Vermox

Frequency Not Defined

Angioedema

Fever

Dizziness

Headache

Hematuria

Leukopenia

Seizures

Drowsiness

Decreased hemoglobin

Rash

Itching

Agranulocytosis

Alopecia (with high doses)

Abdominal pain

Diarrhea

Nausea

Toxic epidermal necrolysis

May increase AST, ALT, and GGT (hepatitis)

Stevens-Johnson syndrome

Vomiting

Neutropenia (sore throat, unusual fatigue)

Toxic epidermal necrolysis

Unusual weakness

Glomerulonephritis

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to mebendazole.

Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish the mebendazole, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with mebendazole, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Dosage Forms And Strengths

Chewable Tablet: 100 mg, round, flat radius-edged white to yellowish chewable tablet that is debossed with “M/100” on one side and “J” on the other side.

Storage And Handling

VERMOX™ (mebendazole) is available as 100 mg, round, flat radius-edged white to yellowish chewable tablets that are debossed with “M/100” on one side and “J” on the other side. They are supplied as follows:

Blister package of 12 tablets      NDC 50580-070-12

Store at controlled room temperature 59°–77°F (15°–25°C).

Manufactured by: Janssen Pharmaceutica NV, Beerse, Belgium. Revised: June 2017

Included as part of the PRECAUTIONS section.

• Pinworms

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Vermox™ Chewable tablets in children. However, safety and efficacy have not been established in children younger than 1 year of age.

Appropriate studies have not been performed on the relationship of age to the effects of Emverm™ chewable tablets in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of mebendazole in geriatric patients.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Metronidazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone marrow problems (eg, agranulocytosis, neutropenia)—Use with caution. May make these conditions worse.

• Liver disease—Use with caution. May increase risk for more serious side effects.

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.

The safety of mebendazole was evaluated in 6276 subjects who participated in 39 clinical trials for treatment of single or mixed parasitic infections of the gastrointestinal tract. In these trials, the formulations, dosages and duration of mebendazole treatment varied. Adverse reactions reported in mebendazole-treated subjects from the 39 clinical trials are shown in Table 2 below.

Postmarketing Experience

The following adverse reactions have been identified in adult and pediatric patients postmarketing with mebendazole formulations and dosages other than the Vermox™ 100 mg chewable tablet. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

You should not use Vermox if you are allergic to mebendazole.

Before you use Vermox, tell your doctor about all your medical conditions or allergies.

It is not known whether Vermox will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether mebendazole passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Vermox is not approved for use by anyone younger than 2 years old.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Call your doctor if you miss more than one dose of this medicine.