natgillin/translations-raw huggingface dataset:
EU/1/12/755/019 [14 tablets] EU/1/12/755/020 [28 tablets] EU/1/12/755/021 [30 tablets] EU/1/12/755/022 [50 tablets] EU/1/12/755/023 [56 tablets] EU/1/12/755/024 [84 tablets] EU/1/12/755/025 [90 tablets] EU/1/12/755/026 [98 tablets] EU/1/12/755/027 [100 tablets] 
EU/1/12/755/019 [14 tableta] EU/1/12/755/020 [28 tableta] EU/1/12/755/021 [30 tableta] EU/1/12/755/022 [50 tableta] EU/1/12/755/023 [56 tableta] EU/1/12/755/024 [84 tablete] EU/1/12/755/025 [90 tableta] EU/1/12/755/026 [98 tableta] EU/1/12/755/027 [100 tableta]
NAME OF THE MARKETING AUTHORISATION HOLDER Actavis Group PTC ehf. 
Nositelj odobrenja za stavljanje lijeka u promet Actavis Group PTC ehf.
EU/1/12/755/010 [14 tablets] EU/1/12/755/011 [28 tablets] EU/1/12/755/012 [30 tablets] EU/1/12/755/013 [50 tablets] EU/1/12/755/014 [56 tablets] EU/1/12/755/015 [84 tablets] EU/1/12/755/016 [90 tablets] EU/1/12/755/017 [98 tablets] EU/1/12/755/018 [100 tablets] 
EU/1/12/755/010 [14 tableta] EU/1/12/755/011 [28 tableta] EU/1/12/755/012 [30 tableta] EU/1/12/755/013 [50 tableta] EU/1/12/755/014 [56 tableta] EU/1/12/755/015 [84 tablete] EU/1/12/755/016 [90 tableta] EU/1/12/755/017 [98 tableta] EU/1/12/755/018 [100 tableta]
Pioglitazone Actavis 30 mg tablets are white, round, flat, bevelled, 7 mm in diameter and engraved with ‘TZ30' on one side. 
- Pioglitazon Actavis 30 mg tablete su bijele, okrugle, ravne s ukošenim rubom, promjera 7 mm s utisnutom oznakom ‘TZ30' na jednoj strani.
There may be an increased possibility of becoming pregnant because you may ovulate again when you take Pioglitazone Actavis. 
Kad uzimate Pioglitazon Actavis, možete ponovno imati ovulaciju pa mogućnost trudnoće može biti povećana.
Pioglitazone Actavis 15 mg tablets pioglitazone 
Pioglitazon Actavis 15 mg tablete pioglitazon
QUALITATIVE AND QUANTITATIVE COMPOSITION Pioglitazone Actavis 15 mg tablets Each tablet contains 15 mg of pioglitazone (as hydrochloride). 
Jedna tableta lijeka Pioglitazon Actavis od 15 mg sadrži 15 mg pioglitazona (u obliku pioglitazonklorida).
Pioglitazone Actavis 30 mg tablets 
Pioglitazone Actavis 30 mg tablete
Allergic reactions have been reported (frequency not known) in patients taking Pioglitazone Actavis. 
Kod bolesnika koji su uzimali Pioglitazon Actavis prijavljene su alergijske reakcije (nepoznate učestalosti).
Pioglitazone Actavis 45 mg tablets pioglitazone 
Pioglitazon Actavis 45 mg tablete pioglitazon
Pioglitazone Actavis 45 mg tablets 
Pioglitazone Actavis 45 mg tablete
Musculoskeletal and connective tissue disorders fracture bone common common common common common arthralgia common common common back pain common 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva prijelom kosti često često često često često artralgija često često često križobolja često
Pioglitazone Actavis 30 mg tablets pioglitazone 
Pioglitazon Actavis 30 mg tablete pioglitazon
Pioglitazone Actavis 15 mg tablets 
Pioglitazone Actavis 15 mg tablete
Pioglitazone Actavis 45 mg 
16. PODACI NA BRAILLEOVOM PISMU Pioglitazon Actavis 45 mg
Pioglitazone Actavis 15 mg 
16. PODACI NA BRAILLEOVOM PISMU Pioglitazon Actavis 15 mg
The risk of fractures should be considered in the long term care of patients treated with pioglitazone (see section 4.8). 
