PYRIDOXINE Tablet (2015)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Pyridoxine 50mg Tablets.
Qualitative and quantitative composition
Pyridoxine Hydrochloride 50mg.
Pharmaceutical form
Oral tablet.
Therapeutic indications
Pyridoxine Hydrochloride is used for isoniazid-induced peripheral neuritis, idiopathic sideroblastic anaemia and Vitamin B<sub>6</sub> deficiency states.
Posology and method of administration
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 ...
Contraindications
Hypersensitivity to any of the ingredients.
Special warnings and precautions for use
If symptoms persist or worsen, seek medical advice. Do not exceed the stated dose.
Interaction with other medicinal products and other forms of interaction
Many drugs may alter the metabolism or bioavailability of pyridoxine, including isoniazid, penicillamine and oral contraceptives, which may increase the requirements for pyridoxine. Pyridoxine hydrochloride ...
Pregnancy and lactation
Data on exposed pregnancies indicate no adverse effects of pyridoxine in therapeutic doses on pregnancy or the health of the foetus or newborn child, or during lactation. Animal studies are insufficient ...
Effects on ability to drive and use machines
None known.
Undesirable effects
Long term administration of large doses of pyridoxine is associated with the development of severe peripheral neuritis. Reporting of suspected adverse reactions Reporting suspected adverse reactions after ...
Overdose
Symptoms None reported. Treatment No treatment necessary.
Pharmacodynamic properties
Pyridoxine hydrochloride is Vitamin B<sub>6</sub>. It is converted to pyridoxal phosphate which is the co-enzyme for a variety of metabolic transformations. It is essential for human nutrition.
Pharmacokinetic properties
Pyridoxine 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 ...
Preclinical safety data
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.
List of excipients
Calcium hydrogen phosphate BP Starch maize BP Sodium lauryl sulphate BP Magnesium stearate BP Purified water BP (non-detectable in the final formulation)
Incompatibilities
None known.
Shelf life
Shelf life: Two years.
Special precautions for storage
Store below 25°C. Protect from light and moisture.
Nature and contents of container
Packs of 100 or 500 tablets contained in polypropylene securitainers or polyethylene containers. Strip packs of opaque white or clear PVC film and 20μm aluminium foil of 10 or 14 tablets. Tablets will ...
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Marketing authorization number(s)
PL 29831/0181 MA154/02601
Date of first authorization / renewal of the authorization
25 June 2007
Date of revision of the text
23/04/2015
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