natgillin/translations-raw huggingface dataset:
Liver disease resulting in hepatic impairment (see section 5.2).
Obolenje jeter, katerega posledica je okvarjeno delovanje jeter (glejte poglavje 5. 2).
ARICLAIM should not be used in combination with nonselective, irreversible Monoamine Oxidase Inhibitors - MAOIs (see section 4.5).
Zdravila ARICLAIM ne smemo uporabljati v kombinaciji z neselektivnimi ireverzibilnimi zaviralci monoaminooksidaze - MAOI (glejte poglavje 4. 5).
ARICLAIM should not be used in combination with CYP1A2 inhibitors, like fluvoxamine, ciprofloxacin or enoxacine since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
Zdravila ARICLAIM ne smemo uporabljati v kombinaciji z zaviralci CYP1A2, kot so fluvoksamin, ciprofloksacin ali enoksacin, ker kombinacija povzroči povišane plazemske koncentracije duloksetina (glejte poglavje 4. 5).
Severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.4).
Hudo okvarjeno delovanje ledvic (očistek kreatinina < 30 ml/ min) (glejte poglavje 4. 4).
The initiation of treatment with ARICLAIM is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and 4.8).
Uvedba zdravljenja z zdravilom ARICLAIM je kontraindicirana pri bolnikih z nenadzorovano hipertenzijo, ki lahko izpostavi bolnike možnemu tveganju za hipertenzivno krizo (glejte poglavje 4. 4 in 4. 8).
Mania and Seizures ARICLAIM should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
Manija in epileptični napadi Zdravilo ARICLAIM moramo pri bolnikih z manijo v anamnezi ali diagnozo bipolarne motnje in/ ali epileptičnimi napadi uporabljati previdno.
Use with antidepressants The use of ARICLAIM in combination with antidepressants (especially with SSRI, SNRI and reversible MAOIs) is not recommended (see below “ Depression, suicidal ideation and behaviour” and Section 4.5).
Sočasna uporaba z antidepresivi Uporabe zdravila ARICLAIM v kombinaciji z antidepresivi (zlasti v kombinaciji s SSRI, SNRI in reverzibilnimi MAOI) ne priporočamo (glejte spodaj “ Depresija, samomorilne misli in vedenje ” in poglavje 4. 5).
3 St John’ s wort Undesirable effects may be more common during concomitant use of ARICLAIM and herbal preparations containing St John’ s wort (Hypericum perforatum).
3 Šentjanževka Ob sočasni uporabi zdravila ARICLAIM in pripravkov rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), so lahko neželeni učinki pogostejši.
Mydriasis Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing duloxetine in patients with increased intraocular pressure, or those at risk of acute narrow- angle glaucoma.
Midriaza V povezavi z duloksetinom so poročali o midriazi, zato je pri predpisovanju bolnikom s povišanim intraokularnim tlakom ali s tveganjem za akutni glavkom z zaprtim zakotjem potrebna previdnost.
Blood pressure and heart rate Duloxetine has been associated with an increase in blood pressure and clinically significant hypertension in some patients.
Krvni tlak in srčna frekvenca Duloksetin je bil pri nekaterih bolnikih povezan s povišanjem krvnega tlaka in klinično pomembno hipertenzijo.
Therefore, in patients with known hypertension and/ or other cardiac disease, blood pressure monitoring is recommended, especially during the first month of treatment.
Zato pri bolnikih z znano hipertenzijo in/ ali drugim srčnim obolenjem priporočamo spremljanje krvnega tlaka, zlasti v prvem mesecu zdravljenja.
In patients with uncontrolled hypertension duloxetine should not be initiated (see section 4.3).
Duloksetina ne smemo uvesti pri bolnikih z nenadzorovano hipertenzijo (glejte poglavje 4. 3).
Renal impairment Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance < 30 ml/ min).
Pri bolnikih s hudo okvarjenim delovanjem ledvic na hemodializi (očistek kreatinina < 30 ml/ min) se pojavijo povišane plazemske koncentracije duloksetina.
For patients with severe renal impairment, see section 4.3.
