What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL15513/0314.


Boots Threadworm Tablets 2 Years Plus

PATIENT INFORMATION LEAFLET

Information for the user

Boots Threadworm Tablets 2 Years Plus

(Mebendazole)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

This medicine is available without prescription to treat threadworm. However, you still need to give it carefully to get the best results from it.

  • Keep this leaflet, you may need to read it again
  • Ask your pharmacist if you need more information or advice
  • If your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet
  • You must talk to a doctor if your child does not feel better or feels worse
  • The leaflet is written in terms of giving this medicine to your child, but if you are an adult who is intending to take this medicine yourself the information in this leaflet will apply to you as well

What this medicine is for

This medicine contains Mebendazole which belongs to a group of medicines called anthelmintics which act to treat worm infections of the gut.

It can be used to treat threadworms (sometimes known as pinworms).

Before you give this medicine

This medicine can be given to children from the age of 2 years and over. However, some children should not be given this medicine or you should seek the advice of their pharmacist or doctor first.

Do not give:

  • If your child is under 2 years
  • If your child is allergic to any of the ingredients

Other important information

If your child is going to have a blood test, tell your doctor that you have given this medicine.

Information about some of the ingredients: The colour sunset yellow (E110) in this medicine may cause allergic reactions.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant. Ask your doctor or pharmacist for advice before taking this medicine if you are breastfeeding.

If your child takes other medicines

Before you give this tablet, make sure that you tell your pharmacist about ANY other medicines you might be giving your child at the same time, particularly the following:

  • Metronidazole (for infections)
  • Cimetidine (for excess stomach acid)

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for your child, including herbal and homeopathic remedies.

How to give this medicine

Check the foil is not broken before use. If it is, do not give that tablet.

The tablets are orange-flavoured and may be chewed, crushed or swallowed whole.

However, always crush the tablet before giving it to a young child. Always supervise a child while they are taking this medicine.

Children of 2 years and over, and adults: Give one tablet once only.

Do not give to children under 2 years.

This medicine will kill threadworms. However, it may not destroy their eggs which can cause reinfection and also infect other people. In cases of reinfection, a second tablet may be given or taken after 2 weeks.

It is therefore recommended that all members of the family (except pregnant or breastfeeding women or children under 2 years), living in the same house, are treated at the same time and that precautions are taken to prevent reinfection (see “All about Threadworms” and “What else should I do” on the back of the leaflet for further information).

Do not give more than the amount recommended above.

If symptoms do not go away within a few days talk to your doctor.

If you give too many tablets: Talk to a doctor straight away. Take the medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

If your child gets any of these serious side effects, see a doctor at once:

  • Difficulty in breathing, swelling of face, neck, tongue or throat (severe allergic reactions)
  • Fits
  • Blistering or peeling of the skin

If your child gets any of the following side effects see your pharmacist or doctor:

Common side effects:

(may affect up to 1 in 10 people)

  • Stomach pain

Uncommon side effects:

(may affect up to 1 in 100 people)

  • Stomach discomfort
  • Diarrhoea, wind

Rare side effects:

(may affect up to 1 in 1000 people)

  • Skin rash, or red, raised itchy skin
  • Dizziness
  • Hair loss
  • Changes in liver function (you may notice severe stomach pain, yellowing of the skin and eyes, abnormal blood tests)
  • An increase in the number of infections (e.g. sore throats) that your child may get – this may be a sign of rare changes in the blood

Very rare side effects:

(may affect up to 1 in 10,000 people)

  • Inflammation of the kidneys*
  • Nausea
  • Vomiting

* observed in higher and prolonged doses

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed on this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store this medicine

Keep this medicine in a safe place out of the sight and reach of children.

Use by date on the end flap of the carton. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to thrown away medicines you no longer use.

These measures will help protect the environment.

What is in this medicine

These tablets contain Mebendazole 100 mg, which is the active ingredient.

As well as the active ingredient, the tablets also contains microcrystalline cellulose, sodium starch glycolate, talc, maize starch, sodium saccharin, magnesium stearate, cottonseed oil – hydrogenated, colloidal anhydrous silica, sodium laurilsulfate, sunset yellow (E110), flavour (orange).

