natgillin/translations-raw huggingface dataset:
Do not take Ulipristal Acetate Gedeon Richter - if you are allergic to ulipristal acetate or any of the other ingredients of Ulipristal Acetate
Ne jemljite zdravila Ulipristal Acetate Gedeon Richter - če ste alergični na ulipristalacetat ali katero koli sestavino zdravila Ulipristal Acetate Gedeon
Renal impairment is not expected to significantly alter the elimination of ulipristal acetate.
Ledvična okvara Ni pričakovati, da bi ledvična okvara bistveno spremenila izločanje ulipristalacetata.
Do not take Ulipristal Acetate Gedeon Richter if you are pregnant.
Ne jemljite zdravila Ulipristal Acetate Gedeon Richter, če ste noseči.
THE TABLE BELOW HELPS YOU TO TRACK YOUR BLOOD TESTS:
SPODNJA PREGLEDNICA SLUŽI KOT POMOČ PRI SPREMLJANJU KRVNIH
Ulipristal Acetate Gedeon Richter is used in adult women (over 18 years of age) before they reach the menopause.
Zdravilo Ulipristal Acetate Gedeon Richter se uporablja pri odraslih ženskah (starejših od 18 let), ki še niso v menopavzi.
Depending on the result of these tests, the doctor will decide if treatment with Ulipristal Acetate Gedeon Richter is suitable for you.
Glede na rezultate teh preiskav bo zdravnik odločil, ali je zdravljenje z zdravilom Ulipristal Acetate Gedeon Richter za vas primerno.
In vitro data indicate that ulipristal acetate and its active metabolite are not P-gp (ABCB1) substrates.
Podatki in vitro kažejo, da ulipristalacetat in njegov aktivni presnovek nista substrata P-gp (ABCB1) Posebne skupine bolnikov
Ulipristal Acetate Gedeon Richter is likely to make some hormonal contraceptives less effective (see “Other medicines and Ulipristal Acetate Gedeon Richter”).
Zdravilo Ulipristal Acetate Gedeon Richter lahko zmanjša učinkovitost nekaterih hormonskih kontracepcijskih sredstev (glejte poglavje »Druga zdravila in zdravilo Ulipristal Acetate Gedeon Richter«).
If you do become pregnant during Ulipristal Acetate Gedeon Richter treatment, you should stop taking Ulipristal Acetate Gedeon Richter immediately and contact your doctor or pharmacist.
Če med zdravljenjem z zdravilom Ulipristal Acetate Gedeon Richter zanosite, morate takoj prenehati jemati zdravilo Ulipristal Acetate Gedeon Richter in obvestiti svojega zdravnika ali farmacevta.
Use in women with severe asthma insufficiently controlled by oral glucocorticoids is not recommended.
Bolnice z astmo Za ženske s hudo obliko astme, ki je neustrezno nadzorovana s peroralnimi glukokortikoidi, uporaba zdravila ni priporočljiva.
• inform the patients about potential adverse reactions related to liver that could be caused by the use of Ulipristal Acetate Gedeon Richter.
• bolnice obvestite o možnih neželenih učinkih, povezanih z jetri, ki jih lahko povzroči jemanje zdravila Ulipristal Acetate Gedeon Richter.
- If you are currently taking hormonal contraception (for example birth control pills) (see “Other medicines and Ulipristal Acetate Gedeon Richter”) you should use an alternative reliable barrier contraceptive method (such as a condom) while taking Ulipristal Acetate Gedeon Richter.
- če trenutno jemljete hormonska kontracepcijska sredstva (na primer kontracepcijske tablete) (glejte poglavje »Druga zdravila in zdravilo Ulipristal Acetate Gedeon Richter«), morate med jemanjem zdravila Ulipristal Acetate Gedeon Richter uporabljati drugo zanesljivo pregradno kontracepcijsko metodo (na primer kondom);
There is no relevant use of ulipristal acetate in the paediatric population.
Pediatrična populacija Ulipristalacetat ni primeren za uporabo pri pediatrični populaciji.
A majority of women taking a therapeutic dose of ulipristal acetate have anovulation, however, the level of fertility while taking multiple doses of ulipristal acetate has not been studied.
Plodnost Pri večini žensk, ki jemljejo terapevtske odmerke ulipristalacetata, se pojavi anovulacija, vendar stopnje plodnosti pri jemanju večkratnih odmerkov ulipristalacetata niso raziskovali.
