a) Symptoms - None reported
b) Treatment - no treatment necessary.
Hypersensitivity to any of the ingredients.
None known
Long term administration of large doses of Piridoxina Clorhidrato Biosano is associated with the development of severe peripheral neuritis.
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 via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the Summary of Product Characteristics.
Piridoxina Clorhidrato Biosano Hydrochloride is used for isoniazid-induced peripheral neuritis, idiopathic sideroblastic anaemia and Vitamin B6 deficiency states.
Piridoxina Clorhidrato Biosano hydrochloride is Vitamin B6. It is converted to pyridoxal phosphate which is the co-enzyme for a variety of metabolic transformations. It is essential for human nutrition.
Piridoxina Clorhidrato Biosano hydrochloride is absorbed from the gastrointestinal tract and is converted to the active forms pyridoxal phosphate and pyridoxamine phosphate. It crosses the placental barrier and appears in breast milk. It is excreted in the urine as 4-pyridoxic acid.
If symptoms persist or worsen, seek medical advice. Do not exceed the stated dose.
None known.
For isoniazid-induced peripheral neuritis
| Adults: | Treatment - 50mg three times daily Prophylaxis - Not suitable with this dosage form |
| Children: | This presentation is not recommended |
For idiopathic sideroblastic anaemia
| Adults: | 100 to 400mg daily in divided doses |
| Children: | This presentation is not recommended |
For deficiency states
| Adults: | 50 to 150mg daily in divided doses |
| Children: | This presentation is not recommended |
| Elderly: | Dosage requirements appear to be similar to those for young adults |
Not applicable.
