SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Nystatin Oral Suspension BP 100,000 units/ml.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Nystatin BP 100,000 Units + 1% (quantity per 1ml of suspension).

Excipient(s) with known effect:

Sorbitol solution (70%) (Non-Crystallising) Ph.Eur Glycerol Ph.Eur

Sodium methyl hydroxybenzoate BP Sodium benzoate Ph. Eur.

For the full list of excipients, see Section 6.1.

3    PHARMACEUTICAL FORM

Ready mixed Oral Suspension.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

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

4.2    Posology and method of administration Posology

Adults

For the treatment of oral lesions, caused by Candida SPP. 100,000 Units (1ml of the suspension) should be dropped into the mouth four times daily; It should be kept in contact with the affected areas as long as possible.

For the treatment of intestinal candidosis 500,000 Units (5ml of suspension) four times daily, but this dose may be doubled in severe infections.

Administration should be continued for 48 hours after clinical cure to prevent relapse.

For prophylaxis of candidosis a daily dosage of 1 million units may be given. Paediatric population

In intestinal and oral candidosis in neonates (from birth to 1 month),infants (1 month to 2 years)and children (> 2 years) 100,000 units (1ml of suspension) should be dropped into the mouth four times a day. The longer the suspension is kept in contact with the affected area in the mouth, before swallowing, the greater will be its effect.For prophylaxis in the new-born the suggested dose is 100,000 units (1ml of suspension) once daily.

Method of administration

For oral administration

4.3 Contraindications

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

4.4 Special warnings and precautions for use

Oral _ form:

Oral preparations of nystatin should not be used for treatment of systemic mycoses.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Interaction with other medicinal products and other forms of interaction

None known though dilution is not recommended.

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 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.

Nursing mothers

Though gastro-intestinal absorption is insignificant, it is not known whether Nystatin is excreted in human breast milk and caution should be exercised when Nystatin is prescribed for nursing women.

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 Nysatin have occasionally produced diarrhoea, gastrointestinal distress, nausea and vomiting. Rash, including urticaria, has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.

Hypersensitivity and angioedema, including facial odedema 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

Nystatin is a fungistatic and fungicidal antibiotic active against a wide range of yeasts and yeast-like fungi including Candida Albicans.

5.2 Pharmacokinetic properties

Nystatin is poorly absorbed from the gastrointestinal tract.

5.3 Preclinical safety data

None available.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sorbitol solution (70%) (Non-Crystallising) Ph.Eur. Glycerol Ph.Eur.

Sodium citrate Ph.Eur.

Xanthan gum USNF Dispersible cellulose BP Sodium methyl hydroxybenzoate BP Sodium benzoate Ph. Eur.

Saccharin sodium BP

Glyceryl Mono/Di-oleate (Atoms 300 ex ICI)

Citric Acid (to pH 5.6 to 5.8) Ph.Eur.

Purified water BP.

Incompatibilities

None.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Store at a temperature not exceeding 25°C. Protect from light.

6.5 Nature and contents of container

Amber glass bottle containing 30ml with a polypropylene screw cap incorporating a low density polyethylene graduated pipette with a rubber dropper bulb.

6.6 Special precautions for disposal

None.

7 MARKETING AUTHORISATION HOLDER

Teva UK Ltd.,

Brampton Road,

Hampden Park,

Eastbourne,

BN22 9AG,

UK

8 MARKETING AUTHORISATION NUMBER(S)

PL 00289/1869

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

08^th March 1993

DATE OF REVISION OF THE TEXT

21/08/2014