BRUFEN 600 Milligram Film Coated Tablet

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
IBUPROFEN
Available from:
Abbott Laboratories Ireland Ltd
INN (International Name):
IBUPROFEN
Dosage:
600 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization number:
PA0038/080/003
Authorization date:
0000-00-00

Patient Information Leaflet

Brufen 600 mg Film-Coated Tablets

Ibuprofen

Important Information

Pleasereadthis leaflet carefully beforeyou start taking your medicine.

Keep this leaflet as you may need to readit again.

This leaflet provides asummary of the informationcurrently available on Brufen 600mg Tablets.

For further information or advice ask yourdoctor orpharmacist.

This medicine is for you and should never be given to anyone else, even if they appear to have

the samesymptoms as you.

Tell your doctor or pharmacist ifyou experience any side effects.

In thisleaflet:

1.What are Brufen 600mg Tablets and what are they used for?

2.What should you knowbefore taking Brufen 600mg Tablets?

3.How should you take Brufen 600mg Tablets?

4.Possible sideeffects of Brufen 600mg Tablets

5.How should you store Brufen 600mg Tablets?

6.Further information about Brufen 600mg Tablets

1. What are Brufen 600mg Tablets andwhat are theyusedfor?

Brufen 600mg Tablets belong to a group of medicinescalled anti-inflammatorypain killers. They

can beused to relieve painand inflammation inconditions such asosteoarthritis,rheumatoid

arthritis (including juvenilerheumatoid arthritis or Still's disease),arthritis of the spine (ankylosing

spondylitis), swollen joints,frozenshoulder, bursitis, tendonitis, tenosynovitis, lower back pain,

sprains andstrains.

Brufen 600mg Tabletscanalso be usedto treat other painful conditions such astoothache, pain

after operations, period pain and headache, includingmigraine.

The active ingredient in Brufen 600mg Tablets isibuprofen and each tablet contains 600mgof

ibuprofen.

2. What shouldyou know before taking Brufen 600mg Tablets?

Do nottakeBrufen 600mg Tablets if;

you are sensitive (allergic)to any of the ingredients in the tablets. These are listedin

Section 6

you previouslyexperiencedstomach bleedingor perforation after taking ibuprofen or

other non-steroidal anti-inflammatory drugs (NSAIDs)

you currently have a pepticulcer(ulcer inyour stomach or duodenum) orbleeding in your

stomach, or have had twoor more episodes of pepticulcers,stomach bleedingor

perforation inthe past

you suffer from severe heart failure, liver failure orkidney failure

you have a conditionwhich increases your tendency to bleeding

you are sensitive (allergic)or previously had an allergicreaction orsuffered from

wheezing after taking ibuprofen, aspirinor other anti-inflammatorypain killers

you are in thethird trimester (last 3 months) of pregnancy

Take specialcarewithBrufen 600mgTablets if:

you have, or previously suffered fromasthma

you suffer fromliver, kidney or heart disease

you suffer fromhigh blood pressure (hypertension)

you are elderly – elderly people are more prone to side effectsto NSAIDs, particularly

stomach bleeding and perforationwhichcan be fatal

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

you have, or you previouslyhad a stomachulcer, stomach bleeding or other gastric

complaint

you have a history of inflammatory boweldisease (ulcerative colitis, Crohn’s disease)

you are dehydrated

you have a conditionwhich increases your tendency to bleedingor have bleedingin the

skull – pleasesee above

you have lupus or aconnective tissue disease (autoimmune diseasesaffecting

connectivetissue)

If anyof these applytoyou, please tellyour doctor or pharmacist BEFORE taking any

Brufen 600mg Tablets.

Brufen 600mg Tablets may make it more difficult to become pregnant. You should inform your

doctor if you are planningto become pregnantor if you have problems becomingpregnant.

Medicines such asBrufen600mg Tablets may be associatedwith asmall increased risk of heart

attack(myocardial infarction) orstroke.Any risk is more likely withhigh doses and prolonged

treatment. Donot exceed the recommended dose orduration of treatment. If youhave heart

problems, previous stroke or think that you mightbe atrisk of theseconditions (e.g. ifyou have

high blood pressure, diabetes, high cholesterolor area smoker) you should discuss your

treatment withyour doctoror pharmacist.

Taking otherMedicines

Canyou take Brufen 600mg Tabletswith other medicines?

Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g.

aspirin/acetylsalicyclicacid, warfarin, ticlodipine), some medicines that reduce high blood

pressure (ACE-inhibitorssuch ascaptopril, beta-blockerssuch asatenolol orangiotensin-II

receptorantagonists such as losartan) and other medicines may affect or beaffected by

treatment withibuprofen. You should therefore alwaysseek the advice of your doctor or

pharmacist before you useibuprofenwithothermedicines. In particular you should tell your

doctor or pharmacist if you are takingany of the following medicines in addition tothose

mentioned above:

any medicines used to treat high blood pressure (seeabove)

any medicines to treat heart conditions(e.g. diureticssuch asbendroflumethiazide or

furosemideor cardiac glycosidessuch as digoxin)

any anti-coagulants oranti-platelet medicines (see above)

lithium or selective serotonin reuptake inhibitors (SSRIs) (used totreat depression)

a medicine called zidovudine (an anti-viral drug)

a medicine called methotrexate (used to treat some forms of cancer)

medicinescalled cyclosporin or tacrolimus(immunosuppressantsused following organ

transplant orin autoimmuneconditionssuch aspsoriasis, eczema)

any other NSAIDs or anti-inflammatorypainkillers, including aspirin and the group of

drugs knownas COX-2 inhibitorssuch ascelecoxib and lumiracoxib

any corticosteroids (e.g. hydrocortisone,betamethasone, prednisolone, used to treat

inflammatory conditions)

a certain type of antibiotic, known asquinolone antibiotics(e.g. ciprofloxacin and

levofloxacin)

probenecid(used to treat gout)

a certain type of antibiotic known as aminoglycosides

mifepristone (now orin the last 12 days)

any oral medicines used totreat diabetes(e.g. metformin, or any sulphonamides)

a herbal remedy called ginkgo bilboa (there isachance that you may bleed more easily if

you are takingibuprofen and ginkgo biloba at the same time).

cholestyramine (used to treat high cholesterol levels)

sulphonylurea medicines (used to treat diabetes)

voriconazoleor fluconazole (anti-fungaldrugs)

Pregnancyand breast-feeding:

Please tell your doctor if you are, or thinkyou are, pregnant. Brufen600mg Tablets are not

recommended during the first andsecondtrimesters(first 6 months) of pregnancyunless clearly

necessary and should notbe taken during the third trimester (last 3months) of pregnancy.

Brufen 600mg Tablets arenot recommendedwhile breast feeding.

Driving and Using Machines:

Medicines such asBrufen600mg Tablets may causedizziness, drowsiness, tiredness and

problems withvision. If affected, you should not driveor operate machines.

3. Howshouldyou take Brufen 600mg Tablets?

ALWAYStake Brufen 600mg Tablets exactly as yourdoctorhas told you. Ifyou are notsure

refer to the label on the carton or checkwith your doctor or pharmacist. The tablets should be

swallowed witha drink of water, preferably with or after food.

Take yourBrufen 600mg Tabletswith a glass of water. You should swallow thetablets whole

without chewing, breaking, crushing orsucking them.

DOSAGE:

Adults -Theusual dosageis 600 to 1800 mg spreadthroughout the day. Your doctor may

choose to increase this depending onwhat you are being treatedfor, but no more than 2400mg

should be taken in one day.

Children -The usual daily dosage is20mg to 30 mg per kg of bodyweight, given in divided

doses.

In children weighingless than 30kg, nomore than500mg of Brufenshould be given each day.

In severecases, your doctor may increasethe dosageup to 40 mg/kg in divideddoses.

Elderly– Refer to adult dosing. If youhave liver orkidney problems however, your dose may

need to be modified in which case you shouldcontactyour doctor for advice.

IF YOU TAKEMORE BRUFEN 600mg TABLETS THANPRESCRIBED(AN OVERDOSE)you

should contact a doctor orgo to thenearest hospitalcasualty departmentIMMEDIATELYtaking

your tabletswith you.

IF YOU FORGET TO TAKE YOUR BRUFEN 600mg TABLETStake them assoonas you

remember, unless it is almost time for your next dose. Ifit is, do not takethe missed dose at all.

Never doubleup on a doseto make up for the one you have missed.

4. Possible side effects of Brufen 600mg Tablets

As with all medicines, Brufen 600mg Tablets maycauseside effects, althoughthey are usually

mild and noteveryonewill suffer from them. If anyside effects become seriousor if you notice

any side effects that are not listed in this leaflet, please tell your doctor orpharmacist. You can

minimise the risk of side effects by takingtheleast amount of tablets for the shortest amountof

time necessary to control your symptoms.

