http___www.krenizdravo.com_korisno_upute_ketonal-forte-100-mg-tablete_1.xml
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Active Ingredient: Ibuprofen BP (800 mg) Sustained-release tablets. Brufen Retard is indicated for its analgesic and anti-inflammatory effects in the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or Still's disease), ankylosing spondylitis, osteoarthritis and other non-rheumatoid (seronegative) arthropathies. In the treatment of non-articular rheumatic conditions, Brufen Retard is indicated in periarticular conditions such as frozen shoulder (capsulitis), bursitis, tendinitis, tenosynovitis and low back pain; Brufen Retard can also be used in soft-tissue injuries such as sprains and strains. Brufen Retard is also indicated for its analgesic effect in the relief of mild to moderate pain such as dysmenorrhoea, dental and post-operative pain and for symptomatic relief of headache including migraine headache. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Adults: Two tablets taken as a single daily dose, preferably in the early evening well before retiring to bed. The tablets should be swallowed whole with plenty of fluid and not chewed, broken, crushed or sucked on to avoid oral discomfort and throat irritation. In severe or acute conditions, total daily dosage may be increased to three tablets in two divided doses. Children: Not recommended for children under 12 years. Elderly: The elderly are at increased risk of serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. If renal or hepatic function is impaired, dosage should be assessed individually. For oral administration. To be taken preferably with or after food. Brufen is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Brufen should not be used in patients who have previously shown hypersensitivity reactions (e.g. asthma, urticaria, angioedema or rhinitis) after taking ibuprofen, aspirin or other NSAIDs. Brufen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Brufen should not be used in patients with active, or history of, recurrent peptic ulcer or gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Brufen should not be given to patients with conditions involving an increased tendency to bleeding. Brufen is contraindicated in patients with severe heart failure, hepatic failure and renal failure (see section 4.4). Brufen is contraindicated during the last trimester of pregnancy (see section 4.6). Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below). As with other NSAIDs, ibuprofen may mask the signs of infection. The use of Brufen with concomitant NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to the increased risk of ulceration or bleeding (see section 4.5). Elderly The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2). Paediatric population There is a risk of renal impairment in dehydrated children and adolescents. Gastrointestinal bleeding, ulceration and perforation GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for 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 gastrointestinal disease, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5). When GI bleeding or ulceration occurs in patients receiving Brufen, the treatment should be withdrawn. NSAIDs should be given with care to patients with a history of ulcerative colitis or Crohn's disease as these conditions may be exacerbated (see section 4.8). Respiratory disorders Caution is required if Brufen is administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients. Cardiovascular, renal and hepatic impairment The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients (see also section 4.3). Brufen should be given with care to patients with a history of heart failure or hypertension since oedema has been reported in association with ibuprofen administration. Cardiovascular and cerebrovascular effects Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Epidemiological data suggest that use of ibuprofen, particularly at a high dose (2400 mg/ daily) and in long term treatment, may be associated with a small increased risk of arterial thrombotic events such as myocardial infarction or stroke. Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 1200mg daily) is associated with an increased risk of arterial thrombotic events, particularly myocardial infarction. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). Renal effects Caution should be used when initiating treatment with ibuprofen in patients with considerable dehydration. As with other NSAIDs, long-term administration of ibuprofen has resulted in renal papillary necrosis and other renal pathologic changes. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependant reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pre-treatment state. SLE and mixed connective tissue disease In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (see below and section 4.8). Dermatological effects Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring within the first month of treatment in the majority of cases. Brufen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Haematological effects Ibuprofen, like other NSAIDs, can interfere with platelet aggregation and has been shown to prolong bleeding time in normal subjects. Aseptic meningitis Aseptic meningitis has been observed on rare occasions in patients on ibuprofen therapy. Although it is probably more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has been reported in patients who do not have an underlying chronic disease. Impaired female fertility The use of Brufen may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Brufen should be considered. Care should be taken in patients treated with any of the following drugs as interactions have been reported in some patients. Antihypertensives, beta-blockers and diuretics: NSAIDs may reduce the effect of anti-hypertensives, such as ACE inhibitors, beta-blockers and diuretics. Diuretics can also increase the risk of nephrotoxicity of NSAIDs. Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma cardiac glycoside levels. Cholestyramine; The concomitant administration of ibuprofen and cholestyramine may reduce the absorption of ibuprofen in the gastrointestinal tract. However, the clinical significance is unknown. Lithium: Decreased elimination of lithium. Methotrexate: NSAIDs may inhibit the tubular secretion of methotrexate and reduce clearance of methotrexate. Ciclosporin: Increased risk of nephrotoxicity. Mifepristone: A decrease in the efficacy of the medicinal product can theoretically occur due to the antiprostaglandin properties of NSAIDs. Limited evidence suggests that coadministration of NSAIDs on the day of prostaglandin administration does not adversely influence the effects of mifepristone or the prostaglandin on cervical ripening or uterine contractility and does not reduce the clinical efficacy of medicinal termination of pregnancy. Other analgesics and cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs, including Cox-2 inhibitors, as this may increase the risk of adverse effects (see section 4.4). Aspirin: As with other products containing NSAIDs, concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential of increased adverse effects. Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional use (see section 5.1). Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding with NSAIDs (see section 4.4). Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4). Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions. Sulfonylureas: NSAIDs may potentiate the effects of sulfonylurea medications. There have been rare reports of hypoglycaemia in patients on sulfonylurea medications receiving ibuprofen. Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding with NSAIDs (see section 4.4). Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus. Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen. Aminoglycosides: NSAIDs may decrease the excretion of aminoglycosides. Herbal extracts: Ginkgo biloba may potentiate the risk of bleeding with NSAIDs. CYP2C9 Inhibitors: Concomitant administration of ibuprofen with CYP2C9 inhibitors may increase the exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased S(+)-ibuprofen exposure by approximately 80 to 100% has been shown. Reduction of the ibuprofen dose should be considered when potent CYP2C9 inhibitors are administered concomitantly, particularly when high-dose ibuprofen is administered with either voriconazole or fluconazole. Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in early pregnancy. In animals, the administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation losses and embryo/foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, Brufen should not be given unless clearly necessary. If Brufen is used by a woman attempting to conceive, or during the first or second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to the following: Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension) Renal dysfunction, which may progress to renal failure with oligohydramnios. At the end of pregnancy, prostaglandin synthesis inhibitors may expose the mother and the neonate to the following: Possible prolongation of bleeding time Inhibition of uterine contractions, which may result in delayed or prolonged labour. Consequently, Brufen is contraindicated during the third trimester of pregnancy. Lactation In the limited studies so far available, NSAIDs can appear in the breast milk in very low concentrations . NSAIDs should, if possible, be avoided when breastfeeding. See section 4.4 Special warnings and precautions for use, regarding female fertility. Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery. Gastrointestinal disorders: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4) have been reported following ibuprofen administration. Less frequently, gastritis has been observed. Gastrointestinal perforation has been rarely reported with ibuprofen use. Pancreatitis has also been reported very rarely. Immune system disorders: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatoses (including Stevens- Johnson syndrome, toxic epidermal necrolysis and erythema multiforme). Cardiac disorders and vascular disorders: Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Epidemiological data suggest that use of ibuprofen, particularly at high dose (2400 mg/ daily), and in long term treatment, may be associated with a small increased risk of arterial thrombotic events such as myocardial infarction or stroke (see section 4.4). Other adverse events reported less commonly and for which causality has not necessarily been established include: Blood and lymphatic system disorders: Leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia. Psychiatric disorders: Insomnia, anxiety, depression, confusional state, hallucination Nervous system disorders: Optic neuritis, headache, paraesthesia, dizziness, somnolence Infections and infestations: Rhinitis and aseptic meningitis (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation (see section 4.4). Eye disorders: Visual impairment and toxic optic neuropathy Ear and labyrinth disorders: Hearing impaired, tinnitus and vertigo Hepatobiliary disorders: Abnormal liver function, hepatic failure, hepatitis and jaundice. Skin and subcutaneous tissue disorders: Bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare), and photosensitivity reaction. Renal and urinary disorders: Impaired renal function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure. General disorders and administration site conditions: Malaise, fatigue Toxicity Signs and symptoms of toxicity have generally not been observed at doses below 100 mg/kg in children or adults. However, supportive care may be needed in some cases. Children have been observed to manifest signs and symptoms of toxicity after ingestion of 400 mg/kg or greater. Symptoms Most patients who have ingested significant amounts of ibuprofen will manifest symptoms within 4 to 6 hours. The most frequently reported symptoms of overdose include nausea, vomiting, abdominal pain, lethargy and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, convulsion, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnoea, diarrhoea and depression of the CNS and respiratory system have also been rarely reported. Disorientation, excitation, fainting and cardiovascular toxicity, including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. Large overdoses are generally well tolerated when no other drugs are being taken. Therapeutic measures Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Good urine output should be ensured. Renal and liver function should be closely monitored. Patients should be observed for at least four hours after ingestion of potentially toxic amounts. Frequent or prolonged convulsions should be treated with intravenous diazepam. Other measures may be indicated by the patient's clinical condition. Ibuprofen is a propionic acid derivative with analgesic, anti-inflammatory and antipyretic activity. The drug's therapeutic effect as an NSAID is thought to result from its inhibitory effect on the enzyme cyclo-oxygenase, which results in a marked reduction in prostaglandin synthesis. Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8 hours before or within 30 minutes after immediate release aspirin dosing (81mg), a decreased effect of aspirin on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use. The pharmacokinetic profile of Brufen Retard compared with that of conventional-release 400mg tablets showed that the sustained-release formulation reduced the peaks and troughs characteristic of the conventional-release tablets and gave higher levels at 5, 10, 15 and 24 hours. Compared with conventional-release tablets, the area under the plasma concentration time curve for sustained-release tablets was almost identical. Both mean plasma profiles and the pre-dose plasma levels showed no major differences between the young and elderly age groups. In several studies, Brufen Retard produced a double peak plasma profile when taken under fasting conditions. The elimination half-life of ibuprofen is approximately 2 hours. Ibuprofen is metabolised in the liver to two inactive metabolites and these, together with unchanged ibuprofen, are excreted by the kidney either as such or as conjugates. Excretion by the kidney is both rapid and complete. Ibuprofen is extensively bound to plasma proteins. Colloidal anhydrous silica, Isopropyl Alcohol*, Povidone, Stearic Acid, Xanthan Gum, Hypromellose, Talc, Opaspray White M-1-7111B** * removed during the drying process ** comprises industrial methylated spirit*, purified water*, hypromellose, titanium dioxide PVC/PVDC blister: do not store above 25°C. Store in the original package. 250 µm, opaque, polyvinyl chloride film coated on face with 40g/m2 polyvinylidene chloride with a 15 µm minimum, aluminium lidding foil, coated on one face with a protective lacquer with a heat-sealable lacquer on the other face. Pack size 56. Abbott Laboratories Limited Abbott House Vanwall Business Park Vanwall Road Maidenhead Berkshire SL6 4XE
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SASTAV 1 filmom obložena tableta sadržava 100 mg ketoprofena. Pomoćne tvari: Jezgra: kukuruzni škrob, laktoza monohldrat Ovojnica: hipromeloza, plava boja indigotin (E132), titan-dioksid (E171). FARMACEUTSKI OBLIK I SADRŽAJ PAKIRANJA filmom obložene tablete (svjetlo plave, okrugle, bikonveksne tablete) FARMAKOTERAPIJSKA SKUPINA nesteroidni protuupalni pripravci, ketoprofen IME I ADRESA PROIZVOĐAČA Lek farmacevtska družba, d. d., Verovškova 57, Ljubljana, Slovenija. Način i mjesto izdavanja lijeka Lijek se izdaje na recept, u ljekarni. TERAPIJSKE INDIKACIJE Ketoprofen pripada skupini protuupalnih lijekova koja se zove nesteroidni antireumatici (NSAR). Namijenjen je za otklanjanje i ublažavanje boli kod nekih bolnih sindroma i za liječenje upalnih, degenerativnih i metaboličkih reumatskih bolesti. Indikacije za uporabu tableta Ketonal forte su: Bol - posttraumatska bol (bol nakon ozljeda) - postoperativna bol - bolne mjesečnice - bol kod koštanih metastaza u bolesnika s neoplazmom Reumatske bolesti - reumatoidni artritis - seronegativni spondilartritis (ankilozantni spondilitis, psorijatični artritis, reaktivni artritis) giht, pseudogiht - artroza - izvanzglobni reumatizam (tendinitis, burzitis, upala ovojnice ramenog zgloba) KONTRAINDIKACIJE Primjena tableta Ketonal forte kontraindicirana je u bolesnika: - koji su preosjetljivi na ketoprofen ili na druge sastojke lijeka - koji su imali napadaje astme, urtikariju 111 reakcije preosjetljivosti nakon primjene - ketoprofena ili drugih nesteroidnih antireumatika ili salicilata (lijekovi za ublažavanje boli i snižavanje povišene temperature) - koji imaju teže oštećenje funkcije srca - za ublažavanje boli kod ugradnje premosnice (bypass) - koji imaju kroničnu dispepsiju (nelagoda i bol u gornjem dijelu trbušne šupljine) koji imaju aktivni ulkus želuca (čir na želucu) i dvanaesnika - koji su u prošlosti imali krvarenja iz probavnog sustava, ulceracije (čirevi želuca crijeva) ili perforacije (prsnuća stijenke želuca ili crijeva) - koji su imali krvarenja iz probavnog sustava, cerebrovaskularna (krvarenja u mozgu) druga krvarenja - sa sklonošću krvarenjima - koji imaju teško poremećenu funkciju bubrega ili jetre - koji imaju astmu ili rinitis (upala nosne sluznice). Primjena tableta Ketonal forte kontraindicirana je tijekom zadnja tri mjeseca trudnoće i u djece mlade od 15 godina starosti. Posavjetujte se s liječnikom ako niste sigurni da 11 smijete primjenjivati tablete Ketonal forte. ODGOVARAJUĆE MJERE OPREZA PRI UPORABI Molimo da pažljivo pročitate