Brufen Retard

IMPORTANT INFORMATION

Read all of this leaflet carefully before you start taking this medicine

• Keep this leaflet as you may need to read it again
• This leaflet provides a summary of the information currently available about Brufen Retard
• For further information or advice ask your doctor or pharmacist
• This medicine is for you only and should never be given to anyone else, even if they appear to have the same symptoms as you
• Tell your doctor or pharmacist if you experience any side effects

Leaflet contents:

1. What is Brufen Retard & what is it used for?
2. What should you know before taking Brufen Retard?
3. How should you take Brufen Retard?
4. Possible side effects of Brufen Retard.
5. How should you store Brufen Retard?
6. Further information about Brufen Retard.

If the answer to any of the following questions is ‘YES’ please tell your doctor or pharmacist BEFORE taking any Brufen Retard tablets:

• Are you pregnant or planning to become pregnant, or are you breast-feeding? Brufen Retard 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.
• Are you sensitive (allergic) to any of the ingredients in the tablets? These are listed in Section 6.
• Do you have, or have you previously had, a stomach ulcer or other gastric complaint?
  Do not take Brufen Retard if you currently have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation in the past.
• Do you have a condition which increases your tendency to bleeding?
• Do you suffer from asthma or have you ever had an allergic reaction or suffered from wheezing after taking ibuprofen, aspirin or other anti-inflammatory pain killers?
• Do you suffer from liver or kidney disease?
• Do you suffer from heart disease?
  Medicines such as Brufen Retard may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. If you have heart problems, previous stroke or think that you might be at risk of these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
• Do you have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (autoimmune diseases affecting connective tissue)?

Can you take Brufen Retard with other medicines?

Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicyclic acid, warfarin, ticlodipine), some medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin-II receptor antagonists such as losartan) and other medicines may affect or be affected by treatment with ibuprofen.

You should therefore always seek the advice of your doctor or pharmacist before you use ibuprofen with other medicines. In particular you should tell your doctor or pharmacist if you are taking any of the following medicines in addition to those mentioned above:

• diuretics (water tablets)
• cardiac glycosides, such as digoxin, used to treat heart conditions
• lithium
• zidovudine (an anti-viral drug)
• steroids (used in the treatment of inflammatory conditions)
• methotrexate (used to treat certain cancers)
• medicines known as immunosuppressants such as ciclosporin and tacrolimus (used to dampen down your immune response)
• medicines known as selective serotonin reuptake inhibitors (SSRIs), used for the treatment of depression
• antibiotics called quinolones such as ciprofloxacin
• aminoglycosides (a type of antibiotic)
• mifepristone
• any other ibuprofen preparations, such as those you can buy without a prescription
• any other anti-inflammatory pain killer, including aspirin
• cholestyramine (a drug used to lower cholesterol)
• medicines known as sulphonylureas such as glibenclamide (used to treat diabetes)
• voriconazole or fluconazole (types of anti-fungal drugs)
• Gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with ibuprofen).

If you suffer from any of the following at any time during your treatment STOP TAKING Brufen Retard and seek immediate medical help:

• Severe headache, high temperature, stiffness of the neck or intolerance to bright light
• Pass blood in your faeces (stools/motions)
• Pass black tarry stools
• Vomit any blood or dark particles that look like coffee grounds.

TELL YOUR DOCTOR AND STOP TAKING THE TABLETS IF YOU EXPERIENCE:

• Unexplained stomach pain or other abnormal stomach symptoms, indigestion, heartburn, feeling sick and/or vomiting
• Unexplained wheezing, shortness of breath, skin rash, itching or bruising
• Yellowing of the eyes and/or skin
• Severe sore throat with high fever
• Blurred or disturbed vision or seeing/hearing strange things
• Fluid retention (e.g. swollen ankles).

Medicines such as Brufen Retard have been associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Blood disorders, kidney problems, liver problems or severe skin reactions may occur rarely with ibuprofen.

Very rarely Brufen Retard may cause aseptic meningitis (inflammation of the protective membrane surrounding the brain).

Other side effects may include headache, hallucinations, dizziness, tingling of hands and feet, ringing in the ears, depression, confusion, difficulty sleeping, anxiety, impaired hearing, diarrhoea, constipation, flatulence (wind), unexpected sensitivity of the skin to the sun, tiredness, malaise, mood swings and swelling and irritation inside the nose. Brufen Retard has also been shown to sometimes worsen the symptoms of Crohn’s disease or colitis.

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