NUROFEN FOR CHILDREN 200MG/5ML STRAWBERRY ORAL SUSPENSION

Active substance: IBUPROFEN

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PACKAGE LEAFLET INFORMATION FOR THE USER

Nurofen for Children 200mg/5ml Strawberry Oral Suspension
PL 00063/0607
For children 6 to 12 years
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take it carefully to
get the best results from it.
- Keep this leaflet. You may need to read it again
- Ask your pharmacist if you need more information or advice
- You must consult your doctor if your symptoms worsen or do not improve after 3
days.
- If any of the side effects get serious or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Nurofen for Children is and what it is used for
2. Before you use Nurofen for Children
3. How to use Nurofen for Children
4. Possible side effects
5. How to store Nurofen for Children
6. Further information
1. What Nurofen for Children is and what it is used for
Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs). These medicines work by changing how the body responds to pain, swelling and
high body temperature. This product has been specifically formulated for children as it is
given by mouth to:


reduce fever



relieve symptoms of mild to moderate pain

2

Before you give/take Nurofen for Children

Do not give Nurofen for Children to children who:










are under 6 years of age
are allergic (hypersensitive) to ibuprofen or other similar painkillers (NSAIDs) or to
any of the other ingredients of the product (see section 6 for further information)
have ever suffered from shortness of breath, asthma, a runny nose or hives after
using aspirin (acetylsalicylic acid) or other similar painkillers (NSAIDs)
have ever had a gastrointestinal bleeding or perforation, related to previous use of
NSAIDs
currently have or have had recurrent stomach/duodenal ulcers (peptic ulcers) or
bleeding (two or more episodes of proven ulceration and bleeding)
have severe liver, kidney or heart failure
have inherited problems coping with with fructose/fruit sugar (see important
information about the ingredients)
have bleeding of the brain (cerebrovascular bleeding) or other active bleeding
suffer from blood clotting disorders as ibuprofen may increase bleeding time




suffer from unclarified blood-formation disturbances such as thrombocytopenia
are taking another NSAID medicine (including COX-2 inhibitors such as celecoxib or
etoricoxib)

If an adult is taking this product do not use Nurofen for Children during the last 3 months
of pregnancy
Take special care with Nurofen for Children if they:
• are taking any other NSAID painkillers or aspirin with a daily dose above 75mg
• have certain diseases of the skin (systemic lupus erythematosus (SLE) or mixed
connective tissue disease)
• have or have ever had bowel disease (ulcerative colitis or Crohn’s disease)
• have disorders of the rectum or anus
• have ever had a high blood pressure and/or heart failure
• have reduced renal function
• have liver disorders
• have gastrointestinal bleeding, ulcer or perforation, related to use of this medicine.
These diseases are not necessarily preceded by warning signals and are not
reserved to patients with a history of such diseases and can be fatal. When
gastrointestinal bleeding or ulceration occurs, the treatment should be stopped
immediately.
• caution should be advised if you take 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).
• undesirable effects may be minimised by using the minimum effective dose for the
shortest duration.
• in general, the habitual use of (several sorts of) analgesics can lead to lasting severe
kidney problems.
• shortness of breath may occur if you have or have had asthma, a chronic runny nose,
nasal polyps or allergic diseases.
• serious skin reactions (such as Steven-Johnson syndrome) have been reported very
rarely in association with the used of NSAIDs. The use of Nurofen for Children should
be stopped immediately at the first appearance of skin rash, mucosal lesions, or any
other signs of allergic reactions.
• medicines such as Nurofen for Children 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 [3 days].
• 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.
• during chicken pox (varicella) it is advisable to avoid use of Nurofen for Children
• have just undergone major surgery
Consult a doctor before using Nurofen for Children if any of the above mentioned conditions
concern your child.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
In particular, tell them if you are taking:




















