natgillin/translations-raw huggingface dataset:
6, 18, 30, 48, 90, 96 og 180 smeltetabletter (ikke alle pakningsstørrelser er nødvendigvis markedsført).
6, 18, 30, 48, 90, 96 and 180 orodispersible tablets (not all pack sizes may be marketed).
[ikke relevant for art 30]
This medicinal product is authorised in the Member States of the EEA under the following names [not applicable for art 30 referral]
Denne indlægsseddel blev senest revideret/ godkendt i
This leaflet was last revised/ approved in.
55 PRODUKTRESUME
55 SUMMARY OF PRODUCT CHARACTERISTICS
Hver Remeron 15 mg filmovertrukne tablet indeholder 15 mg mirtazapin.
Each Remeron 15 mg film-coated tablet contains 15 mg of mirtazapine.
Hver Remeron 30 mg filmovertrukne tablet indeholder 30 mg mirtazapin.
Each Remeron 30 mg film-coated tablet contains 30 mg of mirtazapine.
Hver Remeron 45 mg filmovertrukne tablet indeholder 45 mg mirtazapin.
Each Remeron 45 mg film-coated tablet contains 45 mg of mirtazapine.
Oval, bikonveks, gul, med delekærv og mærket med 'Organon' på den ene side og med en kode på den anden side (TZ/ 3).
Oval, biconvex, yellow, scored and marked with ‘ Organon’ on one side-and a code on the other side (TZ/ 3).
Oval, bikonveks, rødbrun, med delekærv og mærket med 'Organon' på den ene side og med en kode på den anden side (TZ/ 5).
Oval, biconvex, red-brown, scored and marked with ‘ Organon’ on one side-and a code on the other side (TZ/ 5).
Oval, bikonveks, hvid og mærket med 'Organon' på den ene side og med en kode på den anden side (TZ/ 7).
Oval, biconvex, white and marked with ‘ Organon’ on one side-and a code on the other side (TZ/ 7).
57 Den anbefalede dosis er den samme som for voksne.
57 The recommended dose is the same as that for adults.
Nyreinsufficiens Mirtazapins clearance kan være nedsat hos patienter med moderat til svær nyreinsufficiens (kreatinin - clearance < 40 ml/ min).
Renal impairment The clearance of mirtazapine may be decreased in patients with moderate to severe renalimpairment (creatinine clearance < 40 ml/ min).
En metaanalyse af placebo- kontrolleret kliniske undersøgelser med antidepressiva af psykiatriske lidelser hos voksne patienter viste en øget risiko for selvmordspræget adfærd ved indtagelse af antidepressiva sammenlignet med placebo hos patienter under 25 år.
A meta-analysis of placebo- controlled clinical trials of antidepressants in adult patients with psychiatric disorders showed an
58 Patienterne, specielt højrisikopatienterne, bør følges nøje under behandlingen med antidepressiva og især i starten af behandlingen samt ved dosisændringer.
Close supervision of patients and in particular those at high risk should accompany therapy with antidepressants especially in early treatment and following dose changes.
Knoglemarvsdepression Knoglemarvsdepression, der sædvanligvis viser sig som granulocytopeni eller agranulocytose, er blevet rapporteret under behandling med Remeron.
Bone marrow depression Bone marrow depression, usually presenting as granulocytopenia or agranulocytosis, has been reported during treatment with Remeron.
Behandlingen bør afbrydes hos patienter, der udvikler epileptiske anfald, eller hvor der ses en øgning i anfaldsfrekvensen. – Leverinsufficiens:
Treatment should be discontinued in any patient who develops seizures, or where there is an increase in seizure frequency. – hepatic impairment:
55%. – Nyreinsufficiens:
The average plasma concentration of mirtazapine was about 55 %increased. – renal impairment:
30% og 50%, sammenlignet med normale personer.
