VERMOX

Adults and children over 2 years:

Enterobiasis: 1 x 5 ml (1 dosing cup). It is highly recommended that a second dose is taken after 2 weeks, if reinfection is suspected. Ascariasis, trichuriasis, ancylostomiasis, necatoriasis and mixed infections: 1 x 5 ml (1 dosing cup) bd for three days.

Children under 2 years:

Vermox has not been extensively studied in children below the age of 2 years. 2, but no recommendations on a posology can be made. 2). Method of administration. Oral Use Vermox oral suspension should be considered for patients such as young children who are unable to swallow the tablet.

Throughout this section adverse reactions are reported. Adverse reactions are adverse events that were considered to be reasonably associated with the use of Vermox based on the comprehensive assessment of the available adverse event information.

A causal relationship with Vermox cannot be reliably established in individual cases. Further, 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 clinical practice.

The safety of Vermox 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 ≥1% of Vermox-treated subjects.

ADRs identified from clinical trials and post-marketing experience with Vermox are included in Table 1.

The displayed frequency categories use the following convention:

Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10,000 to <1/1000); Very rare (<1/10,000), Not known (cannot be estimated from the available data).

Table 1:

Adverse Drug Reactions Reported in Clinical Trials and Post- marketing Experience for Vermox Adverse Drug Reactions Frequency Category System Organ Class Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1000 to < 1/100) Rare (≥1/10,000 to <1/1000) Blood and Lymphatic System Disorders Neutropeniab Agranulocytosisb * Immune System Disorders Hypersensitivity including anaphylactic reaction and anaphylactoid reactionb Nervous System Disorders Convulsionsb Dizzinessa Gastrointestinal Disorders Abdominal paina Abdominal discomforta; Diarrhoeaa; Flatulencea Nauseaa, Vomitinga Hepatobiliary Disorders Hepatitis; b Abnormal liver function testsb Skin and Subcutaneous Tissue Disorders Rasha Toxic epidermal necrolysis b; Stevens-Johnson syndrome b; Exanthema b; Angioedema b; Urticaria b; Alopecia b Renal and Urinary Disorders Glomerulonephritisb * a ADR frequency data derived from Clinical Trials or Epidemiological Studies b ADRs not observed in clinical trials and frequency calculated based on 6276 patients exposed in clinical trials and epidemiological studies, divided by 3 (Frequency = 1/2092).

8 ‘Undesirable effects’). Agranulocytosis and glomerulonephritis have also been reported in patients treated for Echinococcosis. A case-control study of a single outbreak of Stevens-Johnson syndrome /toxic epidermal necrolysis (SJS/TEN) suggested a possible association with the concomitant use of metronidazole with mebendazole.

Although there are no additional data on this potential interaction, concomitant use of mebendazole and metronidazole should be avoided. 8 ‘Undesirable effects’). Vermox has not been extensively studied in children below the age of 2 years.

Therefore, Vermox should be used in children aged 1-2 years only if the potential benefit justifies the potential risk. Because of the lack of sufficient safety data, Vermox should not be used in children below the age of 1 year. Vermox should only be given to very young children if their worm infestation interferes significantly with their nutritional status and physical development.

Vermox oral suspension contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase- isomaltase insufficiency should not take this medicine. This medicinal product contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially 'sodium-free'.

Vermox is contra-indicated in pregnancy and in patients who have shown hypersensitivity to the product or any components.