What Ulipristal Acetate Gedeon Richter is and what it is used for What you need to know before you take Ulipristal Acetate Gedeon Richter How to take Ulipristal Acetate Gedeon Richter Possible side effects
Kaj je zdravilo Ulipristal Acetate Gedeon Richter in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Ulipristal Acetate Gedeon Richter Kako jemati zdravilo Ulipristal Acetate Gedeon Richter
If you stop taking Ulipristal Acetate Gedeon Richter Ulipristal Acetate Gedeon Richter is to be taken daily during treatment courses of up to 3 months continuously.
Če ste prenehali jemati zdravilo Ulipristal Acetate Gedeon Richter Zdravilo Ulipristal Acetate Gedeon Richter je treba jemati neprekinjeno vsak dan v času cikla zdravljenja, ki traja po največ 3 mesece.
Ulipristal acetate may have minor influence on the ability to drive or use machines as mild dizziness has been observed after ulipristal acetate intake.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Ulipristalacetat ima lahko manjši vpliv na sposobnost vožnje ali upravljanja strojev, saj so pri zaužitju ulipristalacetata opazili blago omotico.
During each course of treatment, do not stop taking your tablets without the advice of your doctor even if you feel better, as symptoms may re-occur later.
če vam tako ne naroči zdravnik, tudi če se počutite bolje, saj se simptomi lahko pozneje pojavijo znova.
Your period should generally return within 4 weeks after treatment with Ulipristal Acetate Gedeon Richter is stopped.
Mesečno perilo se ponavadi povrne v 4 tednih po prekinitvi zdravljenja z zdravilom Ulipristal Acetate Gedeon Richter.
This card provides information on blood tests you will need throughout treatment and on what you should do if liver side effects occur.
Ta kartica vsebuje informacije o krvnih preiskavah, ki jih boste opravili tekom zdravljenja, in o tem,
Treatment with Ulipristal Acetate Gedeon Richter usually leads to a significant reduction or may even stop your menstrual bleeding (your ‘period') within the first 10 days of treatment.
Zdravljenje z zdravilom Ulipristal Acetate Gedeon Richter ponavadi v prvih 10 dneh zdravljenja bistveno zmanjša menstrualne krvavitve (mesečno perilo) ali jih lahko celo ustavi.
Ulipristal Acetate Gedeon Richter is likely to make some hormonal contraceptives less effective.
Zdravilo Ulipristal Acetate Gedeon Richter lahko zmanjša učinkovitost nekaterih hormonskih kontracepcijskih sredstev.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Microcrystalline cellulose
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi mikrokristalna celuloza manitol premreženi natrijev karmelozat smukec magnezijev stearat
- Certain medicines used to treat epilepsy (e.g. phenytoin, fosphenytoin, phenobarbital,
- nekatera zdravila za zdravljenje epilepsije (npr. fenitoin, fosfenitoin, fenobarbital,
Before you start treatment with Ulipristal Acetate Gedeon Richter blood tests will be undertaken to find out how well your liver is working.
- pred uvedbo zdravljenja z zdravilom Ulipristal Acetate Gedeon Richter, boste opravili preiskave krvi, da se ugotovi, kako dobro delujejo vaša jetra.
Ulipristal Acetate Gedeon Richter treatment is to be initiated and supervised by physicians experienced in the diagnosis and treatment of uterine fibroids.
Zdravljenje z zdravilom Ulipristal Acetate Gedeon Richter morajo uvesti in nadzorovati zdravniki, z izkušnjami pri diagnosticiranju in zdravljenju materničnih leiomiomov.
If during the treatment you experience any liver related signs such as feeling of being sick (nausea or vomiting), fatigue, severe tiredness, jaundice (yellowing of the eyes or skin), dark urine, itching or upper stomach ache, you should stop treatment and immediately contact a doctor, who will check the functioning of your liver and decide if you can continue the treatment.
(siljenje na bruhanje) ali bruhanje, utrujenost, huda utrujenost, zlatenica (porumenelost oči ali kože), temen urin, srbenje ali bolečina v zgornjem delu trebuha, morate o tem takoj obvestiti zdravnika, ki bo preveril delovanje vaših jeter in se odločil, ali boste z zdravljenjem nadaljevali.
breast discomfort - swelling due to fluid retention (oedema) - extreme tiredness (asthenia) - increase in blood cholesterol seen in blood tests, increase in blood fats (triglycerides) seen in blood tests.
- izjemna utrujenost (astenija), - povišanje ravni holesterola v krvi pri krvnih preiskavah, povišanje maščob (trigliceridov) v krvi pri krvnih preiskavah.
• key effects of Ulipristal Acetate Gedeon Richter on Progesterone Receptor Modulator Associated Endometrial Changes (PAEC) and how they differ from those of unopposed oestrogen.
• ključni učinki zdravila Ulipristal Acetate Gedeon Richter na spremembe endometrija, povezane z modulatorji progesteronskih receptorjev (PAEC- Progesterone Receptor
You should nonetheless ask your doctor or pharmacist for advice if you take more Ulipristal Acetate Gedeon Richter than you should.
Kljub temu pa se posvetujte s svojim zdravnikom ali farmacevtom, če ste vzeli večji odmerek zdravila Ulipristal Acetate Gedeon Richter, kot bi smeli.
Ulipristal Acetate Gedeon Richter is contraindicated in patients with hepatic disorder (see section 4.3 and 4.4).
Gedeon Richter je kontraindicirano pri bolnicah z jetrno boleznijo (glejte poglavji 4.3 in 4.4).
During treatment with Ulipristal Acetate Gedeon Richter, your doctor will carry out regular blood tests to check your liver function.
Med zdravljenjem z zdravilom Ulipristal Acetate Gedeon Richter boste po navodilu zdravnika opravljali redne krvne preiskave za preverjanje delovanja jeter.
Mechanism of action Ulipristal acetate exerts a direct effect on the endometrium.
Ulipristalacetat ima neposreden učinek na endometrij.
In all Phase III studies including repeated intermittent treatment studies, a total of 7 cases of hyperplasia were observed out of 789 patients with adequate biopsies (0.89%).
789 bolnicami, pri katerih so opravili ustrezno biopsijo (0,89 %), opazili skupno 7 primerov hiperplazije.
If, during repeated intermittent treatment, after the initial reduction in bleeding or amenorrhea, an altered persistent or unexpected bleeding pattern occurs, such as inter-menstrual bleeding, investigation of the endometrium including endometrial biopsy should be performed in order to exclude other underlying conditions, including endometrial malignancy.
Če se med ponavljajočim se intermitentnim zdravljenjem po začetnem zmanjšanju krvavitev ali amenoreji pojavi trajno spremenjen ali nepričakovan vzorec krvavitev, kot so vmesne krvavitve, bo morda potreben pregled endometrija, vključno z biopsijo, za izključitev drugih bolezni, tudi malignih sprememb endometrija.
Ulipristal acetate is indicated for one treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
4.1 Terapevtske indikacije Ulipristalacetat je indiciran za en cikel predoperacijskega zdravljenja zmernih do hudih simptomov materničnih leiomiomov pri odraslih ženskah v rodni dobi.
Therefore, hormonal contraceptives are not recommended and you should use an alternative reliable barrier contraceptive method, such as a condom, during Ulipristal Acetate Gedeon Richter treatment.
Zato uporaba hormonskih kontracepcijskih sredstev ni priporočljiva in morate med zdravljenjem z zdravilom Ulipristal Acetate Gedeon Richter uporabiti drugo zanesljivo pregradno kontracepcijsko metodo, kot je kondom.
- Certain medicines to treat fungal infections (e.g. ketoconazole (except shampoo), itraconazole).
- nekatera zdravila za zdravljenje glivičnih okužb (npr. ketokonazol (razen v obliki šampona),
Study 2 contained the active comparator, leuprorelin 3.75 mg given once per month by intramuscular injection.
levprorelin, 3,75 mg enkrat na mesec v obliki intramuskularnega injiciranja.
What Ulipristal Acetate Gedeon Richter is and what it is used for
Kaj je zdravilo Ulipristal Acetate Gedeon Richter in za kaj ga uporabljamo
You should always start taking Ulipristal Acetate Gedeon Richter within the first week of your menstrual period.
Zdravilo Ulipristal Acetate Gedeon Richter vedno začnite jemati v prvem tednu menstruacije.
INFORMATION IN BRAILLE Ulipristal Acetate Gedeon Richter
PODATKI V BRAILLOVI PISAVI Ulipristal Acetate Gedeon Richter
What Ulipristal Acetate Gedeon Richter looks like and contents of the pack Ulipristal Acetate Gedeon Richter is white to off-white, round curved tablet of 7 mm engraved with code “ES5” on one face.
Zdravilo Ulipristal Acetate Gedeon Richter je bela do umazano bela okrogla izbočena tableta s premerom 7 mm, z vtisnjenim napisom »ES5« na eni strani.
• inform the patients not to take Ulipristal Acetate Gedeon Richter in case of liver problems.
• bolnice opozorite, da ne smejo jemati zdravila Ulipristal Acetate Gedeon Richter, če imajo težave z jetri.
- Certain medicines used to prevent strokes and blood clots (e.g. dabigatran etexilate).
- nekatera zdravila za preprečevanje možganske kapi in krvnih strdkov (npr. dabigatraneteksilat),
Ulipristal Acetate Gedeon Richter passes into the breast milk.
Zdravilo Ulipristal Acetate Gedeon Richter prehaja v materino mleko.
Following administration of the moderate CYP3A4 inhibitor erythromycin propionate (500 mg twice daily for 9 days) to healthy female volunteers, Cmax and AUC of ulipristal acetate increased 1.2 and
Po uporabi zmernega zaviralca CYP3A4, eritromicinpropionata (500 mg dvakrat dnevno, 9 dni) pri zdravih prostovoljkah, se je vrednost Cmax ulipristalacetata povečala 1,2-krat, vrednost AUC pa 2,9
What you need to know before you take Ulipristal Acetate Gedeon Richter
Kaj morate vedeti, preden boste vzeli zdravilo Ulipristal Acetate Gedeon Richter
How to store Ulipristal Acetate Gedeon Richter Contents of the pack and other information
Shranjevanje zdravila Ulipristal Acetate Gedeon Richter Vsebina pakiranja in dodatne informacije
The incidence of hyperplasia did not increase with repeated treatment courses, including data on 340 women who received up to 4 courses of ulipristal acetate 5 or 10 mg and limited data of 43 women who received up to 8 courses of ulipristal acetate 10 mg.
Na podlagi podatkov pri 340 ženskah, ki so prejele do 4 cikle 5 ali 10 mg ulipristalacetata, in omejenih podatkov pri 43 ženskah, ki so prejele do 8 ciklov
The European Medicines Agency has waived the obligation to submit the results of studies with Ulipristal Acetate Gedeon Richter in all subsets of the paediatric population in leiomyoma of uterus (see section 4.2 for information on paediatric use).
Ulipristal Acetate Gedeon Richter za vse skupine pediatrične populacije pri zdravljenju materničnih leiomiomov (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
- If you suffer from severe asthma, treatment with Ulipristal Acetate Gedeon Richter may not be suitable for you.
- če imate hudo astmo, zdravljenje z zdravilom Ulipristal Acetate Gedeon Richter morda ni primerno za vas.
Ulipristal Acetate Gedeon Richter can cause side effects although not everybody gets them.
Zdravilo Ulipristal Acetate Gedeon Richter lahko povzroči neželene učinke, ki pa se ne pojavijo pri vseh bolnicah.
2.9 fold, respectively; the AUC of the active metabolite of ulipristal acetate increased 1.5 fold while the Cmax of the active metabolite decreased (0.52 fold change).
krat; vrednost AUC aktivnega presnovka ulipristalacetata se je povečala 1,5-krat, vrednost Cmax aktivnega presnovka pa se je zmanjšala (0,52-krat).
SPECIAL STORAGE CONDITIONS Keep the blisters in the outer carton in order to protect from light.
Pretisne omote shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
• the posology: 5 mg tablet once daily for treatment courses of up to 3 months each.
• odmerjanje: 5 mg tableta enkrat dnevno v ciklih zdravljenja, od katerih vsak traja do
Uncommon (may affect up to 1 in 100 people) side effects: - drug allergy - anxiety - mood swings - dizziness - dry mouth, constipation - hair loss, dry skin, increased sweating - back pain - leakage of urine - bleeding from the womb (uterine bleeding), vaginal discharge, abnormal vaginal bleeding,
Občasni neželeni učinki (lahko se pojavijo pri manj kot 1 osebi od 100): - alergija na zdravilo, - tesnoba, - nihanje razpoloženja, - omotica, - suha usta, zaprtost, - izpadanje las, suha koža, povečano potenje,
Patients whose menstrual bleeding became normal (PBAC < 75) at week 13 Median change in myoma volume from baseline to week 13a a In Study 1, change from baseline in total myoma volume was measured by MRI.
