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
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Elevations in ALT (Alanine Aminotransferase) and AST (Aspartate Aminotransferase) > twice the upper limit of normal (ULN) have been reported in patients receiving treatment with alverine/simeticone. These elevations may be associated with a concomitant elevation in total serum bilirubin (see section 4.8). In case of an elevation in hepatic aminotransferases >3 times the ULN and even more so in the case of jaundice, treatment with alverine/simeticone should be discontinued.
The available to date data do not suggest the existence of clinically significant interactions.
Simeticone: No effect is expected during pregnancy with the intake of simeticone due to negligible systemic exposure.
Alverine: There are no exhaustive data of teratogenicity in animals. Clinically, no particular malformative or foetotoxic effect has been reported to date. However, follow-up of pregnancies exposed to alverine is insufficient to exclude any risk.
Consequently, as a precautionary measure, it is preferable to avoid the use of METEOSPASMYL during pregnancy.
No effect of simeticone taken during breastfeeding is expected due to negligible systemic exposure.
There are no data on the excretion of alverine in human milk.
As a result, METEOSPASMYL should be avoided during breastfeeding.
METEOSPASMYL has a minor influence on the ability to drive and use machines. Adverse effects such as vertigo have been reported in some patients (see sections 4.8 and 4.9). These types of disorders may affect the ability to drive and use machines.
The adverse reactions listed below have been reported at frequencies corresponding to: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and undetermined frequency (cannot be estimated on the basis of the available data).
Very rare: cytolytic hepatitis (see section 4.4).
Undetermined frequency: elevated transaminases, alkaline phosphatase, and bilirubin.
Undetermined frequency: angioedema, skin rash, urticaria, and pruritus.
Very rare: anaphylactic type reactions, and anaphylactic shock.
Undetermined frequency: vertigo.
Undetermined frequency: headache.
Undetermined frequency: nausea.
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: Agence Nationale de Sécurité du médicament et des produits de santé (Ansm) et réseau des Centres Régionaux de Pharmacovigilance. Site internet: www.ansm.sante.fr.
Not applicable.
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