Nurofen For Children Orange Flavoured Soft Chews 7 Years And Older 100 Mg Chewable Capsule Soft
PACKAGE LEAFLET: INFORMATION FOR THE USER
Nurofen for Children Orange Flavoured soft chews, 7 years and older, 100 mg, chewable capsule,
soft
For use in children from 20 kg body weight (7 years of age) to 40 kg body weight (12 years of age).
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. See section 4.
- 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 this medicine is and what it is used for
2. What you need to know before you give this medicine
3. How to give this medicine
4. Possible side effects
5. How to store this medicine
6. Contents on the pack and other information
1. What this medicine is and what it is used for
The active ingredient (which makes this medicine work) is ibuprofen which is a non-steroidal-antiinflammatory (NSAID) painkiller.
Nurofen for Children Orange Flavoured soft chews, 7 years and older, 100 mg, chewable capsule, soft, is used in children 7 to 12 years of age, weighing 20 - 40 kg for the relief of mild to moderate pain. This medicine 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 this medicine 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 hypersensitivity reaction (e.g. asthma, runny nose, rash, swelling of the face, tongue, lips or throat) after taking acetylsalicyclic acid or other non steroidal anti-inflammatory drugs (NSAIDs)
• they are allergic to peanuts or soya as this medicinal product contains soya lecithin.
• they have (or have had) recurrent stomach or /duodenal ulcers (peptic ulcers), or bleeding (two or more episodes of proven ulceration and bleeding)
• they have ever had a gastrointestinal bleeding or perforation, related to previous use of NSAIDs
• they have severe kidney, heart or liver failure
• they have bleeding of the brain (cerebrovascular bleeding) or other active bleeding
• they have unclarified blood-formation disturbances
• they have severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake) Do not take if you are in the last 3 months of pregnancy
Warnings and precautions
Talk to your doctor or pharmacist before using this medicine if:
• your child has asthma or any allergic diseases as shortness of breath may occur
• your child suffers from hayfever, nasal polyps or chronic obstructive respiratory disorders an increased risk of allergic reactions exists. The allergic reactions may present as asthma attacks (so-called analgesic asthma), Quincke’s oedema or urticaria
• your child has, or has had bowel problems
• your child has reduced renal function
• your child has liver disorders. In prolonged administration of this medicine regular checking of the liver values, the kidney function, as well as of the blood count, is required.
• caution should be advised if your child is taking other medicines which could increase the risk of ulceration or bleeding, such as oral corticosteroids (such as prednisolone), medicines for thinning the blood (such as warfarin), selective serotonin-reuptake inhibitors (a medicine for depression) or anti-platelet agents (such as acetylsalicylic acid).
• your child is taking another NSAID medicine (including COX-2 inhibitors such as celecoxib or etoricoxib) as taking these together should be avoided (see section “Other medicines and Nurofen for Children”).
• 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 certain hereditary blood formation disorder (e.g. acute intermittent porphyria)
• your child suffers from coagulation disturbances
• your child suffers from serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The use of this medicine 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
• your child is dehydrated, as there is a risk of renal impairment in dehydrated children
• your child has j ust had maj or surgery
• your child has chicken pox (varicella), as it is advisable to avoid use of this medicine during period of infection.
Undesirable effects may be minimized by using the minimum effective dose for the shortest duration necessary to control symptoms.
Gastro-intestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious gastro-intestinal events. When gastrointestinal bleeding or ulceration occurs, the treatment should be stopped immediately. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 2 Do not use this medicine) and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for those patients, and also those requiring concomitant low-dose acetylsalicylic acid, or other drugs likely to increase gastrointestinal risk.
In general, the habitual use of (several sorts of) analgesics can lead to lasting severe kidney problems with the risk of renal failure (analgesic nephropathy).
NSAIDs may mask symptoms of infection and fever.
Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking this medicine if you:
- have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”).
- have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
Elderly
The elderly have an increased risk of adverse events when taking NSAIDs, particularly those relating to the stomach and bowel. See section 4 ‘possible side effects’ for more information.
Patients with a history of gastro-intestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.
Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.
Other medicines and Nurofen for Children
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
This medicine may affect or be affected by some other medicines. For example:
- medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
- medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
Some other medicines may also affect or be affected by the treatment of this medicine. You should therefore always seek the advice of your doctor or pharmacist before you use this medicine with other medicines.
