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Buscafem 400 mg capsules, zacht

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PACKAGE LEAFLET: INFORMATION FOR THE USER 
 
Buscafem 400 mg capsules, zacht 
For adolescents from 40 kg body weight (12 years of age) and adults 
Ibuprofen 
 
 
Read all of this leaflet carefully before you start taking this medicine. 

This medicine is available without perscription. However, you still need to take Buscafem carefully to 
get the best results from it. 

Keep this leaflet. You may need to read it again. 

If you have any further questions, ask your doctor or pharmacist. 

You must contact a doctor if your symptoms worsen or do not improve after 3 days if you have fever 
and after 4 days for the treatment of pain. 

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 Buscafem is and what it is used for 
2.  Before you take Buscafem  
3.  How to take Buscafem  
4.  Possible side effects 
5.  How to store Buscafem  
6.  Further information 
 
 
1. 
WHAT BUSCAFEM IS AND WHAT IT IS USED FOR 
 
Buscafem contains a medicine called ibuprofen. This belongs to a group of medicines called non-steroidal 
anti-inflammatory drugs (NSAIDS). NSAIDS provide relief by changing the body’s response to pain and 
fever. 
  
Buscafem is used for the symptomatic treatment of:  
• mild to moderate pain such as headache, dental pain, period pain and 
• fever and pain associated with common cold 
 
Buscafem is indicated in adults and adolescents weighing from 40 kg body weight (aged 12 years and 
above). 
 
 
2. 
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BUSCAFEM 
 
Do not take Buscafem:  
o  if you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of Buscafem. 
o  if you 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). 
o  if you have (or have had two or more episodes of) a stomach ulcer or bleeding of the stomach. 
o  if you have a history of gastro-intestinal bleeding or perforation related to previous NSAID therapy 
o  if you have severe liver, kidney or heart failure 
o  if you suffer from cerebrovascular or other active bleeding 
o  if you suffer from unclarified blood-formation disturbances 
o  if you suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake) 
o  if you are in the last 3 months of pregnancy 
 
 
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Please do not use Buscafem in adolescents under 40 kg body weight and children because of the high active 
substance content. 
 
Warnings and precautions 
 
o  if you have or have had asthma or allergic disease as shortmness of breath may occur 
o  if you have liver disorders 
o  if you have reduced renal function 
o  if you have or have ever had bowel disease (ulcerative colitis or Crohn’s disease) 
o  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 
o  if you have certain diseases of the skin (systemic lupus erythematosus (SLE) or mixed connective tissue 
disease). If you suffer from serious skin reactions such as exfoliative dermatitis, Stevens-Johnson 
syndrome and toxic epidermal necrolysis. The use of Buscafem should be stopped immediately at the first 
appearance of skin rash, mucosal lesions, or any other sings of allergic reactions 
o  if you have hereditary blood formation disorder (acute intermittent porphyria) 
o  if you have ever had a high blood pressure and/or heart failure 
o  directly after major surgery 
o  if you suffer 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 
o  During chicken pox (varicella) it is advisable to avoid use of Buscafem 
o  medicines such as Buscafem 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 fever and 4 days for the treatment of 
pain) 
o  if you suffer from coagulation disturbances 
o  In prolonged administration of Buscafem regular checking of your liver values, the kidney function, as 
well as of the blood count, is required 
o  The use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors, increases risk of 
adverse reactions (see section “Taking other medicines” below) and should be avoided 
 
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. 
In general the habitual use of (several sorts of) analgesics can lead to lasting severe kidney problems. This 
risk may be increased under physical strain associated with loss of salt and dehydration. Therefore it should 
be avoided. 
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. 
 
Consult a doctor before using Buscafem if any above mentioned conditions concerns you. 
 
Other medicines and Buscafem 
 
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including 
medicines without a prescription. 
 
What should you avoid when you are taking other medicines? 
Some medicines that are anti-coagulants (against clotting) (e.g. acetylsalicylic acid, 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. 
 
