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IBUPROFEN FOR CHILDREN 7 YEARS AND OLDER 100 MG CHEWABLE CAPSULES SOFT

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Reckitt Benckiser

0007 A UK-H-5320-001-IA-002-G

PACKAGE LEAFLET: INFORMATION FOR THE USER
Ibuprofen for Children 7 years and older 100 mg, chewable capsules, soft
For use in children from 7 to 12 years
Ibuprofen

Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have
told you.
Keep this leaflet. You may need to read it
again.
Ask your pharmacist if you need more information or
advice.
If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet.
You must talk to a doctor if your child does not feel better or if your child feels worse after 3
days.

What is in this leaflet:
1. What Ibuprofen is and what it is used for
2. What you need to know before you give Ibuprofen
3. How to give Ibuprofen
4. Possible side effects
5. How to store Ibuprofen
6. Contents on the pack and other information

1.

What Ibuprofen is and what it is used for

The active ingredient (which makes this medicine work) is ibuprofen which is a non-steroidalanti- inflammatory (NSAID) painkiller.
Ibuprofen is used in children from 7 to 12 years for the relief of mild to moderate pain such as a
sore throat, dental pain, ear ache, headache, minor aches and sprains, and symptoms of cold and flu.
Ibuprofen also brings down a high temperature (fever).
You must talk to a doctor if your child does not feel better or if your child feels worse after 3
days.
2.

What you need to know before you give Ibuprofen

Please read the following information.
Do not give this medicine to your child if:
 they are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section
6).
 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 , or any of the other ingredients in this medicine (see Section 6 and
Section 2: Important information about some of the ingredients)
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they are under 7 years of age
they have (or have had two or more episodes) of a stomach ulcer, perforation or bleeding
they have severe kidney, heart or liver failure

Warnings and precautions
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 or bowel problems
 your child has SLE (Systemic Lupus Erythematosus, a condition of the immune system
affecting connective tissue resulting in joint pain, skin changes and disorders of other
organs) or a mixed
connective tissue disease
 your child has hereditary blood formation disorder (acute intermittent porphyria)
 your child suffers from serious skin reactions such as exfoliative dermatitis, Stevens-Johnson
syndrome and toxic epidermal necrolysis. The use of Ibuprofen should be stopped
immediately at the first appearance of skin rash, mucosal lesions, or any other signs of
allergic reaction
 your child suffers from chronic inflammatory bowel disease such as Crohn's disease or
ulcerative colitis
 you or your child has just had major surgery
 during chicken pox (varicella) it is advisable to avoid use of Ibuprofen
If you are an adult taking this medicine
The warnings and information given in this section apply and in addition the following:
 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 as Ibuprofen if you are in the last 3 months of your pregnancy
 medicines such as Ibuprofen 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
 if you have a blood coagulation disorder or if you have another bleeding disorder 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.
Elderly patients
If you are elderly talk to your doctor before using this medicine, as you may be more likely to suffer
from side effects.
Other medicines and Ibuprofen
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any
other
medicines, including medicines obtained without a prescription. Especially if it regards one of the
following medicines:
o other medicines containing ibuprofen or other NSAIDs
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low dose aspirin (up to 75 mg a day)
diuretics (to help you pass water)
anticoagulants (blood thinning medicines e.g. warfarin)
medicines for high blood pressure (e.g. captopril, atenolol, losartan)
lithium (for mood disorders)
phenytoin (antiepileptic)
methotrexate (for psoriasis, arthritis and types of cancer)
zidovudine (for HIV)
corticosteroids (anti-inflammatory medicines, such as prednisone)
cardiac glycosides (for heart problems)
ciclosporin or tacrolimus (to prevent organ rejection after transplant)
mifepristone (for termination of pregnancy)
quinolone antibiotics (for infections)
probenecid and sulfinpyrazone (used to treat gout)
SSRI antidepressant medicines
antiplatelet medicines (blood thinning medicines) e.g. dipyridamole, clopidogrel.
sulfonylurea medicines (to lower the blood glucose level).

