natgillin/translations-raw huggingface dataset:
In clinical trials with Glyxambi, the frequency of patients with increased blood creatinine (Glyxambi 25 mg/5 mg: 0.4%; Glyxambi 10 mg/5 mg: 0%) and decreased glomerular filtration rate (Glyxambi 25 mg/5 mg: 0.4%; Glyxambi 10 mg/5 mg: 0.6%) has been comparable to those reported from the empagliflozin clinical trials.
U kliničkim ispitivanjima lijeka Glyxambi učestalost bolesnika s povišenom razinom kreatinina u krvi (Glyxambi 25 mg/5 mg: 0,4%; Glyxambi 10 mg/5 mg: 0%) i sniženom brzinom glomerularne filtracije (Glyxambi 25 mg/5 mg: 0,4%; Glyxambi 10 mg/5 mg: 0,6%) bila je usporediva s učestalostima prijavljenim za klinička ispitivanja empagliflozina.
Name and address of the manufacturer responsible for batch release Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 173
Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Boehringer Ingelheim Pharma GmbH & Co.
The rate and extent of absorption of empagliflozin and linagliptin in Glyxambi are equivalent to the bioavailability of empagliflozin and linagliptin when administered as individual tablets.The pharmacokinetics of empagliflozin and linagliptin as single agents have been extensively characterized in healthy subjects and patients with type 2 diabetes.
Brzina i opseg apsorpcije empagliflozina i linagliptina u lijeku Glyxambi odgovaraju bioraspoloživosti empagliflozina i linagliptina nakon primjene u obliku pojedinačnih tableta.
In patients inadequately controlled on maximally tolerated doses of metformin, open label empagliflozin 10 mg or empagliflozin 25 mg was added for 16 weeks.
U bolesnika s neodgovarajućom kontrolom glikemije liječenih maksimalno podnošenim dozama metformina dodan je empagliflozin 10 mg ili empagliflozin 25 mg u „otvorenom“ obliku tijekom 16 tjedana.
Pale pink, arc triangular, flat faced, bevel-edged, film-coated tablets.
Blijedo ružičaste, trokutaste, plosnate, filmom obložene tablete zaobljenih kuteva i ukošenih rubova.
Adverse effects on renal development were not observed after administration of empagliflozin alone, linagliptin alone or after administration of the combined products.
Štetni učinci na razvoj bubrega nisu bili uočeni nakon primjene empagliflozina u obliku monoterapije, linagliptina u obliku monoterapije ili nakon primjene kombinacije lijekova.
• medicines used to remove water from your body (diuretics).
• lijekove koji se koriste za uklanjanje vode iz tijela (diuretici); Vaš liječnik može zatražiti da prestanete uzimati Glyxambi.
Glyxambi 25 mg/5 mg film-coated tablets (tablets) are pale pink, arc triangular, flat faced and beveledged.
Glyxambi 25 mg/5 mg filmom obložene tablete (tablete) su blijedo ružičaste, trokutaste, plosnate, zaobljenih kuteva i ukošenih rubova.
Rare cases of DKA, including life-threatening cases, have been reported in clinical trials and postmarketing in patients treated with SGLT2 inhibitors, including empagliflozin.
Tijekom kliničkih ispitivanja i nakon stavljanja lijeka u promet, u bolesnika liječenih SGLT2 inhibitorima, uključujući empagliflozin, prijavljeni su rijetki slučajevi DKA, uključujući i slučajeve opasne po život.
- The active substances are empagliflozin and linagliptin.
- Djelatne tvari su empagliflozin i linagliptin.
Baseline (mean) Change from baseline (adjusted mean) Comparison vs. placebo (adjusted mean) (95 % CI)
Promjena od početne vrijednosti (prilagođena srednja vrijednost) Usporedba naspram placeba (prilagođena srednja vrijednost) (95% CI)
OATP2, OATP8, OCTN1, OCT1 and OATP2 activities were slightly to weakly inhibited by linagliptin.
Linagliptin je neznatno do slabo inhibirao aktivnosti OATP2, OATP8, OCTN1, OCT1 i OATP2.
Glyxambi 25 mg/5 mg film-coated tablets Each film-coated tablet contains 25 mg empagliflozin and 5 mg linagliptin.
Glyxambi 25 mg/5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 25 mg empagliflozina i 5 mg linagliptina.
