1. Name Of The Medicinal Product
OVEX SUSPENSION
2. Qualitative And Quantitative Composition
Each 5ml of suspension contains 100mg mebendazole.
For excipients, see section 6.1.
3. Pharmaceutical Form
Oral suspension
White homogeneous suspension
4. Clinical Particulars
4.1 Therapeutic Indications
For the treatment of gastrointestinal infestations of Enterobius vermicularis (threadworm).
There is no evidence that Ovex is effective in the treatment of cysticercosis.
4.2 Posology And Method Of Administration
For oral administration.
Adults and children over 2 years: 1 x 5ml (1 dosing cup).
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 dose is taken after two weeks, if re-infection is suspected.
4.3 Contraindications
Ovex is contraindicated in pregnancy and in patients who have shown hypersensitivity to the product or any components.
4.4 Special Warnings And Precautions For Use
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 mebendazole and metronidazole should be avoided.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Concomitant treatment with cimetidine may inhibit the metabolism of mebendazole in the liver, resulting in increased plasma concentrations of the drug.
Concomitant use of mebendazole and metronidazole should be avoided (see section 4.4).
4.6 Pregnancy And Lactation
Use in pregnancy: Since Ovex is contra-indicated in pregnancy, patients who think they are or may be pregnant should not take this preparation.
Use in lactation: As it is not known whether mebendazole is excreted in human milk, it is not advisable to breast feed following administration of Ovex.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
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 has been 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
ADRs identified from clinical trials and post-marketing experience with mebendazole are included in Table 1. The displayed frequency categories use the following convention:
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4.9 Overdose
In patients treated at dosages substantially higher than recommended or for prolonged periods of time, the following adverse reactions have been reported rarely: reversible liver function disturbances, hepatitis, neutropoenia, and glomerulonephritis. With the exception of glomerulonephritis, these also have been reported in patients who were treated with mebendazole at standard dosages (see Section 4.8).
Symptoms
In the event of accidental overdosage, abdominal cramps, nausea, vomiting and diarrhoea may occur.
Treatment
There is no specific antidote. Within the first hour after ingestion, gastric lavage may be performed. Activated charcoal may be given if considered appropriate.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic classification: Anthelmintic for oral administration, benzimidazole derivatives
ATC code: P02CA01
In vitro and in vivo work suggests that mebendazole blocks the uptake of glucose by adult and larval forms of helminths, in a selective and irreversible manner. Inhibition of glucose uptake appears to lead to endogenous depletion of glycogen stores within the helminth. Lack of glycogen leads to decreased formation of ATP and ultrastructural changes in the cells.
There is no evidence that Ovex is effective in the treatment of cysticercosis.
5.2 Pharmacokinetic Properties
Absorption
Following oral administration, approximately 20% of the dose reaches the systemic circulation, due to incomplete absorption and to extensive pre-systemic metabolism (first-pass effect). Maximum plasma concentrations are generally seen 2 to 4 hours after administration. Dosing with a high fat meal leads to a modest increase in the bioavailability of mebendazole.
Distribution
The plasma protein binding of mebendazole is 90 to 95%. The volume of distribution is 1 to 2 L/kg, indicating that mebendazole penetrates areas outside the vascular space. This is supported by data in patients on chronic mebendazole therapy (e.g., 40 mg/kg/day for 3-21 months) that show drug levels in tissue.
Metabolism
Orally administered mebendazole is extensively metabolized primarily by the liver. Plasma concentrations of its major metabolites (amino and hydroxylated amino forms of mebendazole) are substantially higher than those of mebendazole. Impaired hepatic function, impaired metabolism, or impaired biliary elimination may lead to higher plasma levels of mebendazole.
Elimination
Mebendazole, the conjugated forms of mebendazole, and its metabolites likely undergo some degree of enterohepatic recirculation and are excreted in the urine and bile. The apparent elimination half-life after an oral dose ranges from 3 to 6 hours in most patients.
Steady-state Pharmacokinetics
During chronic dosing (e.g., 40 mg/kg/day for 3-21 months), plasma concentrations of mebendazole and its major metabolites increase, resulting in approximately 3-fold higher exposure at steady-state compared to single dosing.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sucrose
Microcrystalline cellulose and carmellose sodium
Methylcellulose 15 mPa.s
Methylparahydroxybenzoate (E218)
Propylparahydroxybenzoate (E216)
Sodium laurilsulfate
Banana flavour 1
Citric acid, monohydrate
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
5 years.
6.4 Special Precautions For Storage
Keep out of the reach and sight of children.
6.5 Nature And Contents Of Container
Amber glass flask containing 30 ml suspension, with either:
• Pilfer-proof screw cap. Cork insert in cap is coated on both sides with polyvinylchloride
or
• Child-resistant polypropylene screw cap, lined inside with a LDPE insert.
A 5ml natural polypropylene (food-grade) dosing cup is also provided, graduated for 2.5 ml and 5 ml.
6.6 Special Precautions For Disposal And Other Handling
Shake well before use.
7. Marketing Authorisation Holder
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire
SL6 3UG
United Kingdom
8. Marketing Authorisation Number(S)
PL 15513/0313
9. Date Of First Authorisation/Renewal Of The Authorisation
01 August 2008/ 11 August 2009
10. Date Of Revision Of The Text
22 September 2010
LEGAL STATUS:
P
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