Special Warning : אזהרת שימוש

4.4. Special warnings and precautions for use

Treatment with albendazole has been associated with mild to moderate elevations of hepatic enzymes.
Hepatic enzymes generally normalized after treatment discontinuation. Cases of hepatitis have been reported (see section 4.8). Therefore, hepatic function tests should be obtained before the start of each treatment cycle, and at least every two weeks during treatment. If hepatic enzymes are significantly increased (greater than twice the upper limit of normal), treatment should be discontinued. Treatment may be restarted when hepatic enzymes have returned to normal limits, but patients should be carefully monitored for recurrence.

Patients with abnormal hepatic function test results prior to initiating treatment should be closely monitored due to the hepatotoxic potential of albendazole.

Albendazole has been shown to cause bone marrow suppression and therefore, blood counts should be performed at the start of treatment and every two weeks during each 28-day cycle. Patients with hepatic disease, including hepatic echinococcosis, appear to be more susceptible to bone marrow suppression leading to pancytopenia, aplastic anemia, agranulocytosis and leukopenia, and therefore warrant closer monitoring of blood counts. Treatment with albendazole should be discontinued if clinically significant decreases in blood cell counts occur (see sections 4.2 and 4.8).
In order to avoid administering albendazole during early pregnancy, women of child-bearing age should: -     initiate treatment only after a negative pregnancy test. These tests should be repeated at least once before initiating the next cycle.

-     be advised to take effective contraceptive measures during and for one month after completion of treatment with albendazole for a systemic infection.

Pre-existing neurocysticercosis may also be detected in patients treated with albendazole for other conditions, particularly in areas with high taenosis infection. Patients may experience neurological symptoms such as seizures, increased intracranial pressure and focal signs as a result of an inflammatory reaction caused by death of the parasite within the brain. Symptoms may occur soon after treatment, and the appropriate treatment with anticonvulsant drugs and steroids should be started immediately.

In rare cases of retinal neurocysticercosis, the patient should be examined for retinal lesions before beginning treatment. If these lesions are observed, the benefit of the therapy should be weighed against the possibility of retinal damage.

Warnings for excipients

This medicinal product contains lactose. Patients with hereditary galactose intolerance, the Lapp lactase deficiency (deficiency observed in certain populations of Laponia) or glucose-galactose malabsorption should not take this medicine.

This medicinal product may cause allergic reactions because it contains Colour FD&C Yellow #6 Aluminum Lake 20-24% FDA (E110) colorant.

Effects on Driving