FrancophonIA/ELRC3.0 huggingface dataset:
English: A risk management plan has been developed to ensure that Ofev is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Ofev je bil pripravljen načrt obvladovanja tveganj.
English: In patients who do not tolerate this dose, the dose should be reduced to 100 mg twice a day or treatment should be interrupted.
Slovenian: Pri bolnikih, ki tega odmerka ne prenašajo, je treba odmerek zmanjšati na 100 mg dvakrat dnevno ali pa prekiniti z zdravljenjem.
English: What benefits of Ofev have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Ofev izkazalo v študijah?
English: This is a summary of the European public assessment report (EPAR) for Ofev.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ofev.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Ofev can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Ofev je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: What is Ofev and what is it used for?
Slovenian: Kaj je zdravilo Ofev in za kaj se uporablja?
English: The recommended dose is 150 mg taken twice a day with food, approximately 12 hours apart.
Slovenian: Priporočeni odmerek je 150 mg dvakrat dnevno s hrano, med odmerkoma pa mora biti približno 12-urni presledek.
English: It is not intended to provide practical advice on how to use Ofev.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Regarding safety, the side effects associated with Ofev were considered manageable with dose interruptions or reductions.
Slovenian: Kar zadeva varnost, so bili neželeni učinki zdravila Ofev ocenjeni kot obvladljivi s prekinitvijo ali zmanjšanjem odmerkov.
English: These enzymes are present in certain receptors (such as VEGF, FGF and PDGF receptors) in cells in the lungs, where they activate several processes involved in the generation of fibrous tissue seen in IPF.
Slovenian: Ti encimi so prisotni v določenih receptorjih (kot so receptorji VEGF, FGF in PDGF) v celicah v pljučih, kjer aktivirajo več procesov, ki sodelujejo pri tvorbi fibroznega tkiva, kot ga opazimo pri idiopatski pljučni fibrozi.
English: Ofev must not be used in patients who are hypersensitive (allergic) to nintedanib, peanut or soya, or any of the other ingredients.
Slovenian: Zdravilo Ofev se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) nintedanib, arašide ali sojo ali katero koli drugo sestavino zdravila.
English: The most common side effects with Ofev (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), abdominal pain (stomach ache) and raised levels of liver enzymes in the blood (a sign of liver problems); vomiting, decreased appetite and weight loss are also common.
Slovenian: Najpogostejši neželeni učinki zdravila Ofev (ki lahko prizadenejo več kot 1 osebo od 10) so driska, navzeja (slabost), abdominalne bolečine (bolečine v predelu trebuha) in povišane ravni jetrnih encimov v krvi (znak težav z jetri).
English: Because the number of patients with IPF is low, the disease is considered ‘rare', and Ofev was designated an ‘orphan medicine' (a medicine used in rare diseases) on 26 April 2013.
Slovenian: Ker je bolnikov z idiopatsko pljučno fibrozo malo, velja ta bolezen za redko, zato je bilo zdravilo Ofev 26. aprila 2013 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: What are the risks associated with Ofev?
Slovenian: Kakšna tveganja so povezana z zdravilom Ofev?
English: Why is Ofev approved?
Slovenian: Zakaj je bilo zdravilo Ofev odobreno?
English: A further analysis of the results of the 2 main studies, which took into account that some patients stopped treatment, confirmed the benefits of Ofev over placebo, although the difference in FVC between the two was less pronounced.
Slovenian: Nadaljnja analiza rezultatov dveh glavnih študij, pri kateri so upoštevali dejstvo, da so nekateri bolniki prenehali z zdravljenjem, je potrdila koristi zdravila Ofev v primerjavi s placebom, čeprav je bila razlika v FVC med njima manj izrazita.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ofev, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Ofev in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: In both studies, the main measure of effectiveness was the decline in the functioning of the patients' lungs over the course of 1 year of treatment, measured by their forced vital capacity (FVC).
Slovenian: Glavno merilo učinkovitosti v obeh študijah je bilo poslabšanje delovanja pljuč pri bolnikih v enem letu zdravljenja, kar so merili z njihovo forsirano vitalno kapaciteto (FVC).
English: By blocking these enzymes, nintedanib helps to reduce the formation of fibrous tissue in the lungs, thereby helping to prevent the symptoms of IPF from getting worse.
Slovenian: Z zaviranjem teh encimov nintedanib pomaga zmanjšati tvorbo fibroznega tkiva v pljučih in tako pomaga preprečiti slabšanje simptomov idiopatske pljučne fibroze.