Following a single 15 mg oral dose of mirtazapine, in patients with moderate (creatinine clearance < 40 ml/ min) and severe (creatinine clearance ≤ 10 ml/ min) renal impairment the clearance of mirtazapine was about 30% and 50% decreased respectively, compared to normal subjects.
55% og 115%.
The average plasma concentration of mirtazapine was about 55% and 115% increased respectively.
Hos patienter med diabetes, kan antidepressiva påvirke den glykæmiske kontrol.
In patients with diabetes, antidepressants may alter glycaemic control.
Paranoide idéer kan forstærkes. – Når den depressive fase ved bipolar lidelse behandles, kan den ændre sig til manisk fase.
Like with other antidepressants, the following should be taken into account: – Worsening of psychotic symptoms can occur when antidepressants are administered to patients with schizophrenia or other psychotic disturbances; paranoid thoughts can be intensified – When the depressive phase of bipolar disorder is being treated, it can transform into the manic phase.
Blandt de forskellige seponeringssymptomer er de hyppigst rapporterede svimmelhed, agitation, angst, hovedpine og kvalme.
Among the various reported withdrawal symptoms, dizziness, agitation, anxiety, headache and nausea are the most
59 være relateret til en underliggende sygdom.
59 frequently reported.
4. 2, anbefales det at nedtrappe behandling med mirtazapin gradvist. – Der bør udvises forsigtighed hos patienter med miktionsforstyrrelser såsom prostatahypertrofi og hos patienter med akut snævervinklet glaukom og forhøjet intraokulært tryk (også her er der en lille risiko for problemer under behandling med Remeron på grund af den meget svage anticholinerge aktivitet). – Akatisi/ psykomotorisk uro:
As advised in section 4.2, it is recommended to discontinue treatment with mirtazapine gradually. – Care should be taken in patients with micturition disturbances like prostate hypertrophy and in patients with acute narrow-angle glaucoma and increased intra-ocular pressure (although there is little chance of problems with Remeron because of its very weak anticholinergic activity). – Akathisia/ psychomotor restlessness:
Anvendelse af antidepressiva er blevet forbundet med udvikling af akatisi, karakteriseret ved subjektiv ubehagelig eller generende uro og behov for ofte at bevæge sig ledsaget af manglende evne til at sidde eller stå stille.
The use of antidepressants have been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.
Lactose Remeron indeholder lactose.
Lactose This medicinal product contains lactose.
Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/ galactosemalabsortion.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Omvendt bør der gå ca. to uger, inden patienter, der er blevet behandlet med mirtazapin, behandles med MAO hæmmere (se pkt.
In the opposite way about two weeks should pass before patients treated with mirtazapine should be treated with MAO inhibitors (see section 4.3).
- Hos personer i behandling med warfarin forårsagede mirtazapin doseret med 30 mg en gang
- Mirtazapine dosed at 30 mg once daily caused a small but statistically significant increase in
daglig en lille, men statistisk signifikant, øgning i international normaliseret ratio (INR).
the international normalized ratio (INR) in subjects treated with warfarin.
Da det ikke kan udelukkes, at højere doser af mirtazapin kan forårsage en mere udtalt effekt, er det tilrådeligt at monitorere INR i tilfælde af samtidig behandling med warfarin og mirtazapin.
As at a higher dose of
60 Farmakokinetiske interaktioner
60 mirtazapine a more pronounced effect can not be excluded, it is advisable to monitor the INR in case of concomitant treatment of warfarin with mirtazapine.
fordoblet, hvilket medførte et fald i den gennemsnitlige plasma mirtazapin koncentrationen på hhv. ca.
twofold, resulting in a decrease in average plasma mirtazapine concentration of 60% and 45%, respectively.
- Interaktionsstudier indikerede ingen relevante farmakokinetiske effekter på samtidig behandling
- Interaction studies did not indicate any relevant pharmacokinetic effects on concurrent
med mirtazapin og paroxetin, amitriptylin, risperidon eller litium.
treatment of mirtazapine with paroxetine, amitriptyline, risperidone or lithium.
4. 6 Graviditet og amning
4.7 Pregnancy and lactation
Alle randomiserede placebo- kontrollerede forsøg (inklusive andre indikationer end major depression), er blevet vurderet mht. bivirkninger ved Remeron.
All randomized placebo-controlled trials in patients (including indications other than major depressive disorder), have been evaluated for adverse reactions of Remeron.
Tabel 1 viser den kategoriserede forekomst af bivirkninger, der forekom statistisk signifikant hyppigere i de kliniske forsøg under behandlingen med Remeron sammenlignet med placebo, med tilføjelse af bivirkninger fra spontan rapportering.
61 Table 1 shows the categorized incidence of the adverse reactions, which occurred in the clinical trials statistically significantly more frequently during treatment with Remeron than with placebo, added with adverse reactions from spontaneous reporting.
Hyppigheden af
The frequencies of the adverse reactions from spontaneous reporting are based on the reporting rate of these events in the clinical trials.
61 bivirkninger fra spontan rapportering, for hvilke der ikke blev observeret tilfælde i de randomiserede placebo- kontrollerede patientforsøg med mirtazapin, er klassificeret som ‘ ikke kendt ’.
The frequency of adverse reactions from spontaneous reporting for which no cases in the randomized placebo-controlled patient trials were observed with mirtazapine has been classified as ‘ not known’.
Hyponatiæmi
Hyponatraemia
Mareridt2 Mani Agitation2 Hallucina - tioner Psykomoto - risk uro (inkl. akatasi, hyperkinesi)
Nightmares2 Mania Agitation2 Hallucinations Psychomotor restlessness (incl. akathisia, hyperkinesia)
2
Endocrine disorders 1
I kliniske forsøg forekom disse bivirkninger hyppigere under behandlingen med placebo sammenlignet med Remeron, men ikke statistisk signifikant hyppigere.
In clinical trials these events occurred statistically significantly more frequently during treatment with Remeron than with placebo.
3 I kliniske forsøg forekom disse bivirkninger statistisk signifikant hyppigere under behandlingen med placebo sammenlignet med Remeron.
2 In clinical trials these events occurred more frequently during treatment with placebo than with Remeron, however not statistically significantly more frequently.
5 Ved behandling med antidepressiva generelt, kan angst og søvnløshed (der kan være symptomer på depression) udvikle sig eller blive forværret.
62 5 Upon treatment with antidepressants in general, anxiety and insomnia (which may be symptoms of depression) can develop or become aggravated.
62 Laboratorievurderinger i kliniske forsøg har vist kortvarige stigninger i transaminaser og gammaglutamyltransferaser (bivirkningerne er dog ikke set statistisk signifikant hyppigere med Remeron sammenlignet med placebo).
In laboratory evaluations in clinical trials transient increases in transaminases and gamma- glutamyltransferase have been observed (however associated adverse events have not been reported statistically significantly more frequently with Remeron than with placebo).
Efter peroral indtagelse af Remeron absorberes det aktive stof mirtazapin hurtigt og godt (biotilgængelighed ≈ 50%), og maksimale plasmaniveauer nås efter ca. to timer.
After oral administration of Remeron, the active substance mirtazapine is rapidly and well absorbed (bioavailability ≈ 50%), reaching peak plasma levels after approx. two hours.
5. 3 Prækliniske sikkerhedsdata
63 5.3 Preclinical safety data
63 Mirtazapin udviste ikke genotoksicitet i en række tests for genmutation og kromosom - og DNA - skader.
Mirtazapine was not genotoxic in a series of tests for gene mutation and chromosomal and DNA damage.
Fundet af tumorer i skjoldbruskkirtlen i et carcinogenicitetsstudie på rotter og fundet af hepatocellulære neoplasmer i et carcinogenicitetsstudie på mus anses for at være artsbestemt, non - genotoksisk respons i forbindelse med langtidsbehandling med høje doser af leverenzyminduktorer.
Thyroid gland tumours found in a rat carcinogenicity study and hepatocellular neoplasms found in a mouse carcinogenicity study are considered to be species-specific, non-genotoxic responses associated with long-term treatment with high doses of hepatic enzyme inducers.
Hypromellose Macrogol 8000 Titandioxid (E171) Gul jernoxid (E172) Rød jernoxid (E172)
Tablet core: maize starch hyprolose magnesium stearate silica, colloidal anhydrous lactose monohydrate Tablet coating: hypromellose Macrogol 8000 titanium dioxide (E171) yellow iron oxide (E172) (15 and 30 mg film-coated tablets only) red iron oxide (E172)
(kun i 15 og 30 mg filmovertrukne tabletter) (kun i 30 mg filmovertrukne tabletter)
(30 mg film-coated tablets only)
Remeron 15, 30 og 45 mg filmovertrukne tabletter er pakket i blisterkort fremstillet af ugennemsigtig polyvinyl chlorid film og aluminiumsfolie belagt med en varmforseglet belægning på den side, der er i kontakt med de filmovertrukne tabletter.
Remeron 15, 30 and 45 mg film-coated tablets are packed in blisters made of opaque polyvinyl chloride film and aluminium foil containing a heat-seal coating on the side in contact with the film- coated tablets.
Remeron 15, 30 og 45 mg filmovertrukne tabletter fås også i HDPE- glas med sikkerhedslåg (LDPE).
Remeron 15, 30 and 45 mg film-coated tablets are also available in HDPE bottles with a tamper- evident LDPE cap.
De 15 mg filmovertrukne tabletter kan fremstilles i følgende pakkestørrelser:
The following pack sizes are available for the 15 mg film-coated tablets in blisters:
30 (3x10), 60 (6x10), 90 (9x10) og 100 (10x10), 14 (2x7), 28 (4x7), 56 (8x7) og 70 (10x7).
64 30 (3x10), 60 (6x10), 90 (9x10) and 100 (10x10) film-coated tablets; 14 (2x7), 28 (4x7), 56 (8x7), and 70 (10x7) film-coated tablets.
De 30 mg filmovertrukne tabletter kan fremstilles i følgende pakkestørrelser:
The following pack sizes are available for the 30 mg film-coated tablets in blisters:
10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 60 (6x10), 90 (9x10), 100 (10x10), 200 (20x10) og 500 (50x10); 14 (2x7), 28 (4x7), 56 (8x7), og 70 (10x7).
10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 60 (6x10), 90 (9x10), 100 (10x10), 200 (20x10) and 500 (50x10) film-coated tablets; 14 (2x7), 28 (4x7), 56 (8x7), and 70 (10x7) film-coated tablets.
De 45 mg filmovertrukne tabletter kan fremstilles I følgende pakkestørrelser:
The following pack sizes are available for the 45 mg film-coated tablets in blisters:
10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 100 (10x10), 200 (20x10) og 500 (50x10); 14 (2x7), 28 (4x7), 56 (8x7), og 70 (10x7).
10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 100 (10x10), 200 (20x10) and 500 (50x10) film-coated tablets; 14 (2x7), 28 (4x7), 56 (8x7), and 70 (10x7) film-coated tablets.
64 6. 6 Regler for destruktion og anden håndtering
6.6 Special precautions for disposal and other handling
65 ETIKETTERING
65 LABELLING
Remeron og tilhørende navne (se Bilag I) 15 mg filmovertrukne tabletter [Se Bilag I – Udfyldes nationalt]
Remeron and associated names (see Annex I) 15 mg film-coated tablets [See Annex I - To be completed nationally]
1 filmovertrukket tablet indeholder 15 mg mirtazapin
1 film-coated tablet contains 15 mg mirtazapine
Lactosemonohydrat Se yderligere oplysninger i indlægssedlen.
See leaflet for further information.
67 8.
67 8.
Opbevares i den originale pakning for at beskytte mod lys og fugt.
Do not store above 30 °C Store in the original package in order to protect from light and moisture
Glas, 15 mg
Bottle, 15 mg
Opbevares i den originale pakning for at beskytte mod lys og fugt.
SPECIAL STORAGE CONDITIONS 69 Do not store above 30 °C Store in the original package in order to protect from light and moisture
71 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
71 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Remeron og tilhørende navne (se Bilag I) 30 mg filmovertrukne tabletter [Se Bilag I – Udfyldes nationalt]
Remeron and associated names (see Annex I) 30 mg film-coated tablets [See Annex I - To be completed nationally]
1 filmovertrukket tablet indeholder 30 mg mirtazapin
1 film-coated tablet contains 30 mg mirtazapine
72 Opbevares utilgængeligt for børn.
72 Keep out of the reach and sight of children.
73 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
74 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Glas, 30 mg
Bottle, 30 mg
74 Må ikke opbevares over 30 °C Opbevares i den originale pakning for at beskytte mod lys og fugt
SPECIAL STORAGE CONDITIONS 75 Do not store above 30 °C Store in the original package in order to protect from light and moisture
75 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
76 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
76 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
77 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Remeron og tilhørende navne (se Bilag I) 45 mg filmovertrukne tabletter [Se Bilag I – Udfyldes nationalt]
Remeron and associated names (see Annex I) 45 mg film-coated tablets [See Annex I - To be completed nationally]
1 filmovertrukket tablet indeholder 45 mg mirtazapin
1 film-coated tablet contains 45 mg mirtazapine
77 7.
78 7.
Glas, 45 mg
Bottle, 45 mg
79 Må ikke opbevares over 30 °C Opbevares i den originale pakning for at beskytte mod lys og fugt
SPECIAL STORAGE CONDITIONS 81 Do not store above 30 °C Store in the original package in order to protect from light and moisture
81 INDLÆGSSEDDEL
83 PACKAGE LEAFLET
82 INDLÆGSSEDDEL:
84 PACKAGE LEAFLET:
Vær ekstra forsigtig med at tage Remeron Anvendelse til børn og unge under 18 år Remeron bør normalt ikke anvendes til børn og unge under 18 år.
Take special care with Remeron Use in children and adolescents under 18 years of age Remeron should normally not be used for children and adolescents under 18 years.
83 Hvis du er deprimeret, kan du af og til tænke på at skade dig selv eller begå selvmord.
85 Thoughts of suicide and worsening of your depression If you are depressed you can sometimes have thoughts of harming or killing yourself.
Vær ekstra forsigtig med at tage Remeron, • hvis du har eller har haft en af følgende tilstande. → Fortæl lægen om disse tilstande, inden du tager Remeron, hvis ikke du allerede har gjort det. - Epilepsianfald.
Also take special care with Remeron • if you have, or have ever had one of the following conditions. → Tell your doctor about these conditions before taking Remeron, if not done previously -seizures (epilepsy).
Du skal være forsigtig med at tage Remeron samtidig med: • Antidepressiva som serotoningenoptagshæmmere (SSRI’ er), venlafaxin og L- tryptophan eller triptaner (til behandling af migræne), tramadol (smertestillende), linezolid (mod infektion), lithium (til behandling af nogle psykiatriske tilstande) og perikon- produkter (et
Take care when taking Remeron in combination with: • antidepressants such as SSRIs, venlafaxine and L-tryptophan or triptans (used to treat migraine), tramadol (a pain-killer), linezolid (an antibiotic), lithium (used to treat some
84 naturprodukt mod depression).
Johns Wort – Hypericum perforatum preparations (a herbal remedy for depression).
Nogle af symptomerne på syndromet er: uforklarlig feber, sveden, hjertebanken, diarre, (ukontrollerede) muskelsammentrækninger, rysten, overaktive reflekser, rastløshed, humørsvingninger og bevidstløshed.
Some of the symptoms of this syndrome are: inexplicable fever, sweating, increased heart rate, diarrhoea, (uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood changes and unconsciousness.
