Nurofen for Children 100mg / 5ml Orange Oral Suspension

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
for children oldwe than 6 months or after 24 hours for babies aged 3 6 months.
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

Nurofen contains Ibuprofen which belongs to a group of medicines called Non-Steroidal AntiInflammatory 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 infants and children aged 3 months 12 years
to reduce common fever or post-immunisation fever and 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 allergic (hypersensitive) to ibuprofen or other similar painkillers (NSAIDs) or to

any of the other ingredients of the product

-

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

are dehydrated (as a result of vomiting, diarrhea or insufficient water intake
have bleeding of the brain (cerebrovascular bleeding) or other active bleeding
suffer from blood clotting disorders as ibuprofen may increase bleeding time

If an adult is taking this product do not use Nurofen for Children during the last 3 months
of pregnancy.
Do not give to infants under 3 months unless prescribed by a doctor.
Take special care with Nurofen for Children if they:
-

have certain diseases of the skin (systemic lupus erythematosus (SLE) or mixed
connective tissue disease)
if a member of your family suffers from porphyria
have or have ever had bowel disease (ulcerative colitis or Crohns disease)
suffer from blood clotting disorders
have ever suffered from shortness of breath, asthma, a runny nose or hives
suffer from unclarified blood-formation disturbances such as thrombocytopenia
have ever had a high blood pressure and/or heart failure, liver or kidney failure
have recently had a major surgery
in the first 6 months of pregnancy (very rare with children aged 12)
breastfeeding

Gastrointestinal bleeding, ulcer or perforation

If your child had stomach or duodenal ulcer, especially with complications such as severe
bleeding or a hole (perforation), you must be unusual abdominal symptoms (especially GI
bleeding) particularly in the initial stages of treatment. The risk of GI bleeding, ulceration or
perforation is higher with increasing NSAID doses, in patients with a history of ulcer,
particularly if complicated with hemorrhage or perforation.

When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment

should be withdrawn.

Dermatological:
The administration of Nurofen for children must be stopped if there are mild skin
reactions or other signs of allergies as these may be sign of other serious skin reactions, some of
them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal
necrolysis The risk is greater in the first month of Nurofen administration.

Cardiovascular and cerebrovascular effects:

The use of Nurofen may be associated with a small increased risk of myocardial
infarction or stroke. These risks are associated high doses and in long-term treatment.
Caution (discussion with doctor or pharmacist) is required prior to starting treatment in
patients with a history of high blood pressure and/or heart failure as fluid retention, hypertension
and oedema have been reported in association with NSAID therapy.

Renal:
There is a risk of renal impairment even with patients who have never had any kidney
problems. As a result, oedema, heart failure or high blood pressure may appear. Nurofen may
cause renal, heart or liver failures with patients suffering from renal problems or those taking
diuretics or blood pressure medication. But, when one ceases to take them, these conditions are
reversible.
Other precautions
Long-term treatments, associated with high doses of painkillers may bring about
headaches that should not be treated with an increasing dose of Nurofen for children. Common
use of painkillers may result in permanent renal and heart failures.
Taking other medicines
Please talk with your doctor or pharmacist before giving your child Nurofen for children.
Side-effect can be more or less intense if this medicine is given to the child at the same
time with other medication. Nurofen for children can change the effects or cause the increase of
other medications side-effects, when administered simultaneously.

The following medicines interact with Nurofen for children when taken simultaneously:
-

another NSAID medicine

acetylsalicylic acid/aspirin

anti-coagulants, such as heparin

methotrexate (a chemotherapy agent and immune system suppressant)
digoxin (used to treat heart conditions)
phenytoin ( anti-seizure medication)

lithium (a medicine for depression)

diuretics (used to increase the excretion of water from bodies
ACE-inhibitors, for blood pressure treatment (captopril, betareceptor blocking
medicines, angiotensin II antagonists)
colestyramine (which reduces the level of cholesterol)
trimethoprim, aminoglicozide
selective serotonin re-uptake inhibitors (such as serotonin)
tacrolimus (a medicine to suppress the immune reaction)
zidovudine.(a medicine for treating Aids)
mifepristone
probenicid used in treating gout
quinolone antibiotics
sulphonylureas (used for treating diabetes)
corticosteroids (against inflammations)
baclofen

Driving and using machines

Nurofen for children may cause dizziness or visual disturbances. As a result, during treatment, it
is not recommended to drive or operate machines.
3.

How to administer Nurofen for children

Always take Nurofen for Children exactly as indicated. You should check with your
doctor or pharmacist if you are unsure.
Read all of this leaflet carefully
Pain or fever
The Recommended Daily Intake of Nurofen for children is 20-30 mg of ibuprofen /kg,
orally administered. Depending on the age of the child, the following doses are being
administered, using the graduated syringe:

Infants between 3 to 12 months:

The recommended intake is 50 mg of ibuprofen ( 2,5 ml oral suspension Nurofen for children), 3
times a day.

Children between 1 to 3 years:

The recommended intake is 100 mg ibuprofen ( 5 ml oral suspension Nurofen for children), 3
times a day.

Children between 4 to 6 years:

The recommended intake is 150 mg ibuprofen (7,5 ml oral suspension Nurofen for children), 3
times a day.

Children between 7 to 9 years:

The recommended intake is 200 mg ibuprofen ( 10 ml oral suspension Nurofen for children), 3
times a day.

Children between 10 to 12 years:

The recommended intake is 300 mg ibuprofen (15 ml oral suspension Nurofen for children), 3
times a day.

Nurofen for children mustn`t be administered to children younger than 3 months.