Za bolnike s hudo okvarjenim delovanjem ledvic glejte poglavje 4. 3.
See section 4.2 for information on patients with mild or moderate renal dysfunction.
Za podatke o bolnikih z blago ali zmerno okvarjenim delovanjem ledvic glejte poglavje 4. 2.
Haemorrhage There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/ norepinephrine reuptake inhibitors (SNRIs).
Krvavitev Pri selektivnih zaviralcih prevzema serotonina (selective serotonin reuptake inhibitors, SSRI) in selektivnih zaviralcih prevzema noradrenalina (selective norepinephrine reuptake inhibitors, SNRI) so poročali o nenormalnih krvavitvah, kot so ekhimoze, purpure in krvavitve iz prebavil.
Caution is advised in patients taking anticoagulants and/ or medicinal products known to affect platelet function, and in patients with known bleeding tendencies.
Pri bolnikih, ki jemljejo sredstva proti strjevanju krvi in/ ali druga zdravila, za katera je znano, da vplivajo na delovanje trombocitov, ter pri bolnikih z znano nagnjenostjo h krvavitvam je potrebna previdnost.
Discontinuation of treatment Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8).
Prekinitev zdravljenja Ob prekinitvi zdravljenja se lahko pojavijo odtegnitveni simptomi, še zlasti, če je prekinitev nenadna (glejte poglavje 4. 8).
In a clinical trial adverse events seen on abrupt treatment discontinuation occurred in approximately 44% of patients treated with ARICLAIM and 24% of patients taking placebo.
V kliničnih preskušanjih so se neželeni učinki ob nenadni prekinitvi zdravljenja pojavili pri približno 45% bolnic, ki so jemale zdravilo ARICLAIM in pri 23% bolnic, ki so dobivale placebo.
The risk of withdrawal symptoms seen with SSRI’ s and SNRI’ s may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
Tveganje za pojav odtegnitvenih simptomov opaženih pri SSRI in SNRI je odvisno od številnih dejavnikov, med drugim od trajanja zdravljenja in predpisanega odmerka ter stopnje zmanjševanja odmerka zdravila.
The most commonly reported reactions are listed in section 4.8.
Najpogosteje poročane reakcije so navedene v poglavju 4. 8.
Generally the symptoms are mild to moderate, however, in some patients they may be severe in intensity.
Navadno so ti simptomi blagi do zmerni, vendar so pri nekaterih bolnikih lahko tudi zelo intenzivni.
Generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more).
Navadno so ti simptomi samoomejujoči in večinoma minejo v 2 tednih, čeprav lahko pri nekaterih posameznikih trajajo dlje (2- 3 mesece ali več).
It is therefore advised that duloxetine should be gradually tapered when discontinuing treatment over a period of no less than 2 weeks, according to the patient’ s needs (see section 4.2).
Zato svetujemo, da se ob prekinjanju zdravljenja v skladu z bolnikovimi potrebami odmerek duloksetina postopoma zmanjšuje v obdobju ne manj kot 2 tednov (glejte poglavje 4. 2).
Caution is required in patients at increased risk for hyponatremia; such as elderly, cirrhotic, or dehydrated patients or patients treated with diuretics.
Hiponatriemija Ob dajanju zdravila ARICLAIM so redko poročali o hiponatriemiji, zlasti pri starejših. Previdnost je potrebna pri bolnikih z večjim tveganjem za hiponatriemijo; denimo pri starejših, bolnikih s cirozo, dehidriranih bolnikih ali bolnikih, ki jemljejo diuretike.
Hyponatremia may be due to a syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
Hiponatriemija je lahko posledica sindroma neustreznega izločanja antidiuretičnega hormona (syndrome of inappropriate anti- diuretic hormone secretion, SIADH).
4 Depression, suicidal ideation and behaviour Although ARICLAIM is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medication.
4 Čeprav zdravilo ARICLAIM ni indicirano za zdravljenje depresije, njegova zdravilna učinkovina (duloksetin) obstaja tudi kot antidepresiv.
A meta-analysis of placebo- controlled clinical trials of antidepressant medicinal products in psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old Cases of suicidal thoughts and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.8).
