qanastek/EMEA-V3 huggingface dataset:
Infections and infestations Uncommon Psychiatric disorders
Infezzjonijiet u infestazzjonijiet Mhux komuni Disturbi psikjatriċi
Urinary tract infection
Infezzjoni fil- passaġġ ta ’ l- awrina
Uncommon Nervous system disorders
Mhux komuni Disturbi fis- sistema nervuża
Insomnia, thinking abnormal
Nuqqas ta ’ rqad, ħsibijiet mhux tas- soltu
Common Uncommon Eye disorders
Komuni Mhux komuni
Headache Dizziness, dysgeusia, somnolence
Uġigħ ta ’ ras Sturdament, disgwejżija, ngħas
Common Uncommon Vascular disorders
Komuni Mhux komuni Disturbi vaskulari
Dry eye Visual disturbance, including vision blurred
Għajn xotta Disturbi fil- viżta, inkluż viżta mċajpra
5 Respiratory, thoracic and mediastinal disorders Uncommon Gastrointestinal disorders
Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni Disturbi gastro- intestinali
Dyspnoea, cough, rhinitis
Dispneja, sogħla, rinite
Very common Common Uncommon Skin and subcutaneous tissue disorders
Komuni ħafna Komuni Mhux komuni
Constipation, dry mouth Abdominal pain, nausea, dyspepsia Flatulence, diarrhoea, mouth ulceration
Stitikezza, ħalq xott Uġigħ addominali, nawseja, dispepsija Gass, dijarea, ulċeri fil- ħalq
Uncommon Not known Renal and urinary disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Mhux komuni Mhux magħrufa Disturbi fil- kliewi u fis- sistema urinarja
Rash, dry skin, pruritus, hyperhidrosis Angioedema
Raxx, ġilda xotta, prurite, iperidrożi Anġjooedema
Uncommon Reproductive system and breast disorders
Mhux komuni Disturbi fis- sistema riproduttiva u fis- sider
Urinary retention, urinary tract disorder, bladder pain
Ma tkunx tista ’ tgħaddi l- awrina, disturbi fis- sistema ta ’ l- awrina, uġigħ fil- bużżieqa ta ’ l- awrina
Uncommon General disorders and administration site Uncommon Investigations
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Mhux komuni Investigazzjonijiet
Erectile dysfunction, vaginitis conditions Oedema peripheral, asthenia, face oedema, oedema
Edima periferali, astenja, edima fil- wiċċ, edima
Aspartate aminotransferase increased, alanine aminotransferase increased
Aspartate aminotransferase miżjud, alanine aminotransferase miżjud
Injury, poisoning, and procedural complications Uncommon
Korriment, avvelenament u komplikazzjonijiet ta ’ xi proċedura Mhux komuni
Injury
Korriment
In the pivotal clinical trials with doses of Emselex 7.5 mg and 15 mg, adverse reactions were reported as presented in the table above.
mg u 15 mg, reazzjonijiet avversi kienu rapurtati kif qed
Most of the adverse reactions were of mild or moderate intensity and did not result in discontinuation in the majority of the patients.
Il- biċċa l- kbira tar- reazzjonijiet avversi kienu ħfief jew moderati fil - qawwa tagħhom u ma wasslux għall- waqfien tat- trattament fil- parti l- kbira tal- pazjenti.
Treatment with Emselex may possibly mask symptoms associated with gallbladder disease.
Il- kura b’ Emselex tista ’ taħbi sintomi assoċjati ma ’ mard tal- bużżieqa tal- marrara.
However, there was no association between the occurrence of adverse events related to the biliary system in darifenacin-treated patients and increasing age.
Madankollu, ma kienx hemm rabta bejn każijiet ta ’ effetti avversi relatati mas- sistema tal- marrara f’ pazjenti kkurati b’ darifenacin u l- kobor fl- età.
The incidence of adverse events with the doses of Emselex 7.5 mg and 15 mg decreased during the treatment period up to 6 months.
L- effetti avversi b’ dożi ta ’ Emselex ta ’ 7. 5 mg u 15 mg seħħew b’ mod anqas frekwenti tul il- perijodu ta ’ kura sa 6 xhur.
A similar trend is also seen for the discontinuation rates.
Tendenza simili tidher ukoll għar- rati ta ’ twaqqif tal- kura.
Post-marketing experience The following events have been reported in association with darifenacin use in worldwide post- marketing experience: generalised hypersensitivity reactions including angioedema.
Esperjenza ta ’ wara t- tqegħid fis- suq Il- każijeit li ġejjin kienu rrappurtati b’ mod relatat ma ’ l- użu ta ’ darifenacin bl- esperjenza ta ’ wara t - tqegħid fis- suq madwar id- dinja kollha: reazzjonijiet ta ’ sensittività eċċessiva ġenerali inkluż anġjoedema.
Because these spontaneously reported events are from the worldwide post-marketing experience, the frequency of events cannot be estimated from the available data.
Peress li dawn il- każijiet irrappurtati b’ mod spontanju ġejjin minn esperjenza ta ’ wara t - tqegħid fis- suq minn madwar id- dinja kollha, il- frekwenza ta ’ dawn il- każijiet ma jistgħux jiġu stmati mid- dejta li hemm disponibbli.
Emselex has been administered in clinical trials at doses up to 75 mg (five times maximum therapeutic dose).
Waqt provi kliniċi Emselex ngħata b’ dożi sa 75 mg (ħames darbiet l- ogħla doża terapewtika).
The most common adverse events seen were dry mouth, constipation, headache, dyspepsia and nasal dryness.
L- aktar każijiet komuni ta ’ effetti avversi kienu ħalq xott, stitikezza, uġigħ ta ’ ras, dispepsja u nixfa fl - imnieħer.
However, overdose with darifenacin can potentially lead to severe anticholinergic effects and should be treated accordingly.
Madankollu, dożi eċċessivi ta ’ darifenacin jistgħu jwasslu għal effetti antikolinerġici u għandhom ikunu kkurati kif jixraq.
Therapy should be aimed at reversing the anticholinergic symptoms under careful medical supervision.
L- għan tat- terapija għandu jkun li s- sintomi antikolinerġiċi jitreġgħu lura taħt osservazzjoni medika b’ attenzjoni.
The use of agents such as physostigmine can assist in reversing such symptoms.
L- użu ta ’ sustanzi bħal physostigmine jista ’ jgħin biex jitreġgħu lura dawn is- sintomi.
Urinary antispasmodic, ATC code:
Antispażmodiku tas- sistema ta ’ l- awrina, Kodiċi ATC:
6 Darifenacin is a selective muscarinic M3 receptor antagonist (M3 SRA) in vitro.
Darifenacin huwa antagonista silettiv muskariniku tar- riċettur M3 (M3 SRA) in vitro.
The M3 receptor is the major subtype that controls urinary bladder muscle contraction.
Ir- riċettur M3 huwa s- sottotip ewlieni li jikkontrolla l- kontrazzjoni tal- muskolu tal- bużżieqa ta ’ l- awrina.
It is not known whether this selectivity for the M3 receptor translates into any clinical advantage when treating symptoms of overactive bladder syndrome.
