Source: Health Products Regulatory Authority (IE) Revision Year: 2007 Publisher: Norgine Limited, Chaplin House, Widewater Place, Moorhall Road, Harefield, Uxbridge, Middlesex, UB9 6NS, Untied Kingdom
Hypersensitivity to any of the constituents.
Each bottle of PYRALVEX should be used by only one person.
None known.
Animal studies are insufficient with respect to effects on pregnancy and- or embryonal/foetal development. The potential risk for humans is unknown. Caution should be exercised when prescribing to pregnant women. Anthranoid glycosides derived from rhubarb may be excreted in breast milk. However, at therapeutic doses of Pyralvex, it is not known whether these, or salicylic acid are excreted in breast milk. A decision on whether to continue breast-feeding or to continue therapy with Pyralvex should be made taking into account the benefit of breast-feeding to the child and benefit of Pyralvex therapy to the women.
None.
Gastrointestinal Disorders.
A transient local burning sensation at the site of application occurs very commonly (>1/10).
Temporary discolouration of teeth or oral mucosa have been described commonly (>1/100, <1/10) following administration of Pyralvex (see also section 4.2).
None known.
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