VERMOX 100 MG/5ml Oral Suspension
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
07-06-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
MEBENDAZOLE
Available from:
B & S Healthcare
ATC code:
P02CA01
INN (International Name):
MEBENDAZOLE
Dosage:
100 MG/5ml
Pharmaceutical form:
Oral Suspension
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Benzimidazole derivatives
Authorization status:
Authorised
Authorization date:
2013-02-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vermox 100mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of suspension contains 100mg of mebendazole.
Also contains sucrose, methylparabenzoate (E218) and propylparabenzoate (E216).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral suspension.
_Product imported from Greece:_
A banana flavoured opaque white oral suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an anthelmintic against gastrointestinal infestations caused by nematodes and cestodes, including enterobiasis,
ascariasis, trichuriasis, ankylostomiasis, strongyloidiasis and taeniasis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration:
Oral Use.
Adults and children 2 years or older
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 drug or its components.
Ascariasis, trichuriasis, ankylostomiasis and
mixed infections:
100 mg twice daily for 3 consecutive days.
Enterobiasis:
100 mg as a single dose repeated after 2 to 4 weeks.
Taeniasis and strongyloidiasis:
_Adults:_
_Children 2 years or older:_
200 mg twice daily for 3 consecutive days.
100 mg twice daily for 3 consecutive days.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 07/03/2013_
_CRN 2128573_
_page number: 1_
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
Read the complete document
