natgillin/translations-raw huggingface dataset:
CA-raten mellem uge 9 og 12 var 35,9 % i vareniclin-armen sammenlignet med 15,6 % i placebo-armen (OR 3,35 (95 % CI 2,16-5,21)), og CA-raten mellem uge 9 og 52 hhv. 20,3 % og 10,4 % (OR 2,36 (95 % CI 1,40-3,98)).
Continuous abstinence rate between weeks 9-12 was 35.9% in the varenicline treatment group versus 15.6% in the placebo group (OR 3.35 (95% CI 2.16-5.21)) and between weeks 9-52 was 20.3% versus 10.4% respectively (OR 2.36 (95% CI 1.40-3.98)).
Meget almindelig Hovedpine Almindelig
Very common Nausea
Selvmordstanker, aggression, panikanfald, abnorm tankegang, rastløshed, humørsvingninger, depression*, angst*, hallucinationer*, øget libido, nedsat libido
Suicidal ideation, aggression, panic reaction, thinking abnormal, restlessness, mood swings, depression*, anxiety*, hallucinations*, libido increased, libido decreased Psychosis, somnambulism, abnormal behaviour, dysphoria, bradyphrenia Nervous system disorders Very common Headache Common
Blod- og lymfesystem Sjælden
Fungal infection, viral infection Blood and lymphatic system disorders Rare
Behandling med CHAMPIX af patienter med nyresygdom i sidste stadie kan ikke anbefales, på grund af utilstrækkelig klinisk erfaring med denne patientgruppe (se pkt.
Based on insufficient clinical experience with CHAMPIX in patients with end stage renal disease, treatment is not recommended in this patient population (see section 5.2).
CA Uge 9-52
CA Wk 9-52
Cerebrovaskulær hændelse, hypertoni, dysartri, koordinationsforstyrrelser, hypogeusi, forstyrrelse i den cirkadiske søvn-vågencyklus
Cerebrovascular accident, hypertonia, dysarthria, coordination abnormal, hypogeusia, circadian rhythm sleep disorder Transient loss of consciousness
4W-CQR (uge 9-12) for vareniclin og placebo var hhv. 53,9% og 19,4% (difference = 34,5%; 95% CI: 27,0%-42,0%) og CA uge 9-24 var 35,2% (vareniclin) vs. 12,7% (placebo) (difference = 22,5%; 95% CI: 15,8%-29,1%).
The 4 week (week 9-12) CQR for varenicline and placebo was 53.9% and 19.4%, respectively (difference=34.5%, 95% CI: 27.0%42.0%) and the CA week 9-24 was 35.2% (varenicline) vs. 12.7% (placebo) (difference=22.5%, 95% CI: 15.8% - 29.1%).
Angstlidelser og -symptomer
Heart symptoms
Hos patienter med alvorligt nedsat nyrefunktion (anslået kreatininclearance <30 ml/min) er vareniclinniveauet øget 2,1 gange.
In subjects with severe renal impairment (estimated creatinine clearance < 30 ml/min), varenicline exposure was increased 2.1-fold.
Forsøgspersoner, der blev behandlet med CHAMPIX, opnåede en væsentlig højere vedvarende afholdenhedsrate sammenlignet med dem placebogruppen.
Subjects treated with CHAMPIX had a significantly higher Continuous Abstinence Rate compared with placebo; the key results are summarised in the following table:
Hvis De er i tvivl så spørg lægen eller apoteket.
If you have any further questions, ask your doctor or pharmacist.
Neuropsykiatrisk sikkerhed - metaanalyser og observationsstudier Analyser af data fra kliniske studier viste ikke evidens for øget risiko for svære neuropsykiatriske hændelser med vareniclin sammenlignet med placebo.
Analyses of clinical trial data did not show evidence of an increased risk of serious neuropsychiatric events with varenicline compared to placebo.
