Source: Υπουργείο Υγείας (CY) Revision Year: 2018 Publisher: Medilink Pharmaceuticals Ltd., 30 Armenias, 2003 Strovolos, Nicosia, Cyprus
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
For drugs that are dispensed in a Press-Through-Package (PTP), instruct the patient to remove the drug from the package prior to use. [It has been reported that, if the PTP sheet is swallowed, the sharp corners of the sheet may puncture the esophageal mucosa, causing perforation and resulting in serious complications such as mediastinitis.]
No notable interaction has been reported.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy. Clinical studies have been done on pregnant women and no harmful effects have been reported.
It has been shown that mecobalamin is excreted in the milk of lactating rats.
Based on the pharmacodynamic properties and adverse events profile, it is unlikely that Methycobal would cause an impairment of driving performance or compromise the ability to use machinery.
Adverse reactions were reported in 146 of 15,180 patients (0.96%). (At the end of the investigation for incidence of adverse reactions).
5% > ≥0.1% | <0.1% | |
---|---|---|
Gastrointestinal | Anorexia, nausea/vomiting and diarrhea | |
Hypersensitivitynote | Rash |
note: In the event of such symptoms, treatment with Methycobal
Tablets should be discontinued.
Reporting suspected adverse reactions after authorisation 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 tothe Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.
There is not incompatibility reported.
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