 |
| IBUGESIC |
IBUGESIC 200mg & 400mg Tablets
4.7-Effects on ability to drive and use machines
Undesirable eftecls such as dizziness, drowsiness, fatigue and sissat disturbances are possible after taking NSAIDs. If affected. patients should not drive Or operate machinery.
4.8-Undesirable effects
Gastnrnrtestrnat disorders: The mont comnronty observed adverse events era gastrointestinal in nature. Peptic ulcers, perlorason or Gl bleeding, sometimes fetal, perticulady in the elderly, may occur (see section 4.4). Nausea, vornthng, diarrhoea. flatulence, rzeisbpason, dyspepsia, abdominal pein. melnena, hasmstemesis, alcerative stomatitis, ecacerbation of colitis and Crotrn’s disease (see section 4.4) have been reported following ibxprofnn administration l,ess frequenfy, gastritis has been observed. Gastrointestinal perforation has been rarely reported with ibuprofen use. Psncreatths has also been reported very rarely.
Immune system disorders: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of(s) non-specdic allergic mactins sed anaptiylaxis, (b) respiratory sad reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnnea, or (c) assorted sbtir disorders, inclodirrg rastiec of various types, pmrilus. nrticaria, purpsrs. vvgioedema and, more rarely, ecfslistive and butoos derrnrafnses (ardudarg Stevens-Johnson syndrome, toxic epidermel necrolysis and erythema muthforme).
Cardiac disorders and vsscalsr disorders: Oedwrna, hypertension and cardiac tailum have been reported in association with NSAID Ireatment. Epidemiological data suggest that use of rbeprofen, particularly at high dose (240f mgldsily), and in long term beabrmnt, may be associated with a small increased risk of arterial thrornbobu eventn such as myncardial infarction or strobe (see section 4,4). Other adverse events reported less comrrrordy and for which causality has not necessarily been established include:
Blood aed lynsplsetic system disorders: Leulrrrpenia, tlrrombocytopenis, neatropenia, agranelocytosis, splantic anaemia end haemolytic anaense.
Psyctrixbic disorders: Insomnia, arridety, depression, confusional state, hallticirration.
Nervous system disorders: Optic neurItis, headache, paraesthesia. dizziness, somnolence.
Infections and infestations: Rhinitis asd aseptic meorsgitis (especially in patients with existing sutoimmune disorders, such as systemic lupr,m erytlsematosas aed mined connective yssue disease) with symptoms of stilt sects, headache, nausea, vomiting, fever or disorientation (see section 4.4).
Eye disorders: Vmuat impairment and toxic optic neuropathy.
Ear and Labyrinth disorders: Hearing impaired, bonitos and vertigo.
Hepetobitiary disorders: Abnormal liver function, hepatic tedure, hepatitis and jaundice.
Skin arid subcutaneous tissue disorders: Bultous reactions, irtcluding Stevens-Johnson syndrome and tonic epiderrsel snooPyste (very rate), and photosensitivity reaction.
Renal aid iflasy disorders: Impaired meat function and toxin nephropethy in venous forrrm, tirctudirrg intemtitiat rrephrlho, raplwotrc sfndiorr”e aid meal tailure.
General disorders sad edrrrinistration site conddisns: Malaise, fatigue.
4,9-Overdose
Toxicity
Signs and syrr’rrs oltoxicity have generally not been observed at doses below 100 mg/kg in children or adults. However. supportive own nay be needed In some cases. Chitdmn have bees observed to manifest signs and symptoms of toxicity after krgestiorr 0(400 mg/kg or greater.
Symptoms
tibist pehients wtro haee ingested significant amounts at ibaproten will manifest symptoms within 4 tot hours.