In a pre-specified subgroup of patients with baseline HbA1c greater or equal than 8.5 %, the reduction from baseline in HbA1c at 24 weeks with Glyxambi 25 mg/5 mg was -1.8 % (p<0.0001 versus linagliptin 5 mg, p<0.001 versus empagliflozin 25 mg) and with Glyxambi 10 mg/ 5 mg -1.6 % (p<0.01 versus linagliptin 5 mg, n.s. versus empagliflozin 10 mg).
U prethodno specificiranoj podskupini bolesnika s početnom vrijednošću HbA1c većom ili jednakom 8,5%, smanjenje od početne vrijednosti HbA1c uz primjenu lijeka Glyxambi 25 mg/5 mg je iznosilo1,8% u 24. tjednu (p< 0,0001 naspram linagliptina 5 mg, p< 0,001 naspram empagliflozina 25 mg), a uz primjenu lijeka Glyxambi 10 mg / 5 mg je iznosilo -1,6% (p< 0,01 naspram linagliptina 5 mg, bez značajne razlike naspram empagliflozina 10 mg).
Comparison vs. empagliflozin - adjusted mean
Usporedba naspram empagliflozin prilagođena srednja vrijednost
- 95.0 % CI - p-value Last observation (prior to glycaemic rescue ) carried forward (LOCF) Mean adjusted for baseline value and stratification
Last observation carried forward, LOCF) (prije primjene pomoćne terapije za postizanje odgovarajuće glikemije, engl. glycaemic rescue)
Number of Subjects (%)
Početna vrijednost (srednja vrijednost)
Glyxambi 10 mg/5 mg film-coated tablets Each film-coated tablet contains 10 mg empagliflozin and 5 mg linagliptin.
Glyxambi 10 mg/5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 10 mg empagliflozina i 5 mg linagliptina.
About half of the patients (52.2 %) had an eGFR of 60-90 ml/min/1.73 m2, 17.8 % of
Oko polovice bolesnika (52,2%) imalo je vrijednost eGFR 6090 ml/min/1,73 m2, 17,8% njih 45-60 ml/min/1,73 m2 te 7,7% njih 30-45 ml/min/1,73 m
It is important to stay on the diet and exercise program recommended by your doctor during treatment with this medicine.
Važno je, tijekom liječenja ovim lijekom, pridržavati se dijete i provoditi tjelovježbu prema preporuci Vašeg liječnika.
INFORMATION IN BRAILLE Glyxambi 10 mg/5 mg
16. PODACI NA BRAILLEOVOM PISMU Glyxambi 10 mg/5 mg
In clinical trials with Glyxambi, there was no notable difference in the frequency of volume depletion in patients treated with Glyxambi (Glyxambi 25 mg/5 mg: 0.4 %; Glyxambi 10 mg/5 mg: 0.8 %) compared to the patients treated with empagliflozin and linagliptin.
U kliničkim ispitivanjima lijeka Glyxambi nije bilo primjetne razlike u učestalosti deplecije volumena u bolesnika liječenih lijekom Glyxambi (Glyxambi 25 mg/5 mg: 0,4%; Glyxambi 10 mg/5 mg: 0,8%) u usporedbi s bolesnicima liječenim empagliflozinom i linagliptinom.
Patients randomized to the placebo group were receiving the placebo plus linagliptin 5 mg with background metformin Mixed-effects models for repeated measurements (MMRM) on FAS (OC) includes baseline HbA1c, baseline eGFR (MDRD), geographical region, visit treatment,and treatment by visit interaction.
Bolesnici randomizirani u placebo skupinu primali su placebo plus linagliptin 5 mg uz osnovnu terapiju metforminom Modeli miješanih učinaka za ponovljena mjerenja (engl. mixed-effects models for repeated measurements, MMRM)
Each film-coated tablet contains 25 mg empagliflozin and 5 mg linagliptin.
Jedna filmom obložena tableta sadrži 25 mg empagliflozina i 5 mg linagliptina.
INFORMATION IN BRAILLE Glyxambi 25 mg/5 mg
16. PODACI NA BRAILLEOVOM PISMU Glyxambi 25 mg/5 mg
• In patients with an estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 or creatinine clearance (CrCl) ≥60 mL/min, no dose adjustment is required.
(eng. estimated glomerular filtration rate, eGFR) ≥ 60 ml/min/1,73 m2 ili klirensom kreatinina
Each film-coated tablet contains 10 mg empagliflozin and 5 mg linagliptin.
Jedna filmom obložena tableta sadrži 10 mg empagliflozina i 5 mg linagliptina.
In clinical trials with Glyxambi, there was no notable difference of the frequency of urinary tract infections in patients treated with Glyxambi (Glyxambi 25 mg/5 mg: 8.5 %; Glyxambi 10 mg/5 mg: 7.5 %) compared to the patients treated with empagliflozin and linagliptin.
U kliničkim ispitivanjima lijeka Glyxambi nije bilo primjetne razlike učestalosti infekcija mokraćnog sustava u bolesnika liječenih lijekom Glyxambi (Glyxambi 25 mg/5 mg: 8,5%; Glyxambi 10 mg/5 mg: 7,5%) u usporedbi s bolesnicima liječenim empagliflozinom i linagliptinom.
Glyxambi 10 mg/5 mg film-coated tablets Glyxambi 25 mg/5 mg film-coated tablets empagliflozin/linagliptin
Glyxambi 10 mg/5 mg filmom obložene tablete Glyxambi 25 mg/5 mg filmom obložene tablete empagliflozin/linagliptin
Your doctor may want to lower the dose of these other medicines, to prevent your blood sugar levels from getting too low.
• druge lijekove za liječenje šećerne bolesti, poput inzulina ili sulfonilureje; Vaš liječnik će možda htjeti sniziti dozu ovih drugih lijekova kako bi se spriječio nastanak pretjerano niske razine šećera u krvi.
Glyxambi 10 mg/5 mg film-coated tablets
Glyxambi 10 mg/5 mg filmom obložene tablete
Amylase increased
Pojačano mokrenje
Comparison vs. linagliptin 5 mg - adjusted mean
Usporedba naspram linagliptin 5 mg prilagođena srednja vrijednost
Glyxambi 25 mg/5 mg film-coated tablets
Glyxambi 25 mg/5 mg filmom obložene tablete
In the CARMELINA study (see section 5.1), bullous pemphigoid was reported in 0.2% patients treated with linagliptin and in no patients treated with placebo.
U ispitivanju CARMELINA (vidjeti dio 5.1) bulozni pemfigoid bio je prijavljen u 0,2% bolesnika liječenih linagliptinom i ni u jednog bolesnika koji je primao placebo. vidjeti dio 4.4 za dodatne informacije vidjeti dio u nastavku
In clinical trials with Glyxambi, genital infections in patients treated with Glyxambi (Glyxambi 25 mg/5 mg: 3.0 %; Glyxambi 10 mg/5 mg: 2.5 %) were reported more frequently than for linagliptin but less freqeuntly than for empagliflozin.
U kliničkim ispitivanjima lijeka Glyxambi genitalne infekcije u bolesnika liječenih lijekom Glyxambi (Glyxambi 25 mg/5 mg: 3,0%; Glyxambi 10 mg/5 mg: 2,5%) su bile češće prijavljivane u usporedbi s bolesnicima liječenim linagliptinom, ali rjeđe u odnosu na empagliflozin.
In clinical trials with Glyxambi, increased urination in patients treated with Glyxambi (Glyxambi 25 mg/5 mg: 2.6 %; Glyxambi 10 mg/5 mg: 1.4 %) was reported more frequently than for linagliptin and with similar frequency than for empagliflozin.
U kliničkim ispitivanjima lijeka Glyxambi pojačano mokrenje u bolesnika liječenih lijekom Glyxambi (Glyxambi 25 mg/5 mg: 2,6%; Glyxambi 10 mg/5 mg: 1,4%) je bilo češće prijavljeno u usporedbi s bolesnicima liječenim linagliptinom te sa sličnom učestalošću u usporedbi s bolesnicima liječenim empagliflozinom.
CV = cardiovascular, MI = myocardial infarction Treated set (TS), i.e. patients who had received at least one dose of study drug Pooled doses of empagliflozin 10 mg and 25 mg Since data from the trial were included in an interim analysis, a two-sided 95.02% confidence interval applied which corresponds to a p-value of less than 0.0498 for significance.
Budući da su podaci iz ispitivanja bili uključeni u interim analizu, primijenjen je dvostrani 95,02%-tni interval pouzdanosti što odgovara p-vrijednosti od manje od 0,0498 za značajnost.
Empagliflozin improves both fasting and post prandial plasma glucose levels.
Empagliflozin snižava razinu glukoze u plazmi natašte i nakon jela.
NAME OF THE MEDICINAL PRODUCT Glyxambi 10 mg/5 mg tablets empagliflozin/linagliptin
NAZIV LIJEKA Glyxambi 10 mg/5 mg tablete empagliflozin/linagliptin
NAME OF THE MEDICINAL PRODUCT Glyxambi 25 mg/5 mg tablets empagliflozin/linagliptin
NAZIV LIJEKA Glyxambi 25 mg/5 mg tablete empagliflozin/linagliptin
• In patients with an eGFR <60 mL/min/1.73 m 2 or CrCl <60 mL/min, Glyxambi should not be initiated.
• Terapija lijekom Glyxambi ne smije se započeti u bolesnika s eGFR< 60 ml/min/1,73 m 2 ili
However, temporary interruption of Glyxambi should be considered in patients with complicated urinary tract infections.
Međutim, u bolesnika s kompliciranim infekcijama mokraćnog sustava potrebno je razmotriti privremeni prekid terapije lijekom Glyxambi.
NAME OF THE MEDICINAL PRODUCT Glyxambi 10 mg/5 mg film-coated tablets Glyxambi 25 mg/5 mg film-coated tablets
Glyxambi 10 mg/5 mg filmom obložene tablete Glyxambi 25 mg/5 mg filmom obložene tablete
Glyxambi 25 mg/5 mg film-coated tablets EU/1/16/1146/010 (7 x 1 film-coated tablets) EU/1/16/1146/011 (10 x 1 film-coated tablets) EU/1/16/1146/012 (14 x 1 film-coated tablets) EU/1/16/1146/013 (28 x 1 film-coated tablets) EU/1/16/1146/014 (30 x 1 film-coated tablets) EU/1/16/1146/015 (60 x 1 film-coated tablets) EU/1/16/1146/016 (70 x 1 film-coated tablets) EU/1/16/1146/017 (90 x 1 film-coated tablets) EU/1/16/1146/018 (100 x 1 film-coated tablets)
Glyxambi 25 mg/5 mg filmom obložene tablete EU/1/16/1146/010 (7 x 1 filmom obložena tableta) EU/1/16/1146/011 (10 x 1 filmom obložena tableta) EU/1/16/1146/012 (14 x 1 filmom obložena tableta) EU/1/16/1146/013 (28 x 1 filmom obložena tableta) EU/1/16/1146/014 (30 x 1 filmom obložena tableta) EU/1/16/1146/015 (60 x 1 filmom obložena tableta) EU/1/16/1146/016 (70 x 1 filmom obložena tableta) EU/1/16/1146/017 (90 x 1 filmom obložena tableta) EU/1/16/1146/018 (100 x 1 filmom obložena tableta)
The study population included 1211 (17.4 %) patients ≥ 75 years of age, the mean HbA1c was 8.0 %, 63 % were male.
Ispitivana populacija uključivala je 1211 (17,4%) bolesnika u dobi
Hepatic impairment:
Oštećenje jetrene funkcije:
EU/1/16/1146/010 7 x 1 film-coated tablets EU/1/16/1146/011 10 x 1 film-coated tablets EU/1/16/1146/012 14 x 1 film-coated tablets EU/1/16/1146/013 28 x 1 film-coated tablets EU/1/16/1146/014 30 x 1 film-coated tablets EU/1/16/1146/015 60 x 1 film-coated tablets EU/1/16/1146/016 70 x 1 film-coated tablets EU/1/16/1146/017 90 x 1 film-coated tablets EU/1/16/1146/018 100 x 1 film-coated tablets
EU/1/16/1146/010 7 x 1 filmom obložena tableta EU/1/16/1146/011 10 x 1 filmom obložena tableta EU/1/16/1146/012 14 x 1 filmom obložena tableta EU/1/16/1146/013 28 x 1 filmom obložena tableta EU/1/16/1146/014 30 x 1 filmom obložena tableta EU/1/16/1146/015 60 x 1 filmom obložena tableta EU/1/16/1146/016 70 x 1 filmom obložena tableta EU/1/16/1146/017 90 x 1 filmom obložena tableta EU/1/16/1146/018 100 x 1 filmom obložena tableta
EU/1/16/1146/001 7 x 1 film-coated tablets EU/1/16/1146/002 10 x 1 film-coated tablets EU/1/16/1146/003 14 x 1 film-coated tablets EU/1/16/1146/004 28 x 1 film-coated tablets EU/1/16/1146/005 30 x 1 film-coated tablets EU/1/16/1146/006 60 x 1 film-coated tablets EU/1/16/1146/007 70 x 1 film-coated tablets EU/1/16/1146/008 90 x 1 film-coated tablets EU/1/16/1146/009 100 x 1 film-coated tablets
EU/1/16/1146/001 7 x 1 filmom obložena tableta EU/1/16/1146/002 10 x 1 filmom obložena tableta EU/1/16/1146/003 14 x 1 filmom obložena tableta EU/1/16/1146/004 28 x 1 filmom obložena tableta EU/1/16/1146/005 30 x 1 filmom obložena tableta EU/1/16/1146/006 60 x 1 filmom obložena tableta EU/1/16/1146/007 70 x 1 filmom obložena tableta EU/1/16/1146/008 90 x 1 filmom obložena tableta EU/1/16/1146/009 100 x 1 filmom obložena tableta
Glyxambi 10 mg/5 mg film-coated tablets EU/1/16/1146/001 (7 x 1 film-coated tablets) EU/1/16/1146/002 (10 x 1 film-coated tablets) EU/1/16/1146/003 (14 x 1 film-coated tablets) EU/1/16/1146/004 (28 x 1 film-coated tablets) EU/1/16/1146/005 (30 x 1 film-coated tablets) EU/1/16/1146/006 (60 x 1 film-coated tablets) EU/1/16/1146/007 (70 x 1 film-coated tablets) EU/1/16/1146/008 (90 x 1 film-coated tablets) EU/1/16/1146/009 (100 x 1 film-coated tablets)
Glyxambi 10 mg/5 mg filmom obložene tablete EU/1/16/1146/001 (7 x 1 filmom obložena tableta) EU/1/16/1146/002 (10 x 1 filmom obložena tableta) EU/1/16/1146/003 (14 x 1 filmom obložena tableta) EU/1/16/1146/004 (28 x 1 filmom obložena tableta) EU/1/16/1146/005 (30 x 1 filmom obložena tableta) EU/1/16/1146/006 (60 x 1 filmom obložena tableta) EU/1/16/1146/007 (70 x 1 filmom obložena tableta) EU/1/16/1146/008 (90 x 1 filmom obložena tableta) EU/1/16/1146/009 (100 x 1 filmom obložena tableta)
Non-CV mortality N (%) Hazard ratio vs. placebo (95% CI)
Moždani udar bez smrtnog ishoda N (%) Omjer hazarda naspram placeba (95% CI) p−vrijednost Mortalitet svih uzroka N (%) Omjer hazarda naspram placeba (95% CI) p-vrijednost Nekardiovaskularni mortalitet N (%) Omjer hazarda naspram placeba (95% CI)
STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 25 mg empagliflozin and 5 mg linagliptin.
NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 25 mg empagliflozina i 5 mg linagliptina.
STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 10 mg empagliflozin and 5 mg linagliptin.
NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 10 mg empagliflozina i 5 mg linagliptina.
Increased urination Dysuria
Pojačano mokrenje Dizurija
It is not known whether Glyxambi is harmful to the unborn child. As a precautionary measure it is preferrable to avoid the use of this medicine during pregnancy.
Nije poznato je li Glyxambi štetan za nerođeno dijete.
NAME OF THE MEDICINAL PRODUCT Glyxambi 10 mg/5 mg film-coated tablets empagliflozin/linagliptin
Glyxambi 10 mg/5 mg filmom obložene tablete empagliflozin/linagliptin
100 ml vial
Karencija bočica 100
Pharmaceutical form
Farmac eutski oblik
● severe allergic reactions
● teške alergijske reakcije
Adults and adolescents 12 years of age and over
Odrasli i adolescenti u dobi od 12 godina i stariji
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koji druge lijekove.
Do not use this medicine if you notice any change in the appearance of the tablets.
Ovaj lijek se ne smije upotrijebiti ako primjetite bilo kakvu promjenu izgleda tableta.
Date of first authorisation: 24 November 2011 Date of latest renewal: 8 August 2016
Datum posljednje obnove odobrenja: 8. kolovoza 2016.
Desloratadine Teva with food, drink and alcohol
Desloratadin Teva s hranom, pićem i alkoholom
< 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
< 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
The recommended dose is one tablet once a day with water, with or without food.
Preporučena doza je jedna tableta jedanput na dan, a uzima se s vodom, uz obrok ili natašte.
Packs of 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90, 100 and 105 film-coated tablets.
Pakiranja od 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90, 100 i 105 filmom obloženih tableta.
Desloratadine Teva may be taken with or without a meal.
Desloratadin Teva se može uzeti uz ili bez obroka.
Common: the following may affect up to 1 in 10 people
Česte: sljedeće nuspojave mogu se javiti u do 1 na 10 osoba:
Treatment with desloratadine also significantly reduced interference with sleep and daytime function, as measured by a fourpoint scale used to assess these variables.
Liječenje desloratadinom također je značajno smanjilo utjecaj na spavanje i dnevne aktivnosti, što se mjerilo skalom od četiri stupnja za procjenu tih varijabli.
Talk to your doctor or pharmacist before taking Desloratadine Teva
Obratite se svom liječniku ili ljekarniku prije nego uzmete Desloratadin Teva.
Very rare: the following may affect up to 1 in 10,000 people
Vrlo rijetke: sljedeće nuspojave mogu se javiti u do 1 na 10 000 osoba:
OPA/Alu/PVC - Aluminium blisters.
OPA/Alu/PVC-aluminij blisteri.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Neklinički podaci ne ukazuju na poseban rizik za ljude temeljem konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala,
Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Desloratadine Teva.
Vezano za trajanje liječenja, Vaš će liječnik odrediti od kojeg tipa alergijskog rinitisa bolujete te koliko dugo trebate uzimati Desloratadin Teva.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili glukoza-galaktoza malapsorpcijom ne smiju uzimati ovaj lijek.
Adults and adolescents (12 years of age and over) The recommended dose of Desloratadine Teva 5 mg film-coated tablets is one tablet once a day.
Odrasli i adolescenti (u dobi od 12 godina i stariji) Preporučena doza lijeka Desloratadin Teva 5 mg filmom obložene tablete je jedna tableta jedanput na dan.
Other medicines and Desloratadine Teva
Drugi lijekovi i Desloratadin Teva
● liver inflammation ● abnormal liver function tests body movement Not known: frequency cannot be estimated from the available data
● odstupanja od normalnih rezultata pokretima tijela testova jetrene funkcije Nepoznata učestalost: ne može se procijeniti iz dostupnih podataka
Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures
Omaglica, somnolencija, nesanica, psihomotorna hiperaktivnost, napadaji
Each film-coated tablet contains 1.2 mg of lactose monohydrate (see section 4.4).
Jedna filmom obložena tableta sadrži 1,2 mg laktoza hidrata (vidjeti dio 4.4.)
Use caution when taking Desloratadine Teva with alcohol.
Potreban je oprez kada se Desloratadin Teva uzima s alkoholom.
Desloratadine Teva 5 mg
Desloratadin Teva 5 mg
● yellowing of the skin and/or eyes ● increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to UV
● povećana osjetljivost kože na sunčevu svjetlost, čak i u slučaju slabog sunca, i na UV (ultraljubičastu) svjetlost, na primjer UV svjetlost solarija
There are no known interactions of Desloratadine Teva with other medicines.
Nema poznatih interakcija između lijeka Desloratadin Teva i drugih lijekova.
Contents of the pack and other information What Desloratadine Teva contains
Sadržaj pakiranja i druge informacije Što Desloratadin Teva sadrži
The safety and efficacy of Desloratadine Teva 5 mg film-coated tablets in children below the age of 12 years have not been established.
Sigurnost i djelotvornost lijeka Desloratadin Teva 5 mg filmom obložene tablete u djece mlađe od 12 godina nisu ustanovljene.
How to store Desloratadine Teva Contents of the pack and other information
Kako čuvati Desloratadin Teva Sadržaj pakiranja i druge informacije
Desloratadine Teva contains desloratadine which is an antihistamine.
Desloratadin Teva sadrži desloratadin koji je antihistaminik.
• if you are allergic to desloratadine, or any of the other ingredients of this medicine (listed in section 6) or to loratadine.
• ako ste alergični (preosjetljivi) na desloratadin, ili na neki drugi sastojak lijeka Desloratadin Teva (naveden u dijelu 6.) ili na loratadin.
If you take more Desloratadine Teva than you should
Ako uzmete više Desloratadina Teva nego što ste trebali
What Desloratadine Teva looks like and contents of the pack
Kako Desloratadin Teva izgleda i sadržaj pakiranja
It also contains lactose monohydrate.
Također sadrži laktozu hidrat.
A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Desloratadine Teva 5 mg film-coated tablets therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Desloratadin Teva 5 mg filmom obložene tablete uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Podrobnije informacije o ovom lijeku dostupne su na web stranicama Europske agencije za lijekove http://www.ema.europa.eu.
Increased appetite
● povećan apetit
Tachycardia, palpitations QT prolongation
Tahikardija, palpitacije Produljenje QT intervala
What Desloratadine Teva is and what it is used for What Desloratadine Teva is
Što je Desloratadin Teva i za što se koristi Što je Desloratadin Teva