ing
Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Keep bottle tightly closed and protect from moisture.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (INSTRUCTIONS FOR USE).
Embryo-Fetal Toxicity
Advise pregnant women and females of reproductive potential that exposure to Benznidazole Tablets during pregnancy can result in fetal harm.
Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.2) and Use in Specific Populations (8.1)].
Advise females of reproductive potential to use effective contraception while taking
Benznidazole Tablets and for 5 days after the last dose [see Use in Specific Populations (8.3)].
Lactation
Advise women not to breastfeed during treatment with Benznidazole Tablets [see Use in Specific Populations (8.2)].
Infertility
Advise males of reproductive potential that Benznidazole Tablets may impair fertility [see Use in Specific Populations (8.3) and Nonclinical Toxicology (13.1)].
Important Administration Instructions
Advise patients and parents/caregivers of pediatric patients taking Benznidazole Tablets that:
•Benznidazole Tablets 100 mg are functionally scored tablets which can be split into one-half (50 mg) or one-quarter (25 mg) at the scored lines to provide doses less than 100 mg.
•Benznidazole Tablets 12.5 mg and 100 mg (whole or split) can be made into a slurry in a specified volume of water for the pediatric population [see Dosage and Administration (2.3)].
Hypersensitivity Skin Reactions
Advise patients that serious skin reactions can occur with Benznidazole Tablets. In case of skin reactions, presenting with additional symptoms of systemic involvement such as lymphadenopathy, fever and/or purpura, discontinuation of treatment is necessary.
Central and Peripheral Nervous System Effects
Advise patients that treatment can potentially cause paresthesia or symptoms of peripheral neuropathy. In cases where neurological symptoms occur, immediate discontinuation of treatment is recommended.
Hematological Manifestations of Bone Marrow Depression
Advise patients that there have been hematological manifestations of bone marrow depression, such as anemia and leukopenia, which are reversible, and normalized after treatment discontinuation.
Interaction with Alcohol
Advise patients to discontinue consumption of alcoholic beverages or products containing propylene glycol while taking Benznidazole Tablets and for at least three days afterward because abdominal cramps, nausea, vomiting, headaches, and flushing may occur.
Manufactured for Chemo Research, S.L.
Madrid, Spain
Manufactured by Laboratorios Liconsa S.A.
Guadalajara, Spain
Distributed by:
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Exeltis USA, Inc.
Florham Park, NJ 07932
INSTRUCTIONS FOR USE
BENZNIDAZOLE
tablets, for oral use
Read this Instructions for Use before you start taking BENZNIDAZOLE and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.
Note:
•Your doctor may need to change your dose of BENZNIDAZOLE during treatment as needed.
•BENZNIDAZOLE |
