natgillin/translations-raw huggingface dataset:
Det skal De vide, før De begynder at tage CHAMPIX
What you need to know before you take CHAMPIX
Nummereret 1 - 14 sol som symbol måne som symbol
Numbers 1 to 14 sun as symbol moon as symbol
Neuropsykiatrisk sikkerhedsstudie af forsøgspersoner med og uden tidligere psykisk forstyrrelse Vareniclin blev evalueret i et randomiseret, dobbeltblindet, aktivt og placebokontrolleret studie, der inkluderede forsøgspersoner med tidligere psykisk forstyrrelse (psykiatrisk kohorte, N=4074) og forsøgspersoner uden tidligere psykisk forstyrrelse (ikke-psykiatrisk kohorte, N=3984).
Study in Subjects with and without a History of Psychiatric Disorder: Varenicline was evaluated in a randomised, double-blind, active and placebo-controlled study that included subjects with a history of psychiatric disorder (psychiatric cohort, N=4074) and subjects without a history of psychiatric disorder (non-psychiatric cohort, N=3984).
I den psykiatriske kohorte var procentdelen af forsøgspersoner med suicidaltanker og/eller -adfærd baseret på Columbia-Suicide Severity Rating Scale (C-SSRS) den samme for vareniclin- og placebogrupperne under behandlingen og under opfølgningen uden behandling som vist i følgende tabel:
In the psychiatric cohort, the percentage of subjects with suicidal ideation and/or behaviour based on the Columbia-Suicide Severity Rating Scale (C-SSRS) was similar between the varenicline and placebo groups during treatment and in the non- treatment follow-up, as shown in the following table:
Virkninger ved rygeophør
Effect of smoking cessation
Procentdelen af forsøgspersoner med suicidaltanker og/eller -adfærd baseret på Columbia-Suicide Severity Rating Scale (C-SSRS) var den samme for vareniclin- og placebogrupperne under behandlingen og under opfølgningen uden behandling som vist i følgende tabel:
The percentage of subjects with suicidal ideation and/or behaviour based on the Columbia-Suicide Severity Rating Scale (C-SSRS) was similar between the varenicline and placebo groups during treatment and in the non- treatment follow-up, as shown in the following table:
Sammenligning af behandlinger: Oddsratio (95 % CI), p-værdi Vareniclin vs placebo
Treatment Comparisons: Odds ratio (95% CI), p value Varenicline vs Placebo
I meta-analysen var forekomsten af dødsfald (alle årsager) (CHAMPIX 6 (0,14%); placebo 7 (0,25%)) og kardiovaskulære dødsfald (CHAMPIX 2 (0,05%); placebo 2 (0,07%)) i sammenlignelige i CHAMPIX-armen og i placebo-armen.
There were similar rates of all-cause mortality (CHAMPIX 6 [0.14%]; placebo 7 [0.25%]) and cardiovascular mortality (CHAMPIX 2 [0.05%]; placebo 2 [0.07%]) in the CHAMPIX arms compared with the placebo arms in the meta-analysis.
I løbet af opfølgningsperioden uden behandling ind til uge 52 omfattede de hændelser, der blev betragtet som værende relateret til behandlingen: Behov for koronar revaskularisering (2,0% vs. 0,6%), hospitalsindlæggelse for angina pectoris (1,7% vs. 1.1%) og nydiagnosticeret perifer vaskulær sygdom (PVD) eller indlæggelse for PVD-operation (1,4% vs. 0,6%).
During non-treatment follow up to 52 weeks, the adjudicated events included need for coronary revascularisation (2.0% vs. 0.6%), hospitalisation for angina pectoris (1.7% vs. 1.1%), and new diagnosis of peripheral vascular disease (PVD) or admission for a PVD procedure (1.4% vs. 0.6%).
Den vigtigste sikkerhedsanalyse omfattede hændelse og timing af et sammensat endepunkt af alvorlige kardiovaskulære bivirkninger (Major Adverse Cardiovascular Events (MACE)), defineret som kardiovaskulær død, non-letal myokardieinfarkt og non-letal apopleksi.
The key cardiovascular safety analysis included occurrence and timing of a composite endpoint of Major Adverse Cardiovascular Events (MACE), defined as cardiovascular death, nonfatal MI, and nonfatal stroke.
