natgillin/translations-raw huggingface dataset:
Der er sket dødsfald, hovedsageligt med samtidig overdosering af andre lægemidler.
Cases of overdoses, alone or in combination with other medicinal products, with duloxetine doses of 4800mg were reported.
Der har dog også været tilfælde med duloxetin alene i doser på omkring 1000 mg.
Some fatalities have occurred, primarily with mixed overdoses, but also with duloxetine alone at a dose of approximately 1000 mg.
Søvnighed, coma, serotoninsyndrom, kramper, opkastning og takykardi.
Signs and symptoms of overdose (duloxetine alone or in combination with other medicinal products) included somnolence, coma, serotonin syndrome, seizures, vomiting and tachycardia.
Der kendes ingen antidot mod duloxetin men i tilfælde af serotoninsyndrom, kan specifik behandling (såsom for cyproheptadin og/ eller temperatur kontrol) overvejes.
No specific antidote for duloxetine is known but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/ or temperature control) may be considered..
Duloxetin har stor fordelingsvolumen, og forceret diurese, hæmo - perfusion og udskiftningstransfusion har sandsynligvis ingen gavnlig virkning.
Duloxetine has a large volume of distribution and forced diuresis, haemoperfusion, and exchange perfusion are unlikely to be beneficial.
Andre antidepressiva.
Other antidepressants.
N06AX21.
N06AX21
Duloxetin er en kombineret serotonin - (5- HT) og noradrenalin (NA) - genoptagelseshæmmer.
Duloxetine is a combined serotonin (5-HT) and norepinephrine (NE) reuptake inhibitor.
13 I dyreforsøg fører forhøjet niveau af 5- HT og NA i den sakrale ende af rygsøjlen til øget urethral tonus via en forstærket nervus pudendus- stimulering af urinrørets tværstribede lukkemuskel kun i opbevaringsfasen af vandladningscyklussen.
In animal studies, increased levels of 5-HT and NE in the sacral spinal cord, lead to increased urethral tone via enhanced pudendal nerve stimulation to the urethral striated sphincter muscle only during the storage phase of the micturition cycle.
En lignende mekanisme hos kvinder, baseret på begrænset beviser fra urodynamiske og elektrofysiologiske studier, menes at medføre kraftigere urethral lukning under urinopbevaring med fysisk stress der kan forklare effekten af duloxetin i behandling af kvinder med stressinkontinens.
A similar mechanism in women is believed to result in stronger urethral closure during urine storage with physical stress that could explain the efficacy of duloxetine in the treatment of women with SUI.
958 af disse patienter blev randomiseret til duloxetin og 955 til placebo.
The efficacy of duloxetine 40 mg given twice daily in the treatment of SUI was established in four double-blind, placebo-controlled studies, that randomised 1913 women (22 to 83 years) with SUI; of these, 958 patients were randomised to duloxetine and 955 to placebo.
De primære mål for effekten var hyppigheden af inkontinensepisoder (IEF) ud fra dagbøger og et spørgeskema vedrørende livskvalitet i forbindelse med inkontinens (I- QOL).
The primary efficacy measures were Incontinence Episode Frequency (IEF) from diaries and an incontinence specific quality of life questionnaire score (I-QOL).
I alle fire forsøg havde den duloxetin- behandlede gruppe en gennemsnitlig reduktion i Incontinece Episode Frequence (IEF) på 50% eller mere sammenlignet med 33% i den placebo- behandlet gruppe.
Incontinence Episode Frequency: in all four studies the duloxetine-treated group had a 50% or greater median decrease in IEF compared with 33% in the placebo-treated group.
Forskellene blev observeret ved hvert besøg efter medicinering i 4 uger (duloxetin 54% og placebo 22%), 8 uger (52% og 29%) og 12 uger (52% og 29%).
Differences were observed at each visit after 4 weeks (duloxetine 54%, and placebo 22%), 8 weeks (52% and 29%), and 12 weeks (52% and 33%) of medication.
I et yderligere forsøg, som var begrænset til patienter med svær stressinkontinens, blev alle responser på duloxetin opnået inden for 2 uger.