Ifyou sufferfrom anyof the followingat anytime duringyour treatmentSTOP TAKING

Brufen 600mg Tablets andseek immediate medical help:

Severe headache, high temperature, stiffnessof theneck or intolerance to brightlight

Pass blood inyour faeces(stools/motions)

Pass black tarrystools

Vomit any blood or dark particles that look like coffeegrounds

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

Hypersensitivity reactions such asunexplainedwheezing, shortness of breath, skinrash,

itching orbruising

Unexplainedstomach painor other abnormalstomach symptoms, indigestion, heartburn,

feeling sick and/or vomiting

Yellowingof the eyes and/or skin

Severe sore throat with high fever

Blurred or disturbed visionor seeing/hearing strange things

Fluid retention (e.g. swollen ankles)

Medicines such asBrufen600mg Tablets have beenassociatedwith a small increasedrisk of

heart attack (myocardial infarction) orstroke.

Very rarely Brufen 600mg Tablets may cause aseptic meningitis(inflammationof the protective

membranesurrounding thebrain).

Brufen 600mg Tablets may hide the signs of an underlying infection.

Otherside effects of Brufen600mg Tablets may include:

nausea, vomiting, diarrhoea, flatulence (wind), constipation, stomach ache

mouth ulcer

duodenal ulcer

stomach perforation

increase in severity of Crohn’s diease orcolitis

inflammationof the stomach lining

inflammationof the pancreas.

high blood pressure (hypertension)

heart failure

nasal stuffiness orrunny nose (rhinitis)

blood disorderssuch asa reduction indifferent typesof cells in theblood

difficulty sleeping, anxiety, depression,confusion,seeing or hearing things thatare not really

there (hallucinations)

headaches, numbness or tingling, dizziness, drowsiness, tiredness,generally feeling unwell

blurred ordisturbed vision,inflammationof the optic nerve

balance disorder which makes you feel unsteady, giddy, woozy, or have a sensation of

movement, spinning, or floating (vertigo), ringing in the ears, hearingproblems

liver problemssuch ashepatitis or jaundice

skin problemssuch asincreased sensitivityto light and severe reactions (such asblistering of

the skin, mouth, eyes andgenitals)

kidney problems, includingreduced kidney function and kidney failure

5. Howshouldyou store Brufen 600mg Tablets?

Your tablets should not be storedabove25 o

C. They should bekept in a safe place out of the

reach and sight of children, your medicinecould harm them.

The tabletsshould be kept in their original packaging inorder to protect from moisture. DoNOT

take Brufen600mg Tablets after the 'expiry' date shown on the carton and blister.

If your doctordecidesto stop your treatment, return any leftover tablets to your pharmacist. Only

keepthe tablets if your doctor tells you to.

6.Further information about BRUFEN 600mg Tablets

The activesubstance in Brufen 600mg Tablets isIbuprofen. Eachtablet contains600mg of

ibuprofen. The tablets are white,pillow-shaped and film-coated.

The tablets are available inblister packs, each containing 60 tablets.

Brufen 600mg Tablets inactiveingredients:microcrystalline cellulose,croscarmellose sodium,

lactose monohydrate, colloidal anhydrous silica, sodium laurilsulfate, magnesium stearate, talc,

Opaspray white M-1-7111B(hypromellose, titanium dioxide (E171)).

Marketing AuthorisationHolder:

Abbott LaboratoriesIrelandLtd

4051 Kingswood Drive

CitywestBusiness Campus

Dublin 24

Ireland.

Manufacturer:

FAMAR S.A.

7 AnthousasAve

153 44 Anthousa Attiki

Greece.

And:

Abbott GmbH & Co. KG,

Knollstrasse 50,

67061 Ludwigshafen,

Germany

Leaflet was last approved in

Document Outline

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Brufen600mgfilm-coatedtablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains600mgofibuprofen.

Excipients:eachtabletcontains40.0mgoflactosemonohydrate.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablet(tablet).

Awhite,pillow-shaped,film-coatedtablet.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Brufenisindicatedinthesymptomaticmanagementofvariousarthrosessuchasrheumatoidarthritis(including

juvenilerheumatoidarthritisorStill’sdisease)andosteoarthritis,fibrositis,ankylosingspondylitisandothermuscular

syndromes,suchaslowbackpain,softtissuetraumaandvariousinflammationsoftendon,jointcapsulesand

ligaments.

Brufenisalsousedasananalgesicinthereliefofmildtomoderatepain.

4.2Posologyandmethodofadministration

Undesirableeffectsmaybeminimisedbyusingthelowesteffectivedosefortheshortestdurationnecessarytocontrol

symptoms(seesection4.4,specialwarningsandspecialprecautionsforuse).

Adults:TherecommendeddosageofBrufenis1200-1800mgdailyindivideddoses.Somepatientscanbemaintained

on600-1200mgdaily.Thetotaldailydoseshouldnotexceed2400mg.

Children:TherecommendeddoseofBrufenis20-30mg/kgbodyweightdailyindivideddosesbutinjuvenile

rheumatoidarthritis,thedailydosagemaybeincreasedto40mg/kgbodyweightinseverecases.