Nummereret 1 - 28 sol som symbol måne som symbol
Numbers 1 to 28 sun as symbol moon as symbol
Efter markedsføring er der rapporteret om ændringer i adfærd eller tankegang, angst, psykose, humørsvingninger, aggressiv adfærd, depression, selvmordstanker og selvmordsadfærd samt selvmordsforsøg hos patienter, der forsøgte at holde op med at ryge ved hjælp af CHAMPIX.
Changes in behaviour or thinking, anxiety, psychosis, mood swings, aggressive behaviour, depression, suicidal ideation and behaviour and suicide attempts have been reported in patients attempting to quit smoking with CHAMPIX in the post-marketing experience.
Kramper, tremor, letargi, hypæstesi
Seizure, tremor, lethargy, hypoaesthesia
Fra dag 1-3 skal De tage 1 hvid CHAMPIX 0,5 mg filmovertrukken tablet 1 gang dagligt
From day 1 to day 3, you should take one white CHAMPIX 0.5 mg film-coated tablet once a day.
Resultaterne for 4W-CQR (uge 9 til og med uge 12) og CA (uge 9 til og med uge 52) fremgår af tabellen herunder.
The results for the 4W CQR (weeks 9 through 12) and CA rate (weeks 9 through 52) are shown in the following table:
CHAMPIX anbefales ikke til pædiatriske patienter, da der ikke er påvist virkning.
Children and adolescents CHAMPIX is not recommended for use in paediatric patients as efficacy was not demonstrated.
NRT = nikotinplaster (nicotine replacement therapy patch)
NRT=Nicotine replacement therapy patch
Hos patienter med moderat nedsat nyrefunktion (anslået kreatininclearance ≥30 ml/min og 50 ml/min) var vareniclinniveauet øget 1,5 gange sammenlignet med patienter med normal nyrefunktion (anslået kreatininclearance >80 ml/min).
In patients with moderate renal impairment (estimated creatinine clearance  30 ml/min and  50 ml/min), varenicline exposure increased 1.5-fold compared with subjects with normal renal function (estimated creatinine clearance > 80 ml/min).
Gradvis metode til at stoppe med at ryge
Gradual approach to quitting smoking
Følgende tabel viser hyppigheden af det sammensatte primære endepunkt for NPS bivirkninger ifølge behandlingsgruppe og risikodifferenser (RD'er) (95 % CI) vs placebo i den ikke-psykiatriske kohorte.
The following table shows the rates of the composite NPS adverse event primary endpoint by treatment group and the risk differences (RDs) (95% CI) vs placebo in the non-psychiatric cohort.
På grund af fraværet af signifikant hepatisk metabolisme er vareniclins farmakokinetik upåvirket hos patienter med nedsat leverfunktion (se pkt.
Due to the absence of significant hepatic metabolism, varenicline pharmacokinetics should be unaffected in patients with hepatic impairment (see section 4.2).
De hyppigste bivirkninger (≥ 10 %) hos patienter, der tog vareniclin, var kvalme (27,0 % vs. 10,4 % i placebo-gruppen), hovedpine (16,8 % vs. 11,2 %), drømmeforstyrrelser (11,3 % vs. 8,2 %), søvnløshed (10,9 % vs. 4,8 %) og irritabilitet (10,9 % vs. 8,2 %).
The most common adverse events (≥ 10%) in subjects taking varenicline were nausea (27.0% vs. 10.4% on placebo), headache (16.8% vs. 11.2%), abnormal dreams (11.3% vs. 8.2%), insomnia (10.9% vs. 4.8%) and irritability (10.9% vs. 8.2%).
In vitro-forsøg tyder på, at det er usandsynligt, at vareniclin ændrer farmakokinetikken for stoffer, der primært metaboliseres af CYP450-enzymer.
In vitro studies indicate that varenicline is unlikely to alter the pharmacokinetics of compounds that are primarily metabolised by cytochrome P450 enzymes.
Indigotin I (E132) Triacetin
Indigo Carmine Aluminium Lake (E132) Triacetin
Depression
Depression a
42 x 1 mg filmovertrukne tabletter
42 x 1 mg film-coated tablets
Cellulose, mikrokrystallinsk Calciumhydrogenphosphat, vandfri Croscarmellosenatrium Silica, kolloid vandfri Magnesiumstearat
Cellulose, Microcrystalline Calcium Hydrogen Phosphate Anhydrous Croscarmellose Sodium Silica, Colloidal Anhydrous Magnesium Stearate
Brugen af vareniclin, bupropion og nikotinplaster i den ikke-psykiatriske kohorte var ikke forbundet med en øget risiko for NPS bivirkninger i det sammensatte primære endepunkt sammenlignet med placebo (95 % CI var lavere end eller inkluderede nul).
The use of varenicline, bupropion and NRT in the non-psychiatric cohort was not associated with a significantly increased risk of NPS adverse events in the composite primary endpoint compared with placebo (95% CIs were lower than or included zero).
Virkningen af vareniclin blev bekræftet i et randomiseret, placebokontrolleret studie med 525 patienter med svær depression inden for de seneste 2 år eller i stabil behandling for depression.
Study in subjects with a history of major depressive disorder The efficacy of varenicline was confirmed in a randomised placebo-controlled trial in 525 subjects with a history of major depression in the past two years or under current stable treatment.
Det kan i nogle tilfælde være nødvendigt at ændre dosis af anden medicin, f.eks. theofyllin (medicin til behandling af vejrtrækningsbesvær), warfarin (blodfortyndende medicin) og insulin (medicin til behandling af sukkersyge), i forbindelse med at holde op med at ryge.
Examples include theophylline (a medicine to treat breathing problems), warfarin (a medicine to reduce blood clotting), and insulin (a medicine to treat diabetes).
Metformin har ingen effekt på vareniclins farmakokinetik.
Metformin had no effect on varenicline pharmacokinetics.
Det tredje studie viste ingen forskel i risikoen for psykiatriske bivirkninger, diagnosticeret under et besøg på en akutafdeling eller ved indlæggelse, hos vareniclinbrugere sammenlignet med bupropionbrugere (HR 0,85; 95% CI: 0,55-1,30).
The third study reported no difference in risk of psychiatric adverse events diagnosed during an emergency department visit or inpatient admission between varenicline users and bupropion users (HR 0.85; 95% CI: 0.55-1.30).
Vrangforestillinger Hallucinationer Suicidaltanker Mani
Hallucinationsb Homicidal ideationb Maniab
Afkom fra rotter, der får vareniclin, mens de er drægtige, udviser nedsat fertilitet og øget ”auditory startle response” (se pkt.
In the offspring of pregnant rats treated with varenicline there were decreases in fertility and increases in the auditory startle response (see section 4.6).
Følgende tabel viser hyppigheden af det sammensatte primære endepunkt for NPS bivirkninger ifølge behandlingsgruppe og RD'er (95 % CI) vs placebo i den psykiatriske kohorte.
The following table shows the rates of the composite NPS adverse event primary endpoint by treatment group and the RDs (95% CI) vs placebo in the psychiatric cohort.
In vitro inducerede vareniclin desuden ikke aktiviteten af CYP450-enzymerne 1A2 og 3A4 i humane hepatocytter.
Also, in human hepatocytes in vitro, varenicline was shown to not induce the activity of cytochrome P450 enzymes 1A2 and 3A4.
Dette studie viste den gavnlige virkning af yderligere 12 ugers behandling med CHAMPIX 1 mg 2 gange dagligt for at fastholde rygeophør sammenlignet med placebo.
This study showed the benefit of an additional 12-week treatment with CHAMPIX 1 mg twice daily for the maintenance of smoking cessation compared to placebo; superiority to placebo for CA was maintained through week 52.
Nedsat antal blodplader Metabolisme og ernæring Almindelig
Platelet count decreased Metabolism and nutrition disorders Common
I denne gruppe er seponeringsraten for de hyppigste bivirkninger hos patienter, der blev behandlet med vareniclin: kvalme (2,7% versus 0,6% for placebo), hovedpine (0,6% versus 1,0% for placebo), søvnløshed (1,3% versus 1,2% for placebo) og unormale drømme (0,2% versus 0,2% for placebo).
In this group, the discontinuation rates for the most common adverse reactions in varenicline treated patients were as follows: nausea (2.7% vs. 0.6% for placebo), headache (0.6% vs. 1.0% for placebo), insomnia (1.3% vs. 1.2% for placebo), and abnormal dreams (0.2% vs. 0.2% for placebo).
Procentdelen af patienter med selvmordsrelaterede hændelser i den aktive behandlingsfase sammenlignet med fasen efter behandling var uændret i vareniclin-gruppen.
The percentage of subjects with suicide-related events in the active treatment phase compared to post-treatment phase was unchanged in the varenicline group; in the placebo group, this percentage was lower in the post-treatment phase.
Forhøjet blodtryk, hedestigninger Luftveje, thorax og mediastinum Almindelig
Blood pressure increased, hot flush Respiratory, thoracic and mediastinal disorders Common
Oddsratio (95% CI), p-værdi
Odds ratio (95% CI), p value
4-ugers startpakning
4-week treatment initiation pack
Erytem, akne, hyperhidrose, nattesved
Rash, pruritus Erythema, acne, hyperhidrosis, night sweats
Må ikke opbevares ved temperaturer over 30 °C.
Store below 30°C
CO-bekræftet afholdenhed i løbet af uge 9 til og med 12 og 9 til og med 24 sammenlignet med forsøgspersoner, der blev behandlet med bupropion, nikotinplaster og placebo (se nedenstående tabel).
In both cohorts, subjects treated with varenicline demonstrated statistical superiority of CO-confirmed abstinence during weeks 9 through 12 and 9 through 24 compared to subjects treated with bupropion, nicotine patch and placebo (please see table below).
Risikoen for at begynde at ryge igen efter behandling er højest i perioden umiddelbart efter, at behandlingen er slut.
In smoking cessation therapy, risk of returning to smoking may be elevated in the period immediately following the end of treatment.
Højdosis-vareniclin Lavdosis-vareniclin Placebo
High-Dose Varenicline Low-Dose Varenicline Placebo
Tal med lægen, før De starter behandlingen med CHAMPIX, hvis De har haft krampeanfald eller har epilepsi.
Tell your doctor if you have experienced seizures or have epilepsy before your start CHAMPIX treatment.
Patienter, der med succes er stoppet med at ryge efter 12 uger, kan overveje at tage yderligere en kur på 12 uger med CHAMPIX 1 mg 2 gange dagligt for at fastholde afholdenheden (se pkt.
For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with CHAMPIX at 1 mg twice daily may be considered for the maintenance of abstinence (see section 5.1).
Filmovertrukkne tabletter
Film-coated tablets
Prækliniske data afslørede ingen risiko hos mennesker baseret på standard-fertilitetsstudier hos hanog hunrotter (se pkt.
Non-clinical data revealed no hazard for humans based on standard male and female fertility studies in the rat (see section 5.3).
Vedvarende afholdenhedsrate for forsøgspersoner, der fik CHAMPIX, sammenlignet med placebo
Continuous Abstinence Rates in Subjects Treated with Champix versus Placebo
Det primære endepunkt var en CO-bekræftet 4W-CQR fra uge 9 til og med uge 12 og et sekundært endepunkt var CA fra uge 9 til og med uge 52.
The primary endpoint of the study was the CO-confirmed, 4-week Continuous Quit Rate (4W CQR) from week 9 through week 12 and a key secondary endpoint was the Continuous Abstinence (CA) from Week 9 through Week 52.
Hos patienter med nyresygdom i sidste stadie blev vareniclin effektivt fjernet ved dialyse (se pkt.
In subjects with end-stage-renal disease (ESRD), varenicline was efficiently removed by haemodialysis (see section 4.2).
12 til 17 år n/N (%)
12-to-17-Year Olds n/N (%)
Det primære endepunkt for de 2 studier, er den 4 ugers vedvarende kvit-rate (4-week Continuous Quit Rate, 4W-CQR) fra uge 9 til og med uge 12, som er bekræftet ved måling af carbonmonoxid (CO).
The primary endpoint of the two studies was the carbon monoxide (CO) confirmed, 4-week continuous quit rate (4W-CQR) from week 9 through week 12.
De hyppigste bivirkninger i vareniclin-gruppen var kvalme (23,8% vs. 14,0% i placebo-gruppen), hovedpine (10,7% vs. 18,6% i placebo-gruppen) og opkastning (10,7% vs. 9,3% i placebo-gruppen).
The most common adverse events in subjects taking varenicline were nausea (23.8% vs. 14.0% on placebo), headache (10.7% vs. 18.6% on placebo) and vomiting (10.7% vs. 9.3% on placebo).
