FrancophonIA/ELRC3.0 huggingface dataset:
English: Once you have stopped taking Priligy, you will need to wait 7 days before taking any of the medicines listed above.
Danish: Hvis du holder op med at tage Priligy, skal der gå 7 dage, før du må begynde at tage et af de nævnte lægemidler.
English: Avoid alcohol when taking Priligy.
Danish: Undgå alkohol, mens du tager Priligy.
English: If you have taken any of these medicines, you will need to wait 14 days after you stop taking it before you can start taking Priligy.
Danish: Hvis du har taget et af disse midler, skal der gå 14 dage, efter at du stopper med at tage det, før du må begynde at tage Priligy.
English: • You have moderate or severe liver problems.
Danish: • Hvis du har en moderat eller alvorlig leversygdom.
English: Priligy contains an active substance called ‘dapoxetine'.
Danish: Priligy indeholder et aktivt stof, der hedder dapoxetin.
English: • Do not take Priligy more than once every 24 hours or every day.
Danish: • Priligy må højst tages én gang i døgnet (inden for 24 timer).
English: Do not take Priligy at the same time as any of the following medicines:
Danish: Tag ikke Priligy, hvis du samtidig får et af de følgende lægemidler:
English: • Priligy 60 mg filmcoated tablets are grey, round, convex and marked “60” inside a triangle on one side.
Danish: • 60 mg filmovertrukne tabletter er grå, runde, konvekse og præget ”60” i en trekant på den ene side.
English: • You use recreational drugs such as ecstasy, LSD, narcotics or benzodiazepines
Danish: • Hvis du bruger rusmidler såsom ecstasy, LSD, narkotika eller benzodiazepiner
English: In the compliance multi-fold packages, blister strips and cardboard carton are one unit.
Danish: I de compliance-fremmende foldbare pakninger udgør blisterstrips og æske én enhed.
English: Do not take Priligy at the same time as any of the medicines listed above.
Danish: Tag ikke Priligy samtidig med et af de nævnte lægemidler.
English: • Do not take Priligy if you are dehydrated (you do not have enough water in your body).
Danish: • Lad være med at tage Priligy, hvis du lider af væskemangel (er dehydreret).
English: The active substance is dapoxetine.
Danish: Aktivt stof: dapoxetin.
English: • You have ever had mania (symptoms include feeling overexcited, irritable or not being able to think clearly) or severe depression
Danish: • Hvis du nogensinde har lidt af mani (symptomerne omfatter voldsom opstemthed, irritabilitet eller manglende evne til at tænke klart) eller svær depression
English: The medicinal product is provided in compliance multi-fold packages of 3 and 6 film-coated tablets.
Danish: Lægemidlet udleveres i compliance-fremmende foldbare pakninger med 3 eller 6 filmovertrukne tabletter.
English: Priligy contains lactose (a type of sugar).
Danish: Priligy indeholder lactose (sukkerart).
English: The tablets are provided in compliance multi-fold blister packs containing 1, 2, 3 and 6 film coated tablets.
Danish: For at gøre det lettere at overholde behandlingen fås tabletterne i foldbare pakninger med 1, 2, 3 eller 6 filmovertrukne tabletter.
English: • Certain medicines for fungal infection, including ketoconazole and itraconazole
Danish: • Visse lægemidler mod svampeinfektion såsom ketoconazol og itraconazol
English: • Tramadol used to treat serious pain
Danish: • Tramadol mod stærke smerter
English: • Tablet coating: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, black iron oxide (E172), yellow iron oxide (E172).
Danish: • Tabletovertræk: lactosemonohydrat, hypromellose, titandioxid (E171), triacetin, sort jernoxid
English: • Priligy 30 mg filmcoated tablets are light grey, round, convex and marked “30” inside a triangle on one side.
Danish: • 30 mg filmovertrukne tabletter er lysegrå, runde, konvekse og præget ”30” i en trekant på den ene side.
English: • Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
Danish: • Tabletkerne: lactosemonohydrat, mikrokrystallinsk cellulose, croscarmellosenatrium, vandfri kolloid silica, magnesiumstearat.
English: This belongs to a group of medicines called ‘selective serotonin reuptake inhibitors' (SSRIs).
Danish: Det tilhører en gruppe lægemidler mod depression, der kaldes SSRI-præparater (SSRI = selektive serotoningenoptagshæmmere).
English: Tell your doctor or pharmacist if you are taking any of the following medicines:
Danish: Fortæl det til lægen eller på apoteket, hvis du tager nogle af følgende midler:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER To be completed nationally
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Udfyldes nationalt]
English: • Blocked nose (nasal congestion)
Danish: • Tilstoppet næse (næsekongestion)
English: Priligy increases the time it takes to ejaculate and can improve the control over the ejaculation.
Danish: Priligy øger tiden til sædafgang og kan forbedre mandens kontrol over, hvornår han har sædafgang.
English: • Certain medicines for HIV, including ritonavir, saquinavir, nelfinavir and atazanavir
Danish: • Visse lægemidler mod hiv såsom ritonavir, saquinavir, nelfinavir og atazanavir
English: • Certain other medicines for HIV, such as amprenavir and fosamprenavir
Danish: • Visse andre lægemidler mod hiv såsom amprenavir og fosamprenavir
English: • Certain other antibiotics for treating infection, such as erythromycin and clarithromycin
Danish: • Visse andre antibiotika til behandling af infektion såsom erythromycin og clarithromycin
English: • Lithium a medicine for bipolar disorder
Danish: • Lithium medicin mod bipolære lidelser
English: MARKETING AUTHORISATION NUMBER(S) To be completed nationally
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) [Udfyldes nationalt]
English: • Slow or irregular heartbeat or increase in heart rate
Danish: • Langsom eller uregelmæssig puls eller hurtig puls
English: INFORMATION IN BRAILLE Priligy 30 mg
Danish: INFORMATION I BRAILLE-SKRIFT priligy 30 mg priligy 60 mg
English: Your doctor may increase the dose to 60 mg.
Danish: • Den sædvanlige dosis er 30 mg. Din læge kan øge denne dosis til 60 mg.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAPÆSKE
English: • Drinking alcohol while taking Priligy may increase your risk of injury from fainting or from other side effects.
Danish: • Indtagelse af alkohol, mens du tager Priligy, kan øge risikoen for, at du kommer til skade på grund af besvimelse eller andre bivirkninger.
English: • Do not drive or use any tools or machines if you feel faint when taking this medicine.
Danish: • Undgå at færdes i trafikken eller arbejde med maskiner, hvis du føler dig svimmel, mens du tager denne medicin.
English: Do not take Priligy more than once every 24 hours.
Danish: Må højst tages en gang i løbet af 24 timer.
English: • Difficulty getting or keeping an erection
Danish: • Problemer med at opnå eller opretholde rejsning
English: • Linezolid an antibiotic used to treat infections
Danish: • Linezolid et antibiotikum mod infektioner
English: • Feeling depressed, nervous or indifferent
Danish: • Nedtrykthed, nervøsitet eller ligegyldighed
English: OTHER SPECIAL WARNING(S), IF NECESSARY Use care while taking Priligy as it may cause fainting or dizziness.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Vær forsigtig, mens du tager Priligy, da det kan medføre besvimelse eller svimmelhed.
English: • Medicines to thin your blood, such as warfarin
Danish: • Blodfortyndende medicin såsom warfarin
English: • You also have another sexual problem, such as erectile dysfunction.
Danish: • Hvis du også har andre seksuelle problemer såsom problemer med rejsning af penis.
English: - You have an illness where you have a high temperature, diarrhoea or being sick.
Danish: - Hvis du har svedt i længere tid - Hvis du har en sygdom med feber, diarré eller opkastning.
English: The effects of alcohol may be increased if taken with Priligy and you may be more at risk of injury from fainting or from other side effects if you take Priligy with alcohol.
Danish: Alkohol kan virke stærkere, hvis det indtages sammen med Priligy, og du kan have en øget risiko for at komme til skade på grund af besvimelse eller andre bivirkninger, hvis du samtidig tager Priligy og alkohol.
English: • Non steroidal anti inflammatory medicines such as ibuprofen or acetylsalicyclic acid
Danish: • Nonsteroide antiinflammatoriske midler (NSAID) såsom ibuprofen eller acetylsalicylsyre
English: If you notice any of the above, stop taking this medicine and see your doctor straight away.
Danish: Hvis et af disse punkter gælder for dig, skal du holde op med at tage medicinen og straks kontakte lægen.
English: • Only take the medicine 1 to 3 hours before sexual activity is anticipated.
Danish: • Tag først Priligy 1-3 timer, før du forventer at have samleje.
English: GENERAL CLASSIFICATION FOR SUPPLY To be completed nationally
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING [Udfyldes nationalt]
English: Check with your doctor or pharmacist before taking your medicine if:
Danish: Tal med din læge eller apoteket, før du tager medicinen:
English: • You are taking: o Medicines for depression called ‘monoamine oxidase inhibitors' (MAOIs) o Thioridazine used for schizophrenia o Other medicines for depression o Lithium a medicine for bipolar disorder o Linezolid an antibiotic used to treat infections o Tryptophan a medicine to help you sleep o St John's wort an herbal medicine o Tramadol used to treat serious pain o Medicines used to treat migraines.
Danish: • Hvis du tager: o Medicin mod depression - såkaldte monoaminoxidasehæmmere (MAO-hæmmere) o Thioridazin mod skizofreni o Andre midler mod depression o Lithium medicin mod skiftende perioder med mani/depression (bipolære lidelser) o Linezolid et antibiotikum til behandling af infektioner o Tryptophan sovemedicin o Perikon naturlægemiddel o Tramadol mod stærke smerter o Migrænemedicin.
English: Priligy 30 mg film-coated tablets Priligy 60 mg film-coated tablets dapoxetine
Danish: Priligy 30 mg filmovertrukne tabletter Priligy 60 mg filmovertrukne tabletter dapoxetin
English: Each tablet contains 30 mg or 60 mg dapoxetine as a hydrochloride salt.
Danish: En tablet indeholder 30 mg eller 60 mg dapoxetin som dapoxetinhydrochlorid.
English: • Medicines for depression called ‘monoamine oxidase inhibitors' (MAOIs)
Danish: • Medicin mod depression - såkaldte monoaminooxidasehæmmere (MAO-hæmmere)
English: • Combining Priligy with alcohol may increase the chance of fainting and may also increase alcohol-related effects.
Danish: Brug af Priligy sammen med alkohol kan øge risikoen for at besvime, og det kan øge virkningerne af alkohol.
English: • Feeling sick.
Danish: • Kvalme.
English: • You have ever had a mental health problem such as depression, mania (symptoms include feeling over excited, irritable or not being able to think clearly), bipolar disorder (symptoms include serious mood swings between mania and depression) or schizophrenia (a psychiatric disease)
Danish: • Hvis du nogensinde har haft psykiske forstyrrelser såsom depression, mani (symptomerne omfatter opstemthed/overaktivitet, irritabilitet eller manglende evne til at tænke klart), bipolær lidelse (symptomerne omfatter alvorlige voldsomme humørforandringer fra mani til depression)
English: Take special care with Priligy
Danish: Vær ekstra forsigtig med at tage Priligy
English: • You have a history of bleeding or blood clotting problems
Danish: • Hvis du har en blødersygdom eller lider af problemer med størkning af blodet
English: • You have kidney problems
Danish: • Hvis du har nyreproblemer
English: • Swallow the tablets whole to avoid a bitter taste, with at least one full glass of water.
