Logufen film-coated tablets 250 mg blister No. 60

Logufen tablets are indicated as monotherapy (first-line drug) for the treatment of partial seizures with or without secondary generalization in adults and adolescents aged 16 years and older who have been newly diagnosed with epilepsy.

As an additional therapy in the treatment of:

partial seizures with or without secondary generalization in adults and children over 6 years of age with epilepsy; myoclonic seizures in adults and adolescents over 12 years of age with juvenile myoclonic epilepsy; primary generalized convulsive (tonic-clonic) seizures in adults and adolescents over 12 years of age with idiopathic generalized epilepsy.

Composition

Active ingredient: levetiracetam;

1 film-coated tablet contains 250 mg or 500 mg of levetiracetam;

Excipients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate;

Film coating:

250 mg tablets Opadry (II) 85G68918 white (polyvinyl alcohol, titanium dioxide (E 171), talc, polyethylene glycol, lecithin); 500 mg tablets Opadry (II) 85G52482 yellow (polyvinyl alcohol, talc, titanium dioxide (E 171), polyethylene glycol, lecithin, iron oxide yellow (E172)).

Contraindication

Hypersensitivity to levetiracetam or other pyrrolidone derivatives, as well as to any of the excipients of the drug.

Method of application

Tablets should be taken orally, with sufficient liquid, regardless of meals. When taken orally, levetiracetam may have a bitter taste.

Divide the daily dose into 2 equal doses.

Application features

Pregnant women

Levetiracetam may be used during pregnancy if, after careful consideration, it is considered clinically necessary. In such cases, the lowest effective dose is recommended.

Children

Levetiracetam in tablet form is not recommended for use in children under 6 years of age. Levetiracetam in oral solution should be used in children 1 month of age and younger and children under 6 years of age.

Drivers

Patients are advised to refrain from driving or operating machinery until it is established that their ability to engage in such activities is not impaired.

Overdose

Symptoms: In case of overdose of levetiracetam, drowsiness, agitation, aggression, respiratory depression, depression of consciousness, coma were observed.

Treatment. In case of acute overdose, gastric lavage or induce vomiting is necessary. There is no specific antidote. If necessary, symptomatic treatment should be carried out, including hemodialysis (up to 60% of levetiracetam and 74% of the primary metabolite are removed).

Side effects

Nervous system: drowsiness, headache, convulsions, balance disorders, gait disorders, dizziness, lethargy, tremor, amnesia, memory impairment, ataxia, paresthesia, attention disorders, hyperkinesia, dyskinesia, choreoathetosis, encephalopathy. Blood: thrombocytopenia, leukopenia, neutropenia, pancytopenia, agranulocytosis. Immune system: drug reaction with eosinophilia and systemic symptoms (DRESS), hypersensitivity (including angioedema and anaphylaxis). Gastrointestinal: abdominal pain, diarrhea, dyspepsia, nausea, vomiting, pancreatitis. On the part of the psyche: depression, hostility / aggression, anxiety, insomnia, nervousness / irritability, suicide attempts, suicidal thoughts, psychotic disorders, abnormal behavior, hallucinations, anger, confusion, panic attacks, affective lability / mood changes, agitation, personality disorders, thinking disorders.

Interaction

Probenecid (500 mg 4 times daily), a drug that blocks renal tubular secretion, inhibits renal clearance of the major metabolite, but not of levetiracetam itself. However, concentrations of this metabolite remain low.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Shelf life - 2 years.