Package leaflet:

Information for the patient Ibuprofen Tablets BP 200mg AND 400mg

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 questions, 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.

•    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.

In this leaflet:

1.    What Ibuprofen is and what it is 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.    Further Information

1. WHAT IBUPROFEN IS AND WHAT IT IS USED FOR

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAID). Ibuprofen works by reducing swelling and pain in the body and also reducing a high temperature.

Ibuprofen is used to treat:

■    rheumatoid arthritis    ■    inflammation of the area surrounding the joints

■    juvenile rheumatoid arthritis    ■    lower back pain

■    Still’s disease    ■ post operative pain

■    inflammation of the joints of the spine ■    sprains

■    osteoarthritis    ■    muscle strains

■    non- rheumatoid joint diseases    ■    tooth ache

■    frozen shoulder    ■    headache

■    inflammation of the tendons    ■    migraine

■    period pain

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN

DO NOT take Ibuprofen if you:

■    are allergic (hypersensitive) to ibuprofen or any of the other ingredients in these tablets (listed in section 6).

■    ever had an allergic reaction caused by aspirin or other related non-steroidal antiinflammatory painkillers (e.g. swelling of the face or throat, shortness of breath, skin rash, asthma, irritation of the nose)

■    suffer from severe heart failure, kidney failure or liver failure

■    are taking other non-steroidal anti-inflammatory painkillers, or aspirin with a daily dose above 75mg

■    have (or have had two or more episodes of) a stomach ulcer perforation or bleeding

■    have or ever had stomach ulcer perforation or bleeding because of taking NSAIDs in the past

■    are in the last trimester (last 3 months) of pregnancy

■    suffer with conditions involving an increased tendency to bleeding

Warnings and precautions

Talk to your doctor or pharmacist before taking Ibuprofen.

■    if you have a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease), stomach or bowel problems

■    suffer from asthma or a history of asthma

■    suffer from Systemic Lupus Erythematosus (SLE) or mixed connective tissue disease

■    have high blood pressure

■    have kidney, liver or heart problems

■    are elderly

■    have a blood clotting disorder e.g. thrombocytopenia, haemophilia

■    have rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption

Anti-inflammatory/ pain-killer medicines like Ibuprofen may be associated with a small increased risk of heart attack (myocardial infraction) 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 if you have a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet dues 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 are a smoker)

Other medicines and ibuprofen

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:

•    medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic 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)

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.

Warning: The use of Ibuprofen with other NSAIDs including cyclooxygenase- 2 selective (COX-2) inhibitors should be avoided.

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

What should you avoid when you are taking this medicine:

■    anticoagulants (against clotting e.g acetylsalicylic acid/ aspirin, warfarin, ticlopidin)

■    blood pressure medicines (ACE- inhibitors e.g. captopril, beta-receptor blocking medicines, angiotensin II antagonists)

■    diuretics (water tablets)

■    cardiac glycosides e.g. digoxin (used to treat heart conditions)

■    methotrexate (used to treat cancer, rheumatoid arthritis, psoriasis)

■    lithium, venlafaxine or SSRIs (used to treat depression)

■    zidovudine (an anti-viral medicine, used to treat AIDS and HIV)

■    aspirin, with a daily dose above 75mg or other anti- inflammatory painkillers

■    corticosteroids (used to treat inflammation)

■    amino-glycosides (antibiotics that fight against bacteria)

■    Immuno-suppressants (used to treat patients who had an organ transplant, or to treat other problems with immune system e.g. ciclosporin and tracrolimus)

■    mifepristone (to terminate pregnancy) in the last 12 days

■    quinolone antibiotics (used to treat infections e.g. levofloxacin, ciprofloxacin)

■    ginko bilboba, a herbal remedy used as a memory and concentration enhancer

■    cholestyramine (used with diet changes to reduce the amount of cholesterol and certain fatty substances in your blood)

■    sulfonylureas (used to increase the amount of insulin produced by the pancreas)

■    antifungal agents (including voriconazole and fluconazole)

Some other medicines may affect or be affected by the treatment of Ibuprofen.

Always seek advice of a doctor before you use Ibuprofen with other medicines.

Pregnancy, breast-feeding and fertility

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 take Ibuprofen tablets if you are in the last three months (last trimester) of pregnancy. The use of ibuprofen should be avoided during the first 6 months of pregnancy, unless the potential benefits to the patient outweighs the potential risk to the foetus on advice of the doctor.

Note: 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.

In the limited studies so far available, ibuprofen appears in the breast milk in very low concentrations. Ibuprofen should, if possible, be avoided when breast-feeding.

