natgillin/translations-raw huggingface dataset:
- anbefaler opfølgningsforanstaltninger til videre undersøgelse af sikkerheden af lumiracoxib.
- recommended follow up measures to further investigate the safety of lumiracoxib.
8 BILAG III
7 ANNEX III
Dette er det SPC, der var bilag til Europa- Kommissionens beslutning vedrørende denne artikel 31 arbitreringssag vedrørende lægemidler indeholdende lumiracoxib.
This SPC is the one that was Annexed to the Commission Decision on this Article 31 referral for lumiracoxib containing medicinal products.
{SÆRNAVN} 100 mg filmovertrukne tabletter {SÆRNAVN} 100 mg filmovertrukne tabletter {SÆRNAVN} 100 mg filmovertrukne tabletter
{INVENTED NAME} 100 mg film-coated tablets {INVENTED NAME} 200 mg film-coated tablets {INVENTED NAME} 400 mg film-coated tablets
100 mg filmovertrukne tabletter:
100 mg film-coated tablets:
Ovale, røde tabletter med ” NVR ” præget på én side og ” OB ” præget på den anden side.
Ovaloid, red, tablets with “ NVR” debossed on one side and “ OB” on the other side.
200 mg filmovertrukne tabletter:
200 mg film-coated tablets:
Ovale, røde tabletter med ” NVR ” præget på én side og ” OC ” præget på den anden side.
Ovaloid, red, tablets with “ NVR” debossed on one side and “ OC” on the other side.
Ovale, røde tabletter med ” NVR ” præget på én side og ” OD ” præget på den anden side.
Ovaloid, red, tablets with “ NVR” debossed on one side and “ OD” on the other side.
Til korttidsvirkende lindring af moderate til svære akutte smerter forbundet med:
For the short-term relief of moderate to severe acute pain associated with:
- primær dysmenorré,
- primary dysmenorrhea,
- dental kirurgi,
- dental surgery,
- ortopædisk kirurgi.
- orthopaedic surgery.
4. 3 og 4. 4).
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient’ s overall risks (see section 4.3 and 4.4).
Osteoarthrose Den anbefalede startdosis er 100 mg, én gang daglig.
Osteoarthritis The recommended starting dose is 100 mg once daily.
Akut smerte Den anbefalede dosis er 400 mg, én gang daglig.
Acute pain The recommended dose is 400 mg once daily.
Den maksimale behandlingsvarighed i kliniske studier var 24 timer.
9 Relief of acute pain due to dental surgery: the maximum treatment duration in clinical studies was 24 hours.
Den maksimale behandlingsvarighed i kliniske studier var 5 dage.
Relief of acute pain due to orthopaedic surgery: the maximum treatment duration in clinical studies was 5 days.
Den maksimale behandlingsvarighed i kliniske studier var 3 dage.
Relief of pain due to primary dysmenorrhea: the maximum treatment duration in clinical studies was 3 days.
Da den kardiovaskulære risiko ved brug af lumiracoxib kan øges med dosis og behandlingsvarighed, bør den kortest mulige behandlingstid og den lavest effektive daglige dosis anvendes.
As the cardiovascular risks of lumiracoxib may increase with dose and duration of exposure, the shortest duration and the lowest effective daily dose should be used.
Patientens behov for symptomlindring samt behandlingsrespons bør genovervejes med jævne mellemrum, især hos patienter med osteoarthrosis.
The patient’ s need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.
5. 2)
Dosing recommendations are the same for Asians, Blacks and Caucasians (see section 5.2).
Som med andre lægemidler anvendt hos ældre, er det tilrådeligt at initiere behandling med den lavest anbefalede dosis.
As with other drugs used in the elderly, it is prudent to initiate treatment with the lower recommended dose.
4. 4 og 5. 2).
Caution should be exercised in elderly osteoarthritis patients when increasing from a 100 mg to a 200 mg daily dose (see section 4.4 and 5.2).
Patienter med nedsat CYP2C9- metabolisering:
CYP2C9 poor metabolisers:
5. 2).
No dose adjustment is necessary in patients known to be CYP2C9 poor metabolisers (see section 5.2).
Dosisjustering er ikke nødvendig hos patienter med mild (Child- Pugh 5- 6) til moderat (Child- Pugh 7- 8) leverinsufficiens.
