Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Substipharm, 24 rue Erlanger, 75016 Paris, France
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.
In the therapy of Candidal infections, all potential sites of infections should be treated simultaneously.
This medicine contains 182 mg of alcohol (ethanol) in 24 ml (corresponding to 6 ml four times daily; 24 ml is the maximum dose delivered) which is equivalent to 0.76 g in 100 ml. The amount in 24 ml of this medicine is equivalent to less than 4.6 ml of beer or 1.8 ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects.
This medicine contains 0.5 g of sucrose per ml. This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium free”.
This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause (possibly delayed) allergic reactions.
None known.
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.
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 | Stevens-Johnson syndrome; Urticaris |
| Uncommon | Rash |
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.
Not applicable.
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