RESTATIN Coated tablet Ref.[51080] Active ingredients: Nystatin

This product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

None known.

Absorption of nystatin by the gastrointestinal tract is negligible. However, it should be administered only when the benefit is greater than the potential risks that can be caused after administration of the medicine.

It is not known if nystatin is excreted into human milk. Caution is necessary before administration to breast-feeding women.

Restatin has no influence on the ability to drive and use machines.

Nystatin is usually well tolerated by all age groups, even during prolonged use. Rarely, oral irritation or sensitisation may occur. Nausea has been reported occasionally during therapy. Large oral doses of nystatin have occasionally produced diarrhoea, gastro-intestinal distress, nausea and vomiting. Rash, including urticaria, has been reported rarely. Stevens-Johnson’s syndrome has been reported very rarely.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization 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 national reporting system.

Cyprus, Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia
Fax: +357 22608649
Website: www.moh.gov.cy/phs

Not applicable.