qanastek/EMEA-V3 huggingface dataset:
Across all placebo-controlled clinical trials of raloxifene in osteoporosis, venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis occurred at a frequency of approximately 0.8% or 3.22 cases per 1,000 patient years.
Tul il- provi klini i kollha ta ’ raloxifene fl- osteoporo i, ikkontrollati bl- u u tal- pla ebo, l- avvenimenti tromboemboliti i fil- vini, inklu i t- trombo i tal- vini fondi, l- emboli mu pulmonari u t- trombo i tal - vina tar- retina, okkorrew bi frekwenza ta ’ madwar 0. 8% jew 3. 22 ka ijiet g al kull 1, 000 sena ta ’ l - etajiet mag duda tal- pazjenti.
A relative risk of 1.60 (CI 0.95, 2.71) was observed in OPTRUMA treated patients compared to placebo.
Riskju relattiv ta ’ 1. 60 (CI 0. 95, 2. 71) kien osservat fil- pazjenti ittrattati 5 bl- OPTRUMA meta mqabbla ma ’ dawk fuq il- pla ebo.
The risk of a thromboembolic event was greatest in the first four months of therapy.
Ir- riskju ta ’ avvenimenttromboembolika kien l- akbar fl- ewwel erba ’ xhur tat- terapija.
Superficial vein thrombophlebitis occurred in a frequency of less than 1%.
It- tromboflebite tal- vini superfi jali okkorriet bi frekwenza ta ’ inqas minn 1%.
In the RUTH study, venous thromboembolic events occurred at a frequency of approximately 2.0% or 3.88 cases per 1000 patient-years in the raloxifene group and 1.4% or 2.70 cases per 1000 patient-years in the placebo group.
Fl- istudju kliniku RUTH, l- avvenimenti tromboemboliti i fil- vini okkorrew bi frekwenza ta ’ madwar 2. 0% jew 3. 88 ka ijiet g al kull 1, 000 sena ta ’ l- etajiet mag duda tal- pazjenti fil- grupp ta ’ raloxifene u 1. 4% jew 2. 70 ka ijiet g al kull 1000 sena ta ’ l- etajiet mag duda tal- pazjenti fil- grupp ta ’ pla ebo.
The hazard ratio for all VTE events in the RUTH study was
Ir - riskju ta ’ komplikazzjonijiet g al ka ijiet kollha ta ’ VTE fl- istudju RUTH kien ta ’ HR= 1. 44, (1. 06 – 1. 95).
Superficial vein thrombophlebitis occurred in a frequency of 1% in the raloxifene group and 0.6% in the placebo group.
It- tromboflebite tal- vini superfi jali okkorriet bi frekwenza ta ’ 1% fil- grupp ta ’ raloxifene u ta ’ 0. 6% fil- grupp ta ’ pla ebo.
Another adverse reaction observed was leg cramps (5.5% for OPTRUMA, 1.9% for placebo in the prevention population and 9.2% for OPTRUMA, 6.0% for placebo in the treatment population).
Reazzjoni avversa o ra kienu l- bug awwi ijiet fir- ri lejn (5. 5% g al OPTRUMA, 1. 9% g all- pla ebo fil- grupp tal- prevenzjoni u 9. 2% g al OPTRUMA, 6. 0% g all- pla ebo fil- grupp tal- kura).
In the RUTH study, leg cramps were observed in 12.1% of raloxifene-treated patients and 8.3% of placebo-treated patients.
Fl- istudju kliniku RUTH, il- bug awwi ijiet fir- ri lejn kienu osservati f’ 12. 1% ta ’ pazjenti kkurati b’ raloxifene u f’ 8. 3% ta ’ pazjenti kkurati bi pla ebo.
Flu syndrome was reported by 16.2% of OPTRUMA treated patients and 14.0% of placebo treated patients.
Is- sindromu ta ’ l- influwenza kien irrapportat f’ 16. 2% f’ dawk ittrattati bl- OPTRUMA u 14% ta ’ dawk il- pazjenti ittrattati bil- pla ebo.
One further change was seen which was not statistically significant (p > 0.05), but which did show a significant dose trend.
Bidla o ra kienet innotata, li ma kenitx statistikament sinifikanti (p > 0. 05), i da li wriet in idenza sinifikanti relatata mad- do a.
This was peripheral oedema, which occurred in the prevention population at an incidence of 3.1% for OPTRUMA and 1.9% for placebo; and in the treatment population occurred at an incidence of 7.1% for OPTRUMA and 6.1% for placebo.
Din kienet l- edema periferali li okkorriet fil- grupp ta ’ prevenzjoni b’ in idenza ta ’ 3. 1% g al OPTRUMA u 1. 8% g all- pla ebo; u fil- grupp ta ’ trattament l- in idenza kienet ta ’ 7. 1% g all- OPTRUMA u 6. 1% g all- pla ebo.
Slightly decreased (6-10%) platelet counts have been reported during raloxifene treatment in placebo- controlled clinical trials of raloxifene in osteoporosis.
Fl- istudju kliniku RUTH, l- edema periferali okkorriet f’ 14. 1% ta ’ pazjenti kkurati b’ raloxifene u fi 11. 7% ta ’ pazjenti kkurati bi pla ebo u dan kien statistikament sinifikanti. ie rrappurtat li l- g add tal- plejtlits naqas ftit (6- 10%) waqt il- kura b’ raloxifene fi studji klini i kkontrollati bi pla ebo ta ’ raloxifene fl- osteoporo i
Rare cases of moderate increases in AST and/ or ALT have been reported where a causal relationship to raloxifene can not be excluded.
