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Brufen 400 mg bruisgranulaat

RegistratienummerRVG 110571
Farmaceutische vormBruisgranulaat
ToedieningswegOraal gebruik
ATCM01AE01 - Ibuprofen
AfleverstatusUitsluitend recept
Registratiedatum20 december 2012
RegistratiehouderAbbott B.V.
Wegalaan 9
Werkzame stof(fen)IBUPROFEN
Hulpstof(fen)APPELZUUR, (DL)(+-)(E 296)
POVIDON K 30 (E 1201)
Download: Bijsluiter PDF

Brufen 400 mg bruisgranulaat 
Read all of this leaflet carefully before you start taking this medicine - because it contains 
important information for you. 

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 only. Do not pass it on to others. It may harm 
them, even if their signs of illness are the same as yours. 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 
effects not listed in this leaflet. 
What is in this leaflet
What Brufen is and what it is used for 
What you need to know before you take Brufen  
How to take Brufen 
Possible side effects 
How to store Brufen 
Contents of the pack and other information 
Brufen belongs to a group of medicines called ‘non-steroidal anti-inflammatory drugs’ or NSAIDs.  
One sachet of medicine contains 400 mg of ibuprofen. 
This medicine is used: 
  to relieve mild to moderate pain - this includes period pain or joint pain in conditions such as 
rheumatoid arthritis 
  to reduce fever (high temperature).  
It can be used in adults and young people over 12 years (40 kg bodyweight and above). 
Do not give/take Brufen:  
  to children younger than 12 years of age  
  if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in Section 
  if you have ever had an allergic reaction to ibuprofen, acetylsalicylic acid (e.g. Aspirin) or other 
NSAIDs - the signs include a reddening or rash of the skin, swollen face or lips, runny nose, 
wheezing or shortness of breath  
  if you have (or have had two or more episodes of) a stomach/duodenal ulcer (peptic ulcer) or 
  if you have ever had bleeding or a tear in your stomach or gut when taking NSAIDs  
  if you have severe liver or kidney problems 
  if you have severe heart failure or coronary heart disease  

  if you are suffering from bleeding on the brain (cerebrovascular bleeding) or other active 
  if you have an illness that may make you more likely to bleed 
  if you are in the last 3 months of pregnancy. See ‘Pregnancy, breast-feeding and fertility’ below 
for more information.   
  if you are suffering from significant dehydration (caused by vomiting, diarrhoea or insufficient     
       fluid intake) 
Do not take Brufen if any of the above apply to you. If you are not sure, talk to your doctor or 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Brufen:  
  if you have chronic inflammatory intestinal diseases such as inflammation of the colon with 
ulcers (ulcerative colitis), inflammation affecting the digestive tract (Crohn’s disease) or other 
stomach or intestinal diseases 
  if you have disturbances in the formation of blood cells 
  if you have problems with normal blood clotting mechanism 
  if you suffer from allergies, hay fever, asthma, chronic swelling of nasal mucosa, sinuses, 
adenoids, or chronic obstructive respiratory disorders because the risk for developing narrowing 
of the airways with difficulty in breathing (bronchospasm) is greater 
  if you suffer from circulation problems in the arteries of your arms or legs 
  if you have liver, kidney, heart problems or high blood pressure 
  if you have just had major surgery 
  if you are in the first six months of pregnancy 
  if you are breast-feeding 
  if you have chickenpox 
  if you have Systemic Lupus Erythematosus (SLE) or other autoimmune diseases 
  if you have inherited a disorder of the red blood pigment haemoglobin (porphyria) 
Talk to your doctor or pharmacist before taking Brufen if any of the above apply to you.  
Elderly people should be aware of their increased risk of adverse events, especially bleeding and 
perforation in the digestive tract, which may be fatal. 
Lowest effective dose 
The lowest effective dose should always be used to minimize the risk for adverse events. Using a 
higher dose than recommended may increase the risk for adverse events.  
With Brufen, there is a risk of serious side effectsPlease refer to section 4 for information on 
what action to take if this occurs.  
Heart attack and stroke 
Talk to a doctor or pharmacist before taking this medicine if you have heart problems, have had a 
stroke or if you think that you are likely to get these conditions. This is for example, if you have 
high blood pressure, diabetes, high cholesterol levels or if you smoke. 
This medicine may lead to a small increased risk of heart attack or stroke. This increased risk is 
more likely with high doses and long-term treatment. Do not take more than the recommended dose 
of this medicine.  
Children under 12 years of age 
This medicine should not be given to children under 12 years of age. 