Tire rmret frequently reported symptoms of overdose include navsea, vomiting, abdominal pain, lethargy and drowsiness. Canrod rai’enuv syslms’ lCNS) effects include headache, tivetuu, dizziness, conncluion, end lass of consciousness. Nyutagmuu, rrsetdeoic aodaiss, tipdarrnia, reset affects, gastrointestinal bleeding, coma, apeoea, diarrhoea arid depression of the CNS and respiratory system have also tiees rarely mported. Olvorientabon. escitation, fainting and carnhorascndar loxrdty. indurkrg hypoteos’mn, bmttycardia aid tachycarntia lane been reported. In canes of sig* raerdow% renal failure and hoar damage em possible. Large overdoses era generaly web tolerated dpi no dIrer dnrgti am being taken.
Therapeutic measures
Patients should be timated sprnptoetittteetty as requIred. Within one boor of ingestion ot a potentially tonic amount, activated charcoal vtrodd be orewidwed. Altemelively, in odvlln, gastric lavage should tie considered within one hoar of ingestion of a potentialy ttverEig overdoso.
Good retire ordput viwrAd be ensured.
Renal aid bee ft,erctxas should be closely monitored.
Patimas idar,kl be observed for at least tour hours after Ingestion of potentially tonic amounts.
Frequent or fnolengeo osrnrfsiovu should be treated with letmnenoss diazepam. Other meassres may be indicated by the patient’s ‘ Corsr.
5-PHARMACOLOGICAL PROPERTtES 5.1-Pharrnacodynamtc properties
tbuprcten isa propioritc derivative with analgesic, anti-inflemmanory and anti-pyretic activity. The drag’s therapeutic effects uses NSAtD in thought to reset from its ielnikrilory effect on the errzyrrie cy&r-oeygenaso, which renalta in a marked reduction in prostaglendie synthesis.
Experimental data suggest that ibuprofas rrray inhibit the effect of low dove aspirin on platelet aggregation when they are dosed concomitantly. In one study, alien a single dose of r’buprofen 400 erg was taken wdtiie 8 baum before or wittiio 30 minvtea after ;mmediata release aspirin dosing (51 mg). a decreased effect of aspirin on the formation of thrombonene or plsletet aggregation ocosred However, the limitatioss olthese data and the uncertainties regarding extrapolation of envies data to the clinical sduation irrrply that on ttnrr conctoninvs can be made for regatar ibuproten use, end no clinically relevant effect in considered to be Itimly for occasional Ibuproten use.
5.2-Phannacoklnetlc properties
tbsprofmr is mpidty absorbed from the gastrointestinal tract, peek sense concentrations occurring 1-2 hours after administraSon. The ebrninetion haff-titw is approcimataly 2 hours
Ibuproten in metabolized in the liver to two inactive metatioldes and these, together with onctisnged iboprofen. am excreted by the kidney either as suds ores con)ugetes. Excretion by the kidney is both rapid and complete.
Ibuprofen in extensively bound to plenme proteins
6-PHARMACEUTiCAL PARTiCULARS
6.1-list of excipients
Ibugesic 200mg sugar coafed tablets
tnactise inorodieras: Maize starch, steeric acid. Suoa’ coer Opakrx perk AS1 53g, camaebe wax, opaglov regular, sucrose, scecia powder, calcium sniphate defrydrele, sodium cevboayrvethp*wtulosn
lbuges’tc 400 mg sugar coated tablets Inactive eroradients: Colloidal silicone dicicide, pregeted starch, Maize starch, stearic acid, perifed water. uogc.ti: Refined sugar, calcium sulphate dihydrate, sodium cartionymethylcellvlone, Opetun pink AS1t3, cameeba was, opeglos regular. ecacia powder. 6.2-f nconvpafibilitias
Not epphcebte.
6.3-Shelf Ltfe
3 years.
6.4-Speciat precautions for storage
Store at temperature not exceeding 30C, away frorrr tigtit and humidity. 6.5-Nature and contents of container
Ibugesic 200 mg sugar coated tablets Carton box containing 3 strips (PVC/AL) each of tO tablets with inner leaflet.
