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Normon S.A. - Sapin

ANASTROZOLE NORMON
BISOPROLOL NORMON
DESLORATIDINE NORMON
ESCITALOPRAM NORMON
ESOMEPRAZOLE NORMON
ESTECINA Inj.
ESTECINA Tablets
FIXIM
GASTRIMUT
LAMOTRIGINE NORMON
LETROZOLE NORMON
LEVOFLOXACIN NORMON
LIDOCAINE 2% EPINEPHRINE NORMON
NORMOCEF
NORMOPRIL
PARACETAMOL NORMON
SIMVASTATIN NORMON
TOPAGAN

Forms and presentation
Lamotrigine Normon 25 mg: Dispersible Tablets: Box of 21.
Lamotrigine Normon 50 mg: Dispersible Tablets: Box of 42.
Lamotrigine Normon 100 mg: Dispersible Tablets: Box of 56.

Composition
Lamotrigine Normon 25 mg: Each tablet contains: Lamotrigine: 25 mg. Excipients: crospovidone, sodium saccharin, orange essence, magnesium stearate, and coloidal silica.
Lamotrigine Normon 50 mg: Each tablet contains: Lamotrigine: 50 mg. Excipients: crospovidone, sodium saccharin, orange essence, magnesium stearate, and coloidal silica.
Lamotrigine Normon 100 mg: Each tablet contains: Lamotrigine: 100 mg. Excipients: crospovidone, sodium saccharin, orange essence, magnesium stearate, and coloidal silica.

Properties
Lamotrigine belongs to a group of drugs known as antiepileptics.

Indications
Epilepsy: Lamotrigine it is used for the treatment of different types of epilepsy, both alone (monotherapy) in adults or children over 12 years of age, or in combination with other drugs (adjunctive therapy) in adults or children aged 2 years or over.
Bipolar Disorder: Lamotrigine is used in adult patients with bipolar disorder to prevent the appearance of episodes of depression.

Contraindications
Hypersensitivity to lamotrigine or any of the other components of this drug.

Precautions
In case of skin rash, either isolated or accompanied by fever, adenopathies, the treatment must be immediately stoped. Lamotrigine can produce cutaneous reactions that are more frequent during the first 8 weeks of treatment, if high initial doses are received, if administered simultaneously with valproate or in the case of children. In the latter, such reactions may be confused with typical infant infection, as fever may also appear.
A lower dose than normal may be required in case of liver or kidney disease.
If symptoms such as vertigo, gait alterations, visual alterations and nausea occur with simultaneous administration of carbamazepine, a reduction in the dose of carbamazepine is required.
Caution is advised in patients suffering from Parkinson’s disease, as the symptoms may worsen.

Drug interactions
Simultaneous administration of hormonal contraceptives requires an increase in the dose of Lamotrigine Normon. In patients taking oral contraceptives, any change in the menstrual bleeding pattern should be reported to the patient’s physician
Simultaneous administration of antiepileptic drugs (phenytoin, carbamazepine, phenobarbital, and primidone) and the antibiotic rifampicin may require an increase in the dose of lamo-trigine, while joint administration with valproate requires a decrease in the lamotrigine dose. In combination with carbamazepine, starting treatment with lamotrigine may produce symptoms such as difficulty in maintaining balance or blurred vision, which generally clear up by reducing the carbamazepine dose.

Ability to drive and use machine
During treatment with Lamotrigine Normon, symptoms such as vertigo or visual alterations can appear that may affect capacity to drive or use machinery.

Pregnancy and lactation
Pregnancy: Administration of Lamotrigine Normon can be associated with a reduction in folic acid that can affect the development of the foetus.
Lactation: As lamotrigine is excreted in breast milk, mothers are advised to feed their children with artificial food.

Side effects
The most characteristic effect of lamotrigine is the development of cutaneous adverse reactions, which generally appear in the first 8 weeks after starting treatment. Most of these rashes are mild and clear up spontaneously. However, infrequently severe skin reactions may occur that are potentially life threatening. Therefore, all patients who develop a rash must be quickly evaluated and the possible withdrawal of lamotrigine should be considered.
In children, the initial appearance of rash may be confused with an infection. Therefore, parents should inform the doctor of the possibility of a reaction to lamotrigine in children who develop symptoms of rash and fever during the first eight weeks of treatment.
Frequently, adverse reactions related to the nervous system occur, such as headache, dizziness, somnolence, insomnia, tremor, vertigo and behavioural problems such as irritability or aggressiveness. The appearance of problems with vision have also been reported.
Frequently, gastrointestinal alterations such as nausea, vomiting and diarrhoea occur.
Among the adverse effects reported very rarely are: appearance of blood anomalies (including alterations to the number of white cells and platelets), hypersensitivity syndrome, liver alterations, conjunctivitis, tics, hallucinations, agitation, instability, confusion, difficulty in maintaining balance or worsening of Parkinson’s disease.

Dosage and administration
Lamotrigine Normon Dispersible Tablets can be swallowed whole with a small amount of water. They may be chewed or dissolved in a small amount of water, sufficient to completely cover the tablet. Do not stop treatment with Lamotrigine Normon abruptly as it can lead to a rebound effect in the form of epileptic seizures in epileptic patients. Lamotrigine Normon should be reduced progressively over a period of 2 weeks.
Treatment with Lamotrigine Normon should be started gradually, i.e. progressively increasing the dose for a period of 6 weeks until the maintenance dose is reached. This reduces the frequency of cutaneous reactions.
Epilepsy: The initial dose of Lamotrigine Normon varies according to whether the treatment is monotherapy or adjunctive therapy with valproate or other Antiepileptics.
Some formats of Lamotrigine Normon 25 mg and 50 mg are available as “Initiation packaging” for their use during the first weeks of the treatment when the dose has to go away increasing little by little. These “Initiation packaging” only are available for adults use.
Adults (over 12 years of age):
Monotherapy should start with an initial dose of 25 mg, once daily for 2 weeks, followed by 50 mg daily (25 mg every 12 hrs) for the following 2 weeks. For combined therapy with valproate with or without other treatments, the initial dose should be 12.5 mg daily (one 25-mg tablet taken on alternate days) for 2 weeks, followed by 25 mg once daily for the following 2 weeks.
In children (2 to 12 years):
Children taking valproate with or without other antiepileptic drugs should receive an initial Lamotrigine Normon dose of 0.15 mg/kg/day administered once daily for 2 weeks, followed by 0.3 mg/kg administered once daily for the following 2 weeks.
Children taking other antiepileptic drugs (except valproate) should receive an initial Lamotrigine Normon dose of 0.6 mg/kg/day administered in 2 doses for 2 weeks, followed by 1.2 mg/kg/day administered in 2 doses for the following 2 weeks.
Children taking oxcarbazepine without other drugs that modify the metabolism of lamotrigine (except valproate) should receive an initial Lamotrigine Normon dose of 0.3 mg/kg administered once daily or in 2 doses for 2 weeks, followed by 0.6 mg/kg administered once daily or in 2 doses for the following 2 weeks.
Once treatment has been started as indicated, the dose may be progressively increased in accordance with the response to treatment until the optimum maintenance dose is reached.
Bipolar Disorder: Adults or the elderly (over 18 years of age): The normal dose used is between 100 and 400 mg, taken once daily or divided into 2 doses.

Overdosage
The symptoms of an overdose include involuntary eye movements, movement disorders, alterations to consciousness and coma and require hospital care. Gastric lavage should be performed if considered necessary.

Storage conditions
Store below 30 °C. Protect from light and moisture.

Origin: Spain
Laboratories: Normon
Distributor: Droguerie Phenicia
Year of submission: 2010
Number & Year of Registration
25mg: 218725/10
50mg: 218726/10
100mg: 218727/10