Rizik od prijeloma treba uzeti u obzir kod dugotrajnog liječenja bolesnika pioglitazonom.
Pioglitazone Actavis 30 mg 
16. PODACI NA BRAILLEOVOM PISMU Pioglitazon Actavis 30 mg
NAME OF THE MEDICINAL PRODUCT Pioglitazone Actavis 15 mg tablets 
KVALITATIVNI I KVANTITATIVNI SASTAV Pioglitazone Actavis 15 mg tablete
General disorders and administration site conditions oedema very common fatigue uncommon 
Opći poremećaji i reakcije na mjestu primjene edem vrlo često umor manje često
Exforge HCT with food, drink and alcohol 
Exforge HCT s hranom, pićem i alkoholom
Date of first authorisation: 16 October 2009 Date of latest renewal: 30 June 2014 
Datum posljednje obnove odobrenja: 30. lipnja 2014.
• ACE inhibitors or aliskiren (see also information under the headings “Do not take Exforge HCT” and “Warnings and precautions”). 
ACE inhibitori ili aliskiren (vidjeti također informacije pod naslovom „Nemojte uzimati Exforge HCT“ i „Upozorenja i mjere opreza“).
Do not take Exforge HCT if you are more than 3 months pregnant. 
Nemojte uzimati Exforge HCT ako ste trudni više od 3 mjeseca.
Children and adolescents The use of Exforge HCT in children and adolescents under 18 years of age is not recommended. 
Djeca i adolescenti Primjena Exforge HCT-a u djece i adolescenata mlađih od 18 godina se ne preporučuje.
See also information under the heading “Do not take Exforge HCT”. 
Vidjeti također informacije pod naslovom „Nemojte uzimati Exforge HCT“.
Exforge HCT is not recommended in early pregnancy and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy. 
Exforge HCT se ne preporučuje u ranoj trudnoći te se ne smije uzimati kada ste trudni više od 3 mjeseca, jer može ozbiljno naštetiti Vašem djetetu ako se uzima nakon trećeg mjeseca trudnoće.
Protect your skin from sun exposure and UV rays while taking Exforge HCT. 
Zaštitite svoju kožu od izlaganja suncu i UV zrakama za vrijeme uzimanja Exforge HCT.
Your doctor will normally advise you to stop taking Exforge HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Exforge HCT. 
Liječnik će Vas u pravilu savjetovati da prekinete uzimati Exforge HCT prije trudnoće ili čim saznate da ste trudni te će Vas savjetovati da uzmete drugi lijek umjesto Exforge HCT-a.
The usual dose of Exforge HCT is one tablet per day. 
Uobičajena doza Exforge HCT-a je jedna tableta na dan.
Before switching to Exforge HCT patients should be controlled on stable doses of the monocomponents taken at the same time. 
Prije prelaska na Exforge HCT bolesnici trebaju biti kontrolirani na stabilnim dozama monokomponenti koje se uzimaju u isto vrijeme.
(It is also recommended to avoid Exforge HCT in early pregnancy - see Pregnancy section.) 
(Preporučuje se izbjegavati Exforge HCT u ranoj trudnoćividjeti dio Trudnoća.)
Exforge HCT is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is a newborn, or was born prematurely. 
Exforge HCT se ne preporučuje majkama koje doje, a ako želite dojiti liječnik Vam može odabrati drugo liječenje, posebno ako je Vaše dijete novorođenče ili je prijevremeno rođeno.
To date there is no experience of the safe use of Exforge HCT in patients who have had a recent kidney transplantation. 
Do danas ne postoji iskustvo o sigurnoj primjeni Exforge HCT-a u bolesnika kojima je nedavno transplantiran bubreg.
Do not take Exforge HCT with grapefruit or grapefruit juice. 
Ne uzimajte Exforge HCT s grejpom ili sokom od grejpa.
There is no relevant use of Exforge HCT in the paediatric population (patients below age 18 years) for the indication of essential hypertension. 
Nema relevantne primjene Exforge HCT-a u pedijatrijskoj populaciji (bolesnici mlađi od 18 godina) za indikaciju esencijalne hipertenzije.
However, it is important to take into account that Exforge HCT may increase the hypotensive effect of other antihypertensive agents. 