English: The full EPAR and risk management plan summary for Ofev can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Ofev sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Ofev is a medicine used to treat adults with idiopathic pulmonary fibrosis (IPF).
Slovenian: Zdravilo Ofev se uporablja za zdravljenje odraslih z idiopatsko pljučno fibrozo (IPF).
English: Ofev has been compared with placebo (a dummy treatment) in two main studies involving a total of 1,066 patients with IPF.
Slovenian: Zdravilo Ofev so primerjali s placebom (zdravilom brez zdravilne učinkovine) v dveh glavnih študijah, v katerih je sodelovalo skupno 1 066 bolnikov z idiopatsko pljučno fibrozo.
English: For more information about treatment with Ofev, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Ofev preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The active substance in Ofev, nintedanib, blocks the activity of some enzymes known as tyrosine kinases.
Slovenian: Zdravilna učinkovina zdravila Ofev, nintedanib, zavira delovanje določenih encimov, imenovanih tirozin kinaze.
English: In the second study, the average decrease was 114 ml for Ofev compared with 207 ml for placebo.
Slovenian: V drugi študiji je povprečno zmanjšanje pri zdravilu Ofev znašalo 114 ml, pri placebu pa 207 ml.
English: IPF is a long-term disease in which hard fibrous tissue continuously forms in the lungs, causing persistent cough and severe shortness of breath.
Slovenian: Idiopatska pljučna fibroza je dolgotrajna bolezen, pri kateri se v pljučih neprestano tvori trdo fibrozno tkivo, ki povzroča stalen kašelj in hudo zasoplost.
English: For practical information about using Ofev, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Ofev naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The CHMP considered that Ofev has been shown to be effective at slowing down the worsening of lung function in patients with IPF.
Slovenian: CHMP je menil, da je bilo dokazano, da je zdravilo Ofev učinkovito pri upočasnjevanju slabšanja delovanja pljuč pri bolnikih z idiopatsko pljučno fibrozo.
English: In both studies, patients taking Ofev had a smaller decline in FVC than patients taking placebo, meaning that Ofev slowed down the worsening of the condition.
Slovenian: V obeh študijah se je pri bolnikih, ki so prejemali zdravilo Ofev, FVC zmanjšala manj kot pri bolnikih, ki so prejemali placebo, kar pomeni, da je zdravilo Ofev upočasnilo slabšanje bolezni.
English: In the first study, the average decrease in FVC over 1 year was 115 ml in patients taking Ofev compared with a decrease of 240 ml in patients taking placebo.
Slovenian: V prvi študiji se je FVC pri bolnikih, ki so jemali zdravilo Ofev, v enem letu zmanjšala za povprečno 115 ml v primerjavi z 240 ml pri bolnikih, ki so jemali placebo.
English: Ofev can only be obtained with a prescription, and treatment should be started by a doctor experienced in the diagnosis and treatment of IPF.
Slovenian: Izdaja zdravila Ofev je le na recept, zdravljenje pa mora uvesti zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem idiopatske pljučne fibroze.
English: FVC is the maximum amount of air the patient can breathe out forcefully after taking in a deep breath and this decreases as the condition gets worse.
Slovenian: FVC je maksimalna količina zraka, ki jo bolnik lahko na silo izdihne po globokem vdihu.
English: How does Ofev work?
Slovenian: Kako zdravilo Ofev deluje?
English: For the full list of all side effects reported with Ofev, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ofev, glejte navodilo za uporabo.
English: Ofev contains the active substance nintedanib.
Slovenian: Zdravilo Ofev vsebuje zdravilno učinkovino nintedanib.
English: How is Ofev used?
Slovenian: Kako se zdravilo Ofev uporablja?
English: Very rare, not known
Slovenian: Zelo redki, neznana
English: You should take your medicine at the same time each day.
Slovenian: Zdravilo morate jemati vsak dan ob istem času.
English: • low blood sugar
Slovenian: • nizek krvni sladkor,
English: The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%.
Slovenian: Absolutno tveganje za kardiovaskularne malformacije se je povečalo z manj kot 1 % na približno 1,5 %.
English: • worsening of food allergies.
Slovenian: • poslabšanje alergij na hrano.