Bolnice z amenorejo v 13. tednu Bolnice, pri katerih je menstruacijska krvavitev postala normalna (PBAC < 75) v 13. tednu Mediana spremembe prostornine miomov od izhodišča do
In the active comparator controlled study the rates were 24% (10.5% moderate or severe) for ulipristal acetate and 60.4% (39.6% moderate or severe) for leuprorelin-treated patients.
(10,5 %zmernih ali hudih), v skupini bolnic, ki so jih zdravili z levprorelinom pa 60,4 % (39,6 %
Investigations
PREISKAV:
Ulipristal acetate is likely to adversely interact with progestagen-only pills, progestagen-releasing devices or combined oral contraceptive pills, therefore, concomitant use is not recommended.
maternične vložke, ki sproščajo progestagen ali kombinirane peroralne kontracepcijske tablete, zato sočasna uporaba ni priporočljiva.
• darkening of the urine
- uhajanje urina,
Although a majority of women taking a therapeutic dose of ulipristal acetate have anovulation, a non hormonal contraceptive method is recommended during treatment (see sections 4.4 and 4.5).
ovulacija izostaja, kljub temu pa je med zdravljenjem priporočljivo uporabljati nehormonsko kontracepcijsko metodo (glejte poglavji 4.4 in 4.5).
A PBAC >100 within the first 8 days of menses is considered to represent excessive menstrual blood loss.
Chart - PBAC) Čezmerna izguba menstruacijske krvi je opredeljena kot vrednost PBAC > 100 v prvih
In study 4, 61.9% and 72.7% of patients were in amenorrhea at the end of both treatment course 1 and 2 combined (5 mg dose and 10 mg dose, respectively, p=0.032); 48.7 % and 60.5 % were in amenorrhea at the end of all four treatment courses combined (5 mg dose and 10 mg dose,
V študiji 4 je skupno 61,9 % in 72,7 % bolnic imelo amenorejo ob koncu skupnega prvega in drugega cikla zdravljenja (s 5 mg oziroma 10 mg odmerkom, p = 0,032).
The MAH shall ensure that, at launch and thereafter, all prescribers of Ulipristal Acetate Gedeon Richter and pathologists who review samples from Ulipristal Acetate Gedeon Richter-treated patients, as well as patients treated with Ulipristal Acetate Gedeon Richter, are provided with educational material.
patologom, ki pregledujejo vzorce bolnic, ki se zdravijo z zdravilom Ulipristal Acetate Gedeon Richter, in bolnicam, ki se zdravijo z zdravilom Ulipristal Acetate Gedeon Richter, na voljo izobraževalno gradivo.
Ulipristal acetate is highly bound (>98%) to plasma proteins, including albumin, alpha-l-acid glycoprotein, high density lipoprotein and low density lipoprotein.
Ulipristalacetat se v veliki meri veže (> 98 %) na beljakovine v plazmi, vključno z albuminom,
Ulipristal Acetate Gedeon Richter may cause mild dizziness (see section 4 “Possible side effects”).
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Ulipristal Acetate Gedeon Richter lahko povzroči blago omotico (glejte poglavje 4 »Možni neželeni učinki«).
Ear and labyrinth disorders
vključno z motnjami labirinta vertigo
Ulipristal Acetate Gedeon Richter contains the active substance ulipristal acetate.
Zdravilo Ulipristal Acetate Gedeon Richter vsebuje zdravilno učinkovino ulipristalacetat.
Ulipristal acetate should only be prescribed after careful diagnosis.
4.4 Posebna opozorila in previdnostni ukrepi Ulipristalacetat se sme predpisati samo po skrbni diagnozi.
Not applicable.
In ga ni mogoče izključiti.
