- Approval Id
- 44ad549dd152b0a0
- Drug Approval Emc Name
- Thiamine Hydrochloride 50 mg Tablets
- Drug Name
- Thiamine Hydrochloride 50 mg Tablets
- Company Name
- Flamingo Pharma (UK) Ltd
- Company Address
- The BLOC, 38 Springfield Way, Kingston Upon Hull, HU10 6RJ, UK
- Company Website
- http://www.flamingopharma.co.uk
- Company Telephone
- +44 (0) 7784240228
- Company Medical Info Direct Line
- 00 800 890 13370
- Atc Code
- A11DA01
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Flamingo Pharma UK Ltd.
Ist floor, Kirkland House,
11-15 Peterborough Road,
Harrow, Middlesex,
HA1 2AX, United Kingdom.
- Authorisation Number
- PL 43461/0037
- Authorisation Date
- 03/07/2018
- Instruction Authorisation Holder
- Flamingo Pharma UK Ltd.
Ist floor, Kirkland House,
11-15 Peterborough Road,
Harrow, Middlesex,
HA1 2AX, United Kingdom.
- Instruction Authorisation Number
- PL 43461/0037
- Instruction Authorisation Date
- 03/07/2018
- Instruction Composition
- Each tablet contains 50 mg Thiamine Hydrochloride.
Excipient(s) with known effect:
Each tablet contains 85.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Tablet.
White to off white, circular biconvex uncoated tablets embossed with “THT” and “50” separated by break line on one side and plain on other side.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Treatment of thiamine deficiency4.2 Posology and method of administration
\*\*Adults, the Elderly and Children over three years\*\*:
Mild chronic deficiency: 50 mg daily
Severe deficiency: 100 mg three times daily.
Not recommended for children under three years.
\*\*Route of administration:\*\* oral4.3 Contraindications
Hypersensitivity to Thiamine Hydrochloride or to any of the excipients listed in section 6.14.4 Special warnings and precautions for use
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.4.5 Interaction with other medicinal products and other forms of interaction
The thiamine antagonist's 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.4.6 Fertility, pregnancy and lactation
This product is not intended for use in pregnant or lactating women.4.7 Effects on ability to drive and use machines
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.4.8 Undesirable effects
\*\*Gastrointestinal disorders\*\*:
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 at www.mhra.gov.uk/yellowcard.4.9 Overdose
Overdose has not been reported.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
\*\*ATC Code\*\*: A11DA01
\*\*Pharmacotheraputic Group\*\*: Vitamin B1, Plain
Thiamine is an essential co-enzyme for carbohydrate metabolism.5.2 Pharmacokinetic properties
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.5.3 Preclinical safety data
No relevant data.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Lactose Monohydrate
Maize Starch
Pregelatinised Starch
Magnesium Stearate
Talc6.2 Incompatibilities
Not applicable.6.3 Shelf life
2 years.
\*HDPE containers:\* Discard 100 days after first opening the container.6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.6.5 Nature and contents of container
Pack of 100's and 250's tablets in white opaque HDPE bottle with white polypropylene child resistant cap containing a polyester coil and desiccant container.
Pack of 28's tablets in blisters of Aluminium-PVC/PVDC
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
None
- Instruction Content
- ## Composition
Each tablet contains 50 mg Thiamine Hydrochloride.
Excipient(s) with known effect:
Each tablet contains 85.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Tablet.
White to off white, circular biconvex uncoated tablets embossed with “THT” and “50” separated by break line on one side and plain on other side.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
## Clinical Particulars
4.1 Therapeutic indications
Treatment of thiamine deficiency4.2 Posology and method of administration
\*\*Adults, the Elderly and Children over three years\*\*:
Mild chronic deficiency: 50 mg daily
Severe deficiency: 100 mg three times daily.
Not recommended for children under three years.
\*\*Route of administration:\*\* oral4.3 Contraindications
Hypersensitivity to Thiamine Hydrochloride or to any of the excipients listed in section 6.14.4 Special warnings and precautions for use
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.4.5 Interaction with other medicinal products and other forms of interaction
The thiamine antagonist's 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.4.6 Fertility, pregnancy and lactation
This product is not intended for use in pregnant or lactating women.4.7 Effects on ability to drive and use machines
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.4.8 Undesirable effects
\*\*Gastrointestinal disorders\*\*:
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 at www.mhra.gov.uk/yellowcard.4.9 Overdose
Overdose has not been reported.
## Pharmacological Properties
5.1 Pharmacodynamic properties
\*\*ATC Code\*\*: A11DA01
\*\*Pharmacotheraputic Group\*\*: Vitamin B1, Plain
Thiamine is an essential co-enzyme for carbohydrate metabolism.5.2 Pharmacokinetic properties
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.5.3 Preclinical safety data
No relevant data.
## Pharmaceutical Particulars
6.1 List of excipients
Lactose Monohydrate
Maize Starch
Pregelatinised Starch
Magnesium Stearate
Talc6.2 Incompatibilities
Not applicable.6.3 Shelf life
2 years.
\*HDPE containers:\* Discard 100 days after first opening the container.6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.6.5 Nature and contents of container
Pack of 100's and 250's tablets in white opaque HDPE bottle with white polypropylene child resistant cap containing a polyester coil and desiccant container.
Pack of 28's tablets in blisters of Aluminium-PVC/PVDC
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
None