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In particular tell your doctor or pharmacist if you are taking: 
acetylsalicylic acid, or other NSAIDs (anti-
since this may increase the risk of gastrointestinal 
inflammatories and analgesics) 
ulcers or bleeding 
digoxin (for heart insufficiency) 
since the effect of digoxin may be enhanced 
glucocorticoids (medicinal products containing 
since this may increase the risk of gastrointestinal 
cortisone or cortisone-like substances) 
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 warfarin) 
since ibuprofen may enhance the effects of these 
medicines 
phenytoin (for epilepsy) 
since the effect of phenytoin may be enhanced 
selective serotonin reuptake inhibitors (medicines 
as these may increase the risk of gastrointestinal 
used for depression) 
bleeding 
lithium (a medicine for manic depressive illness and 
since the effect of lithium may be enhanced 
depression) 
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 
since this may lead to hyperkalaemia 
methotrexate (a medicine for cancer or rheumatism) 
since the effect of methotrexate may be enhanced 
tacrolimus and cyclosporine (immunosuppressive 
since kidney damage may occur 
medicines) 
zidovudine (a medicine for treating HIV/Aids) 
since the use of Buscafem may result in an increased 
risk of bleeding into a joint or a bleeding that leads 
to swelling in HIV (+) haemophiliacs 
sulfonylureas (antidiabetic medicines) 
interactions may be possible 
quinolone antibiotics 
since the risk for convulsions may be increased 
 
Buscafem with food and drink 
Swallow the capsules with water. It is recommended that patients with sensitive stomachs take Buscafem 
with food. If taken shortly after eating, the onset of action of Buscafem may be delayed. If this happens do 
not take more Buscafem than recommend within section “How to take Buscafem” below or until the correct 
re-dosing interval has passed. 
Some side effects, such as those affecting the gastrointestinal system can be more likely when alcohol is 
taken at the same time as Buscafem. 
 
Pregnancy and breast-feeding 
Tell your doctor if you become pregnant during intake of Buscafem. 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. 
This medicine passes into breast milk but may be used during breast-feeding if it is used at the recommended 
dose and for the shortest possible time. 
 
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The product 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 and at normal dosage this medicine has no or negligible influence on the ability to drive 
and use machines. 
 
Buscafem 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. 
 
 
3. 
HOW TO TAKE BUSCAFEM 
 
Always take Buscafem 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: 
 
Adults and adolescents weighting from 40 kg body weight (aged 12 years and above):  
Initial dose: Take 400 mg ibuprofen (1 capsule, soft), if necessary, take additional doses of 400 mg ibuprofen 
(1 capsule, soft) but do not exceed a total dose of 1200 mg ibuprofen (3 capsules, soft) in any 24 hour period. 
The dosing interval should not be below 6 hours.  
 
Please speak to the doctor or pharmacist if you feel that the effect of this medicine is greater or less than you 
expected. 
 
Use in children 
Buscafem is contraindicated in adolescents under 40 kg body weight and children because of the high active 
substance content. 
 
Method of administration 
For oral use. Capsules should not be chewed. 
 
Duration of treatment 
For short-term use only. 
If you need to take Buscafem for more than 3 days if you have fever or for more than 4 days for the 
treatment of pain or if the symptoms worsen consult your doctor. 
 
If you take more Buscafem than you should 
 
Consult a doctor immediately. The following signs may occur: nausea, vomiting, stomach pain, headache, 
dizziness and drowsiness. Rarely: low blood pressure and loss of consciousness (myoclonic convulsions in 
children), reduced breathing (respiratory depression) and blue discolouring of the skin and mucosa 
(cyanosis). 
 
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
 
 
4. POSSIBLE 
SIDE 
EFFECTS 
 
Like all medicines, Buscafem can cause side effects, although not everybody gets them. 
 
 
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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. 
 
