0% found this document useful (0 votes)
336 views2 pages

(Mebendazole) : Patient Information Leaflet

This document is a patient information leaflet for Vermox oral suspension, which contains mebendazole and is used to treat common worm infections. It provides instructions on who should not take the medicine, dosing based on age and infection type, possible side effects, and storage instructions.

Uploaded by

Muhammad Asad
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
336 views2 pages

(Mebendazole) : Patient Information Leaflet

This document is a patient information leaflet for Vermox oral suspension, which contains mebendazole and is used to treat common worm infections. It provides instructions on who should not take the medicine, dosing based on age and infection type, possible side effects, and storage instructions.

Uploaded by

Muhammad Asad
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Vermox ® 100mg/5ml Oral Suspension Ref: 049/002/270416/1/F

(mebendazole)

Patient Information Leaflet


- This medicine is used to treat threadworm and
other common worm infections of the gut.
• Methyl (E218) and propyl (E216)
parahydroxybenzoate may cause allergic
- This medicine is for use by adults and children reactions which could possibly be delayed.
aged over 2 years.
- Do not use this medicine:
- There are some people who should not use this 3 How to take this medicine
medicine. To find out if you are one of them see
section 2 ▶ Check the table below to see how much
- If you have ever had a bad reaction to any of the medicine to take.
ingredients. To view the list of ingredients see
section 6 ▶
• Always shake the bottle thoroughly before use.
- Speak to your doctor:
• The suspension should be taken using the 5 ml
measuring cup in the pack.
- If you suffer from any of the conditions mentioned
in Section 2. See section 2 ▶
• For oral use only.
- If you are taking any other medicines. See
• Do not use more than the stated dose shown in
the table.
section 2 ▶
- Follow the dosage instructions carefully. These
• Always supervise a child if they are taking this
medicine.
are shown in the dosage table. See section 3 ▶
Children under 2 years old
Now read this whole leaflet carefully before you Do not give to children under 2 years old.
use this medicine. Keep the leaflet: you might need
it again. Adults and children aged 2 years and over
In this leaflet: Threadworm infection (Enterobiasis)
1 What the medicine is for Age Dose
2 Before taking this medicine Adults and children Take one 5ml dose.
aged 2 years and over. After two to four
3 How to take this medicine weeks take another
4 Possible side effects 5ml dose.
5 Storing this medicine
6 Further information Common worm infections (Ascariasis,
trichuriasis, ankylostomiasis and mixed
7 Further advice regarding threadworms infections)

Age Dose
1 What the medicine is for
Adults and children Take one 5ml dose
aged 2 years and over. twice daily (i.e.
Vermox Suspension is a medicine, which is used to
morning and
treat threadworms (sometimes known as pinworms)
evening) for three
and other common worm infections e.g. (whipworm, consecutive days
roundworm, hookworm). The medicine contains or as directed by
mebendazole, which is one of a group of medicines your doctor.
called ‘anthelmintics’.
This medicine is for use in adults and children aged Other worm infections (Taeniasis and
over 2 years. strongyloidiasis)

