Buscafem 400 mg capsules, zacht
PACKAGE LEAFLET: INFORMATION FOR THE USER
Buscafem 400 mg capsules, zacht
For adolescents from 40 kg body weight (12 years of age) and adults
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
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
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
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
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
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.
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
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
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)
lithium (a medicine for manic depressive illness and
since the effect of lithium may be enhanced
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
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
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
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.
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
If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE
Like all medicines, Buscafem can cause side effects, although not everybody gets them.
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
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)
• 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
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.
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:
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
D-55216 Ingelheim am Rhein
Boehringer Ingelheim Ellas AE
5de km Paiania-Markopoulo
Koropi Attiki, 19400
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:
Belgium: Ibuprofen Boehringer Ingelheim
Czech Republic: Buscofem
Germany: Ibuprofen Boehringer Ingelheim 400 mg Weichkapseln
The Netherlands: Buscafem
This leaflet was last approved in november 2011.