MEBENDAZOLE TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
28-04-2024
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:
Cupal Limited
Dosage:
100 Milligram
Authorization date:
2003-09-05
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mebendazole Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Mebendazole 100 mg.
_For excipients, see 6.1._
3 PHARMACEUTICAL FORM
Chewable tablet
Mottled, pale orange, round tablets, shallow, concave with a breakline.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of threadworm (enterobiasis) infestation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults, the elderly and children over two years old:
One tablet to be chewed or swallowed whole. The efficacy in threadworm infestations is such that treatment failure
will be rare. However, the possibility of re-infection means that some patients may require a second tablet after two
weeks, if re-infected.
It is strongly recommended that all members of the family are treated at the same time.
Not recommended for children under two years of age.
4.3 CONTRAINDICATIONS
Pregnancy: Mebendazole has not been studied extensively in children under two years of age - for this reason it is not
currently recommended for children under two years of age.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
1.
Not to be taken during pregnancy, or whilst breast feeding.
2.
Not recommended for children under two years.
3.
Keep out of the reach and sight of children.
4.
If after two weeks you need to take a second tablet following which your symptoms persist, then consult your
doctor.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None stated.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/04/2010_
_CRN 2080858_
_page number: 1_
4.6 PREGNANCY AND LACTATION
Mebendazole has shown embryotoxic and teratogenic activity in rats at single oral doses. N
Read the complete document