Med zdravljenjem z duloksetinom ali kmalu po prenehanju zdravljenja so poročali o primerih samomorilnih misli in samomorilnega vedenja (glejte poglavje 4. 8).
If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of ARICLAIM is recommended (see Section 4.2).
V primeru, da se zdravnik odloči za farmakološko zdravljenje z antidepresivi, svetujemo postopno ukinjanje zdravila ARICLAIM (glejte poglavje 4. 2).
ARICLAIM should not be used in the treatment of children and adolescents under the age of 18 years.
Zdravila ARICLAIM pri otrocih in mladostnikih, mlajših od 18 let, ne smemo uporabljati.
Long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Podatki o dolgoročni varnosti pri otrocih in mladostnikih glede rasti, dozorevanja in kognitivnega ter vedenjskega razvoja so pomanjkljivi.
Medicinal products containing duloxetine Duloxetine is used under different trademarks in several indications (treatment of diabetic neuropathic pain, major depressive episodes as well as stress urinary incontinence).
Zdravila, ki vsebujejo duloksetin Duloksetin se pod različnimi imeni uporablja za več indikacij (zdravljenje bolečine diabetične nevropatije, velikih depresivnih epizod, kot tudi stresne urinske inkontinence).
Hepatitis/ increased liver enzymes Cases of liver injury, including severe elevations of liver enzymes (> 10 times upper limit of normal), hepatitis and jaundice have been reported with duloxetine (see section 4.8).
Hepatitis/ povišane vrednosti jetrnih encimov Ob zdravljenju z duloksetinom so poročali o primerih okvare jeter, vključno z zvišanjem vrednosti jetrnih encimov (> 10 kratna zgornja meja normalnih vrednosti), hepatitisom in zlatenico (glejte poglavje 4. 8).
Duloxetine should be used with caution in patients treated with other medicinal products associated with hepatic injury.
Pri bolnikih, ki jemljejo zdravila, ki lahko povzročijo okvaro jeter, je pri uporabi duloksetina potrebna previdnost..
Akathisia/ psychomotor restlessness The use of duloxetine has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.
Akatizija/ psihomotorični nemir Jemanje duloksetina so povezovali s pojavom akatizije, za katero je značilen subjektivno neprijeten ali mučen nemir in potreba po gibanju, ki ju pogosto spremlja nezmožnost sedenja ali stanja pri miru.
Sucrose ARICLAIM gastro-resistant capsules contain sucrose.
Saharoza ARICLAIM trde gastrorezistentne kapsule vsebujejo saharozo.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
Bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/ galaktoze ali pomanjkanjem saharoze- izomaltaze ne smejo jemati tega zdravila.
5 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Monoamine oxidase inhibitors (MAOIs): due to the risk of serotonin syndrome, ARICLAIM should not be used in combination with nonselective, irreversible monoamine oxidase inhibitors (MAOIs), or within at least 14 days of discontinuing treatment with an MAOI.
Na podlagi
Based on the half-life of duloxetine, at least 5 days should be allowed after stopping ARICLAIM before starting an MAOI (see section 4.3).
5 razpolovnega časa duloksetina mora po prenehanju jemanja zdravila ARICLAIM preteči vsaj 5 dni pred začetkom jemanja MAOI (glejte poglavje 4. 3).
Serotonin syndrome: in rare cases, serotonin syndrome has been reported in patients using SSRIs (e. g. paroxetine, fluoxetine) concomitantly with serotonergic medicinal products.
Serotoninski sindrom: pri bolnikih, ki so uporabljali SSRI (npr. paroksetin, fluoksetin) sočasno s serotoninergičnimi zdravili, so v redkih primerih poročali o serotoninskem sindromu.
Caution is advisable if ARICLAIM is used concomitantly with serotonergic antidepressants like SSRIs, tricyclics like clomipramine or amitriptyline, St John’ s wort (Hypericum perforatum), venlafaxine or triptans, tramadol, pethidine and tryptophan.
