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Active substance(s): IBUPROFEN

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Package leaflet: Information for the user

Read all of this leaflet carefully before you start taking this medicine - because it contains
important information for you.
• Keep this leaflet as you may need to read it again
• This leaflet provides a summary of the information currently available about Ibuprofen
400mg & 600mg tablets
• For further information or advice 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
• Tell your doctor or pharmacist if you experience any side effects
What is in this leaflet
1. What Ibuprofen is and what is it used for
2. What you need to know before you take Ibuprofen
3. How to take Ibuprofen
4. Possible side effects
5. How to store Ibuprofen
6. Contents of the pack and other information
The full name of your medicine is Ibuprofen 400mg tablets or Ibuprofen 600mg tablets. In this
leaflet the shorter name Ibuprofen is used.

1. What Ibuprofen is and what is it used for
Ibuprofen belongs to a group of medicines called anti-inflammatory pain killers. They can be
used to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis
(including juvenile rheumatoid arthritis or Still’s disease), arthritis of the spine, ankylosing
spondylitis, swollen joints, frozen shoulder, bursitis, tendinitis, tenosynovitis, lower back pain,
sprains and strains.
Ibuprofen can also be used to treat other painful conditions such as toothache, pain after
operations, period pain and headache, including migraine.
The active ingredient in Ibuprofen Tablets is ibuprofen and each tablet contains either 400 or
600 mg.

2. What you need to know before you take Ibuprofen
If the answer to any of the following questions is ‘YES’ please tell your doctor or
pharmacist BEFORE taking any Ibuprofen:
Are you pregnant or planning to become pregnant, or are you breast-feeding? 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.
• Are you sensitive (allergic) to any of the ingredients in the tablets? These are listed in Section
• Do you have, or have you previously had, a stomach ulcer or other gastric complaint?
Do not take Ibuprofen if you currently 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 in the past.
• Do you have a condition which increases your tendency to bleeding?
• Do you suffer from asthma or have you ever had an allergic reaction or suffered from wheezing
after taking ibuprofen, aspirin or other anti-inflammatory pain killers?
• Do you suffer from swelling and irritation inside the nose?
• Do you suffer from liver or kidney disease?
• Do you suffer from heart disease?
Medicines such as Ibuprofen 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. You should discuss your
treatment with your doctor or pharmacist before taking Ibuprofen if you:
- have heart problems including heart failure, angina (chest pain) or you have had a heart
attack, bypass surgery or peripheral artery disease (poor circulation in the legs or feet due
to narrow or blocked arteries).
- have any kind of stroke or think that you might be at risk of these conditions (e.g. if you have
a family history of heart disease or stroke, high blood pressure, diabetes, high cholesterol
or are a smoker).
• Do you have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective
tissue disease (autoimmune diseases affecting connective tissue)?
• Do you have chicken pox or shingles?
• Have you been told by your doctor that you have an intolerance to some sugars?
• Is your child dehydrated?
There is a risk of kidney damage in dehydrated children and adolescents.
Can you take Ibuprofen with other medicines?
Some medicines that are anti-coagulants i.e. thin blood/prevent clotting e.g. aspirin/ acetylsalicyclic
acid, warfarin, ticlodipine), some medicines that reduce high blood pressure (ACE-inhibitors such
as captopril, beta-blockers such as atenolol, or angiotensin-II receptor antagonists such as
losartan) and other medicines may affect or be affected by treatment with ibuprofen. You should
therefore always seek the advice of your doctor or pharmacist before you use ibuprofen with
other medicines.
In particular you should tell your doctor or pharmacist if you are taking any of the following
medicines in addition to those mentioned above:
• Diuretics (water tablets)
• Cardiac glycosides, such as digoxin, used to treat heart conditions
• Lithium
• Zidovudine (an anti-viral drug)
• Steroids (used in the treatment of inflammatory conditions)
• Methotrexate (used to treat certain cancers and rheumatoid arthritis)
• Medicines known as immunosuppressants such as ciclosporin and tacrolimus (used to
dampen down your immune response)
• Medicines known as selective serotonin reuptake inhibitors (SSRis), used for the treatment of
• Antibiotics called quinolones such as ciprofloxacin
• Aminoglycosides (a type of antibiotic)
• Mifepristone
• Any other ibuprofen, such as those you can buy without a prescription
• Any other anti-inflammatory pain killer, including aspirin
• Cholestyramine (a drug used to lower cholesterol)
• Medicines known as sulphonylureas such as glibenclamide (used to treat diabetes)
• Voriconazole or fluconazole (type of anti-fungal drugs)
• Gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking
this with ibuprofen).
Pregnancy and breast-feeding: The use of Ibuprofen whilst pregnant or breast feeding should
be avoided. Ibuprofen should not be used in late (the last three months of) pregnancy and should
only be taken in the first six months of pregnancy on the advice of your doctor.
Driving and Using Machines: Ibuprofen may make you feel dizzy or drowsy. If the tablets affect
you in this way do not drive, operate machinery or do anything that requires you to be alert.

3. How to take Ibuprofen
ALWAYS take Ibuprofen exactly as your doctor has told you. If you are not sure refer to the label
on the carton or check with your doctor or pharmacist.
Take your Ibuprofen with or after food, with a glass of water.
Ibuprofen should be swallowed whole and not chewed, broken, crushed or sucked to help prevent
discomfort in the mouth or irritation in the throat.
Adults and children over 12 years - The usual dosage is 600 to 1800 mg spread throughout the
day. Your doctor may choose to increase this depending on what you are being treated for; but
no more than 2400 mg should be taken in one day.
Children -The usual daily dose is 20 mg per kg of bodyweight each day, given in divided doses.
Ibuprofen should NOT be taken by children weighing less than 7 kg. The 600 mg tablets should
not be given to children under the age of 12 years.
In cases of severe juvenile arthritis your doctor my increase the dosage up to 40 mg/kg in divided
You should avoid excessive use of painkillers. If you usually take painkillers, especially
combinations of different painkillers, you may damage your kidneys, tell your doctor if you are
already taking another painkiller before taking this medicine and your doctor will decide whether
you should take this medicine. This risk may be increased if you are dehydrated.
a doctor or go to the nearest hospital casualty department IMMEDIATELY taking your tablets
with you.
IF YOU FORGET TO TAKE YOUR IBUPROFEN take them as soon as you remember, unless it
is almost time for your next dose. If it is, do not take the missed dose at all. Never double up on
a dose to make up for the one you have missed.



