qanastek/EMEA-V3 huggingface dataset:
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.
Madankollu fi klieb konxji, il- metabolit attiv m’ għandu l- ebda effett fuq l- intervall tal- QT u l- intervall tal- QTc f’ espożizzjonijiet fil- plażma ta ’ lanqas 33 darba ogħla mill- medja ta ’ l- ogħla konċentrazzjoni fil - plażma tal- metabolit ħieles f’ suġġetti umani li huma metabolizzaturi estensivi u 21 darba ogħla minn suġġetti li huma metabolizzaturi ta ’ CYP2D6 dgħajfin wara li jkunu ħadu fesoterodine 8 mg darba kuljum.
Tablet core Xylitol Lactose monohydrate Microcrystalline cellulose
Il- qalba tal- pillola Xylitol Lactose monohydrate Microcrystalline cellulose Hypromellose Glycerol dibehenate Talc
Film-coat Polyvinyl alcohol Titanium dioxide (E171) Macrogol (3350) Talc Soya lecithin Indigo carmine aluminium lake (E132)
Il- kisi tar- rita Polyvinyl alcohol Titanium dioxide (E171) Macrogol (3350) Talc Soya lecithin Indigo carmine aluminium lake (E132)
Store in the original package to protect from moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
TOVIAZ 4 mg tablets are packed in aluminium-aluminium blisters in cartons containing 7, 14, 28, 56, 84 or 98 tablets.
Il- pilloli TOVIAZ ta ’ 4 mg huma ppakjati f’ folji ta ’ l- aluminju/ aluminju f’ kartun li fihom 7, 14, 28, 56, 84 jew 98 pillola.
In addition, TOVIAZ 4 mg tablets are also packed in HDPE bottles containing 30 or 90 tablets.
Barra minn hekk, il- pilloli TOVIAZ 4mg huma wkoll ippakkjati ġewwa fliexken ta ’ HDPE li fihom 30 jew 90 pillola.
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ Renju Unit
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - mediċini (EMEA) http: // www. emea. europa. eu /.
TOVIAZ 8 mg prolonged-release tablets
TOVIAZ 8 mg, pilloli li jerħu l- mediċina bil- mod
Each prolonged-release tablet contains fesoterodine fumarate 8 mg corresponding to 6.2 mg of fesoterodine.
Ġo kull pillola li terħi l- mediċina bil- mod hemm 8 mg fesoterodine fumarate, dan jikkorrespondi għal 6. 2 mg ta ’ fesoterodine..
Excipients Each 8 mg prolonged-release tablet contains 0.525 mg of soya lecithin and 58.125 mg lactose monohydrate.
Sustanzi mhux attivi Ġo kull pillola li terħi l- mediċina bil- mod hemm 0. 525mg soya lecithin u 58. 125mg lactose monohydrate.
Prolonged-release tablets The 8 mg tablets are blue, oval, biconvex, film-coated, and engraved on one side with the letters ‘ FT’.
Il- pilloli ta ’ 8 mg huma ta ’ kulur kaħlani ċar, ovali, imbuzzati, miksijin b’ rita rqiqa trasparenti u fuq naħa waħda għandhom imnaqqxin l- ittri ‘ FT ’.
Treatment of the symptoms (increased urinary frequency and/ or urgency and/ or urgency incontinence) that may occur in patients with overactive bladder syndrome.
Trattament tas- sintomi (żieda fil- frekwenza urinarja u/ jew urġenza li tikkaġuna inkontinenza) li jistgħu jinstabu f’ pazjenti li jbatu mill- problema ta ’ bużżieqa ta ’ l- awrina li hi attiva wisq.
4.2 Posology and method of administration
4. 3 Pożoloġija u metodu ta ’ kif għandu jingħata
Hence, it is recommended to re-evaluate the efficacy for the individual patient after 8 weeks of treatment.
Għalekk huwa rrikomandat li l - effikaċja f’ kull pazjent individwali terġa tkun evalwata wara 8 ġimgħat ta ’ trattament.
During concomitant administration of a moderate CYP3A4 inhibitor, a dose increase to 8 mg should be preceded by an evaluation of the individual response and tolerability (see sections 4.4 and 4.5).
Waqt l- għoti flimkien ma inibitur moderat ta ’ CYP3A4, id- doża għandha tkun miżjuda għal 8mg wara evalwazzjoni tar- respons u tollerabilita ’ ta ’ kull pazjent (ara sezzjonijiet 4. 4 u 4. 5).
Renal and hepatic impairment 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).
Indeboliment renali u tal- fwied It- tabella li ġejja tagħti rakkomandazjonijiet tad- doża li tista ’ tingħata kuljum lil pazjenti li għandhom indeboliment renali u epatiku fl- assenza u l- preżenza ta inibituri moderati u qawwija ta ’ CYP3A4 (ara sezzjonijiet 4. 3, 4. 4, 4. 5 u 5. 2)
12 Moderate(3) or potent(4) CYP3A4 inhibitors
12 Inibituri ta’ CYP3A4 moderati( 3) jew qawwija( 4)
• Hypersensitivity to the active substance or to peanut or soya or any of the excipients • Urinary retention • Gastric retention • Uncontrolled narrow angle glaucoma • Myasthenia gravis • Severe hepatic impairment (Child Pugh C) • Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment • Severe ulcerative colitis • Toxic megacolon.
• Sensittività eċċessiva għas- sustanza attiva jew għall- karawett jew soja jew għal xi sustanzi mhux attivi • Żamma tal- awrina • Żamma tal- kontenut ta ’ l- istonku • Glawkoma ta ’ angolu dejjaq mhix ikkontrollata • Majestenja gravis • Indeboliment epatiku serju (Child Pugh C) • Użu fl- istess waqt ta inibituri ta ’ CYP3A4 potenti f’ suġġetti li għandhom indeboliment epatiku jew renali minn moderat sa serju. • Kolite ulċerattiva serja • Megakolon tossiku.
- Clinically significant bladder outflow obstruction at risk of urinary retention (see section 4.3)
TOVIAZ għandu jintuża b ’ kawtela f’ pazjenti bi: − Imblukkar tal- ħruġ ta ’ l- awrina mill- bużżieqa ta ’ l- awrina klinikament sinifikanti bir- riskju ta ’ żamma ta ’ l- awrina (ara sezzjoni 4. 3) − Disturbi ta ’ mblukkar gastro- intestinali (eż. stenosi pilorika) − Rifluss gastro- esofagali u/ jew li qed jieħdu prodotti mediċinali fl- istess waqt (bħal biphosphonates li jittieħdu mill- ħalq) li jistgħu jikkaġunaw jew iħarrxu l- esofaġite − Moviment gastro- intestinali mnaqqas − Newropatija awtonomika − Glawkoma ta ’ angolu dejjaq ikkontrollata
13 In patients with a combination of these factors, additional exposure increases are expected.
13 mid- doża.
