How to take it

THE MEDICINE Age Adults, the elderly and children over 12 years

Dose and how often to take

Take 2 capsules (400mg) each morning and evening, as required. Swallow capsules whole (do not chew) with a glass of water preferably with or after food. Do not exceed 4 capsules in 24 hours.

Do not give to children under 12 years. This medicine is intended for short term use only ■ Take the lowest effective dose for the shortest duration necessary to relieve symptoms. ■

In Adults: Do not take these capsules for longer than 10 days unless your doctor tells you to. Talk to a doctor or pharmacist if you do not get better or get worse, or if new symptoms occur. In Children and Adolescents between 12 and 18 years: If in children and adolescents this medicinal product is required for more than 3 days, or if symptoms worsen, a doctor should be consulted. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2). If you take more capsules than you should: 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.

Possible side effects

Most people take these capsules without any problems, but they can have side effects, like all medicines. To reduce the chance of side effects, especially if you are elderly, use the lowest effective dose for the shortest possible time.

swelling of the face and neck region (angioedema), chest pain have been reported with ibuprofen. Stop taking this medicine immediately and immediately contact your doctor or medical emergency department 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). Skin reactions 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. Talk to your doctor or pharmacist before taking this medicine if you:

• 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,

If you get any of the following at any time during your treatment STOP TAKING, and get medical help straight away: 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.