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OVEX SUSPENSION

Active substance(s): MEBENDAZOLE

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mebendazole
■ This medicine is used to treat threadworm 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 ▶
Now read this whole leaflet carefully before you use this medicine.
Keep the leaflet: 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 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.

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 (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 take this medicine if you are pregnant, or think you might
be pregnant. Ask your doctor or pharmacist for advice before
taking this medicine if you are breast-feeding.

Special warnings about this medicine

Since threadworms can spread very easily, it is strongly
recommended that all the family (except pregnant, breast-feeding
women or children under 2 years) are treated at the same time
and that suitable hygiene precautions are followed to prevent
re-infection (see Section 7 of this leaflet for more advice).

Some of the ingredients can cause problems

■ This medicine contains sucrose. If you have been told by your
doctor that you have an intolerance to some sugars contact
your doctor before taking this medicinal product.
Methyl (E218) and propyl (E216) parahydroxybenzoate may
cause allergic reactions which could possibly be delayed.


3 How to take this medicine

Check the table below to see how much medicine to take.
■ Always shake the bottle thoroughly before use.
■ The suspension should be taken using the 5 ml measuring cup in the
pack.
■ For oral use only.
Do not use more than the stated dose shown in the table.
Always supervise a child if they are taking this medicine.




Children under 2 years old
Do not give to children under 2 years old.

Age

Take one 5 ml dose
per family member.

Dose

Adults and children aged 2 years and over

Adults and children
aged 2 years and over.

■ 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 Accident & Emergency department (Casualty)
taking this leaflet and pack with you.

4 Possible side-effects

Like all medicines, Ovex can cause side-effects, although not everybody
gets them.

If you experience any of the following, stop using the
medicine and seek immediate medical help:

Rare: (may affect up to 1 in 1,000 people)
■ Convulsions (seizures/fits).
■ Allergic reactions including unexplained wheezing, shortness of
breath, sudden swelling of your face or throat, and hives (also
known as ‘nettle rash’ or ‘urticaria’).
Skin rashes (which may be severe and include blistering or peeling of
the skin) and itching, and may be accompanied by a high temperature.



If you experience any of the following, stop using the
medicine and talk to your doctor or pharmacist:

Common: (may affect up to 1 in 10 people)
■ Stomach pain
Uncommon: (may affect up to 1 in 100 people)
■ Stomach discomfort
Diarrhoea
Wind





AW_114200.pdf - Page 1 of 3 - April 28, 2016 - 10:30:24

AW_114200.pdf - Page 2 of 3 - April 28, 2016 - 10:30:24

Ovex is a registered trade mark.

Article no: AW_114200
Job bag no: 16/0116
Dimension: 145 x 260 mm,
Date: 28-04-2016, Version:1

This leaflet was revised April 2016

Manufacturer:
Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.

Product Licence holder:
McNeil Products Ltd, Maidenhead, Berkshire. SL6 3UG, UK.

Ovex Suspension is a banana flavoured liquid available in 30 ml
packs (6 single doses).

What the medicine looks like

The active ingredient in Ovex Suspension is: Mebendazole 100 mg
per 5 ml.
Other ingredients are: Sucrose, Microcrystalline cellulose and carmellose
sodium, Methylcellulose, Methylparahydroxybenzoate (E218),
Propylparahydroxybenzoate (E216), Sodium laurilsulfate, banana
flavour, citric acid monohydrate and purified water.

What’s in this medicine?

6 Contents of the pack and other
information

Keep the product out of the sight and reach of children.
Do not use your medicine after the date shown as the expiry date on
the packaging.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help protect the environment.

5 How to store this medicine

Reporting of side-effects
If you experience any side-effects, talk to your doctor, pharmacist or
nurse. This includes any possible side-effects not listed in this leaflet.
You can also report side-effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting side-effects, you can help
provide more information on the safety of this medicine.

Rare: (may affect up to 1 in 1,000 people)
■ Inflammation of the liver or abnormal liver function
■ Reduction in white blood cells (which reduces the body’s defences
against infection)
■ Unusual hair loss
■ Dizziness

Other effects that may occur include:

Threadworms do not cause serious damage but they are an irritating
problem. Besides the intense itching, which can be distressing and
embarrassing for the sufferer, they can also lead to disturbed sleep,
tummy aches, irritable crying, loss of appetite or an unusually
large appetite. Sometimes, threadworms can be transferred to the
vagina and urinary passage. This can result in vaginal irritation and
discharge, symptoms of cystitis or bed wetting.

Are they harmful?

2 - 6 weeks.
1. Scratching the bottom transfers eggs to fingers and
from there back to the mouth or to others either by
direct contact or via food, bed linen etc.
2. Eggs swallowed.
3. Female worms migrate to the anal area to lay
eggs at night.

Lifecycle of threadworms

Threadworms spread by producing large numbers of tiny eggs.
These eggs are so small that they cannot be seen with the naked eye.
When swallowed, the eggs pass into the bowel where they hatch
into worms. When mature, the female threadworm lays her eggs at
night around the anal area, which causes an “itchy bottom”. The
resulting irritation can cause intense scratching, which may lead to
further infections if the skin becomes sore or broken. Scratching also
allows transfer of the eggs to the fingers and nails. Eggs can then
be easily transferred to the mouth by finger sucking or nail biting,
causing re-infection, and spread to other members of the family by
direct contact or via food, towels and bed linen etc. Threadworm
eggs are present in house dust; they stick to clothing, carpets, towels
and bed linen; they can also be picked up in garden soil, or on
unwashed vegetables and salads. Because the eggs are so small and
so widespread, it is very easy for them to be swallowed.

How do they spread?

Threadworms are extremely common, especially in children. It is
estimated that up to 40% of children under ten years in the UK may
be affected at any one time. Once a child has threadworms, it is very
easy for the rest of the family to get them.

How common are threadworms?

Threadworms (Enterobius vermicularis) are tiny white parasitic worms that
live in the bowel. They are approximately half an inch long and resemble
threads of white cotton – hence the name threadworms.

What are threadworms?

7 Further advice regarding threadworms

16-0116
GB - AW_114200

Threadworms are easily treated but unless the following precautions
are taken the problem may recur:
■ Follow the general advice above.
■ Make sure everyone in the family is treated at the same time.

How can you stop the problem coming back?

No. As long as the children are treated and the general hygiene
measures outlined above are followed, there is no reason to keep
them off school.

Do you need to keep your children off school?

To ensure that you and your family do not infect others or re-infect
yourselves, you should also follow the hygiene measures listed below
for at least six weeks:
■ Keep nails short.
■ Discourage nail biting or finger sucking.
■ Wear pyjamas or underclothes in bed.
■ In the mornings, wash thoroughly around the bottom.
■ Provide a towel for the exclusive use of
each member of the household.
■ Change clothes regularly.
■ Regularly wash and iron bed linen.
■ Thoroughly wash hands and nails after
using the toilet and before each meal.

General advice

Threadworms only affect humans, they do not affect pets.

Important note

The most obvious sign of threadworms is intense itching in the anal
area, especially at night, although this does not affect everyone. If
your children frequently scratch their bottoms, suffer from disturbed
sleep or become irritable, it is worth checking their motions and the
anal area for tiny white threads. If one member of the family has
threadworms, the rest of the family may already have picked up the
infection, even if they do not have obvious symptoms.

How can you tell if someone has threadworms?

Anyone, although they are more common in children. It does not mean
that your family or your home are not clean. Because threadworms are
passed on very easily it is a wise precaution to treat everyone in the
family at the same time.

Who gets threadworms?

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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