qanastek/EMEA-V3 huggingface dataset:
Increased blood pressure Nervous system disorders Very rare:
Żieda fil- pressjoni tad- demm Disturbi fis- sistema nervuża Rari ħafna:
Rash Reproductive system and breast disorders Very rare:
Uġigħ ta ’ ras inkluża l- emikranja Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
6 4.9 Overdose
6 Rari ħafna:
In some clinical trials, daily doses were given up to 600 mg for 8 weeks and 120 mg, for 3 years.
F’ xi studji kliniċi, ġew mogħtija dożi sa 600 mg kuljum għal 8 ġimgħat u 120 mg għal 3 snin.
No cases of raloxifene overdose were reported during clinical trials.
Ma ġie rrapportat ebda każ ta ’ doża eċċessiva b’ raloxifene waqt l- istudji kliniċi.
In adults, symptoms of leg cramps and dizziness have been reported in patients who took more than 120 mg as a single ingestion.
Fl- adulti, sintomi ta ’ bugħawwiġijiet fir- riġlejn u sturdament ġew irrapportati f’ pazjenti li f’ doża orali waħda ħadu iżjed minn 120mg.
In accidental overdose in children younger than 2 years of age, the maximum reported dose has been 180 mg.
L- ogħla doża rrapportata fit- tfal iżgħar minn sentejn li bi żball ħadu doża eċċessiva kienet ta ’ 180 mg.
In children, symptoms of accidental overdose included ataxia, dizziness, vomiting, rash, diarrhea, tremor, and flushing, and elevation in alkaline phosphatase.
Is- sintomi fit- tfal li bi żball ħadu doża eċċessiva jinkludu ataksja, sturdament, rimettar, raxx, dijarrea, tregħid u ħmura fil- wiċċ u żieda f’ alkaline phosphatase.
The highest overdose has been approximately 1.5 grams.
L- ogħla doża eċċessiva kienet ta ’ madwar 1. 5 grammi.
No fatalities associated with overdose have been reported.
Ma ġewx irrapportati mwiet assoċjati ma ’ doza eċċessiva.
There is no specific antidote for raloxifene hydrochloride.
M’ hemmx antidot speċifiku għal raloxifene hydrochloride.
Pharmaco-therapeutic group:
Grupp farmako- terapewtiku:
Selective Oestrogen Receptor Modulator, ATC code:
Kodiċi ATC:
As a selective oestrogen receptor modulator (SERM), raloxifene has selective agonist or antagonist activities on tissues responsive to oestrogen.
Bħala modulatur selettiv għar- riċetturi ta ’ l- estroġenu (SERM), raloxifene għandu attivitajiet selettivi agonistiċi jew antagonistiċi, fuq it- tessuti li jirrispondu għall- effett ta ’ l- estroġenu.
It acts as an agonist on bone and partially on cholesterol metabolism (decrease in total and LDL-cholesterol), but not in the hypothalamus or in the uterine or breast tissues.
Jaġixxi bħala agonista fuq l- għadam u parzjalment fuq il- metaboliżmu tal- kolesterol (tnaqqis fil- kolesterol totali u dak LDL), iżda mhux fuq l- ipotalamus jew fuq it- tessuti ta ’ l- utru jew tas- sider.
Raloxifene's biological actions, like those of oestrogen, are mediated through high affinity binding to oestrogen receptors and regulation of gene expression.
l- effetti bijoloġiċi ta ’ raloxifene, bħal dawk ta ’ l- estroġenu, jiġru permezz ta ’ l- affinità għolja għall - irbit mar- riċetturi ta ’ l- estroġenu u tar- regolazzjoni ta ’ l- espressjoni tal- ġene.
This binding results in differential expression of multiple oestrogen-regulated genes in different tissues.
Dan l- irbit jirriżulta f’ espressjoni li tvarja minn tessut għall- ieħor fuq il- ġeni multipli irregolati mill- estroġenu.
Recent data suggests that the oestrogen receptor can regulate gene expression by at least two distinct pathways which are ligand-, tissue-, and/ or gene-specific.
Informazzjoni reċenti tindika li r- riċettur ta ’ l- estroġenu jista ’ jirregola l- espressjoni tal- ġene b’ mhux inqas minn żewġ metodi differenti li huma speċifiċi għal- ligand, għat- tessut u/ jew għall- ġene.
a) Skeletal Effects
a) Effetti skeletrali
The decrease in oestrogen availability which occurs at menopause, leads to marked increases in bone resorption, bone loss and risk of fracture.
It- tnaqqis fid- disponibbiltà ta ’ l- estroġenu li jseħħ fil- menopawsa, jwassal għal żidiet sostanzjali fit - tmermir ta ’ l- għadam, it- telf ta ’ l- għadam u r- riskju ta ’ ksur.
Bone loss is particularly rapid for the first 10 years after menopause when the compensatory increase in bone formation is inadequate to keep up with resorptive losses.
It- telf ta ’ l- għadam huwa partikolarment mgħaġġel fl- ewwel 10 snin wara l- menopawsa meta il- kumpens biż- żieda fil- formazzjoni ta ’ l- għadam ma jkunx biżżejjed biex ilaħħaq ma ’ l- ammont li qiegħed jintilef.
Other risk factors which may lead to the development of osteoporosis include early menopause; osteopenia (at least 1 SD below peak bone mass); thin body build; Caucasian or Asian ethnic origin; and a family history of osteoporosis.
Fatturi oħra ta ’ riskju li jistgħu jwasslu għall- iżvilupp ta ’ l- osteoporożi jinkludu l- menopawsa minn kmieni, l- ostejopenja (mhux anqas minn 1 SD ’ l isfel mill- ogħla massa ta ’ l- għadam); statura rqiqa tal- ġisem, oriġini etnika Kawkasja jew Asjatika, u passat mediku fil- familja ta ’ osteoporożi.
Replacement therapies generally reverse the excessive resorption of bone.
Terapiji ta ’ sostituzzjoni ġeneralment ireġġgħu lura t- tmermir eċċessiv ta ’ l- għadam.
In postmenopausal women with osteoporosis, EVISTA reduces the incidence of vertebral fractures, preserves bone mass and increases bone mineral density (BMD).
Fin- nisa wara l- menopawsa li għandhom l- osteoporożi, EVISTA tnaqqas l- inċidenza ta ’ ksur tal- vertebri, tippriserva l- massa ta ’ l- għadam u żżid id- densità minerali ta ’ l- għadam (BMD).
Based on these risk factors, prevention of osteoporosis with EVISTA is indicated for women within ten years of menopause, with BMD of the spine between 1.0 and 2.5 SD below the mean value of a normal young population, taking into account their high lifetime risk for osteoporotic fractures.
7 Ibbażati fuq dawn il- fatturi ta ’ riskju, il- prevenzjoni ta ’ l- osteoporożi bl- EVISTA hija indikata Għan - nisa fi żmien għaxar snin mill- menopawsa, li jkollhom il- BMD ta’ l- ispina bejn 1. 0 u 2. 5 SD aktar baxx mill- valur medju tal- popolazzjoni normali żagħżugħa, meta jitqies ir- riskju għoli ta ’ ksur osteoporotiċi tul ħajjithom.
Likewise, EVISTA is indicated for the treatment of osteoporosis or established osteoporosis in women with BMD of the spine 2.5 SD below the mean value of a normal young population and/ or with vertebral fractures, irrespective of BMD.
Hekk ukoll EVISTA hija indikata għall- kura ta ’ l- osteoporożi jew l - osteoporożi stabbilita f’ nisa li għandhom ksur tal- vertebri 2. 5 SD aktar baxx mill- valur medju ta ’ popolazzjoni normali żagħżugħa u/ jew dawk bil- ksur tal- vertebri, irrespettivamentmill- BMD.
i) Incidence of fractures.
i) L- inċidenza ta ’ ksur:
Forty five women with osteoporosis or 15 women with
Fi studju fuq 7, 705 nisa wara l- menopawsa ta ’ età medja ta ’ 66 sena li għandhom l- osteoporożi jew l- osteoporożi bi ksur eżistenti, il- kura b’ EVISTA għal 3 snin naqqset l - inċidenza ta ’ ksur tal- vertebri b’ 47% (RR 0. 53, CI 0. 35 0. 79; p < 0. 001) u 31% (RR 0. 69, CI 0. 56, 0. 86; p < 0. 001), rispettivament.
7 osteoporosis with an existing fracture would need to be treated with EVISTA for 3 years to prevent one or more vertebral fractures.
Ħamsa u erbgħin mara bl- osteoporożi jew 15- il mara bl- osteoporożi u bi ksur eżistenti jkunu jeħtieġu l- kura b’ EVISTA għal 3 snin biex jiġi evitat każ wieħed jew aktar ta ’ ksur tal- vertebri.
EVISTA treatment for 4 years reduced the incidence of vertebral fractures by 46% (RR 0.54, CI 0.38, 0.75) and 32% (RR 0.68, CI 0.56, 0.83) in patients with osteoporosis or osteoporosis with an existing fracture respectively.
Il- kura b’ EVISTA għal 4 snin tnaqqas l- inċidenza ta ’ ksur tal- vertebri b’ 46% (RR 0. 54, CI 0. 38, 0. 75) u 32% (RR 0. 68, CI 0. 56, 0. 83) f’ pazjenti bl- osteoporożi jew l- osteoporożi bi ksur eżistenti, rispettivament.
In the 4th year alone, EVISTA reduced the new vertebral fracture risk by 39% (RR 0.61, CI 0.43, 0.88).
Fir- raba ’ sena biss, EVISTA naqqset ir- riskju ta ’ ksur ġdid tal- vertebri b’ 39% (RR 0. 61, CI 0. 43, 0. 88).
An effect on non-vertebral fractures has not been demonstrated.
Effett fuq ksur li m’ huwiex tal- vertebri ma ġiex evidenzjat.
From the 4th to the 8th year, patients were permitted the concomitant use of bisphosphonates, calcitonin and fluorides and all patients in this study received calcium and vitamin D supplementation.
Mir- raba ’ sat - tmien sena, il- pazjenti setgħu jieħdu wkoll bisphosphonates, calcitonin u fluorides u l- pazjenti kollha f’ dan l- istudju ngħataw supplimenti tal- calcium u tal- vitamina D.
In the RUTH study overall clinical fractures were collected as a secondary endpoint.
Fl- istudju kliniku RUTH, il- ksur kliniku kollu kien miġbur bħala riżultat finali sekondarju.
EVISTA reduced the incidence of clinical vertebral fractures by 35% compared with placebo (HR 0.65, CI 0.47 0.89).
Evista naqqset l- inċidenza ta ’ ksur kliniku tal- vertebri b’ 35% meta mqabbla ma ’ plaċebo (HR 0. 65, CL 0. 47 0. 89).
These results may have been confounded by baseline differences in BMD and vertebral fractures.
Dawn ir- riżultati setgħu ġew imfixkla minħabba differenzi fil- linji bażi tal- BMD u tal- ksur tal - vertebri.
There was no difference between treatment groups in the incidence of new nonvertebral fractures.
Ma kien hemm ebda differenza bejn il- gruppi taħt kura, fl- inċidenza ta ’ ksur ġdid li ma kienx tal- vertebri.
During the whole length of the study concomitant use of other bone-active medications was permitted.
Matul it- terminu kollu ta ’ l- istudju kien permess l- użu konkomitanti ta ’ medikazzjonijiet oħra li jaġixxu fuq l- għadam.
ii) Bone Mineral Density (BMD):
ii) Id- Densità Minerali ta ’ l- Għadam (BMD):
The efficacy of EVISTA once daily in postmenopausal women aged up to 60 years and with or without a uterus was established over a two-year treatment period.
L- effikaċja ta ’ EVISTA darba kuljum fin- nisa wara l - menopawsa ta ’ eta sa 60 sena, kemm f’ dawk li għandhom u dawk li m’ għandhomx utru, kienet stabbilita fuq perijodu ta ’ kura ta ’ sentejn.
The women were 2 to 8 years postmenopausal.
In- nisa kienu ilhom minn 2 sa 8 snin bil- menopawsa.
Three trials included 1,764 postmenopausal women who were treated with EVISTA and calcium or calcium supplemented placebo.
Tliet provi inkludew 1, 764 mara wara l- menopawża li kienu ikkurati b’ EVISTA u calcium, jew il- plaċebo flimkien ma ’ calcium.
In one of these trials the women had previously undergone hysterectomy.
F’ waħda minn dawn il- provi in- nisa kienu għaddew minn isterektomija qabel.
EVISTA produced significant increases in bone density of hip and spine as well as total body mineral mass compared to placebo.
EVISTA kkawżat żidiet sinifikanti fid- densita ta ’ l- għadma tal- ġenbejn u ta ’ l- ispina, kif ukoll fil - massa minerali tal- ġisem kollu meta mqabbla mal- plaċebo.
This increase was generally a 2% increase in BMD compared to placebo.
Din iż- żieda kienet ġeneralment waħda ta ’ 2% fil- BMD, komparata mal- plaċebo.
A similar increase in BMD was seen in the treatment population who received EVISTA for up to 7 years.
Żieda simili fil- BMD dehret fil- grupp tal- kura li rċevew Evista għal perijodu ta ’ 7 snin.
In the prevention trials, the percentage of subjects experiencing an increase or decrease in BMD during raloxifene therapy was: for the spine 37% decreased and 63% increased; and for the total hip 29% decreased and 71% increased.
Fil- provi tal- prevenzjoni, il- perċentaġġ ta ’ individwi li kellhom żieda jew tnaqqis fil- BMD waqt it- terapija b’ raloxifene kienu: fil- każ ta ’ l- ispina 37% tnaqqis u 63% żieda; u għall- għadam sħiħ tal- ġenbejn 29% tnaqqis u 71% żieda.
iii) Calcium kinetics.
iii) Il- kinetiċi tal- calcium.
EVISTA and oestrogen affect bone remodelling and calcium metabolism similarly.
EVISTA u l- estroġenu jeffetwaw bl- istess mod ir- rimodellar ta ’ l- għadam u l- metaboliżmu tal- calcium.