Gastroøsofageal reflukssygdom, opkastning, forstoppelse, diarré, udspilet abdomen, abdominalsmerter, tandpine, dyspepsi, flatulens, mundtørhed
Gastrooesophageal reflux disease, vomiting, constipation, diarrhoea, abdominal distension, abdominal pain, toothache, dyspepsia, flatulence, dry mouth
Under behandlingen Antal vurderet Suicidaladfærd og/eller -tanker Suicidaladfærd Suicidaltanker Under opfølgning Antal vurderet Suicidaladfærd og/eller -tanker Suicidaladfærd Suicidaltanker
During treatment Number assessed Suicidal behaviour and/or ideation Suicidal behaviour Suicidal ideation During follow up Number assessed Suicidal behaviour and/or ideation Suicidal behaviour Suicidal ideation
Ikke-psykiatrisk kohorte N=3984 Vareniclin Bupropion Nikotinplaster Placebo
Non-psychiatric Cohort N=3984 Varenicline Bupropion
Vareniclin (n=5.072)
Varenicline (N=5072)
Dag 8-14 Fra dag 8-14 skal De tage 1 lyseblå CHAMPIX 1 mg filmovertrukken tablet 2 gange dagligt, 1 om morgenen og 1 om aftenen på omtrent samme tidspunkt hver dag
Day 8 - 14 From day 8 to day 14, you should take one light blue CHAMPIX 1 mg film-coated tablet twice daily, once in the morning and once in the evening, at about the same time each day.
Efter enkeltdosis og efter multiple doser til pædiatriske patienter i alderen 12-17 år (begge inklusive) var vareniclins farmakokinetik stort set dosis-proportional i det undersøgte dosisinterval på 0,5-2 mg dagligt.
Single and multiple-dose pharmacokinetics of varenicline have been investigated in paediatric patients aged 12 to 17 years old (inclusive) and were approximately dose-proportional over the 0.5 mg to 2 mg daily dose range studied.
Nogle personer har oplevet krampeanfald, mens de var i behandling med CHAMPIX.
Some people have reported seizures while taking CHAMPIX.
Nedsat leverfunktion Dosisjustering er ikke nødvendig hos patienter med nedsat leverfunktion (se pkt.
Hepatic impairment No dosage adjustment is necessary for patients with hepatic impairment (see section 5.2).
Psykiatrisk kohorte N=4074 Vareniclin Bupropion Nikotinplaster Placebo
Psychiatric Cohort N=4074 Varenicline Bupropion
CA = vedvarende afholdenhedsrate (continuous abstinence rate), CI = konfidensinterval, NRT = nikotinplaster (nicotine replacement therapy patch)
CA = continuous abstinence rate; CI = confidence interval; NRT=Nicotine replacement therapy patch
Vareniclin ændrer ikke farmakokinetikken for warfarin.
Varenicline did not alter the pharmacokinetics of warfarin.
Hos unge med legemsvægt ≤55 kg blev der efter indgift af 0,5 mg 2 gange dagligt set et vareniclin-niveau ved steadystate, der gennemsnitligt var højere (ca. 40%) sammenlignet med voksne.
When 0.5 mg twice daily was given, steady-state daily exposure of varenicline was, on average, higher (by approximately 40%) in adolescent patients with bodyweight ≤ 55 kg compared to that noted in the adult population.
Antal behandlede patienter Sammensat primært endepunkt for NPS AE n (%)
Number of Patients Treated 990 Composite NPS AE Primary Endpoint, n (%)
Filmovertrukne tabletter 11 x 0,5 mg og 14 x 1 mg
11 x 0.5 mg and 14 x 1 mg
Patienterne blev randomiseret til CHAMPIX 1 mg 2 gange dagligt (n=353) eller placebo (n=350) i 12 uger og blev derefter fulgt i 40 uger efter behandling.
Subjects were randomised to CHAMPIX 1 mg twice daily (n=353) or placebo (n=350) for 12 weeks and then were followed for 40 weeks post-treatment.
Fastholdelse af afholdenhed
Treatment discontinuation
Fra dag 15 og til behandlingen er slut, skal De tage 1 lyseblå CHAMPIX 1 mg filmovertrukken tablet 2 gange dagligt, 1 om morgenen og 1 om aftenen på omtrent samme tidspunkt hver dag
From day 15 until the end of treatment, you should take one light blue CHAMPIX 1 mg film-coated tablet twice daily, once in the morning and once in the evening, at about the same time each day.
Hvis De glemmer at tage en dosis, bør De tage den straks, De kommer i tanke om det, medmindre der kun er 3-4 timer til at næste dosis skal tages.
If you forget to take a dose, take it as soon as you remember.
Patienter med stabil skizofreni eller skizoaffektiv sindslidelse Vareniclins sikkerhed og tolerabilitet blev undersøgt i et dobbelt-blindet studie med 128 rygere med stabil skizofreni eller skizoaffektiv sindslidelse, der fik antipsykotika.
Study in subjects with stable schizophrenia or schizoaffective disorder Varenicline safety and tolerability was assessed in a double-blind study of 128 smokers with stable schizophrenia or schizoaffective disorder, on antipsychotic medication, randomised 2:1 to varenicline (1 mg twice daily) or placebo for 12 weeks with 12-week non-drug follow-up.
Kliniske forsøg har vist, at det vil forøge Deres chancer for at holde op med at ryge, hvis alle doser tages på de fastsatte tidspunkter og i den periode, som bliver foreslået.
It has been shown in clinical trials that taking all doses of your medicine at the appropriate times and for the recommended duration of treatment described above will increase your chances of stopping smoking.
Sammenlignet med placebo har CHAMPIX desuden en signifikant reducerende effekt på de forstærkende virkninger af rygningen, der kan føre til, at de patienter, der ryger under behandlingen, ikke kan komme af med deres rygevaner.
CHAMPIX also significantly reduced reinforcing effects of smoking that can perpetuate smoking behaviour in patients who smoke during treatment compared with placebo.
4W-CQR for vareniclin og placebo var hhv. 47,3% og 14,3% og CA uge 9-52 var 19,8% (vareniclin) vs. 7,4% (placebo).
The 4 week CQR for varenicline and placebo was 47.3% and 14.3%, respectively and the CA week 9-52 was 19.8% (varenicline) vs. 7.4% (placebo).
CHAMPIX er beregnet til at tage gennem munden.
Champix is for oral use.
Eksempelvis er følgende symptomer set hos patienter, der prøvede på at holde op med at ryge: dysfori og nedtrykt sindstilstand; søvnløshed, irritabilitet, frustration eller vrede; angst; koncentrationsbesvær; rastløshed; nedsat hjerterytme; øget appetit eller vægtøgning.
For example, dysphoric or depressed mood; insomnia, irritability, frustration or anger; anxiety; difficulty concentrating; restlessness; decreased heart rate; increased appetite or weight gain have been reported in patients attempting to stop smoking.
Fra dag 4-7 skal De tage 1 hvid CHAMPIX 0,5 mg filmovertrukken tablet 2 gange dagligt, 1 om morgenen og 1 om aftenen på omtrent samme tidspunkt hver dag
From day 4 to day 7, you should take one white CHAMPIX 0.5 mg film-coated tablet twice daily, once in the morning and once in the evening, at about the same time each day.
Vareniclin påvirker ikke farmakokinetikken for metformin.
Varenicline did not affect the pharmacokinetics of metformin.
Hvide, kapselformede, bikonvekse tabletter præget ”Pfizer” på den ene side og ”CHX 0.5” på den anden side.
White, capsular-shaped, biconvex tablets debossed with “Pfizer” on one side and “CHX 0.5” on the other side.
Forsøgspersonerne blev randomiseret til at få enten CHAMPIX 1 mg to gange dagligt (n=760) eller placebo (n=750) i 24 uger og blev fulgt efter behandlingen til og med uge 52.
Subjects were randomised to either CHAMPIX 1 mg twice daily (n=760) or placebo (n=750) for 24 weeks and followed up post-treatment through week 52.
I dette 24-ugers studie fik patienterne behandling i 12 uger efterfulgt af en 12-ugers opfølgningsfase uden behandling.
In this 24-week study, patients received treatment for 12 weeks followed by a 12 week non-treatment follow up phase.
Sådan skal De tage CHAMPIX
How to take CHAMPIX
hallucinationer, ændringer i seksuel aktivitet - Krampeanfald, rysten, træthedsfornemmelse, nedsat følesans - Konjunktivitis, øjensmerter - Ringen for ørene (tinnitus) - Brystsmerter, hurtige hjerteslag, hurtig puls, hjertebanken - Forhøjet blodtryk, hedestigninger - Betændelse i næse, bihuler eller hals, tilstoppet næse, hals eller bryst, hæshed, høfeber,
hallucinations, changes in sex drive o Seizure, tremor, feeling sluggish, less sensitive to touch o Conjunctivitis, eye pain o Ringing in the ears o Angina, rapid heart rate, palpitations, increased heart rate o Increased blood pressure, hot flush o Inflammation of nose, sinuses and throat, congestion of nose, throat and chest,
bGrad = AE af moderat og svær intensitet, NRT = nikotinplaster (nicotine replacement therapy patch)
AE, adverse event; aGrade = severe intensity AE; bGrade = moderate and severe intensity AE; NRT=Nicotine replacement therapy patch
Højdosis-vareniclin vs. placebo Lavdosis-vareniclin vs. placebo
High-Dose Varenicline vs Placebo Low-Dose Varenicline vs Placebo