Ka ijiet rari ta ’ idiet moderati fl- AST u/ jew l- ALT kienu irrapportati meta r- relazzjoni kaw ali ma ’ raloxifene ma tistax tkun esklu a.
A similar frequency of increases was noted among placebo patients.
In idenza simili ta ’ idiet kienet innotata fil- pazjenti fuq il- pla ebo.
In a study (RUTH) of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, an additional adverse reaction of cholelithiasis occurred in 3.3% of patients treated with raloxifene and 2.6% of patients treated with placebo.
Fi studju kliniku (RUTH) ta ’ nisa wara l- menopaw a u li huwa dokumentat li jbatu minn mard tal- qalb koronarju jew li qeg din f’ riskju og la li jkollhom xi problemi koronarji, reazzjoni avversa addizzjonali ta ’ kolelitja i se et f’ 3. 3% ta ’ pazjenti kkurati b’ raloxifene u f’ 2. 6% ta ’ pazjenti kkurati bi pla ebo.
Cholecystectomy rates for raloxifene (2.3%) were not statistically significantly different from placebo (2.0%).
Ir- rati ta ’ kole istektomija g al raloxefine (2. 3%) ma kienux differenti b’ mod statistikament sinifikanti minn dawk ta ’ pla ebo (2. 0%).
OPTRUMA (n = 317) was compared with continuous combined (n = 110) hormone replacement therapy (HRT) or cyclic (n = 205) HRT patients in some clinical trials.
OPTRUMA (n=317) kienet imqabbla ma ’ terapija kontinwa (n=110) ta ’ sostituzzjoni bl- ormoni (HRT) jew dik iklika (n=205) f’ xi ftit provi klini i.
The incidence of breast symptoms and uterine bleeding in raloxifene treated women was significantly lower than in women treated with either form of HRT.
L- in idenza ta ’ sintomi fis- sider u t- tnixxija ta ’ demm mill- utru fin- nisa ittrattati b’ raloxifene kienet inqas b’ mod sinifikanti minn dawk in- nisa li adu tip jew ie or tal- HRT.
The adverse reactions reported in post-marketing experience are presented in the table below.
Ir- reazzjonijiet avversi li ew irrappurtati wara li l- prodott tpo a fuq is- suq huma ppre entati fit - tabella hawn ta t.
Blood and lymphatic system disorders Very rare: thrombocytopenia Gastrointestinal disorders Very rare:
Disturbi tad- demm u tas- sistema limfatika Rari afna: trombo itopenija Disturbi gastro- intestinali Rari afna:
Increased blood pressure Nervous system disorders Very rare:
Sintomi gastrointestinali b al dardir, remettar, u ig addominali u dispepsja Disturbi enerali u kondizzjonijiet ta ’ mnejn jing ata Rari: edema periferali Investigazzjonijiet Rari afna: ieda fil- pressjoni tad- demm Disturbi fis- sistema nervu a Rari afna:
Headache, including migraine Skin and subcutaneous tissue disorders Very rare:
U ig ta ’ ras inklu a l- emikranja Disturbi fil - ilda u fit- tessuti ta ’ ta t il - ilda
6 4.9 Overdose
6 Rari afna:
In some clinical trials, daily doses were given up to 600 mg for 8 weeks and 120 mg, for 3 years.
F’ xi studji klini i, ew mog tija do i sa 600 mg kuljum g al 8 img at u 120 mg g al 3 snin.
No cases of raloxifene overdose were reported during clinical trials.
Ma ie rrapportat ebda ka ta ’ do a e essiva b’ raloxifene waqt l- istudji klini i.
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 ’ bug awwi ijiet fir- ri lejn u sturdament ew irrapportati f’ pazjenti li f’ do a orali wa da adu i jed minn 120mg.
In accidental overdose in children younger than 2 years of age, the maximum reported dose has been 180 mg.
L- og la do a rrapportata fit- tfal i g ar minn sentejn li bi ball adu do a e essiva kienet ta ’ 180 mg.
In children, symptoms of accidental overdoseincluded ataxia, dizziness, vomiting, rash, diarrhea, tremor, and flushing, and elevation in alkaline phosphatase.
Is- sintomi fit- tfal li bi ball adu do a e essiva jinkludu ataksja, sturdament, rimettar, raxx, dijarrea, treg id u mura fil- wi u ieda f’ alkaline phosphatase.
The highest overdose has been approximately 1.5 grams.
L- og la do a e essiva kienet ta ’ madwar 1. 5 grammi.
No fatalities associated with overdose have been reported.
Ma ewx irrapportati mwiet asso jati ma ’ doza e essiva.
There is no specific antidote for raloxifene hydrochloride.
M’ hemmx antidot spe ifiku g al raloxifene hydrochloride.
Selective Oestrogen Receptor Modulator.
Modulatur Selettiv g ar- Ri etturi ta ’ l- Estro enu (SERM).
As a selective oestrogen receptor modulator (SERM), raloxifene has selective agonist or antagonist activities on tissues responsive to oestrogen.
B ala modulatur selettiv g ar- ri etturi ta ’ l- estro enu (SERM), raloxifene g andu attivitajiet selettivi agonisti i jew antagonisti i, fuq it- tessuti li jirrispondu g all- effett ta ’ l- estro enu.
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.
Ja ixxi b ala agonista fuq l- g adam u parzjalment fuq il- metaboli mu tal- kolesterol (tnaqqis fil- kolesterol totali u dak LDL), i da mhux fuq l- ipotalamus jew fuq it- tessuti ta ’ l- utru jew tas- sider.
Raloxifene 'biological actions, like those of oestrogen, are mediated through high affinity binding to s oestrogen receptors and regulation of gene expression.
l- effetti bijolo i i ta ’ raloxifene, b al dawk ta ’ l- estro enu, ji ru permezz ta ’ l- affinità g olja g all - irbit mar- ri etturi ta ’ l- estro enu u tar- regolazzjoni ta ’ l- espressjoni tal - ene.
This binding results in differential expression of multiple oestrogen-regulated genes in different tissues.
Dan l- irbit jirri ulta f’ espressjoni li tvarja minn tessut g all- ie or fuq il - eni multipli irregolati mill- estro enu.
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 re enti tindika li r- ri ettur ta ’ l- estro enu jista ’ jirregola l- espressjoni tal - ene b’ mhux inqas minn ew metodi differenti li huma spe ifi i g al- ligand, g at- tessut u/ jew g all - ene.
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- estro enu li jse fil- menopawsa, jwassal g al idiet sostanzjali fit - tmermir ta ’ l- g adam, it- telf ta ’ l- g adam 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- g adam huwa partikolarment mg a el fl- ewwel 10 snin wara l- menopawsa meta il- kumpens bi - ieda fil- formazzjoni ta ’ l- g adam ma jkunx bi ejjed biex ila aq ma ’ l- ammont li qieg ed 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 o ra ta ’ riskju li jistg u jwasslu g all- i vilupp ta ’ l- osteoporo i jinkludu l- menopawsa minn kmieni, l- ostejopenja (mhux anqas minn 1 SD ’ l isfel mill- og la massa ta ’ l- g adam); statura rqiqa tal - isem, ori ini etnika Kawkasja jew Asjatika, u passat mediku fil- familja ta ’ osteoporo i.
Replacement therapies generally reverse the excessive resorption of bone.
Terapiji ta ’ sostituzzjoni eneralment ire g u lura t- tmermir e essiv ta ’ l- g adam.
In postmenopausal women with osteoporosis, OPTRUMA reduces the incidence of vertebral fractures, preserves bone mass and increases bone mineral density (BMD).
Fin- nisa wara l- menopawsa li g andhom l- osteoporo i, OPTRUMA tnaqqas l- in idenza ta ’ ksur tal- vertebri, tippriserva l- massa ta ’ l- g adam u id id- densità minerali ta ’ l- g adam (BMD).
Based on these risk factors, prevention of osteoporosis with OPTRUMA 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 Ibba ati fuq dawn il- fatturi ta ’ riskju, il- prevenzjoni ta ’ l- osteoporo i bl- OPTRUMA hija indikata G an- nisa fi mien g axar 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 ag ug a, meta jitqies ir- riskju g oli ta ’ ksur osteoporoti i tul ajjithom.
Likewise, OPTRUMA 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 OPTRUMA hija indikata g all- kura ta ’ l- osteoporo i jew l - osteoporo i stabbilita f’ nisa li g andhom ksur tal- vertebri 2. 5 SD aktar baxx mill- valur medju ta ’ popolazzjoni normali ag ug a u/ jew dawk bil- ksur tal- vertebri, irrespettivamentmill- BMD.
i) Incidence of fractures.
i) L- in idenza 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 g andhom l- osteoporo i jew l- osteoporo i bi ksur e istenti, il- kura b’ OPTRUMA g al 3 snin naqqset l- in idenza 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. amsa u erbg in mara bl- osteoporo i jew 15- il mara bl- osteoporo i u bi ksur e istenti jkunu je tie u l- kura b’ OPTRUMA g al 3 snin biex ji i evitat ka wie ed jew aktar ta ’ ksur tal- vertebri.
OPTRUMA 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’ OPTRUMA g al 4 snin tnaqqas l- in idenza 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- osteoporo i jew l- osteoporo i bi ksur e istenti, rispettivament.
In the 4th year alone, OPTRUMA reduced the new vertebral fracture risk by 39% (RR 0.61, CI 0.43, 0.88).
Fir- raba ’ sena biss, OPTRUMA naqqset ir- riskju ta ’ ksur did 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 iex 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 setg u jie du wkoll bisphosphonates, calcitonin u fluorides u l - pazjenti kollha f’ dan l- istudju ng ataw 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 mi bur b ala ri ultat finali sekondarju.
Optruma reduced the incidence of clinical vertebral fractures by 35% compared with placebo (HR 0.65, CI 0.47 0.89).
Optruma naqqset l- in idenza ta ’ ksur kliniku tal- vertebri b’ 35% meta mqabbla ma ’ pla ebo (HR 0. 65, CL 0. 47 0. 89).
These results may have been confounded by baseline differences in BMD and vertebral fractures.
Dawn ir- ri ultati setg u ew imfixkla min abba differenzi fil- linji ba i 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 ta t kura, fl- in idenza ta ’ ksur did 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- u u konkomitanti ta ’ medikazzjonijiet o ra li ja ixxu fuq l- g adam.
ii) Bone Mineral Density (BMD):
ii) Id- Densità Minerali ta ’ l- G adam (BMD):
The efficacy of OPTRUMA 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- effika ja ta ’ OPTRUMA darba kuljum fin- nisa wara l- menopawsa ta ’ eta sa 60 sena, kemm f’ dawk li g andhom u dawk li m’ g andhomx utru, kienet stabbilita fuq perijodu ta ’ kura ta ’ sentejn.
Three trials included 1,764 postmenopausal women who were treated with OPTRUMA and calcium or calcium supplemented placebo.
Tliet provi inkludew 1, 764 mara wara l- menopaw a li kienu ikkurati b’ OPTRUMA u calcium, jew il - pla ebo flimkien ma ’ calcium.
In one of these trials the women had previously undergone hysterectomy.
F’ wa da minn dawn il- provi in- nisa kienu g addew minn isterektomija qabel.
OPTRUMA produced significant increases in bone density of hip and spine as well as total body mineral mass compared to placebo.
OPTRUMA kkaw at idiet sinifikanti fid- densita ta ’ l- g adma tal - enbejn u ta ’ l - ispina, kif ukoll fil- massa minerali tal - isem kollu meta mqabbla mal- pla ebo.
A similar increase in BMD was seen in the treatment population who received OPTRUMA for up to 7 years.
Din i - ieda kienet eneralment wa da ta ’ 2% fil- BMD, komparata mal- pla ebo. ieda simili fil- BMD dehret fil- grupp tal- kura li r evew Optruma g al 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- per enta ta ’ individwi li kellhom ieda jew tnaqqis fil- BMD waqt it- terapija b’ raloxifene kienu: fil- ka ta ’ l- ispina 37% tnaqqis u 63% ieda; u g all- g adam s i tal - enbejn 29% tnaqqis u 71% ieda.
iii) Calcium kinetics.
iii) Il- kineti i tal- calcium.
OPTRUMA and oestrogen affect bone remodelling and calcium metabolism similarly.
OPTRUMA u l- estro enu jeffetwaw bl- istess mod ir- rimodellar ta ’ l - g adam u l- metaboli mu tal- calcium.
OPTRUMA 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.
OPTRUMA kienet asso jata ma ’ tnaqqis fit- tmermir ta ’ l - g adam u aqlieq medju u po ittiv fil- bilan tal- calcium ta ’ 60 mg kuljum, dovut primarjament g at - tnaqqis fit- telf ta ’ calcium fl- awrina.
iv) Histomorphometry (bone quality).
iv) istomorfometrija (il- kwalità ta ’ l- g adam).
In a study comparing OPTRUMA 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 OPTRUMA kienet imqabbla ma ’ l - estro enu, l- g adam ta ’ pazjenti ikkurati b’ kull wie ed minn dawn il- prodotti medi inali kien normali istolo ikament, ming ajr evidenza ta ’ difetti fil- minerali azjoni, g adam minsu u fibro i 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- tne ija ta ’ l- g adam; dan l- effett fuq l- g adam jidher b ala tnaqqis fis- serum u fl- awrina tal- livelli ta ’ sustanzi li jimmarkaw il- bidla fl- g adam fis- seru tad- demm u fl- awrina, tnaqqis fit- tmermir ta ’ l- g adam ibba at fuq studji kineti i ta ’ calcium radjuattiv, idiet fil- BMD u tnaqqis fl - in idenza ta ’ ksur.
b) Effects on lipid metabolism and cardiovascular risk
b) Effetti fuq il- metaboli mu tal- lipidi u r- riskju kardjovaskulari
Clinical trials showed that a 60 mg daily dose of OPTRUMA significantly decreased total cholesterol (3 to 6%), and LDL cholesterol (4 to 10%).
Provi klini i wrew li t- te id ta ’ do a ta ’ OPTRUMA f’ do a 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- og la livelli ta ’ kolesterol fil- linja ba i, kellhom l- akbar tnaqqis.
HDL cholesterol and triglyceride concentrations did not change significantly.
8 t- trigli eridi ma ’ nbidlux b’ mod sinifikanti.
After 3 years therapy OPTRUMA decreased fibrinogen (6.71%).
Wara 3 snin ta ’ terapija OPTRUMA naqqset il- fibrino en (6. 71%).
In the osteoporosis treatment study, significantly fewer OPTRUMA-treated patients required initiation of hypolipidaemic therapy compared to placebo.
Fl- istudju dwar il- kura ta ’ l- osteoporo i, numru sinifikantement inqas ta ’ pazjenti ikkurati b’ OPTRUMA kellhom b onn li jinbdew fuq terapija biex jitbaxxa l- livell tax- xa am fid- demm, meta mqabbla ma ’ dawk fuq il- pla ebo.
OPTRUMA therapy for 8 years did not significantly affect the risk of cardiovascular events in patients enrolled in the osteoporosis treatment study.
It- terapija b’ OPTRUMA g al 8 snin ma effetwatx b’ mod sinifikanti r- riskju ta ’ avvenimenti kardjovaskulari f’ pazjenti involuti fl- istudju dwar il- kura ta ’ l- osteoporo i.
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).
L- istess fl- istudju kliniku RUTH, raloxifene meta mqabbel ma ’ pla ebo, ma effettwax l- in idenza ta ’ attakki ta ’ qalb, ta ’ b onn li wie ed jid ol l- isptar min abba sindromu koronarju akut, ta ’ attakk ta ’ puplesija, jew ta’ mortalità in enerali inklu l- imwiet kardjovaskulari kollu, (g a - ieda fir- riskju ta ’ puplesija fatali ara sezzjoni 4. 4)
8 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 hormonal replacement therapy.
Ir- riskju relattiv ta ’ avvenimenti tromboemboliti i fil- vini osservati waqt il- kura b’ raloxifene kien 1. 60 (CI 0. 95, 2. 71) meta mqabbel ma ’ dak tal- pla ebo u kien 1. 0 (CI 0. 3, 6. 2) meta mqabbel mat- terapija bl- estro enu jew mat- terapija ta ’ sostituzzjoni ta ’ l- ormoni.
c) Effects on the endometrium and on the pelvic floor
c) Effetti fuq l- endometriju u l- qieg tal- pelvis
In clinical trials, OPTRUMA did not stimulate the postmenopausal uterine endometrium.
Fi provi klini i, OPTRUMA 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- pla ebo, raloxifene ma kienx asso jat ma ’ tbabar jew tnixxija ta ’ demm, jew xuna ta ’ l- endometriju.
Nearly 3,000 transvaginal ultrasound (TVUs) examinations were evaluated from 831 women in all dose groups.
Kwa i 3, 000 e ami transva inali li saru bl- ultrasawnd (TVU) fuq 831 pazjenta, kienu evalwati fil- gruppi kollha ta ’ do a i differenti.
Raloxifene treated women consistently had an endometrial thickness which was indistinguishable from placebo.
In- nisa kkurati b’ raloxifene kellhom konsistentement xuna ta ’ l- endometriju li ma kenitx tintg araf minn dik bil- pla ebo.
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 ieda fil - xuna ta ’ l- endometriju, kif assessjat bl- ultrasawnd transva inali, 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 r evew il- pla ebo.
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 adu l- pla ebo, fl- in idenza ta ’ tnixxija ta ’ demm mill- utru, li iet irrappurtata.
Endometrial biopsies taken after six months therapy with OPTRUMA 60 mg daily demonstrated non- proliferative endometrium in all patients.
Bijopsiji ta ’ l- endometriju me udin wara terapija ta ’ 60 mg ta ’ OPTRUMA kuljum g al sitt xhur, urew endometriju mhux proliferattiv fil- pazjenti kollha.
In addition, in a study with 2.5 x the recommended daily dose of OPTRUMA there was no evidence of endometrial proliferation and no increase in uterine volume.
Barra minn hekk, fi studju fejn id- do a ta ’ OPTRUMA kienet 2. 5 drabi akbar minn dik irrakkomandata li g andha tittie ed kuljum, ma kienx hemm evidenza ta ’ proliferazzjoni ta ’ l- endometriju, u anqas ieda 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- osteoporo i il - xuna ta ’ l- endometriju kienet evalwata kull sena fi grupp, fi dan il- grupp kollu nvolut (1, 644 pazjenti), g al 4 snin.
Endometrial thickness measurements in OPTRUMA treated women were not different from baseline after 4 years of therapy.
Il- kejl tal - xuna ta ’ l- endometriju fin- nisa ikkurati b’ OPTRUMA ma kienx differenti mill- linja ba i wara 4 snin ta ’ terapija.
There was no difference between OPTRUMA 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’ OPTRUMA u dawk li adu l- pla ebo fl- in idenza ta ’ fsada mill- va ina (tbabar) jew tisfija va inali.
Fewer OPTRUMA treated women than placebo treated women required surgical intervention for uterine prolapse.
Kien hemm inqas nisa minn dawk ikkurati b’ OPTRUMA milli nisa li adu l- pla ebo li kellhom b onn xi intervent kirur iku g all- 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, tissu erixi li l- kura b’ raloxifene ma idx id- dg jufija tal- qieg tal- pelvis u anqas l- interventi kirur i i biex isa u dan.
After 4 years, raloxifene did not increase the risk of endometrial or ovarian cancer.
Wara 4 snin, raloxifene ma iedx ir- riskju ta ’ kan er 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 adu il- kura b’ raloxifene g al 4 snin, il- qarnit beninju tal- endometriju kienu irrapportati f’ 0. 9% meta mqabbel ma ’ 0. 3% f’ nisa li adu il- kura bil- pla ebo.
OPTRUMA does not stimulate breast tissue.
OPTRUMA ma jistimulax it- tessut tas- sider.
Across all placebo-controlled trials, OPTRUMA 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- osteoporo i (li nvolviet 7705 pazjenti), il- kura b’ OPTRUMA meta mqabbla mal- pla ebo naqqset ir- riskju totali ta ’ kan er tas- sider b’ 62%, (RR 0. 38, CI 0. 21, 0. 69) u r- riskju ta ’ kan er mifrux tas- sider li jinfirex b’ 71% (RR 0. 29, CI 0. 13, 0. 58) u r- riskju
Over the 4 years of the osteoporosis treatment trial (involving 7705 patients), OPTRUMA 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 ta ’ kan er tas- sider li jinfirex li hu po ittiv g ar- ri ettur ta ’ l- estro enu (ER) b’ 79% (RR 0. 21, CI 0. 07, 0. 50).
OPTRUMA has no effect on the risk of ER negative breast cancers.
OPTRUMA m’ g andha ebda effett fuq ir- riskju ta ’ kan er tas- sider li huwa negattiv g all- ER.
These observations support the conclusion that raloxifene has no intrinsic oestrogen agonist activity in breast tissue.
Dawn l- osservazzjonijiet isa u l- konklu joni li raloxifene m’ g andu l- ebda attività intrinsika ta ’ natura agonistika g all- estro enu fuq fit- tessut tas- sider.
9 5.2 Pharmacokinetic properties
5. 2 Tag rif farmakokinetiku
Raloxifene is absorbed rapidly after oral administration.
Raloxifene ji i assorbit malajr wara t- te id orali.
Approximately 60% of an oral dose is absorbed.
Madwar 60% ta ’ do a orali ti i assorbita.
Presystemic glucuronidation is extensive.
Qabel ma jid ol fi - irkolazzjoni sistemika jkun hemm glukuronidazzjoni estensiva.