Inchildrenweighinglessthan30kg,thetotaldailydoseofBrufenshouldnotexceed500mg(theliquidformulation

shouldbeused).

Elderly:Nospecificdosagemodificationsarerequiredforelderlypatients,unlessrenalorhepaticfunctionisimpaired,

inwhichcase,dosageshouldbeassessedindividually.

NSAIDsshouldbeusedwithparticularcautioninelderlypatientswhoaremorepronetoadverseevents.Thelowest

dosecompatiblewithadequatesafeclinicalcontrolshouldbeemployed.SeealsoSection4.4.Treatmentshouldbe

reviewedatregularintervalsanddiscontinuedifnobenefitisseenorintoleranceoccurs.

TakeBrufentabletswithaglassofwater.Brufentabletsshouldbeswallowedwholeandnotchewed,broken,crushed

orsuckedontoavoidoraldiscomfortandthroatirritation.

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4.3Contraindications

Brufeniscontraindicatedinpatientswithknownhypersensitivitytotheactivesubstanceortoanyoftheinactive

ingredients.

Brufeniscontraindicatedinpatientswithahistoryofgastrointestinalbleedingorperforation,relatedtoprevious

NSAIDstherapy.Active,orhistoryofrecurrentpepticulcer/haemorrhage(twoormoredistinctepisodesofproven

ulcerationorbleeding).

Brufeniscontraindicatedinpatientswithsevereheartfailure.

Brufeniscontraindicatedinpatientswithsevereliverfailure.

Brufeniscontraindicatedinpatientswithsevererenalfailure(glomerularfiltrationbelow30mL/min).

Brufenshouldnotbegiventopatientswithconditionsinvolvinganincreasedtendencytobleeding.

Brufenshouldnotbeusedinpatientswithknownhypersensitivityorwhohaveexperiencedasthma,urticariaor

allergic-typereactionsaftertakingBrufen,aspirinorotherNSAIDs.

Brufeniscontraindicatedduringthethirdtrimesterofpregnancy(seesection4.6,Fertility,pregnancyandlactation).

4.4Specialwarningsandprecautionsforuse

GeneralPrecautions

Undesirableeffectsmaybeminimisedbyusingthelowesteffectivedosefortheshortestdurationnecessarytocontrol

symptoms(seesection4.2,posologyandmethodofadministrationandGIandcardiovascularrisksbelow).Patients

treatedwithNSAIDslong-termshouldundergoregularmedicalsupervisiontomonitorforadverseevents.

CautionisrequiredifBrufenisadministeredtopatientssufferingfrom,orwithaprevioushistoryof,bronchialasthma

sinceibuprofenhasbeenreportedtocausebronchospasminsuchpatients.

Cautionisrequiredinpatientswithrenal,hepaticorcardiacimpairmentsincetheuseofNSAIDsmayresultin

deteriorationofrenalfunction.Thedoseshouldbekeptaslowaspossibleandassessmentofrenalfunctionshould

occurpriortotheinitiationoftherapyandregularlythereafter.

Cautionisrequiredinpatientswithahistoryofheartfailureand/orhypertensionasfluidretentionandoedemahas

beenreportedinassociationwithNSAIDtherapy.

Theuseofibuprofenmayimpairfemalefertilityandisnotrecommendedinwomenattemptingtoconceive.Inwomen

whohavedifficultiesconceivingorwhoareundergoinginvestigationofinfertility,withdrawalofibuprofenshouldbe

considered.

Elderly:theelderlyhaveanincreasedfrequencyofadversereactionstoNSAIDsespeciallygastrointestinalbleeding

andperforationwhichmaybefatal(seesection4.2,posologyandmethodofadministration).

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

malabsorptionshouldnottakethismedication.

AswithotherNSAIDs,ibuprofenmaymaskthesignsofinfection.

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thepotentialforadditiveeffects.

Gastrointestinalbleeding,ulcerationandperforation:

GIbleeding,ulcerationorperforation,whichcanbefatal,hasbeenreportedwithallNSAIDsatanytimeduring

treatment,withorwithoutwarningsymptomsoraprevioushistoryofseriousGIevents.

TheriskofGIbleeding,ulcerationorperforationishigherwithincreasingNSAIDdoses,inpatientswithahistoryof

ulcer,particularlyifcomplicatedwithhaemorrhageorperforation(Seesection4.3,contraindications),andinthe

elderly.Thesepatientsshouldcommencetreatmentonthelowestdoseavailable.Combinationtherapywithprotective

agents(e.g.misoprostolorprotonpumpinhibitors)shouldbeconsideredforthesepatients,andalsoforpatients

requiringconcomitantlowdoseaspirin,orotherdrugslikelytoincreasegastrointestinalrisk(Seebelowandsection4.5

interactionwithothermedicinalproductsandotherformsofinteraction).

