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1. Nystan Oral Suspension (Ready Mixed)
2. Nystan Oral Suspension (Ready Mixed)

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Nystan 100,000 units/ml Oral Suspension (Ready-Mixed)

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Ready mixed oral suspension containing 100,000 units nystatin per ml. Excipient(s) with known effect:

Excipients with known effect: ethanol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium and sucrose.

For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Oral suspension

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

The prevention and treatment of candidal infections of the oral cavity, oesophagus and intestinal tract. The suspension provides effective prophylaxis against oral candidosis in those born of mothers with vaginal candidosis.

4.2 Posology and method of administration

Posology

Prevention and treatment of oral candidiasis:

Neonates (from birth to 1 month):

Clinical studies of limited size in neonates, including preterm and babies of low weight at birth, indicate that 1 ml (100,000 U) four times daily is an effective regimen.

Infants (1 month to 2 years):

2 ml (200,000 U) 4 times daily (1 ml for each side of the mouth).

Children (over 2 years) and adults:

4 - 6 ml (400,000 - 600,000 U) 4 times daily (half dose in each side of the mouth). It is recommended to keep the medication in contact with the affected areas as long as possible.

Prevention and treatment of intestinal candidiasis:

Neonates (from birth to 1 month) and infants (1 month to 2 years):

1 - 2 ml four times daily administered with milk or other liquid.

If needed, the dose can be increased, even in the neonates. Treatment should be continued for at least 48 hours after clinical cure and/or normalisation of cultures to avoid a relapse.

Children (over 2 years) and adults:

4 - 6 ml (400,000 - 600,000 U) 4 times daily. The suspension should be retained in the mouth for as long as possible (e.g., several minutes) before swallowing. If needed, the dose can be increased. Treatment should be continued for at least 48 hours after clinical cure and/or normalisation of cultures to avoid a relapse.

Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective.

Older people:

No specific dosage recommendations or precautions.

In the prevention and treatment of candidiasis, the dosage regimen for Nystan should be continued for at least 48 hours after symptoms have disappeared. If signs and symptoms worsen or persist (beyond 14 days of treatment), the patient should be reevaluated, and alternate therapy considered.

4.3    Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

4.4    Special warnings and precautions for use

Nystan Oral Suspension contains sucrose.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.

This medicinal product contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).

Nystan oral preparations should not be used for treatment of systemic mycoses.

4.5    Interaction with other medicinal products and other forms of interaction

None known.

4.6    Fertility, pregnancy and lactation

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 potential risk to the foetus.

Breast-feeding

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 nursing woman.

4.7    Effects on ability to drive and use machines

None known.

4.8    Undesirable effects

Nystatin is generally well tolerated by all age groups, even during prolonged use. If irritation or sensitisation develops, treatment should be discontinued. Nausea has been reported occasionally during therapy.

Large oral doses of Nystatin have occasionally produced diarrhoea, gastrointestinal distress, nausea and vomiting. Rash, including urticaria, has been reported rarely. Steven-Johnson Syndrome has been reported very rarely. Hypersensitivity and angioedema, including facial oedema have been reported.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9    Overdose

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.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Antifungals for topical use, ATC code: D01AA01

Nystatin is an antifungal antibiotic active against a wide range of yeasts and yeastlike fungi, including Candida albicans.

5.2    Pharmacokinetic properties

Absorption

Nystatin is formulated in oral and topical dosage forms and is not systemically absorbed from any of these preparations.

Gastrointestinal absorption of nystatin is insignificant.

Elimination

Most orally administered nystatin is passed unchanged in the stool.

5.3    Preclinical safety data

No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or its effect on    male    or female    fertility.

6    PHARMACEUTICAL    PARTICULARS

6.1    List of excipients

Ethanol, flavours, glycerin, methyl parahydroxybenzoate (E218), pH adjusters (hydrochloric acid, sodium hydroxide), propyl parahydroxybenzoate (E216), sodium carboxymethylcellulose (E466), sodium phosphate, sucrose, water.

6.2    Incompatibilities

None known.

6.3    Shelf life

2 years.

6.4    Special precautions    for    storage

Do not store above 25 °C.

6.5    Nature and contents of    container

30 ml amber glass bottle, packed in a cardboard carton with a graduated, polyethylene dropper.

6.6    Special precautions    for    disposal