NEUROBION Coated tablet (2020)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | P&G Health Germany GmbH |
|---|---|
| Διεύθυνση | Sulzbacher Strasse 40, 65824 Schwalbach am Taunus, Germany |
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Περιεχόμενα
Name of the medicinal product
Neurobion coated tablets.
Qualitative and quantitative composition
One coated tablet contains: Thiamine disulphide (vitamin B<sub>1</sub>) 100 mg. Pyridoxine hydrochloride (vitamin B<sub>6</sub>) 200 mg. Cyanocobalamin (vitamin B<sub>12</sub>) 200 µg. <u>Excipients:</u> ...
Pharmaceutical form
Coated tablet White, shiny, round, biconvex coated tablet.
Therapeutic indications
Neurological diseases caused by vitamin B deficiencies.
Posology and method of administration
Posology One coated tablet once daily. In individual cases, the dose may be increased to one coated tablet 3 times daily. The coated tablets are to be swallowed whole with plenty of liquid after meals. ...
Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Neurobion coated tablets must not be used in children and adolescents due to their high active substance content. ...
Special warnings and precautions for use
The clinical picture as well as the laboratory parameters of funicular myelosis or of pernicious anaemia can lose specificity by administration of vitamin B<sub>12</sub>. If symptoms of peripheral sensory ...
Interaction with other medicinal products and other forms of interaction
Thiamine is inactivated by 5-fluorouracil as the latter competitively inhibits the phosphorylation of thiamine to thiamine pyrophosphate. Antacids diminish the absorption of thiamine. Loop diuretics, e.g. ...
Pregnancy and lactation
Pregnancy During pregnancy and the nursing period the generally recommended daily dosage of vitamin B<sub>1</sub> is 1.4 mg and of vitamin B<sub>6</sub> 1.9 mg. These dosages may be exceeded in pregnant ...
Effects on ability to drive and use machines
Neurobion coated tablets do not affect the capability to drive a vehicle or to operate machinery.
Undesirable effects
In the following, the undesirable effects are classified by organ system and frequency. The assessment of undesirable effects is based on the following frequency grouping: Very common (≥1/10), Common (≥1/100, ...
Overdose
Vitamin B<sub>1</sub> Thiamine has a broad therapeutic range. Very high doses (over 10 g) have a ganglion-blocking effect, similar to that of curare, and suppress the conduction of nerve impulses. Vitamin ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Vitamin B<sub>1</sub> in combination with vitamin B<sub>6</sub> and/or vitamin B<sub>12</sub> <b>ATC Code:</b> A11DB Neurobion coated tablets contain a combination of ...
Pharmacokinetic properties
Combined administration of vitamins B<sub>1</sub>, B<sub>6</sub> and B<sub>12</sub> is not expected to have a negative effect on the pharmacokinetics of the individual vitamins. Thiamine (vitamin B<sub> ...
Preclinical safety data
The toxicity of vitamins B<sub>1</sub>, B<sub>6</sub> and B<sub>12</sub> is very low. The data available to date do not suggest any potential risk for humans. The literature available on the subject does ...
List of excipients
<u>Tablet core:</u> Magnesium stearate Methyl cellulose Sodium starch glycolate Gelatin Mannitol Talc Glycerol 85% Colloidal anhydrous silica Purified water <u>Tablet coating:</u> Montan-glycol wax Gelatin ...
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
PVC foil coated with PVDC (40 g/m²) Aluminum Foil Water based print primer lacquer outside <u>Package sizes:</u> 20 coated tablets.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
P&G Health Germany GmbH, Sulzbacher Strasse 40, 65824 Schwalbach am Taunus, Germany
Marketing authorization number(s)
794
Date of first authorization / renewal of the authorization
05.04.1971
Date of revision of the text
27/04/2020
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