English: Pliva Croatia Ltd Prilaz baruna Filipovica 25 10 000 Zagreb Croatia
Slovenian: Pliva Croatia Ltd Prilaz baruna Filipovica 25 10 000 Zagreb Hrvaška
English: • Third trimester of pregnancy (see section 4.6).
Slovenian: • tretje tromesečje nosečnosti (glejte poglavje 4.6).
English: The tablets have a length of 14.0 mm and a width of 6.8 mm.
Slovenian: Tablete so dolge 14,0 mm in široke 6,8 mm.
English: • If you are in your last trimester of pregnancy
Slovenian: • če ste v zadnjem tromesečju nosečnosti.
English: • In children under 18 years of age, there is a possible association between ASA and Reye's syndrome.
Slovenian: • Pri otrocih, mlajših od 18 let, je možna povezava med ASA in Reyevim sindromom.
English: Do not use this medicine if you notice any visible signs of deterioration
Slovenian: Ne uporabljajte tega zdravila, če opazite vidne znake kvarjenja.
English: • Adults and elderly population
Slovenian: • Odrasli in starejši
English: • breathing difficulties sometimes associated with cough
Slovenian: • težave pri dihanju, ki so včasih povezane s kašljem,
English: • the mother and the neonate, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which may occur even
Slovenian: • mater in novorojenčka ob koncu nosečnosti: - možnemu podaljšanju časa krvavitve, antiagregacijskemu učinku, ki se lahko pojavi celo
English: From the beginning of the sixth month of pregnancy, all prostaglandin synthesis inhibitors may expose:
Slovenian: Od začetka šestega meseca nosečnosti lahko vsi zaviralci sinteze prostaglandinov izpostavijo:
English: The patient population included 19.7% women and 29.2% patients ≥65 years.
Slovenian: Populacijo bolnikov je sestavljalo 19,7 % žensk in 29,2 % bolnikov starosti ≥ 65 let.
English: At low concentrations (<100 micrograms/ml), approximately 90% of salicylic acid is bound to albumin.
Slovenian: Pri nizkih koncentracijah (< 100 mikrogramov/ml) je približno 90 % salicilne kisline vezane na albumin.
English: Following toxic doses (10-20 g), the plasma half-life may be increased to over 20 hours.
Slovenian: Po toksičnih odmerkih (10 do 20 g) se lahko razpolovni čas v plazmi podaljša na več kot 20 ur.
English: 74770 Opava-Komarov Czech Republic
Slovenian: 305 74770 Opava-Komarov Češka
English: Therefore, such addition should be undertaken with caution outside of clinical situations where the combination has proven to be beneficial.
Slovenian: Zato je potrebna previdnost pri tovrstni uporabi izven kliničnih stanj, pri katerih se je kombinacija izkazala za učinkovito.
English: If you have had a heart attack, it should be prescribed for at least four weeks.
Slovenian: Če ste imeli srčno kap morate zdravilo jemati najmanj štiri tedne.
English: An occasional use of ASA (no more than 1,000 mg in any 24-hour period) should generally not cause a problem, but prolonged use of ASA in other circumstances should be discussed with your doctor or pharmacist.
Slovenian: Občasna uporaba ASA (ne več kot 1.000 mg v 24 urah) praviloma ne bi smela povzročati težav, toda o dolgotrajnejši uporabi ASA v drugih okoliščinah se morate posvetovati z zdravnikom ali farmacevtom.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/.
English: Given that children, infants and toddlers are often only seen at a late stage of intoxication, they will usually have already reached the acidosis stage.
Slovenian: glede na to, da dojenčki in mali otroci pogosto do zdravnika pridejo šele v pozni fazi zastrupitve, so običajno že v fazi acidoze.
English: It is preferable not to take this product during first and second trimesters of pregnancy.
Slovenian: Bolje je, da tega zdravila ne jemljete v prvem in drugem tromesečju nosečnosti.
English: Bleeding is the most common reaction reported both in clinical studies as well as in the post-marketing experience where it was mostly reported during the first month of treatment.
Slovenian: Krvavitev je najpogostejši učinek o katerih so poročali v kliničnih študijah, kot tudi v obdobju postmarketinške uporabe, kjer so o tem poročali predvsem v prvem mesecu zdravljenja.
English: In addition, your doctor may identify changes in your blood or urine tests.
Slovenian: Poleg tega lahko zdravnik ugotovi tudi spremembe v izvidih preiskav krvi ali urina.
English: Side effects with unknown frequency (frequency cannot be estimated from the available data):
Slovenian: Možni neželeni učinki, katerih pogostnost ni znana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
English: • decrease in blood pressure
Slovenian: • znižanje krvnega tlaka,
English: This was associated with a reduction of the mean inhibition of platelet aggregation by 15% and 11%, respectively.
Slovenian: To je bilo povezano z zmanjšanjem zavrtja agregacije trombocitov za 15 % in 11 %.
English: A patient with poor metaboliser status will possess two loss-of-function alleles as defined above.
Slovenian: Bolnik, ki ima slab presnovni status, bo imel dva hipofunkcijska alela, kot je pojasnjeno zgoraj.
English: Patients should be followed carefully for any signs of bleeding including occult bleeding, especially during the first weeks of treatment and/or after invasive cardiac procedures or surgery.
Slovenian: Bolnike je treba skrbno spremljati zaradi znakov krvavitve, vključno z okultno krvavitvijo, zlasti med prvimi tedni zdravljenja in/ali po invazivnih kardioloških postopkih ali kirurških posegih.
English: • You should tell your doctor if a surgery (including dental) is planned.
Slovenian: • obvestite svojega zdravnika: če imate predvideno kakšno operacijo (vključno z zobozdravstvenim posegom).
English: Consequently, a direct effect (slight toxicity), or an indirect effect (low palatability) cannot be excluded.
Slovenian: Posledično ni mogoče izključiti neposrednega učinka (blaga toksičnost) ali posrednega učinka (neprijeten okus).
English: TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
Slovenian: TTP je lahko usodna in zahteva takojšnje zdravljenje vključno s plazmaferezo.
English: In addition, due to the presence of ASA, its use is also contraindicated in:
Slovenian: Poleg tega je zaradi vsebnosti ASA uporaba kontraindicirana tudi:
English: From literature, limited data in Asian populations are available to assess the clinical implication of genotyping of this CYP on clinical outcome events.
Slovenian: V literaturi je za azijske populacije na voljo omejena količina podatkov, da bi lahko ocenili klinične posledice genotipizacije tega CYP za dogodke kliničnega izida.
English: Interactions with the following medicinal products have been reported with ASA:
Slovenian: Poročali so o interakcijah med ASA in sledečimi zdravili:
English: The results obtained in populations with different characteristics (e.g. unstable angina or non-Q-wave MI, low to high risk levels, diabetes, need for revascularisation, age, gender, etc.) were consistent with the results of the primary analysis.
Slovenian: Rezultati, pridobljeni pri populacijah z različnimi karakteristikami (npr. nestabilna angina, MI brez Q zobca, visoka do nizka raven tveganja, diabetes, potreba po revaskularizaciji, spol, starost, itd), so bili skladni z rezultati primarne analize.
English: Although no formal carcinogenicity studies have been performed with ASA, it has been shown that it is not a tumour promoter.
Slovenian: Čeprav formalnih študij kancerogenosti z ASA ni bilo, je dokazano, da snov ni promotor tumorjev.
English: There is insufficient clinical experience regarding the use of doses above 100 mg/day up to 500 mg/day.
Slovenian: Ni zadostnih kliničnih izkušenj z uporabo odmerkov nad 100 mg/dan in do 500 mg/dan.
English: After first opening bottle: 30 days
Slovenian: Po prvem odprtju plastenke: 30 dni.
English: In addition to clinical studies experience, adverse reactions have been spontaneously reported.
Slovenian: Poleg kliničnih študij, so o neželenih učinkih poročali tudi spontano.
English: If you have been told by your doctor to stop treatment temporarily, ask your doctor when to restart the treatment.
Slovenian: Če vam je zdravnik naročil, da zdravilo nehajte jemati začasno, ga vprašajte, kdaj naj z zdravljenjem ponovno nadaljujete.
English: These may be due to rare decrease of some blood
Slovenian: To so lahko znaki redkega zmanjšanja števila določenih krvnih celic.
English: In COMMIT, the overall rate of noncerebral major bleeding or cerebral bleeding was low and similar in both groups.
Slovenian: V študiji COMMIT je bil celokupni delež večjih necerebralnih krvavitev ali cerebralnih krvavitev nizek in podoben v obeh skupinah.
English: Clinical studies indicate that doses up to 100 mg/day for restricted obstetrical use, which require specialised monitoring, appear safe.
Slovenian: Klinične študije kažejo, da so odmerki do 100 mg/dan pri restriktivni obstetrični rabi, ki zahteva poseben nadzor, varni.
English: Their frequency is defined using the following conventions: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Njihova pogostnost je navedena upoštevaje naslednji dogovor: pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
English: - In patients with ST segment elevation acute myocardial infarction: Therapy should be started as early as possible after symptoms start and continued for at least four weeks.
Slovenian: - Pri bolnikih z akutnim miokardnim infarktom z elevacijo ST spojnice: zdravljenje je potrebno začeti čim prej po nastopu simptomov in z njim nadaljevati vsaj štiri tedne.
English: • If you are allergic to clopidogrel, acetylsalicylic acid (ASA) or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na klopidogrel, acetilsalicilno kislino (ASA) ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
English: With severe intoxication, serious disturbances of the acid-base equilibrium occur.
Slovenian: Pri hudi zastrupitvi se pojavijo resne motnje acido-baznega ravnotežja.
English: • severe abdominal pain with or without back pain
Slovenian: • huda bolečina v trebuhu z ali brez bolečine v hrbtu,
English: The incidence of severe cases was similar for clopidogrel and ASA.
Slovenian: Incidenca hujših primerov je bila podobna za klopidogrel in ASA.
English: If acetylsalicylic acid is used by a woman attempting to conceive, or until the 24th amenorrhea week (5th month of pregnancy), the dose should be kept as low and duration of treatment as short as possible.
Slovenian: Če acetilsalicilno kislino uporablja ženska, ki poskuša zanositi, ali do 24. tedna amenoreje (5. mesec nosečnosti), mora biti odmerek čim manjši, zdravljenje pa čim krajše.
English: Uricosurics (benzbromarone, probenecid, sulfinpyrazone)
Slovenian: Urikozuriki (benzbromaron, probenecid, sulfinpirazon)
English: It is unknown whether ASA alters fertility.
Slovenian: Ni znano, če ASA vpliva na plodnost.
English: • generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting)
Slovenian: • splošne alergijske reakcije (na primer, splošni občutek toplote z nenadnim nelagodjem do nezavesti),
English: The influence of CYP2C19 genotype on clinical outcomes in patients treated with clopidogrel has not been evaluated in prospective, randomised, controlled trials.
Slovenian: Vpliv genotipa CYP2C19 na klinične izide pri bolnikih, zdravljenih s klopidogrelom, ni bil ocenjen v prospektivnih, randomiziranih, kontroliranih raziskavah.
English: Haemodialysis is the preferred treatment for severe intoxication.
Slovenian: Hemodializa je izbrani način zdravljenja hude zastrupitve.
English: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary
Slovenian: - kardiopulmonalnim toksičnim učinkom (s prezgodnjim zaprtjem arterioznega duktusa in
English: The European Medicines Agency has waived the obligation to submit the results of studies with the combination of clopidogrel/acetylsalicylic acid in all subsets of the paediatric population in the treatment of coronary atherosclerosis (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od obveznosti po predložitvi rezultatov študij kombinacije klopidogrela/acetilsalicilne kisline pri vseh podskupinah pediatrične populacije za zdravljenje koronarne ateroskleroze (glejte poglavje 4.2 za informacije o pediatrični uporabi).
English: Thus, the results from this subset are in line with the overall trial results.
Slovenian: Pri tej podskupini bolnikov so rezultati v skladu s celotnimi rezultati študije.
English: In poor metabolisers, active metabolite exposure was decreased by 63-71% compared to extensive metabolisers.
Slovenian: Pri slabih metabolizatorjih je bila izpostavljenost aktivnemu presnovku za 63 do 71 % manjša kot pri obsežnih metabolizatorjih.
English: The combination of clopidogrel/acetylsalicylic acid should not be used during the first two trimesters of pregnancy unless the clinical condition of the woman requires treatment with clopidogrel/ASA.
Slovenian: Kombinacije klopidogrela/acetilsalicilne kisline se ne sme uporabljati v prvih dveh tromesečjih nosečnosti, razen če klinično stanje nosečnice ne zahteva terapije s klopidogrelom/ASA.
English: Patients should be told about the signs and symptoms of GI undesirable effects and what steps to take if they occur (see section 4.8).
Slovenian: Bolnike je treba seznaniti z znaki in simptomi neželenih gastrointestinalnih učinkov ter kako naj ukrepajo, če se le-ti pojavijo (glejte poglavje 4.8).