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Brufen Retard 800 Mg Tablets

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Add/Amend: To bring the current granted leaflet in line with the leaflet granted through variation 0005 which was assessed against

the UK PIL dated May 2014 and include the manufacturer updated through variation 0003.

Add/Amend: To bring the current granted leaflet in line with the leaflet granted through variation 0005 which was assessed against

the UK PIL dated May 2014 and include the manufacturer updated through variation 0003.

APPROVED

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Patient Information Leaflet

Assessed against UK PIL dated May 2014


Brufen® Retard 800 mg Tablets (ibuprofen)

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

•    The name of this medicine is Brufen® Retard 800 mg Tablets but will be referred to as Brufen Retard throughout the remainder of this leaflet

•    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.

1)    WHAT IS BRUFEN RETARD & WHAT IS IT USED FOR?

Brufen Retard belongs 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 Retard 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 Retard is ibuprofen and each tablet contains 800 mg in a sustained-release formulation. This is designed to release ibuprofen gradually into your blood stream throughout the day.

2)    WHAT SHOULD YOU KNOW BEFORE TAKING 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)?

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

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).

Pregnancy and breast-feeding: The use of Brufen Retard whilst pregnant or breast-feeding should be avoided. Brufen Retard 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 Retard may make you feel dizzy or drowsy. If the tablets 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 RETARD?

ALWAYS take Brufen Retard 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.

TAKE YOUR BRUFEN RETARD TABLETS with a glass of water. You should swallow the tablets whole without chewing, breaking, crushing or sucking on them to help prevent feeling discomfort in the mouth or irritation in the throat. The tablets are best taken in the early evening, well before retiring to bed. Take your Brufen Retard with or after food.

Your dosage will depend on what you are being treated for, the usual dose is two tablets taken as a single dose each day, preferably in the evening. In severe or acute conditions, your doctor may prescribe one extra tablet to be taken each morning in addition to the usual dose.

Brufen Retard is NOT suitable for children under 12 years of age.

IF YOU TAKE MORE BRUFEN RETARD THAN PRESCRIBED (AN OVERDOSE) you should contact a doctor or go to the nearest hospital casualty department IMMEDIATELY taking your tablets with you.

IF YOU FORGET TO TAKE YOUR BRUFEN RETARD TABLETS

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 RETARD


6) FURTHER INFORMATION ABOUT BRUFEN RETARD


As with all medicines, Brufen Retard 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.

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.

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: www.mhra.gov.uk/yellowcard.

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

What Brufen Retard contains

Each tablet contains 800 mg of ibuprofen in a sustained-release formulation.

The other ingredients are: Silica colloidal anhydrous, Povidone, Stearic acid, Xanthan gum, Talc, Hypromellose and Titanium dioxide (E171).

What Brufen Retard looks like and contents of the pack

Brufen Retard are white, pillow-shaped, sustained-release tablets.

Each pack contains blister packs of 30 or 60 tablets.

Manufacturer

Famar S.A., 7 Anthousas Ave, 153 44 Anthousa Attiki, Athens, Greece

AbbVie Deutchland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany

Procured from within the EU by the Product Licence holder MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall, WS9 8ER, UK

Repackaged by MPT Pharma Ltd.

PL: 33532/0469 Brufen® Retard 800 mg Tablets

Leaflet date: 28th January 2015 Leaflet code: XXXXXXXXXX

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

POM


5) HOW SHOULD YOU STORE BRUFEN RETARD?

•    Do not store above 25C.

•    Keep the tablets in a safe place out of the sight and reach of children, your medicine could harm them.

•    Store in the original packaging.

•    Do not use this medicine after its expiry date. The expiry date refers to the last day of that month.

•    If your medicine becomes discoloured or shows any sign of deterioration, return them to your pharmacist.

•    If your doctor decides to stop your treatment, return any leftover tablets to your pharmacist. Only keep them if your doctor tells you to.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.