natgillin/translations-raw huggingface dataset:
Immune system disorders Uncommon 
Poremećaji imunološkog sustava Manje često preosjetljivost
Vision-related effects In controlled trials, a higher proportion of patients treated with pregabalin reported blurred vision than did patients treated with placebo which resolved in a majority of cases with continued dosing. 
U kontroliranim kliničkim ispitivanjima, zamagljen vid je prijavio veći udio bolesnika liječenih pregabalinom nego bolesnika koji su primali placebo.
Vertigo Hyperacusis 
Manje često hiperakuzija
Pregabalin Mylan Pharma 100 mg hard capsules EU/1/15/998/023 
Pregabalin Mylan Pharma 100 mg tvrde kapsule EU/1/15/998/023
Pregabalin Mylan Pharma 100 mg hard capsules Each hard capsule contains 100 mg of pregabalin. 
Pregabalin Mylan Pharma 100 mg tvrde kapsule Svaka tvrda kapsula sadrži 100 mg pregabalina.
STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 75 mg pregabalin. 
TVARI Jedna tvrda kapsula sadrži 75 mg pregabalina.
Discontinuation of pregabalin may resolve the reaction. 
Prekidom primjene pregabalina ova se nuspojava može povući.
Tel: + 386 1 236 31 85 
GSP Proizvodi d.o.o. Tel: + 386 1 236 31 85
• Difficulty breathing, dry nose, nasal congestion 
• otežano disanje, suhoća nosne sluznice, začepljen nos
Pregabalin Mylan Pharma 50 mg hard capsules Each hard capsule contains 50 mg of pregabalin. 
Pregabalin Mylan Pharma 50 mg tvrde kapsule Svaka tvrda kapsula sadrži 50 mg pregabalina.
INFORMATION IN BRAILLE Pregabalin Mylan Pharma 150 mg 
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Mylan Pharma 150 mg
INFORMATION IN BRAILLE Pregabalin Mylan Pharma 75 mg 
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Mylan Pharma 75 mg
Pregabalin Mylan Pharma 200 mg hard capsule 
Pregabalin Mylan Pharma 200 mg tvrde kapsule
Pregabalin Mylan Pharma 75 mg hard capsule 
Pregabalin Mylan Pharma 75 mg tvrde kapsule
Pregabalin Mylan Pharma 200 mg hard capsules EU/1/15/998/035 
Pregabalin Mylan Pharma 200 mg tvrde kapsule EU/1/15/998/035
Pregabalin Mylan Pharma 300 mg hard capsule 
Pregabalin Mylan Pharma 300 mg tvrde kapsule
Available in blister packs containing 14, 21, 56, 84, 100 capsules and in perforated unit dose blister packs containing 56 x 1, 84 x 1, 100 x 1 capsules. 
Dostupan je u blister pakiranjima koja sadrže 14, 21, 56, 84, 100 kapsula i perforiranim blister pakiranjima koja sadrže 56 x 1, 84 x 1, 100 x 1 kapsulu.
• Disturbance in attention, clumsiness, memory impairment, loss of memory, tremor, difficulty with speaking, tingling feeling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal 
• poremećaj pažnje, nespretnost, poremećaj pamćenja, gubitak pamćenja, nevoljno drhtanje
STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 150 mg pregabalin. 
TVARI Jedna tvrda kapsula sadrži 150 mg pregabalina.
• Breast pain 
• upala gušterače
Available in blister packs containing 21, 84, 100 capsules and in perforated unit dose blister packs containing 84 x 1, 100 x 1 capsules. 
Dostupan je u blister pakiranjima koja sadrže 21, 84, 100 kapsula i perforiranim blister pakiranjima koja sadrže 84 x 1, 100 x 1 kapsulu.
Pregabalin Mylan Pharma 150 mg hard capsule 
Pregabalin Mylan Pharma 150 mg tvrde kapsule
STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 200 mg pregabalin. 
TVARI Jedna tvrda kapsula sadrži 200 mg pregabalina.