Ibugesic 400 erg sugar coated tablets Carton box containing 3 steps )PVCIAL) each of If tablets with inner leaf aL
QManufactured by L7qKAHIRA PHARM. & CHEM. IN!). Co. be’ CAIRO-EGYPT h-..7n
Undesirable eftecls such as dizziness, drowsiness, fatigue and sissat disturbances are possible after taking NSAIDs. If affected. patients should not drive Or operate machinery.
4.8-Undesirable effects
Gastnrnrtestrnat disorders: The mont comnronty observed adverse events era gastrointestinal in nature. Peptic ulcers, perlorason or Gl bleeding, sometimes fetal, perticulady in the elderly, may occur (see section 4.4). Nausea, vornthng, diarrhoea. flatulence, rzeisbpason, dyspepsia, abdominal pein. melnena, hasmstemesis, alcerative stomatitis, ecacerbation of colitis and Crotrn’s disease (see section 4.4) have been reported following ibxprofnn administration l,ess frequenfy, gastritis has been observed. Gastrointestinal perforation has been rarely reported with ibuprofen use. Psncreatths has also been reported very rarely.
Immune system disorders: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of(s) non-specdic allergic mactins sed anaptiylaxis, (b) respiratory sad reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnnea, or (c) assorted sbtir disorders, inclodirrg rastiec of various types, pmrilus. nrticaria, purpsrs. vvgioedema and, more rarely, ecfslistive and butoos derrnrafnses (ardudarg Stevens-Johnson syndrome, toxic epidermel necrolysis and erythema muthforme).
Cardiac disorders and vsscalsr disorders: Oedwrna, hypertension and cardiac tailum have been reported in association with NSAID Ireatment. Epidemiological data suggest that use of rbeprofen, particularly at high dose (240f mgldsily), and in long term beabrmnt, may be associated with a small increased risk of arterial thrornbobu eventn such as myncardial infarction or strobe (see section 4,4). Other adverse events reported less comrrrordy and for which causality has not necessarily been established include:
Blood aed lynsplsetic system disorders: Leulrrrpenia, tlrrombocytopenis, neatropenia, agranelocytosis, splantic anaemia end haemolytic anaense.
Psyctrixbic disorders: Insomnia, arridety, depression, confusional state, hallticirration.
Nervous system disorders: Optic neurItis, headache, paraesthesia. dizziness, somnolence.
Infections and infestations: Rhinitis asd aseptic meorsgitis (especially in patients with existing sutoimmune disorders, such as systemic lupr,m erytlsematosas aed mined connective yssue disease) with symptoms of stilt sects, headache, nausea, vomiting, fever or disorientation (see section 4.4).
Eye disorders: Vmuat impairment and toxic optic neuropathy.
Ear and Labyrinth disorders: Hearing impaired, bonitos and vertigo.
Hepetobitiary disorders: Abnormal liver function, hepatic tedure, hepatitis and jaundice.
Skin arid subcutaneous tissue disorders: Bultous reactions, irtcluding Stevens-Johnson syndrome and tonic epiderrsel snooPyste (very rate), and photosensitivity reaction.
Renal aid iflasy disorders: Impaired meat function and toxin nephropethy in venous forrrm, tirctudirrg intemtitiat rrephrlho, raplwotrc sfndiorr”e aid meal tailure.
General disorders sad edrrrinistration site conddisns: Malaise, fatigue.
4,9-Overdose
Toxicity
Signs and syrr’rrs oltoxicity have generally not been observed at doses below 100 mg/kg in children or adults. However. supportive own nay be needed In some cases. Chitdmn have bees observed to manifest signs and symptoms of toxicity after krgestiorr 0(400 mg/kg or greater.
Symptoms
tibist pehients wtro haee ingested significant amounts at ibaproten will manifest symptoms within 4 tot hours.
