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ROFEN

Active substance(s): IBUPROFEN

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Patient Information Leaflet
IBUPROFEN TABLETS BP 400 mg
Please read this leaflet carefully before you start taking your medicine. If you want to know
more about this medicine, or you are not sure about anything, ask your doctor or
pharmacist.
What you should know about this medicine

The name of this medicine is Ibuprofen Tablets BP. Each tablet contains 400 mg of Ibuprofen BP,
as the active ingredient. They also contain the inactive ingredients: colloidal silicon dioxide, maize
starch, pregelatinized maize starch, potable water, sodium starch glycollate, stearic acid, dextrin,
talc, gelatin, syrup, nipasept sodium (E214, E216, E218), sucrose, heavy kaolin and titanium
dioxide.
This medicine is available in pack sizes of 100, 112, 250, 500, 1000 and bulk tablets.
The product licence holder and manufacturer of this medicine is Crescent Pharma Limited,
Polhampton Lane, Overton, Hants RG25 3ED.
This medicine belongs to a group of medicines called Non-Steroidal Anti- Inflammatory Drugs
(NSAID's).
This medicine is used to relieve pain, swelling and redness in a number of conditions affecting the
joints and muscle including rheumatism in adults and children. It may also be used for other
conditions such as period pain, dental pain, migraine and pain following surgery.
What you should check before taking this medicine

Do not take this medicine if you :- are allergic to Ibuprofen or any other non s teroi dal anti-inflammatory drugs (NSAIDs),
aspi ri n or to any of the other ingredients listed above. (An allergic reaction may be recognised
as shortness of breath, blocked nose, rash, itching, swollen face or lips)
- have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had
two or more episodes of peptic ulcers, stomach bleeding or perforation
- have ever had stomach bleeding or perforation caused by taking NSAID painkillers
- have a condition which increases your tendency to bleeding
- have severe heart, liver or kidney failure
- are in the last 3 months of pregnancy.
Check with your doctor before taking these tablets if you:
- have or have ever suffered from asthma
- suffer from heart, liver or kidney problems
- have high blood pressure
- suffer from a bleeding disorder
- suffer from systemic lupus erythemotosus (SLE) or another connective tissue disorder
- have a history of stomach or intestinal problems (such as Crohn’s disease or colitis)
- are elderly, as you may be more likely to suffer from side effects
- are in the first 6 months of pregnancy or you are breastfeeding.
Ibuprofen Tablets may affect or be affected by some other medicines. For example:
- aspirin or any other NSAID painkiller
- medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid,
warfarin, ticlopidine)
- medicines that reduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such
as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
- drugs for heart disease e.g. digoxin
- water tablets (diuretics)
- corticosteroids (eg. hydrocortisone, prednisolone)
- lithium or a selective serotonin reuptake inhibitor (SSRI) drug (for treating depression)
- methotrexate (for treating cancer and also can be used for treating psoriasis)
- colestyramine (to lower cholesterol)

-

medicines known as sulfonylureas such as glibenclamide (for treating diabetes)
mifepristone (to terminate a pregnancy)
voriconazole or fluconazole (anti-fungal drugs)
aminoglycosides (a type of antibiotic)
ginko biloba (a herbal medicine)
zidovudine (an antibiotic)
drugs such as ciclosporin or tacrolimus (to prevent rejection following organ or bone marrow
transplants)
- a quinolone antibiotic for treating infection (eg. ciprofloxacin, ofloxacin).
Some other medicines may also affect or be affected by the treatment of Ibuprofen Tablets. You
should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen
Tablets with other medicines.
Other special warnings
Tell your doctor about taking this medicine if you are to undergo tests to check your liver function.
Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased
risk of heart attack or stroke, particularly when used at high doses. Do not exceed the
recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen Tablets
if you:
- have heart problems including heart failure, angina (chest pain), or if you have had a heart
attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to
narrow or blocked arteries), or any kind of stroke (including “mini-stroke” or transient ischaemic
attack TIA”)
- have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or
stroke, or if you are a smoker.
There is a risk of kidney damage in dehydrated children and adolescents.
Ibuprofen may make it more difficult to become pregnant. You should inform your doctor if you are
planning to become pregnant or if you have problems becoming pregnant.
Pregnancy and breastfeeding: The use of ibuprofen whilst pregnant or breastfeeding should be
avoided. Ibuprofen should not be used in the last 3 months of pregnancy and should only be taken
in the first 6 months of pregnancy on the advice of your doctor.
Driving and using machines: Ibuprofen Tablets may make you feel dizzy, tired, drowsy or might
affect your vision. If you think this medicine has affected you do not drive or operate machinery.
This medicine contains E214, E216 and E218 which may cause allergic reactions (possibly
delayed).
This medicine contains sucrose. If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicinal product.
How to take the medicine
Swallow the tablets whole with water after a meal or a snack.
The normal dose will be different for different medical conditions and patients. Always take the
medicine exactly as directed by your doctor.
DOSE

Adults and elderly
Initial dose: 1 to 2 tablets 3 times a day. The maximum dose per day is 6 tablets.
Maintenance dose: 1 to 3 tablets a day.
Children under 12 years; 20 mg/kg bodyweight to 40 mg/kg bodyweight daily, in divided doses,

depending on the treatment indicated by the doctor.
Special care should be taken when this medicine is given to older patients and children who
weigh less than 30 kg.
If you miss a dose of this medicine take it as soon as you remember. If it is almost time for the
next dose, skip the missed dose and continue with the regular dosing schedule. DO NOT
DOUBLE THE DOSES.
If you think you or anyone else has taken too many tablets, contact your doctor straight away or
go to the nearest hospital casualty department. Take any remaining tablets and the container with
you so that the medicine can be identified.
After taking this medicine
Like all medicines ibuprofen can cause side effects, although not everybody gets them. The elderly
are more at risk of developing problems due to side effects. There may be fewer side effects if you
take the lowest effective dose for the shortest time necessary.
If you suffer from any of the following at any time while you are taking these tablets, STOP TAKING
them and seek IMMEDIATE medical help:
• pass blood in your faeces (stools/motions), pass black tarry stools, or vomit any blood or dark
particles that look like coffee grounds (these may be signs of a stomach ulcer or bleeding)
• worsening of asthma, unexplained wheezing, shortness of breath, swelling of the face, tongue
or throat, collapse (these may be signs of a severe allergic reaction)
• severe skin reactions including skin peeling, blistering red swellings or blistering of the mouth,
eyes or genitals.
STOP TAKING the tablets and tell your doctor if you experience any of the following:
• indigestion or heartburn
• pains in your stomach, feeling or being sick or other abnormal stomach symptoms
• allergic skin reactions such as rashes, itching, hives
• inflammation of the pancreas causing severe pain in the abdomen and back.
Tell your doctor, pharmacist or nurse if you suffer from any of the following effects:
• diarrhoea, constipation, vomiting, flatulence (wind), mouth ulcers
• worsening of Crohn’s disease and colitis.
The following other effects have been reported less commonly:
• liver problems (symptoms include yellowing of the skin and eyes)
• kidney damage or kidney failure (symptoms include passing more or less urine than usual,
blood in urine, cloudy or rust-coloured urine, back pain, fever and chills, incontinence,
increased urinary frequency or urgency, painful urination, urinating frequently at night
• changes in blood (symptoms may include fever, sore throat, mouth ulcers, flu-like symptoms,
tiredness, unexplained bleeding or bruising, or makes infections more likely)
• aseptic meningitis, especially in people with existing immune disorders (such as “SLE”);
symptoms are fever, headache, stiff neck, nausea, vomiting, disorientation and skin rash
• headache, feeling of dizziness or “spinning”, ringing in the ears, impaired hearing, eyesight
problems (such as changes in colour vision, blurred, partial or complete loss of vision, blind
spots, halos around lights), tingling or numbness in the hands and feet, depression, anxiety,
hallucinations, nervousness, tiredness, difficulty sleeping, drowsiness, confusion, swelling and
irritation inside the nose.
Fluid retention (symptoms include swollen ankles), high blood pressure and heart failure have been
reported in people being treated with NSAIDs.
Medicines such as ibuprofen may be associated with a small increased risk of heart attack
(“myocardial infarction”) or stroke.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on
the safety of this medicine.
Storing this medicine
Keep this medicine in a closed container in a dry place away from heat and light.
Keep this medicine out of the sight and reach of children.
If your doctor decides to stop treatment, return any left over medicine to the pharmacist. Only
keep it if the doctor tells you to.
This medicine is for YOU. Only a doctor can prescribe it. Never give it to someone else. It may
harm them even if their symptoms are the same as yours.
Do not take the tablets if the expiry date on the label has passed.
Date of revised leaflet October 2015

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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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