Pharmacode Reads This Way

NUROF6N

Nurofen for Children 3 months to 9 years Nurofen for Children 3 months to 9 years IWM-UiJA 100mg / 5ml Oral Suspension

Contains Ibuprofen

[This leaflet is valid for Nurofen for [Children 3 months to 9 years Orange or for Nurofen for Children 3 months to 9

years45trawberry.The only difference--

between both products is the flavour. To [know the flavour of the medicine you are [using, please refer to the carton or label.

•    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.

_TaJkJo_your_xlQctor_Dr_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, heart or bowel problems

•    your child is dehydrated as there is a risk of

__renal i mpa i rrnent

• ^our child has SLE (Systemic Lupus

rythematosus, 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

[Read all of this leaflet carefully before you [use this medicine.

It contains important information. keeplhTs leaflet: you might^-ieed“if“again.^-* Tou oryou r:hf I chare Taking other

If you have any further questions after you have read it ask your doctor or pharmacist.

This medicine is desiqned to help brinq down a high temperature (fever and post-immunisation fever), relieve the

medicines especially: other medicines containing ibuprofen or other NSAIDs, including those you can buy over the counter low dose aspirin (up to 75 mg a day)

[- symptoms of eold-and-flu-and -relievo pain- -O-diuretics -{to-help you-pass-water)---

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.

o anticoagulants (blood thinning medicines e.g. warfarin)

o medicines for high blood pressure

(e.g.captopril, atenolol, losartan) o lithium (for mood disorders)

[- Section 3 showsThe-different amount that--o_methotrexate ffoLpsorigsjs, arthriti_s anc[

types of cancer) zidovudine (for HIV)

corticosteroids (an anti-inflammatory drug) cardiac glycosides (for heart problems)

is taking aspirin at a dose above 75 mg ° ciclosporin or tacrolimus (to prevent

a_dayJSeeSection 2_________⁰I9^a_ⁿ [ejection after hansplant)____

o mifepristone (for termination of”Dregnancy) o quinolone antibiotics (for infections) o SSRI antidepressant drugs o antiplatelet drugs e.g. dipyridamole, clopidogrel.

Seek the advice of your doctor or pKarmacIstTf any of tRe”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 |

-conGera-adufte.-ln-any gqs&, 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 NOTjake this medicine if you_are i[[ 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

children need.

Speak to your doctor if your child:

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

►    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_nat us&this-medkiae-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

- ft is used for-----------

[2. Before giving Nurofen for Children to your child [3. How to use Nurofen for Children A. Possible side effects

5.    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 [non-steroidal-anti-inflammatory (NSAID)

[patfiktllefr-------------■

[ibuprofen is used as an analgesic (painkiller) [for the relief of teething and toothache pain, [muscular minor aches and sprains, sore throats and symptoms of cold and flu as well as the

symptomatic relief of headaches.

[Nurofen for Children also brings down a high    . .    -    , , ,    ,

[temperatttre-(fever) mckjdfflg-posHmmumsation - -exceed^ racommendsd^ose^rjmaton, if_evel    ^a ^    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 This medicine is suitable for the majority of    blood pressure, diabetes or high cholesterol

[people but certain people should not use it.    or are a smoker) you should discuss your

rfalk-to-yourphamnacisTordoctor-if you-are at--treatment with youndoctor-or-pharmaGist—

limited studies, ibuprofen appears in the

Before giving Nurofen for Children to your child

all unsure.

in

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.

or aspirin with CLdail^cbsaakoyeTflnag _._/^_a|_tito|__mQy4_iave^_{0 ffli}y

laxative effect.--[

they have (or have had two or more    Calorific value 2.3 kcal/g maltitol.

episodes) of a stomach ulcer, perforation or bleeding    DJ

they have severe kidney, heart or liver

failure    «->

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,

.aailv dasaabc

3. How to use Nurofen for Children T4. Possible side effects

Always shake the bottle thoroughly before Like all medicines, Nurofen for Children can ^use-    cause side effects, although not everybody

To remove the cap, push it down and turn it gets them.

bnti-clockwise.    The most common side effect is irritation of the

[Thefe-rs-a Smf-desing-syringe-m the-paek    stomach which "can cause problems such" as ^_

(which should be used to give the medicine. indigestion and heartburn.