No dose adjustment is necessary for patients with mild (Child-Pugh 5-6) to moderate (Child-Pugh 7-8) hepatic impairment.
4. 3, 4. 4 og 5. 2).
However, it is prudent to initiate treatment at the lower recommended dose in such patients (see section 4.3, 4.4 and 5.2).
Dosisjustering er ikke nødvendig hos patienter med creatininclearance ≥50 ml/ min.
No dose adjustment is necessary for patients with creatinine clearance ≥ 50 ml/ min.
4. 3, 4. 4 og 5. 2).
Lumiracoxib is contraindicated in patients with moderate to severe renal impairment (estimated creatinine clearance < 50 ml/ min) (see section 4.3, 4.4 and 5.2).
Pædiatrisk brug:
Paediatric use:
{SÆRNAVN} er ikke undersøgt hos børn og er derfor kontraindikeret til børn under 18 år.
{Invented Name} has not been studied in children and thus is contraindicated in children under 18 years of age.
- Kendt overfølsomhed over for lumiracoxib eller over for et eller flere af
- Known hypersensitivity to lumiracoxib or to any of the excipients.
- Patienter som har oplevet astma, akut rhinitis, nasalpolypper, angioneurotisk ødem,
- Patients who have experienced asthma, acute rhinitis, nasal polyps, angioedema, urticaria or
urticaria, eller anden type allergisk reaktion efter indtag af acetylsalicylsyre eller NSAID.
other allergic-type reactions after taking acetylsalicylic acid or NSAIDs.
- Patienter med aktivt peptisk ulcus eller gastrointestinal blødning.
- Patients with active peptic ulceration or gastrointestinal bleeding.
- Patienter med inflammatorisk tarmsygdom
- Patients with inflammatory bowel disease.
- Patienter med venstresidig hjerteinsufficiens (NYHA II- IV).
- Patients with congestive heart failure (NYHA II-IV).
- Patienter med konstateret iskæmisk hjertesygdom, perifer arteriel sygdom og/ eller
- Patients with established ischaemic heart disease, peripheral arterial disease and/ or
cerebrovaskulær sygdom.
cerebrovascular disease.
creatininclearance ≤ 50 ml/ min).
- Patients with moderate to severe renal dysfunction (estimated creatinine clearance < 50 ml/ min).
- Patienter med svær leversygdom (Child- Pugh > 9).
- Patients with severe hepatic disease (Child-Pugh > 9).
4. 6 og 5. 3).
- Third trimester of pregnancy and breast feeding (see section 4.6 and 5.3).
- Patienter under 18 år.
- Patients under 18 years of age.
11 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
4.4 Special warnings and special precautions for use
Gastrointestinal effekt Der er set øvre gastrointestinale komplikationer [perforation, ulcera eller blødninger (PUB)], nogle med fatal udgang hos patienter behandlet med lumiracoxib.
GI effects Upper gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in a fatal outcome, have occurred in patients treated with lumiracoxib.
I kliniske forsøg har få patienter (< 0, 3%) behandlet med lumiracoxib udviklet perforationer, obstruktion eller blødninger (POB).
In clinical studies, few patients (< 0.3%) treated with lumiracoxib developed perforations, obstruction or bleeds (POBs).
Ældre, som får andre NSAID eller acetylsalicylsyre samtidig, eller patienter, der tidligere har haft gastrointestinal sygdom som f. eks. ulcera og gastrointestinal blødning.
10 Caution is advised with treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs: the elderly, patients using any other NSAID or ASA concomitantly, or patients with a prior history of gastrointestinal disease, such as ulceration and GI bleeding.
Patienter med størst risiko for dette, er de med allerede eksisterende nedsat nyrefunktion, ukompenseret hjertesvigt eller cirrhose samt patienter i behandling med diuretika eller ACE- hæmmere.
Patients at greatest risk of this response are those with pre-existing renal dysfunction, uncompensated heart failure, or cirrhosis and those receiving diuretics or ACE inhibitors.
Hypertension og ødem Som med andre lægemidler, der vides at hæmme prostaglandinsyntesen, er der set væskeretention og ødem hos patienter i behandling med lumiracoxib i kliniske studier.