TheconcomitantadministrationofBrufenandotherNSAIDs,includingcyclooxygenase-2(Cox-2)selectiveinhibitors,

shouldbeavoidedduetotheincreasedriskofulcerationorbleeding(Seebelowandsection4.5,Interactionwithother

medicinalproductsandotherformsofinteraction).

PatientswithahistoryofGIdisease,particularlywhenelderly,shouldreportanyunusualabdominalsymptoms

(especiallyGIbleeding)particularlyintheinitialstagesoftreatment.

Cautionshouldbeadvisedinpatientsreceivingconcomitantmedicationswhichcouldincreasetheriskofulcerationor

bleeding,suchasoralcorticosteroids,anticoagulantssuchaswarfarin,selectiveserotonin-reuptakeinhibitorsoranti-

plateletagentssuchasaspirin(Seesection4.5,interactionwithothermedicinalproductsandotherformsof

interaction)).

WhenGIbleedingorulcerationoccursinpatientsreceivingBrufen,thetreatmentshouldbewithdrawn.

NSAIDsshouldbegivenwithcaretopatientswithahistoryofgastrointestinaldisease(ulcerativecolitis,Crohn’s

disease)astheirconditionmaybeexacerbated(Seesection4.8,undesirableeffects).

Cardiovascularandcerebrovasculareffects

Appropriatemonitoringandadvicearerequiredforpatientswithahistoryofhypertensionand/ormildtomoderate

congestiveheartfailureasfluidretentionandoedemahavebeenreportedinassociationwithNSAIDtherapy.

Clinicaltrialdatasuggestthatuseofibuprofen,particularlyatahighdose(2400mg/daily)andinlongtermtreatment

maybeassociatedwithasmallincreasedriskofarterialthromboticevents(forexamplemyocardialinfarctionor

stroke).Overall,epidemiologicalstudiesdonotsuggestthatlowdoseibuprofen(e.g. 1200mgdaily)isassociated

withanincreasedriskofmyocardialinfarction.

Patientswithuncontrolledhypertension,congestiveheartfailure,establishedischaemicheartdisease,peripheralarterial

disease,and/orcerebrovasculardiseaseshouldonlybetreatedwithibuprofenaftercarefulconsideration.Similar

considerationshouldbemadebeforeinitiatinglonger-termtreatmentofpatientswithriskfactorsforcardiovascular

events(e.g.hypertension,hyperlipidaemia,diabetesmellitus,smoking).

RenalEffects

CautionshouldbeusedwheninitiatingtreatmentwithBrufeninpatientswithconsiderabledehydration.

Thereisariskofrenalimpairmentindehydratedchildrenandadolescents.

AswithotherNSAIDs,long-termadministrationofBrufenhasresultedinrenalpapillarynecrosisandotherrenal

pathologicalchanges.Renaltoxicityhasalsobeenseeninpatientsinwhomrenalprostaglandinshaveacompensatory

roleinthemaintenanceofrenalperfusion.Inthesepatients,administrationofanNSAIDmaycauseadose-dependant

reductioninprostaglandinsformationand,secondarily,inrenalbloodflow,whichmayprecipitateovertrenal

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dysfunction,thosewhoaretakingdiureticsandACEinhibitorsandtheelderly.DiscontinuationofNSAIDtherapyis

usuallyfollowedbyrecoverytothepre-treatmentstate.

HaematologicalEffects

AsNSAIDscaninterferewithplateletfunctionandmayprolongbleedingtime,Brufenshouldbeusedwithcautionin

patientswithintracranialhaemorrhageandbleedingdiathesis.

DermatologicalEffects

Seriousskinreactions,someofthemfatal,includingexfoliativedermatitis,Stevens-Johnsonsyndrome,andtoxic

epidermalnecrolysis,havebeenreportedveryrarelyinassociationwiththeuseofNSAIDs(seesection4.8).Patients

appeartobeatthehighestriskofthesereactionsearlyinthecourseoftherapy,theonsetofthereactionoccurringin

themajorityofcaseswithinthefirstmonthoftreatment.Brufenshouldbediscontinuedatthefirstappearanceofskin

rash,mucosallesions,oranyothersignofhypersensitivity.

AsepticMeningitis

AsepticmeningitishasbeenobservedonrareoccasionsinpatientswithBrufentherapy.Althoughitisprobablymore

unlikelytooccurinpatientswithsystematiclupuserythematosusandrelatedconnectivetissuediseases,ithasbeen

reportedinpatientswhodonothaveanunderlyingchronicdisease.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ItisconsideredunsafetotakeNSAIDsincombinationwithwarfarinorheparinunlessunderdirectmedical

supervision.