14 In an additional study limited to patients with severe SUI, all responses with duloxetine were achieved within 2 weeks.
Virkningen af ARICLAIM er ikke blevet undersøgt længere end 3 måneder i placebokontrollerede studier.
The efficacy of ARICLAIM has not been evaluated for longer than 3 months in placebo-controlled studies.
Den kliniske fordel ved ARICLAIM sammenlignet med placebo er ikke blevet undersøgt hos kvinder med let SUI, defineret i randomiserede forsøg som kvinder med IEF < 14 om ugen.
The clinical benefit of ARICLAIM compared with placebo has not been demonstrated in women with mild SUI, defined in randomised trials as those with IEF < 14 per week.
For disse kvinder kan ARICLAIM nok ikke yde nogen fordele udover det som konservativ livsstilsomlægninger kan bidrage med.
In these women, ARICLAIM may provide no benefit beyond that afforded by more conservative behavioural interventions.
Livskvalitet:
Quality of Life:
Resultater fra livskvalitets - / Incontinence Quality of Life (I- QOL) undersøgelser viste sig signifikant forbedret i gruppen med duloxetin- behandlede patienter sammenlignet med placebo - gruppen (9, 2 mod 5, 9 i score forbedring, p < 0, 001).
Incontinence Quality of Life (I-QOL) questionnaire scores were significantly improved in the duloxetine-treated patient group compared with the placebo-treated group (9.2 versus 5.9 score improvement, p < .001).
Ved brug af en Patient Global Improvement (PGI) skala viste kvinder behandlet med duloxetin at vurdere deres symptomer på stressinkontinens som signifikant forbedret i forhold til kvinder på placebo (64, 6% mod 50, 1%, p < 0, 001).
Using a global improvement scale (PGI), significantly more women using duloxetine considered their symptoms of stress incontinence to be improved with treatment compared with women using placebo (64.6% versus 50.1%, p < .001).
Der er begrænset data som tyder på, at fordelene ved ARICLAIM ikke mindskes hos kvinder med stressinkontinens, som tidligere er blevet opereret for inkontinens.
ARICLAIM and Prior Continence Surgery: there are limited data that suggest that the benefits of ARICLAIM are not diminished in women with stress urinary incontinence who have previously undergone continence surgery.
I løbet af et blindt, randomiseret, kontrolleret 12- ugers forsøg viste ARICLAIM større reduktioner i IEF i forhold til enten placebo- behandlingen eller med bækkenbundsøvelser alene.
ARICLAIM and Pelvic Floor Muscle Training (PFMT): during a 12-week blinded, randomised, controlled study, ARICLAIM demonstrated greater reductions in IEF compared with either placebo treatment or with PFMT alone.
Kombinationsbehandling (duloxetin + bækkenbundsøvelser) viste større forbedring både med hensyn til brug af bind og tilstandsspecifikke livskvalitetsmålinger end ARICLAIM alene eller bækkenbundsøvelser alene.
Combined therapy (duloxetine + PFMT) showed greater improvement in both pad use and condition-specific quality of life measures than ARICLAIM alone or PFMT alone.
Effekten af duloxetin som en behandling af diabetiske neuropatiske smerter blev etableret i 2 randomiserede 12- ugers, dobbeltblinde, placebokontrollerede forsøg med fast dosis hos voksne (22 til 88 år), som havde haft diabetiske neuropatiske smerter i mindst 6 måneder.
The efficacy of duloxetine as a treatment for diabetic neuropathic pain was established in 2 randomised, 12-week, double-blind, placebo-controlled, fixed dose studies in adults (22 to 88 years) having diabetic neuropathic pain for at least 6 months.
Patienter, som levede op til diagnosekriterierne for moderat til svær depression, blev ekskluderet fra disse forsøg.
Patients meeting diagnostic criteria for major depressive disorder were excluded from these trials.
Det primære endepunkt var den ugentlige middelværdi af 24- timers gennemsnitlig smerte, som blev noteret hver dag af patienterne i dagbog målt på en 11- punkts Likert skala.
The primary outcome measure was the weekly mean of 24-hour average pain, which was collected in a daily diary by patients on an 11-point Likert scale.
Begge forsøg viste en signifikant smertereduktion sammenlignet med placebo.
In both studies, duloxetine 60 mg once daily and 60 mg twice daily significantly reduced pain compared with placebo.
65% duloxetin- behandlede patienter mod 40% placebo- behandlede.
At least 30% reported pain reduction was recorded in approximately 65% of duloxetine treated patients versus 40% for placebo.
Hos patienter, som ikke havde oplevet somnolens, blev der observeret klinisk respons hos 47% af de duloxetin - behandlede patienter og 27% af de placebo- behandlede patienter.
For patients not experiencing somnolence, clinical response was observed in 47% of patients receiving duloxetine and 27% patients on placebo.
Hos patienter, som havde oplevet somnolens, blev der målt klinisk respons hos 60% af de duloxetin- behandlede patienter og 30% af de placebo- behandlede patienter.
Clinical response rates in patients experiencing somnolence were 60% on duloxetine and 30% on placebo.
Det er usandsynligt, at patienter, som ikke opnåede en smertereduktion på 30% inden for 60 dage, skulle kunne opnå dette niveau af smertereduktion ved yderligere behandling.
Patients not demonstrating a pain reduction of 30% within 60 days of treatment were unlikely to reach this level during further treatment.
Selvom data fra et etårigt open- label forsøg viser nogen evidens på langtidseffekt, er der ikke nogen afgørende effektdata tilgængelige fra placebokontrollerede forsøg for behandling i længere end 12 uger.
Although data from a one-year open label study offer some evidence for longer-term efficacy, no conclusive efficacy data for treatments longer than 12 weeks duration are available from placebo- controlled studies.
5. 2 Farmakokinetiske egenskaber
15 5.2 Pharmacokinetic properties
Duloxetin metaboliseres i udstrakt grad af oxiderende enzymer (CYP1A2 og det polymorfiske CYP2D6) efterfulgt af konjugation.
Duloxetine is extensively metabolised by oxidative enzymes (CYP1A2 and the polymorphic CYP2D6), followed by conjugation.
Duloxetins farmako - kinetik viser stor variation mellem patienter (generelt 50- 60%), delvist på grund af køn, alder, ryger ikke- ryger status og CYP2D6 metaboliseringsstatus.
The pharmacokinetics of duloxetine demonstrate large intersubject variability (generally 50-60%), partly due to gender, age, smoking status and CYP2D6 metaboliser status.
6 timer efter dosisindgift.
Duloxetine is well absorbed after oral administration with a Cmax occurring 6 hours post dose.
Den absolutte orale biotilgængelighed for duloxetin lå på 32- 80% (gns. på 50%, N = 8 patienter).
The absolute oral bioavailability of duloxetine ranged from 32% to 80% (mean of 50%; N=8 subjects).
Fødeindtagelse udsætter tidspunktet for opnåelse af den maksimale serumkoncentration fra 6 til 10 timer og mindsker omfanget af absorptionen marginalt (omtrent 11%).
Food delays the time to reach the peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (approximately 11%).
Duloxetin har en cirka 96% - binding til humane plasmaproteiner.
Duloxetine is approximately 96% bound to human plasma proteins.
Duloxetin bindes til både albumin og alfa- 1- syre- glykoprotein.
Duloxetine binds to both albumin and alpha-1 acid glycoprotein.
Proteinbindingen påvirkes ikke af nedsat nyre - eller leverfunktion.
Protein binding is not affected by renal or hepatic impairment.
Både CYP2D6 og CYP1A2 katalyserer dannelsen af to hovedmetabolitter: glukuronidkonjugat af 4 - hydroxy- duloxetin og sulfatkonjugat af 5- hydroxy, 6- methoxy- duloxetin.
Both CYP2D6 and CYP1A2 catalyse the formation of the two major metabolites glucuronide conjugate of 4-hydroxy duloxetine and sulphate conjugate of 5-hydroxy,6-methoxy duloxetine.
På baggrund af in vitro - forsøg betragtes duloxetins cirkulerende metabolitter som farmakologisk inaktive.
Based upon in vitro studies, the circulating metabolites of duloxetine are considered pharmacologically inactive.
12 timer).
The elimination half-life of duloxetine after an oral dose ranges from 8 to 17 hours (mean of 12 hours).
101 l/ t.).
After an intravenous dose the plasma clearance of duloxetine ranges from 22 l/ hr to 46 l/ hr (mean of 36 l/ hr) After an oral dose the apparent plasma clearance of duloxetine ranges from 33 to 261 l/ hr (mean 101 l/ hr).
Der er fundet farmakokinetiske forskelle mellem mænd og kvinder (den tilsyneladende plasma - clearance er tilnærmelsesvis 50% lavere hos kvinder).
Gender: pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximatively 50% lower in females).
25% længere hos ældre), men omfanget af disse forandringer ikke er tilstrækkelig til at retfærdiggøre dosisjusteringer.
Age: pharmacokinetic differences have been identified between younger and elderly females (≥ 65 years) (AUC increases by about 25% and half-life is about 25% longer in the elderly), although the magnitude of these changes is not sufficient to justify adjustments to the dose.
4. 2 og 4. 4).
As a general recommendation, caution should be exercised when treating the elderly (see sections 4.2 and 4.4).
Patienter med terminal nyresygdom i dialysebehandling havde et dobbelt så højt duloxetin- Cmaks. og dobbelt så høje AUC- værdier som raske patienter.
Renal impairment: end stage renal disease (ESRD) patients receiving dialysis had a 2-fold higher duloxetine Cmax and AUC values compared to healthy subjects.
Moderat leversygdom (Child- Pugh- gruppe B) påvirkede duloxetins farmako - kinetik.
Hepatic insufficiency: moderate liver disease (Child Pugh Class B) affected the pharmacokinetics of duloxetine.
Sammenlignet med raske patienter var den tilsyneladende plasma- clearance for duloxetin 79% lavere, den tilsyneladende terminale halveringstid var 2, 3 gange længere, og AUC var 3, 7 gange højere hos patienter med moderat leversygdom.
Compared with healthy subjects, the apparent plasma clearance of duloxetine was 79% lower, the apparent terminal half-life was 2.3 times longer, and the AUC was 3.7 times higher in patients with moderate liver disease.
Ammende mødre:
Nursing mothers:
Duloxetins fordelingen i kroppen blev undersøgt hos 6 ammende kvinder, som havde født mindst 12 uger forinden.
The disposition of duloxetine was studied in 6 lactating women who were at least 12-weeks postpartum.
Mængden af duloxetin i modermælk er ca.
Duloxetine is detected in breast milk, and steady-state concentrations in breast milk are about one-fourth those in plasma.
7 µg/ dag under en dosering på 40 mg to gange daglig.
The amount of duloxetine in breast milk is approximately 7 µg/ day while on 40 mg twice daily dosing.
5. 3 Prækliniske sikkerhedsdata
16 5.3 Preclinical safety data
I karcino - genitetsstudiet med rotter blev der set celler med flere cellekerner i leveren i fravær af andre histo - patologiske ændringer.
Multinucleated cells were seen in the liver in the absence of other histopathological changes in the rat carcinogenicity study.
Hunmus, som modtog duloxetin i 2 år, havde kun forøget incidens af hepatocellulære adenomer og karcinomer ved den høje dosis (144 mg/ kg/ dag), men disse blev betragtet som værende sekundære til den mikrosomale enzyminduktion i leveren.
Female mice receiving duloxetine for 2 years had an increased incidence of hepatocellular adenomas and carcinomas at the high dose only (144 mg/ kg/ day), but these were considered to be secondary to hepatic microsomal enzyme induction.
Hunrotter, som fik duloxetin før og under parring samt i den tidlige drægtighedsperiode, havde nedsat fødeindtagelse og kropsvægt, afbrydelse af brunstcyklussen, et nedsat indeks for levende fødsler og overlevelse af afkom samt forsinket vækst hos afkommet ved udsættelse for systemisk på - virkning estimeret til at være højst ved den maksimale kliniske eksponering (AUC).
