Neuromultivit film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE

Available from:

Lannacher Heilmittel Ges.m.b.H 8502 Lannach, Austria

ATC code:

A11DB

INN (International Name):

CYANOCOBALAMIN 0.2 mg PYRIDOXINE HYDROCHLORIDE 200 mg THIAMINE HYDROCHLORIDE 100 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

CYANOCOBALAMIN 0.2 mg PYRIDOXINE HYDROCHLORIDE 200 mg THIAMINE HYDROCHLORIDE 100 mg

Prescription type:

POM

Therapeutic area:

VITAMINS

Authorization status:

Authorised

Authorization date:

2005-07-15

Patient Information leaflet

PIL - NEUROMULTIVIT FILM-COATED TABLETS 

1

Patient Information Leaflet 

NEUROMULTIVIT
®
 FILM-COATED TABLETS 

LICENSE NO.: 
MA069/00301 

MANUFACTURER 
Lannacher Heilmittel Ges.m.b.H, A-8502 Lannach, Austria 

COMPOSITION: 
1 Neuromultivit film-coated tablet contains  
Thiamine hydrochloride (Vitamin B
1
)................................................100 mg 
Pyridoxine hydrochloride (Vitamin B
6
).............................................. 200 mg 
Cyanocobalamin (Vitamin B
12
)..........................................................200 µg 

PROPERTIES AND EFFICACY  
Vitamin B
1
 (thiamine
hydrochloride) supports carbohydrate metabolism. Thiamine 
is detectable in nerve tissues and membranes and plays a role
in the synthesis of 
mediators involved in neuronal function. 
Vitamin B
6
 (pyridoxine) induces the metabolism of amino acids
in nerve tissues. In 
addition vitamin B
6
 influences the biosynthesis of many well known mediators such 
as dopamine, adrenaline and noradrenaline. 
Vitamin B
12
 (cyanocobalamin) has an effect on the metabolism of special
cell 
components (nucleic acids), in particular on the fatty
acid metabolism playing a 
major role in nerve tissues. This vitamin is
indispensable for the growth and 
replication of cells. 

THERAPEUTIC INDICATIONS 
To support the treatment of neuropathies, such as: 
-  inflammatory and degenerative neuropathies of various
etiology 
-  neuritis and neuralgia 
-  root neuritis as a result of degenerative back
bone disorders 
-  pain and hypomotility in the neck, shoulder girdle and
the arms due to irritation 
  of the nerve plexus in the neck 
-  pain and hypomotility in the lumbar spine
due to irritation of the nerve plexus in 
 the 
neck 
-  pain in the ischiadic nerve 
-  pain episodes in one or more branches of the trige

Summary of Product characteristics

 
Page 1 of 4   
SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT 

Neuromultivit film-coated tablets 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

1 Neuromultivit film-coated tablet contains  
Thiamine hydrochloride (Vitamin B
1
)................................................ 100 mg 
Pyridoxine hydrochloride (Vitamin B
6
).............................................. 200 mg 
Cyanocobalamin (Vitamin B
12
).........................................................  0.2 mg 

For excipients, see 6.1. 

3. PHARMACEUTICAL FORM 

Film-coated tablets 

4. CLINICAL PARTICULARS 

4.1. THERAPEUTIC INDICATIONS 

For supporting the treatment of neuropathies, such as: 

- polyneuropathies of various etiology 

- neuritis and neuralgia 

- radiculitis as a result of degenerative spinal column diseases 

- intercostal neuralgia 

- trigeminus neuralgia 
 - 
ischalgia 

- shoulder-arm syndrome 

- lumbar syndrome 

- cervical syndrome 

- paresis of the nervus facialis 

4.2. POSOLOGY AND METHOD OF ADMINISTRATION 

One Neuromultivit film-coated tablet is taken three times daily. 
Neuromultivit film-coated tablets are swallowed unchewed with
a small amount of liquid after 
meals. 

4.3. CONTRAINDICATIONS 

- Known hypersensitivity to one of the components. 

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4.4. SPECIAL WARNING AND PRECAUTIONS FOR USE 

The administration of a high dosage preparation for more than
four weeks should not be carried 
out due to a possible triggering of neurological symptoms. Neither
the clinical impression nor 
laboratory findings are able to establish clearly a
funicular myelosis nor pernicious anemia by 
the vitamin B
12
 -preparation. 

4.5. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION 

_Concomitant administration of isoniazid, penicillamine or
oral contraceptives results in reduced _
_efficacy of vitamin B6 and hen