FrancophonIA/ELRC3.0 huggingface dataset:
English: In particular, you should be cautious if you take Wakix together with some antidepressants (e.g. imipramine, clomipramine and mirtazapine) and some medicines to treat allergic conditions (antihistamines, e.g. pheniramine maleate, chlorpheniramine, diphenydramine, promethazine, mepyramine).
Danish: Du skal især være forsigtig, hvis du tager Wakix sammen med visse lægemidler mod depression (f.eks. imipramin, clomipramin og mirtazapin) og visse lægemidler til behandling af allergiske sygdomme (antihistaminer, f.eks. pheniraminmaleat, chlorpheniramin, diphenhydramin, promethazin, mepyramin).
English: If you notice any side effects, contact your doctor.
Danish: Hvis du får bivirkninger, skal du kontakte din læge.
English: If you stop taking Wakix
Danish: Hvis du holder op med at tage Wakix
English: Skin and subcutaneous tissue disorders
Danish: Lidelser i hud og subkutane væv
English: The effect size of pitolisant compared with placebo based on a model for WRC based on BOCF with centre as a fixed effect was 0.581, 95%CI [0.493 to 0.686]; p<0.0001.
Danish: Størrelsen af effekt ved pitolisant sammenlignet med placebo baseret på en model for WRC, baseret på BOCF (Baseline Observation Carried Forward) med center som en fast effekt, var 0,581, 95 % CI [0,493 til 0,686]; p <0,0001.
English: Wakix 18 mg tablet 3 years
Danish: Wakix 18 mg tablet 3 år
English: The following adverse reactions have been reported with pitolisant during clinical studies enrolling more than 1094 patients in narcolepsy and other indications and are listed below as MedDRA preferred term by system organ class and frequency; frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000); within each frequency group, adverse reactions are presented in order of decreasing seriousness:
Danish: Bivirkningerne er angivet nedenfor som MedDRA foretrukken term efter organklasse og frekvens; frekvenser er defineret som: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥ 1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000).
English: Anti-histamines (H1-receptor antagonists) crossing the haemato-encephalic barrier (e.g. pheniramine maleate, chlorpheniramine, diphenydramine, promethazine, mepyramine) may impair the efficacy of pitolisant.
Danish: Antihistaminer (H1-receptorantagonister), der passerer blod-hjerne-barrieren (f.eks. pheniraminmaleat, chlorpheniramin, diphenydramin, promethazin, mepyramin), kan nedsætte virkningen af pitolisant.
English: General physical condition abnormal Electrocardiogram repolarisation abnormality Electrocardiogram T wave inversion
Danish: Unormal generel fysisk tilstand Unormal repolarisering i elektrokardiogram T-bølge-inversion i elektrokardiogram
English: At the highest doses, no histopathological changes were recorded in monkeys and rats presented some limited histopathological changes in some organs (liver, duodenum, thymus, adrenal gland and lung).
Danish: Hos rotter blev der fundet begrænsede histopatologiske forandringer i nogle organer (lever, duodenum, thymus, binyre og lunge).
English: Combination with pitolisant should be made with a careful monitoring (see section 4.4).
Danish: Kombination med pitolisant bør ske under nøje overvågning (se pkt.
English: Loss of consciousness Tension headache Memory impairment Poor sleep quality
Danish: Bevidsthedstab Spændingshovedpine Hukommelsessvækkelse Dårlig søvnkvalitet
English: In the pitolisant group, ESS decreased significantly between baseline and the end of treatment compared to placebo with an observed mean change of -1.9 ± 4.3 and -5.4 ± 4.3 (mean ± sd) for placebo and pitolisant respectively, (p<0.0001) (Figure 3).
Danish: I pitolisantgruppen faldt ESS-scoren betydeligt mellem baseline og behandlingsafslutning i forhold til placebogruppen med en observeret gennemsnitlig ændring på -1,9 ± 4,3 og -5,4 ± 4,3 (gennemsnit ± SD) for henholdsvis placebo og pitolisant (p <0,0001) (figur 3).
English: If you forget to take Wakix
Danish: Hvis du har glemt at tage Wakix
English: Insomnia Anxiety Irritability Depression Sleep disorder
Danish: Søvnløshed Angst Irritabilitet Depression Søvnforstyrrelser
English: Headache Dizziness Tremor
Danish: Hovedpine Svimmelhed Tremor
English: Pitolisant/metabolites were shown to cross the placenta barrier in animals.
Danish: Det er vist, at pitolisant/metabolitter passerer placentabarrieren hos dyr.
English: Figure 1: Changes in Epworth Sleepiness Scale Score (ESS) (mean ± SEM) from Baseline to week 8 in Harmony 1 study
Danish: Figur 1: Ændringer i Epworth Sleepiness Scale (ESS)-score (gennemsnit ± SEM) fra baseline til uge 8 i Harmony 1-studie
English: Co-administration of pitolisant with rifampicin in multiple doses significantly decreases pitolisant mean Cmax and AUC ratio about 39% and 50%, respectively.
Danish: Samtidig administration af pitolisant og gentagne doser rifampicin nedsætter signifikant den gennemsnitlige pitolisant-Cmax og -AUC med henholdsvis ca. 39 % og 50 %.
English: OUTER WRAPPER LABEL ON MULTIPACK OF 90 (3 x 30) TABLETS WRAPPED IN TRANSPARENT FOIL - INCLUDING BLUE BOX
Danish: ETIKET TIL YDRE EMBALLAGE PÅ MULTIPAKNING MED 90 (3 x 30) TABLETTER ANBRAGT PÅ DEN GENNEMSIGTIGE FOLIE - MED BLUE BOX
English: Pitolisant shows greater than 50% inhibition towards OCT1 (organic cation transporters 1) at 1.33 µM, the extrapolated IC50 of pitolisant is 0.795 µM.
Danish: Pitolisant viser mere end 50 % hæmning af OCT1 (organisk kationtransportør 1) ved 1,33 µM, den ekstrapolerede IC50 for pitolisant er 0,795 µM.
English: Decreased appetite Increased appetite Fluid retention
Danish: Appetitløshed Øget appetit Væskeretention
English: Therefore, co-administration of pitolisant with potent CYP3A4 inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) should be done with caution.
Danish: Derfor bør samtidig administration af pitolisant og potente CYP3A4-induktorer (f.eks. rifampicin, phenobarbital, carbamazepin, phenytoin) ske med forsigtighed.
English: Therefore, breastfeeding is contraindicated during treatment with pitolisant (see section 4.3).
Danish: Derfor er amning kontraindiceret under behandling med pitolisant (se pkt.
English: - You are obese or anorexic, as you may have change of your body weight (increase or decrease)
Danish: - Du er overvægtig eller mangler appetit, da din kropsvægt kan ændre sig (stige eller falde), mens du tager Wakix.
English: - Enzyme inducers
Danish: - Enzyminduktorer
English: In narcoleptic patients with or without cataplexy, pitolisant improves the level and duration of wakefulness and daytime alertness assessed by objective measures of ability to sustain wakefulness (e.g.
Danish: Hos narkolepsi-patienter med eller uden katapleksi forbedrer pitolisant omfanget og varigheden af vågenhed og årvågenhed i dagtimerne vurderet ved hjælp af objektive mål for evnen til at opretholde vågenhed (f.eks. Maintainence of Wakefulness Test (MWT)) og opmærksomhed (f.eks. Sustained Attention to Response Task (SART)).
English: Clinically relevant interactions are expected with CYP3A4 and CYP2B6 substrates and by extrapolation, UGTs, CYP2C and P-gp substrates (see section 4.5).
Danish: Klinisk relevante interaktioner forventes med CYP3A4- og CYP2B6-substrater og, ud fra ekstrapolation, med UGT'er, CYP2C- og P-gpsubstrater (se pkt.
English: Medicinal products that pitolisant may affect metabolism
Danish: Lægemidler, hvis metabolisering eventuelt kan påvirkes af pitolisant
English: Wakix 4.5 mg tablet 3 years
Danish: Wakix 4,5 mg tablet 3 år
English: Bottle of 30 or 90 film-coated tablets.
Danish: Tabletbeholder med 30 eller 90 filmovertrukne tabletter.
English: Therefore, an alternative method of effective contraception should be used if the woman is using hormonal contraceptives (see section 4.5).
Danish: Derfor bør en alternativ effektiv præventionsmetode anvendes, hvis en kvinde anvender hormonelle præventionsmidler (se pkt.
English: Therefore, the combination of pitolisant with substrates of CYP3A4 and having a narrow therapeutic margin (e.g. immunosuppressants, docetaxel, kinase inhibitors, cisapride, pimozide, halofantrine) should be avoided (see section 4.4).
Danish: Derfor bør kombination af pitolisant med CYP3A4-substrater, som har en snæver terapeutisk margin (f.eks. immunsuppressiva, docetaxel, kinaseinhibitorer, cisaprid, pimozid, halofantrin), undgås (se pkt.
English: Abnormal behaviour Confusional state Depressed mood Excitability Obsessive thoughts Dysphoria Hypnopompic hallucination Depressive symptom Hypnagogic hallucination Mental impairment
Danish: Unormal opførsel Konfusion Nedtrykthed Ophidselse Tvangstanker Dysfori Hypnopompe hallucinationer Depressive symptomer Hypnagoge hallucinationer Mental svækkelse
English: With other CYP3A4, CYP2B6 (e.g. efavirenz, bupropion), CYP2C (e.g. repaglinide, phenytoin, warfarin), P-gp (e.g. dabigatran, digoxin) and UGT (e.g. morphine, paracetamol, irinotecan) susbtrates, caution should be made with a clinical monitoring of their efficacy.
Danish: Ved kombination med andre CYP3A4-substrater samt substrater for CYP2B6 (f.eks. efavirenz, bupropion), CYP2C (f.eks. repaglinid, phenytoin, warfarin), P-gp (f.eks. dabigatran, digoxin) og UGT (f.eks. morphin, paracetamol, irinotecan) skal der udvises forsigtighed, og deres effektivitet bør overvåges klinisk.
English: Anorexia Hyperphagia Appetite disorder
Danish: Anoreksi Hyperfagi Appetitforstyrrelser
English: The combination of pitolisant with substrates of CYP3A4 and having a narrow therapeutic margin should be avoided (see section 4.5).
Danish: Samtidig anvendelse af pitolisant og CYP3A4-substrater med smal terapeutisk margin bør undgås (se pkt.
English: Tell your doctor or pharmacist if you are taking any of the following medicines: rifampicin (an antibiotic), phenytoin, carbamazepine and phenobarbital (mainly used to control seizures), quinidine, digoxin (used to treat abnormal heart rhythms), paroxetine, fluoxetine, venlafaxine, duloxetine (antidepressants), St John's Wort (Hypericum perforatum) a herbal remedy for depression, bupropion (antidepressant or aid to smoking cessation), cinacalcet (for treatment of disorders of the parathyroid gland), terbinafine (used to treat fungal infections), metformin, repaglinide (used to treat diabete), docetaxel, irinotecan (used to treat cancer), cisapride (used to treat gastric reflux), pimozide (used to treat some mental disorders), halofantrine (to treat malaria), efavirenz (antiviral medicine to treat HIV), morphine, paracetamol (used to treat pain), dabigatran (used to treat problems of the veins), warfarin (used to treat heart diseases), probenecid (used to treat gout and gouty arthritis).Pitolisant can be used with modafinil or sodium oxybate.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager nogen af følgende lægemidler: rifampicin (et antibiotikum), phenytoin, carbamazepin og phenobarbital (hovedsageligt brugt til at kontrollere krampeanfald), kinidin, digoxin (til behandling af unormal hjerterytme), paroxetin, fluoxetin, venlafaxin, duloxetin (mod depression), perikon (Hypericum perforatum - et naturlægemiddel mod depression), bupropion (mod depression eller som hjælp til rygestop), cinacalcet (mod sygdomme i biskjoldbruskkirtlen), terbinafin (mod svampeinfektion), metformin, repaglinid (til behandling af diabetes), docetaxel, irinotecan (mod kræft), cisaprid (mod tilbageløb af maveindholdet), pimozid (mod visse psykiske lidelser), halofantrin (mod malaria), efavirenz (antiviral medicin mod HIV), morphin, paracetamol (mod smerter), dabigatran (mod blodpropper i venerne), warfarin (blodfortyndende medicin ved hjertesygdom), probenecid (til behandling af gigt og gigtartritis).
English: Given the 2-fold increase of pitolisant exposure, its coadministration with CYP2D6 inhibitors (e.g. paroxetine, fluoxetine, venlafaxine, duloxetine, bupropion, quinidine, terbinafine, cinacalcet) should be done with caution.
Danish: Da pitolisant-eksponeringen stiger til det dobbelte, bør samtidig administration af CYP2D6-hæmmere (f.eks. paroxetin, fluoxetin, venlafaxin, duloxetin, bupropion, kinidin, terbinafin, cinacalcet) ske med forsigtighed.
English: Pitolisant shows greater than 50% inhibition towards OCT1 (organic cation transporters 1) at 1.33 µM, the extrapolated IC50 of pitolisant is 0.795 µM (see section
Danish: Pitolisant viser mere end 50% hæmning af OCT1 (organisk kationtransportør 1) ved 1,33 µM, den ekstrapolerede IC50 for pitolisant er 0,795 µM (se pkt.
English: The active substance is pitolisant.
Danish: Aktivt stof: pitolisant.
English: Visual acuity reduced Blepharospasm
Danish: Nedsat synsskarphed Blefarospasme
English: EU/1/15/1068/003 90 film-coated tablets (3 bottles of 30)
Danish: EU/1/15/1068/003 90 filmovertrukne tabletter (3 tabletbeholdere med 30)
English: Dosage was initiated at 4.5 mg once a day and was increased, according to efficacy response and tolerance to 9 mg, 18 mg or 36 mg once a day per 1-week interval.
Danish: Initialdosis var 4,5 mg én gang dagligt, og i henhold til respons og tolerannce blev dosis øget til 9 mg, 18 mg eller 36 mg én gang dagligt med intervaller på 1 uge.
English: Dyskinesia Balance disorder Cataplexy Disturbance in attention Dystonia On and off phenomenon Hypersomnia Migraine Psychomotor hyperactivity Restless Legs Syndrome Somnolence Epilepsy Bradykinesia Paresthesia
Danish: Dyskinesi Balanceforstyrrelser Katapleksi Forstyrrelse i opmærksomhed Dystoni On-off-fænomen Hypersomni Migræne Psykomotorisk hyperaktivitet Restless legs-syndrom Døsighed Epilepsi Bradykinesi Paræstesi
English: Pitolisant should be administered with caution in patients with severe obesity or severe anorexia (see section 4.8).
Danish: Pitolisant bør administreres med forsigtighed hos patienter med svær overvægt eller svær anoreksi (se pkt.
English: EU/1/15/1068/004 90 film-coated tablets
Danish: EU/1/15/1068/004 90 filmovertrukne tabletter
English: Metrorrhagia
Danish: Metroragi
English: Figure 2: Changes in weekly cataplexy episodes (geometric mean) from Baseline to week 7 in Harmony CTP study
Danish: Figur 2: Ændringer i antallet af ugentlige katapleksi-episoder (geometrisk gennemsnit) fra baseline til uge 7 i Harmony CTP-studiet
English: Nevertheless, patients with cardiac disease, co-medicated with other QT-prolonging medicinal products or known to increase the risk of repolarization disorders, or co-medicated with medicinal products that significantly increase pitolisant Cmax and AUC ratio (see section 4.5) or patients with severe renal or moderate hepatic impairment (see section 4.4) should be carefully monitored (see section 4.5).
Danish: Ikke desto mindre skal patienter med hjertesygdom, patienter, der samtidig får andre QT-forlængende lægemidler, lægemidler, der vides at øge risikoen for repolariseringforstyrrelser, eller lægemidler, der øger pitolisant-Cmax og -AUC væsentligt (se pkt.
English: Figure 3: Changes in Epworth Sleepiness Scale Score (ESS) (mean ± SEM) from Baseline to week 7 in Harmony CTP study
Danish: Figur 3: Ændringer i Epworth Sleepiness Scale (ESS) score (gennemsnit ± SEM (standard error of the mean)) fra baseline til uge 7 i Harmony CTP-studiet
English: Gastrooesophageal reflux disease Gastritis Gastrointestinal pain Hyperacidity Paraesthesia oral Stomach discomfort
Danish: Gastroøsofageal reflukssygdom Gastritis Gastrointestinale smerter Hyperaciditet Oral paræstesi Ubehag i maven
English: For a dose of 18 mg, take one 18 mg tablet.
Danish: Ved en dosis på 18 mg, tag en 18 mg tablet.
English: EU/1/15/1068/002 30 film-coated tablets
Danish: EU/1/15/1068/002 30 filmovertrukne tabletter
English: Wakix 4.5 mg: Available in packs containing 1 bottle of 30 tablets.
Danish: Wakix 4,5 mg: Fås i pakninger med 1 tabletbeholdermed 30 tabletter.
English: INNER CARTON FOR MULTIPACK OF 90 (3 x 30) TABLETS - WITHOUT BLUE BOX
Danish: YDRE CARTON PÅ MULTIPAKNING MED 90 (3 x 30) TABLETTER ANBRAGT PÅ DEN GENNEMSIGTIGE FOLIE - UDEN BLUE BOX
English: For a dose of 36 mg, take two 18 mg tablets.
Danish: Ved en dosis på 36 mg, tag to 18 mg tabletter.
English: For a dose of 4.5 mg, take one 4.5 mg tablet.
Danish: Ved en dosis på 4,5 mg, tag en 4,5 mg tablet.
English: For a dose of 9 mg, take two 4.5 mg tablets.
Danish: Ved en dosis på 9 mg, tag to 4,5 mg tabletter.
English: Dry mouth Abdominal pain Diarrhoea Abdominal discomfort Abdominal pain upper Constipation
Danish: Mundtørhed Abdominalsmerter Diarré Abdominalt ubehag Smerter i øvre abdomen Forstoppelse
English: In rats, pitolisant/metabolites were shown to cross the placenta (see section 5.3).
Danish: Det er vist, at pitolisant/metabolitter passerer placenta hos rotter (se pkt.
English: Nausea Vomiting Dyspepsia
Danish: Kvalme Opkastning Dyspepsi
English: Uncommon side effects (may affect up to 1 in 100 people): - Sweating - Decrease or increase of appetite - Oedema - Feeling jittery, nervousness, seeing or hearing things that are not really there - Changing emotions - Abnormal dreams - Tension - Difficulty in falling asleep at the beginning of the night or in the middle of the night or at the end of the night, difficulty in staying asleep, excessive sleepiness, somnolence - State of indifference with lack of emotion - Nightmare - Feeling restless and unable to keep still - Panic reaction - Altered or increased sexual interest - Sudden and transient episode of muscle weakness, uncontrollable muscle spasms or movement of one leg - Disturbance in attention - Migraine - Epilepsy - Weakness - Movement disturbance, slow body movement - Sensation of tingling, tickling, pricking, or burning of the skin - Sudden and unpredictable phases of mobility and immobility - Feeling unsteady - Reduced visual acuity, abnormal contraction or twitch of the eyelid - Hearing of sound when no external sound is present - Abnormal heart beat, slow or fast heart rate, raised or decrease blood pressure , hot flush - Yawning - Dry mouth - Diarrhoea, abdominal pain, discomfort or pain in the belly (abdomen), constipation, heartburn,
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer): - Hedeture - Nedsat eller øget appetit - Ødem (væskeansamling) - Nervøsitet, urolighed, hallucinationer (se eller høre ting, som ikke er der) - Humørændringer - Unormale drømme - Spændinger - Vanskeligheder med at falde i søvn om aftenen, midt om natten eller sidst på natten, for tidlig opvågning, overdreven søvnighed, døsighed - Tilstand af ligegyldighed med manglende følelser - Mareridt - Rastløshed og ude af stand til at holde sig i ro - Panikreaktion - Ændret eller øget seksuel interesse - Pludselig og forbigående episode af muskelsvaghed, ukontrollable muskelkramper eller bevægelse af det ene ben - Forstyrrelse i opmærksomhed - Migræne - Epilepsi - Svaghed - Bevægelsesforstyrrelse, langsomme kropsbevægelser - Prikkende, kildende, stikkende eller brændende fornemmelse i huden - Pludselige og uforudsigelige episoder med mobilitet og immobilitet - Følelse af at være usikker på benene - Nedsat synsstyrke, unormale trækninger i øjenlåget - Hørehallucinationer (høre en lyd, når der ikke er nogen lyde) - Unormal hjerterytme, langsom eller hurtig puls, for højt eller for lavt blodtryk, hedeture - Gaben - Mundtørhed - Diarré, mavesmerter, ubehag eller smerter i maven, forstoppelse, halsbrand, mavekatar, for højt syreindhold i maven - Kløe, hudlidelse i ansigtet, hvor næse og kinder er usædvanligt røde, kraftig sveden - Ledsmerter, rygsmerter, muskelstivhed, muskelsvaghed, smerter i muskler og knogler, smerter i tæer og fingre - Unormal vandladning - Uregelmæssig blødning fra livmoderen - Tab af styrke eller ekstrem træthed, brystsmerter, utilpashed, ødem - Vægtstigning, vægttab, unormalt elektrokardiogram (viser hjertets elektriske aktivitet),
English: - If you get any side effects, talk to your doctor or pharmacist.
Danish: - Hvis du oplever bivirkninger, bør du tale med din læge eller apoteket.
English: Therefore, an alternative method of effective contraception should be used if the woman patient is using hormonal contraceptives (see sections 4.5 and 4.6).
Danish: Derfor bør en alternativ effektiv præventionsmetode anvendes, hvis en kvindelig patient anvender et hormonelt præventionsmiddel (se pkt.
English: As long-term efficacy data are limited (see section 5.1), the continued efficacy of treatment should be regularly evaluated by the physician.
Danish: 5.1), skal lægen løbende evaluere, om der fortsat er virkning af behandlingen.
English: - High blood level of the enzyme creatinine phosphokinase, abnormal general physical condition, modification of the electrical registration of the heart (ECG)
Danish: - Spontan abort - Smerter, nattesved, nedtrykthed - Forhøjet niveau af enzymet kreatinkinase i blodet, unormal generel fysisk tilstand, ændringer i hjertets elektriske aktivitet (ses i EKG)
English: Dosage was initiated at 9 mg once a day and was increased, according to efficacy response and tolerance to 18 mg or 36 mg once a day per 1-week interval.
Danish: Dosis var initialt 9 mg én gang dagligt og blev øget til 18 mg eller 36 mg én gang dagligt med intervaller på 1 uge i henhold til effektivitet og tolerance.
English: - CYP2D6 inhibitors
Danish: - CYP2D6-hæmmere
English: Toxic skin eruption Photosensitivity
Danish: Toksisk hududslæt Øget lysfølsomhed
English: High density polyethylene (HDPE) bottle with a tamper evident, child-resistant, polypropylene screw cap fitted with desiccant (silica gel).
Danish: Tabletbeholder af højdensitetspolyethylen (HDPE) med børnesikret polypropylenskruelåg med anbrudsindikerende forsegling og forsynet med tørremiddel (silicagel).
English: How to take Wakix
Danish: Sådan skal du tage Wakix
English: Agitation Hallucination Hallucination visual, auditory Affect lability Abnormal dreams Dyssomnia Middle insomnia Initial insomnia Terminal insomnia Nervousness Tension Apathy Nightmare Restlessness Panic Attack Libido decreased Libido increased
Danish: Agitation Hallucinationer Visuelle og auditive hallucinationer Affektlabilitet Unormale drømme Søvnforstyrrelser (svært ved at falde i søvn, vågne midt om natten, vågne tidligt) Nervøsitet Spændinger Apati Mareridt Rastløshed Panikanfald Nedsat libido Øget libido
English: CYP2D6 poor metabolizers
Danish: Langsomme CYP2D6-omsættere
English: Wakix 18 mg film-coated tablets Pitolisant
Danish: Wakix 18 mg filmovertrukne tabletter Pitolisant
English: LABEL
Danish: MÆRKAT
English: Wakix 4.5 mg comes in a white, round, film-coated tablet of 3.7 mm, biconvex marked with “5” on one side.
Danish: Wakix 4,5 mg er en hvid, rund, filmovertrukket tablet på 3,7 mm, bikonveks, mærket med "5" på den ene side.
English: There is not enough information available to know whether any particular risk is associated with the use of Wakix during pregnancy.
Danish: Wakix må ikke anvendes under graviditet, medmindre din læge siger det. Der er ikke tilstrækkelig information til rådighed til at vide, om der er en særlig risiko forbundet med at tage Wakix under graviditet.
English: Wakix 18 mg comes in a white, round, film-coated tablet of 7.5 mm, biconvex marked with “20” on one side.
Danish: Wakix 18 mg er en hvid, rund, filmovertrukket tablet på 7,5 mm, bikonveks, mærket med "20" på den ene side
English: Asthenia Chest Pain Feeling Abnormal Malaise Oedema Peripheral oedema
Danish: Asteni Brystsmerter Unormal følelse Utilpashed Ødem Perifert ødem
English: Breastfeeding (see section 4.6).
Danish: Amning (se pkt.
English: Wakix 4.5 mg film-coated tablets Pitolisant
Danish: Wakix 4,5 mg filmovertrukne tabletter Pitolisant
English: Gastric disorders reactions have been reported with pitolisant, therefore it should be administered with caution in patients with acid related gastric disorders (see section 4.8) or when co-administered with gastric irritants such as corticosteroids or NSAID.
Danish: 4.8) eller ved administration sammen med gastriske irritanter såsom kortikosteroider eller NSAID.
English: Common side effects (may affect up to 1 in 10 people): - Difficulty in sleeping, feeling anxious, feeling irritable, feeling depressed, sleeping problems
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1000 personer): - Appetitløshed, øget appetit - Unormal adfærd, forvirring, nedtrykthed, uro, følelsesmæssigt og mentalt ubehag,