Information about FINLEPSIN-UNI CR

Composition:
Each film-coated controlled-release tablet contains: carbamazepine 200 mg or 400 mg.
Pharmacokinetics:
Carbamazepine suspension is absorbed somewhat faster, while extended-release tablets are absorbed slightly more slowly than conventional tablets. The bioavailability of the extended-release tablet is approximately 89% compared with the suspension.
Carbamazepine is approximately 76% bound to plasma proteins. Plasma carbamazepine concentrations are variable and may range from 0.5 to 25 micrograms/mL.
Following administration of carbamazepine extended-release tablets, peak plasma concentrations are generally reached within approximately 3–12 hours.
Indications:
Epilepsy:
Carbamazepine is indicated for use as an anticonvulsant in patients with the following seizure types:
1- Partial seizures with complex symptomatology (psychomotor or temporal lobe seizures). Patients with these seizures may show greater improvement than those with other seizure types.
2- Generalized tonic-clonic seizures (grand mal).
3- Mixed seizure patterns, including the above or other partial or generalized seizures.
Trigeminal Neuralgia:
Carbamazepine is indicated for the treatment of pain associated with true trigeminal neuralgia. Beneficial effects have also been reported in glossopharyngeal neuralgia.
Bipolar Disorder:
Carbamazepine may be used for the treatment or prevention of manic episodes
associated with bipolar disorder.

Contraindications:
Carbamazepine should not be used in patients with:
- A history of bone marrow depression.
- Hypersensitivity to carbamazepine or to any component of the formulation.
- Known hypersensitivity to structurally related tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, or nortriptyline.
- Concomitant use of carbamazepine with monoamine oxidase inhibitors (MAOIs) is not recommended. MAOIs should be discontinued for at least 14 days before initiating carbamazepine therapy, or longer if the clinical situation permits.
- Concomitant administration of carbamazepine and nefazodone is contraindicated.
Adverse Reactions:
Most Common Adverse Reactions:
Dizziness.
Drowsiness.
Nausea.
Vomiting.
Less Common / Serious Adverse Reactions:
Aplastic anemia.
Agranulocytosis.
Pancytopenia.
Bone marrow depression.
Thrombocytopenia.
Skin rash.
Storage Conditions:
Store at a temperature below 30°C.
Protect from moisture.
Packaging:
Carton containing 30 film-coated controlled-release tablets.