Especially if it regards one of the following medicines:
|
Other NSAIDs including COX-2 inhibitors |
Since this may increase the risk of side effects |
|
Digoxin (for heart insufficiency) |
Since the effect of digoxin may be enhanced |
|
Glucocorticoids (medicinal products containing cortisone or cortisone-like substances) |
Since this may increase the risk of gastrointestinal ulcers or bleeding |
|
Anti-platelet agents |
Since this may increase the risk of bleeding |
|
Acetylsalicylic acid (low dose) |
Since the blood-thinning effect may be impaired |
|
Medicines for thinning the blood (such as |
Since ibuprofen may enhance the effects of |
|
warfarin) |
these medicines |
|
Phenytoin (for epilepsy) |
Since the effect of phenytoin may be enhanced |
|
Selective serotonin reuptake inhibitors (medicines used for depression) |
As these may increase the risk of gastrointestinal bleeding |
|
Lithium (a medicine for manic depressive illness and depression) |
Since the effect of lithium may be enhanced |
|
Probenecid and sulfinpyrazones (medicines for gout) |
Since the excretion of ibuprofen may be delayed |
|
Medicines for high blood pressure and water tablets |
Since ibuprofens may diminish the effects of these medicines and there could be a possible increased risk for the kidney |
|
Potassium sparing diuretics e.g. amiloride, potassium canreoate, spironolactone, triamterene. |
Since this may lead to hyperkalaemia |
|
Methotrexate (a medicine for cancer or rheumatism) |
Since the effect of methotrexate may be enhanced |
|
Mifepristone (for pregnancy termination) |
Since the effect of mifepristone may be reduced |
|
Tacrolimus and cyclosporine (immunosuppressive medicines) |
Since kidney damage may occur |
|
Zidovudine: (a medicine for treating HIV/Aids) |
Since the use of this medicine may result in an increased risk of bleeding into a joint or a bleeding that leads to swelling in HIV (+) haemophiliacs |
|
Sulfonylureas (antidiabetic medicines) |
Since the blood sugar levels can be affected |
|
Quinolone antibiotics |
Since the risk for convulsions (fits) may be increased |
|
Voriconazole and fluconazole (CYP2C9 inhibitors) used for fungal infections |
Since the effect of ibuprofen may increase. Reduction of the ibuprofen dose should be considered, particularly when high-dose ibuprofen is administered with either voriconazole or fluconazole. |
|
Aminoglycosides |
NSAIDs may decrease the excretion of aminoglycosides |
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.
This medicine with alcohol
You should not drink alcohol while using this medicine. Some side effects, such as those affecting the gastrointestinal tract or the central nervous system can be more likely when alcohol is taken at the same time as this medicine.
Nurofen for Children with: Pregnancy, breast-feed and fertility; Driving and using machines
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use this medicine if you are in the last 3 months of pregnancy. Avoid the use of this medicine in the first 6 months of pregnancy unless your doctor advises you otherwise.
Breast-feeding
Only small amounts of ibuprofen and its decomposition products pass into breast milk. This medicine may be used during breast-feeding, if it is used at the recommended dose and for the shortest possible time.
Fertility
This medicine belongs to a group of medicines (NSAIDs) which may impair the fertility in women. This effect is reversible on stopping the medicine.
Driving and using machines
For short-term use this medicine has no or negligible influence on the ability to drive and use machines.
This medicine contains soya lecithin. If you are allergic to peanuts or soya do not use this medicinal product.
This medicine contains glucose and sucrose. If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before giving this medicinal product
3. How to give this medicine
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. 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. No water needed.
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 this medicine to children under 7 years of age, or to children weighing less than 20 kg
The recommended dose is as follows:
In children ibuprofen is dosed depending on body weight, as a rule with 5 to 10 mg/kg body weight as a single dose to a maximum of 20- 30 mg/kg body weight as the total daily dose.
|
Child Body Weight (kg) |
Age (Years) |
Single dose |
Maximum daily dose |
|
20-29 |
7-9 |
200 mg ibuprofen (corresponding to 2 capsules) |
600 mg ibuprofen (corresponding to 6 capsules) |
|
30-40 |
10-12 |
300 mg ibuprofen (corresponding to 3 capsules) |
900 mg ibuprofen (corresponding to 9 capsules) |
|
Doses should be given approximately every 6 to 8 hours (or with a minimum of 6 hours between each dose) if required WARNING: Do not exceed the stated dose. If this medicine is required for more than 3 days, or if symptoms worsen, a doctor should be consulted. | |||
If you give more medicine than you should
If you accidentally give more than the recommended dose of medicine, contact your doctor straight away. The following signs may occur: nausea, vomiting, stomach pain or more rarely diarrhoea. In addition, ringing in the ears, headache, gastrointestinal bleeding, drowsiness, excitation, disorientation, coma, convulsions, metabolic acidosis, increased prothrombin time/INR, acute renal failure, liver damage and exacerbation of asthma in asthmatics.