No važno je uzeti u obzir da Exforge HCT može povećati hipotenzivni učinak drugih antihipertenzivnih lijekova.
Exforge HCT was studied in a double-blind, active controlled study in hypertensive patients. 
Exforge HCT je ispitivan u dvostruko slijepoj, aktivno kontroliranom ispitivanju u hipertenzivnih bolesnika.
What Exforge HCT is and what it is used for 
Što je Exforge HCT i za što se koristi
The full blood pressure lowering effect was achieved 2 weeks after being on their maximal dose of Exforge HCT. 
Potpuni učinak na sniženje krvnog tlaka postignut je nakon 2 tjedna primjene najviše doze Exforge HCT-a.
What Exforge HCT is and what it is used for What you need to know before you take Exforge HCT How to take Exforge HCT 
Što je Exforge HCT i za što se koristi Što morate znati prije nego počnete uzimati Exforge HCT Kako uzimati Exforge HCT
The recommended dose of Exforge HCT is one tablet per day, to be taken preferably in the morning. 
Preporučena doza Exforge HCT-a je jedna tableta na dan koju je najbolje uzimati ujutro.
Patients taking Exforge HCT and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur. 
Bolesnici koji uzimaju Exforge HCT i upravljaju vozilima ili rade na strojevima trebaju imati na umu da se katkada mogu javiti omaglica ili iscrpljenost.
If patients taking Exforge HCT suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired. 
Ako bolesnici koji uzimaju Exforge HCT pate od omaglice, glavobolje, umora ili mučnine, njihova sposobnost reagiranja mogla bi biti narušena.
These could be symptoms of an increase of pressure in your eye and can happen within hours to a week of taking Exforge HCT. 
Ti bi mogli biti simptomi povišenog tlaka u Vašem oku, koji se može pojaviti unutar nekoliko sati do tjedan dana nakon uzimanja Exforge HCT-a.
The European Medicines Agency has waived the obligation to submit the results of studies with Exforge HCT in all subsets of the paediatric population in essential hypertension (see section 4.2 for information on paediatric use). 
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Exforge HCT u svim podskupinama pedijatrijske populacije u liječenju esencijalne hipertenzije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Talk to your doctor or pharmacist before taking Exforge HCT if you have a low level of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm). 
Obratite se svom liječniku ili ljekarniku prije nego uzmete Exforge HCT ako imate nisku razinu kalija ili magnezija u Vašoj krvi (sa ili bez simptoma kao što su slabost mišića, spazmi mišića, poremećen srčani ritam).
Therefore, Exforge HCT is not recommended in this population. 
Stoga se u ovoj populaciji Exforge HCT ne preporučuje.
Statistically greater proportions of patients achieved blood pressure control (<140/90 mmHg) with Exforge HCT (71%) compared to each of the three dual combination therapies (45-54%) (p<0.0001). 
Statistički veći udjeli bolesnika postigli su kontrolu krvnog tlaka (<140/90 mmHg) s Exforge HCT-om (71%) u usporedbi s primjenom bilo koje od tri dvojne kombinacijske terapije (45-54%) (p<0,0001).
The dose of Exforge HCT should be based on the doses of the individual components of the combination at the time of switching. 
Dozu Exforge HCT-a treba temeljiti na dozama pojedinih komponenata kombinacije u vrijeme prelaska.
Due to the hydrochlorothiazide component, Exforge HCT is contraindicated in symptomatic hyperuricaemia. 
Zbog hidroklortiazidne komponente Exforge HCT je kontraindiciran u simptomatskoj hiperuricemiji.
If you think you may be allergic, do not take Exforge HCT and talk to your doctor. 
Ako mislite da biste mogli biti alergični, nemojte uzeti Exforge HCT i porazgovarajte sa svojim liječnikom.
Exforge HCT can be used by people aged 65 years and over at the same dose as for other adults and in the same way as they have already taken the three substances called amlodipine, valsartan and hydrochlorothiazide. 
Osobe u dobi od 65 i više godina mogu uzimati Exforge HCT u istoj dozi kao i druge odrasle osobe i na isti način na koji su do sada već uzimale tri djelatne tvari zvane amlodipin, valsartan i hidroklorotiazid.
Elderly patients, particularly those taking the maximum dose of Exforge HCT (10 mg/320 mg/25 mg), should have their blood pressure checked regularly. 