Age Dose
2 Before taking this medicine
Adults Take two 5ml doses
This medicine is suitable for most adults and (10ml) twice daily
children, but a few people should not use it. If you (morning and
are in any doubt, talk to your doctor or pharmacist. evening) for three
consecutive days.
Do not use this medicine… Children 2 years and over Take one 5ml dose
• If you are hypersensitive (allergic) to any of the twice daily (i.e.
ingredients. morning and
• If you are breast-feeding. evening) for three
• If you are pregnant or think you are pregnant. consecutive days.
Your doctor will
If any of these apply to you, get advice from a advise the
doctor or pharmacist before using Vermox appropriate dose
Suspension. depending on the
type of worm
Talk to your doctor or pharmacist... infection.
• If you have been told by your doctor that you have
an intolerance to some sugars. If anyone takes too much
• If you are taking any other medicines, If anyone has taken too much Vermox Suspension,
including: contact a doctor or your nearest Accident &
• Metronidazole (a drug used to treat bacterial Emergency department taking this leaflet and pack
and protozoan infections) as a serious skin with you.
reaction can rarely occur.
• Cimetidine (used to treat excess stomach
acidity). 4 Possible side effects
If you are not sure about any of the medicines you
are taking, show the bottle or pack to your Vermox Suspension can have side-effects, like all
pharmacist. medicines, although these don’t affect everyone and
are usually mild.
If any of the bullet points apply to you now or in the
past, talk to a doctor or pharmacist. If you experience any of the following, stop using
the medicine and seek immediate medical help:
If you are pregnant or breast-feeding Rarely: (less than 1 in 1,000 people are affected)
Do not take this medicine if you are pregnant or • Convulsions (seizures/fits) in infants.
breast-feeding. • Allergic reactions including unexplained wheezing,
shortness of breath, sudden swelling of your face
Special warnings about this medicine or throat and hives (also known as ‘nettle rash’ or
Since threadworms can spread very easily, it is ‘uriticaria’).
strongly recommended that all the family (except • Skin rashes (which may be severe and include
pregnant, breast-feeding women or children under blistering or peeling of the skin) and itching, and
2 years) are treated at the same time and that may be accompanied by a high temperature.
suitable hygiene precautions are followed to
prevent re-infection (see Section 7 of this leaflet If you experience any of the following, stop using
for more advice). the medicine and talk to your doctor:
Commonly: (fewer than 1 in 10 people are affected)
Some of the ingredients can cause problems. • Stomach pain
• This medicine contains sucrose. If you have been
told by your doctor that you have an intolerance Uncommonly: (fewer than 1 in 100 people are
to some sugars contact your doctor before taking affected)
this medicinal product. • Stomach discomfort
• Diarrhoea
• Wind
Other effects which may occur include: How common are threadworms?
Rarely: (fewer than 1 in 1,000 people are affected) Threadworms are extremely common, especially in
• Dizziness. children. It is estimated that up to 40% of children
• Inflammation of the kidneys or liver or abnormal under ten years in the UK may be affected at any
liver function. one time. Once a child has threadworms, it is very
• Reduction in white blood cells (which reduces the easy for the rest of the family to get them.
body’s defences against infections).
• Unusual hair loss. How do they spread?
Threadworms spread by producing large
Reporting of side effects numbers of tiny eggs. These eggs are so small that
If you get any side effects, talk to your doctor, they cannot be seen with the naked eye. When
pharmacist or nurse. This includes any possible side swallowed, the eggs pass into the bowel where they
effects not listed in this leaflet. You can also report hatch into worms. When mature, the female
side effects directly via HPRA Pharmacovigilance, threadworm lays her eggs at night around the anal
Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 area, which causes an “itchy bottom”. The resulting
6764971; Fax: +353 1 6762517. Website:
irritation can cause intense scratching,which may
www.hpra.ie; e-mail: [email protected]. By
lead to further infections if the skin becomes sore or
reporting side effects you can help provide more
information on the safety of this medicine. 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
5 Storing this medicine 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
Keep the product out of the reach and sight of
children. present in house dust; they stick to clothing, carpets,
towels and bed linen; they can also be picked up in
