 |
| IBUGESIC |
IBUGESIC 200mg & 400mg Tablets
WARNING
Cardiovascular Risk NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may
increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. NSAIOs is contraindicated for the treatment of pen-operative pain in the setting of coronary artery bypass graft (CABS) surgery. Gastrointestinal Risk NSAID5 cause an increased risk of serious gastrointestinal adverse events
including inflammation, bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. 1-NAME OF THE MEOICINAL. PROOucT
Ibugesic 200mg sugar coated tablets.
Ibugesic 400 mg sugar costed tablets.
2-QUALITATIVE ANO QUANTITATIVE COMPOSITION
Ibagesic 200 mg sugar coated tablets Each tablet contains 200mg Ibuprofes.
Ibagesic 400 mg sugar coated tablets Each tablet contaiss 400mg Ibaprefee. 3-PHARMACEUTICAL FORM
Red magenta, sugar coated tablets.
4-CLINICAL PARTICULARS
4.1-Therapeutic indications
Ibugesic is indicated for its analgesic and anti-inflammatory effects in me trnu. .::t nnvwrwoid arthritis (iecluding junenile
rheumatoid arthritis or stilt’s disease), ankylosing spondytitis, osteoarthntis and other non-rheumatoid (seronegatfee) arthropathies. In the treatment of non-articutar rheumatic conditions, Ibugesic is indicated ie periaafl’ cendisons such as frozen
shoulder (capsultis), bursitis, tendonitis, tenosynomhs asd low back pam; Ibagesic cae also be used in soft tissue injuries such
- - as sprains and shams. Ibugesic is also indicaled for its analgesic effect in the relief ot mild to moderate pals such as dysmenorrhnea, dental and post-operative pain and for synVptomatic relief of headache, including nrigraine headache.
4.2-Posology and method of administration
undesmwhte events may be minimized by asing the lowest effecline dose for the shortest possible dumtion necessary to control symptoms, (see section 4.4).
Adults: The mcommended dosage of tbugesic a 1200-1800mg daily in m8nided doses, Seine patients con be maintained on 600-1200 mg daily. In severe or acute ormndihons. d can be advantageous to increase the dosage until the acute phase is
- .. brought under control, pmnided that the total daily dose does not enceed 2400 mg in dorded doses.
Children: The daily dosagelbageeic is 20 mg/kg of body weight in divided doses.
In Jueen6e Rheumatoid ArthrItis. Cipfo40 mglkg of body weight daily is divided doses maybe token.
Net mcomnerrerrded for children weighkrg less than T kg. - - -
Elderly: The elderly are at increased rink of serious conseqranmas of adverse mactiort II 4NSAID is considered necessary the towest effective dose should be used and for the shortest posntrle draudan. The patient simuld be mondomd regulady for 01 bleeding during NSAIO therapy. 6 renal or hepalic tssrcton in fished, dosage should be asseseed individually.
For oral aderirisbalion Tn be taken preferably with or after tend,
4.3-Confmindications
Ibugesic is contraindicated in patients with hypersensitivity to the active substance or to wry cit the escipients.
Ibugesic should not be used in patients who have previously shown hypersensitivity readhew (e.g. asthma, articaria, angiedema or rhmsitis) after taking ibuprutev, aspirin or other NSAID5.
Ibagesic is also contralodicated in patienta with a history of gastrointestinal bleedtrrg or perlraation, related to previous NSAIO therapy. lbageaic should not he used in patients with active, or history of, mcument peptic rr or gastrointestinal heemorrhage (two or rrrom distinct episodes of proven ulceration or bleedisg).
Ibugesic should sot be gives to patients with conditions involving an increased tendenep re Needing.
Ibugesmc is conbaindicated is patients with seaem heart failure, hepahc failure and renal .a’e fsee section 4.4). Ibugesic in contraindicated dunng the last fcmenter of pmgeancy (see section 4.6).
4.4-special warnings and precautions for use undesirable effects may be minimized by using the lowest effective dose for the shortest dorason necessary to control symptoms (see section 4.2, and 01 and cardiovascular risks betow(.
Patents with mre hereditary problema of galactose intolerance, the Lapp lactose dehderrcy or glucose-galactose malabsorphon should not take this medication.
As with other NSAIDs. ibsprofen may rrrask the signs of infection.
The use of Ibugesic with concomfant N5AIOv, including cyclcooygenase-2 selective iritWs, should be avoided due to the isoreasod risk of ulceration or bleeding (see section 4.5). Elderly
The elderly have an increased frequency of adverse reactions to NSAIDs, especially gadrniolestmnal bleeding and perforation, which maybe tatal )see section 4.2).
Gastrointestinal bleeding, ulceration and pertnraiinrr
Gt bleeding, ulceration or perforation, which can be fatal, has bees reported with all N5AIOs at asytime during treatment, with or wthsut waming symptoms or a previous history of serious 01 events.
The risk of 01 bleeding, ulceration or perforation in higher with iecmeasing NSAID doses, 1mm patients with a hislory of ulcer, particclafy if complicated with haemorrlsage or perforaeon tsee section 4.3), and is the elderly.
These patients should commerce treatment on the lowest dose available. Cembinahun therapy with protective agents (e.g.
minopmstol or proton pump inhibtiom) sfmstd be onrrsidered for these pahents, and alan hr patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and section 4.5). Patients with a history of gastroistestisal disease, particularly when eldedy, should repratany anussal abdomiaal symptoms (especially gastrointestinal hleediog) particularly in the initial stages of treatment
Caution should be advised is patients receiving concomitant medications which could irsuwase the rink of ulceration or bleeding, such as oral corticosseroids, asticoagalents such as warfare, selective semtosin-reuptake i-,lrtrlrors of anti-pinlelet agents sack an aspirin (see section 4.5).
When 01 bleeding or ulceration occurs in patients receiving tbugesic, the treahoent should be withdrawn.
NSAIDs should be given with care to patients with a history of ulcerative colitis or Crohe’&alvease an these conditions may be enacerbated (see section 4.8).
Respiratory dinorders
Caution is required f tb’’is administered to pabents suffering from, or with a previous history of brorrctrial asthma since NSAIOs have bean reported to precipitate hrorrchospasm in such patients.
Cardiovascular, renal and hepatic impairment
The administration of a NSAIO may cause a dose dependent reduction in pmstagtaedio formation arid precipitate renal failure. Patients at greatest risk of thin reaction are those with impaired renal function, cardiac inrpairment, liver dysfunction, those takleg diuretice and the elderly. Renal function should be montiored is these pabests tsee also section 4.3). Ibegesic should be given with care to patients with a history of heart failure or hypertension since oedema has been reported iv association with ibaprofen administration.
Cardiovascular and cerebmvascnlar effects
Appropriate montioring and advice are required for patients with a iostory of hypnrtens.oe and/or mild to moderate congestive
WARNING
Cardiovascular Risk NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may
increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. NSAIOs is contraindicated for the treatment of pen-operative pain in the setting of coronary artery bypass graft (CABS) surgery. Gastrointestinal Risk NSAID5 cause an increased risk of serious gastrointestinal adverse events
including inflammation, bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. 1-NAME OF THE MEOICINAL. PROOucT
Ibugesic 200mg sugar coated tablets.
Ibugesic 400 mg sugar costed tablets.
2-QUALITATIVE ANO QUANTITATIVE COMPOSITION
Ibagesic 200 mg sugar coated tablets Each tablet contains 200mg Ibuprofes.
Ibagesic 400 mg sugar coated tablets Each tablet contaiss 400mg Ibaprefee. 3-PHARMACEUTICAL FORM
Red magenta, sugar coated tablets.
4-CLINICAL PARTICULARS
4.1-Therapeutic indications
Ibugesic is indicated for its analgesic and anti-inflammatory effects in me trnu. .::t nnvwrwoid arthritis (iecluding junenile
rheumatoid arthritis or stilt’s disease), ankylosing spondytitis, osteoarthntis and other non-rheumatoid (seronegatfee) arthropathies. In the treatment of non-articutar rheumatic conditions, Ibugesic is indicated ie periaafl’ cendisons such as frozen
shoulder (capsultis), bursitis, tendonitis, tenosynomhs asd low back pam; Ibagesic cae also be used in soft tissue injuries such
- - as sprains and shams. Ibugesic is also indicaled for its analgesic effect in the relief ot mild to moderate pals such as dysmenorrhnea, dental and post-operative pain and for synVptomatic relief of headache, including nrigraine headache.
4.2-Posology and method of administration
undesmwhte events may be minimized by asing the lowest effecline dose for the shortest possible dumtion necessary to control symptoms, (see section 4.4).
Adults: The mcommended dosage of tbugesic a 1200-1800mg daily in m8nided doses, Seine patients con be maintained on 600-1200 mg daily. In severe or acute ormndihons. d can be advantageous to increase the dosage until the acute phase is
- .. brought under control, pmnided that the total daily dose does not enceed 2400 mg in dorded doses.
Children: The daily dosagelbageeic is 20 mg/kg of body weight in divided doses.
In Jueen6e Rheumatoid ArthrItis. Cipfo40 mglkg of body weight daily is divided doses maybe token.
Net mcomnerrerrded for children weighkrg less than T kg. - - -
Elderly: The elderly are at increased rink of serious conseqranmas of adverse mactiort II 4NSAID is considered necessary the towest effective dose should be used and for the shortest posntrle draudan. The patient simuld be mondomd regulady for 01 bleeding during NSAIO therapy. 6 renal or hepalic tssrcton in fished, dosage should be asseseed individually.
For oral aderirisbalion Tn be taken preferably with or after tend,
4.3-Confmindications
Ibugesic is contraindicated in patients with hypersensitivity to the active substance or to wry cit the escipients.
Ibugesic should not be used in patients who have previously shown hypersensitivity readhew (e.g. asthma, articaria, angiedema or rhmsitis) after taking ibuprutev, aspirin or other NSAID5.
Ibagesic is also contralodicated in patienta with a history of gastrointestinal bleedtrrg or perlraation, related to previous NSAIO therapy. lbageaic should not he used in patients with active, or history of, mcument peptic rr or gastrointestinal heemorrhage (two or rrrom distinct episodes of proven ulceration or bleedisg).
Ibugesic should sot be gives to patients with conditions involving an increased tendenep re Needing.
Ibugesmc is conbaindicated is patients with seaem heart failure, hepahc failure and renal .a’e fsee section 4.4). Ibugesic in contraindicated dunng the last fcmenter of pmgeancy (see section 4.6).
4.4-special warnings and precautions for use undesirable effects may be minimized by using the lowest effective dose for the shortest dorason necessary to control symptoms (see section 4.2, and 01 and cardiovascular risks betow(.
Patents with mre hereditary problema of galactose intolerance, the Lapp lactose dehderrcy or glucose-galactose malabsorphon should not take this medication.
As with other NSAIDs. ibsprofen may rrrask the signs of infection.
The use of Ibugesic with concomfant N5AIOv, including cyclcooygenase-2 selective iritWs, should be avoided due to the isoreasod risk of ulceration or bleeding (see section 4.5). Elderly
The elderly have an increased frequency of adverse reactions to NSAIDs, especially gadrniolestmnal bleeding and perforation, which maybe tatal )see section 4.2).
Gastrointestinal bleeding, ulceration and pertnraiinrr
Gt bleeding, ulceration or perforation, which can be fatal, has bees reported with all N5AIOs at asytime during treatment, with or wthsut waming symptoms or a previous history of serious 01 events.
The risk of 01 bleeding, ulceration or perforation in higher with iecmeasing NSAID doses, 1mm patients with a hislory of ulcer, particclafy if complicated with haemorrlsage or perforaeon tsee section 4.3), and is the elderly.
These patients should commerce treatment on the lowest dose available. Cembinahun therapy with protective agents (e.g.
minopmstol or proton pump inhibtiom) sfmstd be onrrsidered for these pahents, and alan hr patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and section 4.5). Patients with a history of gastroistestisal disease, particularly when eldedy, should repratany anussal abdomiaal symptoms (especially gastrointestinal hleediog) particularly in the initial stages of treatment
Caution should be advised is patients receiving concomitant medications which could irsuwase the rink of ulceration or bleeding, such as oral corticosseroids, asticoagalents such as warfare, selective semtosin-reuptake i-,lrtrlrors of anti-pinlelet agents sack an aspirin (see section 4.5).
When 01 bleeding or ulceration occurs in patients receiving tbugesic, the treahoent should be withdrawn.
NSAIDs should be given with care to patients with a history of ulcerative colitis or Crohe’&alvease an these conditions may be enacerbated (see section 4.8).
Respiratory dinorders
Caution is required f tb’’is administered to pabents suffering from, or with a previous history of brorrctrial asthma since NSAIOs have bean reported to precipitate hrorrchospasm in such patients.
Cardiovascular, renal and hepatic impairment
The administration of a NSAIO may cause a dose dependent reduction in pmstagtaedio formation arid precipitate renal failure. Patients at greatest risk of thin reaction are those with impaired renal function, cardiac inrpairment, liver dysfunction, those takleg diuretice and the elderly. Renal function should be montiored is these pabests tsee also section 4.3). Ibegesic should be given with care to patients with a history of heart failure or hypertension since oedema has been reported iv association with ibaprofen administration.
Cardiovascular and cerebmvascnlar effects
Appropriate montioring and advice are required for patients with a iostory of hypnrtens.oe and/or mild to moderate congestive
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