Patient leaflet - BRUFEN TABLETS 400 MG
4. possible side effects of brufen tablets
As with all medicines, Brufen Tablets may cause side effects, although they are usually mild and not everyone will suffer from them. If any side effects become serious or if you notice any side effects that are not listed in this leaflet, please tell your doctor or pharmacist. You can minimise the risk of side effects by taking the least amount of tablets for the shortest amount of time necessary to control your symptoms.
STOP TAKING Brufen Tablets and seek immediate medical help if you experience:
- Signs of aseptic meningitis such as severe headache, high temperature, stiffness of the neck or intolerance to bright light.
- Signs of intestinal bleeding such as
- 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 BRUFEN 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 (these may be symptoms of an allergic reaction).
- Loss of vision, blurred or disturbed vision (visual impairment) or seeing/hearing strange things (hallucinations).
- Severe spreading skin rash (‘Stevens-Johnson Syndrome’, ‘toxic epidermal necrolysis’ and ‘erythema multiforme’, symptoms include severe skin rash, blistering of skin, including inside mouth, nose, and genitals, as well as skin peeling which may be accompanied with symptoms such as aching, headaches, and feverishness)
- A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).
Medicines such as Brufen Tablets have been associated with a small increased risk of high blood pressure, heart attack (myocardial infarction), stroke or heart failure.
Medicines such as Brufen Tablets have in exceptional cases been associated with severe skin problems for patients with chicken pox or shingles
Blood disorders such as reduction in blood cells and platelet counts – the first signs are: high temperature, sore throat, mouth ulcers, flu-like symptoms, bleeding from the mouth, nose, ear and the skin. Kidney problems such as reduced kidney function, fluid retention (oedema), inflammation of the kidney and kidney failure. Liver problems such as inflammation of the liver, reduced liver function and yellowing of the eyes and/or skin (jaundice) or severe skin reactions may occur rarely with ibuprofen. Brufen has also been shown to sometimes worsen the symptoms of Crohn’s disease or colitis.
Other side effects
Common (affects up to 1 in 10 people):
- feeling dizzy or tired
- diarrhoea, wind, constipation
- headache – if this happens while you are taking this medicine it is important not to take any other medicines for pain to help with this.
Uncommon (affects up to 1 in a 100 people):
- feeling drowsy
- feeling anxious
- feeling a tingling sensation or ‘pins and needles’
- difficulty sleeping
- hives
- skin becomes sensitive to light
- hearing problems
- sneezing, blocked, itchy or runny nose (rhinitis)
- stomach or gut ulcer, hole in the wall of the digestive tract
- inflammation of your stomach lining
- ringing in ears (tinnitus)
- sensation of spinning (vertigo)
- mouth ulcers
Rare (affects up to 1 in a 1000 people):
- feeling depressed or confused
Very rare (affects up to 1 in 10,000 people):
- inflammation of the pancreas
Not known (cannot be estimated from the available data):
- A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Brufen Tablets if you develop these symptoms and seek medical attention immediately. See also section 2.
Reporting of side effects
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 National reporting systems listed below:
UK:
The Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.
MALTA:
ADR Reporting
Website:
By reporting side effects, you can help provide more information on the safety of this medicine.
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5. How should you store Brufen Tablets?
Your tablets should not be stored above 25° C. They should be kept in a safe place out of the reach and sight of children as your medicine could harm them.
They should be kept in their original packaging. Do NOT take Brufen Tablets after the ‘use by’ date shown on the carton. If your doctor decides to stop your treatment, return any leftover tablets to your pharmacist.
Only keep the tablets if your doctor tells you to.
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6. Further information about Brufen Tablets
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