natgillin/translations-raw huggingface dataset:
A multicenter, randomized, double-blind, placebo-controlled 32-week study to assess the effects of withdrawal of laropiprant showed that dyslipidaemic patients in whom laropiprant was withdrawn after 20 weeks on Trevaclyn experienced significantly more flushing than patients who continued taking Trevaclyn in terms of number of days per week with moderate or greater flushing, p< 0.001, Figure 2. 
Multicentrična, randomizirana, dvojno slepa, s placebom nadzorovana 32-tedenska študija za oceno učinka prenehanja jemanja laropipranta je pokazala, da je bilo pri bolnikih z dislipidemijo, ki so po 20 tednih zdravljenja z zdravilom Trevaclyn prenehali jemati laropiprant, bistveno več zardevanja kot pri bolnikih, ki so nadaljevali z jemanjem zdravila Trevaclyn, kar je bilo izraženo s številom dni v tednu z zmernim ali izrazitejšim zardevanjem, p < 0,001, Slika 2.
Further analysis showed Trevaclyn (2000 mg/40 mg) co-administered with simvastatin when compared with simvastatin alone significantly increased apo A-I (8.6 %, 2.3 % respectively) and significantly decreased Lp(a) (-19.8 %, 0.0 % respectively ). 
Kot je pokazala nadaljnja analiza, je sočasno s simvastatinom uporabljen Trevaclyn 2.000 mg/40 mg v primerjavi s samim simvastatinom bistveno zvišal apo A-I (8,6 % oz. 2,3 %) in bistveno znižal Lp(a) (-19,8 % oz. 0,0 %).
In healthy subjects receiving Trevaclyn, pretreatment with acetylsalicylic acid 325 mg had no additional beneficial effects in reducing nicotinic acid-induced flushing symptoms compared to Trevaclyn alone (see section 4.8). 
Pri zdravih preiskovancih, ki so dobivali zdravilo Trevaclyn, predhodna uporaba 325 mg acetilsalicilne kisline ni dodatno ublažila simptomov zardevanja zaradi nikotinske kisline v primerjavi s samim zdravilom Trevaclyn (glejte poglavje 4.8).
▲ Trevaclyn  nicotinic acid (laropiprant withdrawn at Week 21) 
● Trevaclyn ▲ Trevaclyn Æ nikotinska kislina (ukinitev laropipranta v 21. tednu) ○ Placebo
This is characterised by multiple symptoms that may include: angio-oedema, pruritus, erythema, paraesthesia, loss of consciousness, vomiting, urticaria, flushing, dyspnoea, nausea, incontinence of urine and stool, cold sweats, shivering, chills, increased blood pressure, lip swelling, burning sensation, drug eruption, arthralgia, leg swelling, and tachycardia. 
Poročali so o (< 1 %) očitni preobčutljivostni reakciji, za katero so značilni različni simptomi, ki lahko vključujejo: angioedem, srbenje, eritem, parestezije, izgubo zavesti, bruhanje, urtikarijo, zardevanje, dispnejo, navzeo, inkontinenco urina in blata, hladno znojenje, drgetanje, mrzlico, zvišan krvni tlak, otekanje ustnic, pekoč občutek, medikamentozen izpuščaj, artralgijo, otekanje nog in tahikardijo.
• you are allergic to nicotinic acid, to laropiprant, or to any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na nikotinsko kislino, laropiprant ali katerokoli sestavino tega zdravila
In a pool of four active- or placebo-controlled clinical trials (N=4,747, n=2,548 taking Trevaclyn), flushing was reported in 12.3 % of patients taking Trevaclyn. 
V štirih z učinkovino ali s placebom kontroliranih kliničnih preskušanjih (N = 4.747, n = 2.548 jih je jemalo zdravilo Trevaclyn) so raziskovalci o zardevanju poročali kot o možno, verjetno ali zagotovo z zdravilom povezanem neželenem učinku pri 12,3 % bolnikov, ki so jemali Trevaclyn.
