natgillin/translations-raw huggingface dataset:
Sjældne (forekommer hos op til 1 ud af 1.000 personer)
Rare (may affect up to 1 in 1,000 people)
Der bør udvises forsigtighed ved samtidig administration af fesoterodin og andre lægemidler, som har antimuskarine eller antikolinerge egenskaber (f.eks. amantadin, tricykliske antidepressiva, visse neuroleptika), da dette kan medføre mere udtalte terapeutiske virkninger og bivirkninger (f.eks. forstoppelse, mundtørhed, døsighed, urinretention).
Caution should be exercised in coadministration of fesoterodine with other antimuscarinics and medicinal products with anticholinergic properties (e.g. amantadine, tri-cyclic antidepressants, certain neuroleptics) as this may lead to more pronounced therapeutic- and side-effects (e.g. constipation, dry mouth, drowsiness, urinary retention).
TOVIAZ indeholder sojaolie.
TOVIAZ contains soya oil.
TOVIAZ behandler de symptomer, som du kan få, hvis du har en overaktiv blære, som f.eks.:
TOVIAZ treats the symptoms of an overactive bladder such as
4.4, 4.5 og 5.2 (3) Moderate CYP3A4-hæmmere.
See sections 4.4, 4.5 and 5.2 (3) Moderate CYP3A4 inhibitors.
• Urinretention
• Urinary retention
TOVIAZ bør anvendes med forsigtighed til patienter med risiko for QT-forlængelse (f.eks. hypokaliæmi, bradykardi og samtidig behandling med lægemidler, der forlænger QT-intervallet) og relevante forud bestående hjertekarsygdomme (f.eks. myokardie iskæmi, arytmi, venstresidig hjerteinsufficiens; se pkt.
TOVIAZ should be used with caution in patients with risk for QT prolongation (e.g. hypokalaemia, bradycardia and concomitant administration of medicines known to prolong QT interval) and relevant pre-existing cardiac diseases (e.g. myocardial ischaemia, arrhythmia, congestive heart failure), (see section 4.8).
Udslæt; tør hud; pruritus
Rash; Dry skin; Pruritus
TOVIAZ er kontraindiceret til patienter med svært nedsat leverfunktion (se pkt.
TOVIAZ is contraindicated in subjects with severe hepatic impairment (see section 4.3).
Man bør udvise forsigtighed, når man fører motorkøretøj eller anvender maskiner på grund af mulige bivirkninger som tågesyn, svimmelhed eller søvnighed (se pkt.
Caution should be exercised when driving or using machines due to possible occurrence of side effects such as blurred vision, dizziness, and somnolence (see section 4.8).
• svært ved at tømme blæren helt (urinretention)
• difficulty in completely emptying the bladder (urinary retention)
Sojalecithin Indigotin I (E132)
Indigo carmine aluminium lake (E132)
Efter blokering af CYP3A4 på grund af samtidig administration af den moderate CYP3A4-hæmmer fluconazol 200 mg 2 gange dagligt i 2 dage, blev Cmax og AUC af den aktive metabolit af fesoterodin øget med henholdsvis ca. 19% og 27%.
Following blockade of CYP3A4 by coadministration of the moderate CYP3A4 inhibitor fluconazole 200 mg twice a day for 2 days, Cmax and AUC of the active metabolite of fesoterodine increased approximately 19% and 27%, respectively.
Derfor bør maksimaldosis af fesoterodin begrænses til 4 mg ved samtidig brug af potente CYP3A4-hæmmere (f.eks. atazanavir, clarithromycin, indinavir, itraconazol, ketoconazol, nefazodon, nelfinavir, ritonavir (og alle ritonavir-boostede protease-hæmmer-regimer), saquinovir og telithromycin (se pkt.
Therefore, the maximum dose of fesoterodine should be restricted to 4 mg when used concomitantly with potent CYP3A4 inhibitors (e.g. atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir (and all ritonavir boosted PI-regimens), saquinavir and telithromycin (see sections 4.2 and 4.4)).
30 depottabletter 90 depottabletter
30 prolonged-release tablets 90 prolonged-release tablets
Filmovertræk Poly(vinylalkohol) Titandioxid (E 171) Macrogol (3350) Talkum
Titanium dioxide (E171) Macrogol (3350)
7 depottabletter 14 depottabletter 28 depottabletter 30 depottabletter 56 depottabletter 84 depottabletter 98 depottabletter 100 depottabletter
7 prolonged-release tablets 14 prolonged-release tablets 28 prolonged-release tablets 30 prolonged-release tablets 56 prolonged-release tablets 84 prolonged-release tablets 98 prolonged-release tablets 100 prolonged-release tablets
Hos patienter med let eller moderat nedsat nyrefunktion (GFR 30-80 ml/min) steg Cmax og AUC for den aktive metabolit op til henholdsvis 1,5 og 1,8 gange sammenlignet med raske forsøgspersoner.
In patients with mild or moderate renal impairment (GFR 30 - 80 ml/min), Cmax and AUC of the active metabolite increased up to 1.5 and 1.8-fold, respectively, as compared to healthy subjects.
N=279 N=265 N=276 N=283 N=266 N=267 N=267
N=283 N=266
Efter induktion af CYP3A4 ved samtidig administration af rifampicin 600 mg 1 gang dagligt faldt Cmax og AUC for fesoterodins aktive metabolit med henholdsvis cirka 70% og 75% efter oral administration af 8 mg fesoterodin.
Following induction of CYP3A4 by coadministration of rifampicin 600 mg once a day, Cmax and AUC of the active metabolite of fesoterodine decreased by approximately 70% and 75%, respectively, after oral administration of fesoterodine 8 mg.
TOVIAZ 4 mg tabletter Hver 4 mg depottablet indeholder 0,525 mg sojalecithin og 91,125 mg lactose.
TOVIAZ 4 mg tablets Each 4 mg prolonged-release tablet contains 0.525 mg of soya lecithin and 91.125 mg of lactose.
Farmakologiske interaktioner
Pharmacological interactions
• anstrengelse eller smerter, når blæren tømmes
• straining or pain when emptying the bladder (dysuria)
- Medicin, der indeholder de følgende aktive stoffer, kan øge mængden af fesoterodin i blodet: itraconazol eller ketoconazol (bruges til behandling af svampeinfektioner), ritonavir, atazanavir, indinavir, saquinavir eller nelfinavir (antiviral medicin, der bruges til behandling af HIV), clarithromycin eller telithromycin (der bruges til behandling af bakterieinfektioner), nefazodon (bruges til at behandle depression), fluoxetin eller paroxetin (bruges til behandling af depression eller angst), bupropion (bruges ved rygeafvænning eller til behandling af depression), quinidin (bruges til at behandle uregelmæssig hjerterytme) og cinacalcet (bruges til at behandle problemer med skjoldbruskkirtlen).
- medicines containing any of the following active substances may increase the blood levels of fesoterodine: itraconazole or ketoconazole (used to treat fungal infections), ritonavir, atazanavir, indinavir, saquinavir or nelfinavir (antiviral medicine for treating HIV), clarithromycin or telithromycin (used to treat bacterial infections), nefazodone (used to treat depression), fluoxetine or paroxetine (used to treat depression or anxiety), bupropion (used for smoking cessation or to treat depression), quinidine (used to treat arrhythmias) and cinacalcet (used to treat hyperparathyroidism).
Parameter Placebo Fesoterodin 4 mg
Parameter Placebo Fesoterodine 4 mg
TOVIAZ indeholder lactose.
TOVIAZ contains lactose.
TOVIAZ 8 mg tabletter Hver 8 mg depottablet indeholder 0,525 mg sojalecithin og 58,125 mg lactose.
TOVIAZ 8 mg tablets Each 8 mg prolonged-release tablet contains 0.525 mg of soya lecithin and 58.125 mg of lactose.
I tilfælde af overdosering af fesoterodin bør patienter behandles med udskylning af mavesækken og aktivt kul.
In the event of fesoterodine overdose, treat with gastric lavage and give activated charcoal.
+-strømmen i klonede humane ether-à-go-go-related (hERG)-kanaler og forlænger aktionspotentialets varighed (70% og 90% repolarisering) i isolerede Purkinjefibre fra hunde.
Supratherapeutic concentrations of the active metabolite of fesoterodine, have been shown to inhibit K+ current in cloned human ether-à-go-go-related gene (hERG) channels and prolong action potential duration (70% and 90% repolarisation) in canine isolated Purkinje fibres.
- Svære antikolinerge virkninger (f.eks. hallucinationer, svær ekscitation) med fysostigmin - kramper og udtalt ekscitation med benzodiazepiner - nedsat åndedrætsfunktion med kunstig respiration - takykardi med betablokkere - urinretention med anlæggelse af kateter - mydriasis med pilocarpin-øjendråber og/eller patienten placeres i et mørkt rum.
- Severe central anticholinergic effects (e.g. hallucinations, severe excitation): treat with physostigmine - Convulsions or pronounced excitation: treat with benzodiazepines - Respiratory insufficiency: treat with artificial respiration - Tachycardia: treat with beta-blockers - Urinary retention: treat with catheterisation - Mydriasis: treat with pilocarpine eye drops and/or place patient in dark room.
Virkningen af svage CYP3A4-hæmmere (f.eks. cimetidin) er ikke undersøgt.
The effect of weak CYP3A4 inhibitors (e.g. cimetidine), was not examined; it is not expected to be in excess of the effect of moderate inhibitor.
Hos de patienter, som blev behandlet med fesoterodin, adskilte QT-intervallet korrigeret for hjertefrekvens sig ikke fra det, der blev målt hos patienterne, som fik placebo.
The heart rate corrected QT interval in fesoterodine treated patients did not differ from that seen in placebo treated patients.
Efter oral administration af fesoterodin blev cirka 70% af den administrerede dosis genfundet i urinen som den aktive metabolit (16%), carboxylmetabolitten (34%), carboxyl-N-desisopropyl-metabolitten (18%), eller N-desisopropyl-metabolitten (1%), og en mindre mængde (7%) blev genfundet i fæces.
After oral administration of fesoterodine, approximately 70% of the administered dose was recovered in urine as the active metabolite (16%), carboxy metabolite (34%),
TOVIAZ 4 mg tabletter
TOVIAZ 4 mg tablets
Den maksimale daglige dosis af TOVIAZ hos patienter med normal nyre- og leverfunktion, der samtidig behandles med potente CYP3A4-hæmmere, bør være 4 mg 1 gang dagligt (se pkt.
In subjects with normal renal and hepatic function receiving concomitant administration of potent CYP3A4 inhibitors, the maximum daily dose of TOVIAZ should be 4 mg once daily (see section
Hos patienter med let eller moderat leverinsufficiens (Child Pugh B) steg Cmax og AUC for den aktive metabolit henholdsvis 1,4 og 2,1 gange sammenlignet med raske forsøgspersoner.
In patients with moderate hepatic impairment (Child Pugh B), Cmax and AUC of the active metabolite increased 1.4 and 2.1-fold, respectively, as compared to healthy subjects.
Efter hæmning af CYP3A4 ved samtidig administration af ketoconazol 200 mg 2 gange dagligt blev Cmax og AUC for fesoterodins aktive metabolit øget med henholdsvis 2,0 og 2,3 gange hos hurtige CYP2D6-omsættere og 2,1 og 2,5 gange hos langsomme CYP2D6-omsættere.
Following inhibition of CYP3A4 by co-administration of ketoconazole 200 mg twice daily, Cmax and AUC of the active metabolite of fesoterodine increased 2.0 and 2.3-fold in CYP2D6 extensive metabolisers and 2.1 and 2.5-fold in CYP2D6 poor metabolisers, respectively.
Brug af anden medicin samme med TOVIAZ
Other medicines and TOVIAZ
TOVIAZ 8 mg tabletter EU/1/07/386/006-010 EU/1/07/386/012
TOVIAZ 8 mg tablets EU/1/07/386/006-010 EU/1/07/386/012
Fesoterodins farmakokinetik er ikke undersøgt hos patienter med svært nedsat leverfunktion.
Pharmacokinetics of fesoterodine in patients with severe hepatic impairment have not been studied.
Indre emballage HDPE-beholder - 4 mg
Immediate packaging HDPE Bottle - 4 mg
oC.
A.
Den aktive metabolits gennemsnitlige Cmax og AUC er op til henholdsvis 1,7 og 2 gange højere hos langsomme CYP2D6-omsættere sammenlignet med hurtige omsættere.
Mean Cmax and AUC of the active metabolite are 1.7 and 2-fold higher, respectively, in CYP2D6 poor metabolisers as compared to extensive metabolisers.
Indre emballage HDPE-beholder - 8 mg
Immediate Packaging HDPE Bottle - 8 mg
Tag ikke dette lægemiddel, hvis du er allergisk over for jordnødder eller soja.
If you are allergic to peanut or soya, do not use this medicinal product.
TOVIAZ depottabletter indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for arvelig lactasemangel (Lapp lactase deficiency) eller glucose/galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Fortæl det til lægen, hvis du tager noget af den medicin, som er nævnt her.
Please inform your doctor if you are taking medicines according to the following list.
Symptomerne på overaktiv blære kan komme igen eller blive forværret, når du holder op med at tage TOVIAZ.
Do not stop taking TOVIAZ without talking to your doctor, as your symptoms of overactive bladder may come back again or become worse once you stop taking TOVIAZ.
• hvis du har nyreproblemer, eller moderate til alvorlige leverproblemer, og tager medicin, som indeholder nogen af følgende aktive stoffer: itraconazol eller ketoconazol (anvendes til behandling af svampeinfektioner), ritonavir, atazanavir, indinavir, saquinavir eller nelfinavir
- if you have kidney problems or moderate to severe liver problems and are taking medicines containing any of the following active substances: itraconazole or ketoconazole (used to treat fungal infections), ritonavir, atazanavir, indinavir, saquinavir or nelfinavir (antiviral medicine for treating HIV), clarithromycin or telithromycin (used to treat bacterial infections) and nefazodone (used to treat depression)
Fesoterodin hæmmer ikke P-pillers undertrykkelse af ovulation.
Fesoterodine does not impair the suppression of ovulation by oral hormonal contraception.
Dette gør sig især gældende ved brug af potente CYP3A4-hæmmere (se pkt.
This especially holds true when taking potent CYP3A4 inhibitors (see sections 4.2, 4.5 and 5.1).
Sådan skal du tage TOVIAZ
How to take TOVIAZ
Mave-tarm-kanalen Mundtørhed Abdominalsmerter; diaré; dyspepsi; forstoppelse; kvalme
Dry mouth Abdominal pain; Diarrhoea;
Meget almindelige (forekommer hos flere end 1 ud af 10 personer) Mundtørhed.
Very common (may affect more than 1 in 10 people) You may get a dry mouth.
Hver tablet indeholder 4 mg fesoterodinfumarat
Each tablet contains 4 mg fesoterodine fumarate
• tørhed i halsen
• dry throat
Blisteretiket 4 mg
Blister label 4 mg
4.3) - gastrointestinale obstruktive lidelser (f.eks. pylorusstenose) - gastro-øsofageal refluks og/eller samtidig indtagelse lægemidler (som orale bisfosfonater), som kan forårsage eller forværre oesophagitis - reduceret gastrointestinal motilitet
- Clinically significant bladder outflow obstruction at risk of urinary retention (e.g. clinically significant prostate enlargement due to benign prostatic hyperplasia, see section 4.3) - Gastrointestinal obstructive disorders (e.g. pyloric stenosis) - Gastro-oesophageal reflux and/or who are concurrently taking medicinal products (such as oral bisphosphonates) that can cause or exacerbate oesophagitis - Decreased gastrointestinal motility - Autonomic neuropathy - Controlled narrow-angle glaucoma
Samtidig brug af CYP3A4-induktorer (f.eks. carbamazepin, rifampicin, phenobarbital, phenytoin, perikon) frarådes (se pkt.
Concomitant use with CYP3A4 inducers (e.g. carbamazepine, rifampicin, phenobarbital, phenytoin, St John's Wort) is not recommended (see section 4.4).
4.2, 4.3 og 5.2) - samtidig behandling med potent eller moderat CYP3A4-hæmmer (se pkt.
- Hepatic impairment (see sections 4.2, 4.3 and 5.2) - Renal impairment (see sections 4.2, 4.3 and 5.2) - Concomitant administration of potent or moderate CYP3A4 inhibitors (see sections 4.2 and
EU/1/07/386/001 7 depottabletter EU/1/07/386/002 14 depottabletter EU/1/07/386/003 28 depottabletter EU/1/07/386/019 30 depottabletter EU/1/07/386/004 56 depottabletter EU/1/07/386/005 98 depottabletter EU/1/07/386/011 84 depottabletter EU/1/07/386/017 100 depottabletter
EU/1/07/386/001 7 prolonged-release tablets EU/1/07/386/002 14 prolonged-release tablets EU/1/07/386/003 28 prolonged-release tablets EU/1/07/386/019 30 prolonged-release tablets EU/1/07/386/004 56 prolonged-release tablets EU/1/07/386/005 98 prolonged-release tablets EU/1/07/386/011 84 prolonged-release tablets EU/1/07/386/017 100 prolonged-release tablets
EU/1/07/386/006 7 depottabletter EU/1/07/386/007 14 depottabletter EU/1/07/386/008 28 depottabletter EU/1/07/386/020 30 depottabletter EU/1/07/386/009 56 depottabletter EU/1/07/386/010 98 depottabletter EU/1/07/386/012 84 depottabletter EU/1/07/386/018 100 depottabletter
EU/1/07/386/006 7 prolonged-release tablets EU/1/07/386/007 14 prolonged-release tablets EU/1/07/386/008 28 prolonged-release tablets EU/1/07/386/020 30 prolonged-release tablets EU/1/07/386/009 56 prolonged-release tablets EU/1/07/386/010 98 prolonged-release tablets EU/1/07/386/012 84 prolonged-release tablets EU/1/07/386/018 100 prolonged-release tablets
Det er ukendt, om fesoterodin/metabolitter udskilles i modermælk.
It is unknown whether fesoterodine/metabolites are excreted into human milk; therefore, breast-feeding is not recommended during treatment with TOVIAZ.
Hver tablet indeholder 8 mg fesoterodinfumarat
Each tablet contains 8 mg fesoterodine fumarate
• du har langsomt hjerteslag (bradykardi)
• increased heart beat (tachycardia)
Fund fra mus ved eksponeringer, der var ca. 5 til 19 gange højere end MRHD, viser en påvirkning af hunnens fertilitet.
Findings in mice at exposures approximately 5 to 19 times those at the MRHD show an effect on female fertility, however, the clinical implications of these animal findings are not known (see section 5.3).
4.5 (4) Potente CYP3A4-hæmmere.
See section 4.5 (4) Potent CYP3A4 inhibitors.
Blisteretiket 8 mg
Blister label 8 mg
• besvær med at fordøje maden
• trouble digesting food (dyspepsia)
TOVIAZ 4 mg tabletter EU/1/07/386/001-005 EU/1/07/386/011
TOVIAZ 4 mg tablets EU/1/07/386/001-005 EU/1/07/386/011 EU/1/07/386/013-014
• udslæt
• urticaria
Samtidig brug af fesoterodin og en stærk CYP3A4-induktor (dvs. carbamazepin, rifampicin, phenobarbital, phenytoin, prikbladet perikon) frarådes (se pkt.
The concomitant use of fesoterodine with a potent CYP3A4 inducer (i.e. carbamazepine, rifampicin, phenobarbital, phenytoin, St John's Wort) is not recommended (see section 4.5).
Dette blev målt ved en plasmaeksponering, som var mindst 33 gange højere end plasmakoncentration hos hurtige CYP2D6-omsættere, og 21 gange højere end målt hos personer, som er langsomme CYP2D6-omsættere efter administration af fesoterodin 8 mg 1 gang dagligt.
However in conscious dogs, the active metabolite had no effect on the QT interval and QTc interval at plasma exposures at least 33-fold higher than mean peak free plasma concentration in human subjects who are extensive metabolisers and 21-fold higher than measured in subjects who are poor CYP2D6 metabolisers after fesoterodine 8 mg once daily.
Følgende tabel angiver dosisrekommandationer for patienter med nedsat nyre- og leverfunktion, både med og uden samtidig behandling med potente CYP3A4-hæmmere (se pkt.
The following table provides the daily dosing recommendations for subjects with renal or hepatic impairment in the absence and presence of moderate and potent CYP3A4 inhibitors (see sections 4.3, 4.4, 4.5 and 5.2).
Det skal du vide, før du begynder at tage TOVIAZ Sådan skal du tage TOVIAZ Bivirkninger
What is in this leaflet What TOVIAZ is and what it is used for What you need to know before you take TOVIAZ How to take TOVIAZ Possible side effects How to store TOVIAZ Contents of the pack and other information
Hver depottablet indeholder 8 mg fesoterodinfumarat, som svarer til 6,2 mg fesoterodin.
Each prolonged-release tablet contains 8 mg fesoterodine fumarate, equivalent to 6.2 mg of fesoterodine.
Depottablet.
Dyspepsia;
• hvis du ikke er i stand til at tømme blæren helt (urinretention)
• not being able to control when you empty your bladder (called urgency incontinence)
Svimmelhed; hovedpine
Dizziness; Headache
• smerter i halsen
• pain in the stomach
Hver depottablet indeholder 4 mg fesoterodinfumarat, som svarer til 3,1 mg fesoterodin.
Each prolonged-release tablet contains 4 mg fesoterodine fumarate, equivalent to 3.1 mg of fesoterodine.
Almindelige (forekommer hos mellem 1 og 10 ud af 100 personer)
Uncommon (may affect up to 1 in 100 people)
TOVIAZ 4 mg depottabletter TOVIAZ 8 mg depottabletter
TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets
• oppustethed (afgang af tarmluft)
• wind (flatulence)
Alder og køn påvirker ikke fesoterodins farmakokinetik signifikant.
The pharmacokinetics of fesoterodine are not significantly influenced by age and gender.
TOVIAZ udseende og pakningsstørrelser
What TOVIAZ looks like and contents of the pack
EU/1/07/386/015 30 depottabletter EU/1/07/386/016 90 depottabletter
EU/1/07/386/015 30 prolonged-release tablets EU/1/07/386/016 90 prolonged-release tablets
TOVIAZ 4 mg depottabletter fesoterodinfumarat
TOVIAZ 4 mg prolonged-release tablets fesoterodine fumarate
8 mg-tabletterne er blå, ovale, bikonvekse, filmovertrukne og er på den ene side præget med bogstaverne ‘FT'.
The 8 mg tablets are blue, oval, biconvex, film-coated, and engraved on one side with the letters ‘FT'.
Stærke CYP3A4-induktorer
Potent CYP3A4 inducers
EU/1/07/386/013 30 depottabletter EU/1/07/386/014 90 depottabletter
EU/1/07/386/013 30 prolonged-release tablets EU/1/07/386/014 90 prolonged-release tablets
TOVIAZ 8 mg depottabletter fesoterodinfumarat
TOVIAZ 8 mg prolonged-release tablets fesoterodine fumarate
- Medicin, der indeholder det aktive stof amantadin (der bruges til behandling af Parkinsons syge) - Visse typer medicin til at fremme fordøjelsen, lindre mavekramper eller -spasmer og til at forhindre køresyge, f.eks. medicin, der indeholder metoclopramid - Visse typer medicin til behandling af psykiske lidelser, f.eks. antidepressiva og neuroleptika.
- certain medicines used to enhance gastrointestinal motility or to relieve stomach cramps or spasm and to prevent travel sickness like medicines containing metoclopramide.
4 mg-tabletterne er lyseblå, ovale, bikonvekse, filmovertrukne og er på den ene side præget med bogstaverne ‘FS'.
The 4 mg tablets are light blue, oval, biconvex, film-coated, and engraved on one side with the letters ‘FS'.
TOVIAZ 4 mg depottabletter er lyseblå, ovale, buede udad på begge sider, filmovertrukne og på den ene side præget med bogstaverne ‘FS'.
TOVIAZ 4 mg prolonged-release tablets are light blue, oval, curved outwards on both sides, filmcoated tablets, and engraved on one side with the letters ‘FS'.
TOVIAZ 8 mg depottabletter er blå, ovale, buede udad på begge sider, filmovertrukne og på den ene side præget med bogstaverne ‘FT'.
TOVIAZ 8 mg prolonged-release tablets are blue, oval, curved outwards on both sides, film-coated tablets, and engraved on one side with the letters ‘FT'.
TOVIAZ 8 mg tabletter En depottablet indeholder fesoterodinfumarat 8 mg svarende til 6,2 mg fesoterodin.
Each prolonged-release tablet contains fesoterodine fumarate 8 mg corresponding to 6.2 mg of fesoterodine.
Hvis du har taget for meget TOVIAZ
If you take more TOVIAZ than you should
Ubehag i maven; flatulens; gastroøsofageal refluks
Flatulence, Gastroesophage al reflux
4.2 og 4.5) - samtidig behandling med potent CYP2D6-hæmmer (se pkt.
- Concomitant administration of a potent CYP2D6 inhibitor (see sections 4.5 and 5.2).
Du må ikke tage TOVIAZ, hvis du ammer, da man ikke ved, om fesoterodin udskilles i modermælken hos mennesker.
It is not known whether fesoterodine is excreted into human milk; therefore, do not breast-feed during treatment with TOVIAZ.
TOVIAZ 4 mg tabletter En depottablet indeholder fesoterodinfumarat 4 mg svarende til 3,1 mg fesoterodin.
Each prolonged-release tablet contains fesoterodine fumarate 4 mg corresponding to 3.1 mg of fesoterodine.
• hvis du har svært ved at tømme blæren helt (f.eks. på grund af forstørret blærehalskirtel)
• having to empty your bladder more often than usual (called increased urinary frequency)
• Ventrikelretention
• Gastric retention
Hos patienter med svært nedsat nyrefunktion (GFR < 30 ml/min.)
In patients with severe renal impairment (GFR < 30 ml/min), Cmax and AUC are increased 2.0 and 2.3-fold, respectively.
Yderpakning 8 mg
Outer carton 8 mg
Svage CYP3A4-hæmmere
Weak CYP3A4 inhibitors
Yderpakning 4 mg
Outer carton 4 mg
TOVIAZ 4 mg depottabletter TOVIAZ 8 mg depottabletter fesoterodinfumarat
TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets fesoterodine fumarate
Dosisøgning
Posology
Smerter i hals og svælg; hoste; tørhed i næsen
Pharyngolaryng eal pain; Cough; Nasal dryness