natgillin/translations-raw huggingface dataset:
Clinically important elevations of CK (≥ 10 X ULN) were seen in 0.3% of the patients treated with Trevaclyn with or without a statin (see section 4.4).
Klinično pomembno zvišanje CK (≥ 10- krat ZNM) se je pojavilo pri 0, 3% bolnikov, ki so dobivali zdravilo Trevaclyn s statinom ali brez njega (glejte poglavje 4. 4).
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
Druge opisane laboratorijske nepravilnosti so bile zvišanje LDH, glukoze na tešče, sečne kisline, celotnega bilirubina in amilaze ter znižanje fosforja in števila trombocitov (glejte poglavje 4. 4).
8 controlled clinical studies with Trevaclyn (2000 mg/ 40 mg) (see section 4.4).
Tako kot pri drugih zdravilih z nikotinsko kislino so v kontroliranih kliničnih študijah z zdravilom Trevaclyn (2000 mg/ 40 mg) poročali o povišanju glukoze na tešče (mediano povišanje za 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).
Nicotinic acid-related adverse reactions The following nicotinic acid-related adverse reactions have been seen in clinical trials or post-marketing experience with other nicotinic acid medicinal products at unknown frequency or in clinical trials with Trevaclyn (or the nicotinic acid component of Trevaclyn) in < 1% of the patients treated:
Neželeni učinki, povezani z nikotinsko kislino Naslednje z nikotinsko kislino povezane neželene učinke so z neznano pogostnostjo opazili v kliničnih preskušanjih in med pomarketinško uporabo drugih zdravil z nikotinsko kislino ali pri < 1% zdravljenih bolnikov v kliničnih preskušanjih z zdravilom Trevaclyn (ali nikotinskokislinsko sestavino zdravila Trevaclyn):
Trevaclyn In the event of an overdose, it is reasonable to employ the usual symptomatic and supportive measures.
4. 9 Preveliko odmerjanje 8 Trevaclyn V primeru prevelikega odmerjanja je smiselno uporabiti običajne simptomatske in podporne ukrepe.
Cases of overdose have been reported; the maximum dose of Trevaclyn taken was 5000 mg/ 100 mg.
Opisani so primeri prevelikega odmerjanja; največji zaužiti odmerek zdravila Trevaclyn je bil 5000 mg/ 100 mg.
Trevaclyn contains nicotinic acid, which at therapeutic doses is a lipid-modifying agent, and laropiprant, a potent, selective antagonist of the prostaglandin D2 (PGD2) receptor subtype 1 (DP1).
Trevaclyn vsebuje nikotinsko kislino, ki v terapevtskih odmerkih vpliva na lipide, in laropiprant, močan, selektiven antagonist receptorja prostaglandina D2 (PGD2) podvrste 1 (DP1).
Like LDL, cholesterol-enriched triglyceride-rich lipoproteins, including VLDL, intermediate-density lipoproteins (IDL), and remnants, can also promote atherosclerosis.
Zvišana koncentracija
Elevated plasma TG levels are frequently found in a triad with low HDL-C levels and small LDL particles, as well as in association with non-lipid metabolic risk factors for coronary heart disease (CHD).
9 trigliceridov se pogosto pojavi v trojici z nizko koncentracijo hHDL in majhnimi delci LDL, pa tudi skupaj z nelipidnimi presnovnimi dejavniki tveganja za koronarno bolezen srca (KBS).
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).
Clinical studies Effect on lipids 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.
Klinične študije Učinek na lipide Trevaclyn je učinkovit v zelo različnih populacijah odraslih bolnikov s primarno hiperholesterolemijo ali mešano dislipidemijo, ne glede na raso, spol, izhodiščno koncentracijo hLDL, hHDL in trigliceridov, ali glede na starost, pa tudi v posebnih populacijah, npr. pri sladkornih bolnikih.
4.3%) as measured by percent change from baseline.
Bolnikom, ki so jemali zdravilo Trevaclyn 2000 mg/ 40 mg s statinom ali brez njega, so se v primerjavi s prejemniki placeba bistveno znižali hLDL (- 18, 9% v prim. z - 0, 5%), trigliceridi (- 21, 7% v prim. s 3, 6%), razmerje hLDL: hHDL (- 28, 9% v prim. z 2, 3%), ne- HDL- holesterol (- 19, 0% v prim. z 0, 8%), apo B (- 16, 4% v prim. z 2, 5%), Ch (- 9, 2% v prim. z - 0, 6%), Lp( a) (- 17, 6% v prim. z 1, 1%), in razmerje Ch: hHDL (- 21, 2% v prim. z 1, 9%), bistveno pa sta se jim zvišala hHDL (18, 8% v prim. z 1, 2%) in apo A- I (11, 2% v prim. s 4, 3%), merjeno v odstotkih spremembe od izhodišča.
Patients receiving Trevaclyn, nicotinic acid (prolonged-released formulation), or placebo were also taking statins (29% atorvastatin [5-80 mg], 54% simvastatin [10-80 mg], 17% other statins [2.5-180 mg] (pravastatin, fluvastatin, rosuvastatin, lovastatin)), of which 9% were also taking ezetimibe [10 mg].
Bolniki, ki so dobivali zdravilo Trevaclyn, nikotinsko kislino (pripravek s podaljšanim sproščanjem), ali placebo, so jemali tudi statine (29% atorvastatin [5– 80 mg], 54% simvastatin [10– 80 mg], 17% druge statine [2, 5– 180 mg] (pravastatin, fluvastatin, rosuvastatin, lovastatin)) in 9% od teh jih je jemalo tudi ezetimib [10 mg].
In a multicentre, double-blind, 12-week factorial study, Trevaclyn 1000 mg/ 20 mg co-administered with simvastatin, when compared with simvastatin alone or Trevaclyn 1000 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).
12, 5%).
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
6, 0% oz.
11 (-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).
Kot je pokazala dodatna analiza, je sočasno s simvastatinom uporabljen Trevaclyn 2000 mg/ 40 mg v primerjavi s samim simvastatinom bistveno zvišal apo A- I (8, 6% oz.
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).
0, 0%).
Flushing In two large clinical trials measuring patient-reported flushing symptoms, patients taking Trevaclyn experienced less flushing than those taking nicotinic acid (prolonged-release formulations).
Zardevanje V dveh velikih kliničnih preskušanjih, ki sta ugotavljali simptome zardevanja po navedbi bolnikov, je bilo zardevanja manj med bolniki, ki so prejemali zdravilo Trevaclyn, kot med bolniki, ki so prejemali nikotinsko kislino (pripravek s podaljšanim sproščanjem).
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).
Pri bolnikih, ki so dobivali nikotinsko kislino (pripravek s podaljšanim sproščanjem), pa se pogostnost zardevanja ni spremenila (po 6. tednu).
● 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) ○ Placebo *Includes patients with moderate, severe, or extreme flushing symptoms † Dose advancement at Week 5
● Trevaclyn (1000 mg/ 20 mg do 2000 mg/ 40 mg 5. teden) ▲Nikotinska kislina (s podaljšanim sproščanjem, 1000 mg do 2000 mg 5. teden) ○ Placebo * Vključuje bolnike z zmernimi, hudimi ali izredno hudimi simptomi zardevanja † Povečanje odmerka 5. teden
In the second study (16 weeks) where acetylsalicylic acid was allowed, patients taking Trevaclyn experienced significantly fewer days per week with moderate or greater flushing compared to nicotinic acid (prolonged-release formulation taken as a 12-week multi-step 500 mg to 2000 mg titration) (p < 0.001).
V drugi študiji (16 tednov), v kateri je bilo dovoljeno uporabljati acetilsalicilno kislino, so bolniki, ki so prejemali zdravilo Trevaclyn, doživljali zmerno ali izrazitejše zardevanje statistično značilno manj dni na teden kot bolniki, ki so prejemali nikotinsko kislino (pripravek s podaljšanim sproščanjem, uporabljen v 12- tedenski večstopenjski titraciji od 500 mg do 2000 mg) (p < 0, 001).
12 5.2 Pharmacokinetic properties
11 5. 2 Farmakokinetične lastnosti
Absorption Nicotinic acid Following a 2000 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 μ M·hr and a mean peak plasma concentration (Cmax) of approximately 20.2 μ M.
Absorpcija Nikotinska kislina Po peroralni uporabi 2. 000 mg nikotinske kisline v dveh tabletah nikotinske kisline/ laropipranta s prirejenim sproščanjem, zaužitih s hrano, je bil mediani čas 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.
In vitro studies have shown that the acyl glucuronide conjugate of laropiprant had at least a 65-fold reduced affinity for DP1 as compared to laropiprant; thus, it is not expected to contribute to the overall DP1 activity of laropiprant.
12 laropipranta vsaj 65- krat manjšo afiniteto za DP1 kot laropiprant, zato ni pričakovati, da bi prispeval k celotni DP1- aktivnosti laropipranta.
Characteristics in patients Renal insufficiency Trevaclyn:
Značilnosti pri bolnikih Insuficienca ledvic Trevaclyn:
Hepatic insufficiency Trevaclyn:
Insuficienca jeter Trevaclyn:
Age has no clinically meaningful effect on pharmacokinetics of nicotinic acid (prolonged-release formulation) based on a composite analysis of subjects ages 18-65 years.
Glede na sestavljeno analizo preiskovancev, starih od 18 do 65 let, starost na farmakokinetiko nikotinske kisline (pripravka s
There is no change in the oral bioavailability of nicotinic acid with age.
13 podaljšanim sproščanjem) ne vpliva klinično pomembno.
Paediatric Trevaclyn:
Pediatrični bolniki Trevaclyn:
Trevaclyn Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure, indicating little relevance to human use.
To kaže na majhen pomen za uporabo pri ljudeh.
Increases in serum alanine aminotransferase (ALT) levels were observed in all dog studies, at systemic exposure levels at least 14 times the human exposure based on the AUC of the recommended daily human dose.
14 Zvišanje serumske alanin- aminotransferaze (ALT) so opažali v vseh študijah na psih pri izpostavljenosti, ki je bila vsaj 14- krat tolikšna, kot je (na podlagi AUC) izpostavljenost med uporabo priporočenega dnevnega odmerka pri človeku.
6.5 Nature and contents of container
15 6. 5 Vrsta ovojnine in vsebina
Pack sizes of 14, 28, 56; 168 modified-release tablets and 32 x 1modified-release tablets in a perforated unit dose blister.
14, 28, 56, 168 tablet s prirejenim sproščanjem ter 32 x 1 tableta s prirejenim sproščanjem v perforiranem pretisnem omotu za enkratni odmerek.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
16 Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea. europa. eu /.
18 ANNEX II
17 DODATEK II
LABELLING
21 PODATKI NA ZUNANJI OVOJNINI
Trevaclyn 1000 mg/ 20 mg modified-release tablets Nicotinic acid/ laropiprant
Trevaclyn 1000 mg/ 20 mg tablete s prirejenim sproščanjem nikotinska kislina/ laropiprant
Do not store above 30°C.
