3 years
After 1st opening: 6 months
Not applicable.
Sodium hyaluronate, benzyl alcohol, macrogol monomethyl ether 350 and purified water
Published animal studies have shown that when given orally, the principal adverse effect is on the gastrointestinal tract. Diclofenac inhibited ovulation in the rabbit and impaired implantation, as well as early embryonic development in the rat. The embryo/foeto-toxic potential of diclofenac was evaluated in three animal species (rat, mouse and rabbit). Foetal death and growth retardation occurred at maternal toxic doses, however, on the basis of the available data, diclofenac is not considered to be teratogenic. The gestation period and the duration of parturition were extended by diclofenac. Doses lower than maternal toxic ones did not affect the postnatal development. Results from extensive genotoxicity and carcinogenicity testing suggest that it is unlikely that diclofenac would pose a significant carcinogenic hazard to humans.
12/01/2018
Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona
Spain
Do not store above 25°C.
The product is supplied in an epoxy-phenolic lined sealed aluminium tube with a white polypropylene screw on cap with a pierced tip, in 25 g, 50 g, 60 g, 90 g and 100 g sizes.
Not all pack sizes may be marketed.
PL 16973/0012
No special requirements.
1 September 2000 / 25 July 2007
