Document: leaflet MAH BRAND_PL 00063-0666 change

• leaflet MAH BRAND 2_PL 00063-0666
• leaflet MAH BRAND_PL 00063-0666

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NUROF€N

Nurofen for Children    3 months to 12 years

Nurofen for Children i-Wl'VMn'A 3 months to 12 years

100mg / 5ml Oral Suspension

post-immunisation fever symptoms of cold and ( from headaches, sore throats, minor aches and sprains, teething and toothache.

This medicine is suitable for most babies over 3 months of age, children and adults. Follow the dose instructions carefully. Section 3 shows the different amount that children need.

Speak to your doctor if your child:

►    suffers from any of the conditions listed in Section 2 of the leaflet

►    is taking aspirin at a dose above 75 mg a day. See Section 2

►    is taking other medicines. See Section 2.

►    is not getting better, or you feel at all concerned. See Section 3

►    develops a rash, breathing problems or diarrhoea and gets very tired.

See Section 3.

Do not use this medicine and speak to your doctor if you are pregnant, think you may be pregnant or trying to get pregnant or are breast feeding.

See Section 2.

In this leaflet:

1.    What Nurofen for Children is and what it is used for

2.    Before giving Nurofen for Children to your child

3.    How to use Nurofen for Children

4.    Possible side effects

j5. How to store Nurofen for Children 6. Further Information

1. What Nurofen for Children is and what it is used for

The active ingredient (which makes this medicine work) is ibuprofen which is a Inon-steroidal-anti-inflammatory (NSAID) (painkiller.

(Ibuprofen is used as an analgesic (painkiller) for the relief of symptoms of cola and flu

Before giving Nurofen for Children to your child

(This medicine is suitable for the majority of [people but certain people should not use it. Talk So your pharmacist or doctor if you are at all (unsure.

(Do not give this medicine to your child if: they have ever had a reaction (e.g. asthma, runny nose, rash, swelling of the face, tongue, lips or throat) after taking ibuprofen, aspirin or other non steroidal anti- inflammatory (NSAID) medicines they weigh less than 5kg or are under 3 months of age they are taking any other anti-inflammatory (NSAID) painkillers, or aspirin with a daily dose above 75 mg they have (or have had two or more episodes) of a stomach ulcer, perforation or bleeding

they have severe kidney, heart or liver failure

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

Talk to your doctor or pharmacist if:

your child has or has had high blood pressure^ heart problems or a stroke because there is a small increased risk oF heart problems with ibuprofen

•    your child has a condition which may put them at risk of heart problems, such as diabetes or high cholesterol

•    your child has asthma or any allergic disease of the lungs

•    your child has, or has had liver, kidney, neart or bowel problems

•    your child is dehydrated as there is a risk of renal impairment

•    your child has SLE (Systemic Lupus Erythematosus, a condition of tne immune system) or any similar disease

•    your child suffers from chronic inflammatory bowel disease such as Crohn's disease or ulcerative colitis

•    You or your child are taking other medicines especially:

o other medicines containing ibuprofen or other NSAIDs, including those you can buy over the counter

o low dose aspirin (up to 75 mg a day) o diuretics (to help you pass water) o anticoagulants (blood thinning medicines e.g. warfarin)

o medicines for high blood pressure

(e.g.captopril, atenolol, losartan) o lithium (for mood disorders) o methotrexate (for psoriasis, arthritis and types of cancer) o zidovudine (for HIV) o corticosteroids (an anti-inflammatory drug) o cardiac glycosides (for heart problems) o ciclosporin or tacrolimus (to prevent organ rejection after transplant) o mifepristone (for termination of pregnancy) o quinolone antibiotics (for infections) o SSRI antidepressant drugs o antiplatelet drugs e.g. dipyridamole, clopidogrel.

Seek the advice of your doctor or pharmacist if any of the above apply.

If you are not sure what types of medicines your child is taking, show the medicine to the doctor or pharmacist.

Other warnings

The following warnings are more likely to concern adults. In any case, consider them carefully before giving or taking this medicine.

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

•    you should only take this product on a doctor's advice during the first 6 months of pregnancy

•    DO NOT take Nurofen for Children if you are in the last 3 months of your pregnancy

•    medicines such as Nurofen for Children 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 duration of treatment

•    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

•    in limited studies, ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely

•    if you are elderly talk to your doctor before using this medicine.

Some of the ingredients can cause problems

•    This product contains maltitol. If you have been told by a doctor that you have an intolerance to fructose, contact your doctor before taking this medicine.

•    Maltitol may have a mild laxative effect. Calorific value 2.3 kcal/g maltitol.

3. How to use Nurofen for Children

Always shake the bottle thoroughly before use.

To remove the cap, push it down and turn it anti-clockwise.

There is a 5ml easy dosing syringe or a twoended measuring spoon (2.5ml and 5ml) in the pack which should be used to give the medicine Using the two-ended measuring spoon

-    Measure the correct dose using the 2.5ml or 5ml spoon ends.

-    Wash and dry spoon between doses.

Wash the spoon in warm water and allow to dry, store out of th_e_ reach of chHdrem_____jjj