Mebendazole

VERMOX™ CHEWABLE is indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm). VERMOX™ CHEWABLE is an anthelmintic indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by: Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm) ( 1 ).

• The recommended dosage in patients one year of age and older is one VERMOX™ CHEWABLE 500 mg tablet taken as a single dose
• Chew VERMOX™ CHEWABLE 500 mg tablet completely before swallowing
• Do not swallow the tablet whole
• For patients who have difficulty chewing the tablet, approximately 2 mL to 3 mL of drinking water can be added to a suitably sized spoon and the VERMOX™ CHEWABLE 500 mg tablet placed into the water
• Within 2 minutes, the tablet absorbs the water and turns into a soft mass with semi-solid consistency, which can then be swallowed
• VERMOX™ CHEWABLE 500 mg tablet can be taken without regard to food intake [see Clinical Pharmacology ]
• The recommended dosage in patients one year of age and older is one single tablet of VERMOX™ CHEWABLE 500 mg taken as a single dose, chewed completely before swallowing
• See Full Prescribing Information for administration instructions for patients who have difficulty chewing the tablets

Chewable Tablet: 500 mg round, flat radius-edged white to yellowish chewable tablet that is debossed with "M/500" on one side and "J" on the other side. Chewable Tablet: 500 mg ( 3 )

• The safety and effectiveness of VERMOX™ CHEWABLE 500 mg tablets have been established
• In pediatric patients 1 to 16 years of age
• Use of VERMOX™ CHEWABLE 500 mg tablets in children is supported by evidence from adequate and well-controlled studies of VERMOX™ CHEWABLE 500 mg tablets [see Clinical Studies ]
• The safety and effectiveness of mebendazole, including VERMOX™ CHEWABLE have not been established
• In pediatric patients less than one year of age
• Convulsions have been reported with mebendazole use in this age group [see Warnings and Precautions and Adverse Reactions ]

Clinical studies of mebendazole did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.

• Advise patients that: VERMOX™ CHEWABLE tablet must be chewed completely before swallowing
• For patients who have difficulty chewing the tablet, VERMOX™ CHEWABLE tablet can be turned into a soft mass with semi-solid consistency by adding 2 mL to 3 mL of drinking water to a spoon then placing the tablet into the water, which can then be swallowed. [see Dosage and Administration ] VERMOX™ CHEWABLE tablet must not be swallowed whole. [see Dosage and Administration ] VERMOX™ CHEWABLE tablet can be taken with or without food. [see Dosage and Administration ] Taking VERMOX™ CHEWABLE tablet and metronidazole together may cause serious skin reactions and should be avoided. …

• VERMOX™ CHEWABLE is contraindicated in persons with a known hypersensitivity to the drug or its excipients
• Patients with a known hypersensitivity to the drug or its excipients

Concomitant use of mebendazole and metronidazole should be avoided [see Warnings and Precautions (5.3) ] .

Risk of Convulsions: Convulsions in infants below the age of 1 year have been reported ( 5.1 ) Hematologic Effects: Neutropenia and agranulocytosis have been reported in patients receiving mebendazole at higher doses and for prolonged duration. Monitor blood counts in these patients ( 5.2 ) Metronidazole and Serious Skin Reactions: Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) have been reported with the concomitant use of mebendazole and metronidazole. …

Adverse reactions reported in clinical trials were anorexia, abdominal pain, diarrhea, flatulence, nausea, vomiting and rash. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceuticals, Inc. at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

8.1 Pregnancy Risk Summary The available published literature on mebendazole use in pregnant women has not reported a clear association between mebendazole and a potential risk of major birth defects or miscarriages [see Data ]. There are risks to the mother and fetus associated with untreated helminthic infection during pregnancy [see Clinical Considerations ] . …

In patients treated at dosages substantially higher than recommended or for prolonged periods of time, the following adverse reactions have been reported: alopecia, reversible transaminase elevations, hepatitis, agranulocytosis, neutropenia, and glomerulonephritis. Symptoms and signs In the event of accidental overdose, gastrointestinal signs/symptoms may occur. Treatment There is no specific antidote.

Store below 30°C. Keep container tightly closed. Unused tablets should be discarded 1 month after the bottle is first opened. When the bottle is first opened this Discard After date should be written on the bottle label in the place provided.

Tome assim que lembrar, a menos que esteja quase na hora da próxima dose. Nesse caso, pule a dose esquecida. Nunca tome duas doses de uma vez para compensar. Confira a bula, pois alguns medicamentos são diferentes.