Printing ink 
Prijavljivanje nuspojava
STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 25 mg pregabalin. 
TVARI Jedna tvrda kapsula sadrži 25 mg pregabalina.
STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 300 mg pregabalin. 
TVARI Jedna tvrda kapsula sadrži 300 mg pregabalina.
Pregabalin Mylan Pharma 225 mg hard capsules EU/1/15/998/040 
Pregabalin Mylan Pharma 225 mg tvrde kapsule EU/1/15/998/040
Table 1. 
PRILOG III.
Available in blister packs containing 14, 56, 100 capsules, in perforated unit dose blister packs containing 14 x 1, 56 x 1, 100 x 1 capsules and in bottles containing 200 capsules. 
Dostupan je u blister pakiranjima koja sadrže 14, 56, 100 kapsula, perforiranim blister pakiranjima koja sadrže 14 x 1, 56 x 1, 100 x 1 kapsulu i bocama koje sadrže 200 kapsula.
Vomiting, nausea, constipation, diarrhoea, flatulence, abdominal distension, dry mouth 
Rijetko edem pluća, stezanje u grlu Poremećaji probavnog sustava Često povraćanje, mučnina, konstipacija, proljev, flatulencija, distenzija abdomena, suha usta
Pregabalin Mylan Pharma 300 mg hard capsules EU/1/15/998/045 
Pregabalin Mylan Pharma 300 mg tvrde kapsule EU/1/15/998/045
Pregabalin Mylan Pharma 100 mg hard capsule 
Pregabalin Mylan Pharma 100 mg tvrde kapsule
Pregabalin Mylan Pharma 75 mg hard capsules The 75 mg capsules are No. 4, light peach opaque cap and light peach opaque body, hard-shell gelatin capsule filled with white to off-white powder. 
Pregabalin Mylan Pharma 75 mg tvrde kapsule želatinozna kapsula tvrde ovojnice sa svjetloružičastom neprozirnom kapicom i svjetloružičastim neprozirnim tijelom napunjena bjeličastim prahom.
INFORMATION IN BRAILLE Pregabalin Mylan Pharma 200 mg 
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Mylan Pharma 200 mg
NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 200 mg hard capsules pregabalin 
NAZIV LIJEKA Pregabalin Mylan Pharma 200 mg tvrde kapsule pregabalin
INFORMATION IN BRAILLE Pregabalin Mylan Pharma 100 mg 
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Mylan Pharma 100 mg
Available in blister packs containing 14, 56, 100 capsules and in perforated unit dose blister packs containing 56 x 1, 100 x 1 capsules. 
Dostupan je u blister pakiranjima koja sadrže 14, 56, 100 kapsula i perforiranim blister pakiranjima koja sadrže 56 x 1, 100 x 1 kapsulu.
Discontinuation of pregabalin 
Prekid primjene pregabalina
INFORMATION IN BRAILLE Pregabalin Mylan Pharma 300 mg 
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Mylan Pharma 300 mg
Reduction of pregabalin dose may be required in patients who have age related compromised renal function (see section 4.2 Table 1). 
U bolesnika čija je bubrežna funkcija oslabljena zbog starije dobi možda će biti potrebno smanjiti dozu pregabalina (vidjeti dio 4.2, Tablica 1).
Pregabalin Mylan Pharma 300 mg hard capsules The 300 mg capsule are No. 0, light peach opaque cap and white opaque body, hard-shell gelatin capsules filled with white to off-white powder. 
Pregabalin Mylan Pharma 300 mg želatinozna kapsula tvrde boje sa svjetloružičastom neprozirnom kapicom i bijelim neprozirnim tijelom napunjena bjeličastim prahom.
Pregabalin Mylan Pharma 200 mg hard capsules The 200 mg capsule are No. 1, light peach opaque cap and light peach opaque body, hard-shell gelatin capsules filled with white to off-white powder. 
Pregabalin Mylan Pharma 200 mg tvrde kapsule želatinozna kapsula sa svjetloružičastom neprozirnom kapicom i svjetloružičastim neprozirnim tijelom napunjena bjeličastim prahom.
NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 100 mg hard capsules pregabalin 
NAZIV LIJEKA Pregabalin Mylan Pharma 100 mg tvrde kapsule pregabalin
Pregabalin Mylan Pharma 50 mg hard capsules EU/1/15/998/009 
Pregabalin Mylan Pharma 50 mg tvrde kapsule EU/1/15/998/009
Pregabalin Mylan Pharma 150 mg hard capsules EU/1/15/998/028 
Pregabalin Mylan Pharma 150 mg tvrde kapsule EU/1/15/998/028
Pregabalin Mylan Pharma 150 mg hard capsules The 150 mg capsule are No. 2, light peach opaque cap and white opaque body, hard-shell gelatin capsules filled with white to off-white powder. 
Pregabalin Mylan Pharma 150 mg tvrde kapsule želatinozna kapsula tvrde ovojnice sa svjetloružičastom neprozirnom kapicom i bijelim neprozirnim tijelom napunjena bjeličastim prahom.
NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 300 mg hard capsules pregabalin 
NAZIV LIJEKA Pregabalin Mylan Pharma 300 mg tvrde kapsule pregabalin
NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 150 mg hard capsules pregabalin 
NAZIV LIJEKA Pregabalin Mylan Pharma 150 mg tvrde kapsule pregabalin
NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 225 mg hard capsules pregabalin 
NAZIV LIJEKA Pregabalin Mylan Pharma 225 mg tvrde kapsule Pregabalin
The capsule is axially printed with MYLAN over PB200 in black ink on cap and body. 
Na kapsuli je poprečno otisnuto MYLAN iznad PB200 crnom tintom na kapici i tijelu.
STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 50 mg pregabalin. 
TVARI Jedna tvrda kapsula sadrži 50 mg pregabalina.
Available in blister packs containing 14, 56, 100 capsules, in perforated unit dose blister packs containing 56 x 1, 100 x 1 capsules and in bottles containing 200 capsules. 
Dostupan je u blister pakiranjima koja sadrže 14, 56, 100 kapsula, perforiranim blister pakiranjima koja sadrže 56 x 1, 100 x 1 kapsulu i bocama koje sadrže 200 kapsula.
PVC/PVDC-Al perforated unit dose blister pack containing 84 x 1 and 100 x 1 hard capsules. 
PVC/PVDC-Al perforirana blister pakiranja djeljiva na jedinične doze koja sadrže 84 x 1 i 100 x 1 tvrdu kapsulu.
The capsule is axially printed with MYLAN over PB225 in black ink on cap and body. 
Na kapsuli je poprečno otisnuto MYLAN iznad PB225 crnom tintom na kapici i tijelu.
Available in blister packs containing 14, 21, 56, 84, 100 capsules and in perforated unit dose blister packs containing 84 x 1, 100 x 1 capsules. 
Dostupan je u blister pakiranjima koja sadrže 14, 21, 56, 84, 100 kapsula i perforiranim blister pakiranjima koja sadrže 84 x 1, 100 x 1 kapsulu.
STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 100 mg pregabalin. 
TVARI Jedna tvrda kapsula sadrži 100 mg pregabalina.
14 hard capsules 21 hard capsules 56 hard capsules 84 hard capsules 100 hard capsules 56 x 1 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules 
14 tvrdih kapsula 21 tvrda kapsula 56 tvrdih kapsula 84 tvrde kapsule 100 tvrdih kapsula 56 x 1 tvrda kapsula 84 x 1 tvrda kapsula 100 x 1 tvrda kapsula
Pregabalin Mylan Pharma 25 mg hard capsules EU/1/15/998/001 
Pregabalin Mylan Pharma 25 mg tvrde kapsule EU/1/15/998/001
Pregabalin Mylan Pharma 25 mg hard capsule 
Pregabalin Mylan Pharma 25 mg tvrde kapsule
The capsule is axially printed with MYLAN over PB150 in black ink on cap and body. 
Na kapsuli je poprečno otisnuto MYLAN iznad PB150 crnom tintom na kapici i tijelu.
14 hard capsules 21 hard capsules 56 hard capsules 84 hard capsules 100 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules 
14 tvrdih kapsula 21 tvrda kapsula 56 tvrdih kapsula 84 tvrde kapsule 100 tvrdih kapsula 84 x 1 tvrda kapsula 100 x 1 tvrda kapsula
INFORMATION IN BRAILLE Pregabalin Mylan Pharma 25 mg 
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Mylan Pharma 25 mg
PVC/PVDC-Al perforated unit dose blister pack containing 56 x 1, 84 x 1 and 100 x 1 hard capsules. 
PVC/PVDC-Al perforirana blister pakiranja djeljiva na jedinične doze koja sadrže 56 x 1, 84 x 1 i 100 x 1 tvrdu kapsulu.
Pregabalin Mylan Pharma 50 mg hard capsule 
Pregabalin Mylan Pharma 50 mg tvrde kapsule
NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 75 mg hard capsules pregabalin 
NAZIV LIJEKA Pregabalin Mylan Pharma 75 mg tvrde kapsule pregabalin
Pregabalin Mylan Pharma 225 mg hard capsules The 225 mg capsule are No. 1, dark peach opaque cap and dark peach opaque body, hard-shell gelatin capsules filled with white to off-white powder. 
Pregabalin Mylan Pharma 225 mg tvrde kapsule želatinozna kapsula s tamnoružičastom neprozirnom kapicom i tamnoružičastim neprozirnim tijelom napunjena bjeličastim prahom.
• Increased fluid in the abdomen 
• nakupljanje tekućine u trbuhu
PVC/PVDC-Al perforated unit dose blister pack containing 14 x 1, 56 x 1 and 100 x 1 hard capsules. 
PVC/PVDC-Al perforirana blister pakiranja djeljiva na jedinične doze koja sadrže 14 x 1, 56 x 1 i 100 x 1 tvrdu kapsulu.
INFORMATION IN BRAILLE Pregabalin Mylan Pharma 50 mg 
16. PODACI NA BRAILLEOVOM PISMU Pregabalin Mylan Pharma 50 mg
The capsule is axially printed with MYLAN over PB75 in black ink on cap and body. 
Na kapsuli je poprečno otisnuto MYLAN iznad PB75 crnom tintom na kapici i tijelu.
NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 50 mg hard capsules pregabalin 
NAZIV LIJEKA Pregabalin Mylan Pharma 50 mg tvrde kapsule pregabalin
How to take Pregabalin Mylan Pharma 4. 
Kako uzimati Pregabalin Mylan Pharma 4. Moguće nuspojave
No. 4, light peach opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder. 
Tvrda želatinozna kapsula br. 4 sa svjetloružičastom neprozirnom kapicom i bijelim neprozirnim tijelom napunjena bjeličastim prahom.
PVC/PVDC-Al perforated unit dose blister pack containing 56 x 1 and 100 x 1 hard capsule. 
PVC/PVDC-Al perforirana blister pakiranja djeljiva na jedinične doze koja sadrže 56 x 1 i 100 x 1 tvrdu kapsulu.
14 hard capsules 56 hard capsules 100 hard capsules 200 hard capsules 14 x 1 hard capsules 56 x 1 hard capsules 100 x 1 hard capsules 
14 tvrdih kapsula 56 tvrdih kapsula 100 tvrdih kapsula 200 tvrdih kapsula 14 x 1 tvrda kapsula 56 x 1 tvrda kapsula 100 x 1 tvrda kapsula
Date of last renewal: DDMMYY 
Datum posljednje obnove odobrenja:
14 hard capsules 56 hard capsules 100 hard capsules 56 x 1 hard capsules 100 x 1 hard capsules 
14 tvrdih kapsula 56 tvrdih kapsula 100 tvrdih kapsula 56 x 1 tvrda kapsula 100 x 1 tvrda kapsula
The capsule is axially printed with MYLAN over PB50 in black ink on cap and body. 
Na kapsuli je poprečno otisnuto MYLAN iznad PB50 crnom tintom na kapici i tijelu.
14 hard capsules 56 hard capsules 100 hard capsules 200 hard capsules 56 x 1 hard capsules 100 x 1 hard capsules 
14 tvrdih kapsula 56 tvrdih kapsula 100 tvrdih kapsula 200 tvrdih kapsula 56 x 1 tvrda kapsula 100 x 1 tvrda kapsula
NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 25 mg hard capsules pregabalin 
NAZIV LIJEKA Pregabalin Mylan Pharma 25 mg tvrde kapsule pregabalin
The capsule is axially printed with MYLAN over PB100 in black ink on cap and body. 
Na kapsuli je poprečno otisnuto MYLAN iznad PB100 crnom tintom na kapici i tijelu.
Pregabalin Mylan Pharma 50 mg hard capsules PVC/PVDC-Al blister pack containing 14, 21, 56, 84 and 100 hard capsules. 
PVC/PVDC-Al blister pakiranja koja sadrže 14, 21, 56, 84 i 100 tvrdih kapsula.
The capsule is axially printed with MYLAN over PB25 in black ink on cap and body. 
Na kapsuli je poprečno otisnuto MYLAN iznad PB25 crnom tintom na kapici i tijelu.
Light peach opaque cap and light peach opaque body, hard-shell gelatin capsule filled with white to off-white powder. 
Tvrda želatinozna kapsula br. 0 sa svjetloružičastom neprozirnom kapicom i bijelim neprozirnim tijelom napunjena bjeličastim prahom.
• Weight gain 
• otežano gutanje
Lot 
U
Hypersensitivity Angioedema, allergic reaction 
Rijetko angioedem, alergijska reakcija Poremećaji metabolizma i prehrane Često pojačan tek
Pregabalin Mylan Pharma 100 mg hard capsules The 100 mg capsule are No. 3, dark peach opaque cap and dark peach opaque body, hard-shell gelatin capsules filled with white to off-white powder. 
Pregabalin Mylan Pharma 100 mg tvrde kapsule želatinozna kapsula tvrde ovojnice s tamnoružičastom neprozirnom kapicom i tamnoružičastim neprozirnim tijelom napunjena bjeličastim prahom.
The capsule is axially printed with MYLAN over PB300 in black ink on cap and body. 
Na kapsuli je poprečno otisnuto MYLAN i PB300 crnom tintom na kapici i tijelu.
Pregabalin Mylan Pharma 100 mg hard capsules PVC/PVDC-Al blister pack containing 21, 84 and 100 hard capsules. 
PVC/PVDC-Al blister pakiranja koja sadrže 21, 84 i 100 tvrdih kapsula.
Management 
Zbrinjavanje
Date of latest renewal: 13 November 2013 
Datum posljednje obnove: 13. studenoga 2013.
Take your dose at around the same time every day. 
Uzmite dozu svakoga dana približno u isto vrijeme.
This concern applies especially to patients: 
To se osobito odnosi na bolesnike:
• Sudden difficulty in walking or loss of balance or co-ordination. 
• iznenadne poteškoće pri hodanju ili gubitak ravnoteže ili koordinacije
There is no difference in exposure among Chinese, Japanese, and Korean subjects. 
Nema razlike u izloženosti između kineskih, japanskih i korejskih ispitanika.
For further information please refer to section 5.1. 
Za dodatne informacije molimo vidjeti dio 5.1.
The educational material should include: 
Edukacijski materijal mora sadržavati:
TTP is a serious condition and requires prompt treatment. 
TTP je ozbiljna bolest koja zahtijeva hitno liječenje.
Hazard Ratio (HR) (95% CI) 
Omjer hazarda (HR) (95% CI)
Active pathological bleeding. 
Aktivno patološko krvarenje.