ovu uputu prije nego što primijenite lijek, čak i ako ste ga već koristili. Prije početka liječenja tabletama Ketonal forte svoga liječnika morate upoznati sa svim zdravstvenim tegobama koje ste imali iii ih imate kao i o tome da 11 ste na nešto alergični. Neželjeni učinci mogu se umanjiti primjenom najmanje učinkovite doze kroz najkraće moguće vrijeme. Potrebno je izbjegavati istovremenu uporabu Ketonala s drugim nesteroidnim protuupalnim lijekovima, uključujući selektivne inhibitore ciklooksigenaze. U starijih osoba postoji veća učestalost nuspojava, osobito krvarenja i perforacija (prsnuća) u probavnom sustavu, koje mogu imati smrtni ishod. Bolesnicima s poremećajima u probavnom sustavu preporučuje se poseban oprez kada se primjenjuju nesteroidni protuupalni tijekovi. Iznenadna prsnuća i k rvarenja mogu se javiti bez ikakvih znakova upozorenja. Takvi bolesnici bi trebali započeti liječenje s najnižom mogućom dozom. Ukoliko tijekom primjene Ketonala nastane krvarenje, stvaranje čira ili prsnuće u probavnom sustavu, bolesnik treba odmah prekinuti primjenu lijeka i o tome obavijestiti liječnika. Oprez je potreban u bolesnika koji istodobno primjenjuju druge lijekove koji mogu povećati rizik od nastanka čira ili krvarenja u probavnom sustavu, kao što su peroralni kortikosteroidi (hormoni nadbubrežne žlijezde), antikoagulansi (lijekovi za sprječavanje zgrušavanja krvi) (npr. varfarin), selektivni inhibitori ponovne pohrane serotonina (lijekovi za liječenje depresije ) ili antitrombotici (lijekovi za sprječavanje stvaranja krvnih ugrušaka) (npr. acetilsalicilna kiselina). Oprez je potreban u bolesnika koji su već bolovali od različitih oboljenja probavnog sustava (ulcerozni kolitis , Crohnova bolest ), zbog mogućeg pogoršanja bolesti. Ketoprofen treba davati s oprezom bolesnicima s neliječenom hipertenzijom (povišeni krvni tlak), zatajenjem srca, dokazanom ishemijskom bolešću srca, perifernom arterijskom bolešću i/ili cerebrovaskularnom bolešću (bolest krvnih žila u mozgu) ili drugim stanjima koja uzrokuju zadržavanje tekućine. Tijekom liječenja s nesteroidnim antireumaticima, preporučuje se češće mjerenje krvnog tlaka, osobito u bolesnika s bolestima srca i krvnih žila Prije početka dugotrajnog liječenja nesteroidnim protuupalnim lijekovima, oprez je potreban u bolesnika koji imaju povećani rizik za nastanak kardiovaskularnih bolesti (bolesti srca krvnih žila). To su bolesnici s hipertenzijom (povišeni krvni tlak), hiperlipidemijom (povišena razina masnoća u krvi), šećernom bolešću, pušači i sl. Neki nesteroidni protuupalni lijekovi (posebice u visokim dozama i kod dugotrajnog liječenja) mogu povećati rizik za nastanak srčanog ili moždanog udara. Nedostatak podataka ne isključuje mogućnost istog rizika kod primjene Ketonala. Ketoprofen može izazvati napadaj astme, pogotovo u osoba preosjetljivih na salicilate (lijekovi za ublažavanje boli i snižavanje povišene temperature) na nesteroidne protuupalne lijekove. U bolesnika s astmom praćenom kroničnim rinitisom (upala nosne sluznice), kroničnim sinusitisom (upala sinusa) i/ili nosnim polipima postoji veći rizik za nastanak alergijske reakcije (reakcija preosjetljivosti) nakon primjene acetilsalicilne kiseline (lijek za ublažavanje boli i snižavanje povišene temperature) i/iii nesteroidnih protuupalnih lijekova. Oprez je potreban u bolesnika koji imaju poremećaj rada jetre ili bubrega. Kao i kod svih dugotrajnih liječenja nesteroidnim antireumaticima, liječenje ketoprofenom zahtjeva praćenje krvne slike, jetrene i bubrežne funkcije, osobito u starijih bolesnika. Bolesnike sa zatajenjem jetre ili bubrega, bolesnike koji uzimaju diuretike (lijekovi koji potiču izlučivanje mokraće), bolesnike nakon velikih zahvata koji su uzrokovali hipovolemiju (smanjeni volumen krvi u cirkulaciji) i starije bolesnike treba pažljivo pratiti. Oprez je, također, potreban u bolesnika s poremećajem hemostaze (zaustavljanje krvarenja), hemofilijom (nasljedna bolest praćena sklonošću krvarenju), von Willebrandovom bolešću (nasljedna bolest poremećaja zgrušavanja krvi), teškom trombocitopenijom (smanjeni broj krvnih pločica) i u onih koji uzimaju antikoagulanse (lijekovi za sprječavanje zgrušavanja krvi) (npr. derivate kumarina i heparina). Ketoprofen treba primjenjivati s oprezom u alkoholičara. Vrlo rijetko su uz primjenu nesteroidnih antireumatika zabilježene ozbiljne kožne reakcije, ponekad sa smrtnim ishodom, kao npr. eksfolijativni