[Using the 5ml easy dosing syringe    If your child experiences any of the

Push the syringe firmly into the plug (hole) in following, stop giving this medicine and the neck of the bottle.    tell your doctor immediately:

To fill the syringe, turn the bottle upside • blood in the stools (faeces/motions) dowrLVVhiistJiQlding_the_syringe_in_pbce, _«_blcick tarry-stools__________

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-chtfchs mouth and gently press the plunger down to slowly and gently release the medicine.

vomiting blood or dark particles that look like coffee grounds

unexplained wheezing, shortness of breath, rex

After use replace the bottle cap. Wash the syringe in warm water and allow to dry. Store out of the reach of children.

[How much medicine to use

[DO NOT give to babies under 3 months

or babies weighing less than 5kg.

5. How to store Nurofen for Children

Fever, Pain and_Symptoms of Cold and.F]u

skin rash (which may be severe with blistering or peeling of the skin), itching or bruising, racing heart, fluid retention (swotlerr ankfes“or“decreasedievels"ol passing urine)

•    stiff neck, headache, nausea, vomiting, fever and disorientation.

If your child experiences any of the following side effects, stop giving this _medicine_andlelLyour doctor______

•    unexplained stomach pain, indigestion, heartburn, nausea or vomiting

•    yellowing of the eyes, pale stools and dark urine

•    severe sore throat with high fever

•    unexplained bruising or tiredness or getting ^-mtore~irifecficms7sucniascoldif, tRarT normal

Other side effects which may occur are: Uncommon:

•    headache Rare:

•    diarrhoea, wind or constipation. Tell your “doctorif these IdsfldFmore tharlalew ^-

days or become troublesome Very rare:

•    kidney problems may occur with Ibuprofen

•    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.

One 2.5ml dose 3 times a day.

Do not use for more than 24 hours

Do not use the medicine after the expiry date shown on_the_bottje label anc/carton._

Store below 25°C.

Keep all medicines out of the sight and reach of children

6. Further information

Do not give to babies aged 3-6 months for more than 24 hours. If symptoms persist after 24 hours or worsen, consult your doctor._

6-12 months

One 2.5ml dose 3 or 4 times in 24 hours

One 5ml dose 3 times in 24 hours

One 7.5ml (5ml + 2.5ml) dose 3 times in 24 hours

One 10ml (5ml + 5ml) dose 3 times in 24 hours

Doses should be given every 6-8 hours. Leave at least 4 hours between doses.

For Short-term use only

► Do not give to children aged 6 months or

__older for_morejhan 3 days. Jf symptoms.

persist after 3 days or worsen, consult your doctor.

What is in this medicine?

The “active ingredient “is Ibuprofen 4 00 mg“ per 5ml of medicine.

The other ingredients are:

Maltitol liquid, water, glycerol, citric acid, sodium citrate, sodium chloride, sodium saccharin, orange or strawberry flavour,

.xantharigurTU polysoi_bate_8Q, domiphen.__

bromide.

What the medicine looks like

Nurofen for Children is an off-white liquid available in 100ml bottles.

Each pack contains a dosing syringe (CE 0543).

“Product licence holder: ReckitfBenckiser^-Healthcare (UK) Ltd. Slough, SL1 4AQ

Manufacturer of medicine: Reckitt Benckiser

Healthcare UK Ltd, Hull, HU8 7DS

and

BCM Ltd, Nottingham NG2 3AA

-Syringe manufacturers Reckitt-Benckiser--

Healthcare (UK) Ltd, HU8 7DS.

Product licence numbers:

PL 00063/0668: Nurofen for Children 3 months to 9 years Orange PL 00063/0667: Nurofen for Children 3 months to 9 years Strawberry

This "ledflefwaslevised fjurie “2014f The leaflet gives you the most important information. If you have any questions after you have read it, ask your doctor or

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 pharmacist who will be able to help, or it is accompanied by a rash,

i>reathing_difficulties, diarrhoea or__

excessive tiredness, speak to your doctor straight away.

If anyone has taken too much medicine

If you accidentally give or take more than the [recommended dose, contact your doctor [straight away.

tf you“fo“rgetTo“giveThe medicine"

ilf 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.

CD

. os,

Age

Dose

TR708897C Dimension: 420x148mm

3-6 months Weighing over 5kg

1-3 years

4-6 years

7-9 years

WARNING:

Do not take more medicine than the label tells you to