Careshouldbetakeninpatientstreatedwithanyofthefollowingdrugsasinteractionshavebeenreported:

Antihypertensives,beta-blockersanddiuretics:

NSAIDsmayreducetheeffectofanti-hypertensives,suchasACEinhibitors,beta-blockersanddiuretics.

DiureticscanalsoincreasetheriskofnephrotoxicityofNSAIDs.

Cardiacglycosides:NSAIDsmayexacerbatecardiacfailure,reduceGFRandincreaseplasmacardiacglycosidelevels.

Lithium:NSAIDsmaydecreaseeliminationoflithium.

Methotrexate:NSAIDsmayinhibitthetubularsecretionofmethotrexateandreduceclearanceofmethotrexate

Cyclosporin:increasedriskofnephrotoxicitywithNSAIDs.

Otheranalgesicsincludingcyclooxygenase-2selectiveinhibitors:avoidconcomitantuseoftwoormoreNSAIDs,

(includingaspirin)asthismayincreasetheriskofadverseeffects(seesection4.4,specialwarningsandspecial

precautionsforuse).

Corticosteroids:increasedriskofgastrointestinalulcerationorbleedingwithNSAIDs(Seesection4.4,special

warningsandspecialprecautionsforuse)

Anticoagulants:NSAIDsmayenhancetheeffectsofanticoagulants,suchaswarfarin(Seesection4.4,special

warningsandspecialprecautionsforuse).

Aspirin:AswithotherproductscontainingNSAIDs,concomitantadministrationofibuprofenandaspirinisnot

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Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.However,thelimitationsofthesedataandtheuncertaintiesregardingextrapolationofex

vivodatatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofenuse,andno

clinicallyrelevanteffectisconsideredtobelikelyforoccasionaluse(seesection5.1,pharmacodynamicproperties).

Anti-plateletagentsandselectiveserotoninreuptakeinhibitors(SSRIs):increasedriskofgastrointestinalbleedingwith

NSAIDs(Seesection4.4,specialwarningsandspecialprecautionsforuse).

Aminoglycosides:NSAIDsmaydecreasetheexcretionofaminoglycosides.

Cholestyramine:Theconcomitantadministrationofibuprofenandcholestyraminemayreducetheabsorptionof

ibuprofeninthegastrointestinaltract.However,theclinicalsignificanceisunknown.

Quinoloneantibiotics:animaldataindicatethatNSAIDscanincreasetheriskofconvulsionsassociatedwithquinolone

antibiotics.PatientstakingNSAIDsandquinolonesmayhaveincreasedriskofdevelopingconvulsions.

Sulfonylureas:NSAIDsmaypotentiatetheeffectsofsulfonylreamedications.Therehavebeenrarereportsof

hypoglycemiainpatientsonsulfonylureamedicationsreceivingibuprofen.

Probenacid:therehavebeennoreportsofinteractionsbetweenprobenacidandibuprofen.However,probenacid

producesareductioninmetabolismandeliminationofsomeNSAIDsandmetabolites.

Oralhypoglycaemicagents:inhibitionofmetabolismofsulfonylureadrugs,prolongedhalf-lifeandincreasedriskof

hypoglycaemia.

Mifepristone:

Adecreaseintheefficacyofthemedicinalproductcantheoreticallyoccurduetotheantiprostaglandinpropertiesof

NSAIDs.LimitedevidencesuggeststhatcoadministrationofNSAIDsonthedayofprostaglandinadministrationdoes

notadverselyinfluencetheeffectsofmifepristoneortheprostaglandinoncervicalripeningoruterinecontractility.

Tacrolimus:PossibleincreasedriskofnephrotoxicitywhenNSAIDsaregivenwithtacrolimus.

Zidovudine:IncreasedriskofhaematologicaltoxicitywhenNSAIDsaregivenwithzidovudine.Thereisevidenceof

anincreasedriskofhaemarthrosesandhaematomainHIV(+)haemophiliacsreceivingconcurrenttreatmentwith

zidovudineandibuprofen.

CYP2C9Inhibitors:ConcomitantadministrationofibuprofenwithCYP2C9inhibitorsmayincreasetheexposureto

ibuprofen(CYP2C9substrate).Inastudywithvoriconazoleandfluconazole(CYP2C9inhibitors),anincreasedS(+)-

ibuprofenexposurebyapproximately80to100%hasbeenshown.Reductionoftheibuprofendoseshouldbe

consideredwhenpotentCYP2C9inhibitorsareadministeredconcomitantly,particularlywhenhigh-doseibuprofenis

administeredwitheithervoriconazoleorfluconazole.

