Exalief^® (Tablets) Instructions for Use

Marketing Authorization Holder

Eisai Europe, Limited (United Kingdom)

Manufactured By

Bial-Portela & Ca. S.A. (Portugal)

Labeled By

EISAI MANUFACTURING, LTD. (United Kingdom)

ATC Code

N03AF04 (Eslicarbazepine)

Active Substance

Eslicarbazepine acetate (Rec.INN Mod. registered WHO, modified name)

Dosage Form

Exalief®

Tablets 800 mg: 20, 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Tablets white oblong with engraving “ESL 800” on one side and score on the other.

Auxiliary substances : povidone K29/32, croscarmellose sodium, magnesium stearate.

10 pcs. – blisters (2) – carton packs.
10 pcs. – blisters (3) – carton packs.
10 pcs. – blisters (6) – carton packs.
10 pcs. – blisters (9) – carton packs.
15 pcs. – blisters (2) – carton packs.

Clinical-Pharmacological Group

Anticonvulsant drug

Pharmacotherapeutic Group

Antiepileptic drug, carboxamide derivative

Indications

• Monotherapy in the treatment of focal-onset seizures with or without secondary generalization in adult patients (aged 18 years and older) with newly diagnosed epilepsy.
• Adjunctive therapy in the treatment of focal-onset seizures with or without secondary generalization in adult patients (aged 18 years and older).

The decision to prescribe eslicarbazepine acetate as monotherapy should be made by a physician with appropriate experience in the treatment of epilepsy.

Contraindications

• Hypersensitivity to the active substance eslicarbazepine acetate, other carboxamide derivatives (e.g., carbamazepine, oxcarbazepine), or to any of the excipients.
• Second- or third-degree atrioventricular (AV) block.

Patients with a history of serious dermatological reactions (e.g., Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis) associated with other antiepileptic drugs should be closely monitored, as cross-reactivity cannot be ruled out.

Dosage Regimen

The recommended starting dose for Exalief^® is 400 mg once daily. After one or two weeks, the dose should be increased to the recommended maintenance dose of 800 mg once daily.

Depending on the clinical response and tolerability, the dose may be increased to a maximum of 1200 mg once daily. Dose titration should be performed in steps of 400 mg at intervals of one week or more. The tablet may be broken along the score line for ease of administration, but should not be chewed and should be swallowed with water.

For elderly patients (65 years and older), dose adjustment is not solely based on age, but renal function should be monitored. For patients with renal impairment, dose adjustment is recommended: a maximum dose of 600 mg is recommended for patients with severe renal impairment (CrCl <30 mL/min), and a maximum dose of 800 mg is recommended for patients with moderate renal impairment (CrCl 30-60 mL/min). Exalief^® is not recommended for patients with hepatic impairment.

Adverse Reactions

The most commonly reported adverse reactions (≥10%) are dizziness and somnolence (drowsiness). These reactions are usually mild to moderate in intensity and occur predominantly during the initial titration phase.

Very common (≥1/10) adverse reactions include: dizziness, somnolence, headache, nausea, vomiting, and diplopia (double vision). Common (≥1/100 to <1/10) adverse reactions include: rash, ataxia (impaired coordination), tremor, blurred vision, vertigo, balance disorder, fatigue, and hyponatremia (low blood sodium).

Serious but less frequent adverse reactions may include serious skin rashes (such as Stevens-Johnson Syndrome), hyponatremia, suicidal ideation or behavior, and atrioventricular block. Patients should be advised to report any emergence or worsening of depression, suicidal thoughts, or unusual changes in mood or behavior to their healthcare provider immediately.

Drug Interactions

Concomitant use of Exalief^® with carbamazepine may increase the risk of adverse reactions such as dizziness and diplopia; a dose reduction of Exalief^® may be considered. Eslicarbazepine acetate is a moderate inducer of CYP3A4 and may decrease the plasma concentrations of drugs metabolized by this enzyme.

Concomitant administration with oral contraceptives (ethinylestradiol and levonorgestrel) may lead to a decrease in their plasma levels, potentially reducing their contraceptive efficacy. Women using hormonal contraception should be advised to use additional non-hormonal methods of contraception. Eslicarbazepine acetate may increase the plasma concentrations of phenytoin; dose adjustment of phenytoin may be necessary.

Concomitant use with other drugs that lower serum sodium levels (e.g., diuretics, desmopressin, NSAIDs) may increase the risk of hyponatremia. Caution is advised when co-administering with alcohol, as it may potentiate the central nervous system depressant effects.

Overdose

Symptoms of overdose are primarily related to the central nervous system and are an extension of its known adverse reactions. These may include dizziness, somnolence, headache, nausea, vomiting, ataxia, diplopia, and hyponatremia. In cases of severe overdose, more serious symptoms such as coma or convulsions may occur.

There is no specific antidote for eslicarbazepine acetate overdose. Management should include general supportive care, including monitoring of vital signs and close observation. Gastric lavage may be considered if performed soon after ingestion. Hemodialysis may be effective in removing eslicarbazepine from the circulation, and should be considered in severe cases, particularly if renal function is impaired.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.