BOOTS THREADWORM

Paediatric population Tablets may be chewed or swallowed whole. Crush the tablet before giving it to a young child. Always supervise a child while they are taking this medicine. Ovex Suspension should be considered for patients such as young children who are unable to swallow the tablet.

Posology Adults and children over 2 years:

Take one tablet. Tablets may be chewed or swallowed whole. Crush the tablet before giving it to a young child. Always supervise a child while they are taking this medicine. Care should be taken to avoid re-infection and it is strongly recommended that all members of the family are treated at the same time.

It is highly recommended that a second tablet is taken after two weeks, if re-infection is suspected.

Children under 2 years of age:

This medicine 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

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

A causal relationship with mebendazole 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.

At the recommended dose, Ovex is generally well tolerated. However, patients with high parasitic burdens when treated with Ovex have manifested diarrhoea and abdominal pain. The safety of mebendazole 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 mebendazole-treated subjects. ADRs identified from clinical trials and post-marketing experience with mebendazole are included in Table 1.

The displayed frequency categories use the following convention:

Very common (≥ 1/10); Common (≥ 1/100 and < 1/10); Uncommon (≥ 1/1000 and < 1/100); Rare (≥ 1/10,000 and < 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 Mebendazole Adverse Drug Reactions Frequency Category System Organ Class Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Blood and lymphatic system disorders Neutropenia b Agranulocytosis a, c Immune system disorders Hypersensitivity including anaphylactic reaction and anaphylactoid reaction b Nervous system disorders Convulsions b Dizziness a Gastrointestinal disorders Abdominal pain a Abdominal discomfort a Diarrhoea a Flatulence a Nausea b Vomiting b Hepatobiliary disorders Hepatitis b Abnormal liver function tests b Skin and subcutaneous tissue disorders Rash a Toxic epidermal necrolysis b Stevens-Johnson syndrome b Exanthema b Angioedema b Urticaria b Alopecia b Renal and urinary disorders Glomerulonephritis a, c a ADR frequency data derived from Clinical Trials or Epidemiological Studies b Adverse reactions reported during post-marketing surveillance c Observed in patients treated for Echinococcosis Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Ovex is not recommended in the treatment of children aged under 2 years. If symptoms do not disappear within a few days, consult your doctor. 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). Ovex tablets has not been extensively studied in children below the age of 2 years. Ovex tablets should only be given to very young children if their worm infestation interferes significantly with their nutritional status and physical development.

Therefore, Ovex tablets 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, Ovex tablets should not be used in children below the age of 1 year.

Glomerulonephritis and agranulocytosis have been very rarely reported with dosages substantially above those recommended and with treatment for prolonged periods of time. Ovex Suspension should be considered for patients such as young children who are unable to swallow the tablet.

Orange Yellow S (E110) may cause allergic reactions. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1.