Hypertension and oedema As with other drugs known to inhibit prostaglandin synthesis, fluid retention and oedema have been observed in patients taking lumiracoxib in clinical trials.
Der bør opretholdes medicinsk relevant supervision når lumiracoxib anvendes til ældre og til patienter med mild nyre -, lever - eller hjertedysfunktion.
Medically appropriate supervision should be maintained when using lumiracoxib in the elderly and in patients with mild renal, hepatic, or cardiac dysfunction.
1, 2% af patienterne i kliniske undersøgelser af op til ét års varighed med 100 mg og 200 mg lumiracoxib daglig.
Hepatic effects Elevations of alanine aminotransferase (ALT) and/ or aspartate aminotransferase (AST), greater than three times the upper limit of normal (> 3xULN) have been reported in placebo/ active-controlled clinical studies in approximately 1.2% of patients in clinical trials up to one year with lumiracoxib 100 mg and 200 mg daily.
Betydelige stigninger (> 8 x ULN) er observeret hos 0, 3% behandlet med 100 mg én eller to gange daglig, og hos 0, 6% af patienterne behandlet med 200 mg én gang daglig.
Marked elevations (> 8xULN) have been observed in 0.3% with 100 mg once or twice daily and 0.6% of patients at 200 mg once daily.
Kronisk anvendelse af 400 mg daglig var forbundet med hyppigere og mere betydelige stigninger i ALAT/ ASAT.
Chronic use with 400 mg daily dose was associated with more frequent and more marked elevations in ALT/ AST.
4. 8).
In a long-term controlled study with lumiracoxib 400 mg daily, rare cases of hepatitis have been reported (see section 4.8).
Enhver patient med symptomer og/ eller tegn tydende på leverdysfunktion, eller med abnorm leverfunktionstest, skal monitoreres.
Any patient with symptoms and/ or signs suggesting liver dysfunction, or in whom an abnormal liver function test has occurred, should be monitored.
Hvis der opstår tegn på leverinsufficiens eller vedvarende abnorm leverfunktionstest (ALAT eller ASAT > 3 x ULN) skal behandling med lumiracoxib seponeres.
If signs of hepatic insufficiency occur, or if abnormal liver function tests (ALT or AST > 3xULN) persist, lumiracoxib should be discontinued.
12 COX- 2 selektive hæmmere kan ikke erstatte acetylsalicylsyre som profylakse for kardiovaskulær thromboembolisk sygdom på grund af deres manglende antithrombotiske virkning.
Cardiovascular effects COX-2 selective inhibitors are not a substitute for ASA for prophylaxis of cardiovascular thromboembolic diseases because of their lack of antiplatelet effect.
4. 5 og 5. 1).
Therefore antiplatelet therapies should not be discontinued (see section 4.5 and 5.1).
Kliniske undersøgelser tyder på, at gruppen af selektive COX- 2 hæmmere kan være forbundet med en risiko for thrombotiske hændelser (specielt myokardieinfarkt (MI) og apopleksi), i forhold til placebo og nogle NSAID.
Clinical trials suggest that the selective COX-2 inhibitor class of drugs may be associated with a risk of thrombotic events (especially myocardial infarction (MI)and stroke), relative to placebo and some NSAID’ s.
Da den kardiovaskulære risiko ved brug af lumiracoxib kan øges med dosis og varighed af behandlingen, bør den kortest mulige behandlingstid og den laveste effektive daglige dosis anvendes.
The patients need
4. 2, 4. 3, 4. 8 og 5. 1).
11 for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (see section 4.2, 4.3, 4.8 and 5.1).
5. 1).
Patients with significant risk factors for cardiovascular events (eg hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with lumiracoxib after careful consideration (see section 5.1).
Hudreaktioner I forbindelse med overvågning efter markedsføring af NSAID og visse selektive COX- 2 hæmmere er der meget sjældent indberettet alvorlige hudreaktioner, nogle fatale, inklusiv exfoliativ dermatitis, Steven- Johnson syndrom og toksisk epidermisk nekrolyse.
Skin reactions 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 and some selective COX-2 inhibitors during post-marketing surveillance.
