Vermox 100mg/5ml Oral Suspension

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 mg/5ml

Pharmaceutical form:

Oral suspension

Therapeutic area:

Benzimidazole derivatives; mebendazole

Authorization status:

Marketed

Authorization date:

2009-07-17

Patient Information leaflet

100MG/5ML ORAL SUSPENSION
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 suffer from any of the conditions mentioned in Section 2. See
section 2
▶
■
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 Suspension is a medicine, which is used to treat
threadworms (sometimes known
as pinworms) and other common
worm infections e.g. (whipworm, roundworm,
hookworm). The medicine contains 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 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 SUSPENSION.
TALK TO YOUR DOCTOR OR PHARMACIST...
■
If you have been told by your doctor that you have an INTOLERANCE TO
SOME SUGARS.
■
If you are taking any OTHER MEDICINES, including:
■
_Metronidazole _(a drug used to treat
BACTERIAL AND PROTOZOAN
INFECTIONS
) as a
serious skin reaction can r

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 100mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of suspension contains 100 mg of mebendazole.
Excipient(s) with known effect:
Each 5ml also contains 500 mg of sucrose, 9 mg of methyl
parahydroxybenzoate (E218), 1 mg of propyl parahydroxybenzoate
and 0.819 mg of propylene glycol (E1520).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral suspension
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.
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
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 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
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 of administration:
Oral Use
Adults and children 2 years or older
Ascariasis, trichuriasis, ankylostomiasis and mixed infections:
5ml (100 mg) twice daily for 3 consecutive days.
Enterobiasis:
5ml (100 mg) as a single dose repeated after 2 to