Mhux magħruf jekk din is- silettività għar- riċettur M3 tissarrafx f’ xi vantaġġ kliniku waqt il- kura tas - sintomi tas- sindromu ta ’ bużżieqa ta ’ l- awrina attiva żżejjed.
Cystometric studies performed with darifenacin in patients with involuntary bladder contractions showed increased bladder capacity, increased volume threshold for unstable contractions and diminished frequency of unstable detrusor contractions.
Studji ċistometriċi b’ darifenacin li saru fuq pazjenti li għandhom kontrazzjonijiet involontarji tal - bużżieqa ta ’ l- awrina wrew żieda f’ kemm tesa ’ l- bużżieqa ta ’ l- awrina, żieda fil- volum ta ’ l- awrina li ġġiegħel kontrazzjoniet instabbli u tnaqqis fil- frekwenza tal- kontrazzjonijiet tad- detrusor, li m’ humiex stabbli.
Treatment with Emselex administered at dosages of 7.5 mg and 15 mg daily has been investigated in four double-blind, Phase III, randomised, controlled clinical studies in male and female patients with symptoms of overactive bladder.
Kura b’ Emselex mogħtija b’ dożi ta ’ 7. 5 mg u 15 mg kuljum kienet investigata f’ erba ’ studji kliniċi kontrollati, randomised, Fażi III, double- blind, b’ pazjenti rġiel u nisa b’ sintomi ta ’ bużżieqa ta ’ l - awrina attiva żżejjed.
As seen in Table 2 below, a pooled analysis of 3 of the studies for the treatment with both Emselex 7.5 mg and 15 mg provided a statistically significant improvement in the primary endpoint, reduction in incontinence episodes, versus placebo.
Kif jidher f’ tabella 2 hawn taħt, analiżi miġbura minn 3 mill- istudji għall- kura kemm b’ Emselex 7. 5 mg, kif ukoll bi 15 mg uriet titjib statistikament sinifikanti fl- ewwel endpoint ewlieni, tnaqqis f’ episodji ta ’ inkontinenza, kontra plaċebo.
Pooled analysis of data from three Phase III clinical studies assessing fixed doses of 7.5 mg and 15 mg Emselex
Analiżi miġbura minn tlett Studji kliniċi ta ’ Fazi III fejn ġew valutati dożi fissi ta ’ 7. 5 mg u 15 mg Emselex
Dose
Valur P2 Doża
Baseline
Linja
Incontinence episodes per week Week 12 Change from
Ġimgħa 12
Differences
Tibdil mill -
95% CI
Differenzi
P value2
bażika
(median) (median)
(medjan)
baseline
linja bażika
from placebo1
(medjan)
(median)
(medjan)
Emselex 7.5 mg once daily
Emselex 7. 5 mg darba kuljum
-8.8 (-68%)
- 8. 8 (- 68%)
(-3.6, -0.7)
(- 3. 6, - 0. 7)
0.004
0. 004
16.6
16. 6
-7.0 (-54%)
- 7. 0 (- 54%)
Emselex 15 mg once daily
Emselex 15 mg darba kuljum
16.9
16. 9
-10.6 (-77%)
- 10. 6 (- 77%)
-3.2
- 3. 2
(-4.5, -2.0)
(- 4. 5, - 2. 0)
Placebo 1
Plaċebo 1
-7.5 (-58%)
- 7. 5 (- 58%)
Hodges Lehmann estimate: median difference from placebo in change from baseline 2 Stratified Wilcoxon test for difference from placebo.
Stima Hodges Lehmann: differenza medjana mill- plaċebo fil- bidla mill- linja bażi 2 Test Wilcoxon stratifikat għad- differenza mill- plaċebo.
Emselex 7.5 mg and 15 mg doses significantly reduced both the severity and number of urinary urgency episodes and the number of micturitions, while significantly increasing the mean volume voided from baseline.
Dożi ta ’ 7. 5 mg u 15 mg Emselex naqqsu b’ mod sinifikanti is- severità u n- numru ta ’ episodji ta ’ urġenza li tgħaddi l- awrina, u tan- numru ta ’ drabi li tgħaddi l- awrina, waqt li żdiedet b’ mod sinifikanti il- medja tal- volum li tbattal mill- linja bażika.
Emselex 7.5 mg and 15 mg were associated with statistically significant improvements over placebo in some aspects of quality of life as measured by the Kings Health Questionnaire including incontinence impact, role limitations, social limitations and severity measures.
Emselex 7. 5 mg u 15 mg kienu assoċjati ma ’ titjib statistikament sinifikanti meta mqabbla ma ’ plaċebo f’ ċerti aspetti tal- kwalità tal- ħajja hekk kif imkejjla permezz tal- Kwestjonarju King Health li kien jinkludi impatt ta ’ l- inkontinenza, limitazzjonijiet ta ’ rwoli, limitazzjonijiet soċjali u miżuri ta ’ severità.
For both doses of 7.5 mg and 15 mg, the percentage median reduction from baseline in the number of incontinence episodes per week was similar between males and females.
Għaż- żewġ dożi ta ’ 7. 5 mg u 15 mg, il- perċentwali tat- tnaqqis medju mill- linja bażi fin- numru ta ’ episodji ta ’ inkontinenza kull ġimgħa kienu simili bejn l- irġiel u n- nisa.
The observed differences from placebo for males in terms of percentage and absolute reductions in incontinence episodes was lower than for females.
Id- differenzi li dehru mill - plaċebo għall- irġiel f’ termini ta ’ tnaqqis ta ’ perċentwali u assolut fl- episodji ta ’ inkontinenza kienu anqas minn dawk tan- nisa.
The effect of treatment with 15 mg and 75 mg of darifenacin on QT/ QTc interval was evaluated in a study in 179 healthy adults (44% male:
L- effett tal- kura b’ 15 mg u 75 mg ta ’ darifenacin fuq l- intervall QT/ QTc kien evalwat fi studju
56% females) aged 18 to 65 for 6 days (to steady state).
7 b’ 179 adult b’ saħħithom (44% irġiel: 56% nisa) f’ etajiet ta ’ 18 sa 65 sena għal 6 ijiem (għal stat fiss).
Therapeutic and supra-therapeutic doses of darifenacin resulted in no increase in QT/ QTc interval prolongation from baseline compared to placebo at maximum darifenacin exposure.
Dożi terapewtiċi u ogħla ta ’ darifenacin ma wasslu għall- ebda żieda fl- intervall QT/ QTc mill- linja bażi meta mqabbla mal- plaċebo bl- ogħla esponimenti għal darifenacin.
Darifenacin is metabolised by CYP3A4 and CYP2D6.
Darifenacin jiġi metabolizzat permezz ta ’ CYP3A4 u CYP2D6.
Due to genetic differences, about 7% of the Caucasians lack the CYP2D6 enzyme and are said to be poor metabolisers.
Minħabba differenzi fl- għamla ġenetika, madwar 7% tan- nies Kawkażi għandhom nuqqas ta ’ l- enżima CYP2D6 u jitqiesu bħala metabolizzaturi dgħajfa.
