Wormstop Suspension & Tablet

WORMSTOPu00ae 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 Round Worm; Pinworm; Ternidens Deminutus; Infestations by Moniliformis moniliformis:

Tablets: 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.

Suspension: One medicine measure (5 ml) 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):

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

Suspension: One medicine measure (5 ml) twice daily (morning and evening) for six consecutive days. This standard dosage applies to adults, children and infants.

Threadworm (Strongyloides stercoralis):

Tablets:

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.

Suspension:

Adults: Two medicine measures (10 ml) twice daily (morning and evening) for three consecutive days.

Children: One medicine measure (5 ml) 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 / 10 ml suspension is recommended. The efficacy of WORMSTOPu00ae is dependent upon the duration of physical contact between the medicine and parasite. When gastro-intestinal transit time is accelerated, eg. 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.

Hypersensitivity to mebendazole or to any of the excipients of WORMSTOPu00ae (see section 6.1).

WORMSTOPu00ae should not be used in children below the age of 1 year.

WORMSTOPu00ae should not be given during pregnancy, as it is teratogenic in animals (see section 4.6).

Concomitant use of mebendazole and metronidazole should be avoided.

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

Convulsions in children, including in infants below one year of age, have been reported. WORMSTOPu00ae should not be given to children below 1 year of age.

WORMSTOPu00ae should only be given to very young children if their worm infections interfere significantly with the nutritional status and the physical development.

WORMSTOPu00ae SUSPENSION contains sorbitol 70 % solution and may cause gastrointestinal discomfort and have a mild laxative effect.

Concomitant treatment with cimetidine may inhibit the metabolism of the mebendazole in the liver, resulting in increased plasma concentrations of the medicine especially during prolonged treatment. In the latter case, determination of plasma concentrations is recommended in order to allow dose adjustments.

Concomitant use of WORMSTOPu00ae and metronidazole should be avoided.

WORMSTOPu00ae is contra-indicated during pregnancy and lactation (see section 4.3). Mebendazole has shown embryotoxic and teratogenic activity in rats and in mice at single oral doses. It is not known whether mebendazole is excreted in human breast milk.

WORMSTOPu00ae has no influence on the ability to drive and use machines.

System Organ Class

Frequent

Less frequent

Blood and Lymphatic System Disorders

• Neutropenia
• Agranulocytosis *

Immune System Disorders

• Hypersensitivity including anaphylactic reaction and anaphylactoid reaction

Nervous System Disorders

• Convulsions
• Dizziness

Gastrointestinal Disorders

• Abdominal pain
• Abdominal discomfort
• Diarrhoea
• Flatulence
• Nausea
• Vomiting

Hepatobiliary Disorders

• Hepatitis
• Abnormal liver function tests

Skin and Subcutaneous Tissue Disorders

• Rash
• Toxic epidermal necrolysis
• Stevens-Johnson syndrome
• Exanthema
• Angioedema
• Urticaria
• Alopecia

Renal and Urinary Disorders

• Glomerulonephritis*

* Reported in higher and prolonged doses

Reporting of suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction 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: liver function disturbances, hepatitis, neutropenia and glomerulonephritis. With the exception of glomerulonephritis, these also have been reported in patients who were treated with mebendazole at standard dosages. In the event of accidental overdosage, abdominal cramps, nausea, vomiting and diarrhoea may occur. If poisoning or excessive overdosage is suspected it is recommended, on general principles, that vomiting be induced or gastric lavage be performed, and such symptomatic supportive therapy be administered as appears indicated. Activated charcoal may be given.