Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

− Agisten Lozenges are not indicated for the treatment of systemic mycoses including systemic candidiasis.
− Abnormal liver function tests have been reported in patients treated with Agisten Lozenge; elevated SGOT levels were reported in about 15% of patients in the clinical trials. In most cases the elevations were minimal and it was often impossible to distinguish effects of clotrimazole from those of other therapy and the underlying disease (malignancy in most cases). Periodic assessment of hepatic function is advisable particularly in patients with pre- existing hepatic impairment.

Since patients must be instructed to allow each lozenge to dissolve slowly in the mouth in order to achieve maximum effect of the medication, they must be of such an age and physical and/or mental condition to comprehend such instructions.

Carcinogenesis: An 18 month dosing study with clotrimazole in rats has not revealed any carcinogenic effect.

Pediatric Use
Safety and effectiveness of clotrimazole in children below the age of 3 years have not been established; therefore, its use in such patients is not recommended.

The safety and efficacy of the prophylactic use of Agisten Lozenge in children have not been established.
Geriatric Use
Clinical studies of clotrimazole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

DRUG ABUSE AND DEPENDENCE
No data available.

Important information about some of the ingredients of the medicine
Patients with rare glucose-galactose malabsorption should not take this medicine. Agisten lozenges contains 888 mg dextrose per lozenge.

Effects on Driving

4.7 Effects on ability to drive and use machines
No data available.