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 - in biex tintla aq il- kon entrazzjoni massima medja fil- pla ma u l- bijodisponibbiltà huma funzjonijiet tal- bidla li ssir fi - irkolazzjoni sistemika u - iklu enteroepatiku ta ’ raloxifene u l- metaboli glukuronidi tieg u.
Raloxifene is distributed extensively in the body.
Raloxifene jinfirex estensivament fil - isem.
The volume of distribution is not dose dependent.
Il- volum tad- distribuzzjoni ma jiddependix mid- do a.
Raloxifene is strongly bound to plasma proteins (98-99%).
Raloxifene jintrabat sew mal- proteini tal- pla ma (98 sa 99%).
Metabolism
Metaboli mu
Raloxifene undergoes extensive first pass metabolism to the glucuronide conjugates: raloxifene-4 '- glucuronide, raloxifene-6-glucuronide, and raloxifene-6, 4′ -diglucuronide.
Permezz ta ’ metaboli mu 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 o ra.
Raloxifene comprises less than 1% of the combined concentrations of raloxifene and the glucuronide metabolites.
Raloxifene jag mel inqas minn 1% tal- kon entrazzjonijiet 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 jin amm permezz tar- re iklar enteroepatiku, li jirri ulta f’ half- life fil- pla ma ta ’ 27. 7 sig at.
Increasing doses of raloxifene result in slightly less than proportional increase in the area under the plasma time concentration curve (AUC).
Ir- ri ultati minn do i singoli orali ta ’ raloxifene jintu aw biex jitbassar il- komportament farmakokinetiku ta ’ do i multipli. idiet fid- do i ta ’ raloxifene jirri ultaw f ’ ieda fl- erja ta t il- kurva tal - in u l- kon entrazzjoni fil- plasma (AUC) li hija ftit anqas minn ieda proporzjonali.
Excretion
Tne ija mill - isem
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- do a ta ’ raloxifene u l- metaboli glukuronidi jitne ew mill - isem fi mien 5 ijiem u jinsabu primarjament fl- ippurgar, b’ inqas minn 6% imne ija fl- awrina.
Special populations
Gruppi spe jali ta ’ pazjenti
Renal insufficiency - Less than 6% of the total dose is eliminated in urine.
L- insuffi jenza tal- kliewi – Inqas minn 6% tad- do a totali titne a mill - isem 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- tne ija tal- krejatinina, meta jitqies il- pi tal - isem ming ajr it- tessut xa mi, irri ulta f’ 17% tnaqqis fit- tne ija ta ’ raloxifene u 15% tnaqqis fit - tne ija 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- insuffi jenza tal- fwied – Il- farmakokinetika ta ’ do a wa da ta ’ raloxifene f’ pazjenti b ’ irro i u b’ indeboliment moderat tal- fwied (Klassi A Child- Pugh) kien imqabbel ma ’ dak ta ’ individwi b’ sa ithom.
Plasma raloxifene concentrations were approximately 2.5-fold higher than in controls and correlated with bilirubin concentrations.
Il- kon entrazzjonijiet ta ’ raloxifene fil- pla ma kienu bejn wie ed u ie or 2. 5 drabi og la mill- kontrolli u kienu jikkorrelaw mal- kon entrazzjonijiet 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- kar ino eni ita` li dam sejjer sentejn, ieda fl- in idenza ta ’ tumuri, ta ’ l- ovarji ta ’ ori ini ta - elluli tal- granulo a / 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- espo izzjoni sistemika (AUC) ta ’ raloxifene f’ dan il- grupp kien bejn wie ed u ie or 400 darba akbar minn dik li tintla aq fin- nisa ta ’ wara l- menopawsa li jie du do a 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 - rieden dwar il - kar ino eni ita` li dam sejjer ta ’ 21 xahar, kien, hemm ieda fl- in idenza ta ’ tumuri ta - elluli interstizjali tat- testikoli, adenomi tal- prostata u adenokar inomi fl- annimali ta ’ sess maskil, meta ng ataw 41 jew 210 mg/ kg,, u l- lejomajoblastoma tal- prostata fl- annimali ta ’ sess maskil li ng ataw 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 - rieden ta ’ sess femminil, i - ieda fl- in idenza tat- tumuri tal- ovarji f’ annimali li ng ataw 9 sa 242 mg/ kg (0. 3 sa 32 darba l- AUC fil - bniedem), kienet f’ tumuri beninji u malinni ta ’ ori ini ta - elluli tal- granulo a / tat- teka u tumuri beninji ta ’ ori ini ta - elluli 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 - ajja riproduttiva tag hom, meta l- ovarji kienu jiffunzjunaw u jirrispondu ferm g all - 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 g al stimuli ormonali riproduttivi.
10 Raloxifene was not genotoxic in any of the extensive battery of test systems applied.
Raloxifene ma kienx enotossiku f’ ebda wa da minn serje estensiva ta ’ sistemi ta ’ testijiet li ntu aw.
The reproductive and developmental effects observed in animals are consistent with the known pharmacological profile of raloxifene.
L- effetti riproduttivi u dawk fuq l- i vilupp, osservati fl- annimali, huma konsistenti mal- profil farmakolo iku mag ruf 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’ do i ta ’ 0. 1 sa 10 mg/ kg/ jum fil- firien ta ’ sess femminil, Raloxifene fixkel i - iklu estrous fil- firien ta ’ sess femminil waqt il- kura, i da ma ttardjax it- tg ammir fertili wara li twaqqaf il- kura, u naqqas bi ftit biss id- daqs tal- boton, ied it- tul ta ’ mien tat- tqala, u biddel i - mien fl- avvenimenti ta ’ l- i vilupp 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 ng ata fil- perijodu ta ’ qabel il- bajda iffertili ata te el mal - ajt tal - uf, raloxifene ittardja u arbat il- pro ess ta ’ twa il ta ’ l- embriju li rri ulta f’ perijodu itwal ta ’ tqala u tnaqqis fid- daqs tal- boton, i da m’ effetwax l- i vilupp ta ’ l- annimal mit- twelid sa kemm infatam.
Teratology studies were conducted in rabbits and rats.
Studji terato eni i 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- idro efalija (≥ 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- i vilupp tal- fetu, kustilji mg aww a 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- estro enu qawwi g all- utru tal- far u waqqaf l- i vilupp ta ’ tumuri tas- sider, li huwa dipendenti fuq l- estro enu, fil- firien u l - rieden.
6.3 Shelf-life
11 6. 3 mien kemm idum tajjeb il- prodott medi inali
Do not freeze.
Tiffri ahx.
6.5 Nature and content of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm o fih
OPTRUMA tablets are packed either in PVC/ PE/ PCTFE blisters or in high density polyethylene bottles.
Il- pilloli ta ’ OPTRUMA ji u fil- folji ta ’ PVC/ PE/ PCTFE jew fil- fliexken tal- polyethylene ta ’ densità g olja.
11 Not all pack sizes may be marketed in all countries.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu g al skop kummer jali.
6.6 Special precautions for disposal
6. 6 Prekawzjonijiet spe jali li g andhom jittie du meta jintrema
No special requirements.
L- ebda ti ijiet spe jali.
Eli Lilly Nederland B. V Grootslag 1-5 NL-3991 RA Houten The Netherlands
Eli Lilly Nederland B. V Grootslag 1- 5 NL- 3991 RA Houten L- Olanda
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA 'L- EWWEL AWTORIZZAZZJONI/ TI DID TA' L- AWTORIZZAZZJONI
5 August 1998 Date of last renewal:
5 Awwissu 1998 Data ta ’ l- a ar ti did:
5 August 2003
28 Lulju 2003
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI G ALL - RU LOTT
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI G ALL - RU TAL- LOTT
Lilly SA Avda de la Industria 30 28108 Alcobendas Madrid Spain
Lilly SA Avda de la Industria 30 28108 Alcobendas Madrid Spanja
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 ’ tag rif tal- prodott medi inali g andu jkun hemm l- isem u l- indirizz tal- manifattur responsabbli g all - ru tal- lott kon ernat.
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- U U IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI G AT- TQEG ID FIS - SUQ
• CONDITIONS OR RESTRICTIONS WITH REGARDS TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- U U MING AJR PERIKLU U EFFETTIV TAL- PRODOTT MEDI INALI
The Marketing Authorisation Holder will provide the PSUR at 3-yearly intervals.
Id- Detentur ta ’ l- Awtorizzazzjoni g at- tqeg id fis- Suq se jipprovdi l- PSUR kull 3 snin
LABELLING AND PACKAGE LEAFLET
TIKKETTA U FULJETT TA' TAG RIF
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
16 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OPTRUMA 60 mg film coated tablets raloxifene hydrochloride
OPTRUMA 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 g andha 60 mg ta ’ raloxifene hydrochloride, li hu ekwivalenti g al 56 mg ta ’ raloxifene.
See leaflet for further information
Ara l- fuljett g al aktar informazzjoni.
For oral use
G all- u u orali.
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA( IET) SPE JALI O RA, JEKK ME TIE A
SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPEJALI TA ’ KIF JIN A EN
Marketing Authorisation Holder:
Detentur ta ’ l- Awtorizzazzjoni g at- tqeg id fis- Suq:
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
18 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene
Kull pillola miksija b’ rita g andha 60 mg ta ’ raloxifene hydrochloride, li huwa ekwivalenti g al 56 mg ta ’ raloxifene.
Marketing Authorisation Holder:
Detentur ta ’ l- awtorizzazzjoni g at- tqeg id fis- suq:
EU/ 1/ 98/ 074/ 001 14 film coated tablets EU/ 1/ 98/ 074/ 002 28 film coated tablets EU/ 1/ 98/ 074/ 003 84 film coated tablets
EU/ 1/ 98/ 074/ 001 14- il pillola miksija b’ rita EU/ 1/ 98/ 074/ 002 28 pillola miksija b’ rita EU/ 1/ 98/ 074/ 003 84 pillola miksija b’ rita
Medicinal product subject to medical prescription.
Prodott medi inali jing ata bir- ri etta tat- tabib
20 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (ALL BLISTER PACKS):
20 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI G AT- TQEG ID FIS- SUQ
22 PACKAGE LEAFLET:
22 FULJETT TA ’ TAG RIF:
Read all of this leaflet carefully before you start taking your medicine. • Keep this leaflet.
Aqra sew dan il- fuljett kollu qabel tibda tie u din il- medi ina. • omm 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 b onn ter a ’ taqrah. • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispi jar tieg ek. • Din il- medi ina iet mog tija lilek.
It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Tista ’ tag mlilhom il - sara, anki jekk ikollhom l- istess sintomi b al tieg ek. • Jekk xi wie ed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jog bok, g id lit- tabib jew lill- ispi jar tieg ek.
1.
F 'il- fuljett: dan 1.
What OPTRUMA is and what it is used for 2.
X 'OPTRUMA u g alxiex tintu a inhi 2.
Before you take OPTRUMA 3.
Qabel ma tie u OPTRUMA 3.
How to take OPTRUMA 4.
Kif g andek tie u OPTRUMA 4.
How to store OPTRUMA 6.
Kif ta en OPTRUMA 6.
Further information
Aktar tag rif
WHAT OPTRUMA IS AND WHAT IT IS USED FOR
X’ INHI OPTRUMA U G ALXIEX TINTU A
OPTRUMA belongs to a group of non-hormonal medicines called Selective Oestrogen Receptor Modulators (SERMs).
OPTRUMA tag mel parti minn grupp ta ’ medi ini mhux ormonali msej a Modulaturi Selettivi g ar - Ri etturi ta ’ l- Estro enu (SERMs).
When a woman reaches the menopause, the level of the female sex hormone oestrogen goes down.
Meta mara tasal g all- menopawsa, il- livell ta ’ l- ormon sesswali tal- mara, l- estro enu, jin el.
OPTRUMA mimics some of the helpful effects of oestrogen after the menopause.
OPTRUMA jimita ftit minn dawn l- effetti ta ’ benfi ju ta ’ l- estro enu wara l- menopawsa.
OPTRUMA is used to treat and prevent osteoporosis in postmenopausal women.
OPTRUMA tintu a biex tikkura u tipprevjeni l- osteoporo i fin- nisa wara l- menopawsa.
OPTRUMA reduces the risk of vertebral fractures in women with postmenopausal osteoporosis.
OPTRUMA tnaqqas ir- riskju ta ’ ksur tal- vertebri fin- nisa bl- osteoporo i wara l- menopawsa.
A reduction in the risk of hip fractures has not been shown.
Ma ntweriex tnaqqis fir- riskju ta ’ ksur tal- g adam tal - enbejn.
Osteoporosis is a disease that causes your bones to become thin and fragile - this disease is especially common in women after the menopause.
L- opsteoporo i hija marda fejn l- g adam jirqaq u jiddg ajjef – din il- marda hija spe jalment 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.
G alkemm tista ’ ma tikka unax ebda sintomi g all- ewwel, l- osteoporo i twassal biex g admek jinkiser fa ilment, spe jalment fis- sinsla tad- dahar, il - enbejn, u l- polzijiet, u jista ’ jikkaw a u ig fid- dahar, taqsir mit- tul u dahar mg awwe.
BEFORE YOU TAKE OPTRUMA
QABEL MA TIE U OPTRUMA
Do not take OPTRUMA:
Tie ux OPTRUMA:
• If you are allergic (hypersensitive) to raloxifene or any of the ingredients of OPTRUMA. • If there is still a possibility that you can get pregnant, OPTRUMA could harm your unborn child. • If you are being treated or have been treated for blood clots (deep vein thrombosis, pulmonary embolism or retinal vein thrombosis). • If you have liver disease (examples of liver disease include cirrhosis, mild hepatic impairment or cholestatic jaundice). • If you have any unexplained vaginal bleeding.
• Jekk int aller iku (tbati minn sensittività e essiva) g al raloxifene jew sustanzi o ra ta ’ OPTRUMA • Jekk g ad hemm il- possibbiltà li to ro tqila, OPTRUMA tista ’ tag mel sara lit- tarbija li g ad trid titwieled. • Jekk qed ti i kkurata jew kont ikkurata g al tag qid tad- demm (trombo i tal- vini fondi, emboli mu pulmonari u trombo i tal- vina tar- retina). • Jekk g andek mard tal- fwied (e empji ta ’ mard tal- fwied huma irro i, indeboliment afif tal - fwied jew is- suffejra kolestatika). • Jekk g andek ru ta ’ demm mill- va ina ming ajr spjegazzjoni.
This must be investigated by your doctor. • If you have active uterine cancer, as there is insufficient experience of OPTRUMA use in women with this disease. • If you have severe kidney problems.
Din g andha tkun investigata mit- tabib tieg ek. • Jekk g andek kan er attiv ta ’ l- utru g ax g ad m’ hemmx esperjenza bi ejjed fl- u u ta ’ OPTRUMA fin- nisa li g andhom din il- marda. • Jekk g andek problemi serji fil- kliewi.
23 Take special care with OPTRUMA
23 Oqg od attent afna b’ OPTRUMA:
The following are reasons why this product may not be suitable for you.
Ir- ra unijiet g aliex dan il- prodott jista ’ ma jkunx tajjeb g alik huma elenkati hawn ta t.
If any of them apply to you, talk to your doctor before you take the medicine.
Jekk kwalunkwe wa da minnhom tapplika g alik, kellem lit- tabib tieg ek qabel ma tie u l- medi ina.
• 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 OPTRUMA 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 immobili ata g al xi mien b al meta tkun qieg da f’ si u tar- roti, jew qed tistenna biex tid ol l- isptar jew trid toqg od fis- sodda biex tirkupra wara operazzjoni jew xi marda mhix mistennija. • Jekk inti qieg da tir ievi terapija ta ’ estro eni orali. • Jekk inti qed tbati minn kan er tas- sider, g ax m’ hemmx esperjenza bi ejjed fuq l- u u ta ’ l - OPTRUMA fin- nisa b’ din il- marda. • Jekk kellek xi in ident erebrovaskulari (e. puplesija), jew jekk it- tabib qallek li hemm riskju g oli li jkollok xi in ident erebrovaskulari.
It is unlikely that OPTRUMA will cause vaginal bleeding.
Mhux probabbli li OPTRUMA tikkaw a l - ru tad- demm mill- va ina.