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.
Ibuprofen with food, drink and alcohol
Ibuprofen may be taken on an empty stomach without water. However, a small number of people
might experience mild indigestion with this medicinal product. If your child experiences mild
indigestion, it is recommended to take this medicine with food or milk, to avoid gastrointestinal
problems.
Ibuprofen contains glucose and sucrose. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this medicinal
product

3.

How to give Ibuprofen

Always take this medicine exactly as described in this leaflet. Check with your doctor or
pharmacist if you are not sure.
Ibuprofen is for oral use.
The capsules should be chewed and then swallowed. Capsules can be taken with or without liquid.
This medicine is for short term use only.
The minimum effective dose should be used for the shortest time necessary to relieve symptoms.
Do not give Ibuprofen to children under 7 years of age
The recommended dose is:
Age
Younger than 7 years
7 years – 9 years
10 years – 12 years

Dose
Do not give to children under 7 years of age
Two capsules 3 times in 24 hours
Three capsules 3 times in 24 hours

Doses should be given approximately every 6 to 8 hours, (or with a minimum of 6 hours between each dose if
required)
Consult your doctor if symptoms persist or worsen after 3 days.

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If you give more Ibuprofen than you should
If you accidentally give more than the recommended dose of medicine, contact your doctor straight
away.
If you forget to give Ibuprofen
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 to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If your child experiences any of the following, stop taking 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, light-headedness, racing heart, fluid retention
(swollen ankles or decreased levels of passing urine)
 stiff neck, headache, nausea, vomiting, fever and disorientation
 swelling of the face.
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 and/or skin, pale stools and dark urine
 severe sore throat with high fever
 unexplained bruising or tiredness or getting more infections, such as colds, than normal.
The following frequencies are taken as a basis when evaluating side effects:
very common
common
uncommon
rare
very rare

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than1 user in 10,000

Other side effects which may occur are: Uncommon (affects 1 to 10 users in 1,000)
 headache
Rare (affects 1 to 10 users in 10,000)
 diarrhoea, wind, vomiting or constipation. Tell your doctor if these last for more than a few
days or become troublesome.
Very rare (affects less than 1 user in 10,000)
 kidney and liver problems
 stroke or heart problems. This is unlikely at the dose level given to children
 worsening of inflammation of the large intestine (colitis) and chronic inflammatory bowel
disease (Crohn's disease)
 high blood pressure.
Reporting of side effects
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If you get any side effects, talk to your doctor, pharmacist or nurse. 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.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more
information on the safety of this medicine.
5.

How to store Ibuprofen

Do not store above
30°C.
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers
to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6.

Contents on the pack and other information

What Ibuprofen contains
The active substance is ibuprofen. Each chewable capsule contains 100 mg of
ibuprofen
- The other ingredients are: Gelatin, Purified water, Glucose liquid, Sucrose, Fumaric acid
(E297), Sucralose, Citric acid (E330), Acesulfame K (E950), Disodium edetate, Glycerin,
Natural Orange Flavour*, Red iron oxide (E172), Yellow iron oxide (E172) and Opacode White
NS-78-18011**
*The flavour contains: (R)-p-mentha-1,8-diene (d-limonene), Ethyl acetate and Alpha-Pinene
**The ink contains: Purified water, titanium dioxide (E171), propylene glycol, isopropyl
alcohol, HPMC 2910/hypromellose 3cP (E464)
-

What Ibuprofen looks like and contents of the pack
Ibuprofen is an orange, square shaped chewable soft gelatin capsule with “N100” in white ink.
Ibuprofen is available in PVC/PE/PVdC/Al blisters.
Packs of 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Reckitt Benckiser Healthcare (UK) Ltd
103 – 105 Bath Road, Slough, SL1 3UH, UK
Manufacturer
Reckitt Benckiser Healthcare International Ltd
Thane Road, Nottingham, NG90 2DB, UK
This leaflet was last revised: January 2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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