dermatitis (upala s ljuštenjem kože), Stevens-Johnsonov sindrom (mjehuri na sluznici usta, ždrijela, spolovila i očne spojnice) toksična epidermalna nekroliza (teška kožna bolest sa stvaranjem mjehura). Najveći rizik od pojave ovih reakcija je na početku liječenja i to najčešće unutar prvog mjeseca primjene nesteroidnih antireumatika. Ukoliko se tijekom primjene Ketonala pojave kožni osip, oštećenja sluznice Hi drugi znakovi preosjetljivosti, primjenu lijeka treba odmah prekinuti. Kao i svi nesteroidni protuupalni lijekovi, ketoprofen može prikriti znakove zaraznih bolesti. Prije velikih kirurških zahvata treba prekinuti uzimanje lijeka. Primjena Ketonala ne preporučuje se ženama koje žele zatrudnjeti ili koje su na pretragama zbog neplodnosti, jer ketoprofen može smanjiti plodnost. Važna informacija o nekim sastojcima tablete Ketonal forte Tablete Ketonal forte sadržavaju laktozu i nisu prikladne za osobe s rijetkim nasljednim poremećajima poput nepodnošenja galaktoze, pomanjkanja Lappove laktaze ili glukoza/galaktoza malapsorpcijskog sindroma. Obavijestite svoga liječnika o svim tim stanjima. Molimo da se obratite liječniku i onda ako su se gornje navedene tvrdnje odnosile na vas bilo kada u prošlosti. INTERAKCIJE Obavijestite svoga liječnika ili ljekarnika ako uzimate ili ste nedavno uzimali bilo koji drugi lijek, pa i ako ste ga kupili bez recepta. Nemojte uzimati Ketonal zajedno s drugim nesteroidnim antireumaticima, salicilatima (lijekovi za ublažavanje boli i snižavanje povišene temperature), npr. acetilsalicilnom kiselinom ili neselektivnim inhibitorima ciklooksigenaze-2. Učinak antihipertenziva (lijekovi za liječenje visokog krvnog tlaka) i diuretika (Lijekovi koji potiču izlučivanje mokraće) može biti smanjen ako se uzimaju istodobno s ketoprofenom. Kod istodobne primjene nesteroidnih antireumatika i diuretika (lijekovi koji potiču izlučivanje mokraće) ili ACE-inhibitora (lijekovi za liječenje visokog krvnog tlaka i zatajenja srca) povećava se rizik od oštećenja funkcije bubrega. Učinak lijekova za liječenje epilepsije (padavica) ili šećerne bolesti može biti povećan ako se uzimaju istodobno s ketoprofenom. Zbog povećanog rizika od krvarenja, bolesnici koji istodobno uzimaju ketoprofen i antikoagulanse (lijekovi za sprječavanje zgrušavanja krvi), kortikosteroide (hormoni nadbubrežne žlijezde) ili selektivne inhibitore ponovne pohrane serotonina (lijekovi za liječenje depresije) zahtijevaju stalni liječnički nadzor. Ne preporučuje se istovremena primjena antikoagulansa (lijekovi za sprječavanje zgrušavanja krvi), sulfonamida (lijekovi za liječenje infekcija) ili hidantotna (lijek za liječenje padavice), jer je ponekad potrebno smanjiti njihovu dozu. Ako se istodobno s ketoprofenom uzimaju srčani glikozidi (lijekovi za jačanje snage srca), litij (lijek za liječenje nekih vrsta depresije), ciklosporin (lijek za smanjenje reakcije imunosnog sustava, kako bi se spriječilo odbacivanje presađenog organa ili koštane srži) ili metotreksat (lijek za liječenje zloćudnih bolesti) izlučivanje ovih lijekova može biti smanjeno, a njihov štetni učinak povećan. Učinak mifepristona (hormonski lijek protiv začeća) može biti smanjen ako se koristi istodobno s nesteroidnim antireumaticima. Nesteroidni antireumatici ne bi se smjeli uzimati još 8 do 12 dana nakon primjene mifepristona. Neki lijekovi kao što su: preparati kalija, diuretici (lijekovi koji potiču izlučivanje mokraće) koji štede kalij, ACE-inhibitori (lijekovi za liječenje visokog krvnog tlaka i zatajenja srca), inhibitori angiotenzina II (lijekovi za liječenje visokog krvnog tlaka i zatajenja srca), nesteroidni antireumatici, heparini (lijek za sprječavanje zgrušavanja krvi), ciklosporin (lijek za smanjenje reakcije imunosnog sustava, kako bi se spriječilo odbacivanje presađenog organa ili koštane srži), takrolimus (lijek koji djeluje na imunosni sustav) 111 trimetoprim (antimikrobni lijek) mogu povećati rizik nastanka hiperkalijemije (povišena razina kalija). Ne preporučuje se konzumiranje alkohola tijekom liječenja ketoprofenom. POSEBNA UPOZORENJA Prije nego što uzmete bilo koji lijek posavjetujte se sa svojim liječnikom ili ljekarnikom. Recite liječniku ako ste trudni (iii mislite da ste trudni) ili ako dojite. Nema podataka o sigurnosti primjene ketoprofena u trudnoći. Tijekom prvog i drugog tromjesečja trudnice smiju uzimati tablete Ketonal forte samo ako je očekivana korist liječenja veća od mogućeg rizika za plod. Primjena tableta Ketonal forte je kontraindicirana tijekom zadnja tri mjeseca trudnoće, jer može odgoditi porod, izazvati prerano zatvaranje ductus-a Botalli i plućnu hipertenziju novorođenčeta. Dojenje Prije nego što uzmete bilo koji lijek posavjetujte se sa svojim liječnikom ili ljekarnikom. Sigurnost primjene ketoprofena tijekom dojenja nije utvrđena, zbog čega se njegova primjena u dojilja ne preporučuje. Utjecaj na sposobnost upravljanja vozilima i strojevima Nesteroidni antireumatici rijetko mogu u preosjetljivih bolesnika uzrokovati omaglicu, vrtoglavicu, pospanost i zamagljeni vid. U tim slučajevima, bolesnici ne smiju upravljati vozilima niti rukovati strojevima. DOZIRANJE I PRIMJENA Tablete Ketonal forte se primjenjuju peroralno. Tablete Ketonal forte uzimajte točno kako vam je rekao liječnik. Ne mijenjajte doze i ne prekidajte liječenje bez prethodnog savjetovanja s vašim liječnikom. Liječnik će vam reći koliko dugo će trajati liječenje. Tabletu Ketonal forte treba progutati s čašom vode iti mlijeka. Tablete se mogu uzeti tijekom ili nakon obroka, ili s antacidima (lijekovi koji smanjuju lučenje želučane kiseline), jer smanjuju učestalost neželjenih učinaka ketoprofena na probavni sustav. Odrasli i djeca starija od 15 godina Uobičajeno doziranje je 1 tableta Ketonal forte jedanput ili dvaput na dan (100- 200 mg) ovisno o tjelesnoj masi bolesnika i o težini simptoma bolesti. Preporučena doza za liječenje reumatoidnog artritisa i artroze je 1 tableta Ketonal forte najviše dva puta na dan. Tablete i čepići mogu se kombinirati, na primjer: 1 tableta Ketonal forte (100 mg) ujutro i 1 čepić Ketonal (100 mg) uvečer. Ukupna dnevna doza ketoprofena ne smije biti veća od 200 mg. Treba pažljivo procijeniti omjer rizika i koristi liječenja ketoprofenom u dozi od 200 mg na dan, dok se veće doze ne preporučuju. Neželjeni učinci mogu se umanjiti primjenom najmanje učinkovite doze kroz najkraće moguće vrijeme. Ako vam se čini da je učinak lijeka prejak ili preslab, razgovarajte sa svojim liječnikom ljekarnikom. Stariji bolesnici Nesteroidne protuupalne lijekove treba primjenjivati s oprezom u starijih bolesnika zbog veće učestalosti nuspojava. Potrebno je primijeniti najmanju učinkovitu dozu i pratiti bolesnika tijekom prva 4 tjedna primjene lijeka zbog mogućnosti krvarenje iz probavnog sustava. Djeca Nema dovoljno podataka o doziranju u djece mlađe od 15 godina. PREDOZIRANJE Nikad ne smijete uzeti više tableta nego što vam je propisao liječnik. Ako ste uzeli previše tableta odjedanput, odmah se obratite liječniku. Liječniku pokažite preostale tablete u pakiranju. Prekomjerna doza može izazvati mučninu, povraćanje, epigastričnu bol (bol u području želuca), hematemezu (povraćanje krvi ), crnu stolicu, poremećaj svijesti, otežano disanje , konvulzije (grčeve), smanjenu bubrežnu funkciju i zatajenje bubrega Ako ste zaboravili uzeti lijek Ako ste zaboravili uzeti lijek, nemojte uzeti dvostruku dozu da biste nadoknadili propuštenu. Jednostavno nastavite uzimati lijek prema uobičajenom rasporedu. NUSPOJAVE Kao i svi lijekovi, tablete Ketonal forte mogu imati nuspojave. Nuspojave Ketonala obično su blage i prolazne. Najčešće nuspojave nesteroidnih antireumatika su nuspojave probavnog sustava. Mogu nastati: mučnina , povraćanje, zatvor , proljev , nadutost , grčevi i bol u želucu. Rijetko su zabilježene nuspojave kao što su melena (crna stolica), hematemeza (povraćanje krvi), ulcerozni stomatitis (upala i oštećenje sluznice usne šupljine), čir na želucu ili dvanaesniku, puknuće ili krvarenje iz probavnog sustava i gastritis (upalna bolest želuca). Druge blage nuspojave koje se rjeđe javljaju su glavobolja , omaglica, vrtoglavica, blaga zbunjenost, pospanost, otekline, promjene raspoloženja i nesanica U slučaju teže nuspojave, liječenje Ketonalom treba odmah prekinuti. Nuspojave mogu biti: vrio česte (> 10 %), česte (> 1 % i 0,1 % i 0,01 % i < 0,1 %) i vrio rijetke (< 0,01 %), uključujući pojedinačne slučajeve. Poremećaji srca i krvnih žila Često: edemi (otekline) Neki nesteroidni protuupalni lijekovi (posebice u visokim dozama i kod dugotrajnog liječenja) mogu povećati rizik za nastanak srčanog ili moždanog udara. Nedostatak podataka ne isključuje mogućnost istog rizika kod primjene ketoprofena. Poremećaji krvi i limfnog sustava Manje često: anemija (smanjeni broj crvenih krvnih stanica/hemoglobina), hemoliza (raspadanje crvenih krvnih