Nogle selektive COX- 2 hæmmere er blevet sat i forbindelse med en øget risiko for hudreaktioner hos patienter med enhver form for lægemiddelallergi i anamnesen.
Some selective COX-2 inhibitors have been associated with an increased risk of skin reactions in patients with a history of any drug allergy.
Generelt Hvis der under behandlingen sker en forværring inden for et af de ovennævnte organsystemer, skal passende forholdsregler tages og seponering af behandlingen med lumiracoxib bør overvejes.
General If during treatment, patients deteriorate in any of the organ system functions described above, appropriate measures should be taken and discontinuation of lumiracoxib therapy should be considered.
4. 6).
Use of lumiracoxib, as with any drug known to inhibit COX-2, is not recommended in women attempting to conceive (see section 4.6).
{Særnavn} 100 mg og 200 mg filmovertrukne tabletter indeholder lactose (23, 3 mg og 46, 6 mg respektivt).
{Invented Name} 100 mg and 200 mg film-coated tablets contain lactose (23.3 mg and 46.6 mg, respectively).
Patienter med sjældne, arvelige problemer med galaktoseintolerance, lappisk laktasemangel eller glucose- galactose malabsorption, bør ikke tage 100 mg og 200 mg filmovertrukne tabletter.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take 100 mg and 200 mg film-coated tablets.
15% stigning i protrombintid.
In a drug-drug interaction study in healthy subjects stabilised on warfarin therapy, the administration of lumiracoxib 400 mg once daily for five days was associated with an approximate 15% increase in prothrombin time.
Diuretika, ACE hæmmere og angiotensin II antagonister:
Diuretics, ACE inhibitors and Angiotensin II antagonists:
NSAID kan nedsætte effekten af diuretika og antihypertensiva.
NSAIDs may reduce the effect of diuretics and antihypertensive drugs.
Hos nogle patienter med kompromitteret nyrefunktion (f. eks. dehydrerede patienter eller ældre patinter med kompromiteret nyrefunktion), kan samtidig administration af en ACE- hæmmer eller angiotensin II antagonist og midler der hæmmer cyclooxygenase medføre yderligere forværring af nyrefunktionen, inklusiv muligt akut nyresvigt, som sædvanligvis er reversibelt.
In some patients with compromised renal function (e. g. dehydrated patients or elderly patients with compromised renal functions), the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Disse interaktioner bør overvejes hos patienter der tager lumiracoxib samtidig med ACE- hæmmere eller angiotensin II antagonister.
These interactions should be given consideration in patients taking lumiracoxib concomitantly with ACE-inhibitors or angiotensin II antagonists.
Kombinationsbehandling med disse lægemidler bør
Therefore, the combination should be administered with caution, especially in the elderly.
Andre NSAID:
Other NSAIDs:
Lumiracoxib kan anvendes sammen med lav- dosis aspirin.
Lumiracoxib can be used with low-dose aspirin.
Samtidig administration af lumiracoxib med høje doser aspirin, andre NSAID eller COX- 2 hæmmere bør undgås.
Concomitant administration of lumiracoxib with high doses of aspirin, other NSAIDs or COX-2 inhibitors should be avoided.
Ciclosporin eller tacrolimus:
12 Ciclosporin or tacrolimus:
Selvom denne interaktion ikke er undersøgt med lumiracoxib, kan samtidig administration af ciclosporin eller tacrolimus og ethvert NSAID øge den nefrotoksiske effekt af ciclosporin og tacrolimus.
Although this interaction has not been studied with lumiracoxib, co- administration of ciclosporin or tacrolimus and any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
Den oxidative metabolisme af lumiracoxib er hovedsagelig CYP2C9- medieret.
The oxidative metabolism of lumiracoxib is mainly CYP2C9 mediated.
In vitro studier indicerer, at lumiracoxib ikke er en signifikant hæmmer af andre cytokrom P450- isoformer, inklusiv CYP1A2, CYP2C8, CYP2C19, CYP2D6, CYP2E1 og CYP3A4.
In vitro studies indicate that lumiracoxib is not a significant inhibitor of other cytochrome P450 isoforms, including CYP1A2, CYP2C8, CYP 2C19, CYP2D6, CYP2E1, and CYP3A4.
