qanastek/EMEA-V3 huggingface dataset:
Endometrial thickening Vulvovaginal mycotic infection
Mhux komuni ≥1/ 1, 000; < 1/ 100 Uġigħ fis- sider
Breast pain Breast discomfort
Rari ≥1/ 10, 000; < 1/ 1, 000
19 System organ class General disorders and administration site conditions
sistema riproduttiva u fis - sider
Very c ommon ≥1/10
vaġinali
Common ≥1/100; < 1/10
endometriju Infezzjoni mikotika vulvo- vaġinali
Uncommon ≥1/1,000; < 1/100 Oedema peripheral
Skonfort fis- sider
Rare ≥1/10,000; < 1/1,000
Edima periferali Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata
According to evidence from a large number of epidemiological studies and one randomised placebo- controlled trial, the Women’s Health Initiative (WHI), the overall risk of breast cancer increases with increasing duration of HRT use in current or recent HRT users.
Kanċer tas- sider Skond evidenza minn numru kbir ta 'studji epidemjoloġiċi u prova klinika waħda tat- tip randomised ikkontrollata bil- plaċebo, l- Inizjattiva għal Saħħet in- Nisa (WHI), ir- riskju globali tal- kanċer tas- sider jiżdied maż- żieda fit- tul ta' l- użu tal- HRT f' nisa li attwalment jużaw l- HRT jew użawh riċentement.
For oestrogen-only HRT, estimates of relative risk (RR) from a reanalysis of original data from 51 epidemiological studies (in which > 80% of HRT use was oestrogen-only HRT) and from the epidemiological Million Women Study (MWS) are similar at 1.35 (95%CI 1.21 – 1.49) and 1.30 (95%CI 1.21 – 1.40), respectively.
Għall- HRT b' estroġenu biss, l- istimi ta 'riskju relattiv (RR) minn analiżi mill- ġdid ta' dejta oriġinali minn 51 studju epidemjoloġiku (fejn > 80% ta 'l- użu tal- HRT kien b' estroġenu biss) u mill- Istudju epidemjoloġiku ta' Miljun Mara (MWS) huma simili b' 1. 35 (95% CI 1. 21 – 1. 49) u 1. 30 (95% CI 1. 21 – 1. 40), rispettivament.
F or oestrogen plus progestagen combined HRT, several epidemiological studies have reported an overall higher risk for breast cancer than with oestrogens alone.
Għall- HRT ikkombinat minn estroġenu flimkien ma 'proġestoġenu, diversi studji epidemjoloġiċi rrapportaw riskju globali akbar għall- kanċer tas- sider milli b' estroġenu biss.
The MWS reported that, compared to never users, the use of various types of oestrogen-progestagen combined HRT was associated with a higher risk of breast cancer (RR = 2.00, 95%CI 1.88 – 2.12) than use of oestrogens alone (RR = 1.30, 95%CI 1.21 – 1.40) or use of tibolone (RR=1.45, 95%CI 1.25 – 1.68).
L- MWS irrapporta li, imqabbel ma 'minn qatt ma għamel użu minnhom, l- użu ta' tipi varji ta 'HRT ikkombinat minn estroġenu- proġestoġenu kien assoċjat ma' riskju ogħla ta 'kanċer tas- sider (RR = 2. 00, 95% CI 1. 88 – 2. 12) mill- użu ta' estroġenu waħdu (RR = 1. 30, 95% CI 1. 21 – 1. 40) jew użu ta 'tibolone (RR=1. 45, 95% CI 1. 25 – 1. 68).
The WHI trial reported a risk estimate of 1.24 (95%CI 1.01 – 1.54) after 5.6 years of use of oestrogen- progestagen combined HRT (CEE + MPA) in all users compared with placebo.
Il- prova WHI irrapportat stima ta 'riskju ta' 1. 24 (95% CI 1. 01 – 1. 54) wara 5. 6 snin ta 'użu ta' HRT ikkombinat minn estroġenu- proġestoġenu (CEE + MPA) f' dawk kollha li għamlu użu minnu meta mqabbla mal- plaċebo.
The absolute risks calculated from the MWS and the WHI trial are presented below:
Ir- riskji assoluti kkalkolati mill- MWS u l- prova WHI huma ppreżentati hawn taħt:
The MWS has estimated, from the known average incidence of breast cancer in developed countries, that: • For women not using HRT, about 32 in every 1000 are expected to have breast cancer diagnosed between the ages of 50 and 64 years.
L- MWS ikkalkola, mill- inċidenza medja magħrufa ta 'kanċer tas- sider f' pajjiżi li qegħdin jiżviluppaw, li: • Għan- nisa li ma jagħmlux użu mill- HRT, madwar 32 f' kull 1000 huma mistennija li jiġu ddijanjostikati li jkollhom kanċer tas- sider bejn l- etajiet ta' 50 u 64 sena.
• For 1000 current or recent users of HRT, the number of additional cases during the corresponding period will be
• Għal 1000 mara li attwalment tuża jew riċentement użat l- HRT, in- numru ta 'każi addizzjonali matul il- perjodu korrispondenti jkun
For users of oestrogen-only replacement therapy
Għal min juża terapija ta 'estroġenu biss sostitwit o
Between 0 and 3 (best estimate = 1.5) for 5 years’ use
22 Bejn 0 u 3 (l- aħjar stima = 1. 5) għall- użu ta '5 snin
Between 3 and 7 (best estimate = 5) for 10 years’ use.
Bejn 3 u 7 (l- aħjar stima = 5) għall- użu ta '10 snin.
For users of oestrogen plus progestagen combined HRT,
Għal min juża HRT ikkombinat minn estroġenu flimkien ma 'proġestoġenu, o
Between 5 and 7 (best estimate = 6) for 5 years’ use
Bejn 5 u 7 (l- aħjar stima = 6) għall- użu ta '5 snin
Between 18 and 20 (best estimate = 19) for 10 years’ use.
Bejn 18 u 20 (l- aħjar stima = 19) għall- użu ta '10 snin.
The WHI trial estimated that after 5.6 years of follow-up of women between the ages of 50 and 79 years, an additional 8 cases of invasive breast cancer would be due to oestrogen-progestagen combined HRT (CEE + MPA) per 10,000 women years.
Il- prova WHI ikkalkolat li wara 5. 6 snin ta 'investigazzjonijiet ta' wara f' nisa bejn l- etajiet ta '50 u 79 sena, 8 każi addizzjonali ta' kanċer tas- sider li jinfirex ikun minħabba HRT ikkombinat minn estroġenu- proġestoġenu (CEE + MPA) kull 10, 000 sena tan- nisa kollha.
About 16 cases of invasive breast cancer would be diagnosed in 5 years.
