Albendazol-BP

Albendazol

Albendazole-BP 400 mg film-coated tablets: each tablet contains albendazole 400 mg. Albendazole-BP 200 mg film-coated tablets: each tablet contains albendazole 200 mg. Excipients with known effect: lactose; sodium.

Indication: Antihelminthic/antiprotozoal agent indicated, at low doses, for short-term treatment of intestinal parasitic infections (enterobiasis, ancylostomiasis, hymenolepiasis, taeniasis, strongyloidiasis, ascariasis, trichuriasis, opisthorchiasis/clonorchiasis, giardiasis in children) and cutaneous larva migrans, and, at higher doses, for long-term treatment of systemic parasitic infections, including hepatic, pulmonary and peritoneal cystic echinococcosis.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications − Hypersensitivity to albendazole or to any of the excipients listed in section 6.1; − Suspected or diagnosed pregnancy. Albendazol-BP 400 mg film-coated tablets must not be given to children under 12 years of age because the pharmaceutical form is not suitable for their age.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Use in the treatment of intestinal parasitic infections and cutaneous larva migrans (short-term treatment with low doses): To avoid administering albendazole in early pregnancy, women of childbearing potential should start treatment during the first week of the menstrual cycle or after obtaining a negative pregnancy test result. Treatment with albendazole may reveal pre-existing neurocysticercosis, particularly in areas heavily infected with Taenia sp. Patients may present with neurological symptoms such as convulsions, increased intracranial pressure and focal signs, as a result of the inflammatory reaction caused by the death of the parasite in the brain. Symptoms may appear immediately after treatment; steroid and anticonvulsant therapy should be initiated urgently […]