natgillin/translations-raw huggingface dataset:
The most frequent adverse reactions leading to discontinuation with naltrexone / bupropion were nausea, headache, dizziness and vomiting.
Najčešće nuspojave koje su dovele do prekida liječenja s naltrekson / bupropionom su mučnina, glavobolja, omaglica i povraćanje.
• history of head trauma
• trauma glave u anamnezi,
Comparable results were seen in the NB-303 study, which was of similar design, with significant weight loss observed in naltrexone / bupropion -treated subjects compared to placebo at the Week 28 primary endpoint, and sustained through 56 weeks from baseline (Table 3).
NB-303, koji je bio sličnog dizajna, sa značajnim gubitkom težine opaženim u ispitanika liječenih naltrekson / bupropionom u usporedbi s placebom za primarni ishod 28. tjedna, a održao se tijekom 56 tjedana od početka ispitivanja (Tablica 3).
Administration of naltrexone / bupropion to patients receiving either levodopa or amantadine concurrently should be undertaken with caution.
Primjenu naltrekson / bupropiona u bolesnika koji istodobno primaju ili levodopu ili amantadin treba provoditi s oprezom.
• Patients with a current seizure disorder or a history of seizures (see section 4.4)
• Bolesnici s trenutnim poremećajem napadaja ili napadajima u anamnezi (vidjeti dio 4.4)
Following single oral administration of naltrexone / bupropion tablets to healthy subjects, mean T½ elimination half-life was approximately 5 hours for naltrexone and 21 hours for bupropion.
Nakon jednokratne peroralne primjene tableta naltrekson / bupropiona zdravim ispitanicima, srednja vrijednost poluvijeka eliminacije T½ je bila oko 5 sati za naltrekson i 21 sat za bupropion.
The most frequent adverse reactions for naltrexone / bupropion are nausea, constipation, vomiting, dizziness, and dry mouth.
Najčešće nuspojave za naltrekson / bupropion su mučnina, zatvor, povraćanje, omaglica, i suha usta.
The DEXA assessment showed that treatment with naltrexone / bupropion was associated with greater reductions from baseline in total body fat and in visceral adipose tissue than placebo.
DEXA procjena je pokazala da je liječenje s naltrekson / bupropionom povezano s većim smanjenjima od početnih vrijednosti ukupne tjelesne masti i visceralnog masnog tkiva u odnosu na placebo.
Common events leading to withdrawal among elderly were nausea, vomiting, dizziness, constipation.
Česti događaji koji su doveli do povlačenja kod starijih bili su mučnina, povraćanje, omaglica i zatvor.
Improvements in triglycerides, HDL-C and LDL-C/HDL-C ratio were seen in naltrexone / bupropion-treated subjects diagnosed with baseline dyslipidaemia irrespective of dyslipidaemia treatment.
Poboljšanja u trigliceridima, HDL-K i LDL-K/HDL-K omjeru su opaženi u ispitanika liječenih s naltrekson / bupropionom koji su dijagnosticirani s osnovnom dislipidemijom bez obzira na liječenje dislipidemije.
In patients with moderate (Child-Pugh scores of 7-9 [Class B]) and severe (Child-Pugh scores of 10 or higher [Class C]) hepatic impairment, increases in the maximum concentration of naltrexone of ~6and ~30-fold were observed for the moderate and severe patients respectively, while increases in bupropion were ~2-fold for both groups.
U bolesnika s umjerenim oštećenjem jetre (Child-Pugh rezultat 7-9 [stadij B]) i teškim oštećenjem jetre (Child-Pugh rezultat 10 ili viši [stadij C]), porast maksimalne koncentracije naltreksona od ~6 i ~30 puta uočen je u bolesnika s umjerenim odnosno teškim oštećenjem jetre, dok je porast koncentracije bupropiona bio ~2 puta u obje skupine.
Study NB-304 was conducted in subjects who were overweight or obese and had type 2 diabetes mellitus.
Ispitivanje NB-304 je bilo provedeno s ispitanicima koji su bili prekomjerne težine ili pretili s dijabetes melitusom tipa 2.
Naltrexone / bupropion is contraindicated in patients receiving concomitant treatment with monoamine oxidase inhibitors, bupropion or naltrexone, patients undergoing acute alcohol or benzodiazepine withdrawal, patients currently dependent on chronic opioids, or opiate agonists (see Section 4.3).
