• 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 2 or more episodes of) 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 severe kidney, heart or liver failure
• are taking aspirin with a daily dose above 75 mg
• are in the last 3 months of pregnancy.

Serious skin reactions have been reported in association with Ibuprofen Lysine 342 mg Tablets treatment. You should stop taking this medicine and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See 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, diabetes, high cholesterol 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, have previously had, or are at risk of heart problems, high blood pressure or stroke
• 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.

You must not take these tablets if you are taking certain other medicines – see section 2 ‘Do not take this medicine if you’.

Ibuprofen Lysine 342 mg Tablets 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 Lysine 342 mg Tablets. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen Lysine 342 mg Tablets with other medicines, especially:

• two or more NSAID painkillers, including cyclooxygenase-2 selective inhibitors
• antidepressants called selective-serotonin reuptake inhibitors (SSRIs) e.g. fluoxetine
• corticosteroids (for skin problems and allergies e.g. cortisol)
• methotrexate (a medicine for cancer)
• cardiac glycosides (medicines used to treat heart failure e.g. digoxin)
• 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 e.g. ciprofloxacin).

• 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. You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen Lysine 342 mg 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 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.
• If you are taking Ibuprofen lysine 342 mg Tablets 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).
• Ibuprofen Lysine 342 mg Tablets 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 tablets occasionally it will affect your chances of becoming pregnant talk to your doctor before taking this medicine.
• There is a risk of renal impairment in dehydrated adolescents.

Do not take Ibuprofen Lysine 342 mg Tablets 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 Ibuprofen Lysine 342 mg Tablets 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, Ibuprofen Lysine 342 mg Tablets 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 Ibuprofen Lysine 342 mg Tablets if you are breastfeeding.

Uncommon (affecting 1 in 1000 to 1 in 100 people)

• Stomach discomfort or pain, nausea (feeling sick), indigestion or heartburn
• Headache
• Skin reactions, such as hives, rash and itching.

Rare (affecting 1 in 10,000 to 1 in 1000 people)

• Diarrhoea, flatulence, constipation and vomiting.

Very Rare (affecting less than 1 in 10,000 people)

• Stomach ulcer or perforation, worsening of bowel problems (ulcerative colitis or Crohn’s disease)
• 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.

Ibuprofen lysine 342 mg Tablets, 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.

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

Unknown

• High blood pressure, heart failure, swelling due to fluid build-up (oedema) or stroke
• Skin becomes sensitive to light.

Medicines such as Ibuprofen Lysine 342 mg Tablets may be associated with a small increased risk of heart attack (myocardial infarction). If you experience any of these symptoms, or have any other unusual symptoms or concerns with your medicine, stop taking the tablets and see your doctor.

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: Ibuprofen 200 mg (as ibuprofen lysine) per coated tablet.

The other ingredients are: Crospovidone, copovidone, microcrystalline cellulose, magnesium stearate, Opadry II White (contains polyvinyl alcohol, titanium dioxide E171, macrogol and talc).

Each tablet is a film-coated white tablet, embossed with ‘IBL’ on one side.

This product is available in a pack size of 8, 12 or 16 tablets. Not all pack sizes may be marketed.