Remeron kan i kombination med disse typer medicin øge den sløvende virkning af disse. • Medicin mod infektioner; medicin mod bakterieinfektioner (såsom erytromycin), medicin mod svampeinfektioner (såsom ketoconazol) og medicin mod HIV/ AIDS (såsom HIV proteasehæmmere).
In combination with these medicines Remeron can increase the drowsiness caused by these medicines. • medicines for infections; medicines for bacterial infections (such as erythromycin, medicines for fungal infections (such as ketoconazole) and medicines for HIV/ AIDS (such as HIV- protease inhibitors).
Tag altid Remeron nøjagtigt efter lægens anvisning.
87 Always take Remeron exactly as your doctor or pharmacist tells you to.
85 Den almindelige begyndelsesdosis er 15 eller 30 mg daglig.
How much to take The usual starting dose is 15 or 30 mg every day.
Det er bedst at indtage Remeron som en enkelt dosis før sengetid.
When to take Remeron → Take Remeron at the same time each day. It is best to take Remeron as a single dose before you go to bed.
Lægen kan dog anbefale, at Remeron tages som to doser – én om morgenen og én om aftenen før sengetid.
However your doctor may suggest you to split your dose of Remeron – once in the morning and once at night-time before you go to bed.
Tabletterne skal sluges.
Take your tablets orally.
Hvis du skal tage din dosis to gange daglig • Hvis du har glemt din morgendosis, skal du tage den sammen med din aftendosis. • Hvis du har glemt din aftendosis, skal du ikke tage den sammen med din dosis næste morgen, spring den over og fortsæt behandlingen med din normale morgen - og aftendosis. • Hvis har glemt begge doser, skal du ikke forsøge at erstatte de glemte doser.
If you are supposed to take your dose twice a day • if you have forgotten to take your morning dose, simply take it together with your evening dose. • if you have forgotten to take your evening dose, do not take it with the next morning dose; just skip it and continue with your normal morning and evening doses. • if you have forgotten to take both doses, do not attempt to make up for the missed doses.
De mulige bivirkninger af Remeron er nævnt nedenfor og kan opdeles i: •
The possible side effects of Remeron are listed below and can be divided as: • • • • • •
86 • • • • •
Very common:
forekommer hos 1 til 10 ud af 100 personer forekommer hos 1 til 10 ud af 1. 000, 00 personer forekommer hos 1 til 10 ud af 10. 000, 00 personer forekommer hos mindre end 1 ud af 10. 000, 00 personer kan ikke estimeres ud fra de tilgængelige data
affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 cannot be estimated from the available data
• øget appetit og vægtøgning • søvnighed og træthed • hovedpine • mundtørhed
Very common: • increase in appetite and weight gain • drowsiness or sleepiness • headache • dry mouth
Ikke almindelige: • følelse af opstemthed (mani) → Stop behandlingen med Remeron og kontakt straks lægen. • unormal fornemmelse i huden, som brænden, stikken, kilden og prikken • uro i benene • besvimelse • fornemmelse af følelsesløshed i munden (oral hypoaesthesia) • lavt blodtryk • mareridt • følelse af ophidsethed • hallucinationer • uro i kroppen
Uncommon: • feeling elated or emotionally ‘ high’ (mania) → Stop taking Remeron and tell your doctor straight away. • abnormal sensation in the skin e. g. burning, stinging, tickling or tingling (paraesthesia) • restless legs • fainting (syncope) • sensations of numbness in the mouth (oral hypoaesthesia) • low blood pressure • nightmares • feeling agitated • hallucinations • urge to move
Ikke kendt: • Tegn på infektioner såsom pludselig, uforklarlig høj feber, ondt i halsen eller sår i munden → Stop behandlingen med Remeron og kontakt straks lægen for at få taget en blodprøve.
89 Not known: • signs of infection such as sudden unexplainable high fever, sore throat and mouth ulcers (agranulocytosis) → Stop taking Remeron and contact your doctor straight away for a blood test.