Other causes of frequent urination (treatment of heart failure or renal disease) should be assessed before treatment with fesoterodine.
Kawżi oħra għal għemil ta ’ l- awrina ta ’ spiss (trattament ta ’ insuffiċjenza tal- qalb jew mard renali) għandhom ikunu valudati qabel ma jinbeda t- trattament b’ fesoterodine.
14 Moderate CYP3A4 Inhibitors No study has been performed evaluating the effect of a moderate CYP3A4 inhibitor (e. g. amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, verapamil) on the pharmacokinetics of fesoterodine.
14 Impedituri Moderati ta ’ CYP3A4 Għadu ma sar ebda studju biex jevalwa l- effett ta ’ impedituri moderati ta CYP3A4 (eż. amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, meraq tal- grejpfrut, verapamil) fuq il - farmakokinetika ta ’ fesoterodine.
CYP3A4 Inducers 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.
Stimulaturi ta ’ CYP3A4 Wara stimulazzjoni ta ’ CYP3A4 li rriżultat bl- għoti flimkien ta ’ rifamicin 600 mg darba kuljum, is - Cmax u l- AUC tal- metabolit attiv ta ’ fesoterodine naqas b’ madwar 70% u 75% rispettivament wara l - għoti orali ta ’ 8 mg fesoterodine
CYP2D6 Inhibitors The interaction with CYP2D6 inhibitors was not tested clinically.
Impedituri ta ’ CYP2D6s Ma sar l- ebda studju kliniku fuq l- interazzjoni ma ’ impedituri ta ’ CYP2D6.
Reproductive toxicity studies with fesoterodine in animals show minor embryotoxicity (see section 5.3).
Studji fuq bhejjem dwar tossiċità fis- sistema riproduttiva b’ fesoterodine fuq bhejjem urew tossiċità minuri fl- embriju( ara sezzjoni 5. 3).
The majority of ADRs occurred during the first month of treatment with the exception of cases classified as urinary retention or post void residual urine
Il- maġġoranza ta ’ reazzjonijiet avversi seħħew fl- ewwel xahar tat- trattament, bl- eċċezzjoni tal- każijiet ikklassifikati bħala żamma ta ’ l- awrina
15 greater than 200 ml, which could occur after long term treatment and was more common in male than female subjects.
15 jew li kellhom volum ta ’ awrina residwali ogħla minn 200 ml wara l- iżvojtjar tal- bużżieqa li seta ’ jiġri wara żmien twil ta ’ trattament li kienu iktar komuni fl- irġiel milli fin- nisa.
The table below gives the frequency of treatment emergent adverse reactions from placebo-controlled clinical trials.
It- tabella t’ hawn taħt turi l- frekwenza ta ’ effetti avversi li tfaċċaw waqt studji kontrollati bi plaċebo.
The adverse reactions reported in this table are those events that were very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10) or uncommon (≥ 1/ 1,000 to < 1/ 100).
L - effetti avversi rapportati f’ din it- tabella huma kklassifikati bħala komuni ħafna (≥1/ 10), komuni (≥1/ 100 sa < 1/ 10) jew mhux komuni (≥1/ 1, 000 sa < 1/ 100).
Nervous system disorders
Disturbi marbuta fis- sistema nervuża Disturbi marbuta fl - għajnejn
Dizziness; Headache
Sturdamenti; Uġigħ ta ’ ras Għajnejn xotti
Dysgeusia; Somnolence
Disgewsja; Ngħas
Eye disorders Ear and labyrinth disorders
Disturbi marbuta fil- widnejn u s- sistema labirintika
Urinary tract infection Fatigue
Infezzjoni tal- passaġġ urinarju Għejja
Hepatobiliary disorders
Disturbi fil- fwied u fil - marrara Disturbi psikjatriċi * 5 każijiet jew aktar
ALT increased; GGT increased
Nuqqas ta ’ rqad
Psychiatric disorders *5 or more cases
Żieda fl- ALT; Żieda fil- GGT
In clinical trials of fesoterodine, cases of markedly elevated liver enzymes were reported with the occurrence frequency no different from the placebo group.
Fi studji kliniċi b’ fesoterodine, każijiet innotati ta ’ enzimi tal- fwied elevati sew kienu rrapportati mingħajr ebda differenza fil- frekwenza ta ’ każijiet mill- grupp li ħa l- plaċebo.
The relation to fesoterodine treatment is unclear.
Ir- relazzjoni mat - trattament ta ’ Fesoterodine m’ hix ċara
The incidence rates of QTc ≥ 500 ms post baseline or QTc increase of ≥ 60 ms is 1.9%, 1.3%, 1.4% and 1.5%, for fesoterodine 4 mg, 8 mg, 12 mg and placebo, respectively.
16 1. 9%, 1. 3%, 1. 4% u 1. 5%, għal Fesoterodine 4 mg, 8 mg, 12 mg u plaċebo rispettivament.
16 is recommended; standard supportive measures for managing QT prolongation should be adopted.
Fil- każ ta ’ doża eċċessiva huwa rakkomandat li l- ECG ikun monitorat; miżuri ta ’ appoġġ standard għall- immaniġġar tat- titwil ta ’ l- intervall QT għandhom jiġu adottati.
Severe central anticholinergic effects (e. g. hallucinations, severe excitation): treat with physostigmine
Effetti anti- kolinergiċi ċentrali qawwijin ħafna (eż. alluċinazjonijiet, eċitament kbir): ittratta b’ physostigmine Konvulżjonijiet jew eċitament qawwi ħafna: ittratta b’ benzodiazepines
- - - - -
− − − −
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.
Żamma ta ’ l- awrina: ittratta billi ddaħħal kateter Midrijasi: ittratta bi qtar tal- għajnejn pilocarpine u/ jew poġġi l- pazjent f’ kamra mudlama.
Urinary antispasmodics, ATC code:
Antispasmodiċi urinarji, Kodiċi ATC:
Likewise, the response rate (% of patients reporting that their condition has been “ greatly improved” or “ improved” using a 4-point Treatment Benefit Scale) was significantly greater with fesoterodine compared to placebo.
Hekk ukoll, ir- rata ta ’ respons (% perċentwali ta ’ pażjenti li rrapportaw li l- kondizjoni tagħhom “ tjiebet ħafna ” jew “ tjiebet ”, ikkalkulata skond l- Iskala Ta ’ Siwi tat- Trattament ta ’ 4 punti) kienet sinifikament ogħla b’ fesoterodine meta mqabbla ma ’ plaċebo.
Furthermore, fesoterodine improved the mean change in the voided volume per micturition, and the mean change in the number of continent days per week (see Table 1 below).
Barra minn hekk, fesoterodine tejjeb il - bidla medja tal- volum ta ’ l- awrina li kien prodott ma ’ kull mikturazjoni, u l- bidla fil- medja fl- għadd ta ’ jiem li ma kellhomx episodji ta ’ inkontinenza fil- ġimgħa (ara Tabella 1 taħt).
