Summary of Product Characteristics
last updated on the eMC:
18/07/2011
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 18/07/2011 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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| Date of revision of text on the SPC: 01-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Text added highlighted in red.
4.4 Special warnings and precautions for use
Shake well before use.
Do use if seal is broken.
This product should not be diluted.
Store in a cool place. Avoid freezing.
Protected from light.
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Updated on 03/05/2011 and displayed until 18/07/2011
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1.
4.3 Contraindications
Contraindicated in patients with a history of hypersensitivity to the active substance or excipients.
4.4 Special warnings and precautions for use
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Nystatin oral preparations should not be used for treatment of systemic mycoses.
4.6 Pregnancy and lactation
Pregnancy:
Animal reproductive studies have not been conducted with nystatin.
It is not known whether nystatin can cause foetal harm when taken by pregnant women, 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.
Breastfeeding:
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 breast-feeding mothers.
4.8 Undesirable effects
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 doses of nystatin could cause nausea, vomiting and diarrhoea and gastrointestinal distress.
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Updated on 26/10/2009 and displayed until 03/05/2011
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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