corticosteroids (such as prednisolone) since this may increase the risk of
gastrointestinal ulceration or bleeding
another NSAID medicine (including COX-2 inhibitors such as celecoxib or etoricoxib)
some medicines that are anti-coagulants (against clotting) (e.g. acetylsalicylic
acid/aspirin, warfarin, ticlopidin), some medicines against high blood pressure (ACEinhibitors,e.g. captopril, betareceptor blocking medicines, angiotensin II antagonists),
and even some other medicines may affect or be affected by the treatment of
ibuprofen. Therefore always seek the advice of a doctor before you use ibuprofen
with other medicines.
anti-platelet agents (such as acetylsalicylic acid) and selective serotonin-reuptake
inhibitors (a medicine for depression) since this may increase the risk of
gastrointestinal side effects
medicines for high blood pressure and water tablets since NSAIDs may diminish the
effects of these medicines and there could be a possible increased risk for the kidney.
In this case make sure you drink enough water during the day.
lithium (a medicine for depression), since the effect of lithium may be enhanced
methotrexate (a medicine for cancer or rheumatism) since the effect of methotrexate
may be enhanced
tacrolimus (a medicine to suppress the immune reaction) since the risk of kidney
toxicity is increased
cyclosporin (a medicine to suppress the immune reaction) since there is limited
evidence on an increased risk for kidney toxicity
zidovudine.(a medicine for treating Aids) since the use of Nurofen for Children may
result in an increased risk of bleeding into a joint or a bleeding that leads to swelling
sulphonylureas: Clinical investigations have shown interactions between NSAIDs and
antidiabetics (sulphonylureas). Although interactions between ibuprofen and
sulphonylureas have not been described to date, a check of blood-glucose values is
recommended as a precaution on concomitant intake.
probenecid and sulfinpyrazone: Medicinal products that contain probenecid or
sulfinpyrazone may delay the excretion of ibuprofen
baclofen: Baclofen toxicity may develop after starting ibuprofen.
ritonavir: Ritonavir may increase the plasma concentrations of NSAIDs.
digoxin, phenytoin: Digoxin or phenytoin may increase plasma concentrations of
NSAIDs.
quinolone antibiotics, since taking these and NSAIDs can increase the risk of having
convlusions

Pregnancy and breast-feeding
If an adult is taking this medicine:
Pregnancy
Tell your doctor if you become pregnant during intake of Nurofen for Children. 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. As no
harmful effects to infants are known to date, it is not usually necessary to interrupt breastfeeding during short-term use of ibuprofen at the recommended doses.
Female fertility
Nurofen for Children belongs to a group of medicines (NSAIDs) which may impair the fertility
in women. This effect is reversible on stopping the medicine.

Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
For short-term use this medicine has no or negligible influence on the ability to drive and use
machines.
Important information about some of the ingredients of Nurofen for Children


3.

Nurofen for Children contains maltitol. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this medicinal
product.
HOW TO USE NUROFEN FOR CHILDREN

Always take Nurofen for Children exactly as indicated. You should check with your
doctor or pharmacist if you are unsure.
The usual dose for pain and fever:
Child’s Age (Weight)

How much?

How often in 24h?*

6 – 9 years (20-30kg)

5ml

3 times

10 – 12 years (30-40kg)

7.5ml (use spoon twice: 5ml +
2.5ml)

3 times

*Doses should be given approximately every 6 to 8 hours.
Shake well before use
WARNING: do not exceed the stated dose.
Method of administration using the spoon
1. Shake the bottle well
2. Use the end of the spoon that corresponds to the required dose
3. Pour the medicine onto the spoon
4. Place the spoon in the child’s mouth and administer the dose
5. After use replace the cap. Wash the spoon in warm water and allow to dry.
Store out of the reach and sight of children
Duration of treatment
This medicine is for short-term use only. Do not give to children over 6 years for
longer than 3 days. If symptoms persist or worsen contacts your doctor.
If you or your child forget to take Nurofen for children:
Do not take a double dose to make up for the forgotten dose. If you do forget to take a dose,
take it as soon as you remember and then take the next dose according to the dose interval
detailed above.