How to take Ulipristal Acetate Gedeon Richter
Kako jemati zdravilo Ulipristal Acetate Gedeon Richter
NAME OF THE MARKETING AUTHORISATION HOLDER Gedeon Richter
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Gedeon Richter
Adverse reactions during treatment course 1 Very common Common
Neželeni učinki v 1. ciklu zdravljenja
It is used either before an operation of your fibroids or for long term treatment of your fibroids to reduce their size, to stop or reduce bleeding and to increase your red blood cell count.
za ustavitev ali zmanjševanje krvavitev in za povečevanje števila eritrocitov.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: DD month YYYY Date of latest renewal: DD month YYYY
DATUM ZADNJE REVIZIJE BESEDILA DD/MM/LLLL
If you have been prescribed several courses of Ulipristal Acetate Gedeon Richter 3-month treatment, you should start each course at the earliest during the second menstrual period following the previous treatment completion.
Acetate Gedeon Richter, lahko začnete vsak cikel šele med drugo menstruacijo po koncu prejšnjega zdravljenja.
Administration of the potent CYP3A4 inducer rifampicin (300 mg twice daily for 9 days) to healthy female volunteers markedly decreased Cmax and AUC of ulipristal acetate and its active metabolite by 90% or more and decreased ulipristal acetate half-life by 2.2-fold corresponding to an approximately 10-fold decrease of ulipristal acetate exposure.
Uporaba močnega induktorja CYP3A4, rifampicina (300 mg dvakrat dnevno 9 dni), je pri zdravih prostovoljkah znatno zmanjšala Cmax in AUC ulipristalacetata ter njegovega aktivnega presnovka za
Do not take Ulipristal Acetate Gedeon Richter if you have liver problems.Tell your doctor if you know that you have problems with your liver or if you have any doubts about the condition of your liver.
Povejte svojemu zdravniku, če veste, da imate težave z jetri ali če imate kakšne pomisleke glede stanja jeter.
2nd TEST (4 weeks after starting treatment) 3rd TEST (8 weeks after starting treatment) 4th TEST (12 weeks after starting treatment) 5th TEST (2- 4 weeks after stopping Ulipristal Acetate Gedeon Richter treatment)
PREISKAVA (2 - 4 tedne po prenehanju zdravljenja z zdravilom Ulipristal Acetate Gedeon Richter)
Ulipristal acetate 10 mg/day N=94
Ulipristal acetat 10 mg/dan N=94
Other medicines and Ulipristal Acetate Gedeon Richter Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Following administration of the potent CYP3A4 inhibitor ketoconazole (400 mg once daily for 7 days) to healthy female volunteers, Cmax and AUC of ulipristal acetate increased 2 and 5.9 fold, respectively; the AUC of the active metabolite of ulipristal acetate increased 2.4 fold while the Cmax of the active metabolite decreased (0.53 fold change).
zdravim prostovoljkam, se je Cmax ulipristalacetata povečala za 2-krat, AUC pa za 5,9-krat ; AUC aktivnega metabolita ulipristalacetata se je povečala za 2,4-krat, medtem ko se je Cmax aktivnega metabolite zmanjšala (0,53-kratna sprememba).
Common (may affect up to 1 in 10 people) side effects: - headache - spinning sensation (vertigo) - stomach ache, feeling sick (nausea) - acne - muscle and bone (musculoskeletal) pain - sac of fluid within the ovaries (ovarian cyst), breast tenderness/pain, lower abdominal (pelvic)
- bolečine v mišicah in kosteh, - votlinice s tekočino v jajčnikih (ciste na jajčnikih), občutljive dojke/bolečine v dojkah, bolečine v spodnjem delu trebuha (medenici), vročinski oblivi, - utrujenost,
NAME OF THE MEDICINAL PRODUCT Ulipristal Acetate Gedeon Richter 5 mg tablets
IME ZDRAVILA Ulipristal Acetate Gedeon Richter 5 mg tablete
Uterine haemorrhage
otekanje dojk
• Educational material for prescribers (gynaecologists) which contains: o Cover letter o SmPC o Physician's guide to prescribing Ulipristal Acetate Gedeon Richter
• Izobraževalno gradivo za zdravnike, ki predpisujejo zdravilo (ginekologi), ki vsebuje: o spremno pismo,
Headache*
vročinski oblivi*
If a patient during treatment shows signs or symptoms compatible with liver injury (fatigue, asthenia, nausea, vomiting, right hypochondrial pain, anorexia, jaundice), treatment should be stopped and the patient should be investigated immediately, and liver function tests performed.
bolečina v desnem hipohondriju, anoreksija, zlatenica), je treba zdravljenje prekiniti, bolnico pa nemudoma pregledati in opraviti preiskave delovanja jeter.