Carbamazepin-BP
Tablets
Trade name
Carbamazepin-BP
Active ingridient
Carbamazepinum
Descritpion and Composition
Each tablet contains carbamazepine 200 mg or 400 mg. Excipient with known effect: sodium.Indication: Epilepsy (simple or complex partial seizures, with or without secondary generalisation; generalised tonic-clonic seizures; mixed seizure forms, in mono- or polytherapy); acute mania and maintenance treatment of bipolar affective disorder; alcohol-withdrawal syndrome; idiopathic trigeminal neuralgia and trigeminal neuralgia in multiple sclerosis; idiopathic glossopharyngeal neuralgia; painful diabetic neuropathy.
Contraindications (SmPC sec. 4.3): 4.3 Contraindications − Known hypersensitivity to carbamazepine or to structurally related medicines (e.g. tricyclic antidepressants) or to any of the components of Carbamazepine-BP listed in section 6.1; − Patients with atrioventricular block; − Patients with a history of bone marrow depression; − Patients with a history of hepatic porphyrias (e.g. acute intermittent porphyria, porphyria variegata, porphyria cutanea tarda); − Carbamazepine-BP is not recommended in combination with monoamine oxidase inhibitors (MAOIs) (see section 4.5).
Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Carbamazepine should be used only under medical supervision. Carbamazepine-BP should be prescribed only after a critical assessment of the benefit-risk ratio and with strict supervision of patients with a history of cardiac, hepatic or renal disease, of those with haematological adverse reactions to other medicines, or who have previously received and discontinued carbamazepine treatment. Haematological effects Agranulocytosis and aplastic anaemia have been associated with carbamazepine; however, because of the very low incidence of these conditions, meaningful risk estimates for carbamazepine are difficult to establish. The overall risk in the untreated population has been estimated at 4.7 persons per million per year for agranulocytosis and 2 persons per million per year for aplastic anaemia. Temporary or persistent decrease […]