Priporoča se previdnost pri sočasni uporabi zdravila ARICLAIM s serotoninergičnimi antidepresivi, kot so SSRI, tricikličnimi antidepresivi, kot sta klomipramin ali amitriptilin, šentjanževko (Hypericum perforatum), venlafaksinom ali triptani, tramadolom, petidinom in triptofanom.
CNS medicinal products: caution is advised when ARICLAIM is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Zdravila CŽS: če se zdravilo ARICLAIM jemlje v kombinaciji z drugimi osrednje delujočimi zdravili ali snovmi, vključno z alkoholom in pomirjevali (benzodiazepini, morfinomimetiki, antipsihotiki, fenobarbitalom, sedativnimi antihistaminiki), priporočamo previdnost.
The pharmacokinetics of theophylline, a CYP1A2 substrate, were not significantly affected by co-administration with duloxetine (60 mg twice daily).
Učinki duloksetina na druga zdravila Zdravila, ki jih presnavlja CYP1A2: sočasno dajanje duloksetina (60 mg dvakrat dnevno) ni značilno vplivalo na farmakokinetiko teofilina, substrata CYP1A2.
Duloxetine is a moderate inhibitor of CYP2D6.
Zdravila, ki jih presnavlja CYP2D6: duloksetin je zmeren zaviralec CYP2D6.
When duloxetine was administered at a dose of 60 mg twice daily with a single dose of desipramine, a CYP2D6 substrate, the AUC of desipramine increased 3-fold.
Pri dajanju duloksetina v odmerku 60 mg dvakrat na dan z enkratnim odmerkom dezipramina, substrata CYP2D6, je AUC dezipramina narasel 3- kratno.
The co-administration of duloxetine (40 mg twice daily) increases steady state AUC of tolterodine (2 mg twice daily) by 71%, but does not affect the pharmacokinetics of its active 5-hydroxyl metabolite and no dosage adjustment is recommended.
Sočasno dajanje duloksetina (40 mg dvakrat dnevno) poveča AUC tolterodina (2 mg dvakrat dnevno) v stanju dinamičnega ravnovesja za 71%, ne vpliva pa na farmakokinetiko njegovega aktivnega 5- hidroksi presnovka, zato ne priporočamo prilagajanja odmerjanja.
Caution is advised if ARICLAIM is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Če duloksetin dajemo sočasno z zdravili, ki jih presnavlja predvsem CYP2D6 (risperidon, triciklični antidepresivi [tricyclic antidepressants, TCAs], kot so nortriptilin, amitriptilin in imipramin) in zlasti če imajo ozek terapevtski indeks (kot na primer s flekainidom, propafenonom in metoprololom), svetujemo previdnost.
Caution should be exercised when duloxetine is combined with oral anticoagulants or antiplatelet agents due to a potential increased risk of bleeding.
Antikoagulanti in antitrombotična zdravila: zaradi možnega povečanega tveganja za krvavitev je potrebna previdnost pri kombinaciji duloksetina s peroralnimi antikoagulanti ali antitrombotičnimi zdravili.
Furthermore, increases in INR values have been reported when duloxetine was co-administered with warfarin.
Poleg tega so pri sočasnem dajanju duloksetina z varfarinom, poročali o povišanjih vrednosti INR.
Effects of other medicinal products on duloxetine Antacids and H2 antagonists: co-administration of ARICLAIM with aluminium- and magnesium- containing antacids or with famotidine had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose.
Učinki drugih zdravil na duloksetin Antacidi in antagonisti H2: sočasno dajanje zdravila ARICLAIM z antacidi, vsebujočimi aluminij in magnezij, ali s famotidinom ni imelo pomembnega učinka na hitrost ali obseg absorpcije duloksetina po dajanju 40 mg peroralnega odmerka.
Inhibitors of CYP1A2: because CYP1A2 is involved in duloxetine metabolism, concomitant use of ARICLAIM with potent inhibitors of CYP1A2 is likely to result in higher concentrations of duloxetine.
Zaviralci CYP1A2: ker je CYP1A2 vpleten v presnovo duloksetina, je verjetno, da bo sočasna uporaba zdravila ARICLAIM z močnimi zaviralci CYP1A2 povzročila višje koncentracije duloksetina.