STOP TAKING Buscafem immediately and consult a doctor if you experience one of the following 
conditions, which may be possible signs of severe adverse events: 

•  severe stomach trouble, heartburn or abdominal pain 
•  vomiting of blood or coffee-grounds-like vomit 
•  black stool or blood in the urine 
•  skin reactions, such as itching eruptions 
•  difficult breathing and/or swelling in face or throat  
•  lassitude combined with loss of appetite  
•  sore throat, combined with mouth ulcers, lassitude and fever  
•  heavy nosebleed and skin bleeding 
•  abnormal fatigue combined with reduced urine excretion 
•  swelling of face, feet or legs 
•  breast pain 
 
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 and indigestion, vomiting, wind (flatulence), diarrhoea, 
constipation, and slight blood losses in stomach and/or bowel that may cause anaemia in exceptional 
cases. 
 
Uncommon (affects 1 to 10 users in 1,000) 
•  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 
•  headache, dizziness, sleeplessness, agitation, irritability or tiredness 
•  visual disturbances 
•  allergic reactions , such as skin rashes, itching and asthma attacks. You must stop taking Buscafem and 
inform your doctor at once. 
 
Rare (affects 1 to 10 users in 10,000) 

•  tinnitus (ringing in the ears) 
•  kidney damage (papillary necrosis) and elevated uric acid concentrations in the blood 
 
Very rare (affects less than 1 user in 10,000) 
•  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 Buscafem 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 
 
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immediately and consult a doctor. Any self-treatment with pain killers or medicinal products that reduce 
fever (antipyretic medicinal products) mustn’t be done. 
•  psychotic reactions and depression 
•  exacerbation 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 
Buscafem, you must go to a doctor without delay. It is to be investigated whether there is an indication 
for an antiinfective/antibiotic therapy. 
•  high blood pressure, palpitations, heart failure, heart attack. 
•  liver dysfunction (first signs could be discoloration of the skin), liver damage, especially during long-
term treatment, liver failure, acute inflammation of the liver (acute hepatitis) 
•  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.  
•  severe forms of skin reactions such as skin rash with redness and blistering (e.g. Stevens-Johnson 
syndrome, toxic epidermal necrolysis/Lyell’s syndrome), hair loss (alopecia).  
•  Severe general hypersensitivity reactions. 
 
Medicines such as Buscafem 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 BUSCAFEM 
 
Keep out of the reach and sight of children. 
 
Do not use Buscafem after the expiry date which is stated on the carton. 
The expiry date refers to the last day of that month. 
 
This product does not require any special storage conditions. 
 
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to 
dispose of medicines no longer required. These measures will help to protect the environment. 
 
 
6. 
CONTENTS OF THE PACK AND OTHER INFORMATION 
 
What Buscafem contains 
 
The active substance is ibuprofen. 
 
Each capsule, soft contains 400mg ibuprofen. 
 
The other ingredients are: 
 
Capsule Contents: 
Macrogol 600 
Potassium hydroxide 
Purified water 
 
 
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Capsule Shell
Gelatin  
Sorbitol liquid 
Purified water 
 
Printing Ink 
Ingredients of Opacode WB black NS-78-17821:  
Black iron oxide (E172) 
Propylene glycol (E1520) 
Hypromellose 6cP  
 
What Buscafem looks like and contents of the pack 
Buscafem is a pale yellow, oval-shaped transparent gelatin capsule, soft of 16 - 18 mm in length with a logo 
“B400” printed in black ink  
 
Buscafem is available in a triplex (PVC/PE/PVDC) and aluminium foil blister. Packs of 6 & 12 capsules. 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
Marketing Authorisation Holder
 
Boehringer Ingelheim International GmbH  
Bingerstrasse 173  
D-55216 Ingelheim am Rhein 
Duitsland 
 
Manufacturer 
Boehringer Ingelheim Ellas AE 
5de km Paiania-Markopoulo 
Koropi Attiki, 19400 
Griekenland 
 
 
This medicinal product has been registered under RVG 107542 
 
This medicinal product is authorised in the Member States of the EEA under the following names: 
 
Austria: Buscofem 
Belgium: Ibuprofen Boehringer Ingelheim  
Czech Republic: Buscofem 
Germany: Ibuprofen Boehringer Ingelheim 400 mg Weichkapseln 
Hungary: Buscofem 
Italy: Buscofendol 
Slovakia: Buscofem 
The Netherlands: Buscafem 
 
This leaflet was last approved in november 2011.
 
 
 
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