Mogine

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Lamotrigine 100mg

Disponível em:

Douglas Pharmaceuticals Limited

DCI (Denominação Comum Internacional):

Lamotrigine 100 mg

Dosagem:

100 mg

Forma farmacêutica:

Chewable/dispersible tablet

Composição:

Active: Lamotrigine 100mg Excipient: Calcium carbonate Colloidal silicon dioxide Crospovidone Maize starch Microcrystalline cellulose Purified talc Ribes nigrum Saccharin sodium Sodium stearyl fumarate Sorbitol

Unidades em pacote:

Blister pack, PVC/Al blister, 56 tablets

Classe:

Prescription

Tipo de prescrição:

Prescription

Fabricado por:

Jubilant Generics Limited

Resumo do produto:

Package - Contents - Shelf Life: Blister pack, PVC/Al blister - 56 tablets - 36 months from date of manufacture stored at or below 25°C

Data de autorização:

2006-01-04

Folheto informativo - Bula

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INFORMATION FOR
CONSUMERS
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Information
MOGINE
Lamotrigine 25 mg, 50 mg, 100 mg and 200 mg dispersible/chewable tablets
What is in this leaflet
This leaflet answers some common questions about MOGINE. It does not contain all the available
information.
It does not take the place of talking to your doctor and pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking MOGINE
against the benefits this medicine is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What MOGINE tablets are used for
MOGINE tablets contain the active ingredient lamotrigine. It is used to treat epilepsy in children and
adults.
MOGINE is used in partial (seizures that affect only one part of the brain) or generalised seizures
(seizures that affect the whole brain) including Lennox-Gastaut Syndrome.
Lennox-Gastaut Syndrome (LGS) is a severe form of epilepsy and is characterised by several seizure
types.
MOGINE tablets are initially used in addition to other medicines for the treatment of epilepsy.
The brain consists of a million nerve cells, or neurons. These neurons receive electrical signals from
other neurons and pass them on to the next neurons.
The functions of a normal brain depend on the electrical signals being passed from one neuron to the
next. The brain constantly generates electrical rhythms in an orderly manner.
next. The brain constantly generates electrical rhythms in an orderly manner.
Epilepsy is caused by a disruption in the electrical activity of the brain.
The abnormal elect

Características técnicas

MOGINE 
_LAMOTRIGINE 25 MG, 50 MG, 100 MG AND 200 MG TABLETS _
NAME OF THE DRUG 

MOGINE 
Lamotrigine 25 mg, 50 mg, 100 mg and 200 mg tablets. 

Severe, potentially life-threatening rashes have been reported in
association with the 
use of lamotrigine, particularly in children.  Accordingly,
lamotrigine should be 
discontinued at the first sign of rash unless the rash is clearly not
drug related.  (SEE 
DOSAGE AND ADMINISTRATION). 
DESCRIPTION 

Lamotrigine is a substituted asymmetric triazine. It is a white to
pale cream coloured 
powder. It is slightly soluble in ethanol and chloroform, and very
slightly soluble in 
water. The pKa of lamotrigine at 25 
C is 5.7.  The chemical name for lamotrigine is 
3,5-diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine.  The CAS Number is
84057-84-1 
and the molecular weight: 256.1. 

The structural formula is: 

MOGINE tablets contain as excipients: calcium carbonate, sorbitol,
cellulose- 
microcrystalline, crospovidone, starch- maize, purified talc,
saccharin sodium, sodium 
stearylfumarate, colloidal anhydrous silica, blackcurrant
flavour (ARTG No. 11133).  
PHARMACOLOGY 
_MECHANISM OF ACTION _
Lamotrigine is an anticonvulsant and its action is uncertain. The
results of 
neurochemical and electrophysiological studies with various _in
vitro_ and _in vivo_ 
preparations indicate that lamotrigine can inhibit voltage gated
sodium channels and 
reduce the release of glutamate, an excitatory amino acid implicated
in the 
pathophysiology of epilepsy. It is possible that these effects
underlie inhibition of the 
sustained repetitive firing of action potentials characteristic of
neurones in epileptic 
foci, thereby limiting the spread of seizures.  

In tests designed to evaluate the central nervous system effects of
drugs, the results 
obtained using doses of 240 mg lamotrigine administered to healthy
male and female 
volunteers did not differ from placebo, whereas both 1000 mg
phenytoin and 10 mg 
diaze