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NUROFEN 400 MG CAPSULE SOFT

Active substance: IBUPROFEN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Nurofen 400 mg Capsule, soft
For use in adults and adolescents weighing from 40 kg (12 years of age and above)
Ibuprofen
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 Nurofen 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 contact a doctor if your symptoms worsen or do not improve
after 3days in children and adolescents between 12 and 18 years
after 3 days if you have fever and 4 days for the treatment of pain in adults
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
[For medicinal products available only on prescription:]
Read all of this leaflet carefully before you start taking this medicine.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
 If any of the side effects gets 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 is and what it is used for
2. Before you take Nurofen
3. How to take Nurofen
4. Possible side effects
5. How to store Nurofen
6. Further information
1.

WHAT NUROFEN IS AND WHAT IT IS USED FOR

Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
These medicines provide relief by changing how the body responds to pain and fever.
Nurofen is used in adults and children & adolescents weighing from 40 kg (12 years of age and above)
for the symptomatic treatment of:


2.

mild to moderate pain such as headache, period pain, dental pain
fever and pain associated with the common cold.
BEFORE YOU TAKE NUROFEN

Do not take Nurofen if you:



are allergic to ibuprofen, ponceau 4R (E124) or any of the other ingredients of this medicine
(listed in section 6).



have ever suffered from shortness of breath, asthma, a runny nose, swelling or hives after
using acetylsalicylic acid (known as aspirin) or other similar painkillers (NSAIDs).



have (or have had two or more episodes of) a stomach/duodenal ulcer (peptic ulcer) or
bleeding.



have had gastrointestinal bleeding or perforation when previously taking NSAIDs (Nonsteroidal anti-inflammatory drugs)



suffer from unclarified blood-formation disturbances



suffer from a tendency to uncontrolled bleeding (haemorrhage) or clotting (coagulation)
disorders



have severe liver, kidney or heart failure.



are in the last three months of pregnancy (see section ‘Pregnancy and breast-feeding’).



suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).



suffer from bleeding on the brain (cerebrovascular bleeding) or other active bleeding.

Do not give to adolescents weighing less than 40 kg or children under 12 years of age.
Take special care with Nurofen if you:


have systemic lupus erythematosus (SLE) or mixed connective tissue disease (conditions of
the immune system causing joint pain, skin rashes and fever).



have a hereditary blood formation disorder (acute intermittent porphyria) or problems with
your blood clotting.



have or have ever had bowel disease (ulcerative colitis or Crohn’s disease).



have ever had high blood pressure and/or heart failure.



have reduced kidney function.



have liver problems.



have recently undergone major surgery.



have or have had asthma or allergic disease as shortness of breath may occur.



suffer from hayfever, nasal polyps or chronic obstructive respiratory disorders as an increased
risk of allergic reactions exists. The allergic reactions may present as asthma attacks (so-called
analgesic asthma), swelling of skin (Quincke’s oedema) or a skin rash.



are taking other medicines which could increase the risk of ulceration or bleeding such as oral
corticosteroids, medicines for thinning the blood (such as warfarin), selective serotonin-

reuptake inhibitors (medicines for depression) or anti-platelet agents such as acetylsalicylic
acid (aspirin).
Other warnings


Prolonged use of painkillers for headaches can make them worse. If this situation is
experienced or suspected, you should stop taking Nurofen and contact your doctor.



Medicines such as Nurofen 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 (which is in children
and adolescents 3 days and in adults 3 days for fever and 4 days for pain).



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.



You should avoid taking Nurofen if you have chicken pox (varicella).



When Nurofen is taken over a longer period of time, regular liver, kidney and blood checks
should be done.



Taking Nurofen in combination with other NSAIDS including cyclo-oygenase-2 specific
inhibitors can increase the risk of side effects and should be avoided. (see section “Taking
other medicines” below).



Using more than one painkilling medicine can increase the risk of severe kidney problems and
should be avoided. The risk is increased further by dehydration.



There is a risk of renal impairment in dehydrated children and adolescents.

Undesirable effects are minimised by using the minimum effective dose for the shortest period of
time. The elderly are at increased risk of side effects.
Consult a doctor before using Nurofen if any above mentioned conditions concerns you.

