Ibuprofen For Children 7 Years And Older 100 Mg Chewable Capsules Soft
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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-steroidal-anti- 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)
• 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 maj or 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
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 rej ection 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, clopidogrel. o 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 |
Dose |
|
Younger than 7 years |
Do not give to children under 7 years of age |
|
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 with a minimum of 6 hours between each dose if required) Consult your doctor if symptoms persist or worsen after 3 days. | |
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 |
affects more than 1 user in 10 |
|
common |
affects 1 to 10 users in 100 |
|
uncommon |
affects 1 to 10 users in 1,000 |
|
rare |
affects 1 to 10 users in 10,000 |
|
very rare |
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
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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1.3.1 Package Leaflet - Clean
Ibuprofen 100mg Chewable Capsules UK-H-5320-001