If you or your child take more Nurofen for Children than you should
If you accidentally give or take more than the recommended dose of Nurofen for
Children, contact your doctor straight away.
If you have any further questions on the use of this product ask your doctor.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Nurofen for Children 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.
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 than 1 user in 10,000
not known: frequency cannot be estimated from the available data
STOP TAKING 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 you have any of the following side effects, they become worse or
you notice any effects not listed.
Common (affects 1 to 10 users in 100)
• heart burn, abdominal pain, feeling sick, being sick, flatulence (wind), diarrhoea,
constipation.
Uncommon (affects 1 to 10 users in 1,000)
• inflammation of the stomach, worsening of colitis and Crohn's disease
• headache, dizziness, sleeplessness, agitation, irritability or tiredness
• visual disturbances
• stomach ulcers which may burst or bleed
• mouth ulcers and/or swelling and irritation of the mouth
• hypersensitivity reactions with skin rashes and itching, and asthma attacks
Rare (affects 1 to 10 users in 10,000)
• tinnitus (ringing in the ears)
Very rare (affects less than 1 user in 10,000














inflammation of the oesophagus or pancreas, blockages in the gut
Severe forms of skin reactions including rash with redness and blistering which may peel
accompanied by fever, chills, aching muscles and feeling unwell, Stevens-Johnson
syndrome. In exceptional cases, serious infections of the skin have occurred during
chicken pox (varicella).
.
passing less urine than normal and swelling (acute kidney failure or inflammation may be
possible). Damage to the kidney or increased urea concentrations in the blood (first signs
are passing less urine than normal, cloudy urine, blood in the urine, back pain, swelling,
possibly of the legs and generally feeling miserable)
problems in blood cell production (first signs are fever, sore throat, mouth ulcers, flu-like
symptoms, severe exhaustion, nose and skin bleeding, unexplained or unusual bruising)
psychotic reactions and depression
worsening of inflammation due to infection. If signs of an infection occur or get worse
during use of Nurofen for Children, speak to your doctor.
swelling, high blood pressure, palpitations, heart failure, heart attack.
liver problems or inflammation of the liver. Liver failure or damage, particularly in longterm term use, shown by yellowing of the skin and eyes or pale stools and dark urine
very rarely, the symptoms of aseptic meningitis with neck stiffness, headache, feeling
sick, being sick, fever or consciousness clouding have been observed when using
ibuprofen. Patients with autoimmune disorders (SLE, mixed connective-tissue disease)
may be more likely to be affected. Contact a doctor at once, if these occur.

The elderly have an increased frequency of undesirable reactions to NSAIDs especially
gastrointestinal bleeding.
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 NUROFEN FOR CHILDREN
Keep out of reach and sight of children.
Do not use Nurofen for Children after the expiry date which is stated on the carton and label.
The expiry date refers to the last day of that month. Do not store above 25 °C.
Shelf life after opening the bottle: 6 months
Medicines should not be disposed of via waste water or household waste. Ask your
pharmacist how to dispose of medicines that are no longer required. These measures
will help to protect the environment.

6

FURTHER INFORMATION

What Nurofen for Children contains:
Each 1ml oral suspension contains 40mg ibuprofen

Each 5ml spoonful of oral suspension contains 200mg ibuprofen .
Each 2.5ml spoonful of oral suspension contains 100mg ibuprofen.
The ibuprofen content is equivalent to 4.0%w/v
The other ingredients are; citric acid monohydrate, sodium citrate, sodium chloride, sodium
saccharin, polysorbate 80, domiphen bromide, maltitol liquid, glycerol, xanthan gum,
strawberry flavour (containing propylene glycol) and purified water.
What Nurofen for Children looks like and contents of the pack
Nurofen for Children is an off-white, strawberry flavoured oral suspension. Each bottle
contains either 30ml, 50ml, 100ml, 150ml, or 200ml.
The pack contains a double-ended measuring spoon (with a 2.5 ml bowl with 1.25ml inner
mark at one end and a 5 ml bowl at the other end) to measure the dose correctly. Not all
pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
To be completed nationally
Manufacturer:
To be completed nationally
Last updated October 2014

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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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