Summary of Product Characteristics Updated 08-Mar-2018 | Auden Mckenzie (Pharma Division) Ltd (a subsidiary of Actavis PLC)
Tyvera 50 mg Tablets
Thiamine Hydrochloride 50 mg Tablets
Each tablet contains 50 mg thiamine hydrochloride.
This product contains lactose and sucrose.
For a full list of excipients, see section 6.1.
White uncoated tablets, 8mm in diameter, one side scored, the other marked T/50.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Treatment of thiamine deficiency
Adults, the Elderly and Children over three years:
Mild chronic deficiency: 50mg daily
Severe deficiency: 100mg three times daily.
Not recommended for children under three years.
Route of administration: oral
Hypersensitivity to Thiamine Hydrochloride or to any of the excipients listed in section 6.1
This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicinal product also contains sucrose. Patients with rare hereditary problems of fructose intolerance, malabsorption or sucrose-isomaltase insufficiency should not take this medicine
The thiamine antagonists thiosemicarbazone and 5-fluorouracil can neutralise the effect of thiamine. Patients using any of these treatments may need their thiamine dose adjusted.
Thiamine could give false positive results for urobilinogen determination by the Ehrlich's reaction. High doses of thiamine may interfere with spectrophotometric assays of theophylline plasma concentration.
This product is not intended for use in pregnant or lactating women.
No studies on the effect on the ability to drive and use machines have been performed. However, patients should be cautioned to see how they react before driving or operating machinery.
Mild gastrointestinal events such as nausea, vomiting, diarrhoea, and abdominal pain have been reported. Frequency not known (cannot be estimated from data).
Immune system disorders:
Hypersensitivity reactions have been reported (mainly after parenteral administration). Allergic and anaphylactic reactions, with symptoms of pruritus, urticaria, itching, hives, angioedema, abdominal pain, respiratory distress, tachycardia, palpitations, and shock have been reported in single cases. Frequency not known (cannot be estimated from data).
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; Website: www.mhra.gov.uk/yellowcard.
Overdose has not been reported.
ATC Code: A11DA01
Pharmacotheraputic Group: Vitamin B1, Plain
Thiamine is an essential co-enzyme for carbohydrate metabolism.
Thiamine is well absorbed from the gastrointestinal tract following oral administration, although the absorption of large doses is limited. It is widely distributed to most body tissues and appears in breast milk. Within the cell, thiamine is mostly present as the diphosphate. Thiamine is not stored to any appreciable extent in the body; amounts in excess of the body's requirements are excreted in the urine as unchanged thiamine or metabolites.
No relevant data
Sodium starch glycolate
Do not store above 25°C; store in the original package.
Pack of 100 tablets in a polypropylene bottle with a polyethylene cap.
Accord Healthcare Limited
319 Pinner Road
Mckenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL
+44 (0)1895 627 480
+44 (0)895 627421
+44(0) 1271 385257
+44 (0)1895 627420
+44 (0)1271 385 257