4. Possible side effects
As with all medicines, Ibuprofen may cause side effects, although they are usually mild and not
everyone will suffer from them. If any side effects become serious or if you notice any side effects
that are not listed in this leaflet, please tell your doctor or pharmacist. You can minimise the risk
of side effects by taking the least amount of tablets for the shortest amount of time necessary to
control your symptoms.
STOP TAKING Ibuprofen and seek immediate medical help if you experience:
• Signs of aseptic meningitis such as severe headache, high temperature, stiffness of the neck
or intolerance to bright light.
• Signs of intestinal bleeding such as
o Passing blood in your faeces (stools/motions)
o Passing black tarry stools
o Vomiting any blood or dark particles that look like coffee grounds
• Unexplained stomach pain (abdominal pain) or other abnormal stomach symptoms, indigestion,
heartburn, feeling sick and/or vomiting.
• Unexplained wheezing, shortness of breath, skin rash, itching or bruising (these may be
symptoms of an allergic reaction).
• Yellowing of the eyes and/or skin (jaundice).
• Severe sore throat with high fever (these may be symptoms of a condition known as
• Blurred or disturbed vision (visual impairment) or seeing/hearing strange things (hallucinations).
• Fluid retention e.g. swollen ankles (this may be a sign of kidney problems).
• Severe spreading skin rash (Stevens-Johnson Syndrome and erythema multiforme, symptoms
include severe skin rash, blistering of skin, including inside mouth, nose, and genitals, as well
as skin peeling which may be accompanied with symptoms such as aching, headaches, and
Medicines such as Ibuprofen have been associated with a small increased risk of heart attack
(myocardial infarction) or stroke.
Medicines such as Ibuprofen have in exceptional cases been associated with severe skin
problems for patients with chicken pox or shingles.
Blood disorders, kidney problems, liver problems or severe skin reactions may occur rarely with
Very rarely Ibuprofen may cause aseptic meningitis (inflammation of the protective membrane
surrounding the brain).
Ibuprofen has also been shown to sometimes worsen the symptoms of Crohn’s disease or colitis.
Other side effects
Common (affects up to 1 in 10 people):
• Rash
• Feeling dizzy or tired
• Stomach pain, indigestion, diarrhoea, feeling sick, being sick, wind, constipation
• Headache- if this happens while you are taking this medicine it is important not to take any
other medicines for pain to help with this.
• Passing black tarry stools
• Passing blood in your fasces (stools/motions)
• Vomiting any blood
Uncommon (affects up to 1 in a 100 people):
• Feeling drowsy
• Feeling anxious
• Feeling a tingling sensation or ‘pins and needles’
• Difficulty sleeping
• Hives, itching
• Skin becomes sensitive to light
• Visual disturbances, hearing problems
• Hepatitis, yellowing of your skin or eyes, reduced liver function
• Reduced kidney function, inflammation of the kidneys, kidney failure
• Sneezing, blocked, itchy or runny nose (rhinitis)
• Stomach or gut ulcer, hole in the wall of the digestive tract
• Inflammation of your stomach lining
• Small bruises on your skin or inside your mouth, nose or ears
• Difficulty breathing, wheezing or coughing, asthma or worsening of asthma
• Ringing in ears (tinnitus)
• Sensation of feeling dizzy or spinning (vertigo)
• Mouth ulcers
• Serious allergic reaction which causes swelling of the face or throat
Rare (affects up to 1 in a 1000 people):
• Feeling depressed or confused
• Fluid retention (oedema)
• A brain infection called ‘non-bacterial meningitis’
• Loss of vision
• Changes in blood count - the first signs are: high temperature, sore throat, mouth ulcers, flulike symptoms, feeling very tired, bleeding from the nose and the skin
• Reduction in blood cells (anaemia)
• Serious allergic reaction which causes difficulty in breathing or dizziness
• Severe sore throat with high fever (agranulocytosis)
Very rare (affects up to 1 in 10,000 people):
• Liver failure
• Heart failure
• Heart attack
• Inflammation of the pancreas
• Skin problems (which can also affect inside your mouth, nose or ears) such as ‘StevensJohnson syndrome’, ‘toxic epidermal necrolysis’ or ‘erythema multiforme’.
• High blood pressure
Not known (frequency cannot be estimated from available data):
• Worsening of ulcerative colitis or Crohn’s Disease inflammation of the colon)
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: By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Ibuprofen
Your tablets should not be stored above 25° C. They should be kept in a safe place out of the
reach and sight of children as your medicine could harm them.
They should be kept in the original packaging. Do NOT take Ibuprofen after the ‘use by’ date
shown on the carton. If your doctor decides to stop your treatment, return any leftover tablets to
your pharmacist.
Only keep the tablets if your doctor tells you to.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
The active substance in Ibuprofen Tablets is Ibuprofen Ph.Eur. available as 400 or 600 mg tablets.
The tablets are white, pillow shaped and film-coated.
They are supplied in blister packs containing 60 tablets.
Ibuprofen Tablets inactive ingredients: microcrystalline cellulose, croscarmellose sodium, lactose
monohydrate, colloidal anhydrous, silica, sodium laurilsulfate, magnesium stearate, Opaspray
white M-1- 7111 B (comprising hypromellose 291 0 and titanium dioxide), dry colour dispersion,
white 06A28611 (or a combination of Opaspray white M-1- 7111 B, hypromellose and talc).
Marketing Authorisation Holder:
Abbott Laboratories Limited
Abbott House
Vanwall Business Park
Vanwall Road
7 Anthousas Av.
15344 Anthousa Attiki
This leaflet was last revised in 08/2017




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