Source: Marketing Authorisation Holder Revision Year: 2017 Publisher: Laboratoires MAYOLY SPINDLER, 6 Avenue de lEurope – B.P. 51, 78401 CHATOU CEDEX France, Standard: Tel.: +33(0) 134805555, Medical information: Tel.: +33(0) 134807260
Pharmacotherapeutic group: MUSCULOTROPIC ANTISPASMODIC/ANTIFLATULENT
ATC code: A03AX08 – Other drugs for functional gastrointestinal disorders.
Alverine citrate is a musculotropic antispasmodic.
Simeticone is a physiologically inert substance which has thus no pharmacological activity. It acts by altering the surface tension of gas bubbles, leading to their coalescence.
After oral administration, simeticone is not absorbed and passes through the gastrointestinal tract before being excreted unchanged.
Alverine is absorbed from the gastrointestinal tract and rapidly converted into its pharmacologically active metabolite and into inactive metabolites. Peak plasma concentration is reached 1 hour – 1 hour 30 minutes after oral administration. Renal excretion is the major route of elimination of the metabolites of alverine.
Simeticone is chemically inert and is not absorbed systemically. Systemic toxic effects are therefore not expected.
Conventional non-clinical studies of repeated dose toxicity and genotoxicity, provide evidence that alverine citrate has no significant systemic toxicity.
Animal studies in two species do not indicate harmful effects with respect to embryotoxicity.
Peri- and post-natal study in the rat induced no harmful effects on the foetus development, on the delivery and on the growth and development of offspring during lactation period.
No studies to evaluate carcinogenicity, fertility and early embryonic development have been performed in animals.
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