På baggrund af in vitro studier, forventes interaktioner med plasma- proteinbinding ikke at have klinisk relevant effekt på lumiracoxib eller samtidigt administrerede lægemidler.
Based on in vitro studies, interactions involving plasma protein binding are not expected to have any clinically relevant effects on lumiracoxib or co-administered drugs.
Effekt af lumiracoxib på andre lægemidlers farmakokinetik (FK) Warfarin:
The effect of lumiracoxib on the PK of other drugs Warfarin:
I et forsøg med warfarin, som anses for et CYP2C9- substrat der er følsomt over for lægemiddelinteraktioner, havde samtidig administration af lumiracoxib 400 mg ingen effekt på plasma- AUC, Cmax eller Tmax af R- warfarin eller S- warfarin.
In a study with warfarin, which is considered to be a CYP2C9 substrate sensitive to drug interactions, co-administration with lumiracoxib 400 mg had no effect on plasma AUC, Cmax or Tmax of R-warfarin or S-warfarin.
25% lavere hos patienter behandlet med lumiracoxib.
Compared to placebo treatment, recovery of the S-7-OH warfarin metabolite in urine was about 25% lower in subjects treated with lumiracoxib.
Samtidig administration af lumiracoxib ved doser på 400 mg, én gang daglig, havde ingen klinisk signifikant effekt på plasmafarmakokinetikken, plasmaproteinbindingen eller urinudskillelsen af methotrexat og 7- hydroxy methotrexatmetabolitten.
Co-administration of lumiracoxib at doses of 400 mg once daily had no clinically significant effects on the plasma pharmacokinetics, plasma protein binding or urinary excretion of methotrexate and of the 7-hydroxy methotrexate metabolite.
Samtidig administration af lumiracoxib påvirkede ikke steady- state farmakokinetik eller effekt af ethinyløstradiol og levonorgestrel.
Co-administration of lumiracoxib did not affect the steady state pharmacokinetics or the efficacy of ethinylestradiol and of levonorgestrel.
Litium:
Lithium:
Der er set stigninger i plasmaniveauer af litium og fald i nyreudskillelsen af litium ved samtidig administration af NSAID.
NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance.
Andre lægemidlers effekt på lumiracoxibs FK Fluconazol:
Effects of other drugs on the PK of lumiracoxib Fluconazole:
Samtidig administration af lumiracoxib og den potente CYP2C9- hæmmer fluconazol havde ingen klinisk relevant effekt på lumiracoxibs farmakokinetik eller COX- 2 selektivitet.
Co-administration of lumiracoxib with the potent CYP2C9 inhibitor fluconazole had no clinically relevant effect on the pharmacokinetics or the COX-2 selectivity of lumiracoxib.
Omeprazol havde ingen effekt på lumiracoxibs farmakokinetik.
Omeprazole had no effect on the pharmacokinetics of lumiracoxib.
(Aluminiumhydroxid/ magnesiumhydroxid) havde ingen klinisk relevant effekt på lumiracoxibs farmakokinetik.
(aluminium hydroxide/ magnesium hydroxide) had no clinically relevant effect on the pharmacokinetics of lumiracoxib.
14 Graviditet Brug af lumiracoxib frarådes, ligesom alle andre lægemidler der hæmmer COX- 2, til kvinder der forsøger at blive gravide.
Pregnancy The use of lumiracoxib, as with any drug to inhibit COX-2, is not recommended in women attempting to conceive.
Brug af lumiracoxib er kontraindiceret i sidste trimester af graviditeten, da det, ligesom andre lægemidler der vides at hæmme prostaglandinsyntesen, kan forårsage uterus- atoni og præmatur lukning af ductus arteriosus.
The use of lumiracoxib is contraindicated in the last trimester of pregnancy because, as with other drugs known to inhibit prostaglandin synthesis, it may cause uterine inertia and premature closure of the ductus arteriosus.
Brug af lumiracoxib til gravide kvinder er ikke undersøgt i tilstrækkeligt og velkontrollerede kliniske forsøg, og derfor bør det ikke anvendes i de første 2 trimestre af graviditeten, med mindre fordelen for patienten opvejer den potentielle risiko for fostret.