AE = bivirkning, NRT = Nikotinplaster (nicotine replacement therapy patch)
AE, adverse event; NRT=Nicotine replacement therapy patch
Brugen af vareniclin hos patienter med eller uden tidligere psykisk forstyrrelse var ikke forbundet med en øget risiko for alvorlige, neuropsykiatriske bivirkninger i det sammensatte, primære endepunkt sammenlignet med placebo (se pkt.
The use of varenicline in patients with or without a history of psychiatric disorder was not associated with an increased risk of serious neuropsychiatric adverse events in the composite primary endpoint compared with placebo (see section 5.1 Pharmacodynamic properties - Study in Subjects with and without a History of Psychiatric Disorder).
Der blev rapporteret flere hændelser for patienter i den psykiatriske kohorte i hver behandlingsgruppe sammenlignet med den ikke-psykiatriske kohorte.
There were more events reported in patients in the psychiatric cohort in each treatment group compared with the non-psychiatric cohort, and the incidence of events in the composite endpoint was higher for each of the active treatments compared to placebo.
N=1006 n (%)
NRT N=1006 n (%)
Indeholder: 11 x 0,5 mg filmovertrukne tabletter og
11 x 0.5 mg film-coated tablets and
Sammensat endepunkt for NPS AE af svær grad, n (%)
Composite NPS AE Endpoint of severe intensity n (%)
Nikotinplaster N=2022
NRT N=2022
Effekten af at holde op med at ryge
The effects of stopping smoking
0,5 mg filmovertrukne tabletter på 4 mm x 8 mm: Hvide, kapselformede, bikonvekse tabletter præget ”Pfizer” på den ene side og ”CHX 0.5” på den anden side.
0.5 mg film-coated tablets of 4mm x 8mm: White, capsular-shaped, biconvex tablets debossed with “Pfizer” on one side and “CHX 0.5” on the other side.
Oddsratio (95% CI)
Odds ratio (95% CI)
Inflammation i de øvre luftveje, tilstopning af luftveje, dysfoni, allergisk rhinitis, halsirritation, tilstoppede bihuler, øvre luftvejhoste-syndrom (upper-airway cough syndrom), næseflåd
Upper respiratory tract inflammation, respiratory tract congestion, dysphonia, rhinitis allergic, throat irritation, sinus congestion, upperairway cough syndrome, rhinorrhoea Laryngeal pain, snoring
Kardiovaskulær sikkerhedsvurderingsstudie med forsøgspersoner med eller uden en psykiatrisk lidelse i anamnesen
Neuropsychiatric Safety Study in Subjects with and without a History of Psychiatric Disorder:
Filmovertræk - CHAMPIX 1 mg filmovertrukne tabletter Hypromellose
Tablet film coating - CHAMPIX 1 mg film-coated tablets Hypromellose
Forsøgspersonerne blev randomiseret 1:1 til behandling i 12 uger med CHAMPIX 1 mg to gange dagligt (n=249) eller placebo (n=245) og blev fulgt i op til 40 uger efter behandlingen.
Subjects were randomised 1:1 to CHAMPIX 1 mg twice daily (N=249) or placebo (N=245) for 12 weeks of treatment and followed for up to 40 weeks post-treatment.
CHAMPIX indeholder:
CHAMPIX is available in the following pack presentations:
Pfizer Europe MA EEIG (som logo for indehaver af markedsføringstilladelse)
NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG (as MA Holder Logo)
Brystsmerter, træthed
Chest pain, fatigue
Rygeophør kan give forskellige symptomer, hvad enten det gennemføres med eller uden behandling.
Giving up smoking with or without treatment can cause various symptoms.
Det frarådes at anvende CHAMPIX hos pædiatriske patienter, eftersom der ikke er påvist virkning i denne population (se pkt.
CHAMPIX is not recommended for use in paediatric patients because its efficacy in this population was not demonstrated (see sections 5.1 and 5.2).
Vedligeholdelsespakning indeholdende 56 filmovertrukne tabletter
PHARMACEUTICAL FORM AND CONTENTS 56 Film-coated tablets
CHAMPIX og de nedenfor nævnte lægemidler, kan administreres samtidigt, uden det er nødvendigt at dosisjustere.
No dosage adjustment of CHAMPIX or co-administered medicinal products listed below is recommended.
Filmovertræk - CHAMPIX 0,5 mg filmovertrukne tabletter Hypromellose
Tablet film coating - CHAMPIX 0.5 mg film-coated tablets Hypromellose
Sammensat primært endepunkt for NPS AE, n
Treated Composite NPS AE
Lyseblå, kapselformede, bikonvekse tabletter præget ”Pfizer” på den ene side og ”CHX 1.0” på den anden side.
Light blue, capsular-shaped, biconvex tablets debossed with “Pfizer” on one side and “CHX 1.0” on the other side.
N=1016 n (%)
NRT N=1016 n (%)
Vedligeholdelsespakning indeholdende 28 filmovertrukne tabletter
28 film-coated tablets
Karton indeholdende 2 blisterkort hver med 14 x 1 mg vareniclin filmovertrukne tabletter eller 4 blisterkort hver med 14 x 1 mg vareniclin filmovertrukne tabletter eller 8 blisterkort hver med 14 x 1 mg vareniclin filmovertrukne tabletter eller 10 blisterkort hver med 14 x 1 mg vareniclin filmovertrukne tabletter
Carton pack containing 2 blister packs of 14 x 1 mg varenicline film-coated tablets or 4 blister packs of 14 x 1 mg varenicline film-coated tablets or 8 blister packs of 14 x 1 mg varenicline film-coated tablets or 10 blister packs of 14 x 1 mg varenicline film-coated tablets
Vareniclin ændrer ikke farmakokinetikken for digoxin i steady state.
Varenicline did not alter the steady-state pharmacokinetics of digoxin.
irriteret hals, tilstoppede bihuler, hoste forårsaget af øget slimdannelse i næsen, løbenæse - Rødt blod i afføringen, maveirritation, ændrede afføringsvaner, bøvsen, mundsår, smerter i gummerne - Hudrødmen, bumser, øget svedtendens, nattesved - Muskelspasmer, smerter i brystkassen - Unormal, hyppig vandladning, natlig vandladning - Kraftigere menstruation - Ubehag i brystet, influenzalignende symptomer, feber, svaghedsfølelse eller følelse af ubehag - Højt blodsukker - Hjerteanfald - Selvmordstanker - Ændret tankegang og adfærd (f.eks. aggressiv og unormal adfærd).
pain in the gums o Reddening of the skin, acne, increased sweating, night sweats o Muscle spasms, chest wall pain o Abnormally frequent urination, urination at night o Increased menstrual flow o Chest discomfort, flu like illness, fever, feeling weak or unwell o High blood sugar o Heart attack o Suicidal thoughts o Changes in thinking or behaviour (such as aggression)
Rygeophør kan føre til ændringer i Deres krop, og det kan ændre virkningen af anden medicin.
The effects of changes in your body resulting from stopping smoking, with or without treatment with CHAMPIX, may alter the way other medicines work.
Vareniclin ændrer ikke farmakokinetikken af bupropion i steady state.
Varenicline did not alter the steady-state pharmacokinetics of bupropion.
Den anbefalede dosis af CHAMPIX hos patienter med svært nedsat nyrefunktion (anslået kreatininclearance <30 ml/min) er 1 mg 1 gang dagligt.
For patients with severe renal impairment (estimated creatinine clearance < 30 ml/min), the recommended dose of CHAMPIX is 1 mg once daily.
Er De i tvivl, så spørg lægen eller apotekspersonalet.
If in doubt, you should consult your doctor or pharmacist.
1 mg filmovertrukne tabletter på 5 mm x 10 mm: Lyseblå, kapselformede, bikonvekse tabletter præget ”Pfizer” på den ene side og ”CHX 1.0” på den anden side.
1 mg film-coated tablets of 5mm x 10mm: Light blue, capsular-shaped, biconvex tablets debossed with “Pfizer” on one side and “CHX 1.0” on the other side.
N=1017 n (%)
Bupropion N=1017 n (%)
N=989 n (%)
Bupropion N=989 n (%)
CHAMPIX 0,5 mg CHAMPIX 1 mg Filmovertrukne tabletter Vareniclin
CHAMPIX 0.5 mg CHAMPIX 1 mg Film-coated tablets Varenicline
Efter markedsføringen er der rapporteret om en øget berusende virkning af alkohol hos patienter, der blev behandlet med vareniclin, men der er ikke etableret en årsagssammenhæng.
There have been post marketing reports of increased intoxicating effects of alcohol in patients treated with varenicline.
Lægemidlet er receptpligtigt.
This medicine has been prescribed for you only.
CA* uge 13-52
CA* wk 21-52
Denne indlægsseddel blev senest ændret <{måned ÅÅÅÅ}.>
This leaflet was last revised in
CHAMPIX kan virke dæmpende på Deres trang til at ryge, samtidig med at den lindrer de abstinenssymptomer, der opstår, når De holder op med at ryge.
CHAMPIX can help to relieve the craving and withdrawal symptoms associated with stopping smoking.
Ved at hindre nicotin i at virke på α4β2-receptorerne (antagonist virkning) nedsætter det samtidig belønningsoplevelsen og rygningens selvforstærkende mekanisme.
The efficacy of CHAMPIX in smoking cessation is a result of varenicline's partial agonist activity at the α4β2 nicotinic receptor where its binding produces an effect sufficient to alleviate symptoms of craving and withdrawal (agonist activity), while simultaneously resulting in a reduction of the rewarding and reinforcing effects of smoking by preventing nicotine binding to α4β2 receptors (antagonist activity).
BILAG I
Panic b
MACE, n (%)
During treatment MACE, n (%)
For ældre patienter med nedsat nyrefunktion se pkt.
For elderly patients with reduced renal function please refer to section 4.2.
De vigtigste sekundære endepunkter var CA for uge 13 til og med uge 52.
A key secondary endpoint was the continuous abstinence (CA) rate for week 13 through week 52.
Hver 0,5 mg filmovertrukken tablet indeholder 0,5 mg vareniclin (som tartrat).
- Each 0.5 mg film-coated tablet contains 0.5 mg of varenicline (as tartrate).
- CHAMPIX 1 mg filmovertrukne tabletter er lyseblå, filmovertrukne, kapselformede tabletter, mærket ”Pfizer” på den ene side og ”CHX 1.0” på den anden.
CHAMPIX 1 mg film-coated tablets are light blue film-coated, modified capsular shaped tablets, marked “Pfizer” and “CHX 1.0”
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER TRIP
ANNEX III LABELLING AND PACKAGE LEAFLET
HDPE beholder med polypropylen børnesikret lukning og aluminiumsfolie/polyethylen forsegling, indeholdende 56 x 0,5 mg filmovertrukne tabletter.
High-density polyethylene (HDPE) bottle with polypropylene child resistant closure and an aluminium foil/polyethylene induction seal containing 56 x 0.5 mg film-coated tablets Not all pack sizes may be marketed.
Suicidaladfærd og/eller -tanker Suicidaladfærd Suicidaltanker
Number assessed Suicidal behaviour and/or ideation Suicidal behaviour Suicidal ideation
- Vedligeholdelsespakninger, der indeholder 2 eller 4 gennemsigtige blisterkort hver med 14 eller 2 gennemsigtige blisterkort med 28 x CHAMPIX 0,5 mg filmovertrukne tabletter i en kortpakning.
Follow-on (maintenance) packs containing 2 or 4 clear blisters of 14 or 2 clear blisters of 28 x CHAMPIX 0.5 mg film-coated tablets in card packaging.
Samtidig behandling med cimetidin og vareniclin bør undgås hos patienter med svært nedsat nyrefunktion.
In patients with severe renal impairment, the concomitant use of cimetidine and varenicline should be avoided.
Pollakisuri, nykturi
Pollakiuria, nocturia
Allergiske reaktioner
Adverse Drug Reactions
Karton indeholdende 1 blisterkort med 11 x 0,5 mg vareniclin filmovertrukne tabletter og 1 blisterkort med 14 x 1 mg vareniclin filmovertrukne tabletter
Carton pack with 1 blister pack of 11 x 0.5 mg varenicline film-coated tablets and 1 blister pack of 14 x 1 mg varenicline film-coated tablets
Vareniclin kan fjernes ved dialyse, hvilket blev vist hos patienter med nyresygdom i sidste stadie (se pkt.
Varenicline has been shown to be dialyzed in patients with end stage renal disease (see section 5.2), however, there is no experience in dialysis following overdose.
Her virker det som en partiel agonist, det vil sige en forbindelse, der både viser agonist-virkning, men som er mindre virkningsfuld end nicotin, og som har antagonist-virkning ved tilstedeværelse af nicotin.
Varenicline binds with high affinity and selectivity at the α4β2 neuronal nicotinic acetylcholine receptors, where it acts as a partial agonist - a compound that has both agonist activity, with lower intrinsic efficacy than nicotine, and antagonist activities in the presence of nicotine.
Oddsratio
Odds ratio
Suicidal adfærd Suicidaltanker Gennemført selvmord Sammensat endepunkt for NPS AE af svær grad, n
Completed suicideb Composite NPS AE Endpoint of severe intensity n (%)
HDPE beholder med polypropylen børnesikret lukning og aluminiumsfolie/polyethylen forsegling, indeholdende 56 x 1 mg filmovertrukne tabletter.
High-density polyethylene (HDPE) bottle with polypropylene child resistant closure and an aluminium foil / polyethylene induction seal containing 56 x 1 mg film-coated tablets Not all pack sizes may be marketed.
- Svampeinfektion, virusinfektion - Panikanfald, vanskelighed ved at tænke, rastløshed, humørsvingninger, depression, angst,
Uncommon: may affect up to 1 in 100 people o Fungal infection, viral infection o Feeling of panic, difficulty thinking, restlessness, mood swings, depression, anxiety,
Hver 1 mg filmovertrukken tablet indeholder 1 mg vareniclin (som tartrat).
- Each 1 mg film-coated tablet contains 1 mg of varenicline (as tartrate).
- Vedligeholdelsespakninger, der indeholder 2, 4, 8 eller 10 gennemsigtige blisterkort hver med 14 x 1 mg filmovertrukne tabletter i en karton.
Follow-on (maintenance) packs containing 2, 4, 8, or 10 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in a carton.
Tidligere psykiske forstyrrelser
History of psychiatric disorders
Startpakninger:
Treatment initiation packs:
1,74 (1,43, 2,10), P<0,0001 1,62 (1,32, 1,99), P<0,0001
1.74 (1.43, 2.10), P<0.0001
Hver tablet indeholder 0,5 mg eller 1 mg vareniclin (som tartrat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.5 mg or 1 mg varenicline (as tartrate).
Det skal De vide, før De begynder at tage CHAMPIX Sådan skal De tage CHAMPIX Bivirkninger
What you need to know before you take CHAMPIX 3.
I disse studier, der forløb over 52 uger, fik patienterne behandling i 12 uger efterfulgt af 40 uger uden behandling.
In these 52 week duration studies, patients received treatment for 12 weeks, followed by a 40 week non-treatment phase.
Ubehag i brystet, influenzalignende symptomer, pyreksi, asteni, utilpashed
Chest discomfort, influenza like illness, pyrexia, asthenia, malaise Feeling cold, cyst
- Betændelse i næse og hals, unormale drømme, søvnbesvær, hovedpine - Kvalme
Very common: may affect more than 1 in 10 people o Inflammation of the nose and throat, abnormal dreams, difficulty sleeping, headache, o Nausea
CHAMPIX 0,5 mg filmovertrukne tabletter CHAMPIX 1 mg filmovertrukne tabletter
NAME OF THE MEDICINAL PRODUCT CHAMPIX 0.5 mg film-coated tablets CHAMPIX 1 mg film-coated tablets
2,30 (1,83, 2,90), P<0,0001 2,00 (1,56, 2,55), P<0,0001
2.30 (1.83, 2.90), P<0.0001
Abnorm levertest
Liver function test abnormal
1,52 (1,23, 1,89), P=0,0001 1,51 (1,19, 1,93), P=0,0008
1.52 (1.23, 1.89), P=0.0001
- Vedligeholdelsespakninger, der indeholder 2 eller 4 gennemsigtige blisterkort hver med 14 eller 2 gennemsigtige blisterkort med 28 x CHAMPIX 1 mg filmovertrukne tabletter i en kortpakning.
Follow-on (maintenance) packs containing 2 or 4 clear blisters of 14 or 2 clear blisters of 28 x CHAMPIX 1 mg film-coated tablets in card packaging.
I dette studie, der forløb over 52 uger, fik patienterne behandling i 12 uger efterfulgt af en behandlingsfri opfølgningsperiode på 40 uger.
In this 52-week duration study, patients received treatment for 12 weeks, followed by a 40-week non-treatment follow-up phase.
Et kardiovaskulært sikkerhedsvurderingsstudie, hvori der indgik 4595 af de 6293 forsøgspersoner, som gennemførte hovedstudiet (N=8058) og blev fulgt til og med uge 52.
Cardiovascular safety assessment study in subjects with and without a history of psychiatric disorder The cardiovascular (CV) safety of CHAMPIX was evaluated in the Study in Subjects with and without a History of Psychiatric Disorder (parent study; see section 5.1 - Neuropsychiatric safety) and its nontreatment extension, the Cardiovascular Safety Assessment Study, which enrolled 4595 of the 6293 subjects who completed the parent study (N=8058) and followed them through week 52.
- Startpakning i en ydre carton, der indeholder 1 pakke med 1 gennemsigtig blisterkort med 11 x CHAMPIX 0,5 mg og 14 x 1 mg filmovertrukne tabletter og 1 gennemsigtigt blisterkort med 28 eller 2 gennemsigtige blisterkort med 14 x CHAMPIX 1 mg filmovertrukne tabletter i en kortpakning og 2 pakker, der hver indeholder 2 gennemsigtige blisterkort med 28 eller 4 gennemsigtige blisterkort med 14 x CHAMPIX 1 mg filmovertrukne tabletter i en kortpakning.
Treatment initiation pack in an outer carton containing 1 pack with 1 clear blister of 11 x CHAMPIX 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in card packaging and 2 packs each containing 2 clear blisters of 28 or 4 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in card packaging.
Under behandlingen Antal vurderet Suicidaladfærd og/eller -tanker Suicidaladfærd Suicidaltanker Under opfølgning Antal vurderet
During treatment Number assessed Suicidal behaviour and/or ideation Suicidal behaviour Suicidal ideation
LÆGEMIDDELFORM OG INDHOLDS (PAKNINGSSTØRRELSE)
PHARMACEUTICAL FORM AND CONTENTS
1,96 (1,51, 2,54), P<0,0001 1,5 (1,24, 2,20), P=0,0007
1.96 (1.51, 2.54), P<0.0001
CHAMPIX 0,5 mg filmovertrukne tabletter
NAME OF THE MEDICINAL PRODUCT CHAMPIX 0.5 mg film-coated tablets
KARTON TIL DELPAKNING
Treatment initiation packs
2,99 (2,33, 3,83), P<0,0001 2,50 (1,90, 3,29), P<0,0001
2.99 (2.33, 3.83), P<0.0001
4,00 (3,20, 5,00), P<0,0001 3,24 (2,56, 4,11), P<0,0001
3.24 (2.56, 4.11), P<0.0001
1 varmeforseglet kortpakning indeholdende 11 x 0,5 mg og 14 x 1 mg vareniclin filmovertrukne tabletter og 1 blisterpakning med 28 eller 2 blisterpakninger med 14 x 1 mg vareniclin filmovertrukne tabletter og 2 varmeforseglede kortpakninger, hver indeholdende 2 blisterpakninger med 28 eller 4 blisterpakninger med 14 x 1 mg vareniclin filmovertrukne tabletter - indre og ydre mærkning.
1 x heat sealed card pack containing 11 x 0.5 mg and 14 x 1 mg varenicline film-coated tablets and 1 blister pack of 28 or 2 blister packs of 14 x 1 mg varenicline film-coated tablets and 2 x heat sealed card packs each containing 2 blister packs of 28 or 4 blister packs of 14 x 1 mg varenicline film-coated tablets - outer and inner labelling.
Lidelser og forstyrrelser med nedtrykthed Affektive lidelser og forstyrrelser IKA* * IKA: ikke klassificeret andetsteds
Anxiety disorders and symptoms Depressed mood disorders and disturbances Mood disorders and disturbances NEC*
1,77 (1,46, 2,14), P<0,0001 1,74 (1,41, 2,14), P<0,0001
1.74 (1.41, 2.14), P<0.0001
Blisterpakning med 14 x 0,5 mg og 28 x 0,5 mg vareniclin filmovertrukne tabletter, varmeforseglet kortpakning
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 14 x 0.5 mg and 28 x 0.5 mg varenicline film-coated tablets, heat sealed card
Kontakt lægen, før De tager CHAMPIX.
You should ask your doctor or pharmacist for advice before taking CHAMPIX.
CHAMPIX 1 mg filmovertrukne tabletter
NAME OF THE MEDICINAL PRODUCT CHAMPIX 1 mg film-coated tablets
Øre og labyrint Ikke almindelig
Ear and labyrinth disorders
1,49 (1,20, 1,85), P=0,0003 1,41 (1,11, 1,79), P=0,0047
1.41 (1.11, 1.79), P=0.0047
Forekomsten af hændelser for det sammensatte endepunkt var højere for hver af de aktive behandlinger sammenlignet med placebo, men brugen af vareniclin, bupropion og nikotinplaster i den psykiatriske kohorte var ikke forbundet med en signifikant øget risiko for NPS bivirkninger i det sammensatte primære endepunkt sammenlignet med placebo (95 % CI inkluderede nul).
However, the use of varenicline, bupropion and NRT in the psychiatric cohort was not associated with a significantly increased risk of NPS adverse events in the composite primary endpoint compared with placebo (95% CIs included zero).
Øjne Ikke almindelig
Eye disorders Uncommon Rare
Forhøjet blodtryk, hedestigninger
Blood pressure increased, hot flush Respiratory, thoracic and mediastinal disorders
CHAMPIX 0,5 mg
0.5 mg
- Betændelse i brystkassen, betændelse i bihuler - Vægtstigning, manglende appetit, øget appetit - Søvnighed, svimmelhed, ændret smagssans - Stakåndethed, hoste - Halsbrand, opkastning, forstoppelse, diarré, oppustethed, mavesmerter, tandpine, dårlig fordøjelse, luft i maven, tør mund - Udslæt, kløe - Ledsmerter, muskelsmerter, rygsmerter - Smerter i brystmusklerne, udmattethed
Common: may affect up to 1 in 10 people o Chest infection, inflammation of the sinuses o Increased weight, decreased appetite, increased appetite o Sleepiness, dizziness, changes in the way things taste o Shortness of breath, cough o Heartburn, vomiting, constipation, diarrhoea, feeling bloated, abdominal pain, toothache,
N=1026 n (%)
Varenicline N=1026 n (%)
Varmeforseglet kortpakning indeholdende 2 blisterpakninger med 28 eller 4 blisterpakninger med 14 x 1 mg vareniclin filmovertrukne tabletter - indre og ydre mærkning
Heat sealed card pack containing 2 blister packs of 28 or 4 blister packs of 14 x 1 mg varenicline film-coated tablets- inner and outer labelling