The information below
Perċentwal żgħir tal- popolazzjoni għandhom livelli għoljin ta ’ l- enzima CYP2D6 (metabolizzaturi mgħaġġla ħafna).
7 applies to subjects who have normal CYP2D6 activity (extensive metabolisers) unless otherwise stated.
It- tagħrif li ġej jgħodd għal dawk li għandhom attività ta ’ CYP2D6 normali (metabolizzaturi estensivi) sakemm ma jkunx dikjarat mod ieħor.
Absorption Due to extensive first-pass metabolism darifenacin has a bioavailability of approximately 15% and 19% after 7.5 mg and 15 mg daily doses at steady state.
Assorbiment Minħabba metaboliżmu first- pass estensiv, darifenacin għandu bijodisponibiltà ta ’ madwar 15% u 19% wara dożi ta ’ 7. 5 mg u 15 mg kuljum fi stat fiss.
Maximum plasma levels are reached approximately 7 hours after administration of the prolonged-release tablets and steady-state plasma levels are achieved by the sixth day of administration.
L- ogħla livelli fil- plasma jintlaħqu madwar 7 sigħat wara li jingħataw pilloli li jerħu l- mediċina bil- mod u jintlaħqu livelli ta ’ stat fiss fil- plażma sas- sitt jum minn meta jkun beda jingħata.
At steady state, peak-to-trough fluctuations in darifenacin concentrations are small (PTF:
Fi stat fiss, il- bidliet mill- ogħla konċentrazzjoni ta ’ darifenacin sa dik l- aktar baxxa huma żgħar (PTF:
0.87 for 7.5 mg and 0.76 for 15 mg), thereby maintaining therapeutic plasma levels over the dosing interval.
0. 87 għal 7. 5 mg u 0. 76 għal 15 mg), b’ hekk jinżammu il- konċentrazzjonijiet terapewtiċi fil- plażma matul l- intervall ta ’ bejn doża u oħra.
Food had no effect on darifenacin pharmacokinetics during multiple-dose administration of prolonged-release tablets.
L- ikel ma kellu l- ebda effett fuq il- farmakokinetiċi ta ’ darifenacin meta ngħataw numru ta ’ dożi b’ pilloli li jerħu l- mediċina bil- mod.
Distribution Darifenacin is a lipophilic base and is 98% bound to plasma proteins (primarily to alpha-1-acid- glycoprotein).
Distribuzzjoni Darifenacin huwa bażi lipofiliku u huwa 98% marbutt mal- proteini tal- plażma (fil- parti l- kbira mal - glukoproteina aċiduża alpha- 1).
The steady-state volume of distribution (Vss) is estimated to be 163 litres.
Il- volum ta ’ distribuzzjoni fi stat fiss (Vss) huwa stmat li jkun 163 litru.
Metabolism Darifenacin is extensively metabolised by the liver following oral administration.
Metaboliżmu Wara li jittieħed mill- ħalq, darifenacin jiġi metabolizzat b’ mod estensiv mill- fwied.
Darifenacin undergoes significant metabolism by cytochrome CYP3A4 and CYP2D6 in the liver and by CYP3A4 in the gut wall.
Darifenacin jgħaddi minn metaboliżmu sinifikanti permezz ta ’ ċitokromju CYP3A4 u CYP2D6 fil - fwied u permezz ta ’ CYP3A4 fis- saff ta ’ ġewwa fl- intestini.
The three main metabolic routes are as follows: monohydroxylation in the dihydrobenzofuran ring; dihydrobenzofuran ring opening and N-dealkylation of the pyrrolidine nitrogen.
Monohydroxylation fid- dihydrobenzofuran ring Il- ftuħ tad- dihydrobenzofuran ring u N- dealkylation ta ’ pyrrolidine nitrogen.
The initial products of the hydroxylation and N-dealkylation pathways are major circulating metabolites but none contribute significantly to the overall clinical effect of darifenacin.
L- ewwel prodotti tar- rotot tal- hydroxylation u N- dealkylation huma l- metaboli ewlenin li jkunu jiċċirkolaw, iżda l- ebda wieħed minnhom ma jikkontribwixxi b’ mod sinifikanti għall- effett kliniku ġenerali ta ’ darifenacin.
The pharmacokinetics of darifenacin at steady state are dose-dependent, due to saturation of the CYP2D6 enzyme.
Il- farmakokinetiċi ta ’ darifenacin fi stat fiss jiddependu mid- doża, minħabba li l- enzima CYP2D6 tkun saturata.
Doubling the darifenacin dose from 7.5 mg to 15 mg result in a 150% increase in steady-state exposure.
Meta d- doża ta ’ darifenacin tkun irdoppjata minn 7. 5 mg għal 15 mg, ikun hemm żieda ta ’ 150% fl - esponiment waqt stat fiss.
This dose-dependency is probably caused by saturation of the CYP2D6 catalysed metabolism possibly together with some saturation of CYP3A4-mediated gut wall metabolism.
Din ir- rabta mad- doża x’ aktarx tkun ikkawżata mis- saturazzjoni tal - metaboliżmu katalizzat mis- CYP2D6 u forsi anki b’ xi saturazzjoni tas- CYP3A4 li jkun ġej mill - metaboliżmu tas- saff ta’ gewwa fl- intestini.
Excretion Following administration of an oral dose of 14C-darifenacin solution to healthy volunteers, approximately 60% of the radioactivity was recovered in the urine and 40% in the faeces.
Eskrezzjoni Wara li tingħata doża mill- ħalq ta ’ soluzzjoni ta ’ 14C- darifenacin lil voluntiera b’ saħħithom, madwar 60% tar- radjuattività kienet irkuprata fl- awrina u 40% fl- ippurgar.
Only a small percentage of the excreted dose was unchanged darifenacin (3%).
Perċentwal żgħir biss tad- doża eskretata kienet darifenacin mhux mibdul (3%).
Estimated darifenacin clearance is 40 litres/ hour.
It tneħħija ta ’ darifenacin hija stmata li hi 40 litru/ siegħa.
The elimination half-life of darifenacin following chronic dosing is approximately 13-19 hours.
Il- half life ta ’ l- eliminazzjoni ta ’ darifenacin wara li jingħataw dożaġġi b’ mod kroniku hija ta ’ madwar 13- 19– il siegħa.
Special patient population Gender A population pharmacokinetic analysis of patient data indicated that darifenacin exposure was 23% lower in males than females (see section 5.1).
8 Popolazzjoni speċjali ta ’ pazjenti Sess Analiżi farmakokinetika tal- popolazzjoni ta ’ tagħrif miġbur minn pazjenti indika li l- esponiment għal darifenacin kien 23% aktar baxx fl- irġiel milli fin- nisa (ara sezzjoni 5. 1).
Elderly patients A population pharmacokinetic analysis of patient data indicated a trend for clearance to decrease with age (19% per decade based on Phase III population pharmacokinetic analysis of patients aged 60– 89 years), see section 4.2.
Pazjenti anzjani Analiżi farmakokinetika tal- popolazzjoni ta ’ tagħrif miġbur minn pazjenti indika tendenza għal tnaqqis ta ’ l- eliminazzjoni ma ’ l- età (19% għal kull għaxar snin bażat fuq analiżi farmakokinetika tal - popolazzjoni ta ’ Fażi III f’ pazjenti ta ’ etajiet bejn 60- 89 sena), ara sezzjoni 4. 2.
Paediatric patients The pharmacokinetics of darifenacin have not been established in the paediatric population.
Pazjenti pedjatriċi Il- farmakokinetiċi ta ’ darifenacin ma ġewx stabbiliti fil- popolazzjoni tal- pazjenti pedjatriċi.
8 CYP2D6 poor metabolisers The metabolism of darifenacin in CYP2D6 poor metabolisers is principally mediated by CYP3A4.
Metabolizzaturi dgħajfa ta ’ CYP2D6 F’ metabolizzaturi dgħajfa ta ’ CYP2D6 il- metaboliżmu ta ’ darifenacin huwa medjat prinċipalment permezz ta ’ CYP3A4.
In one pharmacokinetic study the steady-state exposure in poor metabolisers was 164% and 99% higher during treatment with 7.5 mg and 15 mg once daily, respectively.
Fi studju farmakokinetiku f’ metabolizzaturi dgħajfa l- esponiment fi stat fiss kien 164% u 99% ogħla waqt il- kura b’ 7. 5 mg u 15 mg darba kuljum, rispettivament.
However, a population pharmacokinetic analyses of Phase III data indicated that on average steady-state exposure is 66% higher in poor metabolisers than in extensive metabolisers.
Madankollu, analiżi farmakokinetika tal- popolazzjoni ta ’ tagħrif minn Fażi III indikat li bħala medja l- esponiment fi stat fiss ikun 66% ogħla f’ metabolizzaturi dgħajfa milli f’ metabolizzaturi estensivi.
There was considerable overlap between the ranges of exposures seen in these two populations (see section 4.2).
Kien hemm numru konsiderevoli ta ’ medded ta ’ esponimenti li ġew fuq xulxin f’ dawn iż- żewġ popolazzjonijiet (ara sezzjoni 4. 2).
Renal insufficiency A small study of subjects (n=24) with varying degrees of renal impairment (creatinine clearance between 10 ml/ min and 136 ml/ min) given darifenacin 15 mg once daily to steady state demonstrated no relationship between renal function and darifenacin clearance (see section 4.2).
Insuffiċjenza renali Studju żgħir ta ’ individwi (n=24) b’ indeboliment tal- kliewi fi gradi diversi (tneħħija tal- krejatinina bejn 10 ml/ min u 136 ml/ min) meta 15 mg ta ’ darifenacin ingħataw kuljum għal stat fiss ma wera l - ebda relazzjoni bejn il- funzjoni renali u t- tneħħija tal- krejatinina (ara sezzjoni 4. 2).
Hepatic insufficiency Darifenacin pharmacokinetics were investigated in subjects with mild (Child Pugh A) or moderate (Child Pugh B) impairment of hepatic function given darifenacin 15 mg once daily to steady state.
Insuffiċjenza epatika Il- farmakokinetiċi ta ’ darifenacin kienu investigati f’ individwi li kellhom indeboliment ħafif (Child - Pugh A) jew moderat (Child- Pugh B) tal- fwied li ngħataw 15 mg darifenacin darba kuljum għal stat fiss.
Mild hepatic impairment had no effect on the pharmacokinetics of darifenacin.
Indeboliment ħafif tal- fwied ma kellu l- ebda effett fuq il- farmakokinetiċi ta ’ darifenacin.
However, protein binding of darifenacin was affected by moderate hepatic impairment.
Madanakollu, t- twaħħil ta ’ darifenacin mal- proteini kien effettwat minn indeboliment moderat tal - fwied.
Unbound darifenacin exposure was estimated to be 4.7-fold higher in subjects with moderate hepatic impairment than subjects with normal hepatic function (see section 4.2).
L- esponiment ta ’ darifenacin mhux imwaħħal kien stmat li jkun 4. 7 darbiet ogħla f’ dawk li jkollhom indeboliment moderat tal- fwied minn dawk li jkollhom funzjoni epatika normali (ara sezzjoni 4. 2).
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Tagħrif ta ’ qabel l- użu kliniku magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni u riskju ta ’ kanċer ma juri l- ebda periklu speċjali għall- bnedmin.
Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/ foetal development.
Studji fuq annimali ma jindikawx li hemm effetti ta ’ ħsara diretti jew indiretti għal fertilità, tqala, żvilupp ta ’ l- embriju/ fetu.
In peri and post natal studies in rats, dystocia, increased foetal deaths in utero, and toxicity to post natal development (pup body weight and development land marks) were observed at systemic exposure levels up to 11 times higher than the expected clinical exposure.
Fi studji ta ’ waqt u wara t- twelid fuq firien, tbatija tal- ħlas, żieda fl- imwiet tal- feti in utero, u tossiċità għall- iżvilupp wara t- twelid (imfassla fuq markaturi tal- piż tal- ġisem u l - iżvilupp tal- wild) dehru f’ livelli ta ’ esponimeti sistemiċi sa 11- il darba ogħla minn kemm hu mistenni li jkun l- esponiment kliniku.
Calcium hydrogen phosphate, anhydrous Hypromellose Magnesium stearate
Calcium hydrogen phosphate, anhydrous Hypromellose Magnesium stearate
Film coat:
Kisja b’ rita:
Polyethylene glycol Hypromellose Titanium dioxide (E171) Talc
Polyethylene glycol Hypromellose Titanium dioxide (E171) Talc
9 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Keep the blister packs in the outer carton in order to protect from light.
Aħżen il- folji fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
Clear PVC/ CTFE/ aluminium or PVC/ PVDC/ aluminium blisters in cartons containing 7, 14, 28, 49, 56 or 98 tablets as unit pack or in multipacks comprising 10 packs, each containing 14 tablets.
PVC/ CTFE/ aluminium ċar jew folji tal- PVC/ PVDC/ aluminium f’ kartuniet li jkun fihom 7, 14, 28, 49, 56 jew 98 pillola f’ pakketti waħidhom jew f’ ħafna pakketti li jkun fihom 10 pakketti, b’ 14- il pillola f’ kull wieħed.
Emselex 15 mg prolonged-release tablets
Emselex 15 mg pilloli li jerħu l- mediċina bil- mod
Each tablet contains 15 mg of darifenacin (as hydrobromide)
Kull pillola fiha 15 mg ta ’ darifenacin (bħala hydrobromide)
Light peach round, convex tablet debossed with “ DF” on one side and “ 15” on the reverse.
Pillola tonda lewn il- ħawħ, konvessa, imnaqqxa b ’ “ DF ” fuq naħa u “ 15 ” fuq l- oħra.
11 In patients with moderate hepatic impairment (Child Pugh B), patients should only be treated if the benefit outweighs the risk, and patients should be restricted to 7.5 mg daily (see section 5.2).
12 F’ pazjenti li jsofru minn indeboliment moderat tal- fwied (Child- Pugh B), dawn għandhom jiġu kkurati biss jekk il- benefiċju jkun akbar mir- riskju, u l- pazjenti għandhom ikunu limitati għal 7. 5 mg kuljum (ara sezzjoni 5. 2).
12 CYP2D6 inhibitors In patients receiving substances that are potent CYP2D6 inhibitors (e. g. paroxetine, terbinafine, cimetidine and quinidine) the recommended starting dose should be 7.5 mg daily.
13 Inibituri ta ’ CYP2D6 Għal pazjenti li qed jirċievu sustanzi li huma inibituri qawwija ta ’ CYP2D6 (eż. paroxetine, terbinafine, cimetidine u quinidine), id- doża tal- bidu rakkomandata għandha tkun 7. 5 mg kuljum.
Darifenacin AUC24 and Cmax from 30 mg once-daily dosing in subjects who are extensive metabolisers were 95% and 128% higher when erythromycin (moderate CYP3A4 inhibitor) was co-administered with darifenacin than when darifenacin was taken alone.
L- AUC24 u s- Cmax ta ’ Darifenacinminn dużaġġ ta ’ 30 mg darba kuljum f’ persuni li għandhom metaboliżmu mgħaġġel ħafna, kienu 95% u 128% aktar għolja meta erythromycin (inibitur moderat ta ’ CYP3A4) kien mogħti ma ’ darifenacin milli meta darifenacin ittieħed waħdu.
Antimuscarinic agents As with any other antimuscarinic agents, concomitant use of medicinal products that possess antimuscarinic properties, such as oxybutynin, tolterodine and flavoxate, may result in more
Sustanzi antimuskariniċi Bħal ma jiġri bis- sustanzi antimuskariniċi l- oħrajn kollha, l- użu ta ’ prodotti mediċinali oħra li
The potentiation of anticholinergic effects with anti- parkinson agents and tricyclic antidepressants may also occur if antimuscarinic agents are used concurrently with such medicinal products.
14 għandhom effetti antimuskariniċi bħal oxybutynin, tolterodine u flavoxate, jista ’ jwassal għal effetti terapewtiċi u sekondarji aktar qawwija L- effetti antikolinerġici ta ’ mediċini li jintuzaw kontra l- marda ta ’ Parkinson u mediċini kontra d- dipressjoni tat- tip triċikliċi jista ’ jkun aktar qawwi meta jingħataw ma ’ mediċini antimuskariniċi.
However, no studies involving the interaction with anti- parkinson agents and tricyclic antidepressants have been performed.
Madankollu ma sarux studji dwar l- effetti oħra li jista ’ jkollhom meta jingħataw ma ’ mediċini li jintużaw kontra l- marda ta ’ Parkinson jew ma ’ mediċini kontra d- dipressjoni tat- tip triċikliċi.
Common Uncommon Eye disorders
Komuni Mhux komuni Disturbi fl- għajnejn
Common Uncommon Vascular disorders
Komuni Mhux komuni
14 Respiratory, thoracic and mediastinal disorders Uncommon Gastrointestinal disorders
Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni Disturbi gastro- intestinali
15 Darifenacin is a selective muscarinic M3 receptor antagonist (M3 SRA) in vitro.
Darifenacin huwa antagonista silettiv muskariniku tar- riċettur M3 (M3 SRA) in vitro.
56% females) aged 18 to 65 for 6 days (to steady state).
17 b’ 179 adult b’ saħħithom (44% irġiel: 56% nisa) f’ etajiet ta ’ 18 sa 65 sena għal 6 ijiem (għal stat fiss).
16 applies to subjects who have normal CYP2D6 activity (extensive metabolisers) unless otherwise stated.
It- tagħrif li ġej jgħodd għal dawk li għandhom attività ta ’ CYP2D6 normali (metabolizzaturi estensivi) sakemm ma jkunx dikjarat mod ieħor.
Special patient population Gender A population pharmacokinetic analysis of patient data indicated that darifenacin exposure was 23% lower in males than females (see section 5.1).
18 Popolazzjoni speċjali ta ’ pazjenti Sess Analiżi farmakokinetika tal- popolazzjoni ta ’ tagħrif miġbur minn pazjenti indika li l- esponiment għal darifenacin kien 23% aktar baxx fl- irġiel milli fin- nisa (ara sezzjoni 5. 1).
17 CYP2D6 poor metabolisers The metabolism of darifenacin in CYP2D6 poor metabolisers is principally mediated by CYP3A4.
Metabolizzaturi dgħajfa ta ’ CYP2D6 F’ metabolizzaturi dgħajfa ta ’ CYP2D6 il- metaboliżmu ta ’ darifenacin huwa medjat prinċipalment permezz ta ’ CYP3A4.
Polyethylene glycol Hypromellose Talc Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
Polyethylene glycol Hypromellose Talc Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
3 years 18 6.4 Special precautions for storage
3 snin
19 ANNEX II
21 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- RUĠ TAL - LOTT
20 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Novartis Pharma GmbH Roonstraße 25 D-90429 Nuremberg Germany
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott Novartis Pharma GmbH Roonstraße 25 D- 90429 Norimberga Il- Ġermanja
B CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
• CONDITIONS OR RESTRICTIONS REGARDING THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
21 ANNEX III
23 ANNESS III
23 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
25 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON (FOLDING BOX FOR UNIT PACK INCLUDING BLUE BOX)
KARTUNA TA ’ BARRA (KAXXA LI TINTLEWA GĦALL- PAKKETT TA ’ WIEĦED INKLUŻA L- KAXXA ĊELESTI)
Emselex 7.5 mg prolonged-release tablets Darifenacin (as hydrobromide)
Emselex 7. 5 mg pilloli li jerħu l- mediċina bil- mod Darifenacin (bħala hydrobromide)
Each tablet contains 7.5 mg darifenacin (as hydrobromide).
Kull pillola fiha 7. 5 mg darifenacin (bħala hydrobromide).
7 tablets 14 tablets 28 tablets 49 tablets 56 tablets 98 tablets
7 pilloli 14- il pillola 28 pillola 49 pillola 56 pillola 98 pillola
7 tablets (PVC/ CTFE/ alu blisters) 14 tablets (PVC/ CTFE/ alu blisters) 28 tablets (PVC/ CTFE/ alu blisters) 49 tablets (PVC/ CTFE/ alu blisters) 56 tablets (PVC/ CTFE/ alu blisters) 98 tablets (PVC/ CTFE/ alu blisters) 7 tablets (PVC/ PVDC/ alu blisters) 14 tablets (PVC/ PVDC/ alu blisters) 28 tablets (PVC/ PVDC/ alu blisters) 49 tablets (PVC/ PVDC/ alu blisters) 56 tablets (PVC/ PVDC/ alu blisters) 98 tablets (PVC/ PVDC/ alu blisters)
7 pilloli (PVC/ CTFE/ alu folji) 14- il pillola (PVC/ CTFE/ alu folji) 28 pillola (PVC/ CTFE/ alu folji) 49 pillola (PVC/ CTFE/ alu folji) 56 pillola (PVC/ CTFE/ alu folji) 98 pillola (PVC/ CTFE/ alu folji) 7 pilloli (PVC/ PVDC/ alu folji) 14- il pillola (PVC/ PVDC/ alu folji) 28 pillola (PVC/ PVDC/ alu folji) 49 pillola (PVC/ PVDC/ alu folji) 56 pillola (PVC/ PVDC/ alu folji) 98 pillola (PVC/ PVDC/ alu folji)
Emselex 7.5 mg
Emselex 7. 5 mg
25 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
27 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
FOLDING BOX FOR INTERMEDIATE PACK (WITHOUT BLUE BOX)
KAXXA LI TINTLEWA GĦALL- PAKKETT INTERMEDJU (MINGĦAJR L- KAXXA Ċ - ĊELESTI)
One pack containing 14 tablets.
Pakkett wieħed fih 14- il pillola.
Component of a multipack comprising 10 packs, each containing 14 tablets.
Jagħmel parti minn pakkett multiplu li jinkludi 10 pakketti, kull wieħed fih 14- il pillola.
(PVC/ CTFE/ alu blisters) (PVC/ PVDC/ alu blisters)
(PVC/ CTFE/ alu folji) (PVC/ PVDC/ alu folji)
27 PARTICULARS TO APPEAR ON THE OUTER CARTON OF MULTIPACKS
29 TAGĦRIF LI GĦANDU JIDHER FUQ IL- KARTUNA TA ’ BARRA TA ’ PAKKETTI MULTIPLI
Multipack comprising 10 packs, each containing 14 tablets.
Pakkett multiplu li jinkludi 10 pakketti, kull wieħed fih 14- il pillola.
29 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
31 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
30 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Emselex 15 mg prolonged-release tablets Darifenacin (as hydrobromide)
Emselex 15 mg pilloli li jerħu l- mediċina bil- mod Darifenacin (bħala hydrobromide)
Each tablet contains 15 mg darifenacin (as hydrobromide).
Kull pillola fiha 15 mg darifenacin (bħala hydrobromide).
34 PARTICULARS TO APPEAR ON THE OUTER CARTON OF MULTIPACKS
36 TAGĦRIF LI GĦANDU JIDHER FUQ IL- KARTUNA TA ’ BARRA TA ’ PAKKETTI MULTIPLI
36 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
38 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
38 PACKAGE LEAFLET:
40 FULJETT TA ’ TAGĦRIF:
Emselex 7.5 mg prolonged-release tablets Darifenacin
Emselex 7. 5 mg pilloli li jerħu l- mediċina bil- mod Darifenacin
- This medicine has been prescribed for you.
- Din il- mediċina ġiet mogħtija b’ riċetta għalik biss.
What Emselex is and what it is used for 2.
X’ inhu Emselex u għalxiex jintuża 2.
Before you take Emselex 3.
Qabel ma tieħu Emselex 3.
How to take Emselex 4.
Kif għandek tieħu Emselex 4.
How to store Emselex 6.
Kif taħżen Emselex 6.
WHAT EMSELEX IS AND WHAT IT IS USED FOR
X’ INHU EMSELEX U GĦALXIEX JINTUŻA
How Emselex works After Emselex tablets have been taken, the active substance darifenacin hydrobromide is released into the body.
Kif jaħdem Emselex Wara li jittieħdu l- pilloli ta ’ Emselex, is- sustanza attiva darifenacin hydrobromide tinħeles fil- ġisem.
Darifenacin hydrobromide is a substance which reduces the activity of an overactive bladder.
Darifenacin hydrobromide huwa sustanza li tnaqqas l- attività ta ’ bużżieqa ta ’ l- awrina attiva żżejjed.
This enables you to wait longer before you go to the toilet and it increases the amount of urine that your bladder can hold.
Dan jippermetilek tistenna aktar qabel ma jkollok bżonn tmur it- tojlit u żżid l- ammont ta ’ awrina li l - bużżieqa ta ’ l- awrina tiegħek tkun tiflaħ iżżomm.
What Emselex can be used for Emselex belongs to a class of medicines which relax the muscles of the bladder.
Għalxiex jista ’ jintuża Emselex Emselex huwa mediċina li jagħmel parti minn klassi ta ’ mediċini li jirilassaw il- muskoli tal- bużżieqa ta ’ l- awrina.
It is used for the treatment of the symptoms of overactive bladder conditions - such as a sudden urge to rush to the toilet, needing to go to the toilet frequently and/ or not getting to the toilet in time and wetting yourself (urge incontinence).
Jintuża għall- kura ta ’ sintomi li jkollok meta l- bużżieqa ta ’ l- awrina tkun attiva żżejjed – bħal meta tħoss bżonn urġenti li tmur tiġri t- tojlit, bżonn li tmur it- tojlit ta ’ spiss u/ jew ma tilħaqx tasal sat- tojlit fil- ħin u tagħmel taħtek. (impuls ta ’ l- inkontinenza).
BEFORE YOU TAKE EMSELEX
QABEL MA TIEĦU EMSELEX
Do not take Emselex: • if you are allergic (hypersensitive) to darifenacin or any of the other ingredients of Emselex. • if you suffer from urinary retention (inability to empty your bladder). • if you have gastric retention (problems emptying the contents of the stomach). • if you suffer from uncontrolled narrow-angle glaucoma (high pressure in the eyes with loss of eyesight that is not being adequately treated). • if you have myasthenia gravis (a disease marked by abnormal fatigue and weakness of selected muscles). • if you have severe ulcerative colitis or toxic megacolon (acute dilation of the colon associated with amoebic or ulcerative colitis). • if you have severe liver problems. • There are some medicines such as ciclosporin, verapamil, antifungal medicines (e. g. ketoconazole and itraconazole) and some antiviral medicines (e. g. ritonavir) that must not be taken with Emselex.
Tieħux Emselex: • jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal darifenacin jew sustanzi l- oħra ta ’ Emselex. • jekk issofri minn retenzjoni ta ’ l- awrina (ma tistax tbattal il- bużżieqa ta ’ l- awrina). • jekk għandek retenzjoni gastrika (problemi biex tbattal li jkollok fl- istonku). • jekk tbati minn glawkoma tat- tip “ narrow angle ” li ma tkunx kontrollata (pressjoni għolja fl - għajnejn b’ telf tal- vista li ma tkunx kontrollata kif jixraq). • jekk għandek myasthenia gravis (marda karatterizzata minn għeja anormali u dgħjufija ta ’ xi wħud mill- muskoli). • jekk għandek kolite b’ ulċera qawwija, jew megakolon tossiku (dilatazzjoni akuta tal- kolon assoċjata ma ’ b’ kolite ta ’ emiba jew infjammazzjoni tal- musrana l- kbira). • jekk għandek problemi serji fil- fwied. • hemm xi mediċini bħal ciclosporin, verapamil, mediċini kontra l- mard tal- moffa (eż. ketoconazole u itraconazole) u xi mediċini kontra mard virali (eż ritonavir) li m’ għandekx teħodhom ma ’ Emselex.
39 Take special care with Emselex: • if you have autonomic neuropathy - your doctor will have told you if you have this. • if you have heartburn and belching. • if you have difficulties in passing urine and a weak stream of urine. • if you have severe constipation (less than or equal to 2 bowel movements per week). • if you have an obstructive gastrointestinal disorder - your doctor will have told you if you have this. • if you are receiving treatment for narrow-angle glaucoma. • if you have liver problems. • if you have kidney problems.
41 Oqgħod attent ħafna b’ Emselex: • jekk għandek newropatija awtonomika – it- tabib tiegħek ikun qallek jekk għandekx din il - marda. • jkk għandek ħruq ta ’ stonku jew qed titfewwaq. • jekk tbati biex tgħaddi l- awrina jew tgħaddi fluss ta ’ awrina dgħajjef ħafna. • jekk għandek stitikezza qawwija (tipporga darbtejn f’ ġimgħa jew anqas). • jekk għandek xi disturbi li qed jikkawżaw imblokk fis- sistema gastro- intestinali - it- tabib tiegħek ikun qallek jekk għandekx din. • jekk qed tirċievi kura għall- glawkoma tat- tip narrow angle. • jekk għandek problemi tal- fwied. • jekk għandek problemi tal- kliewi.
If any of these apply to you, tell your doctor before you take Emselex.
Jekk xi waħda minn dawn tgħodd għalik, għid lit- tabib tiegħek qabel tieħu Emselex.
Taking other medicines with Emselex Some medicines may interact with Emselex.
Meta tieħu mediċini oħra ma ’ Emselex Xi mediċini jistgħu ma jaqblux ma ’ Emselex.
These include some antibiotics (e. g. erythromycin and clarithromycin), antifungal medicines (e. g. ketoconazole and itraconazole), antipsychotic medicines (e. g. thioridazine), some antidepressants (e. g. imipramine), antiviral medicines (e. g. nelfinavir and ritonavir), some medicines used to treat heart problems (e. g. flecainide, verapamil and digoxin) and other antimuscarinic medicines (e. g. tolterodine, oxybutynin and flavoxate).
Dawn jinkludu xi antibijotiċi (eż. erythromycin u clarithromycin), mediċini kontra l- mard tal- moffa (eż. ketoconazole u itraconazole), mediċini antipsikotiċi (eż. thioridazine), xi mediċini kontra d- dipressjoni (eż. imipramine), mediċini kontra mard virali (eż. nelfinavir u ritonavir), xi mediċini li jintużaw għal problemi tal- qalb (eż. flecainide, verapamil u digoxin) u mediċini antimuskariniċi oħrajn (eż. tolterodine, oxybutynin u flavoxate).
Use in older people Emselex can be used by people older than 65.
L- użu f’ persuni anzjani Emselex jista ’ jintuża minn persuni li għandhom ‘ l fuq minn 65 sena.
If you are older than 65, you will be given the same dose as other adults.
Jekk għandek aktar minn 65 sena, ser tingħata l- istess doża ta ’ l- adulti l- oħrajn.
Pregnancy and breast-feeding If you are pregnant or think you may be pregnant, tell your doctor.
Tqala u treddigħ Jekk ħriġt tqila jew taħseb li jista ’ jkun li ħriġt tqila, għid lit- tabib tiegħek.
Emselex is not recommended during pregnancy.
Emselex mhux rakkomandat waqt it- tqala.
If you are breast-feeding, ask your doctor for advice.
Jekk qed tredda, itlob għall- parir tat- tabib tiegħek.
Emselex should be taken with caution while breast-feeding.
Emselex għandu jittieħed b’ attenzjoni waqt it - treddigħ.
Driving and using machines No studies of the effects of Emselex on the ability to drive and use machines have been performed.
Sewqan u tħaddim ta ’ magni Ma sarux studji dwar l- effetti ta ’ Emselex duq il- ħila biex issuq u tuża magni.
However, Emselex, like other antimuscarinic medicines, may cause effects such as dizziness, blurred vision, trouble sleeping or drowsiness.
Madankollu, Emselex, bħall- mediċini antmuskariniċi oħra, jista ’ jikkawża effetti bħal sturdament, tara mċajpar, problemi ta ’ rqad jew tħeddil.
If you have any of these symptoms whilst taking Emselex, consult your doctor for advice on changing the dose or considering an alternative treatment.
Jekk ikollok xi sintomi minn dawn waqt li qed tieħu Emselex, ikkonsulta mat- tabib tiegħek biex tieħu parir dwar tibdil fid- doża jew possibiltà li tieħu xi mediċina oħra minfloku.
You should not drive or use machines if you are affected by these symptoms.
M’ għandekx issuq jew tħaddem magni jekk tiġi effettwat minn xi sintomu minn dawn.
For Emselex, these side effects have been reported to be uncommon.
Għal Emselex, dawn l- effetti sekondarji kienu rapurtati li ma kienux komuni.
HOW TO TAKE EMSELEX
KIF GĦANDEK TIEĦU EMSELEX
Always take Emselex exactly as your doctor has told you.
Dejjem għandek tieħu Emselex skond il- parir eżatt tat- tabib.
If you have the impression that the effect of Emselex is too strong or too weak, talk to your doctor or pharmacist.
Jekk għandek l- impressjoni li l- effett ta ’ Emselex huwa dgħajjef wisq jew qawwi żżejjed, kellem lit- tabib jew l- ispiżjar tiegħek.
How much Emselex to take Emselex is intended for use in adults (people aged 18 years or older).
Kemm għandek tieħu Emselex Emselex huwa indikat għall- użu fl- adulti (persuni li għandhom 18- il sena jew aktar).
Emselex is not recommended for use in children.
Emselex m’ huwiex rakkomandat għall- użu fit- tfal.
40 For adults and older people, the recommended starting dose is 7.5 mg daily.
42 Għall- adulti u persuni anzjani, id- doża tal- bidu rakkomandata hija 7. 5 mg kuljum.
Depending on your response to Emselex, your doctor may increase your dose to 15 mg daily, two weeks after starting therapy.
Skond ir- rispons tiegħek għal Emselex, it- tabib tiegħek jista ’ jżidlek id- doża għall- 15 mg kuljum, ġimgħatejn wara li tibda t- terapija.
These doses are suitable for people with mild liver problems or people with kidney problems.
Dawn id- dożi jgħoddu għal persuni bi problemi ħfief tal- fwied jew għal persuni bi problemi tal- kliewi.
Eating food has no effect upon Emselex.
L- ikel m’ għandux effett fuq Emselex.
Grapefruit juice may interact with Emselex.
Il- meraq tal- grejpfrut jista ma jaqbilx ma Emselex.
However, the adjustment of Emselex doses is not necessary.
Madankollu, tibdil fid- doża ta ’ Emselex mhux neċessarju.
Please tell your doctor if you have liver problems.
Jekk jogħġbok għid lit- tabib tiegħek jekk għandek problemi tal- fwied.
Emselex is not recommended for use in patients with moderate liver problems.
L- użu ta ’ Emselex mhux rakkomandat f’ pazjenti li għandhom problemi tal- fwied moderati.
Do not take Emselex, if you have severe liver problems.
Tieħux Emselex jekk għandek problemi serji tal- fwied.
Patients taking some other medicines (e. g. erythromycin, clarithromycin, telithromycin and fluconazole) must not normally take more than 7.5 mg of Emselex as a daily dose.
Pazjenti li qed jieħdu xi mediċini oħrajn (eż. erythromycin, clarithromycin, telithromycin u fluconazole) normalment m’ għandhomx jieħdu aktar minn 7. 5 mg ta ’ Emselex bħala d- doża ta ’ kuljum.
However, the dose could be increased to 15 mg if well tolerated.
Madankollu, id- doża tista ’ tiżdied għal 15 mg jekk tkun tiflaħ tajjeb għaliha.
There are some medicines e. g. ciclosporin, verapamil, ketoconazole, itraconazole and some antiviral medicines (e. g. ritonavir) that must not be taken with Emselex.
Hemm xi mediċini eż ciclosporin, verapamil, ketoconazole, itraconazole u xi mediċini oħrajn kontra l- mard virali (eż. ritonavir) li m’ għandhomx jittieħdu ma ’ Emselex.
When and how to take Emselex Take Emselex tablets once a day with water, at about the same time each day.
Meta u kif għandek tieħu Emselex Ħu l- pilloli ta ’ Emselex darba kuljum ma ’ l- ilma, bejn wieħed u ieħor fl- istess ħin tal- ġurnata kuljum.
The tablet may be taken with or without food.
Il- pillola tista ’ tiħodha ma ’ l- ikel jew mingħajr ikel.
Do not chew, split or crush it.
M’ għandekx tomgħodha, taqsamha jew tfarrakha.
How long to take Emselex Your doctor will tell you how long your treatment with Emselex will last.
Kemm għandek iddum tieħu Emselex It- tabib tiegħek ser jgħidlek kemm għandha ddum il- kura b’ Emselex.
Do not stop treatment early because you do not see an immediate effect.
M’ għandekx twaqqaf il- kura kmieni għaliex ma tarax l- effetti mill- ewwel.
Your bladder will need some time to adapt.
Il- bużżieqa ta ’ l- awrina tiegħek ikollha bżonn ftit żmien biex tadatta.
Finish the course of treatment prescribed by your doctor.
Ħu l- kors tal- kura kif qallek it- tabib.
If you have not noticed any effect by then, discuss it with your doctor.
Jekk sa dak iż- żmien ma tkun rajt l- ebda effett, tkellimha mat- tabib tiegħek.
If you take more Emselex than you should If you have taken more tablets than you have been told to take, or if someone else accidentally takes your tablets, go to your doctor or hospital for advice immediately.
Jekk tieħu Emselex aktar milli suppost Jekk ħadt aktar pilloli milli qalulek tieħu, jew jekk xi ħadd ieħor bi żball jieħu l- pilloli tiegħek, mur għand it- tabib tiegħek jew l- isptar mill- ewwel sabiex tieħu parir.
Show them your pack of tablets.
Urihom il- pakkett tal- pilloli tiegħek.
If you forget to take Emselex If you forget to take Emselex at the usual time, take it as soon as you remember, unless it is the time for your next dose.
Jekk tinsa tieħu Emselex Jekk tinsa tieħu Emselex fil- ħin tas- soltu, ħudha hekk kif tiftakar, sakemm ma jkunx sar il- ħin għad - doża li jmiss.
Do not take a double dose to make up for a forgotten dose.
M’ għandekx tieħu doża doppja biex tpatti għal dik li tkun insejt tieħu.
If you stop taking Emselex It has been shown that taking all doses at the appropriate times can greatly increase the effectiveness of your medicine.
Jekk tieqaf tieħu Emselex Intwera li meta jittieħdu d- dożi kollha fil- ħinijiet xierqa jista ’ jżid bil- kbir l- effettivita ’ tal- mediċina tiegħek.
Therefore, it is important to keep taking Emselex correctly, as described above.
Għalhekk, huwa importanti li tibqa tieħu Emselex sewwa, kif spjegat hawn fuq.
Do not stop taking Emselex until your doctor tells you to.
Twaqqafx Emselex sakemm ma jgħidlekx it- tabib tiegħek.
You should not experience any effects when you stop treatment.
M’ għandekx tħoss xi effetti meta twaqqaf il- kura.
Like all medicines, Emselex can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Emselex jista ’ jkollu effetti sekondarji għalkemm ma jidhrux fuq kulħadd.
The side effects caused by Emselex are usually mild and temporary.
L - effetti sekondarji kkawżati minn Emselex normalment ikunu ħfief u jgħaddu.
Some side effects could be serious Serious allergic reactions including swelling, mainly of the face and throat.
Xi effetti sekondarji jstgħu jkunu serji Reazzjonijiet allerġiċi serji jinkludu nefħa, l- aktar fil- wiċċ u griżmejn.
Other side effects Very common side effects (affecting 10 or more in every 100 patients) Dry mouth, constipation.
43 Effetti sekondarji oħrajn Effetti sekondarji komuni ħafna (jeffettwaw 10 jew aktar minn kull 100 pazjent) Ħalq xott, stitikezza.
41 Common side effects (affecting less than 10 in every 100 patients) Headache, abdominal pain, indigestion, feeling sick, dry eyes.
Effetti sekondarji komuni (jeffettwaw anqas minn 10 minn kull 100 pazjent) Uġigħ ta ’ ras, uġigħ fl- addome, indiġestjoni, tħossok marid, għajnejn xotti.
Uncommon side effects (affecting less than 1 in every 100 patients) Fatigue, accidental injury, facial swelling, high blood pressure, diarrhoea, flatulence, inflammation of the mucous membrane of the mouth, increased liver enzymes, swelling, dizziness, sleep disturbance, drowsiness, abnormal thinking, runny nose (rhinitis), cough, shortness of breath, dry skin, itching, rash, sweating, visual disturbance including blurred vision, taste disturbance, urinary tract disorder or infection, impotence, discharge and itching in the vagina, bladder pain, inability to empty your bladder.
Effetti sekondarji mhux komuni (jeffettwaw anqas minn 1 minn kull 100 pazjent) Għeja, korriment aċċidentali, nefħa tal- wiċċ, pressjoni għolja, dijarrea, gass fl- istonku, infjammazzjoni tal- membrana mukuża tal- ħalq, żieda fl- enzimi tal- fwied, nefħa, sturdament, problemi ta ’ rqad, telqa, ħsibijiet anormali, iqattarlek imnieħrek (rinite), sogħla, qtugħ ta ’ nifs, ġilda xotta, ħakk, raxx, għaraq, disturbi tal- vista, inkluża vista mċajpra, disturbi fit- togħma, disturbi fis- sistema ta ’ l- awrina jew infezzjoni, impotenza, tnixxija jew ħakk tal- vaġina, uġigħ fil- bużżieqa ta ’ l- awrina, ma tkunx tista ’ tbattal il- bużżieqa ta ’ l- awrina.
HOW TO STORE EMSELEX
KIF TAĦŻEN EMSELEX