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IBUPROFEN 600MG TABLETS BP
Active substance(s): IBUPROFEN
Patient Information Leaflet
Ibuprofen 600 mg Tablets BP
This medicine will be called Ibuprofen Tablets
in this leaflet.
Read all of this leaflet carefully before you start taking
• Keep this leaflet. You may need to read it again.
• This medicine is only for you. Do not give it to anyone else to
take. It may harm them, even if their symptoms are the same
• If you have any further questions, please ask your doctor or
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. See section 4.
What Ibuprofen Tablets are and what they are used for
Before you take Ibuprofen Tablets
How to take Ibuprofen Tablets
Possible side effects
How to store Ibuprofen Tablets
1. What Ibuprofen Tablets are and what they are
These tablets contain the active ingredient, ibuprofen. Ibuprofen
is a non-steroidal anti-inflammatory drug (NSAID) which relieves
pain and reduces inflammation.
Ibuprofen Tablets are used to relieve mild or moderate pain for
instance when you have:
• Rheumatoid arthritis or osteoarthritis
• Ankylosing spondylitis (where you get stiff and painful back
and hip joints)
• Pain and swelling in and around other joints
• An injury to the soft tissues such as sprains and strains.
2. Before you take Ibuprofen Tablets
Some people must not take these tablets. Do not take
these tablets if:
• You know you are allergic to ibuprofen or to any of the other
ingredients (these are listed in section 6)
• You have had allergic reactions (e.g. asthma, blocked or runny
nose, swelling of the face or throat or itching) when you have
taken aspirin or other NSAID painkillers e.g. naproxen
• You 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
• You have had stomach bleeding or perforation ever caused by
• You have severe heart, liver or kidney problems
• You have a condition which increases your tendency to bleeding
• You are more than 6 months pregnant.
These tablets are not recommended for children.
There is a risk of renal impairment in dehydrated children and
You must be especially careful if:
• You have, or have ever had asthma as ibuprofen might bring
on an attack
• You have a history of problems with your stomach or
intestines e.g. ulcerative colitis or Crohn’s disease
• You have heart, liver or kidney problems
• You have high blood pressure
• You have systemic lupus erythematosus (SLE) or mixed
connective tissue disorder (an immune system disorder)
• You are elderly as you may be more likely to suffer side
effects (see section 4).
If any of the conditions above apply to you, please discuss your
treatment with your doctor before taking this medicine.
Taking other medicines
Ibuprofen Tablets may affect or be affected by some other
medicines. For example:
• Medicines that are anti-coagulants (i.e. thin blood/prevent
clotting e.g. warfarin, acetylsalicylic acid/aspirin, ticlopidine)
• Selective serotonin reuptake inhibitors (to treat depression
• Diuretics (to increase urine output)
• 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
• Lithium (to treat depression)
• Methotrexate (used in cancer treatment)
• Ciclosporin or tacrolimus (to prevent rejection in organ and
bone marrow transplants)
• Mifepristone (used to terminate pregnancy)
• Quinolone antibiotics (for infections)
• Aminoglycosides (a type of antibiotic e.g. neomycin)
• Zidovudine (to treat HIV infection)
• Voriconazole or fluconazole (to treat fungal infections)
• Colestyramine (used to lower cholesterol)
• Sulfonylureas e.g. glibenclamide (to treat diabetes)
• Ginko biloba (a herbal medicine). You may bleed more easily
if you are taking this with ibuprofen
• Oral steroids (used in hormone replacement therapy and to
• Aspirin or any other NSAID painkillers. If you take these at
the same time as ibuprofen you may increase the risk of
getting side effects.
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
• 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
• 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.
Driving and using machinery
Ibuprofen Tablets may make you feel dizzy, tired, drowsy or might
affect your vision. If you are affected you should not drive or
Pregnancy and breastfeeding
Are you pregnant, or breast feeding? Check with your doctor
before taking ibuprofen.
3. How to take Ibuprofen Tablets
The tablets should be swallowed with a drink of water. They
should be taken with or after food to reduce the possibility of
The doctor will decide what dose of tablets you need to take.
Always take the tablets exactly as the doctor has told you. The
dose will be on the pharmacist’s label. If you are not sure, ask
your doctor or pharmacist. Carry on taking them for as long as
you have been told unless you have any problems. In that case,
check with your doctor.
Continued, please turn over.
The usual dose is as follows:
Adults: Take 1 tablet initially, followed by 1 tablet every six hours
Do not take more than 4 tablets in any 24 hour period.
Elderly: Your doctor may have told you to take a lower dose than
the usual adult dose stated above. Follow your doctor’s
instructions. Your doctor may want to do some tests after you
start taking these tablets to check you are not bleeding in your
stomach or intestines.
Not recommended for children.
If you take more tablets than you should
If you have taken more Ibuprofen Tablets than you should, or if
children have taken medicine by accident always contact a
doctor or nearest hospital to get an opinion of the risk and advice
on action to be taken. Take your tablets or the pack with you so
that the doctor knows what you have taken.