13 The use of lumiracoxib in pregnant women has not been studied in adequate and well controlled clinical trials and therefore it should not be used during the first two trimesters of pregnancy unless the potential benefit to the patients justifies the potential risk to the fetus.
Amning Det vides ikke om lumiracoxib udskilles i modermælk.
Breast-feeding mothers It is not known whether lumiracoxib is excreted in human milk.
1. 100 patienter med OA eller RA blev behandlet i 6 måneder og 530 patienter med OA blev behandlet i 1 år).
In clinical trials, lumiracoxib was evaluated for safety in approximately 7,000 patients, including approximately 4,000 patients with OA and 2,100 patients with RA (approximately 1,100 patients with OA or RA were treated for 6 month, and 530 patients with OA were treated for 1 year).
250 patienter i 1 år), er følgende bivirkninger indberettet med en højere forekomst end placebo.
In clinical studies the following undesirable effects were reported at an incidence greater than placebo in patients with OA or RA treated with lumiracoxib 200 mg daily for up to one year (approximately 920 patients for three months and approximately 250 patients for one year).
[Almindelig (> 1/ 100, < 1/ 10) Usædvanlig (> 1/ 1. 000, < 1/ 100) Sjælden (> 1/ 10. 000, < 1/ 1. 000) Meget sjælden (< 1/ 10. 000)]
[Common (> 1/ 100 ,< 1/10) Uncommon (> 1/1000 ,< 1/100) Rare (> 1/10,000, < 1/1,000) Very rare (< 1/10,000)]
Candidiasis, øreinfektion, herpes simplex, tandinfektion
Infections Common: influenza like symptoms, respiratory tract infection (e. g bronchitis), urinary tract infection Uncommon: candidiasis, ear infection, herpes simplex, tooth infection
Pancytopeni, neutropeni, leukopeni
Blood and lymphatic system disorders Uncommon: anaemia Rare: pancytopenia, neutropenia, leucopenia
Depression, søvnløshed, angst
Psychiatric disorders Uncommon: depression, insomnia, anxiety
Synkope, hypoæstesi, migræne, paræstesi, dysgeusi, vertigo, tinnitus
Nervous system disorders Common: dizziness, headache Uncommon: syncope, hypoaesthesia, migraine, paraesthesia, dysgeusia, vertigo, tinnitus
Keratitis
Eye disorders Uncommon: conjunctivitis, dry eye, visual disturbance (e. g. blurred vision) Rare: keratitis
Venøs insufficiens, hypotension, cerebrovaskulære tilfælde *
Cardiac disorders Uncommon: palpitations, myocardial infarction* Rare: cardiac failure, atrioventricular block of first degree Vascular disorders Uncommon: venous insufficiency, hypotension, cerebrovascular accident*
Dyspnø, epistaxis, rinitis, sinuskongestion, astma
Respiratory disorders Common: cough, pharyngitis Uncommon: dyspnoea, epistaxis, rhinitis, sinus congestion, asthma
Gastrointestinal blødning
14 Gastrointestinal disorders Common: abdominal pain, constipation, diarrhoea, dyspepsia, nausea, vomiting, flatulence Uncommon: gastroduodenal ulcer, gastroduodenitis, oesophagitis, abdominal distension, aphthous stomatitis, dry mouth, dysphagia, epigastric discomfort, eructation, gastrooesophageal reflux disease, gingivitis, hyperacidity, toothache Rare: gastrointestinal haemorrhage
Cholecystitis, cholelithiasis, hepatitis
Hepatobiliary disorders Rare: cholecystitis, cholelithiasis, hepatitis
Angioneurotisk ødem
Skin and subcutaneous tissue disorders Uncommon: contusion, exanthem, pruritus, rash, urticaria Rare: angioedema
Hævede led, muskelkramper, artralgi
Musculoskeletal disorders Uncommon: joint swelling, muscle cramps, arthralgia
Chromaturi, nyresvigt
Renal and urinary disorders Uncommon: dysuria, urinary frequency, cystitis Rare: chromaturia, renal failure
Erektil dysfunktion
Reproductive system disorders Rare: erectile dysfunction
Anafylaksi
General disorders Common: fatigue, oedema (e. g lower limb) Uncommon: appetite increased or decreased, chest pain, rigors, thirst Rare: anaphylaxis