PYRALVEX Oromucosal solution Ref.[115951] Active ingredients: Anthraquinone glycosides Salicylic acid

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

4.3. Contraindications

Hypersensitivity to any of the constituents.

4.4. Special warnings and precautions for use

Each bottle of PYRALVEX should be used by only one person.

4.5. Interaction with other medicinal products and other forms of interaction

None known.

4.6. Pregnancy and lactation

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.

4.7. Effects on ability to drive and use machines

None.

4.8. Undesirable effects

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).

6.2. Incompatibilities

None known.

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