THIAMINE HYDROCHLORIDE Tablets (2015)
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Περιεχόμενα
Name of the medicinal product
Thiamine Hydrochloride 100mg Tablets.
Qualitative and quantitative composition
Thiamine Hydrochloride 100mg Tablets are a thiamine (vitamin B1) - containing monovitamin product. Each tablet contains thiamine hydrochloride, 100mg. Excipient(s) with known effect: This product contains ...
Pharmaceutical form
Tablet. Round, white or almost white, biconvex tablets embossed with T100.
Therapeutic indications
For the treatment of thiamine deficiencies due to increased dietary requirements, reduced intakes, reduced absorption or increased excretion. Also for treatment of Wernicke-Korsakoff syndrome, beriberi ...
Posology and method of administration
Posology Treatment Adults and adolescents from 12 years of age Mild deficiency: 50-100mg per day. Severe deficiency: 200-300mg per day in divided doses. Not recommended for children under 12 years. Route ...
Contraindications
Known allergy or hypersensitivity to thiamine or to any of the excipients in Thiamine Hydrochloride 50mg Tablets (see section 6.1).
Special warnings and precautions for use
This 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. ...
Interaction with other medicinal products and other forms of interaction
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 ...
Pregnancy and lactation
This product is not intended for use in pregnant or lactating women.
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.
Undesirable effects
Gastrointestinal disorders Frequency not known (cannot be estimated from data): Mild gastrointestinal events such as nausea, vomiting, diarrhoea, and abdominal pain have been reported. Immune system disorders ...
Overdose
Overdose with this route of administration is unlikely. A suspected overdose should be treated symptomatically.
Pharmacodynamic properties
Pharmacotherapeutic group: Vitamin B1, Plain ATC code: A11DA01 Thiamine pyrophosphate (TPP), the coenzymatic form of thiamine, is involved in two main types of metabolic reactions: decarboxylation of α-ketoacids ...
Pharmacokinetic properties
Absorption Thiamine is rapidly absorbed in humans, largely in the proximal small intestine. There are two mechanisms, one by a carrier mediated transport at low physiological concentrations (<2μM), one ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
List of excipients
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Stearic acid Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
Shelf life Blister: 2 years. Pot: 2 years unopened. After first opening the pot, medicinal product should be used within 100 days.
Special precautions for storage
Store below 25°C. Store in the original package. For storage conditions after first opening of pots, see section 6.3.
Nature and contents of container
Pot: Polypropylene snap Secure Pot with HDPE/LDPE closure. Blister pack: 250μm PVC/PVDC (white opaque) with 40 gsm aluminium foil (20μm). 84 tablets in blisters and 100 tablets in pots packaging. Not all ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland
Marketing authorization number(s)
PL 30464/0137
Date of first authorization / renewal of the authorization
15/05/2015
Date of revision of the text
15/05/2015
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