Fluvoxamine (100 mg once daily), a potent inhibitor of CYP1A2, decreased the apparent plasma clearance of duloxetine by about 77% and increased AUC0-t 6-fold.
Fluvoksamin (100 mg enkrat dnevno), močan zaviralec CYP1A2, je znižal očitni plazemski očistek duloksetina za približno 77% in povečal AUC0- t za 6- krat.
Therefore ARICLAIM should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Zato zdravila ARICLAIM ne smemo dajati skupaj z močnimi zaviralci CYP1A2, kot je fluvoksamin (glejte poglavje 4. 3).
Population pharmacokinetic studies analyses have shown that smokers have almost 50% lower plasma concentrations of duloxetine compared with non-smokers.
Induktorji CYP1A2: analize študij populacijske farmakokinetike so pokazale, da imajo kadilci v primerjavi z nekadilci skoraj za 50% nižje plazemske koncentracije duloksetina.
6 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje
Pregnancy There are no data on the use of duloxetine in pregnant women.
Nosečnost Podatkov o uporabi duloksetina pri nosečnicah ni.
Studies in animals have shown reproductive toxicity at systemic exposure levels (AUC) of duloxetine lower than the maximum clinical exposure (see section 5.3).
Študije na živalih so pokazale reproduktivno toksičnost pri nižjih ravneh sistemskega izpostavljanja (AUC) duloksetinu kot je največja klinična izpostavitev (glejte poglavje 5. 3).
As with other serotoninergic medicinal product, discontinuation symptoms may occur in the neonate after maternal duloxetine use near term.
Po maternalni uporabi duloksetina proti koncu nosečnosti, se lahko pri novorojenčkih pojavijo odtegnitveni simptomi.
ARICLAIM should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Zdravilo ARICLAIM naj se v nosečnostu uporablja le, če možna korist upravičuje možno tveganje za plod.
Breast feeding Duloxetine is very weakly excreted into human milk based on a study of 6 lactating patients, who did not breast feed their children.
Dojenje Na osnovi študije 6 doječih bolnic, ki niso dojile svojih otrok, se duloksetin zelo slabo izloča v materino mleko.
The estimated daily infant dose on a mg/ kg basis is approximately 0.14% of the maternal dose (see section 5.2).
Ocenjen dnevni odmerek pri dojenčku na osnovi mg/ kg je približno 0, 14% vrednosti odmerka pri materi (glejte poglavje 5. 2).
Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 7976 patients, 4370 on duloxetine and 3606 on placebo) in SUI and other lower urinary tract disorders.
Preglednica 1 prikazuje neželene učinke, ki so jih opažali v spontanih poročanjih in v s placebom kontroliranih kliničnih preskušanjih (skupno 7. 976 bolnic, 4. 370 jih je jemalo duloksetin, 3. 606 jih je dobilo placebo) za zdravljenje SUI ali drugih bolezni spodnjih sečil.
The most commonly reported adverse events in patients treated with ARICLAIM in clinical trials in SUI and other lower urinary tract disorders were nausea, dry mouth fatigue and constipation.
Neželeni učinki, o katerih so pri bolnicah, zdravljenih z zdravilom ARICLAIM v kliničnih preskušanjih o SUI in drugih boleznih spodnjih sečil, najpogosteje poročali, so bili slabost, suha usta, utrujenost in zaprtje.
The data analysis of four 12-week, placebo-controlled clinical trials in patients with SUI, including 958 duloxetine-treated and 955 placebo-treated patients, showed that the onset of the reported adverse events typically occurred in the first week of therapy.
Analiza podatkov štirih 12- tedenskih, s placebom kontroliranih kliničnih preskušanj pri bolnicah s SUI, vključno z 958 bolnicami, ki so prejemale duloksetin in 955 bolnicami, ki so prejemale placebo, je pokazala, da so se poročani neželeni učinki značilno pojavili v prvem tednu zdravljenja.
However, the majority of the most frequent adverse events were mild to moderate and resolved within 30 days of occurrence (e. g. nausea).
