148mm

NUROF€N

(Nurofen for Children 3 months to 9 years Nurofen for Children 3 months to 9 years ITirl'.'J-lWA

flOOmg / 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 years Strawberry. 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.

Read all of this leaflet carefully before you

use this medicine.

lit 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, 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

|5. How to store Nurofen for Children £. Further Information

•    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 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 cancerj 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.

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

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

[The active ingredient (which makes this medicine work) is ibuprofen which is a inon-steroida l-anti-i nfla mmatory (NSAID) painkiller.

Ibuprofen is used as an analgesic (painkiller) f Jthe relief of teething and toothache pain, imuscular minor aches and sprains, sore throat pnd symptoms of cold and flu as well as the [symptomatic relief of headaches.

'Nurofen for Children also brings down a high temperature (fever) including post-immunisation Ifever.

Before giving Nurofen for Children to your child

[This medicine is suitable for the majority of jpeople 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

ey failure

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 this medicine 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.    jo

o

o

PO

3. How to use Nurofen for Children 4. Possible side effects

Always shake the bottle thoroughly before use.

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

There is a 5ml dosing syringe in the pack which {should be used to give the medicine.

(Jsing the 5ml easy dosing syringe

*    Push the syringe firmly into the plug (hole) in ] the neck of the bottle.

{• To fill the syringe, turn the bottle upside down.

| Whilst holding 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 ¹ slowly and gently release the medicine.

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

|How much medicine to use

DO NOT give to babies under 3 months or babies weighing less than 5kg.

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 anldes 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, 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 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

•    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.

5. How to store Nurofen for Children

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

6. Further information

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.

|f anyone has taken too much medicine

|f you accidentally give or take more than the fecommended dose, contact your 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 5ml of medicine.

The other ingredients are:

Maltitol liquid, water, glycerol, citric acid, sodium citrate, sodium chloride, sodium saccharin, orange or strawberry flavour, xanthan gum, polysorbate 80, 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: Reckitt Benckiser Healthcare (UK) Ltd. Slough, SL1 4AQ

Manufacturer of medicine: Reckitt Benckiser

Healthcare UK Ltd, Hull, HU8 7DS

and

BCM Ltd, Nottingham NG2 3AA

Syringe manufacturer: 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 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.

Fever caused by Immunisation

Age

Babies and children 3 months and over Weighing more than 5kg

If necessary the second dose should be given

6 hours after the first dose.

•    Do not give more than 2 doses in a 24 hour period.

•    Do not give to a child under 3months of age, unless advised to do so by your doctor.

Dose

One 2.5ml dose up to twice a day

Print

Free

Area

WARNING:

Do not take more medicine than the label tells you to

NUROF6N

Nurofen for Children B months to 9 years

Nurofen for Children 3 months to 9 years fcutmam

100mg / 5ml Oral Suspension

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.

Contains Ibuprofen

!rhjs leaflet is valid forjNlurofen forJZhildren (3 months to 9 years Orange or for Nurofen (for Children 3 months to 9 years Strawberry. 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.

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

It contains important information. _

Keep this leaflet: you might need it again.

Ilf you have any further questions after you have Iread it ask your doctor or pharmacist.

This medicine is desiqned to help brinq down a high temperature (fever and post-immunisation fever), relieve the symptoms of cold and flu and relieve pain from headaches, sore throats, minor aches and

sprains, Jee±hing_and tootha_che._____

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.

£peak 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^-:hil(T

3.    How to use Nurofen for Children (4. Possible side effects

5.    How to store Nurofen for Children

6.    Further Information

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_asihma_ojiany_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 the immune system) or any similar disease

•    your child suffersrfrom xhromcinflammatory 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 jow dose aspirin (ypjo 75_mg a day)_

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

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

(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-fat Children also brings-dowaa-high-(temperature (fever) including post-immunisation (fever.