Starijim bolesnicima, posebno onima koji uzimaju najvišu dozu Exforge HCT-a (10 mg/320 mg/25 mg), treba redovito kontrolirati krvni tlak.
If hypokalaemia develops during hydrochlorothiazide therapy, Exforge HCT should be discontinued until stable correction of the potassium balance. 
Ako se hipokalijemija razvije tijekom terapije hidroklorotiazidom, potrebno je prekinuti uzimanje Exforge HCT-a sve dok se postigne stabilna korekcija ravnoteže kalija.
Clinically significant hypotension due to Exforge HCT overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output. 
Klinički značajna hipotenzija zbog predoziranja Exforge HCT-om zahtijeva aktivnu kardiovaskularnu potporu, uključujući često praćenje srčane i respiratorne funkcije, podizanje ekstremiteta, uz praćenje volumena cirkulirajuće tekućine i mokrenja.
What you need to know before you take Exforge HCT 
Što morate znati prije nego počnete uzimati Exforge HCT
Exforge HCT can be taken with or without food. 
Exforge HCT se može uzimati s hranom ili bez nje.
In this active controlled clinical trial, the most common reasons for discontinuation of therapy with Exforge HCT were dizziness and hypotension (0.7%). 
Najčešći razlozi prekida terapije Exforge HCT-om u ovom aktivno kontroliranom kliničkom ispitivanju bili su omaglica i hipotenzija (0,7%).
You can take Exforge HCT with or without food. 
Exforge HCT možete uzimati s hranom ili bez nje.
Stopping your treatment with Exforge HCT may cause your disease to get worse. 
Prestanak liječenja Exforge HCT-om može dovesti do pogoršanja bolesti od koje bolujete.
Exforge HCT is available in packs containing 14, 28, 30, 56, 90, 98 or 280 film-coated tablets, in multipacks of 280 tablets (comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets), and in hospital packs containing 56, 98 or 280 tablets in single perforated dose blisters. 
Exforge HCT je dostupan u pakiranjima koja sadrže 14, 28, 30, 56, 90, 98 ili 280 filmom obloženih tableta, u višestrukim pakiranjima od 280 tableta (koja sadrže 4 kutije, od kojih svaka sadrži 70 tableta, ili 20 kutija, od kojih svaka sadrži 14 tableta), i u bolničkim pakiranjima koja sadrže 56, 98 ili 280 tableta u perforiranim blisterima djeljivim na jedinične doze.
If Exforge HCT is used during breast-feeding, doses should be kept as low as possible. 
Ako se Exforge HCT uzima tijekom dojenja, doze moraju biti najmanje moguće.
Based on the existing data with the components, the use of Exforge HCT is not recommended during first trimester and contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4). 
Na temelju postojećih podataka o komponentama, primjena Exforge HCT-a ne preporučuje se tijekom prvog tromjesečja, dok je tijekom drugog i trećeg tromjesečja trudnoće kontraindicirana (vidjeti dijelove 4.3 i 4.4).
Exforge HCT should be used with caution to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney since blood urea and serum creatinine may increase in such patients. 
Exforge HCT se treba primjenjivati s oprezom u liječenju hipertenzije u bolesnika s jednostranom ili obostranom stenozom bubrežne arterije ili stenozom bubrežne arterije kod postojanja samo jednog bubrega budući da se u ovih bolesnika može povisiti urea u krvi i serumski kreatinin.
The rate and extent of absorption of amlodipine, valsartan and hydrochlorothiazide from Exforge HCT are the same as when administered as individual dosage forms. 
Brzina i opseg apsorpcije amlodipina, valsartana i hidroklorotiazida iz Exforge HCT-a jednaki su onima pri primjeni pojedinačnih dozirnih oblika.
In a variety of preclinical safety studies conducted in several animal species with amlodipine, valsartan, hydrochlorothiazide, valsartan/hydrochlorothiazide, amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide (Exforge HCT), there was no evidence of systemic or target organ toxicity that would adversely affect the development of Exforge HCT for clinical use in humans. 
U nizu nekliničkih ispitivanja sigurnosti, provedenih na nekoliko vrsta životinja s amlodipinom, valsartanom, hidroklorotiazidom, valsartanom/hidroklorotiazidom, amlodipinom/valsartanom te amlodipinom/valsartanom/hidroklorotiazidom (Exforge HCT), nije bilo dokaza sistemske toksičnosti ili toksičnosti za pojedini ciljni organ koji bi negativno utjecali na razvoj Exforge HCT-a za kliničku primjenu u ljudi.
Exforge HCT combines three antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines and hydrochlorothiazide belongs to the thiazide diuretics class of medicines. 
Exforge HCT kombinira tri antihipertenzivna sastojka s komplementarnim mehanizmima kontrole krvnog tlaka u bolesnika s esencijalnom hipertenzijom: amlodipin pripada skupini kalcijevih antagonista, valsartan pripada skupini antagonista angiotenzina II, a hidroklorotiazid pripada skupini tiazidnih diuretika.
The amlodipine component of Exforge HCT inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle. 
Amlodipinska komponenta Exforge HCT-a inhibira transmembranski ulaz iona kalcija u srčani mišić i glatki mišić krvnih žila.
What Exforge HCT contains 
Što Exforge HCT sadrži
If you get these symptoms, stop taking Exforge HCT and contact your doctor straight away. 
Ako dobijete ove simptome, prekinite uzimati Exforge HCT i odmah se javite svom liječniku.
Since renal clearance of lithium is reduced by thiazides, the risk of lithium toxicity may presumably be increased further with Exforge HCT. 
Budući da je bubrežni klirens litija smanjen s tiazidima, rizik od toksičnosti litija vjerojatno se može povećati s Exforge HCT-om.
In the controlled trial of Exforge HCT, the counteracting effects of valsartan 320 mg and hydrochlorothiazide 25 mg on serum potassium approximately balanced each other in many patients. 
U kontroliranom ispitivanju Exforge HCT-a, suprotni učinci 320 mg valsartana i 25 mg hidroklorotiazida na kalij u serumu su se približno uravnotežili u mnogih bolesnika.
In case severe or rapid hyponatraemia develops during Exforge HCT therapy, the treatment should be discontinued until normalisation of natraemia. 
U slučaju razvoja teškog ili brzog oblika hiponatrijemije tijekom terapije Exforge HCT-om, liječenje je potrebno prekinuti do normalizacije natrijemije.
Exforge HCT is used to treat high blood pressure in adult patients whose blood pressure is already controlled while taking amlodipine, valsartan and hydrochlorothiazide and who may benefit from taking one tablet containing all three substances. 
Exforge HCT se primjenjuje za liječenje povišenog krvnog tlaka u odraslih bolesnika čiji je krvni tlak već kontroliran dok uzimaju amlodipin, valsartan i hidroklorotiazid te kojima uzimanje jedne tablete koja sadrži sve tri djelatne tvari može biti od koristi.
if you have or have had heart failure or coronary artery disease, particularly if you are prescribed the maximum dose of Exforge HCT (10 mg/320 mg/25 mg). 
ako imate ili ste imali zatajenje srca ili bolest koronarnih arterija, posebno ako je propisano da uzimate najvišu dozu Exforge HCT-a (10 mg/320 mg/25 mg).
If excessive hypotension occurs with Exforge HCT, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. 
Ako se uz Exforge HCT pojavi izrazita hipotenzija, bolesnika treba poleći na leđa i po potrebi, mu dati intravensku infuziju fiziološke otopine.
When Exforge HCT is used in patients with renal impairment periodic monitoring of serum electrolytes (including potassium), creatinine and uric acid serum levels is recommended. 
Kada se Exforge HCT primjenjuje u bolesnika s oštećenjem bubrega preporučuje se periodičko praćenje serumskih elektrolita (uključujući kalij), razina kreatinina i mokraćne kiseline u serumu.
Other medicines and Exforge HCT 
Drugi lijekovi i Exforge HCT
In sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur after initiation of treatment with Exforge HCT. 
U bolesnika sa sniženom razinom natrija i/ili smanjenjem volumena tekućine, poput onih koji primaju visoke doze diuretika, nakon početka liječenja Exforge HCT-om moguća je pojava simptomatske hipotenzije.
The safety profile of Exforge HCT presented below is based on clinical studies performed with Exforge HCT and the known safety profile of the individual components amlodipine, valsartan and hydrochlorothiazide. 