EVISTA was associated with reduced bone resorption and a mean positive shift in calcium balance of 60 mg per day, due primarily to decreased urinary calcium losses.
EVISTA kienet assoċjata ma ’ tnaqqis fit- tmermir ta ’ l- għadam u ċaqlieq medju u pożittiv fil- bilanċ tal- calcium ta ’ 60 mg kuljum, dovut primarjament għat- tnaqqis fit- telf ta ’ calcium fl- awrina.
iv) Histomorphometry (bone quality).
iv) Ħistomorfometrija (il- kwalità ta ’ l- għadam).
In a study comparing EVISTA with oestrogen, bone from patients treated with either medicinal product was histologically normal, with no evidence of mineralisation defects, woven bone or marrow fibrosis.
Fi studju fejn EVISTA kienet imqabbla ma ’ l - estroġenu, l- għadam ta ’ pazjenti ikkurati b’ kull wieħed minn dawn il- prodotti mediċinali kien normali ħistoloġikament, mingħajr evidenza ta ’ difetti fil- mineraliżżazjoni, għadam minsuġ u fibrożi tal - mudullun.
Raloxifene decreases resorption of bone; this effect on bone is manifested as reductions in the serum and urine levels of bone turnover markers, decreases in bone resorption based on radiocalcium kinetics studies, increases in BMD and decreases in the incidence of fractures.
Raloxifene inaqqas it- tneħħija ta ’ l- għadam; dan l- effett fuq l- għadam jidher bħala tnaqqis fis- serum u fl- awrina tal- livelli ta ’ sustanzi li jimmarkaw il- bidla fl- għadam fis- seru tad- demm u fl- awrina, tnaqqis fit- tmermir ta ’ l- għadam ibbażat fuq studji kinetiċi ta ’ calcium radjuattiv, żidiet fil- BMD u tnaqqis fl - inċidenza ta ’ ksur.
b) Effects on lipid metabolism and cardiovascular risk
b) Effetti fuq il- metaboliżmu tal- lipidi u r- riskju kardjovaskulari
Clinical trials showed that a 60 mg daily dose of EVISTA significantly decreased total cholesterol (3 to 6%), and LDL cholesterol (4 to 10%).
Provi kliniċi wrew li t- teħid ta ’ doża ta ’ EVISTA f’ doża ta ’ 60 mg kuljum ta ’ naqqset b’ mod sinifikanti il- kolesterol totali (b’ 3 sa 6%) u l- kolesterol LDL (b’ 4 sa 10%).
Women with the highest baseline cholesterol levels had the greatest decreases.
Nisa li kellhom l- ogħla livelli ta ’ kolesterol fil- linja bażi, kellhom l- akbar tnaqqis.
HDL cholesterol and triglyceride concentrations did not change significantly.
Il- konċentrazzjonijiet tal- kolesterol HDL u
EVISTA therapy for 8 years did not significantly affect the risk of cardiovascular events in patients enrolled in the osteoporosis treatment study.
8 t- trigliċeridi ma ’ nbidlux b’ mod sinifikanti.
Similarly, in the RUTH study, raloxifene did not affect the incidence of myocardial infarction, hospitalized acute coronary syndrome, stroke or overall mortality, including overall cardiovascular mortality, compared to placebo (for the increase in risk of fatal stroke see section 4.4).
Wara 3 snin ta ’ terapija EVISTA naqqset il- fibrinoġen (6. 71%).
The relative risk of venous thromboembolic events observed during raloxifene treatment was 1.60 (CI 0.95, 2.71) when compared to placebo, and was 1.0 (CI 0.3, 6.2) when compared to oestrogen or
Fl- istudju dwar il- kura ta ’ l- osteoporożi, numru sinifikantement inqas ta ’ pazjenti ikkurati b’ EVISTA kellhom bżonn li jinbdew fuq terapija biex jitbaxxa l- livell tax- xaħam fid- demm, meta mqabbla ma ’ dawk fuq il- plaċebo.
8 hormonal replacement therapy.
It- terapija b’ EVISTA għal 8 snin ma effetwatx b’ mod sinifikanti r- riskju ta ’ avvenimenti kardjovaskulari f’ pazjenti involuti fl- istudju dwar il- kura ta ’ l- osteoporożi.
The risk of a thromboembolic event was greatest in the first four months of therapy.
Ir- riskju ta ’ avveniment tromboemboliku kien l- akbar fl- ewwel erba ’ xhur tat- terapija.
c) Effects on the endometrium and on the pelvic floor
c) Effetti fuq l- endometriju u l- qiegħ tal- pelvis
In clinical trials, EVISTA did not stimulate the postmenopausal uterine endometrium.
Fi provi kliniċi, EVISTA ma stimulatx l- endometriju ta ’ l- utru fil- perijodu ta ’ wara l- menopawsa.
Compared to placebo, raloxifene was not associated with spotting or bleeding or endometrial hyperplasia.
Meta mqabbel mal- plaċebo, raloxifene ma kienx assoċjat ma ’ tbabar jew tnixxija ta ’ demm, jew ħxuna ta ’ l- endometriju.
Nearly 3,000 transvaginal ultrasound (TVUs) examinations were evaluated from 831 women in all dose groups.
Kważi 3, 000 eżami transvaġinali li saru bl- ultrasawnd (TVU) fuq 831 pazjenta, kienu evalwati fil- gruppi kollha ta ’ dożaġġi differenti.
Raloxifene treated women consistently had an endometrial thickness which was indistinguishable from placebo.
In- nisa kkurati b’ raloxifene kellhom konsistentement ħxuna ta ’ l- endometriju li ma kenitx tintgħaraf minn dik bil- plaċebo.
After 3 years of treatment, at least a 5 mm increase in endometrial thickness, assessed with transvaginal ultrasound, was observed in 1.9% of the 211 women treated with raloxifene 60 mg/ day compared to 1.8% of the 219 women who received placebo.
Wara 3 snin ta ’ kura, mhux inqas minn 5 mm żieda fil- ħxuna ta ’ l- endometriju, kif assessjat bl- ultrasawnd transvaġinali, kien osservat f’ 1. 9% ta ’ 211- il mara, ikkurati b’ 60 mg raloxifene kuljum meta mqabbla ma ’ 1. 8% ta ’ 219- il mara li rċevew il- plaċebo.
There were no differences between the raloxifene and placebo groups with respect to the incidence of reported uterine bleeding.
Ma kienx hemm differenzi bejn il- grupp ikkurat b’ raloxifene u l- grupp li ħadu l- plaċebo, fl- inċidenza ta ’ tnixxija ta ’ demm mill- utru, li ġiet irrappurtata.
Endometrial biopsies taken after six months therapy with EVISTA 60 mg daily demonstrated non- proliferative endometrium in all patients.
Bijopsiji ta ’ l- endometriju meħudin wara terapija ta ’ 60 mg ta ’ EVISTA kuljum għal sitt xhur, urew endometriju mhux proliferattiv fil- pazjenti kollha.
In addition, in a study with 2.5 x the recommended daily dose of EVISTA there was no evidence of endometrial proliferation and no increase in uterine volume.
Barra minn hekk, fi studju fejn id- doża ta ’ EVISTA kienet 2. 5 drabi akbar minn dik irrakkomandata li għandha tittieħed kuljum, ma kienx hemm evidenza ta ’ proliferazzjoni ta ’ l- endometriju, u anqas żieda fil- volum ta ’ l- utru.
In the osteoporosis treatment trial, endometrial thickness was evaluated annually in a subset of the study population (1,644 patients) for 4 years.
Fil- prova dwar il- kura ta ’ l- osteoporożi il- ħxuna ta ’ l- endometriju kienet evalwata kull sena fi grupp, fi ħdan il- grupp kollu nvolut (1, 644 pazjenti), għal 4 snin.
Endometrial thickness measurements in EVISTA treated women were not different from baseline after 4 years of therapy.
Il- kejl tal- ħxuna ta ’ l- endometriju fin- nisa ikkurati b’ EVISTA ma kienx differenti mill- linja bażi wara 4 snin ta ’ terapija.
There was no difference between EVISTA and placebo treated women in the incidences of vaginal bleeding (spotting) or vaginal discharge.
Ma kien hemm l- ebda differenza bejn dawk in- nisa ikkurati b’ EVISTA u dawk li ħadu l- plaċebo fl- inċidenza ta ’ fsada mill - vaġina (tbabar) jew tisfija vaġinali.
Fewer EVISTA treated women than placebo treated women required surgical intervention for uterine prolapse.
Kien hemm inqas nisa minn dawk ikkurati b’ EVISTA milli nisa li ħadu l- plaċebo li kellhom bżonn xi intervent kirurġiku għall- prolass ta ’ l- utru.
Safety information following 3 years of raloxifene treatment suggests that raloxifene treatment does not increase pelvic floor relaxation and pelvic floor surgery.
L- informazzjoni dwar is- sigurtà wara 3 snin ta ’ kura b’ raloxifene, tissuġġerixi li l- kura b’ raloxifene ma żżidx id- dgħjufija tal- qiegħ tal- pelvis u anqas l- interventi kirurġiċi biex isaħħu dan.
After 4 years, raloxifene did not increase the risk of endometrial or ovarian cancer.
Wara 4 snin, raloxifene ma żiedx ir- riskju ta ’ kanċer ta ’ l- endometriju jew ta ’ l- ovarji.
In postmenopausal women who received raloxifene treatment for 4 years, benign endometrial polyps were reported in 0.9% compared to 0.3% in women who received placebo treatment.
Fin- nisa wara l- menopawsa li ħadu il- kura b’ raloxifene għal 4 snin, il- qarnit beninju tal- endometriju kienu irrapportati f’ 0. 9% meta mqabbel ma ’ 0. 3% f’ nisa li ħadu il- kura bil- plaċebo.
d) Effects on breast tissue
d) Effetti fuq it- tessut tas- sider
EVISTA does not stimulate breast tissue.
EVISTA ma jistimulax it- tessut tas- sider.
Across all placebo-controlled trials, EVISTA was indistinguishable from placebo with regard to frequency and severity of breast symptoms (no swelling, tenderness and breast pain).
Tul l- 4 snin tal- prova rigward il- kura ta ’ l- osteoporożi (li nvolviet 7705 pazjenti), il- kura b’ EVISTA meta mqabbla mal- plaċebo naqqset ir- riskju totali ta ’ kanċer tas- sider b’ 62%, (RR 0. 38, CI 0. 21, 0. 69) u r- riskju ta ’ kanċer mifrux tas- sider li jinfirex b’ 71% (RR 0. 29, CI 0. 13, 0. 58) u r- riskju ta ’ kanċer
Over the 4 years of the osteoporosis treatment trial (involving 7705 patients), EVISTA treatment compared to placebo reduced the risk of total breast cancer by 62% (RR 0.38; CI 0.21, 0.69), the risk of invasive breast cancer by 71% (RR 0.29, CI 0.13, 0.58) and the risk of invasive oestrogen receptor (ER) positive breast cancer by 79% (RR 0.21, CI 0.07, 0.50).
9 tas- sider li jinfirex li hu pożittiv għar- riċettur ta ’ l- estroġenu (ER) b’ 79% (RR 0. 21, CI 0. 07, 0. 50).
EVISTA has no effect on the risk of ER negative breast cancers.
EVISTA m’ għandha ebda effett fuq ir- riskju ta ’ kanċer tas- sider li huwa negattiv għall- ER.
These observations support the conclusion that raloxifene has no intrinsic oestrogen agonist activity in breast tissue.
Dawn l - osservazzjonijiet isaħħu l- konklużjoni li raloxifene m’ għandu l- ebda attività intrinsika ta ’ natura agonistika għall- estroġenu fuq fit- tessut tas- sider.
e) Effects on cognitive function
e) Effetti fuq il- funzjoni konjittiva
No adverse effects on cognitive function have been seen.
Ma nstabux effetti avversi fuq il- funzjoni konjittiva.
Raloxifene is absorbed rapidly after oral administration.
Raloxifene jiġi assorbit malajr wara t- teħid orali.
Approximately 60% of an oral dose is absorbed.
Madwar 60% ta ’ doża orali tiġi assorbita.
Presystemic glucuronidation is extensive.
Qabel ma jidħol fiċ- ċirkolazzjoni sistemika jkun hemm glukuronidazzjoni estensiva.
Absolute bioavailability of raloxifene is 2%.
Il- bijodisponibbiltà assoluta ta ’ raloxifene hija ta ’ 2%.
The time to reach average maximum plasma concentration and bioavailability are functions of systemic interconversion and enterohepatic cycling of raloxifene and its glucuronide metabolites.
Il- ħin biex tintlaħaq il- konċentrazzjoni massima medja fil- plażma u l- bijodisponibbiltà huma funzjonijiet tal- bidla li ssir fiċ- ċirkolazzjoni sistemika u ċ- ċiklu enteroepatiku ta ’ raloxifene u l- metaboli glukuronidi tiegħu.
Raloxifene is distributed extensively in the body.
Raloxifene jinfirex estensivament fil- ġisem.
The volume of distribution is not dose dependent.
Il- volum tad- distribuzzjoni ma jiddependix mid- doża.
Raloxifene is strongly bound to plasma proteins (98-99%).
Raloxifene jintrabat sew mal- proteini tal- plażma (98 sa 99%).
Metabolism
Metaboliżmu
Raloxifene undergoes extensive first pass metabolism to the glucuronide conjugates: raloxifene-4'- glucuronide, raloxifene-6-glucuronide, and raloxifene-6, 4′ -diglucuronide.
Permezz ta ’ metaboliżmu first pass, Raloxifene jinbidel estensivament f’ derivattivi glukuronidi: raloxifene- 41- glucuronide, raloxifene- 6- glucuronide u raloxifene- 6, 41- diglucuronide.
No other metabolites have been detected.
Ma nstabux metaboli oħra.
Raloxifene comprises less than 1% of the combined concentrations of raloxifene and the glucuronide metabolites.
Raloxifene jagħmel inqas minn 1% tal- konċentrazzjonijiet ta ’ raloxifene u l- metaboli glukuronidi flimkien.
Raloxifene levels are maintained by enterohepatic recycling, giving a plasma half-life of 27.7 hours.
Il- livelli ta ’ raloxifene jinżamm permezz tar- reċiklar enteroepatiku, li jirriżulta f’ half- life fil- plażma ta ’ 27. 7 sigħat.
Results from single oral doses of raloxifene predict multiple dose pharmacokinetics.
Ir- riżultati minn dożi singoli orali ta ’ raloxifene jintużaw biex jitbassar il- komportament farmakokinetiku ta ’ dożi multipli.
Increasing doses of raloxifene result in slightly less than proportional increase in the area under the plasma time concentration curve (AUC).
Żidiet fid- dożi ta ’ raloxifene jirriżultaw f’ żieda fl- erja taħt il- kurva tal- ħin u l- konċentrazzjoni fil- plasma (AUC) li hija ftit anqas minn żieda proporzjonali.
Excretion
Tneħħija mill- ġisem
The majority of a dose of raloxifene and glucuronide metabolites are excreted within 5 days and are found primarily in the faeces, with less than 6% excreted in urine.
Il- parti l- kbira tad- doża ta ’ raloxifene u l- metaboli glukuronidi jitneħħew mill- ġisem fi żmien 5 ijiem u jinsabu primarjament fl- ippurgar, b’ inqas minn 6% imneħħija fl- awrina.
Special populations
Gruppi speċjali ta ’ pazjenti
Renal insufficiency - Less than 6% of the total dose is eliminated in urine.
L- insuffiċjenza tal- kliewi – Inqas minn 6% tad- doża totali titneħħa mill- ġisem fl- awrina.
In a population pharmacokinetic study, a 47% decrease in lean body mass adjusted creatinine clearance resulted in a 17% decrease in raloxifene clearance and a 15% decrease in the clearance of raloxifene conjugates.
Fi studju farmakokinetiku li sar fuq grupp ta ’ nies, tnaqqis ta ’ 47% fit- tneħħija tal- krejatinina, meta jitqies il- piż tal- ġisem mingħajr it- tessut xaħmi, irriżulta f’ 17% tnaqqis fit- tneħħija ta ’ raloxifene u 15% tnaqqis fit - tneħħija tal- konjugi ta ’ raloxifene.
Hepatic insufficiency - The pharmacokinetics of a single dose of raloxifene in patients with cirrhosis and mild hepatic impairment (Child-Pugh class A) have been compared to that in healthy individuals.
l- insuffiċjenza tal- fwied – Il- farmakokinetika ta ’ doża waħda ta ’ raloxifene f’ pazjenti b’ ċirrożi u b’ indeboliment moderat tal- fwied (Klassi A Child- Pugh) kien imqabbel ma ’ dak ta ’ individwi b’ saħħithom.
Plasma raloxifene concentrations were approximately 2.5-fold higher than in controls and correlated with bilirubin concentrations.
Il- konċentrazzjonijiet ta ’ raloxifene fil- plażma kienu bejn wieħed u ieħor 2. 5 drabi ogħla mill- kontrolli u kienu jikkorrelaw mal- konċentrazzjonijiet tal- bilirubin.
In a 2-year carcinogenicity study in rats, an increase in ovarian tumors of granulosa/ theca cell origin was observed in high-dose females (279 mg/ kg/ day).
Fi studju li sar fuq il- firien, dwar il- karċinoġeniċita`, li dam sejjer sentejn, żieda fl- inċidenza ta ’ tumuri ta ’ l- ovarji ta ’ oriġini taċ- ċelluli tal- granuloża / tat- teka, kienet innotata fl- annimali ta ’ sess femminil li
Systemic exposure (AUC) of raloxifene in this group was approximately 400 times that in postmenopausal women administered a 60 mg dose.
L- espożizzjoni sistemika (AUC) ta ’ raloxifene f’ dan il- grupp kien bejn wieħed u ieħor 400 darba akbar minn dik li tintlaħaq fin- nisa ta ’ wara l- menopawsa li jieħdu doża ta ’ 60 mg.
In a 21-month carcinogenicity study in mice, there was an increased incidence of testicular interstitial cell tumours and prostatic adenomas and adenocarcinomas in males given 41 or 210 mg/ kg, and prostatic leiomyoblastoma in males given 210 mg/ kg.
Fi studju li sar fuq il- ġrieden dwar il - karċinoġeniċita`, li dam sejjer ta ’ 21 xahar, kien hemm żieda fl- inċidenza ta ’ tumuri taċ- ċelluli interstizjali tat- testikoli, adenomi tal- prostata u adenokarċinomi fl- annimali ta ’ sess maskil, meta ngħataw 41 jew 210 mg/ kg,, u l- lejomajoblastoma tal- prostata fl- annimali ta ’ sess maskil li ngħataw 210 mg/ kg.
In female mice, an increased incidence of ovarian tumours in animals given 9 to 242 mg/ kg (0.3 to 32 times the AUC in humans) included benign and malignant tumours of granulosa/ theca cell origin and benign tumours of epithelial cell origin.
Fil- ġrieden ta ’ sess femminil, iż- żieda fl- inċidenza tat- tumuri tal- ovarji f’ annimali li ngħataw 9 sa 242 mg/ kg (0. 3 sa 32 darba l- AUC fil - bniedem), kienet f’ tumuri beninji u malinni ta ’ oriġini taċ- ċelluli tal- granuloża / tat- teka u tumuri beninji ta ’ oriġini taċ- ċelluli epitiljali.
The female rodents in these studies were treated during their reproductive lives, when their ovaries were functional and highly responsive to hormonal stimulation.
Il- mammali gerriema ta ’ sess femminil f’ dawn l- istudji kienu ittrattati waqt il- ħajja riproduttiva tagħhom, meta l- ovarji kienu jiffunzjunaw u jirrispondu ferm għall - istimuli ormonali.
In contrast to the highly responsive ovaries in this rodent model, the human ovary after menopause is relatively unresponsive to reproductive hormonal stimulation.
F’ kuntrast ma ’ dan il- mudell tal- mammali gerriema fejn l- ovarji jirrispondu ferm, l- ovarja umana, wara l- menopawsa, ma tirrispondix relattivament għal stimuli ormonali riproduttivi.
Raloxifene was not genotoxic in any of the extensive battery of test systems applied.
Raloxifene ma kienx ġenotossiku f’ ebda waħda minn serje estensiva ta ’ sistemi ta ’ testijiet li ntużaw.
10 The reproductive and developmental effects observed in animals are consistent with the known pharmacological profile of raloxifene.
L- effetti riproduttivi u dawk fuq l- iżvilupp, osservati fl- annimali, huma konsistenti mal- profil farmakoloġiku magħruf ta ’ raloxifene.
At doses of 0.1 to 10 mg/ kg/ day in female rats, raloxifene disrupted estrous cycles of female rats during treatment, but did not delay fertile matings after treatment termination and only marginally reduced litter size, increased gestation length, and altered the timing of events in neonatal development.
F’ dożi ta ’ 0. 1 sa 10 mg/ kg/ jum fil- firien ta ’ sess femminil, Raloxifene fixkel iċ- ċiklu estrous fil- firien ta ’ sess femminil waqt il- kura, iżda ma ttardjax it- tgħammir fertili wara li twaqqaf il- kura, u naqqas bi ftit biss id- daqs tal- boton, żied it- tul ta ’ żmien tat- tqala, u biddel iż- żmien fl- avvenimenti ta ’ l- iżvilupp tal- wild.
When given during the preimplantation period, raloxifene delayed and disrupted embryo implantation resulting in prolonged gestation and reduced litter size but development of offspring to weaning was not affected.
Meta ngħata fil- perijodu ta ’ qabel il- bajda iffertiliżżata teħel mal- ħajt tal- ġuf, raloxifene ittardja u ħarbat il- proċess ta ’ twaħħil ta ’ l- embriju li rriżulta f’ perijodu itwal ta ’ tqala u tnaqqis fid- daqs tal- boton, iżda m’ effetwax l- iżvilupp ta ’ l- annimal mit- twelid sa kemm infatam.
Teratology studies were conducted in rabbits and rats.
Studji teratoġeniċi saru fuq il- fniek u l- firien.
In rabbits, abortion and a low rate of ventricular septal defects (≥ 0.1 mg/ kg) and hydrocephaly (≥ 10 mg/ kg) were seen.
Fil- fniek, l- abort u rata baxxa ta ’ difetti fis- septum li jifred il- ventrikoli tal- qalb (≥ 0. 1 mg/ kg), u l- idroċefalija (≥ 10 mg/ kg) kienu innotati.
In rats retardation of foetal development, wavy ribs and kidney cavitation occurred (≥ 1 mg/ kg).
Fil- firien kien hemm ittardjar ta ’ l- iżvilupp tal- fetu, kustilji mgħawwġa u kavitajiet fil - kliewi (≥ 1 mg/ kg).
Raloxifene is a potent antioestrogen in the rat uterus and prevented growth of oestrogen-dependent mammary tumours in rats and mice.
Raloxifene huwa anti- estroġenu qawwi għall- utru tal- far u waqqaf l- iżvilupp ta ’ tumuri tas- sider, li huwa dipendenti fuq l- estroġenu, fil- firien u l- ġrieden.
Tablet core:
Il- Qalba tal- pillola:
Povidone Polysorbate 80 Anhydrous lactose Lactose monohydrate Crospovidone Magnesium stearate
Povidone, Polysorbate 80 Anhydrous lactose Lactose monohydrate Crospovidone Magnesium stearate
Tablet coating:
Ir- Rita tal- pillola:
Titanium dioxide (E 171) Polysorbate 80 Hypromellose Macrogol 400 Carnauba wax
Titanium dioxide (E171) Polysorbate 80 Hypromellose Macrogol 400 Carnauba wax
Ink:
Linka:
Shellac Propylene glycol Indigo carmine (E 132)
Shellac Propylene glycol Indigo carmine (E132).
6.3 Shelf-life
11 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Do not freeze.
Tiffriżahx.
EVISTA tablets are packed either in PVC/ PE/ PCTFE blisters or in high density polyethylene bottles.
Il- pilloli ta ’ EVISTA jiġu fil- folji ta ’ PVC/ PE/ PCTFE jew fil- fliexken tal- polyethylene ta ’ densità għolja.
Blister boxes contain 14, 28, or 84 tablets.
Il- kaxex tal- folji fihom 14, 28 jew 84 pilloli.
Bottles contain 100 tablets.
Il- fliexken huma ta ’ 100 pillola.
Not all pack sizes may be marketed in all countries.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
Daiichi Sankyo Europe GmbH Zielstattstrasse 48 D-81379 Munich Germany
Eli Lilly Nederland B. V Grootslag 1- 5 NL- 3991 RA Houten L- Olanda
5 August 1998 Date of last renewal:
5 Awwissu 1998 Data ta ’ l- aħħar tiġdid:
8 August 2008
8 ta ’ Awwissu 2008
Lilly SA Avda de la Industria 30 28108 Alcobendas Madrid Spain
Daiichi Sankyo Europe GmbH Zielstattstrasse 48 D- 81379 Munich Il- Ġermanja
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Fuq il- fuljett ta ’ tagħrif tal- prodott mediċinali għandu jkun hemm l- isem u l- indirizz tal- manifattur responsabbli għall- ħruġ tal- lott konċernat.
• CONDITIONS OR RESTRICTIONS WITH REGARDS TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
The Marketing Authorisation Holder will provide the PSUR at 3-yearly intervals.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq se jipprovdi l- PSUR kull 3 snin
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
16 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
BOTTLE LABEL, BOTTLE CARTON:
TIKKETTA TAL- FLIXKUN, KARTUNA TAL- FLIXKUN:
EVISTA 60 mg film coated tablets raloxifene hydrochloride
EVISTA 60 mg pilloli miksija b’ rita raloxifene hydrochloride
Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene
Kull pillola miksija b’ rita għandha 60 mg ta ’ raloxifene hydrochloride, li hu ekwivalenti għal 56 mg ta ’ raloxifene.
Also includes lactose
Jinkludi wkoll lactose
See leaflet for further information
Ara l- fuljett għal aktar informazzjoni.
100 film coated tablets
100 pillola miksija b’ rita.
For oral use
Għall- użu orali.
EXP {MM/ YYYY}
JIS{ XX/ SSSS}
SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPEJALI TA ’ KIF JINĦAŻEN
Marketing Authorisation Holder:
Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Daiichi Sankyo Europe GmbH Zielstattstrasse 48 D-81379 Munich Germany
Daiichi Sankyo Europe GmbH Zielstattstrasse 48 D- 81379 Munich Il- Ġermanja
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
18 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
BLISTER BOX FILM COATED TABLETS:
KAXXA TAL- FOLJI B ’ PILLOLI MIKSIJA B’ RITA:
Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene
Kull pillola miksija b’ rita għandha 60 mg ta ’ raloxifene hydrochloride, li huwa ekwivalenti għal 56 mg ta ’ raloxifene.
Also includes lactose
Jinkludi wkoll lactose.
14 film coated tablets 28 film coated tablets 84 film coated tablets
14- il pillola miksija b’ rita 28 pillola miksija b’ rita 84 pillola miksija b’ rita
Do not freeze.
Aħżen fil- pakkett oriġinali.
19 10.
19 Tiffriżahx.
Marketing Authorisation Holder:
Detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
EU/ 1/ 98/ 073/ 001 14 film coated tablets EU/ 1/ 98/ 073/ 002 28 film coated tablets EU/ 1/ 98/ 073/ 003 84 film coated tablets
EU/ 1/ 98/ 073/ 001 14- il pillola miksija b’ rita EU/ 1/ 98/ 073/ 002 28 pillola miksija b’ rita EU/ 1/ 98/ 073/ 003 84 pillola miksija b’ rita
20 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
20 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER (ALL BLISTER PACKS):
FOLJA (PAKKETTI KOLLHA TAL- FOLJI)
Lot {number}
Lot {numru}
22 PACKAGE LEAFLET:
22 FULJETT TA ’ TAGĦRIF:
Read all of this leaflet carefully before you start taking your medicine. • Keep this leaflet.
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina. • Żomm dan il- fuljett.
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you.
Jista ’ jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek. • Din il- mediċina ġiet mogħtija lilek.
What EVISTA is and what it is used for 2.
X' inhi EVISTA u għalxiex tintuża 2.
Before you take EVISTA 3.
Qabel ma tieħu EVISTA 3.
How to take EVISTA 4.
Kif għandek tieħu EVISTA 4.
How to store EVISTA 6.
Kif taħżen EVISTA 6.
WHAT EVISTA IS AND WHAT IT IS USED FOR
X’ INHI EVISTA U GĦALXIEX TINTUŻA
EVISTA belongs to a group of non-hormonal medicines called Selective Oestrogen Receptor Modulators (SERMs).
EVISTA tagħmel parti minn grupp ta ’ mediċini mhux ormonali msejħa Modulaturi Selettivi għar - Riċetturi ta ’ l- Estroġenu (SERMs).
When a woman reaches the menopause, the level of the female sex hormone oestrogen goes down.
Meta mara tasal għall- menopawsa, il- livell ta ’ l- ormon sesswali tal- mara, l- estroġenu, jinżel.
EVISTA mimics some of the helpful effects of oestrogen after the menopause.
EVISTA jimita ftit minn dawn l- effetti ta ’ benfiċċju ta ’ l- estroġenu wara l- menopawsa.
EVISTA is used to treat and prevent osteoporosis in postmenopausal women.
EVISTA tintuża biex tikkura u tipprevjeni l- osteoporożi fin- nisa wara l- menopawsa.
EVISTA reduces the risk of vertebral fractures in women with postmenopausal osteoporosis.
EVISTA tnaqqas ir- riskju ta ’ ksur tal- vertebri fin- nisa bl- osteoporożi wara l- menopawsa.
A reduction in the risk of hip fractures has not been shown.
Ma ntweriex tnaqqis fir- riskju ta ’ ksur tal- għadam tal- ġenbejn.
Osteoporosis is a disease that causes your bones to become thin and fragile - this disease is especially common in women after the menopause.
L- opsteoporożi hija marda fejn l- għadam jirqaq u jiddgħajjef – din il- marda hija speċjalment komuni fin- nisa wara l- menopawsa.
Although it may have no symptoms at first, osteoporosis makes you more likely to break bones, especially in your spine, hips and wrists and may cause back pain, loss of height and a curved back.
Għalkemm tista ’ ma tikkaġunax ebda sintomi għall- ewwel, l- osteoporożi twassal biex għadmek jinkiser faċilment, speċjalment fis- sinsla tad- dahar, il- ġenbejn, u l- polzijiet, u jista ’ jikkawża uġigħ fid- dahar, taqsir mit- tul u dahar mgħawweġ.
BEFORE YOU TAKE EVISTA
QABEL MA TIEĦU EVISTA
Do not take EVISTA:
Tieħux EVISTA:
This must be investigated by your doctor. • If you have active uterine cancer, as there is insufficient experience of EVISTA use in women with this disease. • If you have severe kidney problems.
• Jekk int allerġiku (tbati minn sensittività eċċessiva) għal raloxifene jew sustanzi oħra ta ’ EVISTA • Jekk għad hemm il- possibbiltà li toħroġ tqila, EVISTA tista ’ tagħmel ħsara lit- tarbija li għad trid titwieled. • Jekk qed tiġi kkurata jew kont ikkurata għal tagħqid tad- demm (trombożi tal- vini fondi, emboliżmu pulmonari u trombożi tal- vina tar- retina). • Jekk għandek mard tal- fwied (eżempji ta ’ mard tal- fwied huma ċirrożi, indeboliment ħafif tal - fwied jew is- suffejra kolestatika).
23 Take special care with EVISTA
23 • Jekk għandek ħruġ ta ’ demm mill- vaġina mingħajr spjegazzjoni.
The following are reasons why this product may not be suitable for you.
Ir- raġunijiet għaliex dan il- prodott jista ’ ma jkunx tajjeb għalik huma elenkati hawn taħt.
If any of them apply to you, talk to your doctor before you take the medicine.
Jekk kwalunkwe waħda minnhom tapplika għalik, kellem lit- tabib tiegħek qabel ma tieħu l- mediċina.
• If you are immobilised for some time such as being wheel-chair bound, needing to be admitted to a hospital or having to stay in bed while recovering from an operation or an unexpected illness. • If you are receiving oral oestrogen therapy. • If you are suffering from breast cancer, as there is insufficient experience of EVISTA use in women with this disease. • If you have had a cerebrovascular accident (e. g. stroke), or if your doctor has told you that you are at high risk of having one.
• Jekk int immobiliżżata għal xi żmien bħal meta tkun qiegħda f’ siġġu tar- roti, jew qed tistenna biex tidħol l- isptar jew trid toqgħod fis- sodda biex tirkupra wara operazzjoni jew xi marda mhix mistennija. • Jekk inti qiegħda tirċievi terapija ta ’ estroġeni orali. • Jekk inti qed tbati minn kanċer tas- sider, għax m’ hemmx esperjenza biżżejjed fuq l- użu ta ’ l - EVISTA fin- nisa b’ din il- marda. • Jekk kellek xi inċident ċerebrovaskulari (eż. puplesija), jew jekk it- tabib qallek li hemm riskju għoli li jkollok xi inċident ċerebrovaskulari.
It is unlikely that EVISTA will cause vaginal bleeding.
Mhux probabbli li EVISTA tikkawża l- ħruġ tad- demm mill- vaġina.
So any vaginal bleeding while you take EVISTA is unexpected.
Għalhekk, jekk hemm xi demm ġej mill- vaġina waqt li qed tieħu EVISTA dan mhux mistenni.
You should have this investigated by your doctor.
Għandek tkun investigata mit- tabib tiegħek.
EVISTA does not treat postmenopausal symptoms, such as hot flushes.
EVISTA ma tneħħilekx is- sintomi li jitfaċċaw wara l- menopawsa, bħall- fwawar.
EVISTA lowers total cholesterol and LDL ("bad") cholesterol.
EVISTA tbaxxilek il- livell totali tal- kolesterol u tal - kolesterol LDL (dak li hu ‘ ħażin ’).
In general, it does not change triglycerides or HDL ("good") cholesterol.
Bħala regola ġenerali m’ għandhiex effett fuq it- trigliċeridi jew il - kolesterol HDL (dak li hu ‘ tajjeb ’).
However, if you have taken oestrogen in the past and had extreme elevations in triglycerides, you should talk to your doctor before taking EVISTA.
Madankollu, jekk kont tieħu l- estroġenu fil- passat u kellek livelli għoljin ħafna ta ’ trigliċeridi, għandek tkellem lit - tabib tiegħek qabel tieħu EVISTA.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħda tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
If you are taking digitalis medicines for your heart or anticoagulants like warfarin to thin your blood, your doctor may need to adjust your dose of these medicines.