Skond il- kalkoli mid- dejta tal- provi, huwa stmat li:
1000
Għal 1000 mara fil- grupp tal- plaċebo,
women who used oestrogen + progestagen combined HRT (CEE + MPA), the
Madwar 16- il każ ta 'kanċer tas- sider li jinfirex ikun dijanjostikat f' 5 snin. o
number of additional cases would be
Għal 1000 mara li użat HRT ikkombinat minn estroġenu + proġestoġenu (CEE + MPA), in- numru ta 'każijiet addizzjonali jkunu
Between 0 and 9 (best estimate = 4) for 5 years’ use.
Bejn 0 u 9 (l- aħjar stima = 4) għall- użu ta '5 snin. o
The number of additional cases of breast cancer in women who use HRT is broadly similar for women who start HRT irrespective of age at start of use (between the ages of 45-65) (see section 4.4).
In- numru ta 'każijiet addizzjonali ta' kanċer tas- sider f' nisa li jużaw L- HRT huwa simili ħafna għan- nisa li jibdew jużaw l- HRT irrispettivament mill- età meta jibdewh (bejn l- etajiet ta '45- 65 sena) (ara sezzjoni 4. 4).
In women with an intact uterus, the risk of endometrial hyperplasia and endometrial cancer increases with increasing duration of use of unopposed oestrogens.
Kanċer ta 'l- endometriju F' nisa bl- utru intatt, ir- riskju ta' iperplejżja ta 'l- endometriju u kanċer ta' l- endometriju jiżdied maż- żieda fit- tul ta 'l- użu ta' estroġeni waħidhom.
According to data from epidemiological studies, the best estimate of the risk is that for women not using HRT about 5 in every 1000 are expected to have endometrial cancer diagnosed between the ages of 50 and 65.
Skond tagħrif minn studji epidemjoloġiċi, l - aħjar stima tar- riskju huwa li f' nisa li ma jużawx l- HRT madwar 5 f' kull 1000 huma mistenija li jiġu ddijanjostikati b' kanċer ta 'l- endometriju bejn l- etajiet ta' 50 u 65 sena.
Depending on the duration of treatment and oestrogen dose, the reported increase in endometrial cancer risk among unopposed oestrogen users varies from 2-to 12-fold greater compared with non-users.
Skond it- tul tal- kura u d- doża ta 'l- estroġenu, iż- żieda rrapportata ta' riskju ta 'kanċer ta' l- endometriju f' nisa li jużaw estroġenu waħdu tvarja minn darbtejn sa 12- il darba aktar imqabbel ma 'minn ma jużahx.
Adding a progestagen to oestrogen-only therapy greatly reduces this increased risk.
L - addizzjoni ta 'proġestoġenu ma' terapija ta 'estroġenu biss tnaqqas ħafna dan ir- riskju għoli.
Post marketing experience:
Esperjenza wara t- tqegħid fis- suq
In addition to the above mentioned adverse drug reactions, those presented below have been spontaneously reported, and are by an overall judgement considered possibly related to Activelle 1 mg/0.5 mg treatment.
Miżjuda mar- reazzjonijiet avversi tal- mediċina msemmija hawn fuq, dawn ippreżentati hawn taħt ġew irrapportati b' mod spontanju, u huma b' fehma ġenerali kkunsidrati li huma possibbilment relatati mal- kura ta 'Activelle 1 mg/ 0. 5 mg.
The reporting rate of these spontaneous adverse drug reactions is very rare (< 1/10,000 patient years).
Ir- rata ta 'rrapportar ta' dawn ir- reazzjonijiet avversi spontanji tal- mediċina hija rari ħafna (< 1/ 10, 000 sena tal- pazjenti kollha).
Post-marketing experience is subject to underreporting especially with regard to trivial and well known adverse drug reactions.
L- esperjenza wara t - tqegħid fis- suq hija suġġett għal nuqqas fir- rapportar speċjalment fil- każi ta 'reazzjonijiet avversi ordinarji u magħrufa sew.
The presented frequencies should be interpreted in that light:
Il- frekwenzi ppreżentati għandhom jiġu interpretatati f' dan id- dawl:
• Neoplasms benign and malignant (incl. cysts and polyps):
Neoplasmi beninji u malinni (inklużi ċisti u polipi):
Endometrial cancer
Kanċer ta 'l- endometriju •
• Psychiatric disorders:
Disturbi psikjatriċi:
Insomnia, anxiety, libido decreased, libido increased
Insomnja, ansjetà, libido mnaqqas, libido miżjud •
• Nervous system disorders:
23 Disturbi fis- sistema nervuża:
Dizziness
Sturdament •
Visual disturbances
Disturbi fl- għajnejn: disturbi viżivi •
• Vascular disorders:
Disturbi vaskulari:
Hypertension aggravated
Pressjoni għolja ggravata •
• Gastrointestinal disorders:
Disturbi gastro- intestinali:
Dyspepsia, vomiting
Dispepsja, rimettar •
• Hepatobilitary disorders:
Disturbi fil- fwied u fil- marrara:
Gallbladder disease, cholelithiasis, cholelithiasis aggravated, cholelithiasis re-occurrence
Mard tal- marrara, kolelitijasi, kolelitijasi ggravata, ri - • okkorrenza ta 'kolelitijasi
• Skin and subcutaneous tissue disorder:
Disturbi fil- ġilda u fit- tessuti ta 'taħt il- ġilda:
Seborrhoea, rash, angioneurotic oedema
Seborea, raxx, edima anġjonewrotika •
• Reproductive system and breast disorders:
Disturbi fis- sitema riproduttiva u fis- sider:
Hyperplasia endometrial, vulvovaginal pruritus
Iperplejżja ta 'l- endometriju, ħakk vulvo - • vaġinali
Weight decreased, blood pressure increased
Investigazzjonijiet: tnaqqis fil- piż, żieda fil- pressjoni tad- demm •
21 The following adverse reactions have been reported in the literature in association with oestrogen/progestagen treatment:
Ir- reazzjonijiet avversi li ġejjin ġew irrapportati fil- letteratura b' assoċjazzjoni mal- kura b' estroġenu / proġestoġenu:
Oestrogen-dependent neoplasms benign and malignant, e.g. endometrial cancer
Neoplasmi beninji u malinni dipendenti mill- estrogenu, eż. kanċer ta 'l- endometriju
Venous thromboembolism, i.e. deep leg or pelvic venous thrombosis and pulmonary embolism, is more frequent among hormone replacement therapy users than among non-users (For further information, see sections 4.3 and 4.4)
Trombo- emboliżmu tal- vini, jiġifieri trombożi fil- vini fondi tas- sieq jew tal- pelvi u emboliżmu pulmonari, huwa aktar frekwenti f' dawk li jużaw it- terapija ormonali sostitwita milli f' dawk li ma jużawhx (Għal aktar tagħrif, ara sezzjonijiet 4. 3 u 4. 4)
Myocardial infarction and stroke
Infart mijokardijaku u puplesija
Gall bladder disease
Mard fil- marrara
Skin and subcutaneous disorders: chloasma, erythema multiforme, erythema nodosum, vascular purpura
Disturbi fil- ġilda u fit- tessuti ta 'taħt il- ġilda: kloasma, eritema multiforme, eritema nodosum, purpura vaskulari
Probable dementia (For further information, see section 4.4)
Dimenzja probabbli (Għal aktar tagħrif, ara sezzjoni 4. 4)
Overdose may be manifested by nausea and vomiting.
