilial) infections of the oral cavity.

Do not take CANDACIDE ORAL SUSPENSION:

• If you are hypersensitive (allergic) to nystatin or any of the other ingredients of CANDACIDE ORAL SUSPENSION. Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

Warnings and precautions

Take special care with CANDACIDE ORAL SUSPENSION:

• If you have systemic mycosis as CANDACIDE ORAL SUSPENSION should not be used.
• If irritation or sensitization develops, treatment should be discontinued.
• If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before receiving CANDACIDE ORAL SUSPENSION. Do this even if they have applied in the past.

Other medicines and CANDACIDE ORAL SUSPENSION

Always tell your healthcare provider if you or your child is taking any other medicine (this includes all complementary or traditional medicines).

CANDACIDE ORAL SUSPENSION with food and drinks

The intake of food and drinks will have no impact on CANDACIDE ORAL SUSPENSION.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking CANDACIDE ORAL SUSPENSION.

Driving and using machines

CANDACIDE ORAL SUSPENSION will have no impact on driving or using machinery.

Taking your medicine:

Do not share medicines prescribed for you with any other person. Always take CANDACIDE ORAL SUSPENSION exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

SHAKE THE BOTTLE BEFORE USE.

INFANTS:

The usual dose is 1 ml to 2 ml (100 000 to 200 000 units) four times daily, dropped into the mouth.

CHILDREN AND ADULTS:

The usual dose is 1 ml to 2 ml (100 000 to 200 000 units) four times daily, dropped into the mouth and held for some time before swallowing. This dose may be increased to 4 ml to 6 ml (400 000 to 600 000 units) four times daily for more severe infections.

(On administration by dropper, the suspension readily disperses throughout the mouth and is compatible with commonly used systemic antimicrobial agents and may be given concomitantly with these agents). The suspension should be retained in the mouth for as long as possible (e.g. several minutes) before swallowing. In infants and young children, apply one half of the dose in each side of the mouth. The dosage regimen for Candacide Oral Suspension should be continued for at least 48 hours after symptoms have disappeared.

NOTE: If significant regeneration or repair of oral tissue has not occurred in seven days, additional investigation into the etiology of the oral lesion is advised.

If you take more CANDACIDE ORAL SUSPENSION than you should:

Treatment is symptomatic and supportive. You might experience nausea and gastrointestinal disturbances in the event of taking more CANDACIDE ORAL SUSPENSION than the recommended dosage. In the event of over dosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Take the carton and bottle with you. This is so the doctor knows what you have taken.

If you forget to take CANDACIDE ORAL SUSPENSION:

If you forget to take CANDACIDE ORAL SUSPENSION, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

CANDACIDE ORAL SUSPENSION can have side effects. Not all side effects reported for CANDACIDE ORAL SUSPENSION are included in this leaflet. Should your general health worsen or if you experience any untoward effect while taking CANDACIDE ORAL SUSPENSION, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking/using CANDACIDE ORAL SUSPENSION and tell your doctor immediately or go to the casualty department at your nearest hospital:

• if you get swelling of the hands, feet, ankles, face, lips or throat, which may cause difficulty in swallowing or breathing.
• if you could notice an itchy, nettle rash (urticaria). This may mean that you are having an allergic reaction to CANDACIDE ORAL SUSPENSION.
• Fainting

These are all very serious side effects. If your child has them, your child may have had a serious reaction to CANDACIDE ORAL SUSPENSION. Your child may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects

• Gastrointestinal disturbances including nausea, vomiting and diarrhoea

Frequency unknown side effects:

• Swelling, of the area beneath the skin or mucosa including swelling of the face
• Hypersensitivity
• Rash including urticarial (a rash of round, red welts on the skin that itch intensely)
• Stevens - Johnson syndrome (is a rare, serious disorder of the skin and mucous membrane)

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 or nurse. 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 CANDACIDE ORAL SUSPENSION.

• Store all medicines out of reach of children
• Store at or below 25 °C.
• Do not freeze
• Store your medicine in the original packaging in order to protect from light.
• Do not use this medicine after the expiry date shown on the packaging.
• Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets)