FrancophonIA/ELRC3.0 huggingface dataset:
English: In placebo-controlled clinical trials with children and adolescent patients treated with Seroquel, quetiapine was associated with an increased incidence of extrapyramidal symptoms (EPS) compared to placebo in patients treated for schizophrenia and bipolar mania (see section 4.8).
Danish: I placebo-kontrollerede kliniske forsøg med børn og unge patienter behandlet med Seroquel er quetiapin blevet forbundet med en øget forekomst af ekstrapyramidale symptomer (EPS) sammenlignet med placebo hos patienter behandlet for skizofreni og bipolar mani (se pkt.
English: • Discontinuation symptoms (symptoms which occur when you stop taking Seroquel XR) include not being able to sleep (insomnia), feeling sick (nausea), headache, diarrhoea, being sick
Danish: • Seponeringssymptomer (symptomer som forekommer, når du stopper med at tage Seroquel Prolong) inkluderer søvnløshed, kvalme, hovedpine, diarré, opkastning, svimmelhed og irritabilitet.
English: Quetiapine does not produce dopamine D2-receptor supersensitivity after chronic administration.
Danish: Ved kronisk administrering forårsager quetiapin ikke supersensitivitet overfor dopamin D2 receptorer.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Danish: BILAG III PRODUKTRESUME, ETIKETTERING OG INDLÆGSSEDDEL
English: In the treatment of moderate to severe manic episodes, Seroquel demonstrated superior efficacy to placebo in reduction of manic symptoms at 3 and 12 weeks, in two monotherapy trials.
Danish: I to monoterapiforsøg med behandling af moderate til svære maniske episoder har Seroquel vist bedre effekt end placebo på reduktion af maniske symptomer ved uge 3 og 12.
English: In a clinical trial, in patients with depressive episodes in bipolar I or bipolar II disorder, 300 mg/day Seroquel XR showed superior efficacy to placebo in reduction of MADRS total score.
Danish: I et klinisk forsøg i bipolar I og bipolar II lidelse hos patienter med depressive episoder viste Seroquel Prolong 300 mg/dag bedre effekt end placebo i reduktion af MADRS totalscore.
English: In post marketing, QT prolongation was reported with quetiapine at the therapeutic doses (see Section 4.8) and in overdose (see Section 4.9).
Danish: Efter markedsføring er der rapporteret QT-forlængelse for quetiapin ved de terapeutiske doser (se pkt.
English: Antidepressant effect was seen at 150 and 300 mg/day in short-term trials as add-on therapy (with amitriptyline, bupropion, citalopram, duloxetine, escitalopram, fluoxetine, paroxetine, sertraline and venlafaxine - see Section 5.1) and at 50 mg/day in short-term monotherapy trials.
Danish: I korttidsforsøg blev den antidepressive virkning observeret ved 150 og 300 mg daglig, når lægemidlet blev givet som supplerende behandling (i kombination med amitriptylin, bupropion, citalopram, duloxetin, escitalopram, fluoxetin, paroxetin, sertralin og venlafaxin - se pkt.
English: EL - Greece AstraZeneca S.A. 4 Theotokopoulou & Astronafton 151 25
Danish: 4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens Grækenland
English: In clinical studies of patients with MDD the incidence of suicide-related events observed in young adult patients (younger than 25 years of age) was 2.1% (3/144) for quetiapine and 1.3% (1/75) for placebo.
Danish: Kliniske forsøg med patienter med unipolar depression viste, at hyppigheden af selvmordsrelaterede hændelser hos unge voksne patienter (yngre end 25 år) var 2,1 % (3/144) for quetiapin og 1,3 % (1/75) for placebo.
English: Seroquel XR is indicated for:
Danish: Seroquel Prolong er indiceret til:
English: If you suddenly stop taking Seroquel XR, you may be unable to sleep (insomnia), you may feel sick (nausea), or you may experience headache, diarrhoea, being sick (vomiting), dizziness or irritability.
Danish: Hvis du holder op med at tage Seroquel Prolong Hvis du pludselig stopper med at tage Seroquel Prolong, kan det være, at du får svært ved at sove, får kvalme eller hovedpine, diarré, opkastning, bliver svimmel eller irritabel.
English: Seroquel XR tablets contain 50 mg, 150 mg, 200 mg, 300 mg or 400 mg of quetiapine (as quetiapine fumarate).
Danish: Seroquel Prolong tabletter indeholder 50 mg, 150 mg, 200 mg, 300 mg eller 400 mg quetiapin (som quetiapinfumarat).
English: In short term, fixed dose (50mg/d to 800 mg/d), placebo-controlled studies (ranging from 3 to 8 weeks), the mean weight gain for quetiapine-treated patients ranged from 0.8 kg for the 50 mg daily dose to 1.4 kg for the 600 mg daily dose (with lower gain for the 800 mg daily dose), compared to 0.2 kg for the placebo treated patients.
Danish: Placebokontrollerede korttidsforsøg (over 3 til 8 uger) med en fast dosis (50 mg/dag til 800 mg/dag) viste en gennemsnitlig vægtøgning hos quetiapinbehandlede patienter på 0,8 kg ved en daglig dosis på 50 mg til 1,4 kg ved 600 mg/dag (hvor den laveste vægtøgning forekom ved 800 mg/dag) sammenlignet med 0,2 kg hos placebobehandlede patienter.
English: Occurs predominantly during the early weeks of treatment (10) The following withdrawal symptoms have been observed most frequently in acute placebo-controlled, monotherapy clinical trials, which evaluated discontinuation symptoms: insomnia, nausea, headache, diarrhoea, vomiting, dizziness, and irritability.
Danish: (10) I akutte placebokontrollerede monoterapiforsøg, hvor seponeringssymptomer blev evalueret, blev følgende seponeringssymptomer hyppigst observeret: Søvnløshed, kvalme, opkastning, hovedpine, diarré, svimmelhed og irritabilitet.
English: For more convenient dosing, patients who are currently being treated with divided doses of immediate release Seroquel tablets may be switched to Seroquel XR at the equivalent total daily dose taken once daily.
Danish: Et forenklet doseringsregime kan opnås ved, at patienter som bliver behandlet med Seroqueltabletter 2 gange dagligt skiftes til Seroquel Prolong ved ekvivalente totaldoser indtaget én gang dagligt.
English: In all clinical trials (placebocontrolled, open-label, active comparator; patients with a baseline neutrophil count ≥1.5 X 109/L), the incidence of at least one occurrence of neutrophil count <0.5 X 109/L was 0.21% in patients treated with quetiapine and 0% in placebo treated patients and the incidence ≥0.5 - <1.0 X 109/L was 0.75% in patients treated with quetiapine and 0.11% in placebo-treated patients.
Danish: I alle kliniske forsøg (placebokontrollerede, open-label, aktiv komparator; patienter med et baseline neutrofiltal ≥1,5 x 109/l), var hyppigheden af mindst ét tilfælde af et neutrofiltal <1,5 x 109/l hos quetiapin behandlede patienter 0,21 % og 0 % hos de patienter, som fik placebo.
English: Extrapyramidal symptoms1, 21, Dysarthria
Danish: Besvimelse4,17, ekstrapyramidale symptomer1,21 Dysarti
English: National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders: Update the protocols for the following ongoing Post Authorisation Safety Studies (PASSs) to collect long-term safety data of quetiapine XR in MDD patients: ¾ Modified Prescription Event Monitoring (M-PEM) Study;
Danish: Opdatering af protokollerne for følgende igangværende sikkerhedsundersøgelser efter godkendelsen (PASS) med henblik på at indsamle data for sikkerheden af quetiapin XR på lang sigt hos MDD-patienter:
English: For the treatment of depressive episodes in bipolar disorder Seroquel XR should be administered at bedtime.
Danish: Til behandling af depressive episoder inden for bipolar lidelse Seroquel Prolong bør tages ved sengetid.
English: Blood and lymphatic system disorders
Danish: Blod og lymfesystem Almindelig:
English: In a short-term (9 week) study non-demented elderly patients (aged 66 to 89 years) with major depressive disorder, Seroquel XR dosed flexibly in the range of 50 mg to 300 mg/day demonstrated superior efficacy to placebo in reducing depressive symptoms as measured by improvement in MADRS total score (LS mean change vs placebo -7.54).
Danish: Ved et korttidsforsøg (9 uger) med ældre patienter uden demens (i alderen 66 til 89 år) med svær depression blev der påvist en bedre virkning med Seroquel Prolong overfor placebo hvad angik reduktion af de depressive symptomer målt ved forbedring af MADRS-totalscoren (gennemsnitlig ændring vs. placebo på -7,54).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 50 mg quetiapine (as fumarate)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvar tablet indeholder 50 mg quetiapin (som fumarat)
English: Cardiovascular:
Danish: Krampeanfald:
English: • A high temperature (fever), long lasting sore throat or mouth ulcers, faster breathing, sweating,
Danish: • Feber, ondt i halsen over længere tid eller mundsår, hurtigt åndedræt, svedeture, muskelstivhed, følelse af stærk døsighed eller besvimelse.
English: In short-term, placebo-controlled bipolar depression trials the aggregated incidence of extrapyramidal symptoms was 8.9% for quetiapine compared to 3.8% for placebo.
Danish: Placebokontrollerede korttidsforsøg med bipolar depression viste en samlet hyppighed af ekstrapyramidale symptomer på 8,9 % for quetiapin sammenlignet med 3,8 % for placebo.
English: (11) Triglycerides ≥200 mg/dL (≥2.258 mmol/L) (patients ≥18 years of age) or ≥150 mg/dL (≥1.694 mmol/L) (patients <18 years of age) on at least one occasion (12) Cholesterol ≥240 mg/dL (≥6.2064 mmol/L) (patients ≥18 years of age) or ≥200 mg/dL (≥5.172 mmol/L) (patients <18 years of age) on at least one occasion.
Danish: (11) Mindst ét tilfælde af triglycerider ≥200 mg/dl (≥2,258 mmol/l) (patienter ≥18 år) eller ≥150 mg/dl (≥1,694 mmol/l) (patienter <18 år).
English: SE - Sweden AstraZeneca AB AstraZeneca Sverige SE-151 85 Södertälje Sweden
Danish: SE-151 85 Södertälje Sverige
English: Elevations in blood creatine phosphokinase15
Danish: Forhøjet blod-kreatin fosfokinase
English: Dizziness or a severe sense of feeling sleepy.
Danish: - Bliver svimmel eller pludseligt føler dig meget søvnig.
English: • Men and women to have swelling of breasts and unexpectedly produce breast milk.
Danish: Mænd og kvinder kan få øget brystudvikling og uventet produktion af brystmælk (galaktoré).
English: This could increase the risk of accidental injury (fall) in elderly patients.
Danish: Dette kan øge risikoen for ulykker (fald)
English: Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Danish: Seroquel Prolong indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for heriditær lactasemangel (Lapp lactase deficiency) eller glucose/galactosemalabsorption.
English: MT - Malta AstraZeneca UK Ltd Silk Road Business Park Macclesfield
Danish: AstraZeneca UK Ltd Silk Road Business Park Macclesfield Cheshire SK10 2NA Storbritannien
English: Extrapyramidal symptoms:
Danish: Ekstrapyramidale symptomer:
English: An approximately 3-fold increased risk of cerebrovascular adverse events has been seen in randomised placebo controlled trials in the dementia population with some atypical antipsychotics.
Danish: For nogle atypiske antipsykotika er der i randomiserede placebo-kontrollerede forsøg set en ca. 3dobbelt øget risiko for cerebrovaskulære bivirkninger i demens- populationen.
English: Cases of QT prolongation, ventricular arrhythmia, sudden unexplained death, cardiac arrest and torsades de pointes have been reported with the use of neuroleptics and are considered class effects.
Danish: Ved anvendelse af neuroleptika er der rapporteret QT forlængelse, ventrikulær-arytmi, pludselig uforklarlig død, hjertestop og torsades de pointes.
English: • treatment of schizophrenia including preventing relapses in stable schizophrenic patients who have been maintained on Seroquel XR.
Danish: • behandling af skizofreni inklusive: o Forebyggelse af tilbagefald hos stabile skizofrenipatienter, der har vist initialt behandlingsrespons på Seroquel Prolong.
English: • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
Danish: • Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: Rare (affects less than 1 in 1,000 people):
Danish: Sjælden (sker hos færre end 1 ud af 1.000 personer):
English: Quetiapine data in combination with divalproex or lithium in acute moderate to severe manic episodes is limited; however, combination therapy was well tolerated (see section 4.8 and 5.1).
Danish: Der er begrænset data for quetiapin i kombination med divalproex eller lithium til behandling af akutte moderate til svære maniske episoder, dog var kombinations-behandling veltolereret (se pkt.
English: As with other antipsychotics, weight gain, syncope, neuroleptic malignant syndrome, leucopenia, neutropenia and peripheral oedema, have been associated with quetiapine.
Danish: Vægtøgning, besvimelse, malignt neuroleptikasyndrom, leukopeni, neutropeni og perifært ødem har som for andre antipsykotika været forbundet med quetiapin.
English: Very common (affects more than 1 in 10 people):
Danish: Meget almindelig (sker hos flere end 1 ud af 10 personer):
English: Children and adolescents (10 to 17 years of age) The same ADRs described above for adults should be considered for children and adolescents.
Danish: De samme bivirkninger, som er beskrevet ovenfor for voksne, bør forventes hos børn og unge.
English: Seroquel XR should be used with caution in patients with risk factors for stroke.
Danish: Seroquel Prolong bør anvendes med forsigtighed hos patienter med risiko for at få et slagtilfælde.
English: FI - Finland AstraZeneca Oy Luomanportti 3
Danish: AstraZeneca Oy Luomanportti 3 FI-02200 Espoo Finland
English: Clinical trials with Seroquel have shown that in addition to the known safety profile identified in adults (see section 4.8), certain adverse events occurred at a higher frequency in children and adolescents compared to adults (increased appetite, elevations in serum prolactin and extrapyramidal symptoms) and one was identified that has not been previously seen in adult studies (increases in blood pressure).
Danish: 4.8) indtrådte visse bivirkninger med større hyppighed hos børn og unge sammenlignet med voksne (øget appetit, forhøjet serumprolaktin og ekstrapyramidale symptomer), og der blev identificeret én bivirkning, som ikke tidligere er set i forsøg med voksne (forhøjet blodtryk).
English: In short-term placebo-controlled clinical trials with Seroquel in paediatric patients with schizophrenia, the incidence of suicide related events was 1.4% (2/147) for quetiapine and 1.3% (1/75) for placebo in patients <18 years of age.
Danish: Selvmord/selvmordstanker eller klinisk forværring I korttids placebo-kontrollerede kliniske forsøg med Seroquel med pædiatriske patienter med skizofreni var forekomsten af selvmordsrelaterede hændelser 1,4 % (2/147) for quetiapin og 1,3 % (1/75) for placebo hos patienter på <18 år.
English: In a short-term placebo-controlled monotherapy trial in elderly patients with major depressive disorder, the aggregated incidence of extrapyramidal symptoms was 9.0% for Seroquel XR and 2.3% for placebo.
Danish: I et placebokontrolleret korttids-monoterapiforsøg med ældre patienter med unipolar depression var den samlede forekomst af ekstrapyramidale symptomer 9,0 % for Seroquel Prolong og 2,3 % for placebo.
English: Do not split, chew or crush the tablets.
Danish: Må ikke deles, knuses eller tygges.
English: Extrapyramidal Symptoms
Danish: Ekstrapyramidale symptomer
English: Levels of TBG were unchanged and in general, reciprocal increases in TSH were not observed, with no indication that quetiapine causes clinically relevant hypothyroidism.
Danish: Thyroxin-binding globulin (TBG) niveauet var uændret, og generelt sås ingen reciprok stigning i thyrotropin (thyroid stimulating hormone, TSH).
English: In three out of four short term (up to 8 weeks) monotherapy studies, in patients with major depressive disorder, Seroquel XR 50 mg, 150 mg and 300 mg/day demonstrated superior efficacy to placebo in reducing depressive symptoms as measured by improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score (LS mean change vs. placebo of 2-4 points).
Danish: Tre ud af fire korttidsforsøg (op til 8 uger) forsøg, hvor Seroquel Prolong blev givet som monoterapi til patienter med alvorlige depressive lidelser, viste at Seroquel Prolong 50 mg, 150 mg og 300 mg daglig var bedre end placebo til at reducere depressive symptomer, målt ved forbedring af MADRStotalscoren (gennemsnitlig ændring vs. placebo på 2-4 point).
English: Seroquel XR contains a substance called quetiapine.
Danish: Seroquel Prolong indeholder det aktive stof quetiapin.
English: You should check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller på apoteket, hvis der er noget, du er i tvivl om, eller føler dig usikker på.
English: Do not take Seroquel XR if: you are allergic (hypersensitive) to quetiapine or any of the other ingredients of Seroquel XR (see section 6: Further information) you are taking any of the following medicines: - some medicines for HIV - azole medicines (for fungal infections) - erythromycin or clarithromycin (for infections) - nefazodone (for depression).
Danish: Tag ikke Seroquel Prolong hvis: du er overfølsom (allergisk) over for quetiapin eller et af de øvrige indholdsstoffer (se pkt.
English: In placebo controlled clinical trials of adult patients quetiapine was associated with an increased incidence of extrapyramidal symptoms (EPS) compared to placebo in patients treated for major depressive episodes in bipolar disorder and major depressive disorder (see sections 4.8 and 5.1).
Danish: I placebo-kontrollerede kliniske forsøg med voksne patienter var quetiapin forbundet med en øget forekomst af ekstrapyramidale symptomer (EPS) sammenlignet med placebo hos patienter, som blev behandlet for depressive episoder inden for bipolar lidelse og unipolar depression (se pkt.
English: Increases in triglycerides, LDL and total cholesterol, and decreases in HDL cholesterol have been observed in clinical trials with quetiapine (see section 4.8).
Danish: I kliniske forsøg med quetiapin er der set stigninger i triglycerider, LDL- og totalkolesterol, og fald i HDL-kolesterol (se pkt.
English: • Disturbance in speech and language • Thoughts of suicide and worsening of your depression
Danish: Selvmordstanker og forværring af din depression
English: Seroquel XR should be administered once daily, without food.
Danish: Seroquel Prolong bør tages én gang dagligt uden samtidig fødeindtagelse.
English: The pharmacokinetics of quetiapine were not altered following co-administration with cimetidine.
Danish: Quetiapins farmakokinetik ændredes ikke ved samtidig adminitrering af cimetidin.
English: • Feeling more hungryIncreased appetite
Danish: • Øget sultfornemmelse.
English: Elevations in serum transaminases (ALT, AST)3, decreased neutrophil count, blood glucose increased to hyperglycaemic levels 7
Danish: Blodglukose steget til hyperglykæmiske niveauer7
English: Severe neutropenia (neutrophil count <0.5 X 109/L) has been uncommonly reported in quetiapine clinical trials.
Danish: I kliniske forsøg med quetiapin er der set alvorlig neutropeni (neutrofiltal <0,5 x 109/l) med hyppigheden ikke almindelig.
English: 10 prolonged-release tablets 30 prolonged-release tablets 50 prolonged-release tablets 60 prolonged-relaease tablets 100 prolonged-release tablets
Danish: 10 depottabletter 30 depottabletter 50 depottabletter 60 depottabletter 100 depottabletter
English: Long-term efficacy and safety in patients with MDD has not been evaluated as add-on therapy, however long-term efficacy and safety has been evaluated in adult patients as monotherapy (see below).
Danish: Imidlertid er virkning og sikkerhed ved monoterapi hos voksne patienter blevet evalueret ved langtidsforsøg (se nedenfor).
English: In short-term, placebo-controlled monotherapy clinical trials in major depressive disorder the aggregated incidence of extrapyramidal symptoms was 5.4% for Seroquel XR and 3.2% for placebo.
Danish: I placebokontrollerede, kliniske korttids-monoterapiforsøg med patienter med unipolar depression var den samlede forekomst af ekstrapyramidale symptomer 5,4 % for Seroquel Prolong og 3,2 % for placebo.
English: 1 blister of 10 tablets
Danish: 1 blister á 10 tabletter
English: Quetiapine may induce orthostatic hypotension especially during the initial dose-titration period and therefore dose reduction or more gradual titration should be considered if this occurs.
Danish: Quetiapin kan inducere ortostatisk hypotension, især i den indledende dosistitreringsperiode.
English: Jaundice6
Danish: Gulsot6
English: - The CHMP concluded on a positive benefit risk ratio for Seroquel XR as add-on treatment of major depressive episodes in patients with major depressive disorder, who have had suboptimal response to initial antidepressant monotherapy further to consideration of the safety profile of Seroquel.
Danish: - Efter en vurdering af Seroquels sikkerhedsprofil konkluderede CHMP, at benefit/risk-forholdet var positivt for Seroquel XR som tillægsbehandling af svære depressive episoder hos patienter med svær depression, der har responderet suboptimalt på indledende antidepressiv monoterapi,
English: Common (affects less than 1 in 10 people):
Danish: Almindelig (sker hos færre end 1 ud af 10 personer):
English: • Boys and girls to have swelling of breasts and unexpectedly produce breast milk
Danish: - Drenge og piger kan få øget brystudvikling og uventet produktion af brystmælk - Piger kan få manglende eller uregelmæssig menstruationen Øget appetit
English: • Medicines should not be disposed of via wastewater or household waste.
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
English: The pharmacokinetics of quetiapine does not differ between men and women.
Danish: Køn: Der er ingen forskel mellem mænd og kvinder hvad angår quetiapins kinetik.
English: Long-term efficacy and safety in patients with MDD has not been evaluated as add-on therapy, however long-term efficacy and safety has been evaluated in adult patients as monotherapy (see Section 5.1).
Danish: Imidlertid er virkning og sikkerhed ved monoterapi hos voksne patienter blevet evalueret ved langtidsforsøg (se pkt.
English: Very rare (affects less than in 10,000 people):
Danish: Meget sjælden (sker hos færre end 1 ud af 10.000 personer):
English: Uncommon (affects less than 1 in 100 people):
Danish: Ikke almindelig (sker hos færre end 1 ud af 100 personer):
English: For preventing recurrence in bipolar disorder
Danish: o Til forebyggelse af tilbagevendende sygdomsepisoder hos patienter med bipolar lidelse,
English: Eye Disorders Common:
Danish: Øjne Almindelig:
English: TRADE NAME
Danish: NAVN
English: NLNetherlands
Danish: NL-Holland
English: What Seroquel XR is and what it is used for Before you take Seroquel XR How to take Seroquel XR Possible side effects
Danish: Det skal du vide, før du begynder at tage Seroquel Prolong Sådan skal du tage Seroquel Prolong Bivirkninger
English: The dose can be increased in increments of 50 mg/day to an effective dose, depending on the clinical response and tolerability of the individual patient.
Danish: Afhængigt af klinisk respons og tolerabilitet hos den enkelte patient, kan dosis øges trinvist med 50 mg/dag, indtil effektiv dosis er opnået.
English: 10 blisters of 5 tablets
Danish: 10 blistre á 5 tabletter
English: Seizures:
Danish: Seponering:
English: DK - Denmark AstraZeneca A/S Roskildevej 22
Danish: Indehaver af markedsføringstilladelsen AstraZeneca A/S
English: Cardiac disorders Common:
Danish: Kardiovaskulære symptomer:
English: The following studies were conducted with Seroquel XR as monotherapy treatment, however Seroquel XR is only indicated for use as add-on thereapy:
Danish: Følgende forsøg blev gennemført med Seroquel Prolong som monoterapi.
English: The following side effects have been seen more often in children and adolescents: Very Common (affects more than 1 in 10 people):
Danish: Følgende bivirkninger er set oftere hos børn og unge:
English: 5 blisters of 10 tablets
Danish: 5 blistre á 10 tabletter
English: 50 mg, 150 mg 200 mg, 300 mg and 400 mg tablets
Danish: 50 mg, 150 mg