Doża eċċessiva tista 'timmanifesta bħala tqalligħ u rimettar.
Treatment should be symptomatic.
Il- kura għandha tkun sintomatika.
Progestogens and estrogens, fixed combinations, ATC code:
Proġestoġeni u estroġeni, kombinazzjonijiet fissi, Kodiċi ATC:
Oestrogen and progestagen for continuous combined hormone replacement therapy (HRT).
Estroġenu u proġestoġenu għal terapija ta ’ sostituzzjoni bl- ormoni kombinati u kontinwi (HRT).
The active ingredient, synthetic 17β-estradiol, is chemically and biologically identical to endogenous human estradiol.
Estradiol: Is- sustanza attiva, 17ß- estradiol, hija identika kimikament u bijoloġikament għall - estradiol uman endoġenu.
It substitutes for the loss of oestrogen production in menopausal women, and alleviates menopausal symptoms.
Tagħmel tajjeb għan- nuqqas ta ’ produzzjoni ta ’ estroġenu fin- nisa fil - menopawża u ttaffi s- sintomi tal- menopawża.
Norethisterone acetate:
Norethisterone acetate:
As oestrogens promote the growth of the endometrium, unopposed oestrogens increase the risk of endometrial hyperplasia and cancer.
Peress li l- estroġeni jippromwovu t- tkabbir ta ’ l- endometriju, estroġeni li m’ għandhomx oppożizzjoni jżidu r- riskju ta ’ iperplejżja endometrjali u kanċer.
The addition of a progestagen reduces, but does not completely eliminate, the oestrogen-induced risk of endometrial hyperplasia in non- hysterectomised women.
Iż- żieda ta ’ proġestoġenu jnaqqas iżda ma jneħħix għal kollox ir- riskju ta ’ iperplejżja endometrjali kkawżata mill- estroġenu f’ nisa li għad għandhom l- uteru.
Relief of menopausal symptoms is achieved during the first few weeks of treatment.
Ikun hemm serħan mis- sintomi tal- menopawża matul l- ewwel ftit ġimgħat ta ’ kura.
This reduction remained until the conclusion of the study at week 24.
Mat- 3 ġimgħa t- tnaqqis fil- medja ta ’ numru ta ’ fwawwar severi għal moderati fil- grupp taħt kura b’ 0. 5 mg estradiol kien statistikament sinifikanti meta mqabbel mal- grupp tal- plaċebo. Dan it - tnaqqis baqa ’ sat- tmiem l- istudju fl- 24 ġimgħa.
Activelle is a continuous combined HRT product containing 17β-estradiol and norethisterone acetate with the intent of avoiding the regular withdrawal bleeding associated with cyclic or sequential HRT.
Activelle huwa prodott ta ’ l- HRT kombinat u kontiwu li fih 17ß- estradiol u norethisterone acetate bl- għan li jiġi evitat id- dmija regolari ta ’ rtirar assoċjat ma ’ l- HRT ċiklikali u sekwenzjali.
Amenorrhoea (no bleeding or spotting) was seen in 89% of the women in month 6 of treatment.
Fis- 6 xahar ta ’ kura 89% tan- nisa kellhom amenorreja (ebda dmija jew taqtir).
Bleeding and/or spotting appeared in 11 to 15% of the women during the first six months of treatment.
Matul l- ewwel sitt xhur ta ’ kura 11 sa 15% tan- nisa kellhom dmija jew taqtir.
After administration of two Activelle tablets, the average peak plasma
5. 2 Tagħrif farmakokinetiku
It circulates bound to SHBG (37%) and to albumin (61%), while only approximately 1-2% is unbound.
Wara t- teħid orali ta ’ Activelle, 17ß- estradiol jiġi assorbit mil- passaġġ gastrointestinali, jgħaddi fil- fwied u organi enteriċi oħra fejn jiġi metabolizzat għall- ewwel darba u jilħaq l- ogħla konċentrazzjoni fil- plażma fiż- żmien 5- 8 sigħat. Wara t- teħid ta ’ żewġ pilloli ta ’ Activelle, il - medja ta ’ l- ogħla konċentrazzjoni fil- plażma kienet ta ’ 24 pg/ ml (CV 38%).
Metabolism of 17β-estradiol, occurs mainly in the liver and gut but also in target organs, and involves the formation of less active or inactive metabolites, including estrone, catecholestrogens and several oestrogen sulphates and glucuronides.
Il- half- life ta ’ 17ß - estradiol hija ta ’ madwar 15- il siegħa. Jiċċirkola marbut ma ’ SHBG (37%) u ma ’ l- albumina (61%) waqt li madwar 1- 2% biss m’ huwiex f’ rabta. Il- metaboliżmu ta ’ 17ß- estradiol iseħħ l - iżjed fil- fwied u fil- musrana iżda sseħħ ukoll fl- organi fejn se jaġixxi u jinvolvi l- formazzjoni ta ’ metaboliti inqas attivi u inattivi li jinkludu estrone, katekolestroġeni u ħafna sulfati ta ’ l- estroġenu u glukuronidi.
Conjugated oestrogens are excreted with the bile, where they are hydrolysed and reabsorbed (enterohepatic circulation), and mainly in urine in biologically inactive form.
Estroġeni konġjugati jiġu mneħħija fil- bile fejn jiġu idrolizzati u assorbiti mill - ġdid (ċirkolazzjoni enteroepatika) u l- iżjed fl- awrina fil- forma bijoloġikament inattiva.
After oral administration of an Activelle tablet, norethisterone acetate is rapidly absorbed and transformed to norethisterone (NET).
Wara t- teħid ta ’ pillola ta ’ Activelle, norethisterone acetate jiġi assorbit malajr u mbiddel f’ norethisterone (NET).
It undergoes first-pass metabolism in the liver and other enteric organs, and reaches a peak plasma concentration of approximately 2.4 ng/ml CV 41% (after administration of two Activelle tablets) within 0.5 -1.5 hour.
Jgħaddi fil- fwied u f’ organi enteriċi oħra fejn jiġi metabolizzat għall - ewwel darba u jilħaq konċentrazzjoni massima fil- plażma ta ’ madwar 2. 4 ng/ ml CV 41% (wara t- teħid ta ’ żewġ pilloli ta ’ Activelle) fi żmien 0. 5- 1. 5 sigħat.
NET binds to SHBG (36%) and to albumin (61%).
Il- half- life terminali ta ’ NET hija ta ’ madwar 9- 11- il siegħa. NET jintrabat ma ’ SHBG (36%) u ma ’ l- albumina (61%).
The most important metabolites are isomers of 5α-dihydro-NET and of tetrahydro-NET, which are excreted mainly in the urine as sulfate or glucuronide conjugates.
L- aktar metaboliti importanti huma l- isomeri ta ’ 5α- dihydro- NET u ta ’ tetrahydro- NET, li jiġu mneħħija l- iżjed fl- awrina bħala konġjugati sulfati u glukuronidi.
The pharmacokinetics of estradiol is not influenced by norethisterone acetate.
Il- farmakokinetika ta ’ estradiol m’ hijiex influwenzata minn norethisterone acetate
5.3 Preclinical safety data
25 Il- farmakokinetika fl- anzjani ma ġietx studjata.
The acute toxicity of estrogens is low.
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Due to the large differences between animal species and between animals and humans preclinical results are of limited value for predicting the effect on humans.
It- tossiċità akuta ta ’ l- estroġeni hija baxxa. Minħabba d- differenzi kbar bejn is- specji annimali u bejn l- annimali u l- umani, huwa limitat il- valur tar- riżultati ta ’ qabel l- użu kliniku sabiex tbassar l- effett fuq l- umani.
Animal studies have shown embryo -lethal effects of estradiol or estradiol valerate even at relatively low doses; malformations of the urogenital tract and feminization of male fetuses were observed.
Studji fuq l- annimali wrew li anki f’ dożi relattivament baxxi estradiol u estradiol valerate kellhom effetti letali fuq l- embriju; kienu osservati malformazzjonijiet fil- passaġġ uroġenitali u feminizzazzjoni ta ’ feti maskili.
At high doses of norethisterone embryo-lethal effects were observed.
Bħal proġestoġeni oħra, norethisterone jikkawża virilizzazzjoni ta ’ feti femminili fil- firien u fix - xadini. F’ dożi għoljin, ġie osservat li norethisterone kellu effetti letali fuq l- embriju.
Non-clinical data based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential reveal no special hazard for humans apart from those already discussed in other sections of the summary of product characteristics.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku fuq il- ġeni u r- riskju ta ’ kanċer, ma turi l- ebda periklu speċjali għall- bnedmin ħlief għal dawk diġà diskussi f’ sezzjonijiet oħra tas- sommarju tal- karatteristiċi tal- prodott.
Lactose monohydrate Maize starch Hydroxypropylcellulose Talc Magnesium stearate
Lactose monohydrate Maize starch Hydroxypropylcellulose Talc Magnesium stearate
Film-coating:
Il- kisja b’ rita:
Hypromellose Triacetin Talc
Hypromellose Triacetin Talc
23 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Do not refrigerate.
Taħżinx f’ temperatura ’ l fuq minn 25°C. Tagħmlux fil- friġġ.
The calendar dial pack with 28 tablets consists of the following 3 parts:
1 x 28 pillola jew 3 x 28 pillola f’ pakketti bil- kalendarju u li fihom werrej.
- The base made of coloured non-transparent polypropylene
26 Il- pakkett bil- kalendarju u b’ werrej u li fih 28 pillola jikkonsisti f’ dawn it- tliet partijiet li ġejjien:
- The ring-shaped lid made of transparent polystyrene
– Il- bażi magħmula minn polypropylene ikkulurit li m’ huwiex trasparenti – – L- għatu forma ta ’ ċirku magħmul minn polystyrene trasparenti
- The centre-dial made of coloured non-transparent polystyrene
– Id- dajal tan- nofs magħmul minn polystyrene ikkulurit li m’ huwiex trasparenti
[See Annex I – To be completed nationally]
[Ara Anness I - Biex timtela mill- pajjiż partikolari]
{Name and address} < {tel} > < {fax} > < {e-mail} >
[Isem u indirizz] < {telefon} > < {fax} > < {e- mail} >
[To be completed nationally]
[Biex timtela mill- pajjiż partikolari]
Detailed information on this medicinal product is available on the website of:{name of MS/Agency}[PIQ-QRD1]
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website {isem ta ’ l- Istat Membru / Aġenzija}
24 25 LABELLING
27 TIKKETTA
26 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
28 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Activelle and associated names (see Annex I) 0.5 mg/0.1 mg film-coated tablets [See Annex I – To be completed nationally]
Activelle u ismijiet assoċjati miegħu (Ara Anness I) 0. 5mg/ 0. 1mg pilloli miksija b’ rita [Ara Anness I - Biex timtela mill- pajjiż partikolari]
estradiol/norethisterone acetate
estradiol/ norethisterone acetate
Each film-coated tablet contains: estradiol 0.5 mg (as hemihydrate), norethisterone acetate 0.1 mg
Kull pillola miksija b’ rita fiha: estradiol 0. 5mg (bħala hemihydrate), norethisterone acetate 0. 1 mg
Activelle contains lactose.
Activelle fih lactose.
Film-coated tablet 1 x 28 film-coated tablets 3 x 28 film-coated tablets
Pillola miksija b’ rita 1 x 28 pillola miksija b’ rita 3 x 28 pillola miksija b’ rita
Do not store above 25°C Do not refrigerate Keep the container in the outer carton, in order to protect from light
Taħżinx f’ temperatura l’ l fuq minn 25°C Tagħmlux fil- friġġ Żomm il- kontenitur fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl
[See Annex I – To be completed nationally]
[Ara Anness I – Biex timtela mill- pajjiż partikolari]
{Name and address} < {tel} > < {fax} > < {e-mail} >
{Isem u indirizz} < {telefon} > < {fax} > < {e- mail} >
[To be completed nationally]
< [Biex timtela mill- pajjiż partikolari] >
Activelle 0.5 mg/0.1 mg
30 Activelle 0. 5mg/ 0. 1mg
DISPENSER LABEL
TIKKETTA TA ’ TQASSIM
Activelle and associated names (see Annex I) 0.5 mg/0.1 mg film-coated tablets [See Annex I – To be completed nationally]
Activelle u ismijiet assoċjati miegħu (Ara Anness I) 0. 5 mg/ 0. 1 mg pilloli miksijin b’ rita [Ara Anness I - Biex timtela mill- pajjiż partikolari]
estradiol/norethisterone acetate Oral use
estradiol/ norethisterone acetate Użu orali
CONTENT BY WEIGHT, BY VOLUME OR BY UNIT
IL- KONTENUT SKOND IL- PIŻ, VOLUM, JEW PARTI INDIVIDWALI.
MANUFACTURER
MANIFATTUR
29 PACKAGE LEAFLET
32 FULJETT TA ’ TAGĦRIF
Activelle and associated names (see Annex I) 0.5 mg/0.1 mg film-coated tablets [See Annex I – To be completed nationally] Estradiol/norethisterone acetate
Activelle u ismijiet assoċjati miegħu (ara Anness I) 0. 5 mg/ 0. 1 mg pilloli miksijin b’ rita [Ara Anness I - Biex timtela mill- pajjiż partikolari] Estradiol/ norethisterone
Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet.
Jista ’ jkollok bżonn terġa ’ taqrah.
You may need to read it again • If you have further questions, ask your doctor or pharmacist • This medicine has been prescribed for you.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Do not pass it on to others.
Tista ’
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.
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li
What Activelle is and what it is used for 2.
X’ inhu Activelle u għalxiex jintuża 2.
Before you take Activelle 3.
Qabel ma tieħu Activelle 3.
How to use Activelle 4.
Kif għandek tieħu Activelle 4.
How to store Activelle 6.
Kif taħżen Activelle 6.
WHAT ACTIVELLE IS AND WHAT IT IS USED FOR
X’ INHU ACTIVELLE U GĦALXIEX JINTUŻA
Activelle belongs to a group of hormone replacement therapy (HRT) medicines, called continuous combined HRT which are taken every day without interruptions.
Activelle jagħmel parti minn grupp ta ’ mediċini li jintużaw fit- terapija ta ’ sostituzzjoni ta ’ l - ormoni (HRT), li jissejħu HRT kontinwu kombinat, li jittieħdu kuljum mingħajr waqfien.
Activelle is prescribed to relieve unpleasant symptoms like hot flushes, night sweats and vaginal dryness, which occur when the oestrogen levels decline and the periods stop (menopause).
Activelle jingħata biex itaffi sintomi koroh bħal fwawwar, għaraq matul il- lejl u xuttaġni vaġinali, li jseħħu meta l- livelli ta ’ l- estroġenu jonqsu u l- pirjid jieqaf (menopawża).
Activelle is prescribed for women who have not had their womb removed, and whose periods stopped more than a year ago.
Activelle jiġi mogħti lin- nisa li għad għandhom uteru u li ilhom iktar minn sena li waqfilhom il - pirjid.
There is only limited experience of treating women older than 65 years with Activelle.
L- esperjenza fl- użu ta ’ Activelle fin- nisa li għandhom iżjed minn 65 sena hija limitata.
BEFORE YOU TAKE ACTIVELLE
QABEL MA TIEĦU ACTIVELLE
Do not take Activelle If any of the following applies to you, talk to your doctor.
Jekk xi wieħed minn dawn japplika għalik tkellem mat- tabib tiegħek.
Do not start taking Activelle: • If you are allergic (hypersensitive) to estradiol, norethisterone acetate or any of the other ingredients of Activelle (listed in section 6,“Further information”). • If you have or have had breast cancer, or if it is suspected • If you have cancer of the womb lining (endometrium), or if such an oestrogen dependent cancer is suspected • If you have any vaginal bleeding, which has not been diagnosed by your doctor • If you have endometrial hyperplasia (excessive growth of the womb lining) that is not being treated • If you have a blood clot (like deep vein thrombosis or lung embolism) or previously have had a blood clot without obvious cause, e.g. in connection with surgery or pregnancy • If you have recently had a heart attack, stroke, or have angina • If you have or have had a liver disorder and your liver tests have not returned to normal • If you have porphyria (a liver enzyme disease)
- Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal estradiol, norethisterone acetate
Take special care with Activelle
jew għal xi ingredjenti oħra ta ’ Activelle (imniżżla f’ sezzjoni 6, “ Aktar tagħrif ”)
31 If you have (or have had) any of the following conditions, tell your doctor.
- Jekk għandek jew kellek kanċer tas- sider, jew jekk hemm xi suspett
Your doctor may then want to follow your treatment up more closely.
- Jekk għandek kanċer fit- tessut li jiksi l- uteru (endometrium) jew hemm xi suspett ta ’ kanċer li
Rarely, these conditions may come back or get worse during treatment with Activelle:
jew fil- passat kellek xi koagulu tad- demm bla ebda kawża evidenti eż. b’ konnessjoni ma ’ xi operazzjoni jew tqala
• If you have any condition affecting the womb lining, such as myoma (benign tissue tumour), endometriosis (presence of womb lining tissue outside the womb) or have had endometrial hyperplasia (excessive growth of the womb lining) • If you have a history of blood clots (thrombosis) or have risk factors for blood clots (these risk factors and symptoms for a blood clot are listed in section 4,“Other side effects of combined HRT”) • If any of your immediate family has had breast cancer, or other cancers related to oestrogen (endometrial cancer) • If you have high blood pressure • If you have a liver disorder such as liver adenoma (a benign tumour) • If you have a kidney or heart disorder • If you have diabetes or gallstone disease • If you have epilepsy or asthma • If you get migraines or severe headaches • If you have systemic lupus erythematosus (SLE, autoimmune collagen disease, which may affect many organ systems) • If you have high levels of fat in the blood (hypertriglyceridemia) • If you have otosclerosis (hearing loss sometimes linked to pregnancy).
- Jekk għandek porfirja (marda ta ’ enzima fil- fwied)
Medical check-ups Before you start taking Activelle, your doctor will inform you about the risks and benefits of the treatment (see also section 4, “Other side effects of combined HRT”).
Jista ’ jkun li mbagħad it- tabib tiegħek ikun irid isegwi l- kura tiegħek aktar mill- viċin.
Before you start treatment and regularly during treatment, your doctor will evaluate whether Activelle is a suitable treatment for you.
F’ każijiet rari, dawn il- kundizzjonijiet jistgħu jerġgħu jitfaċċaw jew isiru agħar waqt il- kura b’ Activelle:
Your doctor will tell you how often you should go for periodic check-ups, taking into account your general state of health.
- Jekk għandek xi kundizzjoni li taffettwa t- tessut li jiksi l- uteru, bħal mijoma (tumur beninn
If you have any close relative (mother, sister, maternal or paternal grandmother), who has suffered from serious illness, e.g. blood clot or breast cancer, you might also be at increased risk.
tat- tessut), endometrjożi (il- preżenza tat- tessut li jiksi l- uteru barra mill- uteru) jew kellek iperplejżja endometrjali (tkabbir eċċessiv tat- tessut li jiksi l- uteru)
You should therefore always tell your doctor about any close relative suffering from serious illness, and you should also tell your doctor about any changes, you might find in your breasts.
- Jekk għandek passat mediku ta ’ koaguli tad- demm (trombożi) jew għandek fatturi ta ’
As well as regular check-ups with your doctor, be sure to: • Regularly check your breasts for any changes, such as dimpling or sinking of the skin, changes in the nipple, or any lumps you can see or feel • Go for regular breast screening (mammography) and cervical smear tests.
riskju li jistgħu jikkawża koaguli tad- demm (dawn il- fatturi ta ’ riskju u s- sintomi ta ’ xi koagulu tad- demm huma mniżżla f’ sezzjoni 4, “ Effetti sekondarji oħra ta ’ HRT kombinat ”)
If you need a blood test, tell your doctor that you are taking Activelle, since oestrogen can affect the results of certain laboratory tests.
- Jekk xi ħadd qrib fil- familja tiegħek kellha kanċer tas- sider, jew xi kanċer ieħor li għandu
If you are going to have surgery, talk to your doctor.
- Jekk ikollok emigranji jew uġigħat ta ’ ras qawwija
You may need to stop taking these tablets 4 to 6 weeks before the operation, to reduce the risk of a blood clot.
- Jekk għandek livelli għoljin ta ’ xaħam fid- demm (ipertrigliċeridimja)
Your doctor will tell you when you can start treatment again.
- Jekk għandek otosklerożi (telf ta ’ smigħ, xi kultant assoċjat mat- tqala)
Stop taking Activelle If you are experiencing any of the following conditions below, stop taking Activelle, and contact your doctor immediately: • If you get a migraine-type headache for the first time • If you develop yellow skin or eyes (jaundice) or other liver problems • If your blood pressure goes up while you’re taking Activelle • If you become pregnant • If any of the conditions listed in section 2,“Do not take Activelle”, occur.
Flimkien ma ’ eżamijiet ta ’ spiss mat- tabib tiegħek, kun żgur li: • B’ mod regolari tiċċekkja s- sider tiegħek għal xi tibdil bħal formazzjoni ta ’ ħofor żgħar u l - ġilda tinżel ’ l isfel, tibdil fil- beżżula jew xi għoqqod li tista ’ tara jew tħoss • B’ mod regolari mur biex jeżminawlek is- sider (ritratt tas- sider) u għall- eżami ċervikali
Using other medicines Some medicines may reduce the effects of Activelle:
35 Jekk għandek bżonn tieħu xi test tad- demm, għid lit- tabib tiegħek li qiegħda tieħu Activelle, għax l- estroġenu jista ’ jkollu effett fuq ir- riżultati ta ’ xi testijiet tal- laboratorju.
32 • Medicines used for epilepsy (such as phenobarbital, phenytoin and carbamazepin) • Medicines used for tuberculosis (such as rifampicin, rifabutin) • Medicines used for HIV infections (such as nevirapine, efavirenz, ritonavir and nelfinavir) • Herbal products containing St John’s Wort (Hypericum perforatum).
Meta tuża mediċini oħra Xi mediċini jistgħu jnaqssu l- effetti ta ’ Activelle: • Mediċini użati għall- epilessija (bħal phenobarbital, phenytoin, u carbamazepine) • Mediċini użati għat- tuberkulożi (bħal rifampicin, rifabutin) • Mediċini użati għall- infezzjonijiet bl- HIV (bħal nevirapine, efavirenz, ritonavir u nelfinavir) • Prodotti magħmula mill- ħxejjex li fihom St. John’ s Wort (Hypericum perforatum)
Other medicines may increase the effects of Activelle: • Medicines containing ketoconazole (a fungicide).
Xi mediċini oħra jistgħu jżidu l- effett ta ’ Activelle: • Mediċini li fihom ketoconazole (funġiċida)
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription, herbal medicines or other natural products.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra li jinkludu dawk mingħajr riċetta, mediċini magħmula mill- ħxejjex u prodotti naturali oħra.
Using Activelle with food and drink The tablets can be taken with or without food and drink.
Il- pilloli jistgħu jittieħdu ma ’ l- ikel jew max- xorb jew fuq stonku vojt.
Pregnancy and breast-feeding Do not take Activelle if you are pregnant or breast-feeding.
Tqala u Treddigħ Tieħux Activelle jekk inti tqila jew qeda tredda ’.
Driving and using machines Activelle does not affect the use of any machines or the ability to drive safely.
Activelle ma jaffettwax l- użu ta ’ xi magni u l- ħila li ssuq bil- galbu.
Important information about some of the ingredients of Activelle:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Activelle:
If you have an intolerance to some sugars, contact your doctor before taking Activelle.
Jekk għandek xi intolleranza għal xi zokkor, ikkuntattja t- tabib tiegħek qabel ma tieħu Activelle.
HOW TO USE ACTIVELLE
KIF GĦANDEK TUŻA ACTIVELLE
Always take Activelle exactly as your doctor has told you.
Dejjem għandek tieħu Activelle eżatt kif qallek it- tabib.
Check with your doctor or pharmacist if you are unsure.
Għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
Take one tablet once a day, at about the same time each day Take the tablet with a glass of water.
Ħu l- pillola ma ’ tazza ilma.
Take a tablet every day without stopping[PIQ-QRD2].
Ħu pillola darba kuljum mingħajr waqfien.
After you have used all 28 tablets in a calendar pack, go straight to using the next pack.
Wara li tkun użajt it- 28 pillola ġo pakkett bil - kalendarju, mur dritt għall- pakkett li jmiss.
For instructions on the use of the calendar pack, see “USER INSTRUCTIONS” at the end of the package leaflet.
Għall- istruzzjonijiet dwar l- użu ta ’ pakkett bil- kalendarju, ara “ Istruzzjonijiet għal min se jagħmel użu minnhom ” fl- aħħar tal- fuljett ta ’ tagħrif.
You may start treatment with Activelle on any convenient day.
Tista ’ tibda l- kura b’ Activelle f’ xi ġurnata konvenjenti għalik.
However, if you are switching from an HRT product where you have monthly bleeding, start your treatment straight after the bleeding has ended.
Madankollu, jekk tkun qeda tbiddel minn prodott ta ’ l- HRT fejn kont tara d- demm kull xahar, ibda l- kura eżatt meta d- demm ikun waqaf.
Talk to your doctor if your symptoms are not better after three months of treatment.
It- tabib għandu jimmira li jagħtik l- inqas doża għall- inqas żmien biex ikollok serħan mis - sintomi. Tkellem mat- tabib tiegħek jekk is- sintomi m’ humiex aħjar wara tliet xhur ta ’ kura.
If you take more Activelle than you should If you have taken more Activelle than you should, or if for example a child has taken Activelle accidentally, talk to your doctor or hospital to assess the risk and for advice.
Jekk tieħu Activelle aktar milli suppost jew jekk per eżempju xi tifel/ tifla bi żball ħadu Activelle, tkellem mat- tabib jew l- isptar biex tara r- riskju u tieħu parir.
An overdose of Activelle could make you feel sick or vomit.
Doża eċċessiva ta ’ Activelle tista ’ ġġagħlek tħossok se taqla ’ jew tirremetti.
If you forget to take Activelle If you forget to take your tablet at the usual time, take it within the next 12 hours.
Jekk tinsa tieħu l- pillola tiegħek fil- ħin tas- soltu, ħudha fi żmien 12- il siegħa.
If more than 12 hours have gone by, start again as normal the next day.
Jekk ikunu għaddew iżjed minn 12- il siegħa, erġa ’ ibda bħas- soltu l- għada.
