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IBUPROFEN 600MG FILM COATED TABLETS BP

Active substance(s): IBUPROFEN

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Ibuprofen 600 mg film-coated tablets BP
ibuprofen









Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
• 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 is in this leaflet:
1. What Ibuprofen Tablets are and what they are used for
2. What you need to know before you take Ibuprofen Tablets
3. How to take Ibuprofen Tablets
4. Possible side effects
5. How to store Ibuprofen Tablets
6. Contents of the pack and other information
1. What Ibuprofen Tablets are and what they are used for
Ibuprofen tablets belong to a group of medicines called non–steroidal anti-inflammatory
drugs (NSAIDs), which relieve pain and reduce inflammation in conditions such as osteoarthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease), arthritis of spine (ankylosing spondylitis), swollen joints, frozen shoulder, bursitis, tendinitis,
tenosynovitis, lower back pain, sprains and strains.
Ibuprofen Tablets can also be used to treat other painful conditions such as toothache,
pain after operations, period pain and headache, including migraine.
2. What you need to know before you take Ibuprofen Tablets
Do NOT take Ibuprofen Tablets if you:
• are allergic to ibuprofen, aspirin or any other painkillers, or to any of the other
ingredients contained in these tablets (listed in section 6 and end of section 2)
• have or ever have had stomach ulcers, bleeding or perforation or experienced any of
these symptoms in the past while taking NSAIDs
• are taking other NSAIDs, painkillers or aspirin with a daily dose above 75 mg
• suffer from severe liver, kidney or heart problems
• are in the last three months of pregnancy (see “Pregnancy and breast-feeding”)
• have taken mifepristone in the last 12 days (see “Other medicines and Ibuprofen
Tablets”).
Warnings and precautions
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.
There is a risk of renal impairment in dehydrated adolescents.
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
of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’
or transient ischaemic attack “TIA”).

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have high blood pressure, diabetes, high cholesterol, have a family history of heart
disease or stroke, or if you are a smoker.
have asthma, breathing difficulty or suffer from allergies
suffer from liver, kidney or bowel problems
suffer from certain rheumatic conditions (such as Systemic Lupus Erythematosus
(SLE) or mixed collagenosis)
have had a stomach or duodenal ulcer
have had ulcerative colitis or Crohn’s disease
are in the first six months of pregnancy
are having problems becoming pregnant
are elderly, as you might be at higher risk of developing side effects.

Use in children
This medicine is NOT recommended for children under 12 years of age (see section 3).
Other medicines and Ibuprofen Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Ibuprofen may affect or be affected by some other medicines. For example:
• water pills (diuretics such as furosemide, hydrochlorothiazide, triamterene)
• medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetyl
salicylic 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)
• cardiac glycosides such as digoxin (a heart medicine)
• methotrexate used to treat arthritis and certain forms of cancer
• lithium used to treat depression
• corticosteroids (an anti-inflammatory drug)
• zidovudine (an anti-viral drug)
• tacrolimus and ciclosporin (used to dampen down your immune response)
• quinolone antibiotics (e.g. ciprofloxacin)
• mifepristone (for termination of pregnancy). DO NOT take Ibuprofen Tablets if you
have taken mifepristone in the last 12 days
• cox-2 inhibitors e.g. celecoxib
• sulphonylureas such as glibenclamide (used to treat diabetes)
• anti-platelet agents and selective serotinin reuptake inhibitors (SSRIs) (used to for
treatment of depression)
• aminoglycosides (a type of antibiotic)
• ginkgo biloba herbal medicine (there is a chance you may bleed more easily if you are
taking this with ibuprofen)
• voriconazole or fluconazole (type of anti-fungal drugs)
• cholestyramine (a drug used to lower cholesterol).
Some other medicines may also affect or be affected by the treatment of Ibuprofen. You
should therefore always seek the advice of your doctor or pharmacist before you use
Ibuprofen with other medicines.
Ibuprofen Tablets with food and drink
The tablets should be swallowed with a drink of water. Take with or after food to reduce
the possibility of side effects (see section 3).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
• DO NOT use Ibuprofen Tablets in the last three months of pregnancy.
• Speak to your doctor or pharmacist before taking Ibuprofen tablets if you are in the
first six months of pregnancy, are breast-feeding or planning to breast-feed.

