• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor or pharmacist if your symptoms worsen or do not improve.

1. What this medicine is for
2. Before you take the medicine
3. How to take the medicine
4. Possible side effects
5. Storing the medicine
6. Further information

• have or have had a stomach ulcer, perforation or bleeding of the stomach
• are allergic to ibuprofen, to any of the ingredients (listed in section 6), or to aspirin or other painkillers (an allergic reaction may be recognised as shortness of breath, runny nose, skin rash or itching)
• have kidney or heart failure or severe liver failure
• are taking more than 75 mg of aspirin a day
• are in the last 3 months of pregnancy.

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck region (angioedema), chest pain have been reported with ibuprofen. Stop immediately this medicine and contact immediately your doctor or medical emergencies if you notice any of these signs.

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.

If you are taking this medicine for longer than the recommended time or at higher than recommended doses you are at risk of serious harms. These include serious harms to the stomach/gut and kidneys, as well as very low levels of potassium in your blood. These can be fatal (see section 4).

Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using this medicine and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

• are elderly because you may be at more risk of having serious side effects, particularly stomach problems
• have or have suffered from asthma or have allergies
• have liver or kidney problems
• have stomach or bowel disorders including Crohn’s disease or a condition known as ulcerative colitis
• have Systemic Lupus Erythematosus (SLE) – an illness which affects your immune system. It causes joint pains, skin changes and problems with other parts of your body
• 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 or 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 an infection – please see heading ‘Infections’ below.

This medicine may hide signs of infections such as fever and pain. It is therefore possible that this medicine may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen consult a doctor without delay.

There is a risk of renal impairment in dehydrated adolescents.

You must not take these capsules if you taking certain other medicines – see section 2 ‘Do not take this medicine if you’. This medicine 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)
• corticosteroids
• methotrexate (a medicine for cancer)
• cardiac glycosides (medicines used to treat heart failure)
• ciclosporin and tacrolimus (immunosuppressant medicines often used following organ transplants)
• mifepristone (a medicine used to terminate pregnancy – NSAIDs should not be used for 12 days after mifepristone)
• lithium (for depression or mental problems)
• zidovudine (a medicine to treat viruses)
• quinolone antibiotics (medicines used to treat bacterial infections).

Some other medicines may also affect or be affected by the treatment of this medicine. You should therefore always seek the advice of your doctor or pharmacist before you use this medicine with other medicines.

Do not take this medicine if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. You should not take this medicine during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, this medicine can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

Talk to your doctor before taking this medicine if you are breastfeeding.

Ibuprofen Long Lasting 200 mg Capsules belong to a group of medicines which may affect fertility in women. Fertility goes back to normal when you stop taking the medicine. It is unlikely that if you only take these capsules occasionally it will affect your chances of becoming pregnant. If you have problems becoming pregnant talk to your doctor before taking this medicine.

If you have taken more capsules than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken.

The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.

Allergic reactions:

The following reactions may mean you are having an allergic reaction to this medicine:

• asthma, worsening of asthma, unexplained wheezing or shortness of breath
• swelling of the face, lips, tongue and throat (causing difficulty in swallowing or breathing)
• rapid heart rate, low blood pressure, collapse
• also, there may be skin reactions (including hives, rash and itching) – very rarely these can be severe with blistering and peeling skin
• chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Skin Problems:

• reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis]
• widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome)
• a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis)
• skin becomes sensitive to light – frequency unknown.

Stomach and bowel problems including:

• indigestion or heartburn
• pains in your stomach (abdomen) or other abnormal stomach problems
• pass blood in your stools or motions
• pass black tarry stools or motions
• vomit any blood or dark particles that look like coffee grounds
• worsening of bowel problems (ulcerative colitis or Crohn’s disease).

Blood disorders which can cause:

• unexplained or unusual bruising or bleeding
• sore throat or mouth ulcers
• fever (high temperature)
• extreme paleness or weakness and exhaustion.

Heart and circulation effects:

Medicines such as Ibuprofen Long Lasting 200 mg Capsules may be associated with a small increased risk of heart attack (myocardial infarction), high blood pressure, heart failure, swelling due to fluid build-up (oedema) or stroke.

Other side effects that may occur include:

Other stomach and intestine effect including: diarrhoea, flatulence, constipation and vomiting.

Liver problems that might be indicated by yellowing of the skin and eyes (jaundice) and/or pale coloured stools and dark urine.

Kidney problems that might be indicated by passing less or more urine than normal, cloudy urine, blood in the urine, pain in the back and/or swelling (particularly of the legs) – very rarely kidney failure.

This medicine, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood (see section 2). This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness.

Nervous system problems including headache and aseptic meningitis (which can have symptoms such as severe headache, stiff neck, disorientation, fever and eye sensitivity to light in those with existing autoimmune disorders such as lupus).

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active ingredient is: 200mg of Ibuprofen in each prolonged release capsule.

The other ingredients are: Microcrystalline Cellulose, Eudragit NE30D, Hypromellose, Talc, Colloidal Silicon Dioxide. The capsule shell contains Gelatin, Titanium Dioxide (E171), Patent Blue V (E131), Erythrosine (E127).

Ibuprofen Long Lasting 200 mg Capsules are blue and clear capsules containing white coated beads, available in pack sizes of 6, 8, 12 or 16 capsules (not all pack sizes may be marketed).