Mebendazole Tablets 100mg
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start
taking this medicine because it contains
important information foryou.
• Keep this leaflet. You may need to read it again.
• Ifyou have any further questions, askyourdoctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Mebendazole Tablets 100mg are and what they are used for
2. What you need to know before you take Mebendazole Tablets 100mg
3. How to take Mebendazole Tablets 100mg
4. Possible side effects
5. How to store Mebendazole Tablets 100mg
6. Contents of the pack and other information
1. WHAT MEBENDAZOLE TABLETS 100MG ARE AND WHAT THEY ARE USED FOR
Mebendazole Tablets 100mg contain a medicine called mebendazole. This belongs to a group of medicines called "antihelmintics” and is used to kill threadworms.
Mebendazole Tablets 100mg are used for the treatment of threadworm infestation.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEBENDAZOLE TABLETS 100MG
Do not take Mebendazole Tablets 100mg ifyou:
• Are hypersensitive (allergic) to mebendazole or any of the other ingredients of Mebendazole Tablets 100mg (listed in section 6)
• Are pregnant.
Warnings and precautions
Talk to you doctor or pharmacist or nurse before
taking Mebendazole TabletslOOmg if:
• It is for a child under2 years of age
• You are currently taking medicines that may interact with this medicine.
Other medicines and Mebendazole Tablets 100mg
Tell your doctor or pharmacist ifyou are taking, have recently taken, or might take any other medicines.
In particular tell your doctor if you are taking any of the following:
• Metronidazole used to treat bacterial infections
• Cimetidine used to treat stomach disorders such as heartburn.
Pregnancy and breast-feeding
You should not take this medicine if you are pregnant, planning on becoming pregnant or are breast-feeding. Please check with your doctor ifyou are taking these tablets and are planning a pregnancy or you want to breast-feed your baby.
Driving and using machines
You should not drive or operate heavy machinery if you think you are affected by this medicine.
Mebendazole Tablets 100mg contain sunset yellow (E110)
This ingredient may cause allergic reactions.
Mebendazole Tablets 100mg contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE MEBENDAZOLE TABLETS 100MG
Always take Mebendazole Tablets 100mg exactly as your doctor has instructed you. You should check with your doctor or pharmacist ifyou are unsure.
Adults, the elderly and children over 2 years:
One tablet (100mg) to be chewed or swallowed whole.
This dose may be repeated after two weeks if reinfestation occurs.
Children under2 years:
Not recommended for use.
To avoid re-infestation it is recommended that the whole family be treated at the same time.
In addition to treatment with this medicine the following precautions are recommended:
• Hands should be washed thoroughly and nails scrubbed before each meal and after each toilet visit.
• Each morning the anal area should be washed thoroughly to remove any eggs which may have been lain during the night
• Nail biting and insertion of the fingers into the mouth should be avoided
• Separate towels for each family member should be used.
If you take more Mebendazole Tablets 100mg than you should
If you take too many tablets by mistake contact your nearest hospital casualty department or tell your doctor immediately. Take your tablet pack with you. You may experience stomach cramps, feeling or being sick and diarrhoea.
5. HOW TO STORE MEBENDAZOLE TABLETS 100MG
L.
Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the label.
Do not store above 25°C. Store in the original package.
In case of any visible signs of deterioration, you should discard the package.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.
4. POSSIBLE SIDE EFFECTS
Keep out of the sight and reach of children
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop using Mebendazole Tablets 100mg and tell your doctor straight away if you notice or suspect the following serious side effects. You may need urgent medical treatment.
• Sudden swelling of your face or throat. Hives (also known as nettle rash or urticaria), severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction
• Blistering of yourskin, mouth, eyes and genitals
• Fits (convulsions).
Tell your doctor or pharmacist if you notice any of the following side effects:
Common (affects less than 1 in 10 people)
• Stomach pain.
Uncommon (affects less than 1 in 100 people)
• Stomach discomfort
• Diarrhoea
• Wind.
Rare (affects less than 1 in 1,000 people)
• Rash
• Inflammation of the liver
• Changes in liver enzymes (shown in blood tests)
• Reduction in white blood cells (shown in blood tests). You may get more infections
• Unusual hairloss
• Dizziness.
Reporting of side effects
If you get any side effects, talk to your doctor or 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.
6. CONTENTS OF THE PACK AND OTHER L INFORMATION_.
What Mebendazole Tablets 100mg contain:
Each tablet contains 100mg of the active substance mebendazole.
The other ingredients are: lactose, pregelatinised maize starch, sunset yellow (E110), sodium saccharin, sodium lauryl sulphate, natural orange flavour, sodium starch glycollate, microcrystalline cellulose and magnesium stearate.
What Mebendazole Tablets 100mg look like and contents of the pack
Mebendazole Tablets 100mg are orange, flat beveled edged tablets with a breakline on one side.
Mebendazole Tablets 100mg are packed into blisters containing 1,2,4,6 and 8 tablets.
Marketing Authorisation Holder
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
Manufacturer
Sussex Pharmaceutical Ltd
Charlwoods Road
EastGrinstead
West Sussex
RH192HL
United Kingdom
This leaflet was last revised in April 2015.