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NUROFEN FOR CHILDREN

Ibuprofen

Singles

Ibuprofen 100mg/5ml

PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE.

Keep this leaflet. You may want to read it again.

What Is In The Pack?

This pack contains 8 or 16 sachets each of 5ml.

Each 5ml of oral suspension contains the active ingredient Ibuprofen 100 mg.

Also contains: Maltitol Syrup, Water, Glycerol, Citric Acid, Sodium Citrate, Sodium Chloride, Sodium Saccharin, Orange Flavour, Xanthan Gum, Polysorbate 80, Domiphen Bromide.

Licence Holder and Manufacturer:

Crookes Healthcare Limited

Nottingham

NG2 3AA

PL 00327/0140

How Does Nurofen For Children Singles Work?

Nurofen For Children Singles provides relief by changing the body's response to high temperature, pain and swelling.

Nurofen For Children Singles contains the active ingredient ibuprofen, which belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). It acts by targeting the source of fever and pain.

What Is It For?

Nurofen For Children Singles is specially formulated for babies and children from 3 months. It is given by mouth to:

provide fast, effective and long lasting reduction in your child's temperature

soothes away pain from dental pain, minor aches and sprains, headaches and cold and flu symptoms.

Check Before You Give/Take This Product

Do not give to babies or children who:

are under 3 months old or weigh less than 5 kg

have or have ever had a stomach ulcer, or perforation or bleeding of the stomach

are allergic to any of the ingredients or to aspirin or to other painkillers

suffer from severe liver, kidney or heart problems

are taking other NSAID painkillers

have inherited problems coping with fructose/fruit sugar (hereditary fructose intolerance). This is because the body can make some fructose from the ingredient Maltitol.

Adults taking this product should be aware of these factors and additionally not take the product if you:

are taking other NSAID painkillers, or aspirin with a daily dose above 75mg

are in the last 3 months of pregnancy.

Talk to your doctor before giving Nurofen For Children Singles if they/you

have asthma or have suffered from asthma

have kidney, heart, liver or bowel problems

have Systemic Lupus Erythematosus (SLE) – a condition to the immune system affecting connective tissue resulting in joint pains, skin changes and disorder of other organs

are taking any regular medication, especially:
- if you are on low dose aspirin (up to 75mg daily)
- medicines for high blood pressure and water tablets (diuretics)
- medicines for thinning the blood (anti-coagulants)
- corticosteroids
- Methotrexate
- Lithium (used to treat depression)
- Zidovudine (an anti-viral drug)

are in the first 6 months of pregnancy or breast-feeding.

Nurofen For Children Singles belongs to a group of medicines which may impair fertility in women. This is reversible on stopping the medicine. It is unlikely that Nurofen For Children Singles, used occasionally, will affect your chances of
becoming pregnant. However, tell your doctor before taking this medicine if you have problems becoming pregnant.

Some people may react badly to certain ingredients, such as maltitol and glycerin (also known as glycerol)

Maltitol may have a mild laxative effect.

Glycerol may cause headache, stomach ache or diarrhoea.

Medicines such as Nurofen For Children Singles may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or take for longer than necessary to control the symptoms.

If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or
pharmacist.

How Should Nurofen For Children Singles Be Given?

Before opening, massage the sachet to mix the contents well. Gently squeeze the liquid onto the 2-ended measuring spoon (2.5ml or 5ml) provided.

You must measure the dose accurately.

Wash and dry the spoon between doses. Throw away half used sachets.

Fever and Pain:

This medicine is for short term use only.

Do not give it to babies aged 3 to 6 months for more than 24 hours.

Do not give to children aged 6 months and older for more than 3 days.

Talk to your doctor promptly if your child’s symptoms persist for longer than
these times or if you are concerned.

Babies 3-6 months weighing more than 5 kg: One 2.5ml spoonful may be taken three times in 24 hours.

Babies 6-12 months: One 2.5ml spoonful may be taken three to four times in 24 hours.

Children 1-3 years: One 5ml spoonful may be taken three times in 24 hours.

Children 4-6 years: One 7.5ml (5ml +2.5ml) spoonful may be taken three times in 24 hours.

Children 7-9 years: Two 5ml spoonfuls may be taken three times in 24 hours.

The doses should be given approximately every 6 to 8 hours, (or with a minimum
of 4 hours between each dose if required).

WARNING: Do not exceed the stated dose

What To Do If You Give Too Much

If you accidentally give more than the recommended dose contact your doctor straight away.

Side Effects:

Although side effects are uncommon, your child may get one of the known side effects of NSAIDs. If they do, or if you have concerns, stop giving this medicine to your child and talk to your doctor as soon as possible.
Elderly people using the product are at increased risk of developing problems associated with side effects.

Disorders of the stomach and bowel including abdominal discomfort or pain, nausea, dyspepsia, diarrhoea, flatulence (wind), constipation, stomach ulcer, vomiting containing either blood or brown grit (like coffee grounds), black tarry stools, worsening of
existing bowel diseases (ulcerative colitis or Crohn’s disease).

Blood disorders resulting in unexplained or unusual bruising or bleeding, fever, sore throat, mouth ulcers, extreme pallor or weakness.

Allergic reactions including worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face and tongue, collapse. In addition, there may be skin reaction (including hives and itching): these can sometimes be severe with blistering and peeling of skin.

Liver disorders that may be indicated by yellowing of the skin and eyes and/or pale stools and dark urine.
Kidney disorders that may be indicated by passing less
or more urine than normal, cloudy urine, blood in the
urine, pain in the back and /or swelling (particularly of
the legs).

Nervous system disorders indicated by severe
headaches, neck stiffness, disorientation, and light
hurting the eyes.

Medicines such as Nurofen For Children Singles may
be associated with a small increased risk of heart attack
( 'myocardial infarction' ) or stroke.

If you experience any of these, or have any
other unusual symptoms or concerns, stop
taking the product immediately and see
your doctor.

Storage

Do not store above 25°C.

Use by the date shown on the label and carton.

Remember: Keep all medicines out of the
reach and sight of children.

How Can You Obtain More Information About Nurofen For Children Singles?

This leaflet gives you the most important patient
information about Nurofen For Children Singles. If
you have any questions after you have read it, ask
your doctor or pharmacist, who will give you further
information.

Date of revision April 2007