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Johnson & Johnson (Ireland) Ltd

Airton Road, Tallaght, Dublin 24, Ireland
Telephone: +353 1 466 5200
Fax: +353 1 466 53160
Medical Information Direct Line: 1 800 22 00 44
Medical Information e-mail: crc@its.jnj.com
Customer Care direct line: 1 800 22 00 44


Summary of Product Characteristics last updated on medicines.ie: 16/03/2017
SPC Vermox Tablets


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1. NAME OF THE MEDICINAL PRODUCT

Vermox 100mg Tablets


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 100 mg mebendazole.

Excipients: Each tablet also contains 0.06 mg Sunset Yellow (E110).

For a full list of excipients, see section 6.1


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3. PHARMACEUTICAL FORM

Tablet.

Faintly orange circular, flat, half-scored, bevel-edged tablet with 'Me 100' inscribed on one side and 'JANSSEN' on the other.

The half-score is only to facilitate breaking for ease of swallowing and not to divide into equal halves.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

As an anthelmintic against gastrointestinal infestations caused by nematodes and cestodes, including enterobiasis, ascariasis, trichuriasis, ankylostomiasis, strongyloidiasis and taeniasis.


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4.2 Posology and method of administration

Method of administration:

Oral Use.

Adults and children 2 years or older:

Ascariasis, trichuriasis, ankylostomiasis and mixed infections:

100 mg twice daily for three consecutive days.

Enterobiasis:

100 mg as a single dose repeated after 2 to 4 weeks.

Taeniasis and strongyloidiasis:

Adults: 200 mg twice daily for three consecutive days.

Children 2 years or older: 100 mg twice daily for three consecutive days.

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.


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4.3 Contraindications

• Use in pregnancy or lactation in women breast feeding infants. It is not known if mebendazole crosses the placenta or is excreted in breast milk.

• In persons with a known hypersensitivity to the active substance or any of the excipients listed in section 6.1.


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4.4 Special warnings and precautions for use

Not recommended in the treatment of children under 2 years.

Results from a case-control study investigating an outbreak of Stevens-Johnson syndrome /toxic epidermal necrolysis (SJS/TEN) suggested a possible relationship between SJS/TEN and the concomitant use of mebendazole and metronidazole. Further data suggesting such a drug-drug interaction are not available. Therefore, concomitant use of mebendazole and metronidazole should be avoided.

Sunset yellow (E110) may cause allergic reactions.


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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, especially during prolonged treatmentConcomitant use of mebendazole and metronidazole should be avoided (see section 4.4).


4.6 Pregnancy and lactation

Since Vermox is contra-indicated in pregnancy, patients who think they are, or may be, pregnant should not take this preparation.

Lactation: Mebendazole is only absorbed to a small extent. As it is not known whether mebendazole is excreted in human milk, it is not advisable to breast feed following administration of Vermox.


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4.7 Effects on ability to drive and use machines

None known.


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4.8 Undesirable effects

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, Vermox is generally well tolerated. However, patients with high parasitic burdens when treated with Vermox 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 ≥ 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

System Organ Class

Adverse Drug Reactions

Frequency Category

Common

(≥ 1/100 to < 1/10)

Uncommon

(≥ 1/1000 to < 1/100)

Rare

(≥ 1/10,000 and < 1/1000)

Blood and lymphatic system disorders

Neutropoenia b

Immune system disorders

Hypersensitivity including anaphylactic reaction and anaphylactoid reaction b

Nervous system disorders

Convulsions b,

Dizziness b

Gastro-intestinal disorders

Abdominal pain a

Abdominal discomfort a;

Diarrhoea a;

Flatulence a

Hepato-biliary disorders

Hepatitis b;

Abnormal liver function tests b

Skin and sub-cutaneous tissue disorders

Rash a , Toxic epidermal necrolysis b;

Stevens-Johnson syndrome b;

Exanthema b; Angioedema; Urticaria b;

Alopoecia b

a ADR frequency data derived from Clinical Trials or Epidemiological Studies

b ADRs not observed in Clinical Trials and frequency calculated using “Rule 3”, as detailed in SmPC guideline 2009. 6279 patients exposed in clinical trials and epidemiological studies, divided by 3 (frequency = 1/2092). Note: frequencies differ from those reported in august 20019 CCDS, as these were not calculated using the formula detailed in SmPC guideline 2009.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971 +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.


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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: 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 (see Section 4.8).

Sign and Symptoms

In the event of accidental overdosage, abdominal cramps, nausea, vomiting and diarrhoea may occur.

Treatment

There is no specific antidote. Activated charcoal may be given if considered appropriate.


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5. PHARMACOLOGICAL PROPERTIES

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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 Vermox is effective in the treatment of cysticercosis.


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5.2 Pharmacokinetic properties

Absorption

Following oral administration, < 10% 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.


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5.3 Preclinical safety data

No relevant information additional to that contained elsewhere in the Summary of Product Characteristics.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Microcrystalline cellulose

Sodium starch glycollate Type A

Talc

Maize starch

Saccharin sodium

Magnesium stearate

Hydrogenated vegetable oil

Orange flavour

Colloidal anhydrous silica

Sodium laurilsulfate

Sunset Yellow (E110)


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

3 years.


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6.4 Special precautions for storage

Do not store above 25°C.

Keep blister in the outer carton in order to protect from light.


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6.5 Nature and contents of container

Blister strips of PVC genotherm glass clear aluminium foil coated on the inside with a heat seal lacquer.

Pack size: 6 tablet pack.


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6.6 Special precautions for disposal and other handling

No special requirements.


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7. MARKETING AUTHORISATION HOLDER

Johnson & Johnson (Ireland) Ltd

Airton Road

Tallaght

Dublin 24

Ireland


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8. MARKETING AUTHORISATION NUMBER(S)

PA 330/046/002


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 1st April 1988

Date of last renewal: 1st April 2008


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10. DATE OF REVISION OF THE TEXT

01-March-2017



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Active Ingredients

 
   Mebendazole