What Efient looks like and contents of the pack 
Kako Efient izgleda i sadržaj pakiranja
If you miss your scheduled daily dose, take Efient when you remember. 
Ako ste propustili predviđenu dnevnu dozu, uzmite Efient kad se sjetite.
Patients may be counted in more than one row. 
Bolesnici mogu biti uključeni u više od jednog retka.
- The other ingredients are: 
Drugi sastojci su:
• Emphasis that: 
• Mora se naglasiti da:
These may be signs of a severe allergic reaction (see section 2 ‘What you need to know before you take Efient'). 
To mogu biti znakovi teške alergijske reakcije (vidjeti dio 2 'Što morate znati prije nego počnete uzimati Efient').
The format and means of dissemination, of this material should be discussed with the appropriate learned societies. 
O formatu i načinu podjele tog materijala treba raspraviti s odgovarajućim stručnim društvima.
• Sudden confusion, difficulty speaking or understanding others. 
• iznenadnu smetenost, otežano govorenje ili razumijevanje drugih osoba
b Other standard therapies were used as appropriate. 
b Drugi standardni lijekovi primjenjivali su se po potrebi.
Tell your doctor if you are taking morphine or other opioids (used to treat severe pain). 
Obavijestite svog liječnika ako uzimate morfin ili druge opioide (koji se koriste za liječenje jake boli).
Do not stop taking Efient without consulting your doctor; if you stop taking Efient too soon, your risk of a heart attack may be higher. 
Nemojte prestati uzimati Efient bez savjetovanja s liječnikom; ako prerano prestanete uzimati Efient, rizik od srčanog udara može biti povećan.
If this has happened to you, tell your doctor immediately. 
Ako se to dogodi, odmah obavijestite svog liječnika.
Talk to your doctor before taking Efient. 
Obratite se svom liječniku prije nego uzmete Efient.
• If you have an increased risk of bleeding such as: - age of 75 years or older. 
• Ako imate povećan rizik krvarenja, primjerice: - ako imate 75 ili više godina.
No dose adjustment is recommended based on ethnicity alone. 
Ne preporučuje se prilagođavati dozu samo s obzirom na etničko podrijetlo.
Mechanism of action / Pharmacodynamic effects 
Mehanizam djelovanja / Farmakodinamički učinci
It is important that you tell your doctor, dentist and pharmacist, that you are taking Efient. 
Važno je da obavijestite svog liječnika, stomatologa i ljekarnika da uzimate Efient.
Store in the original package in order to protect from air and moisture. 
Čuvati u originalnom pakiranju radi zaštite od zraka i vlage.
85276 Pfaffenhofen Germany 
85276 Pfaffenhofen
81379 Munich 
81379 München
Pharmacokinetics in special Populations 
Farmakokinetika u posebnim populacijama
Inhibitors of CYP3A: 
Inhibitori CYP3A:
Use of any thienopyridine within 5 days before enrolment was an exclusion criterion. 
Primjena bilo kojeg tienopiridina unutar 5 dana prije uključenja u ispitivanje bio je kriterij za isključenje.
• Sudden dizziness or sudden severe headache with no known cause. 
• iznenadnu omaglicu ili iznenadnu jaku glavobolju bez jasnog uzroka
• Small red bruises on the skin (ecchymoses) 
• male crvene modrice na koži (ekhimoze)
The study failed to meet any of the primary or secondary endpoints. 
Ispitivanje nije postiglo nijednu od primarnih ni sekundarnih mjera ishoda.
You should use Efient only after discussing with your doctor the potential benefits and any potential risks to your unborn child. 
Efient smijete uzimati samo nakon što ste s liječnikom razgovarali o mogućoj koristi liječenja i mogućim rizicima za Vaše nerođeno dijete.
The results of the discussion, and where appropriate the material, should be agreed with the national competent authority and be available prior to launch in each member state. 
Rezultati rasprave i po potrebi materijal moraju biti usuglašeni s nacionalnom nadležnim tijelom i moraju biti dostupni prije stavljanja lijeka na tržište u svakoj državi članici.
The usual dose of Efient is 10 mg per day. 
Uobičajena doza lijeka Efient je 10 mg na dan.
Children and adolescents Efient should not be used in children and adolescents below 18 years of age. 
Efient se ne smije koristiti u djece i adolescenata mlađih od 18 godina.
Body weight: 
Tjelesna težina:
The patient population was 92% Caucasian, 26% female, and 39% ≥ 65 years of age. 
U populaciji bolesnika bilo je 92% bijelaca, 26% žena i 39% osoba u dobi od ≥ 65 godina.
It is particularly important to tell your doctor if you are being treated with: 
Posebno je važno da obavijestite liječnika ako se liječite:
• While you are taking Efient: 
• Dok uzimate Efient:
Tell your doctor if you become pregnant or are trying to become pregnant while you are taking Efient. 
Obavijestite svog liječnika ako zatrudnite ili pokušavate zatrudnjeti dok uzimate Efient.
81366 Munich 
81366 München
What you need to know before you take Efient 
Što morate znati prije nego počnete uzimati Efient
This interaction may be related to reduced gastrointestinal motility and apply to other opioids. 
Ta bi interakcija mogla biti povezana sa smanjenim gastrointestinalnim motilitetom te bi mogla vrijediti i za druge opioide.
The benefit of prasugrel was apparent within the first 3 days and it persisted to the end of study. 
Korist od primjene prasugrela vidjela se već u prva 3 dana i trajala je do kraja ispitivanja.
• Sudden numbness or weakness of the arm, leg or face, especially if only on one side of the body. 
• iznenadnu utrnulost ili slabost u ruci, nozi ili na licu, osobito ako je zahvaćena samo jedna strana tijela
Excipient(s) with known effect 
Pomoćna(e) tvar(i) s poznatim učinkom
Your doctor may wish you to stop taking Efient temporarily due to the increased risk of bleeding 
Vaš liječnik može zatražiti da privremeno prestanete uzimati Efient zbog povećanog rizika od krvarenja.
Therefore, platelets are essential to help stop bleeding. 
Zato su trombociti neophodni za zaustavljanje krvarenja.
The safety and efficacy of Efient in children below age 18 has not been established. 
Sigurnost i djelotvornost lijeka Efient u djece mlađe od 18 godina nisu ustanovljene.
You may take Efient with or without food. 
Efient možete uzimati s hranom ili bez nje.
Patients should be advised to inform physicians and dentists that they are taking prasugrel before any surgery is scheduled and before any new medicinal product is taken. 
Bolesnike treba upozoriti da obavijeste liječnika ili stomatologa da uzimaju prasugrel prije planiranja bilo kojeg kirurškog zahvata i prije početka uzimanja bilo kojeg novog lijeka.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, genotoxicity, carcinogenic potential, or toxicity to reproduction. 
Neklinički podaci ne ukazuju na poseban hazard za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti i toksičnosti vezane za reprodukciju.
Frequencies are defined as follows: 
Učestalost je definirana kako slijedi:
Because animal reproduction studies are not always predictive of a human response, Efient should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus. 
Budući da se iz ispitivanja reprodukcije na životinjama ne može uvijek predvidjeti odgovor u ljudi, Efient se tijekom trudnoće smije primjenjivati samo ako moguća korist za majku opravdava mogući rizik za plod.
If you take more Efient than you should 
Ako uzmete više Efient tableta nego što ste trebali
Avda de la Industria 30 E-28108 Alcobendas (Madrid) Spain 
Avda de la Industria 30 E-28108 Alcobendas (Madrid) Španjolska
These patients may have an increased bleeding risk. 
Ovi bolesnici mogu imati povećan rizik od krvarenja.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 February 2009 
Datum provog odobrenja: 25. veljače 2009.
Platelets are very small cell particles that circulate in the blood. 
Trombociti (krvne pločice) su vrlo male stanice koje cirkuliraju u krvi.