Driving and using machines

Ibuprofen tablets may cause drowsiness, problems with your eyesight, dizziness, drowsiness and tiredness. If affected do not drive or operate machinery.

Ibuprofen Tablets contain Sucrose

■ If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product

3. HOW TO TAKE IBUPROFEN

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Note to patient: This medicine is intended for short-term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms. This may reduce side effects.

Dosage

For oral use

Take your medicine with or after food with a glass of water. This will reduce stomach upset. Ibuprofen tablets should be swallowed whole and not chewed, broken, crushed or sucked on to avoid oral discomfort and throat irritation.

The recommended dose is:

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.

Elderly

If you are elderly you are more likely to suffer from side effects when you take your tablets. A lower dose should be considered for elderly patients and those with liver and kidney problems.

Children under 12 years

Please take exactly as prescribed by your doctor. The usual daily dosage of Ibuprofen for children is 20mg per kilogram of body weight in divided doses. This may be doubled in the case of juvenile rheumatoid arthritis. In children weighing less than 30kg the total daily dose should not exceed 500mg. In children weighing less then 7kg the use of ibuprofen is not recommended.

If you take more Ibuprofen than you should

If you (or somebody else) take too many Ibuprofen tablets, or you begin to feel unwell after taking Ibuprofen tablets, contact your doctor or go to the nearest hospital casualty department immediately.

If you forget to take Ibuprofen

If you forget to take a dose, take it as soon as you remember it, unless it is almost time for your next dose. Do not take a double dose to make up for the forgotten 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, this medicine can cause side effects, although not everybody gets them. Do not be alarmed by the possible side effects. Most people taking this medicine find it causes them no problems.

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

STOP taking Ibuprofen and tell your doctor immediately or go to your nearest hospital emergency department if you:

■    have an allergic reaction to the tablets (symptoms include swelling of the face and throat, wheezing, difficulty breathing, itching and skin rash that may include blistering or peeling of the skin)

■    pass blood in your faeces (stools/ motions)

■    pass black tarry stools

■    vomit any blood or dark particles that look like coffee grounds

STOP TAKING Ibuprofen and tell your doctor as soon as possible if you experience:

■ indigestion (dyspepsia) or heart bum

■    hypertension (high blood pressure) and heart problems (heart failure) or stroke

■    flatulence (wind) and constipation

■    worsening of colitis and Crohn’s disease

■    nausea, vomiting, diarrhoea

■    aseptic meningitis with symptoms such as stiff neck, headache, nausea, vomiting, fever and disorientation

■    depression

■    insomnia

■    anxiety

■    fatigue (tiredness)

■    malaise

■    pancreatitis (inflammation of the pancreas) symptoms include abdominal pain, fever and increased heart rate

■    abdominal pains (pain in your stomach) or other abdominal symptoms

■    swelling of the legs or ankles caused by water retention

■    kidney problems or kidney failure (blood in the urine, difficulty in passing urine)

■    liver problems (nausea, vomiting, loss of appetite, fever, light coloured stools)

■    jaundice (yellowing of the skin or eyes)

■    hepatitis

■    anaemia or other blood disorders (fever, sore throat, mouth ulcers, exhaustion, unexplained bleeding or bruising)

■    skin disorders including Stevens Johnson Syndrome, blistering of the skin and increased sensitivity of the skin to sunlight

■    headaches, confusion, hallucinations, ringing in the ears, hearing impaired, vertigo dizziness, drowsiness, problems with vision, pins and needles

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 at 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

Do not use the medicine after the expiry date shown on the label.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Do not store above 25^oC (room temperature). Store in a dry place and protect them from light. Keep the tablets in the original container.

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 to protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Ibuprofen contains

The active ingredient is Ibuprofen.

The other ingredients are: magnesium stearate, talc, stearic acid, aerosil, kollidon C, starch, water, FD&C Red No. 3 (E127), quinoline yellow (E104), sodium benzoate, titanium dioxide (E171), sucrose, beeswax, carnauba wax, ethanol, and shellac.

What Ibuprofen looks like and contents of the pack

The tablets are available in two different strengths containing either 200mg or 400mg of ibuprofen.

Ibuprofen Tablets BP 200mg and 400mg are pink, sugar coated tablets containing 200mg or 400mg of the active ingredient ibuprofen.

Ibuprofen tablets are available in containers of 84, 250 or 500 tablets or in white blister packs of 12, 24, 48, 84, 96 or 100.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland

Manufacturer responsible for release: Kent Pharmaceuticals Limited, Wotton Road, Ashford, Kent TN23 6LL, United Kingdom

This leaflet was last revised 26/04/16