Ovex 100mg/5ml oral suspension

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mebendazole

Available from:

Johnson & Johnson Ltd

ATC code:

P02CA01

INN (International Name):

Mebendazole

Dosage:

20mg/1ml

Pharmaceutical form:

Oral suspension

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05050100; GTIN: 5027097376981

Patient Information leaflet

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This medicine is used to treat threadworm infections of the gut.
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This medicine is for use by adults and children aged over 2 years.
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DO NOT USE THIS MEDICINE:
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There are some people who should not use this medicine._ To fi nd _
_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 _
▶
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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 _
▶
NOW READ THIS WHOLE LEAFL ET CAREFULLY BEFORE YOU USE THIS MEDICINE.
Keep the leafl et: you might need it again.
1 WHAT THE MEDICINE IS AND WHAT IT IS
USED FOR
Ovex Suspension is a medicine, which is used to treat threadworm
(sometimes known as pinworm) infections of the gut. 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 WHAT YOU NEED TO KNOW BEFORE YOU
TAKE 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 have ever had a BAD REACTION 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
WITHOUT USING OVEX SUSPENSION. ADULTS AND CHILDREN AGED 2 YEARS AND OVER
AGE
DOSE
ADULTS AND CHILDREN
Take ONE 5 ML dose
AGED 2 YEARS AND OVER.
per family member.
■
If symptoms do not disappear within a few days, speak to your doctor.
■
If you are re-infected your pharmacist may recommend that a second
dose is taken after 2 weeks.
IF ANYONE TAKES TOO MUCH
If anyone has taken too much Ovex Suspension, contact a doctor
or your nearest

Summary of Product characteristics

OBJECT 1
OVEX SUSPENSION
Summary of Product Characteristics Updated 06-Apr-2018 | McNeil
Products Ltd
1. Name of the medicinal product
OVEX SUSPENSION
2. Qualitative and quantitative composition
Each 5ml of suspension contains 100mg mebendazole.
Excipient(s) with known effect:
Sucrose 500mg/5ml
Methylparahydroxybenzoate (E218) 9mg/5ml
Propylparahydroxybenzoate (E216) 1mg/5ml
For the full list of excipients, see Section 6.1.
3. Pharmaceutical form
Oral suspension
White homogeneous suspension
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of gastrointestinal infestations of _Enterobius
vermicularis_ (threadworm).
There is no evidence that Ovex is effective in the treatment of
cysticercosis.
4.2 Posology and method of administration
Posology
Adults and children over 2 years: 1 x 5ml (1 dosing cup).
Care should be taken to avoid re-infection and it is strongly
recommended that all members of the family
are treated at the same time.
It is highly recommended that a second dose is taken after two weeks,
if re-infection is suspected.
Method of administration
Oral
4.3 Contraindications
Ovex is contraindicated in pregnancy and in patients who have shown
hypersensitivity to the active
substance or any of the excipients listed in _Section 6.1_.
4.4 Special warnings and precautions for use
Ovex is not recommended in the treatment of children aged under 2
years.
If symptoms do not disappear within a few days, consult your doctor.
A case-control study of a single outbreak of Stevens-Johnson
syndrome/toxic epidermal necrolysis
(SJS/TEN) suggested a possible association with the concomitant use of
metronidazole with
mebendazole. Although there are no additional data on this potential
interaction, concomitant use
mebendazole and metronidazole should be avoided.
Convulsions in children, including in infants below one year of age,
have been reported very rarely during
post-marketing experience with Ovex. Ovex Suspension should only be
given to very young children if
their worm infestation interferes significan