Vermox 100 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mebendazole

Available from:

Johnson & Johnson (Ireland) Limited

ATC code:

P02CA; P02CA01

INN (International Name):

Mebendazole

Dosage:

100 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Benzimidazole derivatives; mebendazole

Authorization status:

Marketed

Authorization date:

1988-04-01

Patient Information leaflet

100mg Tablets
mebendazole
■
This medicine is used to treat threadworm and other common worm
infections of
the gut.
■
This medicine is for use by adults and children aged over 2 years.
■
DO NOT USE THIS MEDICINE:
■
There
are some people who should not use this medicine. _To find out_
_ _
_if you are _
_one of them see section 2 _
▶
■
If you have ever had a
BAD REACTION
to any of the ingredients. _To view_
_ _
_the list of _
_ingredients see section 6 _
▶
■
SPEAK TO YOUR DOCTOR:
■
If
you
are taking any other medicines. _See section 2 _
▶
■
FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY.
These are shown in the dosage
table.
_See section 3 _
▶
■
YOU MUST TALK TO A DOCTOR IF YOU DO NOT FEEL BETTER OR IF YOU FEEL WORSE
AFTER A FEW
DAYS.
NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE.
Keep
the leaflet:
you might need it again.
1
WHAT THE MEDICINE IS FOR
Vermox Tablets is a medicine which is used to treat threadworms
(sometimes known
as pinworms) and other common worm infections eg
(whipworm, roundworm,
hookworm). The tablets contain mebendazole,
which is one of a group of medicines
called ‘anthelmintics’.
This medicine is for use in adults and children aged over 2 years.
2
BEFORE TAKING THIS MEDICINE
This medicine is suitable for most adults and children, but a few
people should not use it.
If you are in any doubt, talk to your doctor or pharmacist.
DO NOT USE THIS MEDICINE…
■
If you are
HYPERSENSITIVE
(allergic) to any of the ingredients.
■
If it is for a
CHILD UNDER 2 YEARS
.
■
If you are
PREGNANT OR THINK YOU ARE PREGNANT
.
If any of these apply to you,
GET ADVICE FROM A DOCTOR OR PHARMACIST
BEFORE USING
VERMOX TABLETS
.
TALK TO YOUR DOCTOR OR PHARMACIST...
■
If you are taking any
OTHER MEDICINES, INCLUDING
:
■
_Metronidazole _(a drug used to treat
BACTERIAL AND PROTOZOAN
INFECTIONS
) as a
serious skin reaction can rarely occur.
■
_Cimetidine _(a medicine used to treat excess
STOMACH ACIDITY
).
If you are not sure about any of the medicines you are taking, s

Summary of Product characteristics

Health Products Regulatory Authority
31 March 2021
CRN00C4YY
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vermox 100 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg mebendazole.
Excipients: Each tablet also contains 0.06 mg Sunset Yellow (E110) and
3.8 mg sodium.
For a full list of excipients, see section 6.1
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.
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.
Official guidelines should be taken into consideration. Official
guidelines will normally include WHO and public health authorities'
guidelines.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Paediatric population
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.
Vermox Oral Suspension should be considered for patients such as young
children who are unable to swallow the tablet.
Children under 2 years of age:
Vermox Tablets has not been extensively studies in children below the
age of 2 years. Currently available data are described in
section 4.4, 4.8 and 5.2, but no recommendations on a posology can be
made. Because of the lack of sufficient safety data,
Vermox Tablets should not be used in children below the age of 1 year
(see section 4.4, 4.8 and 5.2).
For the indication Strongyloidiasis and Taeniasis:
Paediatric population / Children and adolescents (≥2 to 16 years)
Data on efficacy and safety in children and adolescents ≥2 years to
16 years are limited.
Mebendazole should be used only, if there is no therapeutic
alternative.
Method