Tire rmret frequently reported symptoms of overdose include navsea, vomiting, abdominal pain, lethargy and drowsiness. Canrod rai’enuv syslms’ lCNS) effects include headache, tivetuu, dizziness, conncluion, end lass of consciousness. Nyutagmuu, rrsetdeoic aodaiss, tipdarrnia, reset affects, gastrointestinal bleeding, coma, apeoea, diarrhoea arid depression of the CNS and respiratory system have also tiees rarely mported. Olvorientabon. escitation, fainting and carnhorascndar loxrdty. indurkrg hypoteos’mn, bmttycardia aid tachycarntia lane been reported. In canes of sig* raerdow% renal failure and hoar damage em possible. Large overdoses era generaly web tolerated dpi no dIrer dnrgti am being taken.
Therapeutic measures
Patients should be timated sprnptoetittteetty as requIred. Within one boor of ingestion ot a potentially tonic amount, activated charcoal vtrodd be orewidwed. Altemelively, in odvlln, gastric lavage should tie considered within one hoar of ingestion of a potentialy ttverEig overdoso.
Good retire ordput viwrAd be ensured.
Renal aid bee ft,erctxas should be closely monitored.
Patimas idar,kl be observed for at least tour hours after Ingestion of potentially tonic amounts.
Frequent or fnolengeo osrnrfsiovu should be treated with letmnenoss diazepam. Other meassres may be indicated by the patient’s ‘ Corsr.
5-PHARMACOLOGICAL PROPERTtES 5.1-Pharrnacodynamtc properties
tbuprcten isa propioritc derivative with analgesic, anti-inflemmanory and anti-pyretic activity. The drag’s therapeutic effects uses NSAtD in thought to reset from its ielnikrilory effect on the errzyrrie cy&r-oeygenaso, which renalta in a marked reduction in prostaglendie synthesis.
Experimental data suggest that ibuprofas rrray inhibit the effect of low dove aspirin on platelet aggregation when they are dosed concomitantly. In one study, alien a single dose of r’buprofen 400 erg was taken wdtiie 8 baum before or wittiio 30 minvtea after ;mmediata release aspirin dosing (51 mg). a decreased effect of aspirin on the formation of thrombonene or plsletet aggregation ocosred However, the limitatioss olthese data and the uncertainties regarding extrapolation of envies data to the clinical sduation irrrply that on ttnrr conctoninvs can be made for regatar ibuproten use, end no clinically relevant effect in considered to be Itimly for occasional Ibuproten use.
5.2-Phannacoklnetlc properties
tbsprofmr is mpidty absorbed from the gastrointestinal tract, peek sense concentrations occurring 1-2 hours after administraSon. The ebrninetion haff-titw is approcimataly 2 hours
Ibuproten in metabolized in the liver to two inactive metatioldes and these, together with onctisnged iboprofen. am excreted by the kidney either as suds ores con)ugetes. Excretion by the kidney is both rapid and complete.
Ibuprofen in extensively bound to plenme proteins
6-PHARMACEUTiCAL PARTiCULARS
6.1-list of excipients
Ibugesic 200mg sugar coafed tablets
tnactise inorodieras: Maize starch, steeric acid. Suoa’ coer Opakrx perk AS1 53g, camaebe wax, opaglov regular, sucrose, scecia powder, calcium sniphate defrydrele, sodium cevboayrvethp*wtulosn
lbuges’tc 400 mg sugar coated tablets Inactive eroradients: Colloidal silicone dicicide, pregeted starch, Maize starch, stearic acid, perifed water. uogc.ti: Refined sugar, calcium sulphate dihydrate, sodium cartionymethylcellvlone, Opetun pink AS1t3, cameeba was, opeglos regular. ecacia powder. 6.2-f nconvpafibilitias
Not epphcebte.
6.3-Shelf Ltfe
3 years.
6.4-Speciat precautions for storage
Store at temperature not exceeding 30C, away frorrr tigtit and humidity. 6.5-Nature and contents of container
Ibugesic 200 mg sugar coated tablets Carton box containing 3 strips (PVC/AL) each of tO tablets with inner leaflet.
Ibugesic 400 erg sugar coated tablets Carton box containing 3 steps )PVCIAL) each of If tablets with inner leaf aL
QManufactured by L7qKAHIRA PHARM. & CHEM. IN!). Co. be’ CAIRO-EGYPT h-..7n
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