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PACKAGE LEAFLET: INFORMATION FOR THE USER

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”).

•    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.

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.

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

Use in children

This medicine is NOT recommended for children.

DO NOT exceed the stated dose.

If symptoms persist, consult your doctor or pharmacist.

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.

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.

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.

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.

Do not store above 25°C.

Store in the original package.

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.

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.

6. Contents of the pack and other information

What Ibuprofen Tablets contain

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