Parameter
4 mg
Active
Attiv
Placebo Fesoterodine4 mg Fesoterodine Active Placebo
4 mg 8 mg Attiv 4 mg
Fesoterodine Fesoterodine
8 mg
12.0 -1.02
12. 0
53.4%
53. 4%
74.7%
74. 7%
79.0%
79. 0%
72.4%
72. 4%
45.1%
45. 1%
63.7%
63. 7%
74.2%
74. 2%
17 p-value
valur- p
Metabolism After oral administration, fesoterodine is rapidly and extensively hydrolysed to its active metabolite.
Il- medja tal- volum ta ’ distribuzzjoni fiss wara infużjoni ġol- vina tal- metabolit attiv hu 1691.
18 N-desisopropyl metabolite with involvement of CYP2D6 and CYP3A4.
18 Metaboliżmu Wara l- għoti mill- ħalq, fesoterodine huwa idrolizzat malajr u estensivament biex jifforma l- metabolit attiv.
TOVIAZ 8 mg tablets are packed in aluminium-aluminium blisters in cartons containing 7, 14, 28, 56, 84 or 98 tablets.
Il- pilloli TOVIAZ ta ’ 8 mg huma ppakjati f’ folji ta ’ l- aluminju/ aluminju f’ kartun li fihom 7, 14, 28, 56, 84 jew 98 pillola.
In addition, TOVIAZ 8 mg tablets are also packed in HDPE bottles containing 30 or 90 tablets.
Barra minn hekk, il- pilloli TOVIAZ 8mg huma wkoll ippakkjati ġewwa fliexken ta ’ HDPE li fihom 30 jew 90 pillola.
35 89257 Illertissen Germany
35 89257 Illertissen Il- Ġermanja
The MAH must ensure that the system of pharmacovigilance, as described in version 1.1 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jassigura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ versjoni 1. 1 ppreżentata f’ sezzjoni 1. 8. 1 ta ’ l- applikazzjoni għat - tqegħid fis- suq, taħdem sewwa qabel u waqt li l- prodott qiegħed fuq is- suq.
Outer Carton 4 mg
Kartuna ta ’ Barra 4mg
TOVIAZ 4 mg prolonged-release tablets fesoterodine fumarate
TOVIAZ 4 mg pilloli li jerħu l- mediċina bil- mod fesoterodine fumarate
STATEMENT OF ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA (I) ATTIVA
1 tablet contains 4 mg fesoterodine fumarate
Pillola 1 fiha 4 mg fesoterodine fumarate
Contains lactose and soya lecithin: see the package leaflet for further information.
Fih lactose u soya lecithin: ara l- fuljett ta ’ tagħrif għal aktar informazzjoni.
7 prolonged-release tablets 14 prolonged-release tablets 28 prolonged-release tablets 56 prolonged-release tablets 84 prolonged-release tablets 98 prolonged-release tablets
7 pilloli li jerħu l- mediċina bil- mod 14- il pillola li jerħu l- mediċina bil- mod 28 pillola li jerħu l- mediċina bil- mod 56 pillola li jerħu l- mediċina bil- mod 84 pillola li jerħu l- mediċina bil- mod 98 pillola li jerħu l- mediċina bil- mod
Sealed pack Do not use if box has been opened
Tużax jekk il- kaxxa tkun diġà infetħet.
Do not store above 25oC.
Taħżinx f’ temperatura ’ l fuq minn 25oC.
Store in the original package to protect from moisture.
Aħżen fil- pakkett oriġinali biex tilqa ’ mill- umdità.
EU/ 1/ 07/ 386/ 001 7 tablets EU/ 1/ 07/ 386/ 002 14 tablets EU/ 1/ 07/ 386/ 003 28 tablets EU/ 1/ 07/ 386/ 004 56 tablets EU/ 1/ 07/ 386/ 005 98 tablets EU/ 1/ 07/ 386/ 011 84 tablets
EU/ 1/ 07/ 386/ 001 7 pilloli EU/ 1/ 07/ 386/ 002 14- il pillola EU/ 1/ 07/ 386/ 003 28 pillola EU/ 1/ 07/ 386/ 004 56 pillola EU/ 1/ 07/ 386/ 005 98 pillola EU/ 1/ 07/ 386/ 011 84 pillola
Blister label 4 mg
Tikketta tal- folja 4mg
Immediate Packaging HDPE Bottle – 4 mg
Pakkett li jmiss mal- prodott - Flixkun ta ’ HDPE – 4 mg
1 tablet contains 4 mg fesoterodine fumarate
Pilolla 1 fiha 4 mg fesoterodine fumarate
30 prolonged-release tablets 90 prolonged-release tablets
30 pilloli li jerħu l- mediċina bil- mod 90 pilloli li jerħu l- mediċina bil- mod
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT TQEGĦID FIS- SUQ
EU/ 1/ 07/ 386/ 013 30 tablets EU/ 1/ 07/ 386/ 014 90 tablets
EU/ 1/ 07/ 386/ 013 30 pilloli EU/ 1/ 07/ 386/ 014 90 pilloli
30 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
30 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Outer Carton 8 mg
Kartuna ta ’ Barra 8mg
TOVIAZ 8 mg prolonged-release tablets fesoterodine fumarate
TOVIAZ 8 mg pilloli li jerħu l- mediċina bil- mod fesoterodine fumarate
1 tablet contains 8 mg fesoterodine fumarate
Pillola 1 fiha 8 mg fesoterodine fumarate
Contains lactose and soya lecithin: see the package leaflet for further information.
Fih lactose u soya lecithin: ara l- fuljett ta ’ tagħrif għal aktar informazzjoni
EU/ 1/ 07/ 386/ 006 7 tablets EU/ 1/ 07/ 386/ 007 14 tablets EU/ 1/ 07/ 386/ 008 28 tablets EU/ 1/ 07/ 386/ 009 56 tablets EU/ 1/ 07/ 386/ 010 98 tablets EU/ 1/ 07/ 386/ 012 84 tablets
EU/ 1/ 07/ 386/ 006 7 pilloli EU/ 1/ 07/ 386/ 007 14- il pillola EU/ 1/ 07/ 386/ 008 28 pillola EU/ 1/ 07/ 386/ 009 56 pillola EU/ 1/ 07/ 386/ 010 98 pillola EU/ 1/ 07/ 386/ 012 84 pillola
32 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
32 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blister label 8 mg
Tikketta tal- folja 8mg
33 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
33 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Immediate Packaging HDPE Bottle – 8 mg
Pakkett li jmiss mal- prodott - Flixkun ta ’ HDPE – 8 mg
1 tablet contains 8 mg fesoterodine fumarate
Pilolla 1 fiha 8 mg fesoterodine fumarate
EU/ 1/ 07/ 386/ 015 30 tablets EU/ 1/ 07/ 386/ 016 90 tablets
EU/ 1/ 07/ 386/ 015 30 pilloli EU/ 1/ 07/ 386/ 016 90 pilloli
TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets
TOVIAZ 4 mg Pilloli li jerħu l- mediċina bil- mod TOVIAZ 8 mg Pilloli li jerħu l- mediċina bil- mod
if their symptoms are the same as yours.
anki jekk ikollhom l- istess sintomi bħal tiegħek
What TOVIAZ is and what it is used for 2.
X’ inhu TOVIAZ u għalxiex jintuża 2.
Before you take TOVIAZ 3.
Qabel ma tieħu TOVIAZ 3.
How to take TOVIAZ 4.
Kif għandek tieħu TOVIAZ 4.
How to store TOVIAZ 6.
Kif taħżen TOVIAZ 6.
WHAT TOVIAZ IS AND WHAT IT IS USED FOR
X’ INHU TOVIAZ U GĦALXIEX JINTUŻA
TOVIAZ is a so called antimuscarinic medicinal product which reduces the activity of an overactive bladder and treats the symptoms.
TOVIAZ huwa prodott mediċinali li jissejaħ antimuskariniku, li jnaqqas l- attivita eċċessiva tal - bużżieqa ta ’ l- awrina u jittratta s- sintomi.
TOVIAZ treats the symptoms of an overactive bladder such as • not being able to control when you empty your bladder (called urgency incontinence) • suddenly needing to empty your bladder (called urgency) • having to empty your bladder more than usual (called increased urinary frequency)
TOVIAZ jittratta s- sintomi ta ’ bużżieqa ta ’ l- awrina li hi attiva wisq bħal ma huma • nuqqas ta ’ kontroll meta tbattal il- bużżieqa ta ’ l- awrina (magħruf bħala inkontinenza ta ’ urġenza) • ħtieġa qawwija f’ daqqa li tbattal il- bużżieqa (msejħa urġenza) • ikollok tbattal il- bużżieqa aktar ta ’ spiss mis- soltu (msejħa żieda fil- frekwenza urinarja)
BEFORE YOU TAKE TOVIAZ
QABEL MA TIEĦU TOVIAZ
Do not take TOVIAZ
Tieħux TOVIAZ
- if you are allergic (hypersensitive) to fesoterodine or to peanut or soya or to any of the other
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal fesoterodine jew għal karawett jew
ingredients of TOVIAZ (see section 2, “ Important information about some of the ingredients of TOVIAZ”)
għal soja jew għal xi wieħed mis- sustanzi l- oħra ta ’ TOVIAZ (ara sezzjoni 2, “ Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ TOVIAZ ”)
- if you are not able to completely empty your bladder (urinary retention)
- jekk ma tistax tbattal kompletament l- bużżieqa ta ’ l- awrina (żamma ta ’ l- awrina)
- if your stomach empties slowly (gastric retention)
- jekk l- istonku tiegħek jitbattal bil- mod (żamma gastrika)
- if you have an eye disease called narrow angle glaucoma (high pressure in the eye), which is not
- jekk għandek il- marda ta ’ l- għajnejn imsejħa glawkoma ta ’ l- angolu dejjaq (pressjoni għolja
under control
ġewwa l- għajn) li m’ hix ikkontrollata
- if you have excessive weakness of the muscles (myasthenia gravis)
- jekk għandek dgħjufija eċċessiva tal- muskoli (majestenja gravis)
- if you have ulceration and inflammation of the colon (severe ulcerative colitis)
- jekk għandek ulċerazjoni u infjammazzjoni tal- kolon (kolite ulċerattiva qawwija)
- if you have an abnormally large or distended colon (toxic megacolon)
- jekk għandek kolon ikbar minn normal jew minfuħ (megakolon tossiku)
- if you have severe liver problems.
- jekk għandek problemi serji tal- fwied.
Take special care with TOVIAZ Fesoterodine may not always be suitable for you.
Oqgħod attent ħafna b’ TOVIAZ Jista ’ jkun li fesoterodine mhux dejjem ikun adattat għalik.
Talk to your doctor before you take TOVIAZ, if any of the following apply to you:
Kellem lit- tabib tiegħek qabel ma tieħu TOVIAZ, jekk xi wieħed minn dawn li ġejjin japplika għalik:
- if you have difficulties in completely emptying your bladder
- jekk ikollok diffikultà tbattal kompletament il- bużżieqa ta ’ l- awrina
- if you have serious kidney or liver problems, your doctor may need to adjust your dose
- jekk għandek tnaqqis fil- moviment ta ’ l- imsaren jew tbati minn stitikezza qawwija
changes in your blood pressure or disorders in the bowel or sexual function
- jekk qed tkun ittrattat għall- marda ta ’ l- għajnejn li tissejjaħ glawkoma ta ’ l- angolu dejjaq
- if you have a gastrointestinal disease that affects the passage and/ or digestion of food
- jekk għandek mard serju tal- kliewi jew fwied, it- tabib għandu mnejn jirranġa d- doża
- if you have heartburn or belching.
- jekk għandek marda msejħa newropatija autonomika li tinnutaha minn sintomi bħall- bdil fil -
Talk to your doctor if you suffer from any of the following conditions
pressjoni tad- demm tiegħek, u disturbi ta ’ l- imsaren jew il- funzjoni sesswali
- you have an ECG (heart tracing) abnormality known as QT prolongation or you are taking any
- jekk għandek mard gastrointestinali li jaffettwa l- passaġġ u/ jew id- diġestjoni ta ’ l- ikel
medicine known to cause this
- jekk għandek ħruq ta ’ stonku jew tifwiq.
- you have a slow heart rate (bradycardia)
Problemi fil- qalb:
- you suffer from heart disease such as myocardial ischaemia (reduced blood flow to the heart
Kellem lit- tabib jekk tbati minn xi wieħed minn dawn li ġejjin: − jekk għandek ECG (jittraċċa l- funzjoni tal- qalb) mhux normali magħruf bħala titwil tal- QT jew qed tuża xi mediċina magħrufa li tikkawża dan − jekk għandek rata ta ’ taħbit tal- qalb baxxa (bradikardja) − jekk tbati minn xi marda tal- qalb bħal iskimja mijokardijaka (ċirkolazzjoni baxxa tad- demm għall- muskolu tal- qalb), taħbit tal- qalb irregolari jew insuffiċjenza tal- qalb − għandek livelli baxxi ħafna ta ’ potassju fid- demm
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines you do not have a prescription for.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Your doctor will tell you whether you can take TOVIAZ with other medicines.
It- tabib ikun jista ’ jgħidlek jekk tistax tieħu TOVIAZ ma ’ mediċini oħrajn.
Please inform your doctor if you are taking medicines according to the following list.
Jekk jogħġbok għid lit- tabib jekk qiegħed tieħu mediċini skond il- lista hawn taħt.
Concomitant treatment with fesoterodine may make side effects such as dry mouth, constipation, difficulty in completely emptying your bladder or drowsiness more serious or occur more often.
Użu flimkien ma ’ fesoterodine jista jikkawża l- effetti sekondarji bħal ħalq xott, stitikezza, diffikulta biex tbattal il - bużżieqa ta ’ l- awrina kompletament jew ħedla jkunu iktar serji jew jiġru aktar spiss.
- medicines containing the active substance amantadine (used to treat Parkinson’ s disease)
- mediċini li fihom is- sustanza attiva amantadine (li tintuża biex titratta l- marda ta ’ Parkinson)
- certain medicines used to enhance gastrointestinal motility or to relieve stomach cramps or spasm
- ċertu mediċini li jintużaw biex iqanqlu l- moviment gastrointestinali jew biex itaffu il -
and to prevent travel sickness
bugħawwieġ jew l- ispażmi ta ’ l- istonku u biex jipprevjenu dardir għal matul l- ivjaġġar
- certain medicines used to treat psychiatric diseases.
- ċertu mediċini li jittrattaw mard psikjatriku.
Please also inform your doctor if you are taking any of the following medicines:
Jekk jogħġbok informa lit- tabib jekk qiegħed tieħu uħud minn dawn il- mediċini:
- medicines containing any of the following active substances may increase the break-down of
- mediċini li fihom uħud minn dawn is- sustanzi attivi jistgħu jżidu r- rata tal- metaboliżmu ta ’
fesoterodine and thus decrease its effect:
fesoterodine u b’ hekk inaqqsu l- effett tiegħu:
John’ s Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy)
John’ s Wort (prodott mediċinali bbażat fuq il - hxejjex), rifampicin (użat għat- trattament ta ’ infezzjonijiet batteriċi), carbamazepine, phenytoin u Phenobarbital (użati, fost affarijiet oħra għat- trattament ta ’ l- epilessija)
- medicines containing any of the following active substances may increase the blood levels of
- mediċini li fihom uħud minn dawn is- sustanzi attivi jistgħu jżidu il- livelli ta ’ fesoterodine fid -
fesoterodine: itraconazole or ketoconazole (used to treat fungal infections), ritonavir, atazanavir, indinavir, saquinavir or nelfinavir (antiviral medication for treating HIV), clarithromycin or telithromycin (used to treat bacterial infections) and nefazodone (used to treat depression)
Itraconazole jew ketoconazole (użati biex jittrattaw infezzjonijiet tal- fungu), ritonavir, atazanavir, indinavir, saquinavir jew nelfinavir (mediċini anti- virali użati għat- trattament ta ’ HIV), clarithromycin jew telithromycin (użati għat- trattament ta ’ infezzjonijiet batteriċi) jew nefazodone (użat għat- trattament tad- depressjoni)
- medicines containing any of the following active substances may also slightly increase the blood
- mediċini li fihom uħud minn dawn is- sustanzi attivi jistgħu jżidu ftit il- livelli ta ’ fesoterodine
levels of fesoterodine: amprenavir or fosamprenavir (antiviral medication for treating HIV), fluconazole (used to treat fungal infections), erythromycin (used to treat bacterial infections), aprepitant (medicine to prevent nausea), diltiazem and verapamil (medicines to treat angina and high blood pressure)
fid- demm: amprenavir jew fosamprenavir (mediċini anti- virali għat- trattament ta ’ HIV), fluconazole (użat biex jittratta infezzjonijiet tal- fungu), erythromycin (użat sabiex jittratta infezzjonijiet batteriċi), aprepitant (mediċina li tipprevjeni n- nawsja), diltiazem u verapamil (mediċini biex jittrattaw l- anġina u pressjoni għolja)
- medicines containing the active substance methadone (used in the treatment of severe pain and abuse
- mediċini li fihom is- sustanza attiva methadone (użata fit- trattament ta ’ uġiegħ qawwi u
problems).
problemi ta ’ abbuż)
Taking TOVIAZ with food and drink TOVIAZ can be taken with or without food.
Meta tieħu TOVIAZ ma 'l- ikel u xorb TOVIAZ jista ’ jittieħed ma ’ l- ikel jew mingħajru.
However, grapefruit juice should be avoided since grapefruit juice may alter the effect of the medicine.
Imma, l- meraq tal- grejpfrut għandu jiġi evitat minħabba li jista ’ jbiddel l- effett tal- mediċina.
Pregnancy and breast-feeding You should not take TOVIAZ if you are pregnant, as the effects of fesoterodine on pregnancy and the unborn baby are not known.
Tqala u Treddigħ M’ għandekx tieħu TOVIAZ jekk inti tqila, peress li l- effetti ta ’ fesoterodine fuq t- tarbija li għada ma twielditx m’ humiex magħrufin.
Tell your doctor if you are pregnant or planning to become pregnant.
Għid lit- tabib tiegħek jekk inti tqila jew qed tippjana li tinqabad tqila.
It is not known whether fesoterodine is excreted into human milk; therefore, breast-feeding is not recommended during treatment with TOVIAZ.
M’ hux magħruf jekk fesoterodine jiġiex eliminat ġol- ħalib tal- bniedem; għalhekk treddigħ mhux rakkomandat waqt użu ta ’ TOVIAZ.
Ask your doctor or pharmacist for advice before taking any medicine.
38 Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
38 Driving and using machines TOVIAZ can cause blurred vision, dizziness, and sleepiness.
Sewqan u tħaddim ta 'magni TOVIAZ jista ’ jikkaġuna vista mċajpra, sturdament u ngħas.
If you experience any of these effects, do not drive or use any tools or machines.
Jekk tbati minn xi effetti bħal dawn, issuqx u tużax għodda jew magni.
Important information about some of the ingredients of TOVIAZ TOVIAZ contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'TOVIAZ TOVIAZ fih lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal ċerti tipi ta 'zokkor, ikkuntattja lit- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
TOVIAZ contains soya oil.
TOVIAZ fih iż- żejt tas- soja.
If you are allergic to peanut or soya, do not use this medicinal product.
Jekk inti allerġiku għall- karawett jew soja, tieħux dan il- prodott mediċinali.
HOW TO TAKE TOVIAZ
KIF GĦANDEK TIEĦU TOVIAZ
Always take TOVIAZ exactly as your doctor has told you.
Dejjem għandek tieħu TOVIAZ eżatt kif qallek it- tabib tiegħek.
The recommended starting dose of TOVIAZ is one 4 mg tablet a day.
Id- doża rakkomandata tal- bidu ta ’ TOVIAZ hi ta ’ pillola waħda ta ’ 4 mg kuljum.
Based on how you respond to the medicine, your doctor may prescribe you a higher dose; one 8 mg tablet a day.
Skond kif tirrispondi għall- mediċina, it- tabib jista ’ jzid id- doża sa pillola waħda ta ’ 8 mg kuljum.
You should swallow your tablet whole with a glass of water.
Għandek tibla ’ il- pillola sħiħa b’ tazza ilma.
Do not chew the tablet.
M’ għandekx tomgħod il- pillola.
To help you remember to take TOVIAZ, you may find it easier to take it at the same time every day.
Sabiex tiftakar li għandek tieħu TOVIAZ, għandek mnejn issibha aktar faċli li tieħu l- pillola fl- istess ħin kuljum.
If you take more TOVIAZ than you should If you have taken more tablets than you have been told to take, or if someone else accidentally takes your tablets, contact your doctor or hospital for advice immediately.
Jekk tieħu TOVIAZ aktar milli suppost Jekk ħadt iktar pilloli milli suppost, jew jekk xi ħadd ieħor jieħu l- pilloli tiegħek bi żball, għarraf mill - ewwel it- tabib tiegħek jew sptar għal parir.
If you forget to take TOVIAZ If you forget to take a tablet, take your tablet as soon as you remember, but do not take more than one tablet in one day.
Jekk tinsa tieħu TOVIAZ Jekk tinsa tieħu pillola, ħudha malli tiftakar, imma tieħux iktar minn pillola waħda f’ ġurnata.
Do not take a double dose to make up for a forgotten tablet.
Tieħux doża doppja biex tpatti għall- pillola li tkun insejt tieħu.
If you stop taking 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.
Jekk tieqaf tieħu TOVIAZ Twaqqafx TOVIAZ mingħajr ma tgħarraf it- tabib tiegħek għaliex is- sintomi tiegħek ta ’ bużżieqa ta ’ l - awrina attiva ħafna jistgħu jerġgħu jitfaċċaw, u jmorru għall- agħar ladarba tieqaf tieħu TOVIAZ.
Like all medicines, TOVIAZ can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, TOVIAZ jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common side effects (more than one in 10 patients) You may get a dry mouth.
Effetti sekondarji komuni ħafna (aktar minn wieħed f’ kull 10 pazjenti) Jista ’ jkollok ħalq xott.
This effect is usually mild or moderate.
Dan l- effett jista ’ jkun ħafif jew moderat.
This may lead to a greater risk of dental caries.
Dan jista jwassal għal riskju akbar ta ’ problemi tas- snien.
Therefore, you should brush your teeth regularly with fluoride toothpaste twice daily.
Għalekk huwa rakkomandat li taħsel snienek regolarment b’ pejst għat- tindif tas- snien tal- fluoride darbtejn kuljum.
Common side effects (between one in 100 patients and one in 10 patients) • dry eye • constipation • trouble digesting food (dyspepsia) • straining or pain when emptying the bladder (dysuria) • dizziness • headache • pain in the stomach • diarrhoea • feeling sick (nausea)
Effetti sekondarji komuni (bejn wieħed f’ 100 pazjent u wieħed f’ 10 pazjenti) • għajnejn xotti • stitikezza • problemi fid- diġestjoni tal- ikel (dispepsja) • tqanżih jew uġigħ waqt il- passaġġ ta ’ l- awrina (disurja) • sturdament
39
39 • uġigħ ta ’ ras • uġigħ f ’ l- istonku • dijarea • dardir (nawsja) • problemi ta ’ rqad (nuqqas ta ’ rqad) • grieżmejn xotti
Uncommon side effects (occuring in 1 in 1,000 to 1 in 100 patients) • urinary tract infection • sleepiness (somnolence) • difficulty tasting (dysgeusia) • vertigo • rash • dry skin • an uncomfortable feeling in the stomach • wind (flatulence) • difficulty in completely emptying the bladder (urinary retention) • delay in passing urine (urinary hesitation) • extreme tiredness (fatigue) • increased heart beat (tachycardia) • liver problems • cough • nasal dryness • throat pain
Effetti sekondarji mhux komuni (li jseħħu f’ 1 minn 1, 000 sa 1 f’ 100 pazjent) • infezzjoni fil- passaġġ urinarju • ħedla (somnolenza) • problemi fis- sens tat - togħma (disgewsja) • vertigo • raxx • ġilda xotta • dwejjaq fl- istonku • gass (gass fl- istonku) • diffikultà biex tbattal kompletament il- bużżieqa ta ’ l- awrina (żamma urinarja) • dewmien fil- passagg ta ’ l- awrina (eżitazjoni urinarja) • għeja eċċessiva (għeja) • żieda fir- rata tat- taħbit tal- qalb (takikardja) • problemi fil- fwied • sogħla • nixfa ġo l- imnieħer • uġigħ fil- griżmejn
HOW TO STORE TOVIAZ
KIF TAĦŻEN TOVIAZ
Do not use TOVIAZ after the expiry date which is stated on the carton and the blister after “EXP”.
Tużax TOVIAZ wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folja wara "JIS".
Do not store above 25°C.
Taħżinx f' temperatura 'il fuq minn 25°C.
What TOVIAZ contains
X' fih TOVIAZ
The active substance is fesoterodine fumarate.
• Is- sustanza attiva hi fesoterodine fumarate.
TOVIAZ 4 mg 1 prolonged-release tablet contains 4 mg fesoterodine fumarate, equivalent to 3.1 mg of fesoterodine.
TOVIAZ 8 mg
TOVIAZ 8 mg 1 prolonged-release tablet contains 8 mg fesoterodine fumarate, equivalent to 6.2 mg of fesoterodine.
40 • Pillola 1 li terħi l- mediċina bil- mod fiha 8 mg Fesoterodine fumerate li hu ekwivalenti għal 6. 2mg ta ’ fesoterodine.
The tablet core: xylitol, lactose monohydrate, microcrystalline cellulose, hypromellose, glycerol dibehenate, talc.
Il- qalba tal- pillola: xylitol, lactose monohydrate, microcrystalline cellulose, hypromellose, glycerol dibehenate, talc.
40 The coating: polyvinyl alcohol, titanium dioxide, macrogol, talc, soya lecithin, indigo carmine aluminium lake (E132)
Il- kisja: polyvinyl alcohol, titanium dioxide, macrogol, talc, soya lecithin, indigo carmine aluminium lake (E132
What TOVIAZ looks like and contents of the pack
Id- dehra ta 'TOVIAZ u d- daqs tal- pakkett
TOVIAZ 4 mg prolonged-release tablets are light blue, oval, curved outwards on both sides, film- coated tablets, and engraved on one side with the letters ‘FS’.
TOVIAZ 4 mg, pilloli li jerħu l- mediċina bil- mod, huma ta ’ kulur kaħlani ċar, ovali, imbuzzati fuq iż - żewg naħat, miksijin b’ rita trasparenti u mnaqqxin fuq naħa waħda bl- ittri ‘ FS ’.
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, pilloli li jerħu l- mediċina bil- mod, huma ta ’ kulur kaħlani, ovali, imbuzzati fuq iż - żewg naħat, miksijin b’ rita trasparenti u mnaqqxin fuq naħa waħda bl- ittri ‘ FT ’.
TOVIAZ is available in blister packs of 7, 14, 28, 56, 84 and 98 prolonged-release tablets.
TOVIAZ jinsab fi folji ta ’ 7, 14, 28, 56, 84 u 98 pillola li jerħu l- mediċina bil- mod.
In addition, TOVIAZ is also available in HDPE bottles containing 30 or 90 tablets.
Barra minn hekk, TOVIAZ jinsab ukoll fi fliexken ta ’ HDPE li fihom 30 jew 90 pillola.
Please note that not all the above pack sizes may be marketed.
Jekk jogħġbok innota li mhux il- pakketti tad- daqsijiet kollha msemmijin hawn fuq huma għal skop kummerċjali.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - mediċini (EMEA) http: // www. emea. europa. eu /.
What is TOVIAZ?
X’ inhu TOVIAZ?
TOVIAZ is a medicine containing the active substance fesoterodine.
TOVIAZ huwa mediċina li fiha s- sustanza attiva fesoterodine.
It is available as prolonged- release oval 4 mg tablets (light blue) and 8 mg tablets (blue).
Jiġi bħala pilloli ovali ta ’ 4 mg (blu ċar) u ta ’ 8 mg (blu) b’ rilaxx fit- tul.
Prolonged-release means that fesoterodine is released slowly from the tablet over a few hours.
Rilaxx fit- tul ifisser li fesoterodine jiġi rilaxxat bil- mod mill- pillola fuq perjodu ta ’ ftit sigħat.
What is TOVIAZ used for?
Għalxiex jintuża TOVIAZ?
TOVIAZ is used in patients with overactive bladder syndrome to treat the symptoms of the disease: increased urinary frequency (need to urinate frequently), urgency (sudden urge to pass urine), and urgency incontinence (sudden lack of control over urination).
TOVIAZ jintuża f’ pazjenti bis- sindrome tal- bużżieqa ta ’ l- awrina attiva żżejjed biex jiġu kkurati s - sintomi tal- marda: frekwenza akbar ta ’ l- awrina (bżonn li tagħmel l- awrina ta ’ spiss), urġenza (xewqa f’ daqqa biex tagħmel l- awrina) u inkontinenza ta ’ l- urġenza (nuqqas għal għarrieda ta ’ kontroll l - għamil ta ’ l- awrina).
How is TOVIAZ used?
Kif jintuża TOVIAZ?
The recommended starting dose of TOVIAZ is 4 mg once a day.
Id- doża tal- bidu rakkomandata ta ’ TOVIAZ hi 4 mg darba kuljum.
The tablets are swallowed whole with a glass of water, must not be chewed, and can be taken with or without food.
Il- pilloli jinbelgħu sħaħ ma ’ tazza ilma, ma jridux jiġu mimgħuda, u jistgħu jittieħdu ma ’ l- ikel jew waħedhom.
The patient normally gets the full effect of the treatment after two to eight weeks.
Il- pazjent normalment jieħu l- effett sħiħ tal- kura wara żewġ sa tmien ġimgħat.
Based upon individual response, the dose may be increased to 8 mg once daily.
Fuq il- bażi tar- rispons individwali, id- doża tista ’ tiżdied għal tmien mg darba kuljum.
The dose of TOVIAZ must be adjusted, or the medicine not used, in patients with problems with their kidneys or liver, especially when they are also receiving at the same time other medicines that may affect the way TOVIAZ is broken down in the body.
Id- doża ta ’ TOVIAZ trid tiġi aġġustata, jew il- mediċina ma tintużax, f’ pazjenti li jkollhom problemi bil- kliewi jew fwied tagħhom, speċjalment meta jkunu qegħdin jirċievu wkoll fl- istess ħin mediċini oħra li jistgħu jaffettwaw il- mod kif TOVIAZ jiġi mkisser fil- ġisem.
How does TOVIAZ work?
Kif jaħdem TOVIAZ?
The active substance in TOVIAZ, fesoterodine, is an anticholinergic medicine.
Is- sustanza attiva f’ TOVIAZ, fesoterodine, hija mediċina antikolinerġika.
It blocks some receptors in the body, the muscarinic receptors, and in the bladder, this causes the muscles that push urine out of the bladder to relax.
Hija timblokka ċerti riċetturi fil- ġisem, ir- riċetturi muskariniċi, u fil- bużżieqa ta ’ l- awrina, dan iġiegħel lill- muskoli li jimbuttaw l - awrina ’ l barra mill- bużżieqa jirrilassaw.
This leads to an increase in the capacity of the bladder, and to changes in the way the bladder muscles contract as the bladder fills up.
Dan iwassal għal żieda fil- kapaċità tal- bużżieqa ta ’ l- awrina, u għal bidliet fil- mod kif il- muskoli tal- bużżieqa ta ’ l- awrina jinġibdu hekk kif il- bużżieqa timtela.
This helps TOVIAZ to prevent unwanted urination.
Dan jgħin lil TOVIAZ jevita għamil mhux mixtieq ta ’ l- awrina.
How has TOVIAZ been studied?
Kif ġie studjat TOVIAZ?
The effects of TOVIAZ were first tested in experimental models before being studied in humans.
L- effetti ta ’ TOVIAZ l- ewwel ġew ittestjati f’ mudelli sperimentali qabel ma ġew studjati fil- bniedem.
The two main studies involved 1,964 patients (average age:
Iż- żewġ studji prinċipali kienu jinvolvu 1, 964 pazjent (età medja:
58 years) and compared the effectiveness of TOVIAZ (4 or 8 mg a day) with that of placebo (a dummy treatment).
58) u qabblu l- effikaċja ta ’ TOVIAZ (4 jew 8 mg kuljum) ma ’ dik tal- plaċebo (kura finta).
One of the studies also compared TOVIAZ with tolterodine (another medicine used in overactive bladder syndrome).
Il- kejl prinċipali
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged main measure of effectiveness was the change in the number of times the patients needed to urinate in a 24-hour period, before and after 12 weeks on the medicine.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged ta ’ l- effikaċja kien it- tibdil fl- għadd ta ’ drabi li l- pazjenti ħteġilhom jagħmlu l- awrina f’ perjodu ta ’ 24 siegħa, qabel u wara 12- il ġimgħa fuq il- mediċina.
What benefit has TOVIAZ shown during the studies?
X’ benefiċċju wera TOVIAZ matul l- istudji?
TOVIAZ was more effective than placebo and as effective as tolterodine in reducing the number of times the patients urinated in a 24-hour period.
TOVIAZ kien aktar effettiv mill- plaċebo u effettiv daqs tolterodine fit- tnaqqis ta ’ l- għadd ta ’ drabi li l - pazjenti għamlu l- awrina f’ perjodu ta ’ 24 siegħa.
Before treatment, patients needed to urinate about 12 times in 24 hours.
Qabel il- kura, il- pazjenti kellhom bżonn jagħmlu l - awrina madwar 12- il darba f’ 24 siegħa.
This number was decreased by 1.74 or 1.86 (4 mg dose) and by 1.94 (8 mg dose) after 12 weeks on TOVIAZ, and by 1.02 in patients receiving placebo.
Dan in- numru tnaqqas b’ 1. 74 jew 1. 86 (doża ta ’ 4 mg) u b’ 1. 94 (doża ta ’ 8 mg) wara 12- il ġimgħa fuq TOVIAZ, u b’ 1. 02 fil- pazjenti li ngħataw il- plaċebo.
The decrease seen in patients who received tolterodine was 1.69.
It - tnaqqis li deher fil- pazjenti li rċevew tolterodine kien 1. 69.
What is the risk associated with TOVIAZ?
X’ inhu r- riskju assoċjat ma ’ TOVIAZ?
The most common side effect with TOVIAZ (seen in more than 1 patient in 10) is dry mouth.
L- aktar effett sekondarju komuni b’ TOVIAZ (jidher f’ aktar minn 1 minn kull 10 pazjenti) huwa ħalq xott.
For the full list of all side effects reported with TOVIAZ, see the Package Leaflet.
Għal- lista kompleta ta ’ l- effetti sekondarji kollha rrapportati b’ TOVIAZ, ara l- Fuljett ta ’ Tagħrif.
TOVIAZ should not be used in people who may be hypersensitive (allergic) to fesoterodine, to peanut, to soya or to any of the other ingredients.
TOVIAZ m’ għandux jintuża f’ persuni li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal fesoterodine, għall- karawett, għas- sojja jew għal xi sustanzi oħra.
TOVIAZ should also not be used in patients with: • urinary retention (difficulty in passing urine), • gastric retention (when the stomach does not empty properly), • uncontrolled narrow-angle glaucoma (increased eye pressure even with treatment), • myasthenia gravis (a disease of the nerves causing muscle weakness), • severe hepatic impairment (severe liver disease), • severe ulcerative colitis (severe inflammation of the large intestine causing ulceration and bleeding), • toxic megacolon (a very serious complication of colitis).
TOVIAZ m’ għandux jintuża wkoll f’ pazjenti bi: • żamma ta ’ l- awrina (diffikultà biex tagħmel l- awrina), • żamma gastrika (meta l- istonku ma jitbattalx sewwa), • glawkoma ostruttiva mhux ikkontrollata (pressjoni għolja fl- għajn anki bil- kura), • myasthenia gravis (marda tan- nervi li tikkawża indeboliment tal- muskoli), • indeboliment akut tal- fwied (mard tal- fwied akut), • kolite ulċerattiva severa (infjammazzjoni akuta tal- musrana l- kbira li tikkawża tiġriħ u fsada), • megacolon tossiku (kumplikazzjoni serja ħafna tal- kolite).
TOVIAZ should not be given to patients with moderate liver or moderate to severe kidney disease at the same time as other medicines which have a strong blocking effect on one of the liver enzymes (CYP3A4).
TOVIAZ m’ għandux jingħata lil pazjenti b’ mard tal- fwied moderat jew mard tal- kliewi moderat għal sever fl- istess ħin ma ’ mediċini oħra li għandhom effett qawwi ta ’ imblokk fuq waħda mill- enzimi tal - fwied (CYP3A4).
These are medicines such as ketoconazole and itraconazole (used to treat fungal infections), atazanavir, indinavir, nelfinavir, ritonavir and saquinavir (medicines used in HIV-positive patients), clarithromycin and telithromycin (antibiotics), and nefazodone (used to treat depression).
Dawn huma mediċini bħal ketoconazole u itraconazole (użati għall- kura ta ’ infezzjonijiet fungali), atazanavir, indinavir, nelfinavir, ritonavir u saquinavir (mediċini użati f’ pazjenti bl- HIV), clarithromycin u telithromycin (antibijotiċi), u nefazodone (użat għall- kura tad - depressjoni).
Why has TOVIAZ been approved?
Għaliex ġie approvat TOVIAZ?
The Committee for Medicinal Products for Human Use (CHMP) decided that TOVIAZ’ s benefits are greater than its risks for the treatment of the symptoms (increased urinary frequency and/ or urgency and/ or urgency incontinence) that may occur in patients with overactive bladder syndrome.
Il- Kumitat dwar Prodotti Mediċinali għal Użu fil- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ TOVIAZ huma akbar mir- riskji tiegħu għall- kura tas- sintomi (frekwenza akbar ta ’ l- awrina u/ jew urġenza u/ jew inkontinenza ta ’ l- urġenza) li jistgħu jseħħu f’ pazjenti bis- sindrome tal- bużżieqa ta ’ l - awrina attiva żżejjed.
The Committee recommended that TOVIAZ be given marketing authorisation.
Il- Kumitat irrakkomanda li TOVIAZ jingħata l- awtorizzazzjoni għat- tqegħid fis - suq.
Other information about TOVIAZ:
Tagħrif ieħor dwar TOVIAZ:
The marketing authorisation holder is Pfizer Limited.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal TOVIAZ nhar l- 20 ta ’ April 2007.
The full EPAR for TOVIAZ can be found here.
L- EPAR sħiħ għal TOVIAZ jista ’ jinstab hawn.
EU/ 1/ 07/ 386/ 001 EU/ 1/ 07/ 386/ 002 EU/ 1/ 07/ 386/ 003 EU/ 1/ 07/ 386/ 004 EU/ 1/ 07/ 386/ 005 EU/ 1/ 07/ 386/ 006 EU/ 1/ 07/ 386/ 007 EU/ 1/ 07/ 386/ 008 EU/ 1/ 07/ 386/ 009 EU/ 1/ 07/ 386/ 010 EU/ 1/ 07/ 386/ 011 EU/ 1/ 07/ 386/ 012 EU/ 1/ 07/ 386/ 013 EU/ 1/ 07/ 386/ 014 EU/ 1/ 07/ 386/ 015 EU/ 1/ 07/ 386/ 016
Numru ta ’ l- EU EU/ 1/ 07/ 386/ 001 EU/ 1/ 07/ 386/ 002 EU/ 1/ 07/ 386/ 003 EU/ 1/ 07/ 386/ 004 EU/ 1/ 07/ 386/ 005 EU/ 1/ 07/ 386/ 006 EU/ 1/ 07/ 386/ 007 EU/ 1/ 07/ 386/ 008 EU/ 1/ 07/ 386/ 009 EU/ 1/ 07/ 386/ 010 EU/ 1/ 07/ 386/ 011 EU/ 1/ 07/ 386/ 012 EU/ 1/ 07/ 386/ 013 EU/ 1/ 07/ 386/ 014 EU/ 1/ 07/ 386/ 015 EU/ 1/ 07/ 386/ 016
Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz
Isem inventat Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz Toviaz
4 mg 4 mg 4 mg 4 mg 4 mg 8 mg 8 mg 8 mg 8 mg 8 mg 4 mg 8 mg 4 mg 4 mg 8 mg 8 mg
Qawwa 4 mg 4 mg 4 mg 4 mg 4 mg 8 mg 8 mg 8 mg 8 mg 8 mg 4 mg 8 mg 4 mg 4 mg 8 mg 8 mg