Epileptal tablets are used for the indications listed below.
epilepsy:
adults and children from 12 years of age: monotherapy and adjunctive therapy of epilepsy, in particular partial and generalized seizures, including tonic-clonic seizures, as well as seizures associated with Lennox-Gastaut syndrome; children from 2 to 12 years of age: adjunctive therapy of epilepsy, in particular partial and generalized seizures, including tonic-clonic seizures, as well as seizures associated with Lennox-Gastaut syndrome (after seizure control is achieved, the use of adjunctive drugs can be discontinued and monotherapy with Epileptal can be continued); monotherapy of typical absences;
Bipolar disorder (adults): for the prevention of phases of emotional disturbances in patients with bipolar disorder, mainly by preventing depressive episodes.
Composition
Active ingredient: lamotrigine;
1 tablet contains lamotrigine 25 mg, 50 mg or 100 mg in terms of 100% substance;
Excipients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), povidone, yellow iron oxide (E 172), magnesium stearate.
Contraindication
Epileptal is contraindicated in patients with known hypersensitivity to lamotrigine or any other component of the drug.
Method of application
Epileptal tablets should be swallowed without chewing or breaking.
If the prescribed dose of Epileptal, for example for use in children (epilepsy only) or patients with impaired liver function, does not correspond to the amount of active substance in whole tablets, it is necessary to prescribe a dose that corresponds to a smaller number of whole tablets.
Application features
Pregnant women
Epileptal can be prescribed during pregnancy only if the expected benefit to the mother outweighs the possible risk to the fetus.
The benefits of breastfeeding should be weighed against the potential risk of side effects in the infant. If a woman decides to breastfeed during therapy with Epileptal, the infant should be monitored for side effects.
Children
There is insufficient information on the use of Epileptal for the treatment of children under 2 years of age with epilepsy, therefore the drug is not recommended for this age group.
Lamotrigine is not indicated for use in children and adolescents with bipolar disorder under 18 years of age.
The efficacy and safety of lamotrigine in the treatment of patients with bipolar disorder in this age group have not been studied, therefore, recommendations on dosage regimen cannot be provided.
Drivers
Two studies in volunteers found that the effects of lamotrigine on visual coordination, eye movement, body control and subjective sedation were no different from those of placebo. Dizziness and diplopia have been reported with lamotrigine, so patients should first assess their own response to lamotrigine treatment before driving or operating machinery. Since there is individual response to antiepileptic drugs, the patient should consult their doctor regarding the specifics of driving in such cases.
Overdose
There have been reports of cases of acute overdose (doses 10-20 times the maximum therapeutic dose), including fatalities. Symptoms of overdose included ataxia, nystagmus, impaired consciousness, grand mal seizures and coma. Also, prolonged QRS interval on the electrocardiogram (intraventricular conduction delay) was observed in patients with overdose.
In case of overdose, the patient should be hospitalized for appropriate supportive therapy. Therapy should be aimed at reducing absorption (activated charcoal), further therapy should be symptomatic. There is no experience with the use of hemodialysis as a treatment for overdose.
Side effects
Mental disorders: often (> 1/100, <1/10) - aggressiveness, irritability.
Nervous system disorders: very common (> 1/10) - headache; common (> 1/100, <1/10) - drowsiness, insomnia, dizziness, tremor.
Gastrointestinal disorders: often (> 1/100, <1/10) - nausea, vomiting, diarrhea, dry mouth.
Musculoskeletal and connective tissue disorders: common (> 1/100, <1/10) - arthralgia.
Interaction
In a study of 10 male volunteers, rifampicin increased the clearance and decreased the half-life of lamotrigine due to induction of hepatic enzymes responsible for glucuronidation. In patients receiving concomitant rifampicin therapy, the treatment regimen recommended for lamotrigine and appropriate inducers of glucuronidation should be used (see Dosage and Administration).
In healthy volunteers, lopinavir/ritonavir approximately halved the plasma concentration of lamotrigine by inducing glucuronidation. Patients already taking lopinavir/ritonavir should be treated with the same regimen recommended for lamotrigine and glucuronidation inducers.
According to studies in healthy volunteers, the use of atazanavir / ritonavir (300 mg / 100 mg) reduced the AUC and Cmax of lamotrigine in plasma (at a dose of 100 mg) by an average of 32% and 6%, respectively (see section "Method of administration and dosage").
Store in a place protected from light at a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life - 3 years.
