Vermox Sd 500mg/10ml Suspension

VERMOX u00ae SD suspension 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)
• Enterobius vermicularis (pinworm)

Whipworm; hookworm; large roundworm; pinworm:

Adults and children older than 1 year: 10 mL given as a single dose. A single dose of VERMOX u00ae SD suspension may not be sufficient to cure infestations with hookworm and whipworm (Trichuris) although a substantial reduction in egg count can be expected. 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. The efficacy of VERMOX u00ae SD suspension is dependent upon the duration of physical contact between the medicine and parasite. For infants under 1 year of age, see u201csection 4.3 and 4.4u201d.

Instructions for use of VERMOX u00ae SD suspension: Shake the bottle before use. The bottle comes with a child-proof cap, and should be opened as follows:

1. Push the plastic screw cap down
2. While pressing down, turn the cap counterclockwise.

VERMOX u00ae SD suspension should not be used in children below the age of 1 year. VERMOX u00ae SD suspension is contraindicated in persons with a known hypersensitivity to mebendazole or to any of the other ingredients in VERMOX u00ae SD suspension (see section 6.1). VERMOX u00ae SD suspension 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 (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 SD suspension (see section 4.8). VERMOX u00ae SD suspension should not be given to children below 1 year of age. VERMOX u00ae SD suspension should only be given to very young children if their worm infections interfere significantly with the nutritional status and the physical development.

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 SD suspension and metronidazole. Further data on interactions are not available. Therefore, concomitant use of VERMOX u00ae SD suspension and metronidazole should be avoided (see section 4.3 and 4.5). Patients with high parasitic burdens when treated with VERMOX u00ae SD suspension have manifested diarrhea and abdominal pain.

Sucrose VERMOX u00ae SD suspension contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take VERMOX u00ae SD suspension.

Concomitant treatment with cimetidine may inhibit the metabolism of the mebendazole in the liver, resulting in increased plasma concentrations of VERMOX u00ae SD suspension especially during prolonged treatment. Concomitant use of VERMOX u00ae SD suspension and metronidazole should be avoided (see section 4.3 and 4.4).

Pregnancy VERMOX u00ae SD suspension 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 date from case reports demonstrate that a small amount of mebendazole is present in human milk following oral administration. VERMOX u00ae SD suspension is therefore not recommended during lactation.

Fertility The effect on human fertility has not been evaluated.

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

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 SD suspension and metronidazole. Further data on interactions are not available. Therefore, concomitant use of VERMOX u00ae and metronidazole should be avoided. Patients with high parasitic burdens when treated with VERMOX u00ae SD suspension have manifested diarrhea and abdominal pain.

Clinical trial data The safety of VERMOX u00ae SD suspension 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 SD suspension-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

Post-marketing Blood and the lymphatic system disorders Less frequent: neutropenia, agranulocytosis (higher and prolonged doses) 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 Renal and urinary disorders Less frequent: glomerulonephritis (higher and prolonged doses)

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of VERMOX u00ae SD suspension is important. It allows continued monitoring of the benefit/risk balance of VERMOX u00ae SD suspension. 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 mebendazole 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.