Jekk qiegħda tieħu xi mediċini għall- qalb li fihom id- diġitalis jew qiegħda tieħu xi antikoagulanti bħal warfarin biex traqaq id- demm, hemm il- possibilità li t- tabib tiegħek ikollu bżonn jagħmel xi tibdil żgħir fid- doża ta ’ dawn il- mediċini.
Tell your doctor if you are taking cholestyramine which is mainly used as lipid-lowering medicine.
Għid lit- tabib tiegħek jekk qiegħda tieħu cholestyramine, mediċina li tintuża l- iżjed biex tbaxxi l - livelli tax- xaħam fid- demm.
Pregnancy and breast-feeding EVISTA is for use only by postmenopausal women and must not be taken by women who could still have a baby.
Tqala u Treddigħ EVISTA hija biss għall- użu minn nisa wara l- menopawsa u m’ għandhiex tittieħed minn nisa li għad jista ’ jkollhom tarbija.
Evista could harm your unborn child.
Evista tista ’ tagħmel ħsara lit- tarbija tiegħek li għad trid titwieled.
Do not take EVISTA if you are breast-feeding as it might be excreted in mother's milk.
Tieħux EVISTA jekk inti qed tredda ’ għax tista ’ toħroġ fil- ħalib tas- sider.
Driving and using machines EVISTA has no known effects on driving or using machines.
Sewqan u tħaddim ta ’ magni EVISTA m’ għandhiex effetti magħrufa fuq is- sewqan jew it- tħaddim ta ’ magni.
Important information about some ingredients of EVISTA If you have been told by your doctor that you have an intolerance to lactose, a type of sugar, contact your doctor before taking this medicinal product.
Jekk ġejt mgħarraf mit- tabib tiegħek li għandek xi intolleranza għal- lactose, tip ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel ma tieħu dan il- prodott mediċinali.
HOW TO TAKE EVISTA
KIF TITTIEĦED EVISTA
Always take this product exactly as your doctor has told you.
24 Dejjem għandek tieħu dan il- prodott skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you are not sure.
Għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
The dose is one tablet a day.
Id- doża hija pillola waħda kuljum.
You may take it with or without food.
Ma tagħmilx differenza f’ liema ħin tal- ġurnata tieħu l- pillola tiegħek, iżda jekk tieħu l- pillola fl- istess ħin kuljum, dan jgħin biex tiftakar teħodha. Tista ’ teħodha ma ’ l- ikel jew fuq stonku vojt.
24 The tablets are for oral use.
Il- pilloli huma għall- użu orali.
If you wish you may take a glass of water with it.
Jekk trid, tista ’ tniżżilha b’ tazza ilma.
Your doctor will tell you how long you should continue to take EVISTA.
It- tabib tiegħek sejjer jgħidlek għal kemm żmien għandek tieħu EVISTA.
The doctor may also advise you to take calcium and vitamin D supplements.
It- tabib għandu mnejn jagħtik parir biex tieħu supplimenti tal- calcium u tal- vitamina D.
If you stop taking EVISTA You should talk to your doctor first.
Jekk tieqaf tieħu EVISTA Għandek tkellem l- ewwel lit- tabib tiegħek.
If you have the impression that the effect of this product is too strong or too weak, talk to your doctor or pharmacist.
Jekk għandek l- impressjoni li l- effett ta ’ dan il- prodott huwa qawwi wisq jew fjakk wisq, kellem lit - tabib tiegħek jew lill- ispiżjar.
If you forget to take EVISTA Take a tablet as soon as you remember and then continue as before.
Jekk tinsa tieħu EVISTA Ħu l- pillola hekk kif tiftakar, imbagħad kompli bħas- soltu.
If you take more EVISTA than you should Tell your doctor or pharmacist.
Jekk tieħu EVISTA aktar milli suppost Staqsi lit- tabib tiegħek jew lill- ispiżjar.
Like all medicines, EVISTA can cause side effects although not everybody gets them.
Bħal kull mediċini oħra, EVISTA jista ’ jkollha effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The majority of side effects seen with EVISTA have been mild.
Il- maġġoranza ta ’ l- effetti sekondarji li dehru b’ EVISTA kienu ħfief.
The most common side effects (affects more than 1 user in 10) are: • Hot flushes (vasodilatation) • Flu syndrome
L- aktar effetti sekondarji komuni (jaffettwaw aktar minn pazjent 1 minn kull 10) huma: • Fwawar (vażodilatazzjoni) • Sindromu ta ’ l- influwenza
Common side effects (affects 1 to 10 users in 100) are: • Leg cramps • Swelling of hands, feet and legs (peripheral oedema) • Gallstones
Effetti sekondarji komuni (jaffettwaw minn 1 sa 10 pazjenti minn kull 100) huma: • Bugħawwiġijiet fir- riġlejn • Nefħa ta ’ l- idejn, tas- saqajn u tar- riġlejn (edima periferali) • Ġebel fil- marrara
Uncommon side effects (affects 1 to 10 users in 1000) are: • Increased risk of blood clots in the legs (deep vein thrombosis) • Increased risk of blood clots in the lungs (pulmonary embolism) • Increased risk of blood clots in the eyes (retinal vein thrombosis) • Skin around the vein is red and painful (superficial vein thrombophlebitis)
Effetti sekondarji mhux komuni (jaffettwaw minn 1 sa 10 pazjenti minn kull 1000) huma: • Riskju ogħla ta ’ koaguli tad- demm fir- riġlejn (trombożi tal- vini fil- fond) • Riskju ogħla ta ’ koaguli tad- demm fil- pulmuni (emboliżmu pulmonari) • Riskju ogħla ta ’ koaguli tad- demm fl- għajnejn (trombożi fil- vina tar- retina) • Il- ġilda madwar vina tkun ħamra u tuġa ’ (tromboflebite tal- vini superfiċjali)
Very rare side effects (affects less than 1 user in 10,000) are: • Rash • Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset • Increased blood pressure • Decrease in the number of the platelets in the blood • Blood clot in an artery (for example stroke) • Headache including migraine • Mild breast symptoms such as pain, enlargement and tenderness
Effetti sekondarji rari ħafna (jaffettwaw inqas minn pazjent 1 minn kull 10, 000) huma:
In rare cases, blood levels of liver enzymes may increase during treatment with EVISTA.
• • • • • • •
HOW TO STORE EVISTA
KIF TAĦŻEN EVISTA
25 Keep out of the reach and sight of children.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Do not use after the expiry date which is stated on the pack.
Tużahx wara d- data ta ’ skadenza li tidher fuq il- pakkett.
What EVISTA contains
X’ fiha EVISTA
- The active substance is raloxifene hydrochloride.
- Is- sustanza attiva hi raloxifene hydrochloride.
Each tablet contains 60 mg of raloxifene
Kull pillola fiha 60 mg ta ’ raloxifene
hydrochloride, which is equivalent to 56 mg raloxifene.
hydrochloride li hi ekwivalenti ghal 56 mg raloxifene.
- The other ingredients of EVISTA tablets are:
- Is- sustanzi l- oħra tal- pilloli ta ’ EVISTA huma:
Tablet Core:
Il- Qalba tal- Pillola: