Out of date information, search another

Brufen 600mg Effervescent Granules

Out of date information, search another
Informations for option: Brufen 600mg Effervescent Granules, show other option

(leaflet continued)

Brufen Granules are manufactured by Abbott S.r.L. S.R. 148 Pontina km 52 snc, 04011 Campoverde di Aprilia (LT), Italy or AbbVie S.r.L. S.R. 148 Pontina km 52 snc, 04011 Campoverde di Aprilia (LT), Italy. Procured from within the EU. Product Licence holder: Quadrant Pharmaceuticals Ltd. Lynstock House, Lynstock Way, Lostock, Bolton,

BL6 4SA. Repackaged by Maxearn Ltd. Bolton, BL6 4SA.


PL 20774/1047

Leaflet revised 31st October 2014

Brufen is a registered trademark of Abbott GmbH & Co. KG.


Patient Information Leaflet

Brufen® 600mg Effervescent Granules


Your medicine is called Brufen 600 mg Effervescent Granules but will be referred to as Brufen Granules throughout the remainder of this leaflet.


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 Granules

•    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 are Brufen Granules & what are they used for?

2.    What should you know before taking Brufen Granules?

3.    How should you take Brufen Granules?

4.    Possible side effects of Brufen Granules.

5.    How should you store Brufen Granules?

6.    Further information about Brufen Granules.

1. What are Brufen Granules & what are they used for?

Brufen Granules belong to a group of medicines called anti-inflammatory pain killers. They can be used to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis or Still's disease), arthritis of the spine (ankylosing spondylitis), swollen joints, frozen shoulder, bursitis, tendinitis, tenosynovitis, lower back pain, sprains and strains.

Brufen Granules can also be used to treat other painful conditions such as toothache, pain after operations, period pain and headache, including migraine.

The active ingredient in Brufen Granules is ibuprofen and each sachet contains 600 mg.

2. What should you know before taking Brufen Granules?

If the answer to any of the following questions is 'YES' please tell your doctor or pharmacist BEFORE taking any Brufen Granules:

•    Are you pregnant or planning to become pregnant, or are you breast-feeding?

Brufen Granules 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 granules? 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 Granules 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 Granules 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) ora connective tissue disease (autoimmune diseases affecting connective tissue)?

•    Has your doctor advised you to follow a low sodium diet?

•    Have you been told by your doctor that you have an intolerance to some sugars?

•    Is your child dehydrated? As there is a high risk of kidney damage in dehydrated children and adolescents.

Can you take Brufen 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-ll 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 antifungal drugs)

•    Gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with ibuprofen).

Pregnancy and breast-feeding: The use of

Brufen Granules whilst pregnant or breast feeding should be avoided. Brufen Granules should not be used in late (the last three months) of pregnancy and should only be taken in the first six months of pregnancy on the advice of your doctor.

Driving and Using Machines: Brufen Granules may make you feel dizzy or drowsy.

If they affect you in this way do not drive, operate machinery or do anything that requires you to be alert.

3. How should you take Brufen Granules? ALWAYS take Brufen Granules exactly as your doctor has told you. If you are not sure refer to the label on the carton or check with your doctor or pharmacist.


emptying the contents of the sachet into a glass full of water to make an orange flavoured fizzy drink. Stir and drink immediately. Take with or after food.


Adults and Children over 12 years - The

usual dosage is 1 sachet taken two or three times a day. Your doctor may choose to increase or decrease this depending on what you are being treated for, but no more than 4 sachets should be taken in one day.

Brufen Granules are NOT recommended for children under 12 years of age.


should contact a doctor or go to the nearest hospital casualty department IMMEDIATELY taking your granules with you.

IF YOU FORGET TO TAKE YOUR BRUFEN GRANULES take them as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed dose at all. Never double up on a dose to make up for the one you have missed.

4. Possible side effects of Brufen Granules

As with all medicines, Brufen Granules 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 granules for the shortest amount of time necessary to control your symptoms.

STOP TAKING Brufen Granules 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 fasces (stools/motions)

-    Passing black tarry stools

-    Vomiting any blood or dark particles that look like coffee grounds


•    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 Granules 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 Granules 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, a temporary sensation of burning in the mouth or throat, diarrhoea, constipation, flatulence (wind), unexpected sensitivity of the skin to the sun, tiredness, malaise, mood swings and swelling and irritation inside the nose.

Brufen has also been shown to sometimes worsen the symptoms of Crohn’s disease or colitis.

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 Yellow Card Scheme at:

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How should you store Brufen Granules?

Keep out of the sight and reach of children.

Do not take your granules after the “use by date” shown on the carton or sachet.

Do not store above 25°C.

If your doctor decides to stop the treatment, return any left over to your pharmacist. Only keep the granules if your doctor tells you to.

If the granules show any signs of deterioration or discolouration, consult your pharmacist for advice. If damaged please tell your doctor or pharmacist.

6.    Further information about Brufen Granules

Brufen Granules are fine white granules with orange flavour.

The active ingredient in Brufen Granules is ibuprofen. Each sachet contains 600 mg ibuprofen in effervescent granule form. Also contains: microcrystalline cellulose, croscarmellose sodium, sucrose, malic acid, sodium bicarbonate, anhydrous sodium carbonate, orange flavour, sodium saccharin, povidone and sodium lauryl sulphate.

Each pack contains 20 sachets.

(leaflet continued overleaf)