Source: Υπουργείο Υγείας (CY) Revision Year: 2022 Publisher: Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Paralytic ileus, porphyria.
In cases of intestinal atony.
In patients with ulcerative colitis.
No interaction studies have been performed with the exception of alcohol. In vitro and in vivo-studies in animals have demonstrated the absence of any interaction between Duspatalin Retard 200mg and ethanol.
There are no or limited amount of data from the use of mebeverine in pregnant women.
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Duspatalin Retard 200mg is not recommended during pregnancy.
It is unknown whether mebeverine or its metabolites are excreted in human milk. The excretion of mebeverine in milk has not been studied in animals. Duspatalin Retard 200mg should not be used during breast-feeding.
There are no clinical data regarding impact on male or female fertility; however, available animal studies do not indicate harmful effects of Duspatalin Retard 200mg (see section 5.3).
No studies on the effects on the ability to drive and use machines have been performed. The pharmacodynamic and pharmacokinetic profile as well as post-marketing experience do not indicate any harmful effect of mebeverive on the ability to drive or to use machines.
Mebeverine is generally well tolerated.
The following adverse events have been reported spontaneously during post-marketing use. A precise frequency cannot be estimated from available data.
Allergic reactions mainly but not exclusively limited to the skin have been observed.
Skin and subcutaneous tissue disorders: Urticaria, angioedema, face edema, exanthema
Immune system disorders: Hypersensitivity (anaphylactic reactions).
Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Tel: +357 22608607, Fax: +357 22608669, Webpage: www.moh.gov.cy/phs.
Not applicable.
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