Vermox 100mg/5ml Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mebendazole

Available from:

McNeil Healthcare (Ireland) Ltd

ATC code:

P02CA; 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; mebendazole

Authorization status:

Marketed

Authorization date:

1978-07-12

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 rarely occur.
■
Cimetidine

Summary of Product characteristics

Health Products Regulatory Authority
24 November 2020
CRN009YKY
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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 4 weeks.
Taeniasis and strongyloidiasis:
_ _
_Adults:_
_ _
_Children 2 years or older:_
2x 5ml (200 mg) twice daily for 3 consecutive days.
5ml (100 mg) twice daily for 3 consecutive days.
4.3 CONTRAINDICATIONS

Vermox is contraindicated in pregnancy.

Hypersensitivity to the active ingredient or to any of the excipients
listed in section 6.1
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Not recommended in the treatment of children under 2 years.
Convulsions in children, including in infants below one year of age,
have been reported very rarely during postmarketing
experience with Vermox (see section 4.8). Vermox Oral Suspension is
indicated for use in children aged 2 years onwards (see
Health Products Regulatory Authority
24 November 2020
CRN009YKY
Page 2 of 6
section 4.2). Vermox Oral Suspension should only be given to very
young children if their worm infestation interferes
significantly wi