If you forget to give this medicine
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 everyone gets them.
Side effects may be minimised by taking the lowest dose for the shortest time necessary to relieve the symptoms. Although side effects are uncommon, your child may get one of the known side effects of NSAIDs. If they do, or if you have concerns, stop giving this medicine to your child and talk to your doctor as soon as possible. Elderly people using this product are at increased risk of developing problems associated with side effects.
STOP USING this medicine and seek immediate medical help if your child develops:
• signs of intestinal bleeding such as: severe pain in the abdomen, black tarry stools, vomiting blood or dark particles that look like coffee grounds.
• signs of rare but serious allergic reaction such as worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, racing heart, drop in blood pressure leading to shock. These can happen even on first use of this medicine. If any of these symptoms occur, call a doctor at once.
• severe skin reactions such as rashes covering the whole body, peeling, blistering or flaking skin.
Tell your doctor if your child has any of the following side effects, they become worse or you notice any effects not listed.
Common (may affect up to 1 to 10 people)
• Stomach and intestinal complaints such as as acid bum, stomach pain and nausea, indigestion, diarrhoea, vomiting, flatulence (wind) and constipation and slight blood losses in stomach and/or bowel that may cause anaemia in exceptional cases..
Uncommon (may affect up to 1 to 100 people)
• gastrointestinal ulcers, perforation or bleeding, inflammation of the mucous membrane of the mouth with ulceration, worsening of existing bowel disease (colitis or Crohn’s disease), gastritis
• headache, dizziness, sleeplessness, agitation, irritability or tiredness
• visual disturbances
• various skin rashes
• hypersensitivity reactions with hives and itch
Rare (may affect up to 1 to 1000 people)
• tinnitus (ringing in the ears)
• increased urea concentrations in blood, pain in the flanks and/or the abdomen, blood in the urine and a fever may be signs of damage to kidneys (papillary necrosis)
• increased uric acid concentrations in the blood
• decreased haemoglobin levels
Very rare (may affect up to 1 in 10,000 people)
• oesophagitis, pancreatitis, and formation of intestinal diaphragm-like strictures
• heart failure, heart attack and swelling in the face or hands (oedema)
• passing less urine than normal and swelling (especially in patients with high blood pressure or reduced kidney function), swelling (oedema) and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis) that may lead to acute kidney failure. If one of the above mentioned symptoms occur or if you have a general miserable feeling, stop taking this medicine and consult your doctor immediately as these could be first signs of a kidney damage or kidney failure.
• Psychotic reactions, depression
• high blood pressure, vasculitis
• palpitations
• liver dysfunction, damage to the liver (first signs could be discoloration of the skin), especially during long-term treatment, liver failure, acute inflammation of the liver (hepatitis)
• problems in the blood cell production - first signs are: fever, sore throat, superficial mouth ulcers, flulike symptoms, severe exhaustion, nose and skin bleeding and unexplained bruising. In these cases you must stop the therapy immediately and consult a doctor. Any self-treatment with pain killers or medicinal products that reduce fever (antipyretic medicinal products) mustn’t be done.
• severe skin infections and soft tissue complications during chicken pox (varicella) infection
• worsening of infection-related inflammations (e.g. necrotizing fasciitis) associated with the use of certain painkillers (NSAIDs) has been described. If signs of an infection occur or get worse, you must go to the doctor without delay. It is to be investigated whether there is an indication for an anti-infective/antibiotic therapy
• symptoms of aseptic meningitis with stiff neck, headache, nausea, vomiting, fever or clouding of consciousness have been observed when using ibuprofen. Patients with auto-immune disorders (SLE, mixed connective tissue disease) may be more likely to be affected. Contact a doctor at once, if these occur.
• severe forms of skin reactions such as skin rash with redness and blistering (e.g. Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis/Lyell’s syndrome), hair loss (alopecia)
Not known: (frequency cannot be estimated from the available data)
• Respiratory tract reactivity comprising asthma, bronchospasm or dyspnoea.
Medicines such as this may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
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 this medicine
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 What this medicine 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, Glycerol, Orange Flavour Red iron oxide (E172), Yellow iron oxide (E172) Titanium dioxide (E171), Propylene glycol and HPMC 2910/hypromellose 3cP.
Processing aids: Medium chain triglyerides, Soya lecithin and Stearic Acid.
What this medicine looks like and contents of the pack
This medicine is an orange, square shaped chewable soft gelatin capsule with "N100" in white ink.
This medicine 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, Berkshire, SL1 3UH, UK
Manufacturer
Reckitt Benckiser Healthcare International Ltd
Thane Road
Nottingham
NG90 2DB
UK