Hypersensitivity to albendazole or to any of the excipients.
Albendazole must not be administred during pregnancy or in women in the child bearing period.
Special warnings and precautions of use
Vermizole® Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.
- Use in intestinal infestations: short duration treatment and low dosage In women of child bearing age, Vermizole® must be administered in the first seven days after the beginning of the menstruation or after a negative pregnancy test.
- Use in systemic infestations: Treatment of long duration and high dosage
• Treatment with albendazole has been associated with mild to moderate elevation of hepatic enzymes in about 16% of the patients.
- These patients normalize with the discontinuation of treatment.
- Hepatic function tests must be performed before beginning of each cycle of treatment and at least every two weeks during the treatment If there is a significant increase of the liver enzymes, twice the upper limit of the normal state, the treatment with albendazole must be discontinued.the Treatment with albendazole can be resumed when the hepatic enzymes are back to the normal values, however Lab tests must be done frequently when the therapy resumed.
• Albendazole has occasionally caused mild reversible reduction in the total number of white blood cells Blood tests must be made in the beginning of the treatment and then every two weeks during the cycles of 28-day.The Treatment with albendazole can be continued if the decrease of total number of white blood cells is mild and stationary.
- The vermizole suspension : Contains saccharine not to be used for patients with hepatic disease as there were reports of increase in hepatic enzymes associated with the use of saccharine even if small dose.
- Diseases affecting Blood and lymphatic system : Uncommon (a 1/1.000, <1 100) leucopenia
- Very rare (<1/10.000): pancytopenia, aplastic anemia, agranulocytosis.
- Patients with hepatic disease, including hepatic Echinococcus seem to have a more susceptible bone marrow.
- Immune system disorders: Uncommon (a 1/1.000, <1/100): hypersensitivity reactions including rash, pruritis and urticaria
Nervous system disorders: Very common (a 1/10): headache. Common (s 1/100, <1/10): dizziness.
- Gastrointestinal disorders. Common (a 1/100, <1/10): gastrointestinal disorders (abdominal pain, nausea, vomiting).
- Gastrointestinal disturbances have been associated with > rnnococcus in patents treated with albendazole.
- Hepatobiliary disorders: Very common (a 1/10); mild to moderate elevation of hepatic enzymes.
- Uncommon (a 1/1.000, <1/100): hepatitis.
- Disorders of Skin and subcutaneous tissue Disorders ;
Common (a 1/100, <1/10): reversible alopecia (thinning hair, mild to moderate hair loss).
- Very rare (<1/10.000): erythema multiform, Stevens-Johnson Syndrome.
- General disturbances and application site.
Common (a 1/100, <1/10): fever.
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