BUFIGEN 400 Milligram Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
IBUPROFEN
Available from:
Mercury Pharmaceuticals (Ireland) Ltd
INN (International Name):
IBUPROFEN
Dosage:
400 Milligram
Pharmaceutical form:
Tablets
Authorization status:
Withdrawn
Authorization number:
PA0073/063/002
Authorization date:
2008-02-20

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Bufigen Tablets400 mg.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each tabletcontains400 mg ofIbuprofen B.P

Forexcipients, see6.1.

3PHARMACEUTICALFORM

Tablets.

4CLINICALPARTICULARS

4.1TherapeuticIndications

In themanagementofvariousarthrosessuch asrheumatoid arthritisand osteoarthritis, fibrositis, ankylosing

spondylitis, and othermuscularsyndromes, such aslowback pain, softtissuetraumaand variousinflammationsof

tendon, jointcapsulesand ligaments.

Bufigen may beused foritsanalgesiceffectin thereliefofmild to moderatepain.

4.2Posologyandmethodofadminstration

Bufigen tabletsarefororaladministration.

Adults:

Theusualdailydoseis1200to1800mgdailyindivideddoses.Somepatientscanbemaintainedon600-1200mg.

Themaximumrecommended daily doseis2400 mg.

Elderly:

Nospecialdosagemodificationsarerequiredforelderlypatients,unlesshepaticorrenalfunctionisimpaired,inwhich

casedosageshould beassessed individually.

Children:

20mgperkgofbodyweightdailyindivideddosesforchildrenover30kgbodyweight.Thetotaldoseinchildren

weighinglessthan30kgshouldnotexceed500mgin24hours.Notrecommendedforchildrenweighinglessthan

7kg.

4.3Contraindications

Bufigen should notbeadministeredto patientswith activepepticulceration.Bufigen should notbeused in patients

with aknown hypersensitivity to ibuprofen, norshould itbegiven to patientsin whomibuprofen, aspirin orothernon-

Irish Medicines Board

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Date Printed 27/02/2006 CRN 2020465 page number: 1

4.4Special warningsandprecautionsforuse

Non-steroidalanti-inflammatory drugshavebeen reported to causenephrotoxicity in variousforms:interstitial

nephritis, nephroticsyndromeand renalfailure.Caution isrequired in patientswith renal, cardiacorhepatic

impairment, sincetheuseofnon-steroidalanti-inflammatory drugsmay resultin deterioration ofrenalfunction.The

doseshould bekeptaslowaspossibleand renalfunction shouldbemonitored in thesepatients.

Bufigen should beused with greatcaution in patientswith ahistory orevidenceofpepticorotherintestinalulceration,

cardiovasculardiseaseorbleeding disorders.

Careisalso required when using ibuprofen in patientswith ahistory ofasthmaorbronchospasm, asbronchospasmmay

beprecipitated in such patients.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Bufigen should beused only with caution in patientsreceiving oralanticoagulantsorthiazidediuretics.

4.6Pregnancyandlactation

Ibuprofen should only beused during pregnancy ifconsidered essentialby thephysician. Studiesin animalsand

experienceto datein human beingshavenotrevealed evidenceofteratogenicity.Ibuprofen appearsin breastmilk in

very lowconcentrationsand isunlikely to affectthebreast-fed infantadversely.

4.7Effectsonabilitytodriveandusemachines

Patientswhoexperiencedizzinessorblurred vision whilsttaking N.S.A.I.D.s. should refrain fromdriving oroperating

machinery.

4.8Undesirableeffects

Possibleside-effectsincludegastrointestinaldisturbancesoccasionally leading to gastrointestinalorpepticulceration,

dizziness, headache, rash, pruritus, oedema, blurred vision,hypersensitivity.Thrombocytopenia, abnormalliver

function and impaired renalfunction havealso been reported.

4.9Overdose

Thereisno specificantidoteto ibuprofen.In acuteoverdosage, thestomach should beemptied by gastricaspiration

and lavage, orby inducing emesis.Treatmentissymptomaticand supportive;blood electrolytesshould becorrected if

necessary.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Bufigen containsibuprofen, anon-steroidalanti-inflammatory drug derivativeofphenylpropionicacid.Bufigen has

both analgesicand anti-inflammatory effects.

5.2Pharmacokineticproperties

Ibuprofen isabsorbed rapidly afteroraladministration, isstrongly bound to plasmaproteinsand hasaserumhalf-lifeof

Irish Medicines Board

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Date Printed 27/02/2006 CRN 2020465 page number: 2

5.3Preclinical safetydata

No furtherrelevantinformation otherthan thatwhich isincluded in othersectionsoftheSummary ofProduct

Characteristics.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Magnesiumstearate

Maizestarch

Lactose

Microcrystallinecellulose

Povidone

Colloidalsilicon dioxide

Sodiumstarch glycollate

SugarCoating

Shellac, Povidone, Acetylated glycerides, Calciumcarbonate, Sucrose, Titaniumdioxide, Erythrosinelake, Sodium

benzoate, Polyethyleneglycol6000, Shellacvegetablecarbon, Antifoam, Acacia, Talc, Methylhydroxybenzoate,

Propylhydroxybenzoate, Maizestarch.

6.2Incompatibilities

None

6.3ShelfLife

4 years.

6.4Special precautionsforstorage

Do notstoreabove25 0

Protectfromlight.

6.5Natureandcontentsofcontainer

Polypropylenesecuritainerswith tamperevidentpolypropylenecaps.

Pack sizes:100 and 500 tablets.

6.6Instructionsforuseandhandling

None

7MARKETINGAUTHORISATIONHOLDER

Antigen PharmaceuticalsLimited

Roscrea

County Tipperary

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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Date Printed 27/02/2006 CRN 2020465 page number: 3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstapproval:13 th

May 1981.

Dateoflastrenewal: 13 th

May 2001.

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 27/02/2006 CRN 2020465 page number: 4

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