Other medicines and Brufen  
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. This is because Brufen can affect the way some other medicines work. Also, some other 
medicines can affect the way Brufen works. 
In particular tell your doctor or pharmacist if you are taking any of the following medicines:  
  acetylsalicylic acid (e.g. Aspirin).  
  Do not use this medicine if you are taking other NSAID painkillers. 
  other medicines containing ibuprofen, such as those you can buy without a prescription 
  medicines for heart problems - such as digoxin 
  medicines for diabetes  
  medicines to stop blood clots - such as acetylsalicylic acid (e.g. Aspirin), warfarin or 
  medicines that suppress your immune system - such as ciclosporin or tacrolimus  
  medicines for high blood pressure - including ACE-inhibitors (such as captopril), beta blockers  
or angiotensin-II receptor antagonists 
  diuretics (water tablets) 
  steroids - used for inflammatory conditions 
  selective serotonin reuptake inhibitors (SSRIs) - used for depression 
  some antibiotics for infections - including aminoglycosides and quinolones 
  zidovudine - used for HIV or AIDS 
  methotrexate - used for some cancers 
  cholestyramine - used to lower cholesterol 
  lithium - used for some forms of depression 
  voriconazole or fluconazole - used for fungal infections  
  mifepristone - used for medical termination of pregnancy 
  ginko biloba – a herbal medicine often used in dementia 
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before 
taking Brufen. 
Brufen with alcohol 
If you drink alcohol whilst taking this medicine, you may be more likely to get side effects.  
Pregnancy, breast-feeding and fertility 
  Do not take this medicine if you are in the last 3 months of pregnancy. 
  Talk to your doctor or pharmacist before taking this medicine if you are in the first 6 months of 
pregnancy or you are breast-feeding. You should only take this medicine on the advice of your 
Tell your doctor or pharmacist before taking this medicine if you are planning to become pregnant 
or if you are having problems getting pregnant. This is because this medicine may make it more 
difficult to get pregnant.  
Driving and using machines 
This medicine may make you feel dizzy or sleepy. If this happens, do not drive or use any tools or 
machines. Do not do anything else where you need to be alert. 
Brufen contains sucrose 
Sucrose is a sugar. If you have been told by your doctor that you cannot tolerate or digest some 
sugars, talk to your doctor before taking this medicine. 

Brufen contains sodium 
Brufen  contains 100 mg sodium per sachet. This should be taken into account if you are on a low 
sodium diet. You may need to have less sodium in your diet because of the sodium in this medicine. 
Always take this medicine exactly as your doctor has told you. Check with your doctor or 
pharmacist if you are not sure.  
The product is intended for short-term use only. You should take the lowest dose for the shortest time 
necessary to relieve your symptoms. 
How much to take 
Mild to moderate pain and fever 
Adults and adolescents over 12 years of age (40 kg or above): 
400 mg given as a single dose or up to 3 times a day with an interval of 4 to 6 hours.  
Period pain 
Adults and adolescents over 12 years of age (40 kg or above): 
400 mg 1‑ 3 times a day, with an interval of 4‑ 6 hours, as needed.  
For period pain, mild to moderate pain and fever: Do not take more than a total of 3 sachets 
(1200 mg) in any 24 hours. 
Rheumatic diseases 
A usual dose for adults is 400 mg 3 times a day.  
Always use the dose prescribed by your doctor.  
Adolescents over 12 years of age (40 kg or above): 
The required dose will be decided by your doctor and will depend on your body weight.   
The usual total daily dose is between 20 and 40 mg per kg of body weight.  This dose will be split 
into 3 or 4 separate doses to be taken throughout the day.   
Always use the dose prescribed by your doctor.  
Do not take more than a total of 6 sachets (2400 mg) in any 24 hours. 
People with liver or kidney problems 
If you have liver or kidney problems, your doctor will tell you the correct dose to take. This will be 
the lowest dose possible. 
The elderly (over 65 years) 
If you are elderly, your doctor will tell you the correct dose to take. This will be the lowest dose 
Taking this medicine 
In order to achieve a faster onset of action, the dose may be taken on an empty stomach.  
  Empty the granules from one sachet into a small glass of water (about 125 ml). 
  Make sure that you use all of the granules in the sachet.  
  Stir the medicine until it stops bubbling and the granules have dissolved - this will make an 
orange flavoured, fizzy drink.  

If you take more Brufen than you should 
If you have taken more of this medicine than you should, contact a doctor or go to the nearest 
hospital straight away. Take the medicine pack with you. 
The signs of an overdose can include: feeling sick, stomach pain, being sick (may have blood in it), 
headache, ringing in the ears, confusion and shaky eye movement. At high doses, there may be loss 
of consciousness, fits (mainly in children), feeling weak or dizzy, blood in the urine, feeling cold 
and breathing problems. 
If you usually take painkillers, especially combinations of different substances with painkilling 
effect, you may damage your kidneys permanently, with the risk of kidney failure. This risk may be 
increased if you are dehydrated. Therefore you should avoid excessive use of any painkillers.  
If you use painkillers for a long time, this can cause headaches, which should not be treated with 
more painkillers. If you think this applies to you, talk to your doctor or pharmacist. 
If you forget to take Brufen 
  If you forget a dose, take it as soon as you remember. However, if it is nearly time for your 
next dose, skip the missed dose. 
  Do not take a double dose to make up for a forgotten dose. 
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
Serious side effects  
Stop taking this medicine and see your doctor straight away if you notice any of the following 
serious side effects - you may need urgent medical attention: 

