Nurofen For Children 100 Mg Chewable Capsules Soft
Reads This Way
Contains Ibuprofen
Read all of this leaflet carefully before you start using this ;medlclne because It contains Important Information for you.
Always use this medicine exactly as described in this leaflet or ps 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.
r You must talk to a doctor if your child does not feel better or If your child feels worse after 3 days.
jWhat is in this leaflet:
1. What Nurofen for Children 1 OOmg chewable capsules are and what they are used for
12. What you need to know before you give Nurofen for Children lOOmg chewable capsules ;3. Howto give Nurofen for Children lOOmg chewable capsules 4. Possible side effects
15. How to store Nurofen for Children 1 OOmg chewable capsules |6. Contents of the pack and other information
1. What Nurofen for Children lOOmg chewable capsules are and what they are used for
;The active ingredient (which makes this medicine work) is ibuprofen which is a non-steroidal-anti- inflammatory l(NSAID) painkiller.
iNurofen for Children 1 OOmg chewable capsules are used in Children from 7 to 12 years for the relief of mild to moderate ipain 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 lor if your child feels worse after 3 days.
2. What you need to know before you give Nurofen for Children lOOmg chewable capsules
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).
• 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)
they are allergic to peanuts or soya as this medicinal product contains soya lecithin, are under 7 years of age
have (or have had Iwo or more episodes) of a stomach ulcer, perforation or bleeding » 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.
• has a condition which may put them at risk of heart problems, such as diabetes or high cholesterol
• has asthma or any allergic disease of the lungs
• has, or has had liver, kidney or bowel problems
is dehydrated, as there is a risk of kidney problems in dehydrated children and adolescents 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
• has hereditary blood formation disorder (acute intermittent porphyria)
• suffers from serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The use of Nurofen for Children lOOmg chewable capsules should be stopped immediately at the first appearance of skin rash, mucosal lesions, or any other signs of allergic reaction
• suffers from chronic Inflammatory bowel disease such as Crohn's disease or ulcerative colitis
• has just had major surgery
• During chicken pox (varicella) it is advisable to avoid use of Nurofen for Children 1 OOmg chewable capsules.
If you ore on ADULT taking this medicine
The warnings and information given in this section apply and also 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 Nurofen for Children 1 OOmg chewable capsules if you are in the last 3 months of your pregnancy
• Medicines such Nurofen for Children lOOmg chewable capsules 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 clotting 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 Nurofen for Children lOOmg chewable capsules
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: o other medicines containing ibuprofen or other NSAIDs 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 phenytoin (antiepileptic)
o methotrexate (for psoriasis, arthritis and types of cancer) o zidovudine (for HIV)
o corticosteroids (anti-inflammatory medicines, such as prednisone)
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 probenecid and sulfinpyrazone (used to treat gout) o SSRI antidepressant medicines o antiplatelet medicines (blood thinning medicines) e.g. dipyridamole, clopldogrel.
o sulfonylurea medicines (to lower the blood glucose level).
Seeklhe advice of your doctor or pharmaclsllf any ofthe pbove apply. If you are not sure what types of medicines your child is taking, show the medicine to the doctor or Ipharmaclst.
Nurofen for Children lOOmg chewable capsules with food bnd drink
ilbuprofen may be taken on an empty stomach without water. However, a small number of people might experience mild lindigestion 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.
INurofen for Children lOOmg chewable capsules contain soya lecithin. If you are allergic to peanuts or soya do not use Ithis medicinal product.
Nurofen for Children lOOmg chewable capsules contain glucose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your floctor before taking this medicinal product_
3. How to give Nurofen for Children lOOmg chewable capsules
Always take this medicine exactly as described in this leaflet. Check with your doctor or pharmacist if you are not sure.
This medicine is for oral use.
The capsules should be chewed and then swallowed, papsules 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.
iDo not give Nurofen for Children lOOmg chewable capsules ;to children under 7 years of age.
fhe recommended dose is:_
Age_Dose_
7 years - 9 years Two capsules 3 times in 24 hours_
10 years -12 years Three capsules 3 times in 24 hours
Doses should be given approximately every 6 to 8 hours,
(or wilh a minimum of 6 hours between each dose if required)
If in children this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
If you give more Nurofen for Children lOOmg chewable papsules than you should
If you accidentally give more than the recommended dose of Imedicine, contact your doctor straight away.
Ilf you forget to give Nurofen for Children lOOmg chewable Aapsules
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 to make up for a forgotten dose.
Ilf you have any further questions on the use of this medicine, psk your doctor or pharmacist.
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
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.
You can report side effects directly in Ireland via;
HPRA Pharmacovigilance, Earlsfort Terrace, IRL-Dublin 2.
Tel: +353 1 6764971, Fax: 353 1 6762517.
Website: www.hpra.ie, e-mail: medsafety@hpra.ie.
By reporting side effects you can help provide more information on the safety of this medicine._
5. How to store Nurofen for Children lOOmg chewable capsules
Do not store above 25°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
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 giving Ithis 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 1 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.
;lf 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,
1 _su_ch_a_s_coJds_, than normal._ _
What Nurofen for Children lOOmg chewable capsules contain
- 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 (El72), Yellow iron oxide (El 72) and Opacode White NS-78-18011 ** Processing aids: Medium chain triglyerides, Soya lecithin, Stearic Acid and Isopropyl alcohol
*The flavour contains: (R)-p-mentha-1,8-diene (d-limonene), Ethyl acetate and Alpha-Pinene **The ink contains: Purified water, titanium dioxide (El 71), propylene glycol, isopropyl alcohol, HPMC 2910/ hypromellose 3cP (E464)
What Nurofen for Children lOOmg chewable capsules looks like and contents of the pack
Nurofen for Children 1 OOmg chewable capsules are orange, square shaped chewable soft gelatin capsules with 'N100' in white ink.
Nurofen for Children 1 OOmg chewable capsules are available in PVC/PE/PVdC/AI 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 Holders
Reckitt Benckiser Healthcare (UK) Ltd 103-105 Bath Road, Slough, SL1 3UH, UK
Reckitt Benckiser Ireland Ltd.
7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Manufacturer
Reckitt Benckiser Healthcare International Ltd, Thane Road, Nottingham, NG90 2DB, UK Licence Numbers:
PL 00063/0721 PA 979/69/1
This leaflet was last revised: October 2015
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