Vendar je bila večina najpogostejših neželenih učinkov blagih do zmernih in so minili v 30 dneh od pojava (npr. slabost).
Very
Neželeni učinki Ocene pogostnosti: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 in < 1/ 10), občasni (≥ 1/ 1. 000 in < 1/ 100), redki (≥ 1/ 10. 000 in < 1/ 1. 000), zelo redki (< 1/ 10. 000), ni znano (ocena iz danih podatkov ni možna).
Very Common Uncommon Rare Very
Zelo redki
common
Srčne bolezni
Investigations Cardiac Disorders
Zmanjšanje telesne mase Povečanje telesne mase Zvišanje krvnega holesterola
Weight decrease Weight increase Blood cholesterol increased
Zvišanje kreatinin - fosfokinaze
Creatinine phosphokinase increase
Bolezni živčevja
Palpitations Nervous System Disorders
Palpitacije
Supra-ventricular arrhythmia, mainly atrial fibrillation
Supra - ventrikularna aritmija, zlasti atrijska fibrilacija
Headache Dizziness Tremor Lethargy Somnolence Paraesthesia
Glavobol Omotica
Poor quality of sleep Disturbance in attention Nervousness Dysgeusia
Slaba kvaliteta spanja
Dyskinesia Myoclonus
Diskinezija Mioklonus
Serotonin syndrome Psychomotor restlessness Convulsions AkathisiaExtrapyramidal symptoms
Serotoninski sindrom
Blurred vision
Tremor Letargija Zaspanost Parestezija
Visual disturbance Mydriasis
Motnje pozornosti Živčnost Disgevzija
Glaucoma
Psihomotoričn i nemir Konvulzije Akatizija Ekstrapiramid ni simptomi
Ear and Labyrinth Disorders
Zamegljen vid
Vertigo
Motnje vida Midriaza
Tinnitus1 Ear pain
Glavkom
Respiratory, thoracic and mediastinal disorders Gastrointestinal Disorders
Ušesne bolezni, vključno z motnjami labirinta Tinitus1 Vrtoglavica Ušesna bolečina Bolezni dihal, prsnega koša in mediastinalnega prostora Bolezni prebavil
Epistaxis Throat tightness
Epistaksa Stisnjeno grlo
Nausea (23.3%) Dry mouth (11.9%) Constipation (10.3%)
Navzea (23, 3%) Suha usta (11, 9%) Zaprtje (10, 3%) Bolezni sečil
Diarrhoea Vomiting Dyspepsia
Driska Bruhanje Dispepsija
Gastroenteritis Haematochezia Stomatitis Gastritis Flatulence Eructation Breath odour
Gastroenteritis Hematohezija Stomatitis Gastritis Napenjanje Kolcanje Slab zadah
Urinary hesitation Dysuria Nocturia Urine odour abnormal
Odlašanje Slabši curek uriniranja urina Disurija Poliurija Nokturija Nenormalen vonj urina
Sweating increased
Povečano znojenje
Rash Increased tendency to
Izpuščaj Povečano nagnjenje k modricam Nočno znojenje Hladen znoj
Photo- sensitivity reactions 8
Fotosenzitivno stne reakcije Kontaktni dermatitis Urtikarija
Stevens-Johnson Syndrome Angioneurotic oedema
Stevens - Johnsonov sindrom Angionevrotič ni edem
Muscoskeletal and connective tissue disorders
Bolezni mišično- skeletnega sistema in vezivnega tkiva Bolezni endokrinega sistema Presnovne in prehranske motnje
Muscle spasm Muscle tightness Musculo- skeletal pain Trismus
Mišični krč Napetost mišic Mišično - skeletna bolečina Trizem Hipotiroidize m
Muscle twitching
Trzanje mišic
Endocrine disorders
Zmanjšanje apetita
Hypo- thyroidism Metabolism and Nutrition Disorders
Hiperglikemija (poročana zlasti pri diabetičnih bolnikih) Sindrom neustreznega
Appetite decreased
Infekcijske in parazitske bolezni Žilne bolezni