The post-immunisation fever`s treatment:

The recommended intake is 50 mg ibuprofen (2,5 ml oral suspension Nurofen for children)
followed, if needed, by another dose of 50 mg ibuprofen (2,5 ml oral suspension Nurofen for
children), after a 6 hours break. Within 24 hours, do not administer more than 5 ml oral
suspension (100 mg ibuprofen).

This treatment must be taken for a short period of time.

For children over 6 months, if the symptoms last longer than 3 days, please contact your family
doctor.
For children between 3 to 6 months, if the symptoms last longer than 24 hours, please contact
your family doctor.
Side effects can be reduced to minimum by using the smallest effective doses for the shortest
period of time needed to control the symptoms.

Special groups of patients:

Kidney failure:
Reducing the dose is not necessary for the patients with a low or moderate form of kidney failure
(for the patients with a severe form of kidney failure).

Liver failure:
Reducing the dose is not necessary for the patients with a low or moderate form of liver failure
(for the patients with a severe form of liver failure).

Administration:
1.
2.
3.
4.
5.
6.
7.
8.

Shake the bottle before administrating.

Remove the cap (push, then rotate counterclockwise).
Insert the graduated syringe through the cap.
to slowly fill the syringe, turn the bottle upside down and slowly pull the suspension until
you have the necessary amount, marked on the syringe.
Put the bottle back as it was before, and take the syringe out of the cap.
Insert the end of the syringe in the childs mouth and slowly push the piston to
administrate the suspension.
Close the bottle after administering.
Wash the syringe with hot water and let it dry. Keep out of reach of children.

If you accidentally give or take more than the recommended dose of Nurofen for Children,
contact your doctor straight away

4. Possible side effects

As all medications, Nurofen for children can cause side effects, although they dont show up to
everyone.

The frequency of reactions is defined as follows:

Very frequent

affecting more than 1 person out of 10

Frequent
Less frequent

affecting less than 1 person out of 10

affecting less than 1 person out of 100

Rare

affecting less than 1 person out of 1000

Very rare

affecting less than 1 person out of 10000

With unknown frequency

which cannot be estimated from the available data

Medicines like Nurofen for children can be associated with a slightly high risk of cardiac events
(heart attack) or a stroke. Please notice that using the smallest necessary dose can reduce the
possibility of appearing of side effects. The oedema, blood pressure and heart block have been
reported relating to AINS treatment.

Very frequent
Indigestion, diarrhea.

Less frequent
Unspecified allergic reactions associated with hive and skin rash, headaches, abdominal pain,
sickness, indigestion, epidermal rash.

Rare

heart burn, abdominal pain, feeling sick, being sick, flatulence (wind), diarrhoea, constipation.
Very rare
Severe reactions of hyper sensibility (anaphylaxis, angioedema, which determines symptoms
such as oedema of the face, tongue and larynges, dyspnoea, tachycardia, blood pressure or
shock), meningitis with no infection (aseptic meningitis), Bronchial hyperresponsivenes
(bronchial asthma, exacerbation of the bronchial asthma, bronchospasm), ulcer and perforation
of the stomach (the tube which connects the stomach with the small intestine), black tarry stools,
vomiting blood or dark particles that look like coffee grounds, mouth ulcers and/or swelling and
irritation of the mouth, inflammation of the stomach.
With unknown frequency
Dizziness, unexplained wheezing or shortness of breath, severe skin reactions such as
rashes covering the whole body, peeling, blistering or flaking skin.

Immediately stop the administration of Nurofen for children and contact your family
doctor if the child shows symptoms of angioedema, such as:
-swelling of the face, tongue or throat
-unexplained wheezing or shortness of breath,
-severe skin reactions such as rashes covering the whole body, peeling, blistering or flaking skin.

Nurofen for children can hide the signs or symptoms of a possible infection (fever, pain and
oedema). In case of your child showing an infection with symptoms, like fever and critical
general health affection or fever with symptoms of local infection, like throat, pharynx or mouth
pain or urinating problems, you must immediately consult your family doctor. He will
recommend you a blood check and will prescribe a treatment against the infection.

Should any of the side effects get serious or should you notice any side effect mentioned in
this prospect, please inform your family doctor or pharmacist.
Administrating ibuprofen for longer periods, for treating chronic affections, can cause more
side effects.
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.
FURTHER INFORMATION
What Nurofen for Children contains:
Each 1ml oral suspension contains 20mg ibuprofen
Each 5ml spoonful of oral suspension contains 100mg ibuprofen .
Each 2.5ml spoonful of oral suspension contains 50mg ibuprofen.
The other ingredients are; citric acid monohydrate, sodium citrate, sodium chloride,
sodium
saccharin, polysorbate 80, domiphen bromide, maltitol liquid, glycerol, xanthan gum, orange
flavour (containing wheat starch) and purified water.
What Nurofen for Children looks like and contents of the pack
Nurofen for Children is an off-white, orange flavoured oral suspension. Each bottle
contains either 100ml or 150ml.
The pack contains a double-ended measuring spoon to measure the dose correctly. Not all
pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED
103-105 Bath Road, Slough, Berkshire SL1 3UH, Great Britain
The manufacturer
BCM LIMITED
Thane Road, Beeston, Nottingham
Nottinghamshire, NG2 3AA, Great Britain
RCKITT BENCKISER HEALTHCARE (UK) LIMITED
Dansom Lane
Hull
East Yorkshire

HU8 7DS, Great Britain

For any information about this medicine, please contact the owner of the authorization of
marketings local representative:
Reckitt Benckiser Romania SRL
Street GrigoreAlexandrescu, Nr.89-97, Corp A, Floor 5, Section 1, Bucharest, Romania
Tel: +40215296700
office-romania@rb.com
This leaflet was approved in April 2013.