Nurofen For Children
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7
Sive e
NUROF6N
for Children
100mg / 5ml Oral Suspension
Contains Ibuprofen
Read all of this leaflet carefully before you use this medicine.
It contains important information.
Keep this leaflet: you might need it again.
If you have any further questions after you have read it ask your doctor or pharmacist.
• This medicine is designed to help bring down a high temperature (fever and post-immunisation fever), relieve the symptoms of cold and flu and relieve pain from headaches, sore throats, ear ache, 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 applied by the pharmacist on the carton.
• 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 [5. How to store Nurofen for Children 16. 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 [non-steroida l-anti-i nfla mmatory (NSAID) painkiller.
ibuprofen is used as an analgesic (painkiller) for (the relief of symptoms of cold and flu and mild Ito moderate pain, such as a sore throat,
[teething pain, toothache, ear ache, headache, [minor aches and sprains.
[Nurofen for Children also brings down a high [temperature (fever) including fever caused by 'immunisation.
2. 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
[to 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 _he_art_pro_b]ems_with ibuprofen_ _
• your childTias 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, heart or bowel problems
• your child is dehydrated as there is a risk of renal impariment
• your child has SLE (Systemic Lupus Erythematosus, a condition of the 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, consicfer) 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 doctors 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 ma’ be associated with a small increased risk ol heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses ancf 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, confact 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
Follow all directions given to you by the doctor or pharmacist. You should always follow the doctor's advice about when and how to this medicine and always read the label pharmacist applied on the carton.
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 two-ended measuring spoon (2.5ml and 5ml)
in the pack which shou medicine
be used to give the
Using the spoon or the syringe, measure the quantity of medicine prescribed by the doctor.
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 the reach of children.
Using the 5ml easy dosing syringe
• Push the syringe firmly into the plug (hole) in the neck of the bottle.
stroke or heart problems may occur with Ibuprofen. This is unlikely at the dose level given to children
worsening of colitis and Crohn's disease high blood pressure.
Do not use the medicine after the expiry date shown on the bottle label and carton.
Store below 25°C.
Keep all medicines out of the sight and reach of children
TR688213E
Dimension: 148x420mm
the syringe, turn the bottle upside Whilst nc11 '
To I
down. WhilstTiolding the syringe in place, gently pull the plunger down drawing the medicine to the correct mark on the syringe. See section "How much medicine to use". Turn the bottle the right way up, remove the syringe from the bottle plug by gently twisting the syringe.
Place the end of the syringe into the child's mouth and gently press the plunger down to slowly and gently release the medicine.
After use replace the bottle cap. Wash the syringe in warm water and allow to dry. Store out of the reach of children.
Talk to your doctor
* If your child's symptoms do not go away as soon as possible or worsen.
* If you are not sure of your child's illness or it is accompanied by a rash, breathing difficulties, diarrhoea or excessive tiredness, speak to
your doctor straight away. | ” Prjpt
I
If anyone has taken too much medicine
If you accidentally give or take more Ithan the recommended dose, contact fyour doctor straight away.
If you forget to give the medicine
If you forget a dose, give the next dose when needed, provided that the last dose was taken at least 4 hours ago. Do not give a double dose.
What is in this medicine?
The active ingredient is Ibuprofen 100 mg per 5 ml.
The other ingredients are:
Maltitol liquid, water, glycerol, citric acid, sodium citrate, sodium chloride, sodium saccharin, orange flavour, xanthan gum, polysorbate 80, domiphen bromide.
What the medicine looks like
Nurofen for Children is an off-white liquid available in 200ml, 150ml and 100ml bottles. Not all pack sizes will be marketed.
Each pack contains a dosing device: a two-ended spoon (CE 01 20) or a syringe (CE 0543).
It contains lOOmg of the active Ibuprofen in every 5 ml of medicine.
Product licence holder: Reckitt Benckiser Healthcare (UK) Ltd. Slough, SL1 4AQ
Manufacturer of medicine: Reckitt Benckiser
Healthcare UK Ltd, Hull, HU8 7DS .-.
and P
BCM Ltd, Nottingham NG2 3AA
Syringe manufacturer: Reckitt Benckiser Healthcare (UK) Ltd, HU8 7DS
Spoon manufacturer: Massmould, LU1 1XL. Product license number: PL 00063/0665
This leaflet was revised: June 2014.
The leaflet gives you the most important information. If you have any questions after you have read it, ask your doctor or pharmacist who will be able to help.
Like all medicines, Nurofen for Children can cause side effects, although not everybody gets them.
The most common side effect is irritation of the stomach which can cause problems such as indigestion and heartburn.
If your child experiences any of the following, stop giving this medicine and tell your doctor immediately:
• blood in the stools (faeces/motions)
• black tarry stools
• vomiting blood or dark particles that look like coffee grounds
• unexplained wheezing, shortness of breath, skin rash (which may be severe with blistering or peeling of the skin), itching or bruising, racing heart, fluid retention (swollen ankles or decreased levels of passing urine)
• stiff neck, headache, nausea, vomiting, fever and disorientation.
If your child experiences any of the following side effects, stop giving this medicine and tell your doctor
• unexplained stomach pain, indigestion, hearfburn, nausea or vomiting
• yellowing of the eyes, pale stools and dark urine
• severe sore throat with high fever
• unexplained bruising or tiredness or getting more infections, such as colds, than normal.
Other side effects which may occur are:
Uncommon:
• headache
Rare:
• diarrhoea, wind or constipation. Tell your doctor if these last for more than a few days or become troublesome
Very rare:
kidney problems may occur with Ibuprofen