VERMOX Tablet (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Vermox 100 mg tablets.
Qualitative and quantitative composition
Each tablet contains 100 mg of mebendazole. <u>Excipients:</u> Each tablet also contains 0.06 mg of sunset yellow (E110). This medicine contains sodium. For a full list of excipients, see section 6.1. ...
Pharmaceutical form
Tablet. Flat, circular, pale orange tablets with Me/100 on one side and JANSSEN on the other.
Therapeutic indications
For the treatment of <em>Trichuris trichuria</em> (whipworm), <em>Enterobius vermicularis</em> (pinworm or threadworm), <em>Ascaris lumbricoides</em> (roundworm), <em>Ancylostoma duodenale</em> (common ...
Posology and method of administration
Adults and children over 2 years For the control of trichuriasis, ascariasis and hookworm infections, one tablet twice a day for three consecutive days. For the control of enterobiasis a single tablet ...
Contraindications
Vermox is contraindicated in pregnancy and in patients who have shown hypersensitivity to the product or any components.
Special warnings and precautions for use
Not recommended in the treatment of children under 2 years. There have been rare reports of reversible liver function disturbances, hepatitis and neutropenia described in patients who were treated with ...
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 ...
Pregnancy and lactation
Pregnancy Since Vermox is contraindicated in pregnancy, patients who think they are, or may be, pregnant should not take this preparation. Breast-feeding Limited data from case reports demonstrate that ...
Effects on ability to drive and use machines
Vermox has no influence on the ability to drive and use machines.
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 Vermox based on the comprehensive assessment ...
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, ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> anthelmintic for oral administration, benzimidazole derivatives <b>ATC code:</b> P02CA01 <em>In vitro</em> and <em>in vivo</em> work suggests that mebendazole blocks the ...
Pharmacokinetic properties
Absorption Following oral administration, <10% of the dose reaches the systemic circulation, due to incomplete absorption and pre-systemic metabolism (first-pass effect). The majority of an orally administered ...
Preclinical safety data
In animal reproduction studies, adverse developmental effects (i.e. skeletal malformations, soft tissue malformations, decreased pup weight, embryolethality) were observed when mebendazole was administered ...
List of excipients
Microcrystalline cellulose Sodium starch glycolate Talc Maize starch Sodium saccharin Magnesium stearate Cottonseed oil hydrogenated Orange flavour Colloidal anhydrous silica Sodium laurilsulfate Sunset ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Blister strips of PVC genotherm glass clear aluminium foil coated on the inside with a heat seal lacquer. <u>Pack sizes:</u> 1 and 6 tablet packs. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
Marketing authorization number(s)
PL 00242/0011
Date of first authorization / renewal of the authorization
Date of First Authorisation: 9 April 1975 Date of Renewal of Authorisation: 30 September 2003
Date of revision of the text
15 February 2021
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