stanica), purpura (gusto, točkasto krvarenje u koži), trombocitopenija (smanjeni broj krvnih pločica), agranulocitoza (gubitak granulocita) Ketoprofen u visokim dozama može smanjiti agregaciju (nakupljanje) trombocita (krvne pločice), produžiti vrijeme krvarenja, izazvati krvarenja iz nosa i pojavu modrica. Poremećaji središnjeg živčanog sustava Nuspojave mogu biti: vrio česte (> 10 %), česte (> 1 % i 0,1 % i 0,01 % i < 0,1 %) i vrio rijetke (< 0,01 %), uključujući pojedinačne slučajeve. Poremećaji središnjeg živčanog sustava često: glavobolja, astenija (gubitak snage), slabost, umor , omaglica, vrtoglavica, parestezije (umrtvljenost ili trnci u prstima na rukama i nogama), depresija , nervoza, pospanost, noćne more Rijetko: delirij (poremećenost svijesti) s vidnim i slušnim priviđanjima, dezorijentacija (poremećaj orijentacije), smetnje u govoru Vrlo rijetko: moždani pseudotumor (povećanje krvnog tlaka u glavi) – (jedan slučaj) Poremećaji dišnog sustava, prsnog koša Manje često: hemoptiza (iskašljavanje krvi ), dispneja (otežano disanje), faringitis (upala ždrijela), rinitis (upala nosne sluznice), bronhospazam (suženje dušnica), edem tarinksa (otok grkljana) znaci reakcije preosjetljivosti Rijetko: napadaj astme Poremećaji probavnog sustava Vrlo često: dispepsija (nelagoda i bol u gornjem dijelu trbušne šupljine) Često: mučnina, boi u trbuhu, proljev, zatvor, nadutost, anoreksija (gubitak teka), povraćanje, stomatitis (upala sluznice usne šupljine) Vrio rijetko: gastritis (upalna bolest želuca), intestinalna perforacija (puknuće crijeva), pogoršanje ulceroznog kolitisa (upala i oštećenje sluznice debelog crijeva) ili Crohnove bolesti (teška upalna bolest crijeva), enteropatija (bolest crijeva) s perforacijom (prsnuće), ulceracijom (nastajanje čira) ili strikturom (suženje crijeva) Enteropatija može biti praćena blagim krvarenjem i gubitkom bjelanjčevina. Zabilježen je slučaj (starija žena) perforacije kolona (prsnuće debelog crijeva). čir na želucu, perforacija (prsnuće) ili krvarenje iz probavnog sustava, ponekad su sa smrtnim ishodom, osobito u starijih osoba. Poremećaj funkcije jetre, žučnjaka i žučnih vodova Vrio često: granično povećane vrijednosti jetrenih testova Manje često: značajno povećanje vrijednosti jetrenih enzima Vrlo rijetko: poremećaj funkcije jetre sa žuticom i hepatitisom (upala jetre) Poremećaji bubrega i mokraćnog sustava Vrlo rijetko: akutno zatajenje bubrega , intersticijski nefritis (upala bubrega), nefrotski sindrom, akutni pijelonefritis (upala bubrega i bubrežne nakapnice) Poremećaji reprodukcijskog sustava Manje često: menometroragija (poremećaj krvarenja tijekom ili između menstruacijskih ciklusa) Poremećaji kože i potkožnog tkiva Često: osip Manje često: alopecija (gubitak kose ), ekcem, crvenilo kože, urtikarija , eksfolijativni dermatitis (upala kože s ljuštenjem) Rijetko: fotoosjetljivost (preosjetljivost na svjetlost), fotodermatitis (kožne promjene izazvane preosjetljivošću na svjetlost) Vrlo rijetko: bulozne (mjehuraste) kožne promjene uključujući Stevens-Johnsonov sindrom (mjehuri na sluznici usta, ždrijela, spolovila i očne spojnice) i toksičnu epidermalnu nekrolizu (teška kožna bolest sa stvaranjem mjehura). Poremećaji funkcije oka često: smetnje vida Vrio rijetko: konjunktivitis (upala očne spojnice) (jedan slučaj) Poremećaji funkcije uha i labirinta Ostale nuspojave Rijetko: alergijske reakcije (preosjetljivost) ili anafilaksija (teška reakcija preosjetljivosti). Prekinite primjenu Ketonala i odmah se javite liječniku ako: - teško dišete - imate bol u prsima - imate promjene srčanog ritma - imate osip, urtikariju - postanete preosjetljivi na svjetlost — primijetite oticanje gležnjeva, nogu ili lica — primijetite neuobičajena krvarenja ili modrice na koži - imate žutu kožu i žute bjeloočnice - mokrite manje nego inače - imate jake bolove u trbuhu ili povraćate krv - imate krvavu, crnu stolicu - imate neobjašnjivo povišenje tjelesne temperature ili bolove u grlu - imate povišeni krvni tlak. Nemojte se zabrinjavati zbog gore navedenih nuspojava jer većina bolesnika uzima ketoprofen bez ikakvih problema; ozbiljne nuspojave su vrlo rijetke. UVJETI ČUVANJA Lijek treba čuvati izvan dohvata djece. Lijek se čuva pri temperaturi do 25° C. Lijek se čuva u originalnoj ambalaži. Napomena: Ove upute o proizvodima samo su ilustrativnog karaktera. Ukoliko trebate savjet u vezi korištenja lijeka obratite se liječniku ili ljekarniku.