Caution should be used when Trevaclyn is co-administered with medicinal products metabolised predominantly by UGT2B4 or UGT2B7, for instance zidovudine. 
Previdnost je potrebna, če zdravilo Trevaclyn uporabljate hkrati z zdravili, ki se presnavljajo predvsem z UGT2B4 ali UGT2B7, kot je zidovudin.
What Trevaclyn looks like and contents of the pack Each modified-release tablet is a capsule-shaped, white to off-white tablet, with “552” debossed on one side. 
Izgled zdravila Trevaclyn in vsebina pakiranja Tablete s prirejenim sproščanjem so v obliki kapsul, bele do kremaste barve in imajo na eni strani vtisnjeno oznako "552".
There is no difference in the oral bioavailability of nicotinic acid in men and women receiving Trevaclyn. 
Biološka uporabnost peroralne nikotinske kisline se med moškimi in ženskami, ki so dobivali zdravilo Trevaclyn, ni razlikovala.
Trevaclyn should be used in patients in combination with HMG-CoA reductase inhibitors (statins), when the cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate. 
Zdravilo Trevaclyn je treba uporabljati v kombinaciji z zaviralci reduktaze HMG-CoA (statini), če monoterapija z zaviralcem reduktaze HMG-CoA holesterola ne zniža v zadostni meri.
• See your doctor regularly to check your LDL (bad) and HDL (good) cholesterol levels and your triglyceride level. 
• Redno obiskujte zdravnika, da boste preverili raven LDL holesterola (slabi holesterol), HDL holesterola (dobri holesterol) in trigliceridov.
• Your doctor should do a blood test before you start taking Trevaclyn to check how well your liver is working. 
• Pred začetkom uporabe zdravila Trevaclyn vas mora zdravnik poslati na preiskavo krvi, da bo preveril delovanje vaših jeter.
• If you are switching from a medicine containing 2,000 mg or more of a prolonged-release nicotinic acid, your doctor can start you with two tablets of Trevaclyn a day. 
• Če prehajate z zdravila, ki vsebuje 2.000 mg nikotinske kisline s podaljšanim sproščanjem ali več, vam zdravnik lahko predpiše, da začnete jemati dve tableti zdravila Trevaclyn na dan.
The no-observed-adverse-effect level (NOAEL) was at least 118 times the human exposure based on the AUC of the recommended daily human dose. 
Raven brez ugotovljenih neželenih učinkov (NOAEL) je bila vsaj 118-krat tolikšna, kot je (na podlagi AUC) izpostavljenost med uporabo priporočenega dnevnega odmerka pri človeku.
Following a 2,000 mg dose of nicotinic acid administered orally as two modified-release tablets of nicotinic acid/laropiprant with food, nicotinic acid was absorbed with a median time to peak plasma concentration (Tmax) of 4 hours, a mean area under the plasma concentration-time curve (AUC0-last) of approximately 58.0 μM·hr and a mean peak plasma concentration (Cmax) of approximately 20.2 μM. 
Po peroralni uporabi 2.000 mg nikotinske kisline v obliki dveh tablet nikotinske kisline/laropipranta s prirejenim sproščanjem, zaužitih s hrano, je bila mediana časa do največje koncentracije nikotinske kisline v plazmi (tmax) 4 ure, povprečna površina pod krivuljo plazemske koncentracije v odvisnoti od časa (AUC0-last) približno 58,0 µM·h in povprečna največja koncentracija v plazmi (Cmax) približno 20,2 µM.
Trevaclyn: Use in patients with renal insufficiency has not been studied. 
Trevaclyn: Uporaba pri bolnikih z ledvično insuficienco ni raziskana.
• tingling or numbness of the hands or feet 
• mravljinčenje in omrtvelost dlani ali stopal
Aluminium/Aluminium blister with push-through lidding containing 7 modified-release tablets. 
Aluminijsko/aluminijski pretisni omot s prekritjem, skozi katerega se potisne tableta; omot vsebuje 7 tablet s prirejenim sproščanjem.
If you are switching from a medicine with less than 2,000 mg of prolonged-nicotinic acid, you should start by taking one tablet of Trevaclyn a day. 