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 jo your pharmacist or doctor if you are at all ^insure________________

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 areTakmg anyotlTer□htMnftammaTory (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

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 antiptatelet 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 fdlcwrng-warrrings crre-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-th-is medic-ine-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 this medicine 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 ottack^_("myacardid^_rnforcticn")^_or3troke'. Any risk is more likely with high doses and prolonged treatment. Do not exceed the . recommended dose or duration of treatment I • 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

-    treatmentwritfryour 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.

RB211177

3. How to use Nurofen for Children

4. Possible side effects

! Always shake the bottle thoroughly ! before use.

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

There is a 5ml dosing syringe in the

---pack which-should -beujsecuo-give the_

medicine.

Using the 5ml easy dosing syringe

•    Push the syringe firmly into the plug (hole) in the neck of the bottle.

•    To fill the syringe, turn the bottle upside down. Whilst holding the

syringe in place, gently pull the plunger cfown drawing the medicine to the correct ^—marlTorT the syringe."See sedTorT"l⁼low 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.

"1

• 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.

Like all medicines, Nurofen for    r“_“_V_V((

Children can cause side effects,    I (    l((

although not everybody gets them.    |(    !((

The most common side effect is    ((j

irritation of the stomach which can cause problems such as indigestion and-heartbum.-------------l

I

If your child experiences any of the    I

following, stop giving this medicine_______(

and tell your doctor immediately:    ; i-----₁ (I

•    blood in the stools (faeces/motions)    (I    (|l

•    black tarry stools    | \_____(h

•    vomiting blood or dark particles that¹"' look like coffee grounds

^uaexplainedjrvheezinashortness of breathy _(_ skin rash (which may be severe with blistering' or peeling of the skin), itching or bruising, racing heart, fluid retention (swollen ankfes orl decreased levels of passing urine)    I

•    stiff neck, headache, nausea, vomiting, fever i

and disorientation.    I

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

medicine cmcHetl your doctor------(-

•    unexplained stomach pain, indigestion,    (

heartburn, nausea or vomiting    (

•    yellowing of the eyes, pale stools and dark    I

urine    (

•    severe sore throat with high fever

•    unexplained bruising or tiredness or getting

more infections, such as colds, than normal.    '

©therside-effects which may occur tire: —r

Uncommon:

•    headache    I

Rare:    I

•    diarrhoea, wind or constipation. Tell your    I

doctor if these last for more than a few days I 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    I

given to children    (

•    worsening of colitis and Crohn's disease

•    high blood pressure.

5. How to store Nurofen for Children

6. Further information

Do"no7use theanedtoine after the‘expiry’date^- f shown on the bottle label and carton.

Store below 25°C.    I

I

Keep all medicines out of the sight and I reach of children    (

I    WARNING:

I    Do not take more    medicine than

(    the label tells you    to

(Talk to your doctor

'•-If-yaur-childLs-symptoms-da not go away _ I as soon as possible or worsen, i* If you are not sure of your child's illness I or it is accompanied by a rash, breathing I 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 ⁱrecammeTCted"da5e7cantad"'yaurdactar ^-straight away.

Ilf you forget to give the medicine

Ilf you forget a dose, give the next dose when Ineeded, provided that the last dose was taken (at least 4 hours ago. Do not give a double (dose.

What is in this medicine?    i

I

The^-active ingredientisrlbTiproferrlf)0^-mg / per 5ml of medicine.    (

l

The other ingredients are:    (

Maltitol liquid, water, glycerol, citric acid, sodium citrate, sodium chloride, sodium saccharin, orange or strawberry flavour, xanthan gum, polysorbate 80, domiphen bromide.    I

I

WhatJhe 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: Reckitt Benckiser    (

Healthcare (UK) Ltd. Slough, SL1 4AQ    (

Manufacturer of medicine: Reckitt Benckiser i Healthcare UK Ltd, Hull, HU8 7DS    I

Syringe manufacturer: Reckitt Benckiser Fealtincare |UK] Ltd/HUSVDS.

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

Neutral Code: HP/174/06

This leaflet was revised: January 2016.

The/eaflei gives youlhe rffosTimportant^-information. If you have any questions after you ( have read it, ask your doctor or pharmacist who( will be able to help.

RB211177