Taking other medicines:
What should you avoid when you are taking other medicines?
Some medicines that are anti-coagulants (against clotting) (e.g. acetylsalicylic acid/aspirin, warfarin,
ticlopidin), some medicines against high blood pressure (ACE-inhibitors e.g. captopril, betareceptor
blocking medicines, angiotensin II antagonists), and even some other medicines may effect or be
effected by the treatment of ibuprofen. Seek therefore always advice of a doctor before you use
ibuprofen with other medicines.
Do not take this medicine if you are taking acetylsalicylic acid (aspirin) at doses above 75mg daily.
If you are on low-dose acetylsalicylic acid (aspirin) (up to 75mg daily) speak to your doctor or
pharmacist before taking Nurofen.
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:

other NSAIDs (anti-inflammatories and analgesics)
digoxin (for heart insufficiency)
glucocorticoids (medicinal products containing
cortisone or cortisone-like substances)
Anti-platelet agents
medicines for thinning the blood (such as warfarin,
acetylsalicylic acid and ticlopidin)
phenytoin (for epilepsy)
selective serotonin reuptake inhibitors (medicines
used for depression)
lithium (a medicine for manic depressive illness and
depression)
probenecid and sulfinpyrazones (medicines for gout)
medicines for high blood pressure (ACE-inhibitors
e.g. captopril, betareceptor blocking medicines,
angiotensin II antagonists) and water tablets
potassium sparing diuretics
methotrexate (a medicine for cancer or rheumatism)
tacrolimus and cyclosporine (immunosuppressive
medicines)
zidovudine (a medicine for treating Aids)

may increase the risk of gastrointestinal
ulcers or bleeding
effect of digoxin may be enhanced
may increase the risk of gastrointestinal
ulcers or bleeding
may increase the risk of gastrointestinal
ulcers or bleeding
ibuprofen may enhance the effects of these
medicines
effect of phenytoin may be enhanced
may increase the risk of bleeding
effect of lithium may be enhanced
it may take longer for ibuprofen to be broken
down by the body
ibuprofen may reduce the effects of these
medicines and there could be a possible
increased risk for the kidney
may lead to high blood potassium levels
(hyperkalaemia)
effect of methotrexate may be enhanced
kidney damage may occur

sulfonylureas (antidiabetic medicines)

use of Nurofen may result in an increased
risk of bleeding into a joint or a bleeding that
leads to swelling in HIV (+) haemophiliacs
interactions may be possible

quinolone antibiotics

risk of convulsions (fits) may be increased

mifepristone (used to terminate pregnancies)

effect of mifepristone can be reduced.

Taking Nurofen with food and drink

Swallow the capsules with water. It is recommended that patients with sensitive stomachs take
Nurofen with food. Some side effects, such as those affecting the gastrointestinal system can be more
likely when alcohol is taken at the same time as Nurofen.
Pregnancy and breast-feeding
Pregnancy
Tell your doctor if you become pregnant whilst taking Nurofen.
Do not take this medicine in the last 3 months of pregnancy. Avoid the use of this medicine in the first
6 months of pregnancy, unless the doctor advises otherwise.
Breast-feeding
Only small amounts of ibuprofen and its metabolites pass into breast-milk. This may be taken during
breast-feeding if it is used at the recommended dose and for the shortest possible time.
Female Fertility
Nurofen belongs to a group of medicines (NSAIDs) which may impair the fertility in women. This
effect is reversible on stopping the medicine. Avoid taking this medicine if you are trying to become
pregnant.
Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machines
For short-term use and at normal dosage this medicine has no or negligible influence on the ability to
drive and use machines.
Patients who experience dizziness, drowsiness, vertigo or visual disturbances while they are taking
Nurofen, should avoid driving or using machinery. These effects may be worse when taken in
combination with alcohol.
Important information about some of the ingredients of Nurofen
This medicinal product contains sorbitol. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicinal product contains the colour ponceau 4R (E124). It may cause allergic reactions.
3.

HOW TO TAKE NUROFEN

Always take Nurofen exactly as stated in this package leaflet. You should check with your doctor or
pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the standard dose is:
Dosage:
Adults and children & adolescents weighing from 40 kg (12 years old and above):
Initial dose: Take 1 capsule (400 mg ibuprofen) with water, then if necessary 1 capsule (400 mg
ibuprofen) every six hours. Do not exceed 3 capsules (1200 mg ibuprofen) in 24 hours.
Do not give Nurofen to adolescents weighing under 40 kg or children under 12 years of age.
Method of administration:
For oral use. Do not chew.
It is recommended that patients with a sensitive stomach take Nurofen with food. If taken shortly after
eating, the onset of action of Nurofen may be delayed. If this happens, do not take more Nurofen than
recommended within this section or until the correct re-dosing interval has passed.

Duration of treatment
This product is intended for short term use only. You should only take the lowest dose for the shortest
time necessary to relieve your symptoms.
In children and adolescents
If in children and adolescents between 12 and 18 years Nurofen is required for more than 3 days, or if
symptoms worsen a doctor should be consulted.
In adults
If Nurofen is required for longer than 3 days for the treatment of fever and 4 days for treatment of pain
or if the symptoms worsen, consult your doctor.
Please speak to the doctor or pharmacist if you feel that the effect of this medicine is greater or less
than you expected.
If you take more Nurofen than you should
Consult a doctor immediately. The following signs may occur: feeling sick, being sick, stomach pain,
diarrhoea, ringing in the ear, headache, blood in stools or vomit (gastrointestinal bleeding), dizziness,
drowsiness, confusion, disorientation. Rarely: loss of consciousness.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Nurofen can cause side effects, although not everybody gets them.
Side effects may be minimised by taking the lowest dose for the shortest time necessary to relieve the
symptoms. You may suffer one of the known side effects of NSAIDs (see below). If you do, or if you
have concerns, stop taking this medicine 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 you develop:
 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 very 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.
 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



gastrointestinal complaints, such as heart burn, abdominal pain, feeling sick and indigestion,
vomiting, wind (flatulence), diarrhoea, constipation, and slight blood losses in stomach and/or
bowel that may cause anaemia in exceptional cases.

