Ovex 100mg chewable tablets

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:

100mg

Pharmaceutical form:

Chewable tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05050100; GTIN: 5012674049884 5012674049907

Patient Information leaflet

TOP
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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:
■
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_
▶
■
SPEAK TO YOUR DOCTOR:
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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 is a medicine which is used to treat threadworm (sometimes known
as pinworm) infections of the gut.
The tablet 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.
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, show
the bottle or pack to your
pharmacist.
If any of the bullet points apply to you now or in the past, TALK TO A
DOCTOR OR PHARMACIST.
IF YOU ARE PREGNANT OR BREAST-FEEDING
Do not t

Summary of Product characteristics

OBJECT 1
OVEX FAMILY PACK
Summary of Product Characteristics Updated 06-Apr-2018 | McNeil
Products Ltd
1. Name of the medicinal product
Ovex/Ovex Family Pack/Boots Threadworm Tablets/ Threadworm Tablets 2
Years Plus
2. Qualitative and quantitative composition
Each tablet contains Mebendazole 100 mg.
Excipient(s) with known effect: 0.06 mg of orange yellow S (E110).
For the full list of excipients, see Section 6.1.
3. Pharmaceutical form
Tablet.
Flat, circular, pale orange tablets inscribed with 'ME 100' 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
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:_
Take one tablet.
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. 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 tablet is taken after two
weeks, if re-infection is suspected.
Method of administration
Oral
Ovex Suspension should be considered for patients such as young
children who are unable to swallow the
tablet.
4.3 Contraindications
Ovex is contra-indicated in pregnancy and in patients who have shown
hypersensitivity to the active
substance or to 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 concomit