Female rats receiving duloxetine before and during mating and early pregnancy had a decrease in maternal food consumption and body weight, oestrous cycle disruption, decreased live birth indices and progeny survival, and progeny growth retardation at systemic exposure levels estimated to be at the most at maximum clinical exposure (AUC).
I et embryotoxi - citetstudie foretaget på kaniner blev der observeret en højere incidens af kardiovaskulære - og knogle - deformationer, hvor hunkaninerne blev udsat for systemiske påvirkninger under den maksimale kliniske eksponering (AUC).
In an embryotoxicity study in the rabbit, a higher incidence of cardiovascular and skeletal malformations was observed at systemic exposure levels below the maximun clinical exposure (AUC).
Duloxetin fremkaldte adfærdsmæssige bivirkninger hos afkommet i et pre - / postnatal toxicitetstudie med rotter, hvor hunrotter blev udsat for systemiske påvirkninger under den maksimale kliniske eksponering (AUC).
In pre/ postnatal toxicity study in the rat, duloxetine induced adverse behavioural effects in the offspring at systemic exposures levels below maximum clinical exposure (AUC).
Kapsel indhold:
Capsule content:
Hypromellose Hydroxypropylmethylcelluloseacetatsuccinat Saccharose Saccharosekugler Talcum Titandioxid (E171) Triethylcitrat.
Hydroxypropyl methylcellulose acetate succinate Sucrose Sugar spheres Talc Titanium dioxide (E171) Triethyl citrate.
Gelatine, natriumlaurilsulfat, titandioxid (E171), indigotin (E132), rød jernoxid (E172), gul jernoxid (E172) og Edible black ink.
Gelatin Sodium Lauryl Sulfate Titanium Dioxide (E171) Indigo Carmine (E132) Red Iron oxide (E172) Yellow Iron Oxide (E172) Edible black ink.
Edible black ink:
Edible Ink:
Syntetisk sort jernoxid (E172), propylenglycol og Shellac
Black Iron Oxide-Synthetic (E172) Propylene glycol Shellac.
16 6. 2 Uforligeligheder
6.2 Incompatibilities
6. 4 Særlige opbevaringsforhold
17 6.4 Special precautions for storage
PVC - (polyvinylchlorid), PE - (polyethylen) og PCTFE- blister (polychlorotrifluoroethylen) forseglet med aluminiumfolie.
Polyvinylchloride (PVC), Polyethylene (PE), and Polychlorotrifluoroethylene (PCTFE) blister sealed with an aluminum foil.
Eli Lilly Nederland BV, Grootslag 1- 5, NL- 3991 RA Houten, Holland.
Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten, The Netherlands.
ARICLAIM 20 mg hårde enterokapsler
ARICLAIM 20 mg hard gastro-resistant capsules.
Hjælpestoffer:
Excipients: sucrose 5.7 mg.
Mat blå kapselbund med påskriften ” 20 mg ” og mat blå kapseltop med påskriften ” 9544 ”.
Opaque blue body, imprinted with ‘ 20 mg’ and an opaque blue cap, imprinted with ‘ 9544’.
18 Leverinsufficiens:
Hepatic insufficiency:
4. 3).
19 ARICLAIM should not be used in patients with liver disease resulting in hepatic impairment (see section 4.3).
Derefter kan lægen fortsætte nedsættelse af dosis – denne gang i flere trin.
Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.).
Perikum Uønskede virkninger kan forekomme hyppigere ved samtidig brug af ARICLAIM og naturlægemidler samt kosttilskud indeholdende perikum (Hypericum perforatum).
20 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).
19 Mydriasis Der er rapporteret om tilfælde af mydriasis i forbindelse med duloxetin, og der skal derfor udvises forsigtighed ved udskrivning af duloxetin til patienter med forhøjet intraokulært tryk eller til patienter med risiko for akut snævervinklet glaukom.
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.