Uncommon
 stomach or intestinal ulcers, sometimes with bleeding and perforation, inflammation of the lining
of the mouth with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis),
worsening of colitis and Crohn's disease
 central nervous disturbances such as headache, dizziness, sleeplessness, agitation, irritability or
tiredness
 visual disturbances
 allergic reactions , such as skin rashes, itching and asthma attacks. You must stop taking Nurofen
and inform your doctor at once.
Rare
 tinnitus (ringing in the ears)
 kidney damage (papillary necrosis) and elevated uric acid concentrations in the blood
Very rare
 swelling (oedema), high blood pressure (hypertension) and cardiac failure have been reported in
association with NSAID treatment.
 inflammation of the oesophagus or pancreas, formation of membrane-like narrowing in the small
and large intestines (intestinal, diaphragm-like strictures)
 serious infections of the skin and soft-tissue complications have occurred during chicken pox
(varicella) infection.
 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 my lead to acute kidney failure. If one of
the above mentioned symptoms occur or if you have a general miserable feeling, stop taking
Nurofen and consult your doctor immediately as these could be first signs of a kidney damage or
kidney failure.
 problems in the blood cell production - first signs are: fever, sore throat, superficial mouth ulcers,
flu-like symptoms, severe exhaustion, nose and skin bleeding. In these cases you must stop the
therapy immediately and consult a doctor. You must not treat these symptoms with pain killers or
medicinal products that reduce fever (antipyretic products).
 psychotic reactions and depression
 worsening of infection-related inflammations (e.g. necrotising fasciitis) associated with use of
certain painkillers (NSAIDs) has been described. If signs of an infection occur or get worse during
use of Nurofen, you must go to a doctor without delay to investigate whether there is a need for an
anti-infective/antibiotic therapy.
 high blood pressure, palpitations, heart failure, heart attack.
 liver dysfunction, liver damage, especially during long-term treatment, liver failure, acute
inflammation of the liver (hepatitis)
 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.
 severe forms of skin reactions such as skin rash with redness and blistering (e.g. StevensJohnson syndrome, toxic epidermal necrolysis/Lyell’s syndrome), hair loss (alopecia).
 severe general hypersensitivity reactions
 worsening of asthma and bronchospasm

This medicinal product contains Ponceau 4 R (E124) which may cause allergic reactions.

Medicines such as Nurofen may be associated with a small increased risk of heart attack ("myocardial
infarction") or stroke.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet,
please stop taking the product immediately and tell your doctor or pharmacist.
5.

HOW TO STORE NUROFEN

Keep out of the sight and reach of children. Do not use Nurofen after the expiry date which is stated
on the carton and blister. The expiry date refers to the last day of that month. Do not store above 25°C.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6. FU

RTHER INFORMATION

What Nurofen contains:
Each capsule contains 400mg ibuprofen. The other ingredients are:
- Fill:
- Macrogol 600
- Potassium hydroxide
- Purified water
- Capsule shell:
- Sorbitol liquid (E420)
- Gelatin
- Ponceau 4R (E124)
- Ink:
- Titanium Dioxide (E171)
- Propylene Glycol,
- Hypromellose (E464)
- Processing Aids:
- Triglycerides (medium chain)
- Lecithin (E322)

What Nurofen looks like and contents of the pack
The capsules are red, oval-shaped and transparent with a nurofen logo printed in white. The capsules
are available in packs of 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 40 or 50 soft capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
To be completed nationally

Manufacturer
To be completed nationally
This medicinal product is authorised in the Member States of the EEA under the following
names:

Austria
Bulgaria
Cyprus
France
Germany
Hungary
Italy
Netherlands
Poland
Portugal
Romania
UK

Nurofen Rapid 400 mg Weichkapseln
Nurofen Express Forte
Nurofen Express 400mg Capsule, soft
NurofenCaps 400mg, capsule molle
Nurofen Immedia 400 mg Weichkapseln
Nurofen Rapid Forte 400 mg lágy kapszula
Nurofencaps 400 mg capsule molli
Nurofen Fastine Liquid Caps 400 mg, capsule, zacht
Nurofen Caps
Nurofen Zavance 400 mg cápsulas moles
Nurofen Express Forte 400 mg capsules moi
Nurofen 400mg Capsules, soft

This leaflet was last approved in DD/MMM/YYYY

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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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