Summary of Product Characteristics
last updated on the eMC:
16/02/2010
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 16/02/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 08-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.4 Special Warningswarnings and Special Precautionsprecautions for Useuse
Nystan Oral Suspension contains sugar.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Nystan oral preparations should not be used for treatment of systemic mycoses.
4.8 Undesirable Effectseffects
Nystatin is generally well tolerated by all age groups, even during prolonged use. Rarely, hypersensitivity,oral irritation or sensitisation may occur. Nausea has been reported occasionally during therapy.
Large oral doses of Nystatin have occasionally produced diarrhoea, gastrointestinal distress, nausea and vomiting. Rash, including urticaria, and face oedema has been reported rarely. Steven-Johnson Syndrome has been reported very rarely.
9. DATE OF FIRST AUTHORIZATIONAUTHORISATION/RENEWAL OF AUTHORIZATIONTHE AUTHORISATION
28 November 1990 / 19 January 2001
08/02/2010
10. DATE OF (PARTIAL) REVISION OF THE TEXT
24 June 200508/02/2010
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Updated on 19/09/2007 and displayed until 16/02/2010
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Reasons for adding or updating:
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Addition of separate SPCs covering individual presentations
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