Reckitt Benckiser

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Pharmacode Reads This Way

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Pharmacode Reads This Way

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 milcTlaxative effect. Calorific value 2.3 kcal/g maltitol.

3. How to use Nurofen for Children Singles

Before opening, massage the sachet to !mix_the contents well. Gently squeeze the_ iTTquid onto The two-endecTmeasuring kpoon (2.5ml and 5ml) provided in the Ipack. Measure the correct dose Accurately using the 2.5ml or 5ml spoon bnds.

Wash and dry spoon between doses. Wash the spoon in warm water and allow [to dry.

[Throw"away half"JsecTsdchetsT "

[Store out of the reach of children.

|How much medicine to use

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

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

• 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 more than 3 days. If

Sour chilcTexperiences any of the owing 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 KigTi fever • unexplained bruising or tiredness or getting more infections, such as colds, than normal.

Other side effects which may occur are: Uncommon:

• headache

-Rarer--------------

• 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 I bu profen

_•—stroke or heart problems-raay-occut -with Ibuprofen. This is unlikely at the dose level given to children • worsening of colitis and Crohn's disease

• high blood pressure.

Reporting of side effects

If you get any side effects, talk to your “doctor, pharmacisfor^-iurse7 This“includes“ any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www. m h ra. gov. u k/yel lowca rd By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nurofen for Children Singles

6. Further information

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“sympfoms~peTsisT after 3 days or worsen, consult your doctor.

If you are not sure

It you are not s of your child's illness or it is accompanied by a ; rash_/^_breaThing"difficulties_/^_diarrhoea^— ; or excessive tiredness, speak to your ; doctor straight away.

;lf anyone has taken too much medicine

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

If youHorgef to gTVelhe medicine^-

jlf you forget a dose, give the next dose wnen 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 _r________________

strawberry flavour,

xanthan gum,    I    PRINT

polysorbate 80,

domiphen bromide.    j    FREE

What the medicine ----------------

Jooks like _

Nurofen for Children

Singles is an off-white ;----------------

liquid available in    |    r-.r-.m-i-

packs of 8 or 16    I    PRINT

sachets each of 5ml.    I    p^pp

Each pack contains a

two-ended measuring ¹----------------

_spoo_n (CE_0J_20)._________

Product licence holder: Reckitt Benckiser Healthcare (UK) Ltd. Slough, SL1 4AQ

Manufacturer of medicine:

Reckitt Benckiser Healthcare UK Ltd, Hull, HU8 7DS

Spoon manufacturer: Massmould,

_liu j.xi_____________

4. Possible side effects

(Like all medicines, Nurofen for Children camcause side effectsy although not^-everybody gets them.

The most common side effect is irritation of Ithe stomach which can cause problems such as indigestion and heartburn.

Ilf your child experiences any of the following, stop giving this medicine and tell yourploctor 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),

[_ Jtching or bruising,jacing heart, Juid retention (swollen ankles or decreased^-levels of passinq urine) stiff neck, headache, nausea, vomiting, fever and disorientation.

Product licence numbers:

PL 00063/0669: Nurofen for Children Orange Singles

PL 00063/0670: Nurofen for Children Strawberry Singles

This leaflet was revised: April 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.

NUROFEN'

for Children    ^J * Singles

Nurofen for Children    Singles

lOOmg / 5ml Oral Suspension

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WARNING:

Do not take more

medicine than--

the label or leaflet tells you to

5

10

5

[Contains Ibuprofen

|This leaflet is valid for Nurofen for Children Orange Singles or for Nurofen fer"ChTldreff Strawberry Singles. 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.

[KeepThis leaflet: you might neecTit again.

^r 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) and relieves pain from headaches, sore throats,

" “minoTaches andspraTnd 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 dodordf your ctiild:^-

►    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

I--concerned rSee Section 3----

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

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.

I—See Seetion 2.---------

In this leaflet:

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

i f°^r

2.    Before giving JNurofenJor Children Singles to your child

;3. How to use Nurofen for Children Singles

4.    Possible side effects

5.    How to store Nurofen for Children Singles

5. Further Information^-

1. What Nurofen for Children Singles 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 muscular pain, [headache, dental pain, fever, or symptoms [of colds and flu.

Nurofen for Children Singles also brings down a high temperature (fever).

2. Before giving Nurofen for Children Singles 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 bad-a-reaction-je.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 areJaking any_olheL_____

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 Icidney, 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 ecause 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 lun

ngs

your child has, or nas had liver, kidney, heart or bowel pi " "

•    your child is dehydrated < risk of renal impairment

•    your child has SLE (Systemic Lupus Erythematosus, a condition of the

“immune system/oTariy sirhllaTdTsease

•    your chilcf 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

--canbuy 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 (fer -pseriasis7 ofthfitis-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_mirepristone_(far termination of___

pregnancy)

o quinolone antibiotics (tor infections) o SSRI antidepressant druqs o antiplatelet drugs e.g. dipyridamole, clopidogrel.

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

you afe-noTsure-whaHypes-oF---

medicines your child is talcing,, 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.

--ThisAs -reversible on stopptng-rthe--

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-dwring 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 _('[myocardlahnfgrction")_OL_strpke. 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

^—    hlglTcftolesteroToTale a sThokeT) 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-ustng^his medictner "

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