33 Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting unless you have had your womb removed.
Meta tinsa doża jiżdied ir- riskju li tara d- demm jew xi taqtir f’ nofs il- kura sakemm ma kellekx l - uteru mneħħi.
If you stop taking Activelle If you want to stop taking Activelle, talk to your doctor first.
Jekk trid tieqaf tieħu Activelle, l- ewwel tkellem mat- tabib.
Your doctor will explain the effects of stopping treatment and discuss other possibilities with you.
It- tabib se jispjegalek x’ jiġri meta twaqqaf il- kura u jiddiskuti possibilitajiet oħra miegħek.
Like all medicines, Activelle can have side effects, although not everybody gets them.
Bħal kull mediċina oħra, Activelle jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Bleeding with Activelle Activelle will not cause regular monthly bleeding, but when first starting the tablets, many women experience slight vaginal bleeding or spotting.
Fsada b’ Activelle Activelle m’ huwiex se jikkawża fsada regolari kull xahar, iżda meta tibda tieħu l- pilloli għall - ewwel darba, ħafna nisa jaraw xi ftit demm mill- vaġina jew xi taqtir.
If you get breakthrough bleeding or spotting, it is usually nothing to worry about, especially during the first few months of taking HRT.
Jekk tara xi demm jew taqtir f’ nofs il- kura, m’ hemm xejn x’ tinkwieta, speċjalment fl- ewwel ftit xhur li tkun qeda tieħu l- HRT.
But contact your doctor as soon as possible: • If bleeding carries on for more than the first few months • If bleeding starts after taking HRT for a while • If bleeding continues after stopping HRT.
• Jekk id- demm ikompli anki wara l- ewwel ftit xhur • Jekk tara d- demm wara li tkun hadt l- HRT għal xi żmien • jekk id- demm ikompli wara li tkun waqqaft l- HRT
Your doctor may ask you about any vaginal bleeding with Activelle at your regular check-ups.
37 It- tabib se saqsik dwar fsada mill- vaġina minħabba Activelle meta tmur għall- eżami regolari tiegħek.
You may find it helpful to make a note of any bleedings in a diary.
Tkun idea tajba jekk tieħu nota ta ’ xi dmija f’ dijarju.
The frequency of possible side effects listed below is defined using the following convention:
Il- frekwenza ta ’ l- effetti sekondarji li jista ’ jkollok imniżżla aktar ’ l isfel huma skond il - konvenzjoni li ġejja:
Very common (affects more than 1 user in 10) Common (affects 1 to 10 users in 100) Uncommon (affects 1 to 10 users in 1,000) Rare (affects 1 to 10 users in 10,000) Very rare (affects less than 1 user in 10,000) Not known (frequency cannot be estimated from the available data).
Komuni ħafna (jaffettwa aktar minn pazjent 1 minn kull 10) Komuni (jaffettwa minn 1 sa 10 pazjenti minn kull 100) Mhux komuni (jaffetwa minn 1 sa 10 pazjenti minn kull 1, 000) Rari (jaffettwa minn 1 sa 10 pazjenti minn kull 10, 000) Rari ħafna (jaffettwa inqas minn pazjent 1 minn kull 10, 000) Mhux magħruf (ma tistax tittieħed stima mid- dejta disponibbli)
Very common side effects • Vaginal bleeding.
Effetti sekondarji komuni ħafna • Fsada vaġinali
Common side effects • Fungal infection of the genitals or vaginal inflammation • Excessive growth of the womb lining (endometrial hyperplasia) • Feeling sick • Abdominal (stomach) pain • Pain in back or neck • Pain in arms or legs • Headache.
Effetti sekondarji komuni • Infezzjoni kawża ta ’ fungus fil- ġenitali jew infjammazzjoni vaġinali • Tkabbir eċċessiv tat- tessut li jiksi l- uteru (iperplejżja endometrjali) • Tħossok imdardra • Uġigħ addominali (ta ’ l- istonku) • Uġigħ fid- dahar jew fl- għonq • Uġigħ fl- idejn jew fis- saqajn • Uġigħ ta ’ ras
Uncommon side effects • Allergic reaction (hypersensitivity) • Depression or worsening of existing depression • Nervousness • Dizziness • Migraine (see “Stop taking Activelle” in section 2) • Breast pain or breast discomfort • Swelling or discomfort of the abdomen (stomach) • Weight gain caused by fluid retention • Swelling of arms and legs (peripheral oedema) • Leg cramps
Effetti sekondarji mhux komuni • Reazzjoni allerġika (sensittività eċċessiva) • Depressjoni jew tmur għall- agħar depressjoni li diġà teżisti • Nervożità • Sturdament • Emigranja (ara “ Ieqaf tieħu Activelle ” f’ sezzjoni 2) • Uġigħ fis- sider jew skumdità fis- sider • Nefħa jew skumdità fl- addome (l- istonku) • Żieda fil- piż minħabba żamma ta ’ l- ilma • nefħa fl- idejn jew fis- saqajn (edima periferali) • Bugħawwiġijiet fis- saqajn • Ħruq ta ’ stonku (dispepsja) • Akni • Twaqqigħ ta ’ xagħar • Hakk u urtikarja
Other side effects of combined HRT
Effetti sekondarji oħra b’ HRT kombinata
The following side effects have been reported after taking medicines containing oestrogen/progestagens.
L- effetti sekondarji li ġejjien ġew irrapportati wara li ttieħdu mediċini li fihom estroġenu/ prgestoġeni.
Excessive growth of the womb lining (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer) In women with an intact womb, the risk of excessive growth of the womb lining (endometrial hyperplasia) is increased.
Tkabbir eċċessiv tat- tessut li jiksi l- uteru (iperplejżja endometrjali) u kanċer tat- tessut li jiski l- uteru (kanċer endometrjali) F’ nisa li għandhom l- uteru intatt, jiżdied ir- riskju li jkollhom tkabbir eċċessiv tat- tessut li jiksi l - uteru (iperplejżja endometrjali).
Treatment with unopposed oestrogens for long periods of time also increases the risk of cancer of the lining of the womb (endometrial cancer).
Kura b’ estroġeni mingħajr oppożizzjoni għal perijodi twal ta ’ żmien iżid ukoll ir- riskju ta ’ kanċer fit- tessut li jiksi l- uteru (kanċer endometrjali).
Adding a progestagen, such as in Activelle, greatly reduces this increased risk.
Iż- żieda ta ’ proġestaġen bħal f’ Activelle inaqqas bi kbir din iż- żieda ta ’ riskju.
Breast cancer Every woman is at risk of getting breast cancer whether or not she takes HRT.
38 Kanċer tas- sider Kull mara għandha r- riskju li jkollha kanċer tas- sider kemm jekk tieħu jew ma tieħux l- HRT.
This risk increases with the duration of intake of HRT, but returns to normal within a few (at most five) years of having stopped HRT.