GinkgobilobamaypotentiatetheriskofbleedingwithNSAIDs.

4.6Fertility,pregnancyandlactation

Inhibitionofprostaglandinsynthesismayadverselyaffectthepregnancyand/orembryo/fetaldevelopment.Datafrom

epidemiologicalstudiessuggestanincreasedriskofmiscarriageandofcardiacmalformationandgastroschisisafterthe

useofaprostaglandinsynthesisinhibitorinearlypregnancy.Inanimals,theadministrationofaprostaglandinsynthesis

inhibitorhasbeenshowntoresultinincreasedpre-andpost-implantationlossesandembryo/fetallethality.Inaddition,

increasedincidencesofvariousmalformations,includingcardiovascular,havebeenreportedinanimalsgivena

prostaglandinsynthesisinhibitorduringtheorganogeneticperiod.Duringthefirstandsecondtrimesterofpregnancy,

ibuprofenshouldnotbegivenunlessclearlynecessary.Ifibuprofenisusedbyawomanattemptingtoconceive,or

duringthefirstorsecondtrimesterofpregnancy,thedoseshouldbekeptaslowanddurationoftreatmentasshortas

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Duringthethirdtrimesterofpregnancy,allprostaglandinsynthesisinhibitorsmayexposethefetustothefollowing:

Cardiopulmonarytoxicity(withprematureclosureoftheductusarteriosusandpulmonaryhypertension)

Renaldysfunction,whichmayprogresstorenalfailurewitholigohydramnios.

Attheendofpregnancy,prostaglandinsynthesisinhibitorsmayexposethemotherandtheneonatetothefollowing:

Possibleprolongationofbleedingtime

Inhibitionofuterinecontractions,whichmayresultindelayedorprolongedlabor.

Consequently,ibuprofeniscontraindicatedduringthethirdtrimesterofpregnancy.

Labouranddelivery:Administrationofibuprofenisnotrecommendedduringlabouranddelivery.Theonsetoflabour

maybedelayedandthedurationincreasedwithagreaterbleedingtendencyinbothmotherandchild.

Inlimitedstudiestodate,ibuprofenappearsinbreastmilkinverylowconcentrations.Brufenisnotrecommendedfor

useinnursingmothers.

FemaleFertility:Theuseofibuprofenmayimpairfemalefertilityandisnotrecommendedinwomenattemptingto

conceive.Inwomenwhohavedifficultiesconceivingorwhoareundergoinginvestigationofinfertility,withdrawalof

ibuprofenshouldbeconsidered.

4.7Effectsonabilitytodriveandusemachines

Undesirableeffectssuchasdizziness,drowsiness,fatigueandvisualdisturbancesarepossibleaftertakingNSAIDs.If

affected,patientsshouldnotdriveoroperatemachinery.

4.8Undesirableeffects

Gastrointestinaldisorders:

Themostcommonlyobservedadverseeventsaregastrointestinalinnature.Pepticulcers,perforationorGIbleeding,

sometimesfatal,particularlyintheelderly,mayoccur(seesection4.4,Specialwarningsandprecautionsforuse).

Nausea,vomiting,diarrhoea,flatulence,constipation,dyspepsia,abdominalpain,melaena,haematemesis,ulcerative

stomatitis,exacerbationofcolitisandCrohn’sdisease(seesection4.4-Specialwarningsandprecautionsforuse)have

beenreportedfollowingadministration.Lessfrequently,gastritisandduodenalulcerhasbeenobserved.

Gastrointestinalperforationhasbeenrarelyreportedwithibuprofenuse.Pancreatitishasbeenreportedveryrarely.

Immunesystemdisorders:

Hypersensitivityreactionshavebeenreportedfollowingtreatmentwithibuprofen.Thesemayconsistof(a)non-

specificallergicreactionandanaphylaxis,(b)respiratorytractreactivitycomprisingasthma,aggravatedasthma,

bronchospasmordyspnoea,or(c)assortedskindisorders,includingrashesofvarioustypes,pruritus,urticaria,purpura,

angioedemaand,veryrarely,bullousdermatoses(includingStevens-Johnsonsyndrome,toxicepidermalnecrolysis

anderythemamultiforme).

Cardiacdisordersandvasculardisorders:Oedema,hypertensionandcardiacfailurehavebeenreportedinassociation

withNSAIDtreatment.Clinicaltrialandepidemiologicaldatasuggestthatuseofibuprofen,particularlyathighdose

(2400mg/daily),andinlongtermtreatmentmaybeassociatedwithasmallincreasedriskofarterialthromboticevents

(forexamplemyocardialinfarctionorstroke)(seesection4.4,specialwarningsandprecautionsforuse).

Otheradverseeventsreportedinclude:

Infectionsandinfestations:rhinitisandmeningitisaseptic

Bloodandlymphaticsystemdisorders:leukopenia,thrombocytopenia,neutropenia,agranulocytosis,aplasticanaemia

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Psychiatricdisorders:insomnia,anxiety,depression,confusionalstate,hallucinations

Nervoussystemdisorders:headaches,paraesthesia,dizziness,somnolence

Eyedisorders:visualimpairment,opticneuritis,toxicopticneuropathy

Earandlabyrinthdisorders:hearingimpaired,vertigo,tinnitus

Hepatobiliarydisorders:abnormalhepaticfunction,hepaticfailure,hepatitis,jaundice

Skinandsubcutaneoustissuedisorders:photosensitivityreaction,bullousreactionsincludingSteven'sJohnson

syndromeandtoxicepidermalnecrolysis(veryrare).

Generaldisordersandadministrationsiteconditions:malaise,fatigue

Renalandurinarydisorders:impairedrenalfunction,toxicnephropathyinvariousforms,includinginterstitial

nephritis,nephroticsyndromeandrenalfailure.

4.9Overdose

Toxicity:

Signsandsymptomsoftoxicityhavegenerallynotbeenobservedatdosesbelow100mg/kginchildrenoradults.

However,supportivecaremaybeneededinsomecases.Childrenhavebeenobservedtomanifestsignsandsymptoms

oftoxicityafteringestionof400mg/kgorgreater.

Symptoms:

Mostpatientswhohaveingestedsignificantamountsofibuprofenwillmanifestsymptomswithin4to6hours.The

mostfrequentlyreportedsymptomsofoverdoseincludenausea,vomiting,abdominalpain,lethargyanddrowsiness.

Centralnervoussystem(CNS)effectsincludeheadache,tinnitus,dizziness,convulsion,andlossofconsciousness.

Nystagmus,metabolicacidosis,hypothermia,renaleffects,gastrointestinalbleeding,coma,apneaanddepressionofthe

CNSandrespiratorysystemhavealsobeenrarelyreported.Cardiovasculartoxicity,includinghypotension,

bradycardiaandtachycardia,hasbeenreported.Incasesofsignificantoverdose,renalfailureandliverdamageare

possible.Largeoverdosesaregenerallywelltoleratedwhennootherdrugsarebeingtaken.

Treatment:

Thereisnospecificantidoteforibuprofenoverdose.Gastricemptyingfollowedbysupportivemeasuresis

recommendedifthequantityingestedexceeds400mg/kgwithintheprevioushour.Forthemostcurrentinformation,

contactthelocalpoisoncontrolcenter.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:M01AE01

Ibuprofenisaphenylpropionicacidderivativewithanalgesic,anti-inflammatoryandantipyreticactivity.Thedrug's

therapeuticeffectsasaNSAIDarethoughttoresultfromitsinhibitoryeffectontheenzymecyclo-oxygenase,which

resultsinamarkedreductioninprostaglandinsynthesis.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.Inonestudy,whenasingledoseofibuprofen400mgwastakenwithin8hoursbeforeor

within30minutesafterimmediatereleaseaspirindosing(81mg),adecreasedeffectofASAontheformationof

thromboxaneorplateletaggregationoccurred.However,thelimitationsofthesedataandtheuncertaintiesregarding

extrapolationofexvivodatatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofen

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5.2Pharmacokineticproperties

Ibuprofenisrapidlyabsorbedafteroraladministration,isstronglyplasmaproteinbound,andisexcretedmainlyinthe

urineasmetabolites.Thedrughasaplasmahalf-lifeof2hours.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Microcrystallinecellulose

CroscarmelloseSodium

LactoseMonohydrate

ColloidalAnhydrousSilica

SodiumLaurilsulfate

MagnesiumStearate

Opadrywhite(containinghypromellose,titaniumdioxideandtalc)

or

Hypromellose

Plus

Talc

Plus

OpaspraywhiteM-1-7111B(contains:TitaniumDioxide(E171)andHypromellose)

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

C.Storeintheoriginalpackinordertoprotectfrommoisture.

6.5Natureandcontentsofcontainer

Blisterpackcomprisingoftransparentpolyvinylchloride(PVC)orpolyvinylchloride/polyvinylidene(PVC/PVDC)

filmwithaluminiumfoilbacking.

Packsize:60tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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7MARKETINGAUTHORISATIONHOLDER

AbbottLaboratoriesIrelandLtd,

4051KingswoodDrive,

CitywestBusinessCampus,

Dublin24

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA0038/080/003

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01June1982

Dateoflastrenewal:01June2007

10DATEOFREVISIONOFTHETEXT

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Date Printed 05/06/2014 CRN 2143294 page number: 9

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