Nedsat nyrefunktion Forhøjede plasmakoncentrationer af duloxetin forekommer hos patienter med svært nedsat nyre - funktion i hæmodialyse (kreatinin- clearance < 30 ml/ min.).
Renal impairment Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance < 30 ml/ min).
4. 3.
For patients with severe renal impairment, see section 4.3.
Blødning Blødningsabnormaliteter såsom ekkymoser, purpura og gastrointestinal blødning er set ved brug af selektive serotoningenoptags- hæmmere – (SSRI- præparater) og serotonin/ noradrenalin- genoptags - hæmmere (SNRI- praparater).
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).
ARICLAIM og placebo.
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.
Depression, selvmordsforestillinger og - adfærd Selvom ARICLAIM ikke er godkendt til behandling af depression, findes dets aktive lægemiddelstof (duloxetin) også i et antidepressivt lægemiddel.
21 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.
20 tilstanden i de første få uger eller mere af behandlingen, skal patienterne overvåges nøje, indtil der er sket en forbedring.
As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Hvis patienten under ARICLAIM- behandling udvikler agitation eller depressive symptomer bør en specialist konsulteres, eftersom depression er en alvorlig medicinsk tilstand.
If while on ARICLAIM therapy, the patient develops agitation or depressive symptoms, specialised medical advice should be sought, as depression is a serious medical condition.
4. 5 Interaktion med andre lægemidler og andre former for interaktion
22 4.5 Interaction with other medicinal products and other forms of interaction
Dårlig søvnkvalitet Koncentrations - besvær Nervøsitet Smags - forstyrrelser
Poor quality of sleep Disturbance in attention Nervousness Dysgeusia
Luftveje, thorax og Mave- tarmkanalen
Respiratory, thoracic and mediastinal disorders Gastrointestinal Disorders
Kvalme (23, 3%) Mundtørhed (11, 9%) Forstoppelse (10, 3%)
Nausea (23.3%) Dry mouth (11.9%) Constipation (10.3%)
Nyrer og urinveje
Renals and Urinary Disorders
Besværet vandladning Dysuria Natlig vandladning Abnorm urinlugt
Urinary hesitation Dysuria Nocturia Urine odour abnormal
Hud og subkutane
Skin and Subcutaneous Tissue Disorders
Lysfølsomheds reaktioner Kontaktdermatit is Nældefeber
Photo- sensitivity reactions 25
24
common
Synkope2 Blodtryksfor - øgelse
Syncope2 Blood pressure increase
Generel utilpashed Varmefølelse Generel unormal følelse Tørst
Malaise Feeling hot Feeling abnormal Thirst
Gangforstyr - relser Føler sig kold
Gait disturbance Feeling cold
Selvmords - forestilling Selvmords - adfærd4 Mani Aggression og angst5
Suicidal behaviour Suicidal ideation 4 Mania Aggression and anger 5
25 Seponering af duloxetin (særlig ved pludseligt ophør) fører normal til seponeringssymptomer.
Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms.
De mest almindelige observerede bivirkninger hos patienter med diabetiske neuropatiske smerter i behandling med ARICLAIM var: kvalme, hovedpine, mundtørhed og søvnighed.
The most commonly observed adverse reactions in patients with diabetic neuropathic pain treated with ARICLAIM were: nausea; headache, dry mouth and somnolence.
Tabel 2:
27 Table 2:
Indenfor hver frekvensgruppe er bivirkningerne opført med hensyn til faldende alvorlighed
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Nervesystemet Hovedpine (13, 8%) Søvnighed (10, 7%)
Headache (13.8%) Somnolence (10.7%) Eye Disorders
Øjne
Blurred vision
Øre og labyrint
Visual disturbance Mydriasis
Sløret syn
Glaucoma
Synsforstyrrelser Mydriasis
Ear and Labyrinth Disorders
Hud og subkutane væv
28
27
known
28 1 Der er også rapporteret tilfælde af tinnitus efter behandlingsophør.
Cases of tinnitus have also been reported after treatment discontinuation.
2 Sager med orthostatisk hypotension og synkope er blevet rapporteret - særligt i behandlingsopstarten 3 Se pkt 4. 4.
2 Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment.