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PACKAGE LEAFLET - INFORMATION FOR THE USER

IBUPROFEN 200MG TABLETS BP

(Ibuprofen)

Read all of this leaflet carefully because it contains important information for you:

This medicine is available without prescription.

Nevertheless, you still need to use Ibuprofen 200mg

tablets carefully to get the best results from it.

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

•    Ask your pharmacist if you need more information or advice.

•    You must see a doctor if your symptoms worsen or do not improve in 3 days.

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

In this leaflet:

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

2.    Before you take Ibuprofen tablets

3.    How to take Ibuprofen tablets

4.    Possible side effects

5.    How to store Ibuprofen tablets

6.    Further information

1. WHAT ARE IBUPROFEN TABLETS AND WHAT ARE THEY USED FOR

Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-inflammatory Drugs (NSAIDs) that work by relieving pain, reducing inflammation, swelling and fever.

Adults, Elderly and Children over 12 years:

Rheumatic or muscular pain, backache, neuralgia, migraine, headache, dental pain, period pain, feverishness and symptoms of cold and infuenza.

Children under 12 years:

Rheumatic or muscular pain, headache, dental pain, feverishness symptoms of cold and infuenza.

2. BEFORE YOU TAKE IBUPROFEN TABLETS

Do not take Ibuprofen tablets if any of the following apply to you.

•    I f you are allergic (hypersensitive) to Ibuprofen, or to any of the ingredients of Ibuprofen tablets (see What Ibuprofen Tablet contains, section 6).

•    If you have ever had a stomach ulcer or other gastric problems.

•    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.

•    If 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.

•    If you suffer from severe heart, kidney or liver problems.

•    If you are pregnant and in the last 3 months of pregnancy.

Take special care with Ibuprofen tablets

Talk to your doctor or pharmacist before taking this medicine:

•    If you have a history of ulcerative colitis or crohn’s disease.

•    If you suffer from kidney or liver problems.

•    If you suffer from heart problems.

Medicines such as Ibuprofen Tablets 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. If you have heart problems, previous stroke or think that you might be at risk of these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

•    If you are suffering or have a previous history of bronchial asthma.

•    If you are elderly-you may get more side effects.

•    If you are trying to become pregnant (ibuprofen belongs to a group of medicines (NSAIDs) which may impair fertility in women. This effect is reversible upon stopping the medicine. It is unlikely that ibuprofen, used occasionally will affect your chances of becoming pregnant, however, tell your doctor before taking this medicine, if you have problems becoming pregnant).

•    If you are taking aspirin at doses of above 75mg daily or if you are on low-dose aspirin (up to 75mg daily).

•    If you are in the first 6 months of pregnancy.

Taking other medicines

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those medicines obtained without a prescription.

In particular you should tell your doctor or pharmacist if you are taking any of the following medicines in addition to those mentioned above:

•    Anti-coagulants (used to thin blood/prevent clotting e.g. aspirin/acetylsalicyclic acid, warfarin, ticlodipine).

•    ACE-inhibitors (used to reduce high blood pressure such as captopril, beta-blockers such as atenolol, or angiotensin-II receptor antagonists such as losartan).

•    Diuretics (water tablets).

•    Cardiac glycosides (used to treat heart conditions e.g. digoxin).

•    Lithium (used to treat depression).

•    Zidovudine (an anti-viral drug).

•    Steroids (used in the treatment of inflammatory conditions).

•    Methotrexate (used to treat certain cancers).

•    Ciclosporin and tacrolimus (used to dampen down your immune response).

•    Selective serotonin reuptake inhibitors (SSRIs)(used to treat depression).

• Antibiotics called    quinolones    such as

ciprofloxacin.

•    Aminoglycosides (a type of antibiotic).

•    Mifepristone (used to induce abortion).

•    Any other ibuprofen preparations, such as those you can buy without a prescription.

•    Any other anti-inflammatory pain killer, including aspirin.

• Cholestyramine (a    drug used to lower cholesterol).

•    Glibenclamide (used to treat diabetes).

•    Voriconazole or fluconazole (used to reduce fungal infection).

Pregnancy and Breastfeeding

The use of Ibuprofen tablets 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.

Taking with Food and Drink

Ibuprofen can be taken with or after food.

Driving and using Machines

Ibuprofen may make you feel dizzy. If the tablets affect you in this way do not drive, operate machinery or do anything that requires you to be alert.

Important information about some of the ingredients of Ibuprofen tablets

These tablets contain lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Ibuprofen tablets.

3. HOW TO TAKE IBUPROFEN TABLETS

For oral administration and short term use only.

Adults, the elderly and children over 12 years:

Ibuprofen 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.

1 or 2 tablets up to 3 times a day, as required. The tablets should be taken with water. Take only as much as you need and leave at least 4 hours between each dose. Do not take more than 6 tablets in any 24 hour period. Do not give to children under 12 years.

If you take more Ibuprofen tablets than you should

If you or someone else swallows several of these

tablets all together, or you think a child has swallowed any of these tablets, contact your doctor or pharmacist or hospital emergency department immediately. Always take any tablets left over with you, also the box and leaflet as this will allow easier identification of the tablets.

If you forget to take Ibuprofen tablets

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose and just carry on as before. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

If any of the following happens, stop taking Ibuprofen tablets and tell your doctor immediately or go to the casualty department at your nearest hospital.

•    Swelling of the face, neck, lips, tongue or throat, leading to difficulty breathing or swallowing; skin rash, hives (allergic reaction).

•    Severe headache, high temperature, stiffness of the neck or intolerance to light.

•    Passing blood in your faeces (stools/motions).

•    Passing black tarry stools.

•    Vomiting any blood or dark particles that look like coffee grounds.

Tell your doctor and stop taking the tablets if you experience:

•    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,

•    Yellowing of the eyes and/or skin,

•    Severe sore throat with high fever,

•    Blurred or disturbed vision or seeing/hearing strange things,

•    Fluid retention (e.g. swollen ankles).

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

Blood disorders, kidney problems, liver problems or severe skin reactions may occur rarely with ibuprofen.

Very rarely Ibuprofen Tablets may cause aseptic meningitis    (inflammation of the protective

membrane surrounding the brain).

Other unusual effects may include headache, hallucinations, dizziness, tingling of hands and feet, ringing in the ears, depression, confusion, difficulty sleeping, anxiety, impaired hearing, diarrhoea,    constipation,    flatulence (wind),

unexpected sensitivity of the skin to the sun, tiredness, malaise, mood swings and swelling and irritation inside the nose.

Ibuprofen has also been shown to sometimes worsen the symptoms of Crohn’s disease or colitis.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Glycollate and Colloidal Anhydrous Silica (see section 2 for Important information about some of the ingredients of Ibuprofen tablets).

Coating ingredients

Ibuprofen 200mg tablets contains Opaglos NA 7150(Shellac, Acetylated monoglyceride, Povidone), Sucrose, Titanium dioxide, Starch (maize), Talc, Calcium carbonate, Sodium benzoate, Acacia, Opalux AS-F-1537(Sucrose, Titanium dioxide, Erythrosine, Sodium benzoate),Sugar syrup 70%(Sugar and Sodium benzoate) and Opaglos    6000P(Beeswax,

Carnauba wax, Shellac).

The printing ink is composed of Ferric oxide black and Shellac.

What Ibuprofen Tablet looks like and contents of the pack?

Ibuprofen 200mg tablets are round, pink, sugar coated, plain on one side, IB2 on the other side.

Ibuprofen 200mg tablets are available in blister pack of 12 tablets.

Marketing Authorisation Holder

Accord Healthcare Limited,

Sage House, 319, Pinner Road,

North Harrow, Middlesex, HA1 4HF,

United Kingdom.

Manufacturer

Ranbaxy Ireland Ltd.,

Spafield, Cork Road, Cashel,

Co. Tipperary, Ireland.

This leaflet was last approved in {07/2012}.

(GSL)

5. HOW TO STORE IBUPROFEN TABLETS

Keep out of the reach and sight of children.

Do not use your tablets after the expiry date stated on the label or carton.

Do not store above 25°C. Store in the original package.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Ibuprofen Tablet contains?

The active substance is Ibuprofen 200mg.

The inactive ingredients are Povidone K30, Lactose monohydrate, Starch Maize, Microcyrstalline Cellulose, Sodium Starch