Danish: • Synk tabletten hel for at undgå den bitre smag.
English: • Certain antibiotics for treating infection, including telithromycin
Danish: • Visse antibiotika til behandling af infektion såsom telithromycin
English: • Aprepitant used to treat nausea.
Danish: • Aprepitant mod kvalme.
English: • Avoid alcohol when taking Priligy.
Danish: • Hold dig fra alkohol, mens du tager Priligy.
English: • This medicine has been prescribed for you.
Danish: • Lægen har ordineret Priligy til dig personligt.
English: NAME OF THE MEDICINAL PRODUCT Priligy 30 mg Film-Coated Tablets Priligy 60 mg Film-Coated Tablets Dapoxetine
Danish: LÆGEMIDLETS NAVN Priligy 30 mg filmovertrukne tabletter Priligy 60 mg filmovertrukne tabletter dapoxetin
English: • Certain other medicines for fungal infection, such as fluconazole
Danish: • Visse andre lægemidler mod svampeinfektion såsom fluconazol
English: • Feeling dizzy following exertion
Danish: • Svimmelhed efter anstrengelse
English: You may feel sick or be sick.
Danish: Du kan få kvalme eller kaste op.
English: • You faint or feel light headed when you stand up
Danish: • Hvis du besvimer eller føler dig uklar, når du rejser dig
English: (see section “Taking other medicines”) o Certain medicines for fungal infection, including ketoconazole and itraconazole (see section “Taking other medicines”) o Certain medicines for HIV, including ritonavir, saquinavir, nelfinavir and atazanavir (see section “Taking other medicines”) o Certain antibiotics for treating infection, including telithromycin (see section “Taking other medicines”) o Nefazodone an antidepressant (see section “Taking other medicines”)
Danish: Hvis du er i tvivl, så spørg lægen eller på apoteket, før du begynder at tage Priligy (se afsnittet “Brug af anden medicin”) o Visse lægemidler mod svampeinfektion såsom ketoconazol og itraconazol (se afsnittet “Brug af anden medicin”) o Visse lægemidler mod hiv såsom ritonavir, saquinavir, nelfinavir og atazanavir (se afsnittet
English: • You have a history of dizziness from low blood pressure
Danish: • Hvis du lider af svimmelhed på grund af lavt blodtryk
English: Tablet should be swallowed whole
Danish: Skal synkes hel.
English: Take with at least 1 full glass of water.
Danish: Indtages med mindst 1 helt glas vand.
English: • Sudden onset of sleep
Danish: • Pludseligt søvnanfald
English: • Vision problems or dilated pupils
Danish: • Synsforstyrrelser eller udspilede pupiller
English: • Feeling irritable, anxious, agitated or restless
Danish: • Irritabilitet, angst, ophidselse eller rastløshed
English: sweaty or an abnormal heart beat), or feel light headed when you stand up, immediately lie down so your head is lower than the rest of your body or sit down with your head between your knees until you feel better.
Danish: • Hvis du føler, at du er en besvimelse nær (hvis du har kvalme, føler dig svimmel, uklar, forvirret, sveder meget eller har unormal puls), eller hvis du føler dig uklar, når du rejser sig: Læg dig straks ned, så hovedet er lavere end resten af kroppen, eller sæt dig med hovedet mellem knæene, indtil du får det bedre.
English: What Priligy is and what it is used for Before you take Priligy How to take Priligy Possible side effects How to store Priligy Further information
Danish: Det skal du vide, før du begynder at tage Priligy Sådan skal du tage Priligy Bivirkninger
English: You may feel sleepy, dizzy, faint, have difficulty concentrating and blurred vision while taking Priligy.
Danish: Brug af Priligy kan virke sløvende og medføre svimmelhed og uklarhed, nedsat koncentrationsevne og uskarpt syn.