The symptoms can include nausea, stomach pain, vomiting (may
be blood streaked), headache, ringing in the ears, confusion and
shaky eye movement. At high doses, drowsiness, chest pain,
palpitations, loss of consciousness, convulsions (mainly in
children), weakness and dizziness, blood in urine, cold body
feeling, and breathing problems have been reported.
If you forget to take a dose of Ibuprofen Tablets
If you have missed a dose, take it as soon as you remember and
then take your next dose after 6 hours. Do not take a double
dose to make up for the missed dose.
4. Possible side effects
Like all medicines Ibuprofen Tablets can cause side effects,
although not everybody gets them. There will be fewer side effects
if you take the lowest effective dose for the shortest time necessary.
Stop taking the tablets and seek immediate medical help
• Pass blood in your faeces (stools/motions)
• Pass black tarry stools
• Vomit any blood or dark particles that look like coffee grounds.
These may be signs of a stomach ulcer or bleeding in your
Stop taking the tablets and tell your doctor if you
• Stomach pain or other abnormal stomach symptoms,
indigestion or heartburn
• Allergic reactions which can include skin rash, itching,
bruising, painful red areas, flaking, peeling or blistering,
dizziness, difficulty in breathing, wheezing or shortness of
breath, swollen face, throat, lips, hands or fingers or sores
around the nose, mouth, ears, genitals or anus
• Yellowing of your skin or whites of your eyes and/or pale
stools, dark urine, loss of appetite as these may be signs of
• Passing more or less urine than normal, difficult or painful
urination, cloudy or foamy urine, blood in urine, pain in the
back, fever, rash, swelling (particularly of the ankles), high
blood pressure, as these may be signs of kidney
Effects reported vary rarely are:
• Inflammation of the pancreas causing severe pain in the
abdomen and back
• Stevens-Johnson syndrome (serious illness causing blistering
of the skin, mouth, eyes and genitals)
• Toxic epidermal necrolysis (serious illness causing blistering of
If you get any of these, stop taking the tablets and tell your
doctor as soon as possible.
Other effects which have been reported are:
• High blood pressure, oedema (water retention), heart failure
(which can cause shortness of breath or swollen ankles)
• Feeling or being sick, diarrhoea, constipation, flatulence (wind)
or sore mouth
• Worsening of the symptoms of colitis and Crohn’s disease
• Blood disorders including severe reduction in the number of
white or red blood cells which may cause pale skin, weakness
or breathlessness and increase the risk of bleeding or bruising
or make infections more likely
• Increased sensitivity to sunlight, skin rashes. A severe skin
reaction known as DRESS syndrome can occur. Symptoms of
DRESS include skin rash, fever, swelling of lymph nodes and
an increase of eosinophils (a type of white blood cell)
• Headache, feeling of dizziness or “spinning”, ringing in the
ears, impaired hearing, difficulty sleeping, tiredness,
drowsiness, confusion, anxiety, eyesight problems (such as
blurred, partial or complete loss of vision, change in colour
vison, blind spots, halos around lights), tingling or numbness
in the hands and feet, depression or hallucinations
• Aseptic meningitis (especially in patients with auto-immune
disorders such as systemic lupus erythematosus and mixed
connective tissue disease). Symptoms include fever,
headache, stiff neck and back, feeling or being sick, skin rash,
eyes being very sensitive to bright light, disorientation and
• Swelling and irritation inside the nose
• Inflammation of the stomach lining. Symptoms include
stomach pain or discomfort, feeling or being sick, loss of
appetite, bad taste in the mouth, belching and indigestion
• 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 or search
for MHRA Yellow Card in the Google Play or Apple App Store. By
reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Ibuprofen Tablets
Keep out of the sight and reach of children.
Blisters: Do not store above 25°C. Store in the original package
and in the outer carton to protect the tablets from light and
Tablet containers: Do not store above 25°C. Store in the
original container and keep the container tightly closed, in order
to protect the tablets from light and moisture.
Do not use the tablets after the expiry date shown on the carton
If your doctor tells you to stop taking the tablets, please take any
left over back to your pharmacist to be destroyed.
6. Further Information
Each coated tablet contains 600 mg of the active ingredient,
ibuprofen. The other ingredients are maize starch, microcrystalline
cellulose, croscarmellose sodium, povidone, colloidal anhydrous
silica, alginic acid, sodium laurilsulfate, sodium starch glycollate,
magnesium stearate, hydroxypropylcellulose,
hydroxypropylmethylcellulose, polyethylene glycol, erythrosine
(E127) and titanium dioxide (E171).
What the medicine looks like
The tablets are oblong, pink and film coated.
They are supplied to your pharmacist in containers of 50, 84, 100,
250 or 500 tablets. Not all pack sizes may be available.
Product licence holder and manufacturer
The product licence holder is Dalkeith Laboratories Ltd., 2 Park
Street, Woburn, Bedfordshire, MK17 9PG, UK.
Manufactured by RxFarma Ltd., Colonial Way, Watford, Herts,
WD24 4YR, UK.
Product Licence Number: PL 17496/0019
Date of revision: February 2018
If you would like the leaflet in a different format, please contact
the licence holder at the above address.