Niže prikazani sigurnosni profil Exforge HCT-a temelji se na kliničkim ispitivanjima Exforge HCT-a i poznatom sigurnosnom profilu pojedinačnih komponenti amlodipina, valsartana i hidroklorotiazida.
There is no experience on the use of Exforge HCT in pregnant women. 
Nema iskustva s primjenom Exforge HCT-a u trudnica.
The following adverse reactions, listed by MedDRA System Organ Class and frequency, concern Exforge HCT (amlodipine/valsartan/HCT) and amlodipine, valsartan and HCT individually. 
Sljedeće nuspojave, navedene prema MedDRA-inoj klasifikaciji organskih sustava i učestalosti, odnose se na Exforge HCT (amlodipin/valsartan/HCT) i amlodipin, valsartan i HCT pojedinačno.
In the 8-week controlled clinical study, changes in laboratory parameters observed with the combination of Exforge HCT were minor and consistent with the pharmacological mechanism of action of the monotherapy agents. 
Promjene vrijednosti laboratorijskih parametera opažene s kombinacijom Exforge HCT tijekom 8tjednog kontroliranog kliničkog ispitivanja bile su manje i u skladu s farmakološkim mehanizmom djelovanja pojedinačnih komponenti.
Furthermore, concomitant use of Exforge HCT and NSAIDs may lead to worsening of renal function and an increase in serum potassium. 
Osim toga, istodobna primjena Exforge HCT-a i NSAIL-a može dovesti do pogoršanja bubrežne funkcije i povećanja kalija u serumu.
Exforge HCT tablets contain three substances called amlodipine, valsartan and hydrochlorothiazide. 
Exforge HCT tablete sadrže tri djelatne tvari koje se zovu amlodipin, valsartan i hidroklorotiazid.
The use of Exforge HCT during breastfeeding is not recommended. 
Primjena Exforge HCT-a tijekom dojenja se ne preporučuje.
When switching eligible elderly hypertensive patients (see section 4.1) to Exforge HCT, the lowest available dose of the amlodipine component should be used. 
Prilikom prebacivanja starijih hipertenzivnih bolesnika koji ispunjavaju uvjete za liječenje (vidjeti dio 4.1) na Exforge HCT, treba se koristiti najniža dostupna doza amlodipina kao komponente.
Due to the hydrochlorothiazide component, Exforge HCT is contraindicated for use in patients with anuria (see section 4.3) and in patients with severe renal impairment (glomerular filtration rate (GFR) <30 ml/min/1.73 m2) (see sections 4.3, 4.4 and 5.2). 
Zbog hidroklorotiazidne komponente, primjena Exforge HCT je kontraindicirana u bolesnika s anurijom (vidjeti dio 4.3) i u bolesnika s teškim oštećenjem bubrega (brzina glomerularne filtracije (GFR) <30 ml/min/1,73 m2) (vidjeti dijelove 4.3, 4.4 i 5.2).
The side effects reported with Exforge HCT or one of its three active substances (amlodipine, valsartan and hydrochlorothiazide) are listed below and may occur with the use of Exforge HCT. 
Nuspojave prijavljene za Exforge HCT ili za jednu od tri komponente (amlodipin, valsartan i hidroklorotiazid) navedene su niže i mogu se javiti kod uzimanja Exforge HCT.
The safety of Exforge HCT has been evaluated at its maximum dose of 10 mg/320 mg/25 mg in one controlled short-term (8 weeks) clinical study with 2,271 patients, 582 of whom received valsartan in combination with amlodipine and hydrochlorothiazide. 
Sigurnost primjene Exforge HCT-a je ispitivana u njegovoj najvišoj dozi od 10 mg/320 mg/25 mg u jednom kontroliranom kratkotrajnom (8 tjedana) kliničkom ispitivanju s 2271 bolesnikom, od kojih je 582 primalo valsartan u kombinaciji s amlodipinom i hidroklorotiazidom.
Exforge HCT is contraindicated in patients with hypercalcaemia and should only be used after correction of any pre-existing hypercalcaemia. 
Exforge HCT je kontraindiciran u bolesnika s hiperkalcijemijom te se smije primjenjivati tek nakon korekcije eventualne, već postojeće hiperkalcijemije.