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Mebendazole Tablets 100mg

Document: leaflet MAH BRAND_PL 00240-0085 change

Pripsen Mebendazole Tablets

Important information about Pripsen

Mebendazole Tablets

•    This medicine is used to get rid of threadworms (pinworms).

•    It can be used by adults, the elderly and children over 2 years.

•    Since threadworms can spread very easily, it is strongly recommended that all the family members are treated at the same time.

•    You can take a second tablet 14 days after the first one if re-infected. See section 3.

Do not use.....

•    During pregnancy or whilst breastfeeding.

Do not give____

•    To children under 2 years.

Now read the rest of the leaflet before you use

this medicine. It includes other information

which might be especially important for you.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need any more information or advice.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1.    What the medicine is for

Pripsen Mebendazole Tablets belong to a group of medicines called Anthelmintics which are used to eliminate threadworm infections.

The tablets contain mebendazole which kills the worms within a few days of taking.

2.    Before you use this medicine

Do not use the medicine if you or your child have.....

•    An allergy to any of the ingredients listed in section 6.

•    Or is under 2 years old.

A Talk to your doctor if you or your child have....

• Porphyria (a rare disease of the blood pigments).

A Talk to your doctor or pharmacist if you or your child are taking....

• Cimetidine (used to treat peptic ulcers).

• Metronidazole (an antibiotic used to treat some types of infection).

Pregnant or breastfeeding ....

Ask your doctor or pharmacist for advice before using this medicine if you are pregnant, might be pregnant or are breastfeeding. Pripsen Mebendazole Tablets should not be used in pregnancy or breastfeeding.

A Important information about some of the ingredients

• This product contains sorbitol (E420). 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 use this medicine

Chew or swallow the tablet.

O Adults, the elderly and children over 2 years

One tablet.

□ Children under 2 years

Do not give to children under 2 unless your doctor tells you to.

Follow up dose, if re-infected:

On rare occasions the first tablet may not kill all worms, or you may be re-infected from other family members.

• Take another tablet 14 days after the first one, if you still have worms or have become re-infected.

If symptoms persist after taking two tablets you should ask your doctor for advice.

^Wlf you take too many

If you accidentally take too many, see a doctor straight away. Take the pack with you to show which medicine you have swallowed.

Turn over #

23637108

PM/20/332

Read direction


MHRA Header Box

Product

Title

Pripsen Mebendazole Tablets

Colours Used

Fonts Used

Process Black

Helvetica

Component

Leaflet

Keyline (Does not print)

Pack Size

2's and 8 s

IG Code

23637108

Dimensions

210 x 148mm

Proof No.

1 Date 03.09.2013

4.    Possible side effects

Like all medicines, Pripsen Mebendazole Tablets can have side effects, although these don't affect everyone.

Stop using Pripsen Mebendazole Tablets and tell your doctor straight away if you notice or suspect the following serious side effects.

You may need urgent medical treatment.

•    Possible signs of severe allergic reactions such as rash, skin redness or blistering, itching, swelling or hives.

•    Allergic reactions such as serious illness with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome and toxic epidermal necrolysis).

•    Headache. • Dizziness. • Fits (convulsions). Other possible side effects are:

•    Stomach pain. • Diarrhoea. • Stomach discomfort, wind. • Inflammation of the liver.

If you notice these or any other side effect not included above, stop use and tell your doctor or pharmacist. They will tell you what to do.

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 in this leaflet. You can also report side effects directly via the Yellow Care Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    Storing this medicine

•    Keep it out of the reach and sight of children.

•    Do not store above 25°C.

•    Store in the original package.

•    Do not use after the expiry date shown on the carton. The expiry date refers to the last day of that month.


• Medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine. These measures will help to protect the environment.

6. Further information

What is in this medicine

The active ingredient per tablet is:

mebendazole 100mg.

The other ingredients are: sorbitol (E420), magnesium stearate, orange flavour, povidone, maize starch, croscarmellose sodium and sodium saccharin.

What the medicine looks like

Pripsen Mebendazole Tablets are mottled off-white, round, flat faced tablets with a bevelled edge.They are available in cartoned blister packs as a one-person treatment containing 2 tablets or as a family pack containing 8 tablets.

Marketing authorisation holder

Thornton and Ross Ltd., Huddersfield,

HD7 5QH, UK.

Manufacturer

Custom Pharmaceuticals Ltd., Conway Street, Hove, East Sussex, BN3 3LW, UK.

This leaflet was revised in September 2013

Pripsen is a trade mark of Thornton and Ross Ltd.

Health and Hygiene Information

What are threadworms (pinworms)?

Threadworms, as their name suggests, are threadlike, white worms about a centimetre long. They can often be seen in the stools or on the toilet paper, where they look like threads of white cotton.

Threadworms are very common, especially in children. Experts have estimated that as many as four out of every ten children suffer from


threadworms before their tenth birthday. People of all ages can catch threadworms, however careful they are about their cleanliness.

Although this disorder is a nuisance, it is harmless and easily treated.

Where do threadworms come from?

Threadworms cannot be caught from pets since they only live in humans. Even the cleanest household can catch threadworms because the microscopic eggs are easily carried on clothes and bed linen, on skin, under fingernails and on food.


Threadworms are passed from person to person very easily so it is important to follow a few simple hygiene rules. If followed carefully for six weeks they will reduce the risk of threadworms coming back into your home. The most important rule is to treat the whole family on the same day and repeat after 14 days, if necessary.

Home Hygiene Rules

•    Fingers and nails must be washed and scrubbed with a nailbrush after each visit to the toilet and before each meal.

•    Disinfect the toilet seat, toilet handle or chain and the door handle regularly.

•    Vacuum bedrooms daily, damp-dust surfaces and try not to raise dust.

Personal Hygiene Rules

•    Keep finger nails cut short.

•    Wear pyjamas or pants in bed.

•    Bathe each morning, remembering to wash your bottom thoroughly.

•    Have a towel for sole use.

•    Change and wash clothes and bed clothes regularly.


Follow these hygiene rules for six weeks from the date of the family taking the first dose of Pripsen Mebendazole Tablets.    23637108

First dose taken..................(date) PM/20/332


Pharmacode Read Direction to be confirmed


MHRA Header Box

Product

Title

Pripsen Mebendazole Tablets

Colours Used

Fonts Used

Process Black

Helvetica

Component

Leaflet

Keyline (Does not print)

Pack Size

2's and 8 s

IG Code

23637108

Dimensions

210 x 148mm

Proof No.

1 Date 03.09.2013