English: • Feeling itchy or cold sweat
Danish: • Kløe eller koldsved
English: Tell your doctor or pharmacist if you have taken more tablets than you should.
Danish: Kontakt lægen, skadestuen eller apoteket, hvis du har taget flere tabletter, end der står her, eller flere, end lægen har foreskrevet.
English: • Take Priligy with at least one full glass of water.
Danish: • Tag Priligy med mindst et helt glas vand.
English: If you are not sure, talk to your doctor or pharmacist before taking Priligy.
Danish: Hvis du er i tvivl, så spørg din læge eller på apoteket, inden du tager Priligy.
English: • Feeling tired or sleepy, yawning
Danish: • Træthed eller søvnighed, gaben
English: • Change in mood, feeling overly excited or feelings of paranoia
Danish: • Humørforandringer, voldsom opstemthed eller forrykthed (paranoia)
English: Very common side effects (affects more than 1 user in 10):
Danish: Meget almindelige bivirkninger (forekommer hos flere end 1 ud af 10 behandlede):
English: If you experience any of these or similar effects, you should avoid driving or operating hazardous machinery.
Danish: Det skal du tage hensyn til, hvis du skal færdes i trafikken eller arbejde med maskiner.
English: • Shaking or trembling
Danish: • Rysten/skælven
English: Each film-coated tablet contains 30 mg of dapoxetine (as hydrochloride) Each film-coated tablet contains 60 mg of dapoxetine (as hydrochloride)
Danish: En filmovertrukket tablet indeholder 60 mg dapoxetin (som hydrochlorid).
English: How to take Priligy
Danish: Sådan skal du tage Priligy
English: • Tryptophan a medicine to help you sleep
Danish: • Tryptophan sovemedicin
English: This includes medicines you get without a prescription, such as herbal medicines.
Danish: Dette gælder også medicin, som ikke er købt på recept, medicin købt i udlandet, naturlægemidler, stærke vitaminer og mineraler samt kosttilskud.
English: Rare side effects (affects 1 to 10 users in 10,000):
Danish: Sjældne bivirkninger (forekommer hos mellem 1 og 10 ud af 10.000 behandlede):
English: This is because Priligy can affect the way some other medicines work.
Danish: Anden medicin kan påvirke behandlingen med Priligy, og/eller Priligy kan påvirke behandling med anden medicin.
English: PACKAGE LEAFLET
Danish: • Omtågethed
English: • Diarrhoea, constipation or having wind
Danish: • Diarré, forstoppelse eller øget luftafgang fra tarmen
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Danish: Spørg din læge eller på apoteket, hvis du har yderligere spørgsmål om brug af medicinen.
English: • Feeling dizzy
Danish: • Unormal smagssans
English: Common side effects (affects 1 to 10 users in 100):
Danish: Almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 100 behandlede):
English: • Medicines used to treat migraines.
Danish: • Migrænemedicin.
English: • Feeling weak, sedated, lethargic or fatigued
Danish: • Svækkelse og kraftesløshed, sløvhed, døsighed eller træthed
English: • Stomach pain, bloating or being sick
Danish: • Mavesmerter, oppustethed eller kvalme
English: Talk to your doctor before you stop taking this medicine.
Danish: Kontakt lægen, hvis du ønsker at stoppe behandlingen med denne medicin.
English: Uncommon side effects (affects 1 to 10 users in 1,000):
Danish: Ikke almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 1.000 behandlede):
English: • Feeling hot, jittery, abnormal or drunk
Danish: • Varmefornemmelse, nervøs skælven, følelse af at være ved siden af sig selv eller beruset
English: • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Danish: • Tal med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre, eller hvis du får bivirkninger, som ikke er nævnt her.
English: Before you take Priligy
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE PRILIGY
English: EXPIRY DATE EXP {MM/YYYY}
Danish: EXP
English: • You have a history of fainting
Danish: • Hvis du tidligere har haft tendens til at besvime
English: • Certain medicines used to treat erectile dysfunction, such as sildenafil, tadalafil or vardenafil,
Danish: • Visse lægemidler mod problemer med rejsning af penis (erektil dysfunktion) såsom sildenafil, tadalafil eller vardenafil, da denne type medicin kan sænke blodtrykket, f.eks. når du rejser dig op
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Priligy.
Danish: Tal med lægen igen, hvis et af disse punkter passer på dig (eller hvis du har mistanke om det), før du tager Priligy.
English: The effects of treatment were greatest in the first year.
Danish: Virkningerne af behandlingen var størst i det første år.
English: The morning dose should be taken at least 30 minutes before the morning meal, whereas the evening dose can be taken with or without food.
Danish: Morgendosen bør tages mindst 30 minutter inden morgenmåltidet, mens aftendosen kan tages med eller uden mad.
English: Doses may need to be reduced in patients taking certain other medicines.
Danish: Det kan være nødvendigt at reducere dosen hos patienter, der får visse andre lægemidler.
English: Jinarc received a marketing authorisation valid throughout the EU on 27 May 2015.
Danish: Jinarc fik markedsføringstilladelse med gyldighed i hele EU den 27. maj 2015.
English: Further information can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Jinarc findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Jinarc is available as tablets (15, 30, 45, 60 and 90 mg).
Danish: Jinarc fås som tabletter (15, 30, 45, 60 og 90 mg).
English: Patients should be started with a dose of 45 mg in the morning and 15 mg in the evening (45+15 mg), and the dose should then be increased to 60+30 mg or 90+30 mg, depending on the medicine's side effects.
Danish: Patienten bør starte med en dosis på 45 mg om morgenen og 15 mg om aftenen (45+15 mg), og dosen bør derefter øges til 60+30 mg eller 90+30 mg alt efter bivirkningernes omfang.
English: Jinarc must also not be used in pregnant and breastfeeding women.
Danish: Jinarc må heller ikke anvendes hos gravide eller ammende kvinder.
English: Vasopressin controls the amount of water and sodium that the kidneys remove.
Danish: Vasopressin kontrollerer den mængde vand og natrium, som nyrerne fjerner.
English: As for all medicines, data on the use of Jinarc are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Jinarc løbende overvåget.
English: Patients should drink plenty of water or other fluids (except grapefruit juice) while on treatment.
Danish: Patienterne skal drikke masser af vand eller anden væske (bortset fra grapefrugtjuice), mens de er i behandling.
English: Other information about Jinarc
Danish: Andre oplysninger om Jinarc
English: The company will also carry out a study to further investigate the safety of the medicine, including the risk of liver toxicity.
Danish: Virksomheden skal også gennemføre et studie for at fremskaffe flere data om lægemidlets sikkerhed, herunder risikoen for levertoksicitet.
English: Blood tests to check the patient's liver function should be performed before starting treatment with Jinarc, and then repeated every month for 18 months and every three months thereafter.
Danish: Der skal tages blodprøver for at kontrollere patientens leverfunktion, inden behandling med Jinarc iværksættes, og disse skal gentages hver måned i 18 måneder og derefter hver tredje måned.
English: For more information about using Jinarc, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Jinarc, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: What measures are being taken to ensure the safe and effective use of Jinarc?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Jinarc?
English: Jinarc contains the active substance tolvaptan.
Danish: Jinarc indeholder det aktive stof tolvaptan.
English: The European Medicines Agency decided that Jinarc's benefits are greater than its risks and that it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur vurderede, at fordelene ved Jinarc opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with Jinarc are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Jinarc vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: An overview of Jinarc and why it is authorised in the EU
Danish: En oversigt over Jinarc, og hvorfor det er godkendt i EU
English: The second study included 1,370 patients with moderately to severely reduced kidney function.
Danish: Det andet studie omfattede 1.370 patienter med moderat til svært nedsat nyrefunktion.