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Driving and using machines
Ibuprofen Tablets may cause dizziness, drowsiness, visual disturbances or headache.
Make sure you know how this medicine affects you before you drive or operate machinery.
3. How to take Ibuprofen Tablets
Always take Ibuprofen Tablets exactly as your doctor has told you. If you are not sure how
much to take, ask your doctor or your pharmacist.
The tablets should be swallowed with a drink of water. Take with or after food to reduce
the possibility of side effects.
Adults (including elderly)
Take one 600 mg tablet initially, followed by one 600 mg tablet every six hours if
necessary. DO NOT take more than four tablets (2400 mg) in any 24 hour period.

Uncommon side effects (affecting between 1 in 100 and 1 in 1,000 people)
• kidney damage or kidney failure with symptom such as swelling of the ankle
• liver problems including hepatitis and jaundice (yellowing of the skin or the white of
the eyes)
• headache, dizziness, ringing in the ears, tiredness, drowsiness, confusion, blurred
vision, pins and needles, depression or hallucinations.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow
Card Scheme: www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.
5. How to store Ibuprofen Tablets
Keep this medicine out of the sight and reach of children.

If you are not sure how much to take, ask your doctor or your pharmacist.

Do not store above 25°C.

Use in children
This medicine is NOT recommended for children.

Store in the original package.

DO NOT exceed the stated dose.
If symptoms persist, consult your doctor or pharmacist.

Do not use the tablets after the expiry date which is stated on the label or carton, after
EXP (“EXP” will need to be confirmed by yourselves first). The expiry date refers to the
last day of that month.

If you take more Ibuprofen Tablets than you should
If you have taken more tablets than you should, speak to your doctor or pharmacist
straight away. Signs of overdose may include headache, vomiting (being sick),
drowsiness, dizziness and fainting.

Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will help
protect the environment.

If you forget to take Ibuprofen Tablets
If you have missed a dose, take it as soon as you remember and then take your next dose
after six hours. DO NOT take a double dose to make up for the missed dose.

What Ibuprofen Tablets contain

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Ibuprofen Tablets may sometimes cause side effects although not
everyone gets them.
STOP taking these tablets and seek medical help IMMEDIATELY if you experience any
of the following reactions:
• difficulty breathing or swallowing, swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised lumps
• pass blood in your faeces (stools/motions)
• pass black tarry stools
• vomiting any blood or dark particles that look like coffee grounds
• indigestion or heart burn
• abdominal pain (pain in your stomach) or other abnormal stomach symptoms
• blurred or disturbed vision or seeing/hearing strange things.
Other possible side effects:
Common side effects (affecting between 1 in 10 and 1 in 100 people)
• hypersensitive reactions with hives and itchy rash
• nausea (feeling sick), sickness, diarrhoea, flatulence, constipation
• peptic ulcers
• perforation or gastric bleeding, especially in the elderly
• abdominal pain, acid indigestion.

6. Contents of the pack and other information
The active substance is ibuprofen.
The other ingredients are maize starch, microcrystalline cellulose, croscarmellose sodium,
povidone, colloidal anhydrous silica, alginic acid, sodium laurilsulfate, sodium starch
glycolate Type A, magnesium stearate, hyprolose, hypromellose, macrogol 400,
erythrosine aluminum Lake (E127) and titanium dioxide (E171).
What Ibuprofen Tablets look like and contents of the pack
The tablets are pink and film coated.
They are available in packs of 50, 84, 100, 250 or 500 tablets (not all pack sizes may be
marketed).
Marketing Authorisation Holder
Aurobindo Pharma Limited
Ares, Odyssey Business Park
West End Road
South Ruislip, HA4 6QD
United Kingdom
Manufacturer
Bristol Laboratories Limited
Unit 3, Canal side, Northbridge road
Berkhamsted, Herts, HP4 1EG
United Kingdom
This leaflet was last revised in 11/2015

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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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