22 Shranjujte pri temperaturi do 30 °C.
EU/ 1/ 08/ 458/ 009 14 modified-release tablets EU/ 1/ 08/ 458/ 010 28 modified-release tablets EU/ 1/ 08/ 458/ 011 56 modified-release tablets EU/ 1/ 08/ 458/ 013 168 modified-release tablets EU/ 1/ 08/ 458/ 014 32 x 1modified-release tablets
EU/ 1/ 08/ 458/ 009 14 tablet s prirejenim sproščanjem EU/ 1/ 08/ 458/ 010 28 tablet s prirejenim sproščanjem EU/ 1/ 08/ 458/ 011 56 tablet s prirejenim sproščanjem EU/ 1/ 08/ 458/ 013 168 tablet s prirejenim sproščanjem EU/ 1/ 08/ 458/ 014 32 x 1 tableta s prirejenim sproščanjem
24 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
23 PODATKI NA ZUNANJI OVOJNINI
EXP
24 Uporabno do:
EU/ 1/ 08/ 458/ 001 14 modified-release tablets EU/ 1/ 08/ 458/ 002 28 modified-release tablets EU/ 1/ 08/ 458/ 003 56 modified-release tablets EU/ 1/ 08/ 458/ 004 84 modified-release tablets EU/ 1/ 08/ 458/ 005 98 modified-release tablets EU/ 1/ 08/ 458/ 006 168 modified-release tablets EU/ 1/ 08/ 458/ 007 196 modified-release tablets EU/ 1/ 08/ 458/ 008 49 x 1 modified-release tablets EU/ 1/ 08/ 458/ 012 196 (2 packs of 98) modified-release tablets
EU/ 1/ 08/ 458/ 001 14 tablet s prirejenim sproščanjem EU/ 1/ 08/ 458/ 002 28 tablet s prirejenim sproščanjem EU/ 1/ 08/ 458/ 003 56 tablet s prirejenim sproščanjem EU/ 1/ 08/ 458/ 004 84 tablet s prirejenim sproščanjem EU/ 1/ 08/ 458/ 005 98 tablet s prirejenim sproščanjem EU/ 1/ 08/ 458/ 006 168 tablet s prirejenim sproščanjem EU/ 1/ 08/ 458/ 007 196 tablet s prirejenim sproščanjem EU/ 1/ 08/ 458/ 008 49 x 1 tableta s prirejenim sproščanjem EU/ 1/ 08/ 458/ 012 196 (2 zavoja po 98) tablet s prirejenim sproščanjem
27 PARTICULARS TO APPEAR ON THE INTERMEDIATECARTON
25 PODATKI NA SEKUNDARNI OVOJNINI
29 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
27 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Trevaclyn 1000 mg/ 20 mg modified-release tablets nicotinic acid/ laropiprant
Trevaclyn 1000 mg/ 20 mg tablete s prirejenim sproščanjem nikotinska kislina/ laropiprant
What Trevaclyn is and what it is used for 2.
Kaj je zdravilo Trevaclyn in za kaj ga uporabljamo 2.
Before you take Trevaclyn 3.
Kaj morate vedeti, preden boste vzeli zdravilo Trevaclyn 3.
How to take Trevaclyn 4.
Kako jemati zdravilo Trevaclyn 4.
How to store Trevaclyn 6.
Shranjevanje zdravila Trevaclyn 6.
WHAT TREVACLYN IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO TREVACLYN IN ZA KAJ GA UPORABLJAMO
Trevaclyn is used in addition to diet • to lower your ‘ bad’ cholesterol level.
Zdravilo Trevaclyn se uporablja poleg diete za: • znižanje "slabega" holesterola.
32 In most people, at first there are no signs of cholesterol problems.
30 Pri večini ljudi nenormalna raven holesterola sprva ne povzroča nobenih bolezenskih znakov.
Trevaclyn is used if you need to improve cholesterol and fat levels in your blood (primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia): • when you cannot control your cholesterol levels with a statin (class of cholesterol-lowering medicines working in the liver); • when you cannot tolerate a statin or when a statin is not recommended for you.
Trevaclyn ste dobili, če morate izboljšati raven holesterola in maščob v krvi (primarna hiperholesterolemija (heterozigotna družinska in nedružinska) ali mešana dislipidemija): • če holesterola ne morete obvladati z enim od statinom (statini so skupina zdravil za zniževanje holesterola, ki delujejo v jetrih). • če statinov ne prenesete ali za vas niso priporočljivi.
Trevaclyn can be used by itself or with other medicines to treat cholesterol problems.
Zdravilo Trevaclyn se lahko uporablja sámo ali skupaj z drugimi zdravili za uravnavanje holesterola.
BEFORE YOU TAKE TREVACLYN
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO TREVACLYN
Do not take Trevaclyn if • you are allergic (hypersensitive) to nicotinic acid, to laropiprant, or to any of the other ingredients of Trevaclyn (listed in section 6). • you currently have liver problems. • you have an ulcer in your stomach. • you have arterial bleeding.
Ne jemljite zdravila Trevaclyn: • če ste alergični na (preobčutljivi za) nikotinsko kislino, laropiprant ali katerokoli sestavino zdravila Trevaclyn (naštete so v poglavju 6). • če imate trenutno težave z jetri. • če imate razjedo na želodcu. • če krvavite iz arterije.
Take special care with Trevaclyn Tell your doctor about all of your medical conditions.
Bodite posebno pozorni pri jemanju zdravila Trevaclyn Zdravniku morate povedati za vse svoje zdravstvene težave.
33 If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Trevaclyn.
Če niste prepričani, ali kaj od naštetega velja za vas, se, preden vzamete zdravilo Trevaclyn, posvetujte z zdravnikom ali s farmacevtom.
Blood tests and monitoring • See your doctor regularly to check your LDL (bad) and HDL (good) cholesterol levels and your triglyceride level. • Your doctor should do a blood test before you start taking Trevaclyn to check how well your liver is working. • Your doctor may also want you to periodically have blood tests after you start taking Trevaclyn, to check how well your liver is working and for other side effects.
31 Preiskave krvi in spremljanje • Redno obiskujte zdravnika, da boste preverili raven LDL holesterola (slabi holesterol), HDL holesterola (dobri holesterol) in trigliceridov. • Pred začetkom uporabe zdravila Trevaclyn vas mora zdravnik poslati na preiskavo krvi za ugotavljanje delovanja jeter. • Morda vas bo zdravnik na preiskave krvi napotil tudi med zdravljenjem z zdravilom Trevaclyn, da bo preveril delovanje jeter in druge neželene učinke.
Children and adolescents Trevaclyn has not been studied in children and adolescents who are under 18 years of age.
Otroci in mladostniki Zdravilo Trevaclyn ni raziskano pri otrocih in mladostnikih, mlajših od 18 let.
Taking Trevaclyn with food and drink • Take Trevaclyn with food. • To lower your chance of flushing, avoid drinking alcohol or hot drinks near the time you take your dose of Trevaclyn. • It is important to follow the advice given in section 3 How to take Trevaclyn.
Jemanje zdravila Trevaclyn skupaj s hrano in pijačo • Zdravilo Trevaclyn jemljite skupaj s hrano. • Da zmanjšate možnost zardevanja, v času zaužitja zdravila Trevaclyn (ter malo pred tem in po tem) ne pijte alkohola ali vročih pijač. • Pomembno je, da upoštevate navodila v poglavju 3 Kako jemati zdravilo Trevaclyn.
Pregnancy and breast-feeding Talk with your doctor before taking Trevaclyn if: • You are pregnant or plan to become pregnant.
Nosečnost in dojenje Preden vzamete zdravilo Trevaclyn, se posvetujte z zdravnikom: • če ste noseči ali nameravate zanositi.
It is not known if Trevaclyn will harm your unborn baby. • You are breast-feeding or plan to breast-feed.
Ni znano, ali Trevaclyn škoduje nerojenemu otroku. • če dojite ali nameravate dojiti.
However, nicotinic acid a component of Trevaclyn does pass into breast milk.
Znano pa je, da v mleko prehaja nikotinska kislina, sestavina zdravila Trevaclyn.
34 Driving and using machines The effects of Trevaclyn on the ability to drive and use machines have not been studied.
Vpliv na sposobnost upravljanja vozil in strojev Vplivov zdravila Trevaclyn na sposobnost upravljanja vozil in strojev niso preučevali.
However, some people get dizzy after taking Trevaclyn.
A nekateri ljudje po zaužitju zdravila Trevaclyn postanejo omotični.
If you get dizzy, you should avoid driving or operating machines after taking Trevaclyn.
Če kdaj postanete omotični, se med jemanjem zdravila Trevaclyn izogibajte vožnji ali upravljanju strojev.
Important information about some of the ingredients of Trevaclyn Trevaclyn contains a sugar called lactose.
Pomembne informacije o nekaterih sestavinah zdravila Trevaclyn Trevaclyn vsebuje sladkor, imenovan laktoza.
HOW TO TAKE TREVACLYN
KAKO JEMATI ZDRAVILO TREVACLYN
Always take Trevaclyn exactly as your doctor has told you.
Pri jemanju zdravila Trevaclyn natančno upoštevajte zdravnikova navodila.
How to take • Take Trevaclyn once a day, in the evening or at bedtime. • Take Trevaclyn with food. • Swallow each tablet whole.
Kako morate jemati zdravilo • Zdravilo Trevaclyn vzemite enkrat na dan, zvečer ali pred spanjem. • Vzemite ga s hrano. • Tablete morate pogoltniti cele.
In order for your medicine to work as intended, do not split, break, crush, or chew the tablet before you swallow it. • Avoid drinking alcohol or hot drinks near the time you take your dose of Trevaclyn.
Da bo zdravilo delovalo tako kot mora, tablet ne razpolavljajte, ne lomite, ne drobite in ne grizite, preden jih pogoltnete. • Ne pijte alkohola ali vročih pijač kmalu pred zaužitjem odmerka Trevaclyn ali kmalu po njem.
This will lower your chance of flushing (redness of the skin, feeling warm, itching, or tingling, particularly in your head, neck, chest and upper back). • Taking aspirin before you take Trevaclyn does not reduce your flushing more than taking Trevaclyn alone.
Tako bo manjša možnost, da se pojavi zardevanje (pordelost kože, občutek toplote, srbenje ali mravljinčenje, še zlasti v predelu glave, vratu, prsi in zgornjega dela hrbta). • Jemanje acetilsalicilne kisline pred zaužitjem zdravila Trevaclyn ne bo bolj zmanjšalo zardevanja, kot če vzamete samo zdravilo Trevaclyn.
If you take more Trevaclyn than you should • In the event of an overdose, the following adverse events were reported: flushing, headache, pruritus (itching), nausea, dizziness, vomiting, diarrhoea, abdominal pain/ discomfort, and back pain. • If you take more than you should, talk to a doctor or pharmacist straight away.
Če ste vzeli večji odmerek zdravila Trevaclyn, kot bi smeli • V primeru prevelikega odmerjanja so poročali o naslednjih neželenih učinkih: zardevanje, glavobol, srbenje, siljenje na bruhanje, omotica, bruhanje, driska, bolečine/ nelagodje v trebuhu, bolečine v hrbtu. • Če vzamete več zdravila, kot bi smeli, se morate takoj posvetovati z zdravnikom ali s farmacevtom.
If you forget to take Trevaclyn • If you miss a dose, do not take an extra dose.
Če ste pozabili vzeti zdravilo Trevaclyn • Če ste pozabili vzeti odmerek, ne vzemite dodatnega.
However, if you do not take Trevaclyn for 7 or more days in a row, talk to your doctor before restarting Trevaclyn.
Če pa se zgodi, da zdravila Trevaclyn niste vzeli 7 ali več dni zapored, se morate pred ponovnim začetkom jemanja posvetovati z zdravnikom.
If you stop taking Trevaclyn Do not stop taking Trevaclyn without talking to your doctor.
Če ste prenehali jemati zdravilo Trevaclyn Ne nehajte jemati zdravila Trevaclyn, ne da bi se posvetovali s svojim zdravnikom.
Like all medicines, Trevaclyn can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Trevaclyn neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Common (affects less than 1 in 10 patients) • diarrhoea • nausea (feeling sick) • dizziness • rash • pruritus (itching) • hives • upset stomach or heartburn • getting sick (vomiting) • headache • tingling or numbness of the hands or feet
33 Pogosti (pojavijo se pri manj kot 1 od 10 bolnikov) • driska • siljenje na bruhanje (slabost v želodcu) • omotica • izpuščaj • srbenje • koprivnica • razdražen želodec ali zgaga • slabost (bruhanje) • glavobol • mravljinčenje ali omrtvelost v dlaneh ali stopalih