natgillin/translations-raw huggingface dataset:
Fra startdoseringen øges dosis gradvis efter 3 til 7 dage, indtil man når op på den mest effektive dosis.
Starting doses are increased gradually, after an interval of 3 to 7 days, until the most effective dose is reached.
Hvis man ophører med behandlingen med Lyrica, bør dette ligeledes ske gradvis i løbet af mindst en uge.
Stopping treatment with Lyrica should also be done gradually, over at least one week.
Kapslerne skal synkes hele med vand med eller uden samtidig fødeindtagelse.
The capsules should be swallowed whole with water, and can be taken with or without food.
Patienter med nyresygdom skal have lavere dosis.
Patients who have kidney problems will need lower doses.
Det aktive stof i Lyrica, pregabalin, ligner i sin struktur kroppens egen "neurotransmitter" (signalstof) GABA (gamma- aminosmørsyre), men dets biologiske virkninger er meget anderledes.
The active substance in Lyrica, pregabalin, is similar in structure to the body’ s own ‘ neurotransmitter’ GABA (gamma-amino butyric acid), but has very different biological effects.
Neurotransmittere virker ved at overføre signaler fra den ene nerve til den anden.
Neurotransmitters are substances in the body that relay signals across from one nerve to the other.
Den nøjagtige måde, pregabalin virker på, er ikke fuldstændig kendt.
The exact way pregabalin works is not fully known.
Derved bliver det vanskeligere at stimulere centralnervesystemets nerver, hvilket nedsætter frigivelsen af andre neurotransmittere.
It seems that pregabalin acts on the way calcium ions enter nerve cells, making the nerves in the central nervous system less excitable, and reducing the release of other neurotransmitters.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvordan blev Lyrica undersøgt?
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Lyrica been studied?
Der er udført 21 undersøgelser med Lyrica, hvor det er blevet sammenlignet med placebo (uvirksom behandling).
Lyrica has been studied in 21 studies, where it was compared with a placebo (a dummy treatment).
Ti af undersøgelserne med tilsammen over 3 100 patienter vedrørte nervesmerter:
For neuropathic pain, ten studies involved over 3,100 patients:
En undersøgelse vedrørte centrale nervesmerter (137 patienter med rygmarvsbeskadigelse).
Nine studies looked at peripheral neuropathic pain (about half of the patients had diabetic neuropathy and the other half had post- herpetic neuralgia) and one study was in central neuropathic pain (137 patients with spinal cord injury).
Virkningen af Lyrica blev registreret ved hjælp af et spørgeskema for smertescore.
The effectiveness of Lyrica was measured using a pain score questionnaire.
Virkningen af Lyrica blev her registreret som forskellen i det månedlige antal anfald før og under behandlingen.
In epilepsy, three studies involved 1,328 patients, and the measure of the effectiveness of Lyrica was based on the difference in the monthly number of seizures before and during treatment.
Virkningen af Lyrica blev her registreret ved hjælp af et spørgeskema, hvor angsten blev vurderet på Hamilton - skalaen.
In the treatment of generalised anxiety disorder, eight studies involved over 3,000 patients, the effectiveness of Lyrica was measured using an anxiety questionnaire (Hamilton Anxiety Rating Scale).
I den ene undersøgelse blev der desuden specielt fokuseret på, hvor lang tid der gik, før angstsymptomerne vendte tilbage med og uden behandling.
One study also specifically looked at how long it took for anxiety symptoms to return (relapses) with and without treatment.
I undersøgelserne af nervesmerter var Lyrica mere effektivt end placebo til at mindske smertescoren.
In neuropathic pain studies, Lyrica was more effective than placebo in decreasing the pain scores.
Den tilsvarende forbedring var 18% hos de patienter, der var blevet behandlet med placebo.
In peripheral neuropathic pain, over one third of the patients treated with Lyrica had a 50% or more improvement in pain score, compared to 18% for the patients treated with a placebo.
Ved centrale nervesmerter oplevede 21, 7% af de patienter, der var blevet behandlet med Lyrica, en forbedring på mindst 50% i deres smertescore.
In central neuropathic pain, 21.7% of patients treated with Lyrica had a 50% or more improvement in pain score compared to 7.5% of the patients treated with a placebo.
10% en sådan forbedring.
In epilepsy, Lyrica was effective in reducing the number of seizures: the percentage of patients treated with Lyrica who had a 50% or more improvement in their monthly seizure was about 45% when they received 600 mg/ day, and about 35% when they received 300 mg a day, compared to about 10% of patients treated with placebo.
Hos over halvdelen af de patienter, der fik Lyrica, sås en forbedring på mindst 50% i scoreværdien på spørgeskemaet vedrørende angst, sammenholdt med 38% af dem, der fik placebo.
Lyrica was more effective than placebo in generalised anxiety disorders: an improvement of at least 50% in the anxiety questionnaire score was seen in over half of the patients treated with Lyrica, compared to 38% of the patients treated with a placebo.
De hyppigste bivirkninger (som ses hos flere end 1 ud af 10 patienter) er svimmelhed og søvnighed.
The most common side effects (seen in more than 1 patient in 10) are dizziness and somnolence (sleepiness).
Den fuldstændige liste over de indberettede bivirkninger for Lyrica fremgår af indlægssedlen.
For the full list of all side effects reported with Lyrica, see the Package Leaflet.
Lyrica bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for pregabalin eller andre af indholdsstofferne.
Lyrica should not be used in people who may be hypersensitive (allergic) to pregabalin or to any of the other ingredients.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Lyrica er større end risiciene ved behandling af perifere og centrale nervesmerter hos voksne, til behandling af voksne med partielle epileptiske anfald med eller uden sekundær generalisering og til behandling af generaliseret angst hos voksne.
The Committee for Medicinal Products for Human Use (CHMP) decided that Lyrica’ s benefits are greater than its risks for the treatment of peripheral and central neuropathic pain in adults, as therapy in adults with partial seizures with or without secondary generalisation, and for the treatment of Generalised Anxiety Disorder in adults.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Lyrica.
They recommended that Lyrica be given marketing authorisation.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Lyrica til Pfizer Limited den 6. juli 2004.
The European Commission granted a marketing authorisation valid throughout the European Union for Lyrica to Pfizer Limited on 6 July 2004.
Den europæiske offentlige vurderingsrapport (EPAR) for Lyrica kan ses i sin helhed her.
The full EPAR for Lyrica can be found here.
Særnavn Lyrica Lyrica Lyrica Lyrica Lyrica
Invented name Lyrica Lyrica Lyrica Lyrica Lyrica
Styrker 25 mg 25 mg 25 mg 25 mg 25 mg
Strength 25 mg 25 mg 25 mg 25 mg 25 mg
Lægemiddelform Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård
Pharmaceutical Form Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Indgivelsesvej Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Route of Administration Oral use Oral use Oral use Oral use Oral use
Emballage Blister (PVC/ alu) Blister (PVC/ alu) Blister (PVC/ alu) Blister (PVC/ alu) Perforeret enkeltdosisblister (PVC/ alu)
Packaging blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) perforated unit dose blister (PVC/ alu)
Pakningsstør relser 14 21 56 84 100 x 1
Package size 14 21 56 84 100 x 1
Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård
Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Blister (PVC/ alu) Blister (PVC/ alu) Blister (PVC/ alu) Blister (PVC/ alu) Perforeret enkeltdosisblister (PVC/ alu)
blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) perforated unit dose blister (PVC/ alu)
14 21 56 84 1 x 60
14 21 56 84 100 x 1
Kapsel, hård Kapsel, hård Kapsel, hård
Capsule, hard Capsule, hard Capsule, hard
Blister (PVC/ alu) Blister (PVC/ alu) Perforeret enkeltdosisblister (PVC/ alu)
blister (PVC/ alu) blister (PVC/ alu) perforated unit dose blister (PVC/ alu)
EU/ 1/ 04/ 279/ 026 EU/ 1/ 04/ 279/ 027
EU/ 1/ 04/ 279/ 026 EU/ 1/ 04/ 279/ 027
Lyrica Lyrica
Lyrica Lyrica
25 mg 75 mg
25 mg 75 mg
Kapsel, hård Kapsel, hård
Capsule, hard Capsule, hard
Blister (PVC/ alu) Blister (PVC/ alu)
blister (PVC/ alu) blister (PVC/ alu)
112 (2 x 56) 112 (2 x 56)
112 (2 x 56) 112 (2 x 56)
1/ 2 EU/ 1/ 04/ 279/ 028 EU/ 1/ 04/ 279/ 029 EU/ 1/ 04/ 279/ 030 EU/ 1/ 04/ 279/ 031 EU/ 1/ 04/ 279/ 032 EU/ 1/ 04/ 279/ 033 EU/ 1/ 04/ 279/ 034 EU/ 1/ 04/ 279/ 035
1/ 2 EU/ 1/ 04/ 279/ 028 EU/ 1/ 04/ 279/ 029 EU/ 1/ 04/ 279/ 030 EU/ 1/ 04/ 279/ 031 EU/ 1/ 04/ 279/ 032 EU/ 1/ 04/ 279/ 033 EU/ 1/ 04/ 279/ 034 EU/ 1/ 04/ 279/ 035
Lyrica Lyrica Lyrica Lyrica Lyrica Lyrica Lyrica Lyrica
Lyrica Lyrica Lyrica Lyrica Lyrica Lyrica Lyrica Lyrica
150 mg 300 mg 75 mg 150 mg 300 mg 225 mg 225 mg 225 mg
150 mg 300 mg 75 mg 150 mg 300 mg 225 mg 225 mg 225 mg
Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård
Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Blister (PVC/ alu) Blister (PVC/ alu) Beholder (HDPE) Beholder (HDPE) Beholder (HDPE) Blister (PVC/ alu) Blister (PVC/ alu) Perforeret enkeltdosisblister (PVC/ alu)
blister (PVC/ alu) blister (PVC/ alu) bottle (HDPE) bottle (HDPE) bottle (HDPE) blister (PVC/ alu) blister (PVC/ alu) perforated unit dose blister (PVC/ alu)
112 (2 x 56) 112 (2 x 56) 200 200 200 14 56 100 x 1
112 (2 x 56) 112 (2 x 56) 200 200 200 14 56 100 x 1
Ikke perforeret blister (PVC/ ALu)
blister (PVC/ alu) non perforated
LYRICA 25 mg hårde kapsler
LYRICA 25 mg hard capsules
Lyrica kapsler indeholder også lactosemonohydrat.
Lyrica capsules also contain lactose monohydrate.
Hvide mærket ” Pfizer ” på overdelen og ” PGN 25 ” på underdelen med sort blæk.
Hard capsule White, marked “ Pfizer ” on the cap and “ PGN 25 ” on the body with black ink.
Lyrica er indiceret til behandling af generaliseret angst (GAD) hos voksne.
LYRICA is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Dosis er 150- 600 mg dagligt fordelt på enten 2 eller 3 doser.
The dose range is 150 to 600 mg per day given in either two or three divided doses.
Lyrica kan tages sammen med eller uden føde.
Lyrica may be taken with or without food.
Behandling med pregabalin kan startes med doser på 150 mg dagligt.
Pregabalin treatment can be started at a dose of 150 mg per day.
Afhængigt af patientens respons og tolerabilitet kan dosis efter 3- 7 dage øges til 300 mg dagligt, og hvis nødvendigt kan dosis øges til maksimalt 600 mg dagligt efter yderligere 7 dage.
Based on individual patient response and tolerability, the dosage may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval.
Behandling med pregabalin kan startes med doser på 150 mg.
Pregabalin treatment can be started with a dose of 150 mg per day.
Afhængigt af patientens respons og tolerabilitet kan dosis efter 7 dage øges til 300 mg dagligt.
Based on individual patient response and tolerability, the dosage may be increased to 300 mg per day after 1 week.
Den maksimale dosis på 600 mg dagligt kan nås efter yderligere 7 dage.
The maximum dosage of 600 mg per day may be achieved after an additional week.
2 Generalisert angst
2 Generalised Anxiety Disorder
Dosis er 150- 600 mg dagligt fordelt på 2 eller 3 doser.
The dose range is 150 to 600 mg per day given as two or three divided doses.
Efter yderligere 7 dage kan dosis øges til 450 mg dagligt.
Following an additional week the dosage may be increased to 450 mg per day.
Efter yderligere 7 dage kan dosis øges til den maksimale dosis på 600 mg dagligt.
The maximum dosage of 600 mg per day may be achieved after an additional week.
4. 8).
In accordance with current clinical practice, if pregabalin has to be discontinued it is recommended this should be done gradually over a minimum of 1 week independent of the indication (see section 4.8).
5. 2), skal dosis individuelt tilpasses patienter med nedsat nyrefunktion i henhold til kreatininclearance.
As pregabalin clearance is directly proportional to creatinine clearance (see section 5.2), dosage reduction in patients with compromised renal function must be individualised according to creatinine clearance (CLcr), as indicated in Table 1 determined using the following formula:
Disse fremgår af tabel 1 og er udregnet med følgende formel:
⎡ 1.23 × [140 - age (years)] x weight (kg) ⎤
Kreatininclearance (ml/ min) =
CLcr(ml/ min) =
[
⎢ ⎢
]
⎣
1, 23 x 140 - alder (år) x vægt (kg) (x 0, 85 for kvinder) serumkreatinin (µmol/ l)
serum creatinine (μmol/l)
Udover den daglige dosis, skal supplerende dosis gives umiddelbart efter hver 4. times hæmodialysebehandling (se tabel 1).
In addition to the daily dose, a supplementary dose should be given immediately following every 4- hour haemodialysis treatment (see Table 1).
Pregabalin dosisjustering i forhold til nyrefunktion
Pregabalin dosage adjustment based on renal function
Kreatininclearance
Creatinine
(ml/ min)
Clearance (CLcr) (mL/min)
Total daglig
Total Pregabalin Daily dose *
Dosisinterval
Dose Regimen
Startdosis (mg/ døgn)
Starting dose (mg/day)
Maksimal dosis (mg/ døgn)
Maximum dose (mg/day)
≥60
≥ 60 ≥30 - < 60 ≥15 - < 30 < 15
150
150 75 25 – 50 25
150
600 300 150 75
1 gang dagligt eller 2 gange dagligt
BID or TID BID or TID Once Daily or BID Once Daily
* Total døgndosis (mg/ døgn) skal fordeles som anført under dosisinterval for at give mg/ dosis + Supplerende dosis er en enkelt tillægsdosis.
* Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose + Supplementary dose is a single additional dose
3 Patienter med nedsat leverfunktion
3 Use in patients with hepatic impairment
5. 2).
No dosage adjustment is required for patients with hepatic impairment (see section 5.2).
5. 3).
Lyrica is not recommended for use in children below the age of 12 years and adolescents (12 - 17 years of age) due to insufficient data on safety and efficacy (see section 5.3).
Ældre (over 65 år)
Use in the elderly (over 65 years of age)
Nogle diabetespatienter, der er i pregabalinbehandling, kan få vægtøgning, og den hypoglykæmiske medicin bør justeres i overensstemmelse med gældende klinisk praksis.
In accordance with current clinical practice, some diabetic patients who gain weight on pregabalin treatment may need to adjust hypoglycaemic medications.
Behandling med pregabalin skal straks seponeres i tilfælde af symptomer på angioødem, f. eks. hævelse af ansigtet, læberne eller de øvre luftveje.
Pregabalin should be discontinued immediately if symptoms of angioedema, such as facial, perioral, or upper airway swelling occur.
Efter markedsføring er der også set tilfælde af bevidsthedstab, konfusion og mental svækkelse.
There have also been post marketing reports of loss of consciousness, confusion and mental impairment.
Derfor bør patienter tilrådes at udvise forsigtighed, indtil de er bekendt med bivirkningerne af medicinen.
Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medication.
I de kontrollerede studier er der rapporteret om sløret syn hos flere patienter behandlet med pregabalin end hos patienter behandlet med placebo.
In controlled studies, a higher proportion of patients treated with pregabalin reported blurred vision than did patients treated with placebo which resolved in a majority of cases with continued dosing.
I de kliniske studier, hvor der blev udført øjenundersøgelse, var hyppigheden af reduktion af synsskarphed og ændringer i synsfelt større hos patienter behandlet med pregabalin end hos patienter behandlet med placebo.
In the clinical studies where ophthalmologic testing was conducted, the incidence of visual acuity reduction and visual field changes was greater in pregabalin-treated patients than in placebo-treated patients; the incidence of fundoscopic changes was greater in placebo-treated patients (See section 5.1).
Efter markedsføring er der set tilfælde af øjenbivirkninger, og de fleste vedrører forbigående sløring af synet eller andre forandringer i synsskarpheden.
In the postmarketing experience, visual adverse reactions have also been reported, most of which refer to transient visual blurring or other changes of visual acuity.
Der er set tilfælde af nyresvigt, og denne bivirkning er reversibel ved seponering af pregabalin.
Cases of renal failure have been reported and discontinuation of pregabalin did show reversibility of this adverse effect.
Ved tillægsbehandling med pregabalin, er der ikke tilstrækkelig dokumentation for at seponere samtidig brug af anden antiepileptika, selv om anfaldskontrol er opnået, for derved at monoterapibehandle med pregabalin.
There are insufficient data for the withdrawal of concomitant antiepileptic medicinal products, once seizure control with pregabalin in the add-on situation has been reached, in order to reach monotherapy on pregabalin.
Efter seponering af kortidsbehandling og langtidsbehandling med pregabalin, er der set seponeringssymptomer hos visse patienter.
After discontinuation of short-term and long-term treatment with pregabalin withdrawal symptoms have been observed in some patients.
Følgende symptomer er set: søvnløshed, hovedpine, kvalme, diarré, influenza- syndrom, nervøsitet, depression, smerte, svedtendens og svimmelhed.
The following events have been mentioned: insomnia, headache, nausea, diarrhoea, flu syndrome, nervousness, depression, pain, sweating and dizziness.
4 Der er ingen data tilgængelig vedrørende hyppighed og sværhedsgrad af seponeringssymptomer i relation til varighed og dosering af pregabalin i forbindelse med seponering af langtidsbehandling med pregabalin.
4 Concerning discontinuation of long-term treatment of pregabalin there are no data of the incidence and severity of withdrawal symptoms in relation to duration of use and dosage of pregabalin.
Disse hændelser er overvejende set hos ældre kardiovaskulært, kompromiterede patienter, der er i behandling med pregabalin for en neuropatisk indikation.
There have been post-marketing reports of congestive heart failure in some patients receiving pregabalin These reactions are mostly seen in elderly cardiovascular compromised patients during pregabalin treatment for a neuropathic indication.
Hændelsen kan gå i sig selv ved seponering af behandlingen.
Discontinuation of pregabalin may resolve the reaction..
Ved behandling af centrale neuropatiske smerter, der skyldes rygmarvsskader, ses generelt en øget forekomst af bivirkninger, CNS bivirkninger og især søvnighed.
In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse events in general, CNS adverse events and especially somnolence was increased.
Dette kan tilskrives en additiv effekt på grund af samtidig medicin (f. eks. antispastisk medicin), som er nødvendig for behandling af denne tilstand.
This may be attributed to an additive effect due to concomitant medication (e.g. anti-spasticity agents) needed for this condition.
Derfor er det usandsynligt, at pregabalin vil forårsage eller selv vil blive påvirket af farmakokinetiske interaktioner.
Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (< 2% of a dose recovered in urine as metabolites), does not inhibit drug metabolism in vitro, and is not bound to plasma proteins, it is unlikely to produce, or be subject to, pharmacokinetic interactions.
Følgelig har in- vivo forsøg ikke vist klinisk relevante farmakokinetiske interaktioner mellem pregabalin og phenytoin, carbamazepin, valproat, lamotrigin, gabapentin, lorazepam, oxycodon eller ethanol.
Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone or ethanol.
Samtidig indgift af pregabalin og orale kontraceptiva norethisteron og/ eller ethinyløstradiol påvirker ikke steady- state farmakokinetikken af nogen af stofferne.
Co-administration of pregabalin with the oral contraceptives norethisterone and/or ethinyl oestradiol does not influence the steady-state pharmacokinetics of either substance.
Efter markedsføring er der rapporteret om respirationssvigt og koma hos patienter, der tager pregabalin og andre CNS- depressiva.
In the postmarketing experience, there are reports of respiratory failure and coma in patients taking pregabalin and other CNS depressant medications.
Lyrica bør ikke anvendes under graviditet, medmindre det er klart nødvendigt (hvis fordelene for moderen klart opvejer den mulige risiko for fosteret/ det nyfødte barn).
Lyrica should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Kvinder i den fertile alder skal anvende sikker antikonception under behandlingen med pregabalin.
Effective contraception must be used in women of child bearing potential.
Det udskilles i modermælk hos rotter.
It is not known if pregabalin is excreted in the breast milk of humans; however, it is present in the milk of rats.
Derfor kan amning ikke anbefales under behandling med pregabalin.
Therefore, breast-feeding is not recommended during treatment with pregabalin.
5 4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
5 4.7 Effects on ability to drive and use machines
Lyrica kan påvirke evnen til at føre motorkøretøj eller betjene maskiner i mindre eller moderat grad.
Lyrica may have minor or moderate influence on the ability to drive and use machines.
Lyrica kan forårsage svimmelhed og søvnighed, og derfor kan det have indflydelse på evnen til at køre bil.
Lyrica may cause dizziness and somnolence and therefore may influence the ability to drive or use machines.
Patienter opfordres til ikke at køre, betjene indviklede maskiner eller udsætte sig for andre potentielt farlige aktiviteter før det vides, hvordan denne medicin påvirker deres evne til at udføre disse aktiviteter.
Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether this medication affects their ability to perform these activities.
Heraf har over 5000 deltaget i dobbelt- blinde placebokontrollerede forsøg.
The pregabalin clinical programme involved over 9000 patients who were exposed to pregabalin, of whom over 5000 were in double-blind placebo controlled trials.
I de kontrollerede forsøg udgik 13% af patienterne, der fik pregabalin, og 7% af patienterne, der fik placebo, på grund af bivirkninger.
In all controlled studies, the discontinuation rate due to adverse reactions was 13% for patients receiving pregabalin and 7% for patients receiving placebo.
De hyppigste bivirkninger, som førte til seponering af behandlingen i pregabalin - gruppen, var svimmelhed og søvnighed.
The most common adverse reactions resulting in discontinuation from pregabalin treatment groups were dizziness and somnolence.