METHYCOBAL Tablet Ref.[11043] Active ingredients: Mecobalamin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: Medilink Pharmaceuticals Ltd., 30 Armenias, 2003 Strovolos, Nicosia, Cyprus

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

  1. Methycobal Tablets should not be aimlessly used for more than one month unless it is effective.
  2. Prolonged use of larger doses of Methycobal Tablets is not recommended for patients whose occupation requires the handling of mercury or its compounds.
  3. Caution in handing over drug.

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.]

4.5. Interaction with other medicinal products and other forms of interaction

No notable interaction has been reported.

4.6. Pregnancy and lactation

Pregnancy

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.

Brest-feeding

It has been shown that mecobalamin is excreted in the milk of lactating rats.

4.7. Effects on ability to drive and use machines

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.

4.8. Undesirable effects

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%
GastrointestinalAnorexia, nausea/vomiting and diarrhea 
Hypersensitivitynote  Rash

note: In the event of such symptoms, treatment with Methycobal

Tablets should be discontinued.

Reporting of suspected adverse reactions

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.

6.2. Incompatibilities

There is not incompatibility reported.

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