Naltrekson / bupropion je kontraindiciran u bolesnika koji primaju istodobno liječenje s inhibitorima monoaminooksidaze, bupropionom ili naltreksonom, bolesnika koji trenutno prolaze kroz ustezanje od alkohola ili benzodiazepina, bolesnika trenutno ovisnih o kroničnoj primjeni opioida ili agonista opijata (vidjeti dio 4.3).
NAME OF THE MEDICINAL PRODUCT Mysimba 8 mg/90 mg prolonged-release tablets
Mysimba 8 mg/90 mg tablete s produljenim oslobađanjem
Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
Weight loss of at least 5% baseline body weight was observed more frequently for subjects treated with naltrexone / bupropion (31%) compared to placebo (12%) (Table 4).
Gubitak težine od najmanje 5 % od početne tjelesne težine opažen je učestalije u ispitanika liječenih s naltrekson / bupropionom (31 %) u usporedbi s placebom (12 %) (Tablica 3).
In contrast, formation of threohydrobupropion has been reported in the literature to be mediated by 11-beta-hydroxysteroid dehydrogenase 1.
Nasuprot tome, stvaranje treohidrobupropiona je prikazano u literaturi kao posredovano 11-beta-hidroksisteroid dehidrogenazom 1. Metabolički put odgovoran za stvaranje eritrohidrobupropiona je nepoznat.
As it is unknown whether the risk for seizure with bupropion is related to bupropion or a metabolite of bupropion, and there are no data demonstrating comparability of plasma concentrations with repeated dosing, there is uncertainty whether repeated-dose administration naltrexone / bupropion may be associated with a similar rate of seizures as bupropion SR 300 mg.
Kako nije poznato da li se rizik od napadaja s bupropionom odnosi na bupropion ili njegov metabolit, i nema podataka koji bi pokazali usporedivost koncentracija u plazmi nakon ponavljanog doziranja, neizvjesno je da li je primjena ponavljane doze naltrekson /
Studies NB-301, NB-302, and NB-303 were conducted in subjects who were obese, or overweight or obese with comorbidities.
Ispitivanja NB-301, NB-302, i NB-303 su provedena s ispitanicima koji su bili pretili, prekomjerne težine ili pretili s popratnim bolestima.
For individuals who are at elevated risk for renal impairment, in particular, individuals with diabetes or elderly individuals, estimated glomerular filtration rate (eGFR) should be assessed prior to initiating therapy with naltrexone / bupropion.
Za pojedince koji imaju povišen rizik od oštećenja bubrega, osobito osobe s dijabetesom ili starije osobe, treba se odrediti procijenjena glomerularna filtracija (EGFR) prije započinjanja liječenja s naltrekson / bupropionom.
The clinical consequences of the inhibition of the metabolism of bupropion via CYP2B6 enzyme and the consequent changes in the bupropion-hydroxybupropion ratio are currently unknown, but could potentially lead to reduced efficacy of naltrexone / bupropion.
CYP2B6 i posljedične promjene u omjeru bupropion-hidroksibupropion trenutno nisu poznate, ali mogu potencijalno dovesti do smanjenja djelotvornosti naltrekson / bupropiona.
Tablet core: microcrystalline cellulose, hydroxypropyl cellulose, lactose anhydrous, lactose monohydrate (see section 2 “Mysimba contains lactose”), cysteine hydrochloride, crospovidone, magnesium stearate, hypromellose, edetate disodium, colloidal silicon dioxide, and indigo carmine aluminium lake (E132).
- Drugi sastojci (pomoćne tvari) su: Jezgra tablete: mikrokristalična celuloza, hidroksipropilceluloza, bezvodna laktoza, laktoza hidrat (vidjeti dio 2. „Lijek Mysimba sadrži laktozu”), cisteinklorid, krospovidon, magnezijev stearat, hipromeloza, dinatrijev edetat, koloidni silicijev dioksid i indigo carmine aluminium lake (E132).
The results of a single dose relative bioavailability study in healthy subjects demonstrated that naltrexone / bupropion tablets, when dose adjusted, are bioequivalent based on AUC0-∞ mean ratio and 90% confidence intervals to naltrexone immediate release (IR) or bupropion prolonged release (PR) administered as single agents.
Rezultati ispitivanja relativne bioraspoloživosti jedne doze u zdravih ispitanika pokazali su da su tablete naltrekson / bupropiona, kada su doze prilagođene, bioekvivalentne na temelju srednje vrijednosti omjera AUC0-∞ i 90 % intervala pouzdanosti, s naltreksonom s trenutnim oslobađanjem
Based on studies in animals, it is recommended that seizures be treated with intravenous benzodiazepine administration and other supportive measures, as appropriate.
preporučuje se da se napadaji liječe s intravenskom primjenom benzodiazepina i po potrebi s drugim potpornim mjerama.
Mean HbA1c change from baseline at week 56 was -0.63% for subjects treated with naltrexone / bupropion compared to subjects on placebo -0.14% (p<0.001).
Srednja vrijednost promjene HbA1c od početne razine 56. tjedan je bila -0,63 % u ispitanika liječenih naltrekson / bupropionom u odnosu na ispitanike na placebu -0,14 % (p < 0,001).
Arthralgia, myalgia, and fever with rash and other symptoms suggestive of delayed hypersensitivity have been reported in association with bupropion.
Artralgija, mijalgija, i vrućica s osipom i drugim simptomima koji upućuju na odgođenu preosjetljivost zabilježene su u vezi s bupropionom.
The safety profile of naltrexone / bupropion (NB) summarised in Table 1 below is based on clinical studies performed with the fixed-dose combination (adverse reactions at an incidence of at least 0.1% and twice that of placebo).
Nuspojave prijavljene s fiksnom kombinacijom naltreksona i bupropiona Sigurnosni profil naltrekson / bupropiona (NB) sažet u tablici 1 u nastavku temelji se na kliničkim ispitivanjima provedenim s fiksnom kombinacijom doza (nuspojave s incidencijom od najmanje 0,1 % te dvostruko višom od one s placebom).
Naltrexone / bupropion should be given with caution to those patients with controlled hypertension and must not be given to patients with uncontrolled hypertension (see section 4.3).
Naltrekson / bupropion treba davati s oprezom bolesnicima s kontroliranom hipertenzijom i ne smije se davati bolesnicima s nekontroliranom hipertenzijom (vidjeti dio 4.3).
The use of naltrexone/bupropion has been associated with somnolence and episodes of loss of consciousness, sometimes caused by seizure.
Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Primjena naltrekson / bupropiona povezana je sa somnolencijom i epizodama gubitka svijesti, ponekad uzrokovanih napadajima.
Therefore, naltrexone / bupropion should not be used in children and adolescents below 18.
Prema tome, naltrekson / bupropion se ne smije koristiti u djece i adolescenata ispod 18 godina starosti.
NAME OF THE MARKETING AUTHORISATION HOLDER Orexigen
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Orexigen
If serum sickness is suspected, naltrexone / bupropion should be discontinued.
Ako se sumnja na serumsku bolest, treba prekinuti liječenje s naltrekson / bupropionom.
• you have any liver problems before you start Mysimba.
• imate bilo kakvih problema s jetrom prije nego što počnete uzimati lijek Mysimba.
In addition, in subjects who did not have type 2 diabetes, there were reductions in fasting insulin and HOMA-IR, a measure of insulin resistance, in naltrexone / bupropion-treated subjects.
Osim toga, u ispitanika koji nisu imali dijabetes tipa 2, a liječeni su naltrekson / bupropionom bilo je smanjenja inzulina natašte i HOMA-IR, mjere rezistencije na inzulin.
Blood and Lymphatic system disorders Uncommon Idiopathic thrombocytopenic purpura (N) Immune system disorders
Poremećaji krvi i limfnog sustava manje često idiopatska trombocitopenična purpura (N)
Following single oral administration of naltrexone / bupropion tablets to healthy subjects, peak concentrations of naltrexone and bupropion occurred approximately 2 and 3 hours post administration of naltrexone / bupropion, respectively.
Nakon jedne peroralne primjene tableta naltrekson / bupropiona u zdravih ispitanika, vršne koncentracije naltreksona i bupropiona su postignute oko 2 odnosno 3 sata nakon primjene naltreksona / bupropiona.
Elderly patients may be more sensitive to some of the central nervous system-related adverse reactions of naltrexone / bupropion (primarily dizziness and tremor).
Stariji bolesnici mogu biti osjetljiviji na neke nuspojave naltrekson / bupropiona u središnjem živčanom sustavu (prvenstveno omaglica i tremor).
No effect on fertility in reproductive toxicity studies have been observed with bupropion.
Nisu opaženi učinci bupropiona na plodnost u ispitivanjima reproduktivne toksičnosti.
The additional undesirable effects occurring with either of the individual components (bupropion or naltrexone) when used for non-obesity indications are summarized in Table 2.
Dodatne nuspojave koje se mogu pojaviti s jednom ili drugom komponentom (bupropion ili naltrekson) kad se primjenjuju u drugim indikacijama osim pretilosti sažeti su u tablici 2.
Suomi/Finland Navamedic AB Puh.
Danmark Navamedic AB Tel.
Effect on cardiovascular and metabolic parameters Improvements were observed for waist circumference (including subjects with type 2 diabetes), triglycerides, HDL-C and LDL-C/HDL-C ratio for subjects treated with naltrexone / bupropion vs. placebo in all Phase 3 studies (Table 5).
Opažena su poboljšanja obujma struka (uključujući ispitanike s dijabetesom tipa 2), triglicerida, HDL-K i LDL-K/HDL-K omjera za ispitanike liječene naltrekson / bupropionom naspram placeba u svim ispitivanjima faze 3 (Tablica 5).
Naltrexone and bupropion are known to be substantially excreted by the kidney, and the risk of adverse reactions to naltrexone / bupropion may be greater in patients with impaired renal function, a condition that is more common in elderly individuals.
Poznato je da se naltrekson i bupropion značajno izlučuju preko bubrega, pa rizik od nuspojava na naltrekson / bupropion može biti veći u bolesnika s oštećenom funkcijom bubrega,
Four multicentre, double-blind, placebo-controlled obesity Phase 3 studies (NB-301, NB-302, NB-303 and NB-304) were conducted to evaluate the effect of naltrexone / bupropion in conjunction with lifestyle modification in 4,536 subjects randomised to naltrexone/bupropion or placebo.
NB-302, NB-303 i NB-304) su provedena kako bi se procijenio učinak naltrekson / bupropiona uz promjene stila života u 4536 ispitanika randomiziranih na naltrekson / bupropion ili placebo.
Renal impairment: A single-dosepharmacokinetic study has been conducted for naltrexone / bupropion in subjects with mild, moderate, and severe renal impairment, compared with subjects with normal renal function.
Oštećenje bubrega: Farmakokinetičko ispitivanje jedne doze provedeno je za naltrekson / bupropion u ispitanika s blagim, umjerenim i teškim oštećenjem bubrega, u usporedbi s ispitanicima s normalnom funkcijom bubrega.
PharmaSwiss Hellas A.E. Τηλ: 008001 612 2030 465
Τηλ: 008001 612 2030 465
In patients with moderate or severe renal impairment, the maximum recommended daily dose for naltrexone / bupropion is two tablets (one tablet in the morning and one tablet in the evening) (see sections 4.4, 4.8 and 5.2).
U bolesnika s umjerenim ili teškim oštećenjem bubrega, maksimalna preporučena dnevna doza naltreksona / bupropiona iznosi dvije tablete (jedna tableta ujutro i jedna tableta uvečer) (vidjeti dijelove 4.4, 4.8 i 5.2).
≥10% Weight
izgubilo ≥ 10 % tjelesne težine.
Rare side effects (may affect up to 1 in 1,000 people): - Low amount of certain white blood cells (Lymphocyte count decreased) - Decreased haematocrit (indicating loss of red blood cell volume) - Swelling of eyelids, face, lips, tongue or throat, which can cause great difficulty in breathing
Rijetke nuspojave (mogu se pojaviti u do 1 na 1000 osoba): - niska količina određenih bijelih krvnih stanica (smanjeni broj limfocita) - niski hematokrit (ukazuje na smanjenje volumena crvenih krvnih stanica)
Eye irritation, Eye pain or asthenopia, Eye swelling, Lacrimation increased, Photophobia, Vision blurred
Poremećaji oka nepoznato iritacija oka, bol u oku ili astenopija, oticanje oka, pojačano suzenje, fotofobija, zamagljen vid
Since monoamine oxidase A and B inhibitors also enhance the catecholaminergic pathways, by a different mechanism from bupropion, naltrexone / bupropion must not be used with MAOI (see section 4.3).
A i B također olakšavaju katekolaminergične puteve mehanizmom koji je različit od bupropionovog, naltrekson / bupropion se ne smije uzimati s MAOI
Full analysis set+
Komplet analize namjere liječenja+
Naltrexone/bupropion is not recommended in patients over 75 years of age.
Ne preporučuje se davati naltrekson/bupropion bolesnicima preko 75 godina starosti.
There is no clinical experience with overdose with combined use of bupropion and naltrexone.
Nema kliničkih iskustava o predoziranju s kombiniranom uporabom bupropiona i naltreksona.
Naltrexone / bupropion should not be used during breast-feeding.
Naltrekson / bupropion se ne smije koristiti tijekom dojenja.
HOMA-IR, % change + Based on LOCF with the last on-drug observation carried forward.
Na temelju LOCF sa zadnjim zapažanjem na lijeku prenesenim dalje.
When driving vehicles or using machines, it should be taken into account that dizziness, somnolence, loss of consciousness and seizure may occur during treatment.
Kad se upravlja vozilima ili se radi sa strojevima mora se uzeti u obzir da se tijekom liječenja može pojaviti omaglica,
Co-administration of medicinal products that may inhibit the metabolism of bupropion via CYP2B6 isoenzyme (e.g., CYP2B6 substrates: cyclophosphamide, ifosfamide, and CYP2B6 inhibitors: orphenadrine, ticlopidine, clopidogrel), may result in increased bupropion plasma levels and lower levels of active metabolite hydroxybupropion.
Istodobna primjena lijekova koji mogu inhibirati metabolizam bupropiona putem CYP2B6 izoenzima (npr. CYP2B6 supstrati: ciklofosfamid, ifosfamid i CYP2B6 inhibitori: orfenadrin, tiklopidin,
Naltrexone / bupropion is contraindicated in patients currently dependent on chronic opioid or opiate agonist therapy (e.g., methadone), or patients in acute opiate withdrawal (see section 4.3).
Naltrekson / bupropion je kontraindiciran u bolesnika trenutno ovisnih o kroničnoj terapiji opioidima ili agonistima opijata (npr. metadon), ili u bolesnika u akutnom ustezanju od opijata (vidjeti dio 4.3).
Improvements were observed for fasting glucose, fasting insulin, HOMA-IR and percent of subjects requiring rescue diabetes medicinal products for subjects treated with naltrexone / bupropion vs. placebo.
Poboljšanja su opažena za glukozu natašte, inzulin natašte, HOMA-IR i postotak ispitanika kojima je trebalo hitno liječenje dijabetesa lijekovima a koji su liječeni naltrekson / bupropionom naspram placeba.
• if you have diabetes for which you use insulin or oral medicines that may cause low sugar levels in your blood (hypoglycaemia); or
• ako imate dijabetes za koji koristite inzulin ili oralne lijekove koji mogu uzrokovati niske razine šećera u krvi (hipoglikemija); ili • ako uzimate lijekove koji mogu povećati rizik od napadaja (vidjeti „Drugi lijekovi i lijek
For patients with moderate or severe renal impairment, the maximum recommended daily dose for naltrexone / bupropion should be reduced (see section 4.2).
Za bolesnike s umjerenim ili teškim oštećenjem bubrega, maksimalnu preporučenu dnevnu dozu naltreksona / bupropiona potrebno je smanjiti (vidjeti dio 4.2).
Decreased appetite (N) Uncommon Anorexia (B), Blood glucose disturbances (B)
manje često anoreksija (B), poremećaji glukoze u krvi
Mysimba should not be used during pregnancy, or while breast-feeding.
Trudnoća i dojenje Lijek Mysimba se ne smije koristiti tijekom trudnoće ili dojenja.
Naltrexone / bupropion should be used cautiously in patients with a history of mania.
bupropion treba koristiti oprezno u bolesnika s manijom u anamnezi.
As expected, naltrexone / bupropion -treated subjects had a greater mean increase from baseline compared with placebo-treated subjects in percent of total body lean mass.
Kao što se očekivalo, ispitanici liječeni naltrekson / bupropionom su imali veću srednju vrijednost povećanja od početnih vrijednosti ukupne tjelesne bezmasne mase u usporedbi s ispitanicima koji su primali placebo.
Mean (95% CI)
LS srednja vrijednost (95% CI) % promjene od početne
No specific antidotes for combined use of bupropion and naltrexone are known.
Nisu poznati specifični antidoti kombinirane uporabe bupropiona i naltreksona.
Adverse reactions reported in subjects who received Naltrexone/Bupropion as a fixed-dose combination
Nuspojave prijavljene u ispitanika koji su primali naltrekson/bupropion, kao fiksnu kombinaciju MedDRA - klasifikacije organskih sustava
In patients with moderate or severe renal impairment, the maximum recommended daily dose for naltrexone / bupropion should be reduced, as these patients may have higher drug concentrations which could result in an increase in adverse drug reactions (see sections 4.2, 4.8, and 5.2).
U bolesnika s umjerenim ili teškim oštećenjem bubrega, maksimalnu preporučenu dnevnu dozu naltreksona / bupropiona potrebno je smanjiti jer ti bolesnici mogu imati povećane koncentracije lijeka što može dovesti do porasta nuspojava (vidjeti dijelove 4.2, 4.8 i 5.2).
Diarrhoea, Flatulence, Haemorrhoids , Ulcer
Učestalost Nuspojava (lijek*) nepoznato dijareja, flatulencija, hemoroidi, ulkus
Effects on glycaemic control in obese subjects with type 2 diabetes After 56 weeks of treatment in subjects with type 2 diabetes (NB-304), naltrexone / bupropion exhibited improvements in glycaemic control parameters compared to placebo (Table 5).
Nakon 56 tjedana liječenja u bolesnika s dijabetesom tipa 2 (NB-304), naltrekson / bupropion je pokazao poboljšanja parametara glikemijske kontrole u usporedbi s placebom (Tablica 5).
Mechanism of action and pharmacodynamic effects The exact neurochemical appetite suppressant effects of naltrexone / bupropion are not fully understood.
Točni neurokemijski učinci naltrekson / bupropiona na suzbijanje apetita nisu u potpunosti razjašnjeni.
Naltrexone and bupropion are well absorbed from the gastrointestinal tract (>90% absorbed), however, naltrexone has a significant first pass effect thereby limiting systemic bioavailablity, with only 5-6% reaching the systemic circulation intact.
međutim, naltrekson ima značajan učinak prvog prolaska čime se ograničava sistemska bioraspoloživost, sa samo 5-6 % u sistemskoj cirkulaciji u nepromijenjenom obliku.
For individuals who are at elevated risk for renal impairment, in particular patients with diabetes or elderly individuals, estimated glomerular filtration rate (eGFR) should be assessed prior to initiating therapy with naltrexone / bupropion.
Za osobe u kojih je rizik od oštećenja bubrega povećan, naročito u bolesnika s dijabetesom ili starijih osoba, procijenjena brzina glomerularne filtracije se mora utvrditi prije početka liječenja s naltrekson / bupropionom.
Do not cut, chew or crush.
Ne smijete rezati, žvakati, ili drobiti.
There have also been cases of elevated liver enzymes from post-marketing reporting.
Nakon stavljanja lijeka u promet, također su prijavljeni slučajevi povećanja razine jetrenih enzima.
How to take Mysimba
Kako uzimati lijek Mysimba
Hepatic impairment: A single-dose pharmacokinetic study has been conducted with naltrexone / bupropion in patients with hepatic impairment.
Oštećenje jetre: Provedena su farmakokinetička ispitivanja jedne doze naltreksona / bupropiona u bolesnika s oštećenjem jetre.
Cysteine Hydrochloride Microcrystalline Cellulose Hydroxypropyl Cellulose Magnesium Stearate
Jezgra tablete: cisteinklorid celuloza, mikrokristalična hidroksipropilceluloza magnezijev stearat laktoza, bezvodna laktoza hidrat krosprovidon vrste