Hemm żieda żgħira fir- riskju għal nisa li ilhom jieħdu l- HRT għal iżjed minn 5 snin meta mqabbla ma ’ nisa ta ’ l- istess età li qatt ma ħadu l- HRT. Dan ir- riskju jiżdied skond kemm tinqa tieħu l- HRT iżda jirritorna għan- normal fi ftit (l- iżjed ħames) snin minn mindu tieqaf tieħu l - HRT.
The risk seems to be higher for women, who use oestrogen in combination with progestagen as compared to oestrogen alone.
Ir- riskju jidher li huwa ogħla f’ nisa li jużaw l- estroġenu flimkien ma ’ prġestoġen meta mqabbel ma ’ l- estroġenu waħdu.
Also go for regular health check, including mammography.
Biex issib tumur fis- sider l- iktar kmieni possibbli, huwa importanti li b; mod regolari tiċċekkja s - sider għal xi tibdil u tidiskuti mat- tabib dawn it- tibdil. Mur ukoll għal eżamijiet kliniċi regolari li jikludu mammografija.
If you are anxious for the risk of breast cancer, you should talk to your doctor about the risks and benefits of HRT.
Jekk inti anzjuża minħabba r- riskju ta ’ kanċer fis- sider għandek titkellem mat- tabib dwar ir- riskji u l- benefiċċji ta ’ HRT.
Blood clots in the deep veins Every woman is at risk of getting a blood clot whether or not she takes HRT.
Koaguli tad- demm fil- vini fil- fond Kull mara għandha r- riskju li jkollha koagulu tad- demm kemm jekk tieħu jew ma tieħux l- HRT.
HRT may increase the risk of blood clots 2-3 times in the veins, especially in the first year of treatment.
L- HRT tista ’ żżid ir- riskju ta ’ koaguli tad- demm fil- vini minn 2- 3 darbiet, speċjalment fl- ewwel sena ta ’ kura.
These are not always serious, but they may need to be treated.
Dawn m’ humiex dejjem serji iżda għandhom jiġu kkurati.
You are also more likely to get a blood clot: • If you are very overweight • If you have had a blood clot before, or have had any blood clotting problem that needed treatment with a medicine such as Warfarin • If any of your close family has had blood clots • If you have had a miscarriage • If you are bed-ridden for a longer period through surgery, injury or illness • If you have systemic lupus erythematosus (SLE, autoimmune collagen disease, which may affect many organ systems)
Għandek ukoll tendenza ogħla li jkollok koagulu tad- demm: • Jekk għandek piż żejjed • Jekk kellek koagulu tad- demm qabel, jew kellek xi problema ta ’ koagulazzjoni tad- demm li kellha bżonn il- kura b’ mediċina li tissejjaħ Warfarin • Jekk xi ħadd li jiġi minnek mill- viċin kellu xi koaguli tad- demm • Jekk kellek xi korriment • Jekk trid toqgħod fis- sodda għal perijodu twil minħabba xi operazzjoni, ferita jew mard • Jekk għandek lupus erythematosus sistemika (SLE, marda tal- kollaġini awtoimmunitarja li tista ’ taffettwa ħafna sistemi ta ’ organi)
You may be at risk of having a blood clot if you get: • Painful swelling in your leg • Sudden chest pain • Difficulty breathing.
Qiegħed f’ riskju li jkollok koagulu tad- demm jekk ikollok: • Nefħa f’ saqajk li tkun qed tuġgħek • Uġigħ f’ daqqa f’ sidrek • Diffikultà biex tieħu n- nifs
See a doctor as soon as possible.
Ara tabib mill- aktar fis possibbli.
Stop taking HRT until your doctor says you can take it again.
Ieqaf tieħu HRT sakemm it- tabib jgħidlek li tista ’ terġa ’ tibda.
Heart disease If you ever have had angina or heart attack, you should talk to your doctor about the risks and benefits of HRT.
Mard tal- qalb Jekk qatt kellek anġina jew attakk ta ’ qalb, għandek tkellem lit- tabib tiegħek dwar ir- riskji u l - benefiċċji ta ’ l- HRT.
There is no evidence of beneficial effects on the risks of cardiovascular disease with HRT in the menopause.
M’ hemm ebda evidenza ta ’ effetti benefiċċjali fir- riskji ta ’ mard kardjovaskulari bl- HRT fil - menopawża.
Results from two clinical studies showed that women, who used another type of oestrogen/progestagen combination than the one in Activelle, had a slightly increased risk of cardiovascular disease in the first year of use.
Riżultati minn żewġ studji kliniċi wera li nisa li użaw tip differenti ta ’ kombinazzjoni ta ’ estroġenu/ proġestaġen minn dak ta ’ Activelle kellhom daqxejn ta ’ żieda fir - riskju ta ’ mard kardjovaskulari fl- ewwel sena ta ’ użu.
35 For other HRT products there are only limited data from trials examining the effects on the risk of cardiovascular disease.
Għal prodotti ta ’ HRT oħra hemm biss dejta limitata minn studji li eżaminaw l- effetti fuq ir- riskju ta ’ mard kardjovaskulari.
Stroke There may be a slightly higher risk of having a stroke if you are taking HRT.
Puplesija Hemm daqxejn ta ’ riskju ogħla li jkollu puplesija jekk qeda tieħu l- HRT.
Other factors that also increase the risk of stroke are: • Getting older • High blood pressure • Smoking • Drinking too much alcohol • An irregular heartbeat.
Fatturi oħra li jistgħu jżidu r- riskju ta ’ puplesija huma: • Li tikber fl- età • Pressjoni għolja • It- tipjip
See a doctor as soon as possible.
Jekk ikollok: • Uġigħat ta ’ ras emigraniku mingħajr kawża evidenti, b’ disturbi fil- viżta jew mingħajr Ara tabib mill- aktar fis- possibbli.
Stop taking HRT until your doctor says you can.
Ieqaf tieħu l- HRT sakemm jgħidlek it- tabib.
Ovarian cancer There are some evidence from clinical studies that use of oestrogen-only products for more than 5 years increases the risk of ovarian cancer among women who have had their womb removed.
Kanċer ta ’ l- ovarji Hemm xi ftit evidenza minn studji kliniċi li turi li l- użu għal iżjed minn 5 snin ta ’ prodotti li fihom biss estroġenu iżid ir- riskju ta ’ kanċer ta ’ l- ovarji f’ nisa li tneħħilhom l- uteru.
It is not yet known whether other types of HRT increase the risk in the same way.
S’ issa m’ huwiex magħruf jekk tipi oħra ta ’ HRT iżidux ir- riskju bl- istess mod.
Dementia There is no evidence that HRT improves processes of remembering, learning and judging (cognitive function).
Demenzja M’ hemm ebda evidenza li l- HRT itejjeb il- proċess li tiftakar, li titgħallem jew li tiġudika (funzjoni konjittiva).