Če prehajate z zdravila, ki vsebuje manj kot 2.000 mg nikotinske kisline s podaljšanim sproščanjem, morate na začetku jemati po eno tableto zdravila Trevaclyn na dan.
Nicotinic acid Nicotinic acid is excreted in human breast milk. 
Nikotinska kislina Nikotinska kislina se izloča v materino mleko.
Common: elevations in ALT and/or AST (consecutive, ≥ 3 X ULN), fasting glucose (see below) Uncommon: elevations in CK (≥ 10 X ULN), LDH, uric acid (see 
Laboratorijski izvidi zvišanje ALT in/ali AST (zaporedno, ≥ 3 x ZMN), glukoze na tešče, sečne kisline (glejte spodaj)
Laropiprant is metabolised primarily via acyl glucuronidation, with a smaller component of oxidative metabolism, followed by excretion of the glucuronide into faeces (via bile) and urine. 
Laropiprant se presnovi predvsem z acilglukuronidacijo, z manjšim deležem oksidativne presnove; temu sledi izločanje glukuronida v blatu (z žolčem) in urinu.
Trevaclyn (2000 mg/40 mg) co-administered with simvastatin when compared with simvastatin alone or Trevaclyn (2000 mg/40 mg) alone for 12 weeks, significantly lowered LDL-C (-47.9 %, -37.0 %, -17.0 % respectively), TG (-33.3 %, -14.7 %, -21.6 % respectively), apo B (-41.0 %, -28.8 %, -17.1 % respectively), and TC (-29.6 %, -24.9 %, -9.1 % respectively), as well as LDL-C:HDL-C (-57.1 %, -39.8 %, -31.2 % respectively), non-HDL-C (-45.8 %, -33.4 %, -18.1 % respectively), and TC:HDL-C (-43.0 %, -28.0 %, -24.9 % respectively), and significantly increased HDL-C (27.5 %, 6.0 %, 23.4 % respectively). 
Trevaclyn 2.000 mg/40 mg, uporabljen sočasno s simvastatinom, je v primerjavi s samim simvastatinom ali samim zdravilom Trevaclyn 2.000 mg/40 mg v 12 tednih bistveno znižal hLDL (-47,9 % oz. -37,0 % oz. -17,0 %), trigliceride (-33,3 % oz. -14,7 % oz. -21,6 %), apo B (-41,0 % oz. -28,8 % oz. -17,1 %) in Ch (-29,6 % oz. -24,9 % oz. -9,1 %) kot tudi razmerje hLDL:hHDL (-57,1 % oz. -39,8 % oz. -31,2 %), ne-HDL-holesterol (-45,8 % oz. -33,4 % oz. -18,1 %) in razmerje Ch:hHDL (-43,0 % oz. -28,0 % oz. -24,9 %) ter bistveno zvišal hHDL (27,5 % oz. 6,0 % oz. 23,4 %).
Do not take Trevaclyn if 
Ne jemljite zdravila Trevaclyn:
In a multicentre, double-blind, 12-week factorial study, Trevaclyn 1,000 mg/20 mg co-administered with simvastatin, when compared with simvastatin alone or Trevaclyn 1,000 mg/20 mg alone, for 4 weeks, significantly lowered LDL-C (-44.2 %, -37.4 %, -8.2 % respectively), TG (-25.8 %, -15.7 %, -18.7 % respectively), TC (-27.9 %, -25.8 %, -4.9 % respectively) and significantly increased HDL-C (19.2 %, 4.2 %, 12.5 % respectively). 
V multicentrični, dvojno slepi 12-tedenski faktorski študiji je 4-tedenska uporaba zdravila Trevaclyn 1.000 mg/20 mg skupaj s simvastatinom v primerjavi s simvastatinom samim oz. z zdravilom Trevaclyn 1.000 mg/20 mg samim bistveno znižala hLDL (-44,2 %, -37,4 % oz. -8,2 %), trigliceride (-25,8 %, -15,7 % oz. -18,7 %), Ch (-27,9 %, -25,8 % oz. -4,9 %) in bistveno zvišala hHDL (19,2 %, 4,2 % oz. 12,5 %).
Capsule-shaped, white to off-white tablet, with “552” debossed on one side. 
FARMACEVTSKA OBLIKA tableta s prirejenim sproščanjem tablete v obliki kapsule in bele do kremaste barve z vtisnjeno oznako "552" na eni strani
Trevaclyn was consistently efficacious across all prespecified patient subpopulations defined by race, gender, baseline LDL-C, HDL-C and TG levels, age and diabetes status. 
Trevaclyn je bil enako učinkovit v vseh skupinah populacije bolnikov, ne glede na raso, spol, izhodiščno koncentracijo hLDL, hHDL in trigliceridov, ali glede na starost, pa tudi v skupini sladkornih bolnikov.
If muscle pain, weakness or cramps occur while a patient is receiving Trevaclyn with a statin, their CK levels should be measured. 
Če se med jemanjem zdravila Trevaclyn skupaj s statinom pojavijo bolečine v mišicah, oslabelost mišic ali mišični krči, je treba bolniku izmeriti raven CK.
In controlled clinical studies, the incidence of clinically important elevations in serum transaminases (ALT and/or AST ≥ 3 X ULN, consecutive) was 1.0 % for patients treated with Trevaclyn with or without a statin. 
V kontroliranih kliničnih študijah je bila pri bolnikih, ki so prejemali zdravilo Trevaclyn (s statinom ali brez njega), incidenca klinično pomembnih zvišanj serumskih transaminaz (ALT in/ali AST ≥ 3 x ZMN, zaporedno) 1,0 %.
Each tablet contains 1000 mg nicotinic acid and 20 mg laropiprant. 
Vsaka tableta vsebuje 1000 mg nikotinske kisline in 20 mg laropipranta.
Trevaclyn 1,000 mg/20 mg modified-release tablets nicotinic acid/laropiprant 
Trevaclyn 1.000 mg/20 mg tablete s prirejenim sproščanjem nikotinska kislina/laropiprant
Laropiprant is eliminated primarily via acyl glucuronidation, followed by excretion of the glucuronide in faeces (via bile) and urine. 
Laropiprant se odstrani predvsem z acilglukuronidacijo, sledi pa izločanje glukuronida v blatu (z žolčem) in urinu.
Hepatic insufficiency Trevaclyn: Use in patients with hepatic insufficiency has not been studied. 
Jetrna insuficienca Trevaclyn: Uporaba pri bolnikih z jetrno insuficienco ni raziskana.
Multi-pack containing 196 (2 packs of 98) modified-release tablets 49 x 1 modified-release tablets 
Multi pakiranje po 196 (2 pakiranji po 98) tablet s prirejenim sproščanjem 49 x 1 tableta s prirejenim sproščanjem
How Trevaclyn Works 
Kako deluje zdravilo Trevaclyn
• nicotinic acid, a lipid modifying medicine, and 
• nikotinsko kislino, ki je zdravilo z vplivom na maščobe (lipide) in
The incidence and frequency of moderate or greater flushing in patients treated with Trevaclyn for the duration of the study decreased. 
Pri bolnikih, zdravljenih z zdravilom Trevaclyn, sta se pojavnost in pogostnost zmernega ali izrazitejšega zardevanja v času študije zmanjšali.
Physicians should consider the nicotinic acid intake from vitamins and nutritional supplements when prescribing Trevaclyn. 
Pri predpisovanju zdravila Trevaclyn morate upoštevati vnos nikotinske kisline z vitamini in prehranskimi dopolnili.
No studies in lactating animals have been conducted with Trevaclyn. 
Na doječih živalih študije z zdravilom Trevaclyn niso bile izvedene.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (for Alu/Alu blister) 
PODATKI NA ZUNANJI OVOJNINI Škatla (z Alu/alu pretisnimi omoti)
How to take Trevaclyn 
Kako jemati zdravilo Trevaclyn
Therefore, caution should be used when treating Chinese patients with Trevaclyn co-administered with simvastatin or ezetimibe/simvastatin (particularly simvastatin doses of 40 mg or higher). 
Zato je pri zdravljenju kitajskih bolnikov, ki jemljejo zdravilo Trevaclyn skupaj s simvastatinom ali z ezetimibom/simvastatinom (zlasti pri odmerkih simvastatina 40 mg ali več) potrebna previdnost.
In patients continuing in the first study (24 weeks), the frequency of moderate or greater flushing in patients treated with Trevaclyn declined and approached that of patients receiving placebo (see Figure 1), whereas in patients treated with nicotinic acid (prolonged-release formulation) the flushing frequency remained constant (after Week 6). 
Med bolniki, ki so nadaljevali sodelovanje v prvi študiji (24 tednov), se je pogostnost zmernega ali izrazitejšega zardevanja med tistimi, ki so prejemali zdravilo Trevaclyn, zmanjšala in se je približala tisti pri bolnikih, ki so dobivali placebo (glejte sliko 1).
14 modified-release tablets 28 modified-release tablets 56 modified-release tablets 168 modified-release tablets 32 x 1modified-release tablets 
14 tablet s prirejenim sproščanjem 28 tablet s prirejenim sproščanjem 56 tablet s prirejenim sproščanjem 168 tablet s prirejenim sproščanjem 32 x 1 tableta s prirejenim sproščanjem
As with other nicotinic acid medicinal products, elevations in fasting glucose (a median increase of approximately 4 mg/dL), and uric acid (mean change from baseline of +14.7 %), and reductions in platelet counts (a mean change from baseline of -14.0 %) were reported in controlled clinical studies with Trevaclyn (2,000 mg/40 mg) (see section 4.4). 
Tako kot pri drugih zdravilih z nikotinsko kislino so v kontroliranih kliničnih študijah z zdravilom Trevaclyn (2.000 mg/40 mg) poročali o zvišanju glukoze na tešče (mediana vrednost zvišanja je bila približno 4 mg/dl) in sečne kisline (povprečna sprememba glede na izhodišče +14,7 %) ter zmanjšanju števila trombocitov (povprečna sprememba glede na izhodišče -14,0 %) (glejte poglavje 4.4).
Because the risk of myopathy with statins is dose-related, the use of Trevaclyn with simvastatin 80 mg or ezetimibe/simvastatin 10/80 mg is not recommended in Chinese patients. 
Ker je tveganje za miopatijo pri statinih odvisno od odmerka, pri kitajskih bolnikih ne priporočamo uporabe zdravila Trevaclyn skupaj s simvastatinom 80 mg ali z ezetimibom/simvastatinom 10/80 mg. Ni znano, ali je tveganje za miopatijo povečano tudi pri drugih azijskih bolnikih, zdravljenih z zdravilom Trevaclyn in s simvastatinom ali z ezetimibom/simvastatinom.
●Trevaclyn (1000 mg/20 mg to 2000 mg/40 mg at week 5) ▲Nicotinic acid (prolonged-release 1000 mg to 2000 mg at week 5) 
● Trevaclyn (1.000 mg/20 mg do 2.000 mg/40 mg 5. teden) ▲Nikotinska kislina (s podaljšanim sproščanjem, 1.000 mg do 2.000 mg 5. teden) ○ Placebo * Vključuje bolnike z zmernimi, hudimi ali izredno hudimi simptomi zardevanja † Povečanje odmerka 5. teden
168 modified-release tablets 
168 tablet s prirejenim sproščanjem
• rapid heart rate. 
• hitro bitje srca
Rare: elevations in total bilirubin, amylase; reductions in phosphorus and platelet counts (see below) 
pogosti zvišanje CK (≥ 10 x ZMN), celotnega bilirubina, znižanje fosforja in števila trombocitov (glejte spodaj)
Physicians contemplating combined therapy with statins and Trevaclyn should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and when the dose of either medicinal product is increased. 
Poleg tega morate bolnika natančno spremljati glede mišičnih bolečin, občutljivosti ali šibkosti mišic, še posebej v prvih mesecih zdravljenja in ob povečanju kateregakoli zdravila.
196 modified-release tablets 
196 tablet s prirejenim sproščanjem
The name of your medicine is Trevaclyn. 
Vaše zdravilo se imenuje Trevaclyn.
Acetylsalicylic acid provides no additional reduction of flushing beyond that achieved by Trevaclyn. 
Acetilsalicilna kislina zardevanja ne zmanjša nič bolj, kot ga že zdravilo Trevaclyn.
• Avoid drinking alcohol or hot drinks or eating spicy foods near the time you take your dose of Trevaclyn. 
• Ne pijte alkohola ali vročih pijač in ne jejte začinjene hrane malo pred zaužitjem odmerka zdravila Trevaclyn ali kmalu po njem.
Therefore, patients switching from immediate-release nicotinic acid to Trevaclyn should be initiated at the 1,000 mg/20 mg dose. 
Pri bolnikih, ki preidejo na zdravilo Trevaclyn z nikotinske kisline s takojšnjim sproščanjem, morate zdravljenje začeti z odmerkom 1.000 mg/20 mg.
Laropiprant was not teratogenic in rats or in rabbits at systemic exposure levels at least 153 and 438 times the human exposure based on the AUC of the recommended daily human dose. 
Laropiprant pri podganah oz. kuncih ni bil teratogen pri sistemski izpostavljenosti, ki je bila vsaj 153- oz. 438-krat tolikšna, kot je (na podlagi AUC) izpostavljenost med uporabo priporočenega dnevnega odmerka pri človeku.
Patients receiving Trevaclyn concomitantly with acetylsalicylic acid and clopidogrel should be closely monitored as recommended in the Summary of Product Characteristics for those medicinal products and should be told that it might take longer than usual to stop bleeding and that they should report any unusual bleeding (site or duration) to their physician. 
Povedati jim je treba, da lahko traja dalj časa kot običajno, da se krvavitev ustavi, ter da morajo svojemu zdravniku poročati kakršnokoli neobičajno krvavitev (mesto ali trajanje).
Caution should be used when treating Chinese patients with Trevaclyn co-administered with simvastatin or ezetimibe/simvastatin (particularly simvastatin doses of 40 mg or higher). 
Pri zdravljenju kitajskih bolnikov, ki jemljejo zdravilo Trevaclyn skupaj s simvastatinom ali z ezetimibom/simvastatinom (zlasti pri odmerkih simvastatina 40 mg ali več), je potrebna previdnost.
Uncommon: palpitations Rare: atrial fibrillation and other cardiac arrhythmias; tachycardia 
Srčne bolezni: atrijska fibrilacija in druge motnje srčnega ritma, palpitacije, tahikardija.
Opaque PVC/Aclar blister with push-through aluminium lidding in pack sizes of 14, 28, 56, 84, 98, 168, 196 modified-release tablets, multi-packs containing 196 (2 packs of 98) modified-release tablets and 49 x 1 modified-release tablets in perforated unit dose blister. 
Neprozoren pretisni omot iz PVC/Aclarja z aluminijskim prekritjem, skozi katerega se potisne tableta, v pakiranjih s 14, 28, 56, 84, 98, 168, 196 tabletami s prirejenim sproščanjem, multi pakiranje s 196 (2 pakiranji po 98) tabletami s prirejenim sproščanjem in z 49 x 1 tableto s prirejenim sproščanjem v perforiranem pretisnem omotu za enkratni odmerek.
In these studies, the percentage of patients taking Trevaclyn, nicotinic acid (pooled prolonged-release formulations) or pooled placebo/simvastatin who discontinued due to any flushing-related symptom (redness, warmth, itching and tingling) was 7.2 %, 16.6 %, and 0.4 %, respectively. 
Zaradi kateregakoli od simptomov zardevanja (rdečica, toplota, srbenje in mravljinčenje) je zdravilo Trevaclyn v teh študijah nehalo jemati 7,2 % bolnikov, nikotinsko kislino (skupno vse pripravke s podaljšanim delovanjem) 16,6 % bolnikov in placebo/simvastatin 0,4 % bolnikov.
As with other nicotinic acid medicinal products, Trevaclyn (2,000 mg/40 mg) was associated with small increases in uric acid levels (see section 4.8). 
Tako kot druga zdravila z nikotinsko kislino je bilo tudi zdravilo Trevaclyn (2.000 mg/40 mg) povezano z majhnim zvišanjem koncentracije sečne kisline (glejte poglavje 4.8).
The rate and extent of absorption are not altered with a high-fat meal. 
Hitrost in obseg absorpcije se z zelo mastnim
EU/1/08/458/014 32 x 1modified-release tablets 
EU/1/08/458/010 28 tablet s prirejenim sproščanjem
In addition, one or more of the following symptoms have been reported as part of an allergic reaction to Trevaclyn. 
Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov) Kot del alergijske reakcije na zdravilo Trevaclyn so poročali še o enem ali večih od naslednjih simptomov:
Common: erythema; pruritus; rash; urticaria Uncommon: dry skin; macular rash Rare: acanthosis nigricans; hyperpigmentation; sweating (night or cold sweat) 
Bolezni kože in podkožja: acanthosis nigricans, suha koža, hiperpigmentacija, makularen izpuščaj, znojenje (ponoči ali hladno znojenje), vezikularni ali vezikulobulozni izpuščaj.
Very common: flushing Uncommon: hypotension Rare: orthostatic hypotension 
Žilne bolezni: hipotenzija, ortostatska hipotenzija.
• dry skin 
• otekanje nog
Aluminium/Aluminium blister with push-through lidding in pack sizes of 14, 28, 56, 168 modified-release tablets and 32 x 1 modified-release tablets in perforated unit dose blister. 
Aluminijsko/aluminijski pretisni omot s prekritjem, skozi katerega se potisne tableta, v pakiranjih s 14, 28, 56, 168 tabletami s prirejenim sproščanjem ter z 32 x 1 tableto s prirejenim sproščanjem v perforiranem pretisnem omotu za enkratni odmerek.
Studies in animals have shown foetal developmental toxicity at high doses of nicotinic acid (see section 5.3). 
Študije na živalih so pokazale škodljive učinke na razvoj ploda pri velikih odmerkih nikotinske kisline (glejte poglavje
Nicotinic acid For an overdose of nicotinic acid, supportive measures should be employed. 
Nikotinska kislina V primeru prevelikega odmerjanja nikotinske kisline je treba uporabiti podporne ukrepe.
However, nicotinic acid a component of Trevaclyn does pass into breast milk. 
da v materino mleko prehaja nikotinska kislina, sestavina zdravila Trevaclyn.
As with other nicotinic acid medicinal products, Trevaclyn (2,000 mg/40 mg) was associated with small reductions in platelet count (see section 4.8). 
Tako kot druga zdravila z nikotinsko kislino je bilo tudi zdravilo Trevaclyn (2.000 mg/40 mg) povezano z majhnim zmanjšanjem števila trombocitov (glejte poglavje 4.8).
Pack sizes of 14, 28, 56; 168 modified-release tablets and 32 x 1modified-release tablets in a perforated unit dose blister. 
Velikosti pakiranj: 14, 28, 56, 168 tablet s prirejenim sproščanjem ter 32 x 1 tableta s prirejenim sproščanjem v perforiranem pretisnem omotu za enkratni odmerek.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified-release tablet contains 1,000 mg of nicotinic acid and 20 mg of laropiprant. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta s prirejenim sproščanjem vsebuje 1.000 mg nikotinske kisline in 20 mg laropipranta.
As with other nicotinic acid medicinal products, Trevaclyn was associated with small decreases in phosphorus levels. 
Tako kot druga zdravila z nikotinsko kislino je bilo tudi zdravilo Trevaclyn povezano z manjšim zmanjšanjem koncentracije fosforja, zato morate bolnike s tveganjem za hipofosfatemijo skrbno spremljati.