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PACKAGE LEAFLET: INFORMATION FOR THE USER

= IBUPROFEN COATED TABLETS 200 mg

•    PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE

•    Keep this leaflet. You may want to read it again

•    If you have any further questions, ask your pharmacist

•    This medicine has been prescribed for you. Do NOT pass it on to others. It may harm them even if their symptoms are the same as yours

•    If any of the side effects become severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet:

1.    What Ibuprofen tablets are and what they are used for

2.    Before you take Ibuprofen

3.    How to take Ibuprofen tablets

4.    Possible side effects

5.    How to store Ibuprofen tablets

6.    Further information

1.    What Ibuprofen tablets are and what they are used for

Ibuprofen is one of a group of medicines called non-steroidal anti-inflammatory drugs or NSAIDs, which work by changing the body's response to pain, swelling and high temperature. These tablets are used to provide relief of headache, muscular pain, rheumatic pain, backache, neuralgia (nerve pain), migraine, period pain, dental pain, feverishness and the symptoms of colds and flu.

2.    Before you take Ibuprofen Tablets

Do not take these tablets if:

•    you have had an allergic reaction to aspirin, Ibuprofen, any other NSAIDs or any of the ingredients (see section 6 for further information)

•    you have had worsening of asthma, developed an allergic rash, facial swelling or an itchy runny nose when taking Ibuprofen, aspirin or similar medicines

•    you have had liver, kidney or severe heart problems

•    you have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding

•    you are in the last 3 months of pregnancy

•    you are under 12 years of age

Take special care and tell your doctor or pharmacist if:

•    you have high blood pressure

•    you have asthma or have suffered from asthma

•    you have kidney, heart, bowel or liver problems

•    you have a condition known as Systemic Lupus Erythematosus (SLE) - an illness which affects your immune system. It causes joint pain, skin changes and problems with other parts of your body

•    you are elderly

•    you are pregnant or breastfeeding (see section You are pregnant or breastfeeding)

•    you have heart problems, previous stroke or think that you might beat risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker), in which case, you should discuss your treatment with your doctor or pharmacist

Important warning

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 stated dose or duration of treatment of (10 days).

Taking other medicines

Do not take this medicine if you are taking aspirin at doses above 75mg daily. If you are on low dose aspirin (up to 75mg daily) speak to your doctor or pharmacist before you take Ibuprofen.

Tell your doctor if you are taking other medicines especially the following

•    other pain relievers or products containing aspirin, Ibuprofen or other NSAIDs

•    medicines for high blood pressure e.g. diuretics (frusemide, bendroflumethiazide, hydrochlorothiazide), ACE inhibitors (enalapril, ramipril). Angiotensin II receptor blockers (losartan), beta blockers (atenolol), calcium channel blockers (amlodipine)

•    medicines for treating heart conditions e.g. digoxin for atrial fibrillation (a condition with an irregular heart beat)

•    medicines for thinning the blood (e.g. warfarin and tidopidine)

•    corticosteroids (e.g. prednisolone)

•    mifepristone (a medicine which is used to start labour)

•    medicines which weaken the immune system (cidosporin)

•    methotrexate (a medicine for cancer) and rheumatoid arthritis

•    medicines for depression and mood stabilising drugs (lithium, citalopram and fluoxetine)

•    quinolone antibiotics and zidovudine (medicines used to treat bacterial and viral infection)

You should therefore always seek the advice of your doctor or pharmacist before you take Ibuprofen with other medicines.

You are pregnant or breast-feeding

Ibuprofen belongs to a group of medicines which may impair fertility in women. This effect is reversible on stopping Ibuprofen. It is unlikely that Ibuprofen, when used occasionally, will affect your chances of becoming pregnant, however, tell your doctor before taking this medicine if you have problems becoming pregnant.

Speak to your doctor or pharmacist before taking Ibuprofen, if you are pregnant, think you are pregnant, are planning to become pregnant or are breastfeeding.

Driving and using machinery

Taking Ibuprofen will not affect your ability to drive or use machines.

Important information about the ingredients in Ibuprofen Tablets

Ibuprofen tablets contain lactose monohydrate and sucrose. If you have been told by you doctor that you have intolerance to some sugars you should not take this medicine.

Taking with food and drink

Ibuprofen tablets should be taken with water, preferably with or after food.

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3.    How to take Ibuprofen

This product is intended for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms. You should not take Ibuprofen for longer than 10 days unless your doctor tells you to. If symptoms persist or worsen consult your doctor.

Adults, the elderly and children over 12 years:

Dose for Ibuprofen:

•    take one to two tablets with water to start with, preferably with or after food, followed by one to two tablets every four hours if necessary up to three times a day

•    Do not take more than six tablets in any twenty-four hour period

Children under 12 years:

Do not give Ibuprofen to children under 12 years old.

If you think you have taken more Ibuprofen than you should:

If you take too many Ibuprofen tablets talk to your doctor straight away or go to the nearest hospital casualty unit.

If you forget to take Ibuprofen:

If you have missed a dose, do not double up on a dose to make up for the forgotten dose. Take the next dose at the usual time.

If you stop using Ibuprofen:

Please speak to your doctor or pharmacist before stopping this or any medicine.

4.    Possible side effects

Like all medicines Ibuprofen can have side effects, although not everybody gets them.

If you get any of these SERIOUS side effects, stop taking the tablets and go to your nearest casualty department at once:

•    Vomit any blood or dark particles that look like coffee grounds

•    Pass blood in your faeces (stools/motions)

•    Pass black tarry stools

•    Stomach problems including pain, indigestion or heartburn

•    Severe skin conditions, causing peeling and blistering of the skin, mouth and eyes

•    Unexplained wheezing, shortness of breath, swelling of the lips, face or neck, skin rash or itching, fast heart beat, or low blood pressure, as these may be signs of an allergic reaction

•    Meningitis (e.g. stiff neck, fever, disorientation)

These other effects are LESS SERIOUS. If they bother you talk to a doctor or pharmacist:

•    Kidney or liver problems

•    Nausea (feeling sick)

•    Headaches

•    Abdominal pain (pains in your stomach) or other abdominal stomach symptoms

•    Indigestion or heartburn

•    Fever, sore throat, mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising

Uncommon side effects (less than 1 per 100 but more than 1 per 1000) which may occur are as follows:

•    Headaches

•    Nausea (feeling sick)

•    Various skin rashes

Rare side effects (less than 1 per 1000 but more than 1 per 10,000) which may occur are as follows:

•    Diarrhoea

•    Flatulence (passing wind)

•    Constipation

•    Vomiting

Very rare side effects (less than 1 per 10,000) which may occur are as follows:

•    Kidney or liver problems

•    Symptoms of aseptic meningitis (stiff neck, headache, feeling sick, vomiting, fever or disorientation)

The following side effects may also occur but it is not known how frequently they occur:

•    Worsening of a previous asthmatic condition

•    High blood pressure

•    Abnormal fluid accumulation in tissues of the body (oedema)

•    Heart failure, a condition in which the heart is unable to pump blood and oxygen to the rest of the body

•    Worsening of inflammatory bowel conditions such as ulcerative colitis and Crohn's disease.

Medicines such as Ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

If you experience any of these symptoms, or have any other unusual symptoms or concerns with your medicine, stop taking Ibuprofen and see your doctor.

5.    How to store Ibuprofen

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

•    do not store above 25°C

•    store in the original package to protect from moisture

•    do not use after the expiry date shown on the package

6.    Further information

What does each Ibuprofen tablet contain:

Each tablet contains the active ingredient Ibuprofen BP 200mg. Other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycollate, starch, colloidal anhydrous silica, magnesium stearate, sucrose, talc,titanium dioxide (E171)and carnauba wax.

What is in the pack:

This product contains white round sugar coated tablets. Ibuprofen is available in blister packs of 6,12 and 16 tablets*.

Marketing Authorisation Holder and Manufacturer: Ibuprofen 200 mg Coated Tablets are manufactured by Marksans Pharma Ltd. Lotus Business Park, 21st Floor, Off New Link Road, Andheri (West), Mumbai for the Marketing Authorisation Holder Bell, Sons & Co. (Druggists) Ltd. Southport PR9 9AL England.

*not all pack sizes may be marketed PL03105/0086

C73-0290Ver B Revised July 2012 GULT301