Do not store above 25°C. Keep the bottle in the garden soil, or on unwashed vegetables and salads.
outer carton to protect fromlight. Do not use your Because the eggs are so small and so widespread,
medicine after the expiry date which is stated on the it is very easy for them to be swallowed.
carton and bottle label after ‘Expiry’.
Lifecycle of threadworms
Medicines should not be disposed of via wastewater 2 - 6 weeks.
or household waste. 1. Scratching the bottom
Ask your pharmacist how to dispose of medicines no transfers eggs to fingers and
longer required. from there back to the mouth
These measures will help protect the environment. or to others either by direct
contact or via food, bed linen
6 Further Information etc.
2. Eggs swallowed.
3. Female worms migrate to the
What this medicine contains:
anal area to lay eggs at night.
The active ingredient in Vermox Suspension is:
Mebendazole 100 mg per 5 ml.
Are they harmful?
Other ingredients are: sucrose (sugar)*, Threadworms do not cause serious damage but
microcrystalline cellulose and carmellose sodium, they are an irritating problem. Besides the intense
methylparahydroxybenzoate (E218)** and itching, which can be distressing and embarrassing
propylparahydroxybenzoate (E216)**, for the sufferer, they can also lead to disturbed
methylcellulose, sodium lauryl sulphate, banana sleep, tummy aches, irritable crying, loss of appetite
flavour, citric acid monohydrate and purified water. or an unusually large appetite. Sometimes,
* If you have been told by your doctor that you have threadworms can be transferred to the vagina and
an intolerance to some sugars, contact your doctor urinary passage. This can result in vaginal irritation
before taking this medicinal product. and discharge, symptoms of cystitis or bed wetting.
** May cause allergic reactions (possibly delayed).
Who gets threadworms?
What this medicine looks like and contents of Anyone, although they are more common in
the pack children. It does not mean that your family or your
Each 5 millilitre (5 ml) spoonful of the white, banana home are not clean. Because threadworms are
flavoured suspension contains 100 mg of passed on very easily it is a wise precaution to
mebendazole, and is supplied to the pharmacist in treat everyone in the family at the same time.
bottles containing 30 ml and a dosing spoon with
markings for 2.5 ml and 5 ml. How can you tell if someone has threadworms?
The most obvious sign of threadworms is intense
Manufacturer and Licence Holder itching in the anal area, especially at night,
Parallel Product Authorisation Holder: although this does not affect everyone. If your
LTT Pharma Limited, Unit 18, Oxleasow Road, East children frequently scratch their bottoms, suffer
Moons Moat, Redditch, Worcestershire, B98 0RE, from disturbed sleep or become irritable, it is worth
UK checking their motions and the anal area for tiny
white threads. If one member of the family has
Repackaged by: threadworms, the rest of the family may already
Lexon (UK) Limited, Unit 18, Oxleasow Road, East have picked up the infection, even if they do not
Moons Moat, Redditch, Worcestershire, B98 0RE, have obvious symptoms.
UK.
Important note:
Manufactured by: Threadworms only affect humans, they do not affect
Farma SA, Factory Liquid Medicines, 49th km pets.
Athens-Lamia, Greece and Janssen Pharmaceutica,
Beerse, Belgium. General advice
To ensure that you and your family do not infect
P PPA1562/049/002 others or re-infect yourselves, you should also follow
the hygiene measures listed below for at least six
Vermox is a registered trademark of Johnson &
weeks:
Johnson.
• Keep nails short.
Revision date: 27/04/2016 • Discourage nail biting or finger sucking.
• Wear pyjamas or underclothes in bed.
Blind or partially sighted? • In the mornings, wash thoroughly around the
bottom.
Is this leaflet hard to see or read? • Provide a towel for the exclusive use
of each member of the
Phone LTT Pharma Limited, Tel: household.
+44 (0) 1527 505414 for help. • Change clothes regularly.
• Regularly wash and iron bed
linen.
Further advice regarding threadworms
• Thoroughly wash hands and 

7 nails after using the toilet and before each meal.


What are threadworms? Do you need to keep your children off school?
Threadworms (Enterobius vermicularis) are tiny No. As long as the children are treated and the
white parasitic worms that live in the bowel. They general hygiene measures outlined above are
are approximately half an inch long and resemble followed, there is no reason to keep them off school.
threads of white cotton – hence the name
threadworms. How can you stop the problem coming back?
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.

Ref: 049/002/270416/1/B

You might also like