Uncommon (may affect up to 1 in 100 people): 
black tarry stools  (faeces/motions) or blood in the stools 
           vomiting any blood or dark particles that look like coffee grounds 
Very rare (may affect up to 1 in 10,000 people): 

swelling of the face, tongue or throat (larynx) which can cause great difficulty in breathing 
(angioedema), rapid heartbeat, severe fall in blood pressure or life threatening shock 
a sudden allergic reaction with shortness of breath, wheezing and drop of blood pressure 
severe rash with blisters on the skin, especially on the legs, arms, hands and feet which can 
also involve the face and lips (erythema multiforme, Stevens-Johnson´s syndrome). This can 
get even more severe, where the blisters get larger and spread out and parts of the skin may 
slough off (toxic epidermal necrolysis). There may also be severe infection with destruction 
(necrosis) of skin, subcutaneous tissue and muscle 
      disorders of blood cell formation (agranulocytosis, with symptoms like fever, sore throat,   
            surface mouth ulcers, flu-like symptoms, severe fatigue, nasal and skin bleeding). Your 
doctor will need to check the amount of blood cells in your blood. 
Stop taking this medicine and see your doctor straight away if you notice any of the side effects 

Stop taking this medicine and tell your doctor if you notice any of the following: 
Common (may affect up to 1 in 10 people): 

heartburn, abdominal pain, indigestion 
Uncommon (may affect up to 1 in 100 people): 
blurred vision or other eye problems such as sensitivity to light 
hypersensitivity reactions such as skin rash, itching, asthma attacks (sometimes with low 
blood pressure) 
Rare (may affect up to 1 in 1,000 people): 
vision loss 
Very rare (may affect up to 1 in 10,000 people): 
sudden filling of lungs with water resulting in difficulty to breathe, high blood pressure, 
water retention and weight gain 
Stop taking this medicine and tell your doctor if you notice any of the side effects above. 
Other side effects 

Common (may affect up to 1 in 10 people)
Disturbances in the digestive tract, such as diarrhoea, feeling sick, vomiting, wind, 
Uncommon (may affect up to 1 in 100 people):  
    Digestive tract ulcer with or without perforation 
       Bowel inflammation and worsening of inflammation of the colon (colitis) and  
digestive tract (Crohn’s disease) and complications of diverticula of the large bowel 
(perforation or fistula) 
     Microscopic bleeding from the intestine which may result in anemia 
Mouth ulcers and inflammation 
Headache, sleepiness, vertigo, dizziness, fatigue, agitation, insomnia and irritability 
Uncommon (may affect up to 1 in 100 people):  
     Inflammation of the stomach lining 
       Kidney problems including development of oedema, inflammation of the kidneys and  kidney 
Runny nose 
Difficulty breathing (bronchospasm) 
Rare (may affect up to 1 in 1,000 people):  
     Depression, confusion, hallucinations 
       Lupus erythematosus syndrome 
        Increase of blood urea nitrogen and other liver enzymes, decrease in haemoglobin and 
  haematocrit values, inhibition of platelet aggregation and prolonged bleeding time,  
  decrease of serum calcium and increase in serum uric acid values 
Very rare (may affect up to 1 in 10,000 people): 

    Unpleasant awareness of heart beat, heart failure, heart attack or high blood pressure 
Ringing or buzzing in the ears 
Inflammation of the oesophagus or pancreas 
Narrowing of the bowel 

Acute inflammation of the liver, yellowish discolouration of the skin or whites of the eyes, 
liver dysfunction, damage or failure 
Inflammation of the brain membrane (without bacterial infection) 
Damage of the kidney tissue 
     Hair loss 
The following side effects have also been reported with other NSAIDs: 

  high blood pressure or heart failure 
  worsening of ulcers in the large intestine and Crohn’s disease (bowel disease) 
  a small increased risk of heart attack or stroke. 
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed 
in this leaflet. 
Keep out of the sight and reach of children. 
Store below 25C.  Store in the original package in order to protect from light and moisture. 
Do not use this medicine after the expiry date stated on the sachet and 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. 
What Brufen

  The active substance is ibuprofen. One sachet contains: ibuprofen 400 mg 
  The other ingredients are malic acid, saccharin sodium, sucrose, povidone, orange flavour, 
sodium lauril sulfate, sodium hydrogen carbonate and anhydrous sodium carbonate. 
What Brufen looks like and contents of the pack  
Brufen is a white powder with an orange flavour. Your medicine will be contained in sachets.  
Each pack contains 20, 30 or 40 sachets. 
In het register ingeschreven onder nummer: 
RVG 110571 
Marketing Authorisation holder and Manufacturer

Marketing Authorisation holder: 
Abbott B.V. 
Wegalaan 9 
2132 JD Hoofddorp 

088 822 2688 
Abbott S.r.L. 
Via Pontina Km 52 
Campoverde di Aprilia 
04010 – APRILIA 
This leaflet was last approved in December 2012 

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