Mycostatin 100,000 units/ml Oral Suspension (Ready Mixed).

Ready mixed oral suspension containing 100,000 units nystatin per ml.

Excipient(s) with known effect:

Excipients with known effect: ethanol, methyl parahydroxybenzoate (E218, 1.0mg), propyl parahyrdroxybenzoate (E216, 0.2mg), sodium and sucrose (500mg).

For the full list of excipients, see Section 6.1.

Oral suspension.

Light creamy, yellow suspension.

The prevention and treatment of mycotic infections due to Candida albicans, affecting the oral cavity. Consideration should be given to official guidance on the appropriate use of antifungal agents.

Posology

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) three times daily is an effective regimen.

Infants (1 month to 2 years):

The recommended dose is one to two mL (100,000 to 200,000 units nystatin) four times daily.

Children (over 2 years) and adults:

Dosage ranges of one to six mL (100,000 to 600,000 units nystatin) four times daily have been used. It is recommended to keep the medication in contact with the affected areas as long as possible.

Older people:

No specific dosage recommendations or precautions.

In the prevention and treatment of candidiasis, the dosage regimen for Mycostatin 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.

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

Mycostatin Oral Suspension should not be used for treatment of systemic mycoses.

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

In the therapy of Candidal infections, all potential sites of infections should be treated simultaneously.

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

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

None known.

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.

None known.

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

The table below lists all adverse events. The list is presented by system organ class and frequency, which is defined using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).

System Organ Class	Frequency	Adverse Event (MedDRA)
Immune System Disorders	Rare	Hypersensitivity, angioedema, including facial oedema
Gastrointestinal Disorders	Uncommon	Diarrhoea, abdominal discomfort, nausea, vomiting
Skin and Subcutaneous Tissue Disorders	Rare Uncommon	Stevens-Johnson syndrome; Urticaris Rash

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie

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.

Pharmacotherapeutic group: Antifungals for topical use. ATC code: D01 AA01

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

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.

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.

Cherry flavour, cinnamic aldehyde, ethanol, glycerol, methyl parahydroxybenzoate (E218), peppermint oil, pH adjusters (hydrochloric acid, sodium hydroxide), propyl parahydroxybenzoate (E216), sodium carboxymethycellulose (E466), anhydrous disodium phosphate, sucrose, purified water.

Not applicable.

2 years

Do not store above 25° C.

Do not freeze.

Store in the original container.

30 ml Type III amber glass bottle with polypropylene cap, packed in a cardboard carton with a graduated, polyethylene dropper with natural rubber bulb.

Shake well before use.

Dilution is not recommended as this may reduce therapeutic efficacy.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Bristol-Myers Squibb Pharmaceuticals Limited

Swords

County Dublin

Ireland.

PA 0002/007/007

Date of first authorisation: 01 April 1977

Date of latest renewal: 01 April 2007

July 2017