Candacide Oral Suspension

u2022 Treatment of candidal (monilial) infections of the oral cavity.

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 a compatible with commonly used systemic antimicrobial agents and may be given concomitantly with these agents).

The suspension should be retained in the mouth for a 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

Method of Administration SHAKE THE BOTTLE BEFORE USE.

u2022 Hypersensitivity to nystatin or any of the excipients listed in section 6.1

Candacide Oral Suspension should not be used for the treatment of systemic mycoses. If irritation or sensitization develops, treatment should be discontinued . CANDACIDE ORAL SUSPENSION contains propyl p-hydroxybenzoate and methyl p- hydroxybenzoate which may cause allergic reactions (possibly delayed). Sorbitol: CANDACIDE ORAL SUSPENSION contains liquid sorbitol non crystallising. Patients with hereditary fructose intolerance (HFI) should not take/be given CANDACIDE ORAL SUSPENSION

Glycerol: CANDACIDE ORAL SUSPENSION contains glycerol which may cause headache, stomach upsets and diarrhoea

No interaction studies have been performed.

Pregnancy Animal reproductive studies have not been conducted with nystatin. It is not known whether nystatin can cause foetal harm when administered to a pregnant woman or can affect reproductive capacity; however absorption of nystatin from the gastro-intestinal tract is negligible. Nystatin should be prescribed during pregnancy only if the potential benefits to be derived outweigh the possible risks involved.

Lactation It is not known whether Nystatin is excreted in human milk. Although gastrointestinal absorption is insignificant, caution should be exercised when Nystatin is prescribed for a breast-feeding woman.

Not relevant

MedDRA System Organ Class Frequent Less Frequent Frequency Unknown Immune system disorders hpersensitivity -Angioedema including facial oedema Gastrointestinal disorders Gastrointestinal disturbances -nausea -vomiting -diarrhoea Skin and subcutaneous tissue disorders -Rash including - Urticaria -Steven Johnson syndrome

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactionu201d Reporting Formu201d, found online under SAHPRAu2019s publications : https://www.sahpra.org.za/Publications/Index/

Treatment is symptomatic and supportive Since the absorption of nystatin from the gastro-intestinal tract is negligible, overdosage or accidental ingestion causes no systemic toxicity. Oral doses of nystatin in excess of 5 million units daily have caused nausea and gastrointestinal upset.