Vermox 100mg Tablet

VERMOX u00ae 100 mg is indicated for the treatment of single and mixed helminth gastrointestinal infestations caused by:

• Nematodes such as:
• Trichuris trichiura (whipworm)
• Ancylostoma duodenale (hookworm)
• Necator americanus (hookworm)
• Ascaris lumbricoides (large roundworm)
• Ternidens deminutus
• Enterobius vermicularis (pinworm)
• Strongyloides stercoralis (threadworm)
• Cestodes such as:
• Taenia spp. (tapeworm)
• Infestations by Moniliformis moniliformis

Whipworm; Hookworm; Large Roundworm; Pinworm; Ternidens deminutus; Infestations by Moniliformis moniliformis:

One tablet (100 mg) twice daily (morning and evening) for three consecutive days. This standard dosage applies to adults, children and infants over the age of 1 year.

Tapeworm (Taenia spp.):

One tablet (100 mg) twice daily (morning and evening) for six consecutive days. This standard dosage applies to adults, children and infants.

Threadworm (Strongyloides stercoralis):

Adults: Two tablets (200 mg) twice daily (morning and evening) for three consecutive days.

Children: One tablet (100 mg) twice daily (morning and evening) for three consecutive days.

A second course of treatment should be given to those patients who are still infected three to four weeks after the first course.

In worm-eradication campaigns the standard course should be administered every quarter during the first year. If a helminth is not susceptible to the standard dosage, a treatment course of longer than three days and/or involving higher doses than 100 mg tablet is recommended. The efficacy of VERMOX u00ae 100 mg is dependent upon the duration of physical contact between the medicine and parasite. When gastro-intestinal transit time is accelerated, e.g. in diarrhoea, it is necessary to repeat the dose at more frequent intervals daily. For infants under 1 year of age, see section 4.3 and 4.4.

VERMOX u00ae 100 mg should not be used in children below the age of 1 years.

VERMOX u00ae 100 mg is contraindicated in persons with a known hypersensitivity to mebendazole or to any of the other ingredients in VERMOX u00ae 100 mg (see section 6.1).

VERMOX u00ae 100 mg should not be given during pregnancy, as it is teratogenic in animals (see section 4.6).

Concomitant use of VERMOX u00ae 100 mg and metronidazole should be avoided (see section 4.4 and 4.5).

Convulsions in children, including in infants below one year of age, have been reported during post-marketing experience with VERMOX u00ae 100 mg (see section 4.8). VERMOX u00ae 100 mg should not be given to children below 1 year of age. VERMOX u00ae 100 mg should only be given to very young children if their worm infections interfere significantly with the nutritional status and the physical development.

To reduce the risk of choking, mebendazole oral suspension should be considered for patients such as young children who are unable to swallow the tablet.

There have been reports of reversible liver function disturbances, hepatitis, neutropenia, agranulocytosis and glomerulonephritis described in patients who were treated with dosages substantially above those recommended for prolonged periods of time (see section 4.9).

Results from a case control study investigating an outbreak of Stevens Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) indicated a possible relationship between SJS/TEN and the concomitant use of VERMOX u00ae 100 mg and metronidazole. Further data on interactions are not available. Therefore, concomitant use of VERMOX u00ae 100 mg and metronidazole should be avoided (see section 4.3 and 4.5).

Concomitant treatment with cimetidine may inhibit the metabolism of the mebendazole in the liver, resulting in increased plasma concentrations of VERMOX u00ae 100 mg, especially during prolonged treatment.

Concomitant use of VERMOX u00ae 100 mg and metronidazole should be avoided (see section 4.3 and 4.4).

Pregnancy

VERMOX u00ae 100 mg is contraindicated during pregnancy (see section 4.3). Mebendazole has shown embryotoxic and teratogenic activity in rats and in mice at single oral doses.

Lactation

Limited data from case reports demonstrate that a small amount of mebendazole is present in human milk following oral administration. VERMOX 100 mg is not recommended during lactation.

Fertility

The effect on human fertility has not been evaluated.

VERMOX u00ae 100 mg can cause side effects such as dizziness. Caution is advised before driving a vehicle or operating machinery until the effects of VERMOX u00ae 100 mg are known.

Patients with high parasitic burdens when treated with VERMOX u00ae 100 mg have manifested diarrhea and abdominal pain.

Clinical trial data

The safety of VERMOX u00ae 100 mg was evaluated in 6276 subjects who participated in 39 clinical trials for the treatment of single or mixed parasitic infestations of the gastrointestinal tract. In these 39 clinical trials, no adverse drug reactions (ADRs) occurred in u2265 1 % of VERMOX u00ae 100 mg-treated subjects. ADRs occurring in u2264 1 % of VERMOX u00ae -treated subjects are shown below.

Blood and the lymphatic system disorders

Less frequent: agranulocytosis (higher and prolonged doses)

Nervous system disorders

Less frequent: dizziness

Gastrointestinal disorders

Frequent: abdominal pain

Less frequent: abdominal discomfort, diarrhoea, flatulence

Skin and subcutaneous tissue disorders

Less frequent: rash

Renal and urinary disorders

Less frequent: glomerulonephritis (higher and prolonged doses)

Post-marketing

Blood and the lymphatic system disorders

Less frequent: neutropenia

Immune system disorders

Less frequent: hypersensitivity including anaphylactic reaction and anaphylactoid reaction

Nervous system disorders

Less frequent: convulsions

Gastrointestinal disorders

Less frequent: nausea, vomiting

Hepato-biliary disorders

Less frequent: hepatitis, abnormal liver function tests

Skin and subcutaneous tissue disorders

Less frequent: toxic epidermal necrolysis, Stevens Johnson syndrome, exanthema, angioedema, urticaria, alopecia

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of VERMOX u00ae 100 mg tablets is important. It allows continued monitoring of the benefit/risk balance of VERMOX u00ae 100 mg tablets. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

In patients treated at dosages substantially higher than recommended or for prolonged periods of time, the following adverse reactions have been reported: alopecia, reversible liver function disturbances, hepatitis, agranulocytosis, neutropenia and glomerulonephritis. With the exception of agranulocytosis and glomerulonephritis, these also have been reported in patients who were treated with VERMOX u00ae 100 mg tablets at standard dosages.

Symptoms

In the event of accidental overdose, abdominal cramps, nausea, vomiting and diarrhoea may occur.

Treatment

There is no specific antidote. If poisoning or excessive overdosage is suspected it is recommended, on general principles, that vomiting be induced and such symptomatic supportive therapy be administered as appears indicated. Activated charcoal may be given.