The pack contains 4 pale orange tablets.

Who makes this medicine

Manufactured for
The Boots Company PLC
Nottingham
NG2 3AA

by

Lusomedicamenta
Sociedade Técnica Farmacêutica, S.A.
Estrada Consiglieri Pedroso 69-B
Queluz
2730- 055 Barcarena
Portugal

Marketing Authorisation held by

McNeil Products Ltd
Maidenhead
Berkshire
SL6 3UG
UK

Leaflet prepared April 2018

If you would like any further information about this medicine, please contact

The Boots Company PLC
Nottingham
NG2 3AA

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots Threadworm Tablets 2 Years Plus

Reference number: 15513/0314

This is a service provided by the Royal National Institute of Blind People.

All about Threadworms

(Enterobius vermicularis)

What are threadworms?

Threadworms are the most common worm infestation affecting humans in the UK. They are particularly common in children. Up to 40 percent of children under 10 years are estimated to suffer from threadworms at any one time.

Threadworms live in the bowel. The females grow to about half an inch long (10 mm). This makes them look like tiny threads of white cotton - hence their popular name "threadworms".

How can I tell if my child has threadworms?

Threadworms can be difficult to detect. The first signs are likely to be itching and irritation around the anal area, particularly at night. This is when the female worm lays her eggs. A child may also become irritable from disturbed sleep or bedwetting, or suffer from tummy aches and loss of appetite.

Are threadworms harmful?

Normally threadworms cause no problems other than itching, which can be distressing and embarrassing. Complications from threadworms are unusual, though girls may develop an infection in the vaginal area or urinary passage. If your child is showing any signs of vaginal irritation, discharge, cystitis or bedwetting, you should see your doctor.

How do threadworms spread?

The first thing to be assured of is that having threadworms doesn't mean that you, or your family are not clean. In fact, children are more likely to pick up threadworms at school than at home. Threadworm eggs are very widespread and so small that they can't be seen with the naked eye. They are often found in house dust, bedding, clothes, towels, on furniture or toys, unwashed salad vegetables and sometimes contaminated food.

Once the eggs are on the hands, they are easily transferred to the mouth and swallowed. In the bowel the eggs hatch and the mature female threadworms crawl through the anus to lay more eggs.

When the child scratches, eggs are picked up under the fingernails. These find their way onto toys or other objects, or pass straight into the mouth when the child sucks its fingers or bites its nails. Quite often other members of the family can become infected and once a pattern of infection and reinfection has been established, the correct treatment is needed to break the cycle.

Are threadworms easy to treat?

Yes. It is strongly recommended that all members of the family are treated at the same time as a precaution against reinfection. If a family member is pregnant, planning to become pregnant or breastfeeding, or if there's a child under 2 years old, a threadworm tablet will not be suitable and you should see your doctor.

What else should I do?

As well as a threadworm tablet, you'll need to take some extra precautions to guard against reinfection. The eggs are taken into the body through the mouth, so it pays to be particularly careful with hygiene.

General Advice

  • Scrub hands and under finger nails after each visit to the toilet and before preparing or eating food
  • Disinfect the toilet seat, toilet handle and bathroom door handle regularly
  • Vacuum and dust bedrooms thoroughly
  • After treatment, wash all nightwear, bedclothes, and towels on the hottest wash cycle they will tolerate to destroy any eggs that may be present

To help against reinfection

  • Make sure everyone in the family is treated at the same time
  • Keep nails short and discourage children from nail-biting and finger-sucking
  • For young children wearing a pair of mittens in bed will help to discourage scratching
  • Daily bathing, with thorough washing around the bottom is also important
  • Wearing underwear in bed will help to prevent eggs falling onto sheets

The lifecycle of an adult threadworm can be as long as six weeks, so it's wise to continue with these measures for at least six weeks after treatment.

If reinfection is suspected, further treatment may be required. If you have any concerns or want further advice talk to your pharmacist or doctor.