Dorzol 20 mg ml kapi za oko otopina

Glavna informacija

  • Trgovački naziv:
  • Dorzol 20 mg/ml kapi za oko, otopina
  • Doziranje:
  • 20 mg/ml
  • Farmaceutski oblik:
  • kapi za oko, otopina
  • Sastav:
  • Urbroj: 1 ml otopine sadrži 20 mg dorzolamida u obliku dorzolamidklorida
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Jadran Galenski laboratorij d.d., Rijeka, Republika Hrvatska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Dorzol 20 mg/ml kapi za oko, otopina
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 5 ml otopine u bočici s kapaljkom, u kutiji [HR-H-890324180-01] Urbroj: 381-12-01/38-16-06

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-890324180
  • Datum autorizacije:
  • 27-05-2016
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za korisnika

Dorzol 20 mg/ml kapi za oko, otopina

dorzolamid

Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek jer sadrži Vama

važne podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovo pročitati.

Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.

Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im štetiti, čak i ako

su njihovi znakovi bolesti jednaki Vašima.

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika. To

uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi, vidjeti dio 4.

Što se nalazi u ovoj uputi:

Što je Dorzol i za što se koristi?

Što morate znati prije nego počnete primjenjivati Dorzol?

Kako primjenjivati Dorzol?

Moguće nuspojave

Kako čuvati Dorzol?

Sadržaj pakiranja i druge informacije

1. ŠTO JE DORZOL I ZA ŠTO SE KORISTI?

Dorzol kapi za oko sadrže dorzolamid koji pripada skupini lijekova koji se zovu „inhibitori

karboanhidraze”.

Dorzol se propisuje za snižavanje povišenog očnog tlaka i za liječenje glaukoma. Može se

koristiti sam ili kao dodatak drugim lijekovima za snižavanje povišenog očnog tlaka (tzv. beta-

blokatorima).

2. ŠTO MORETE ZNATI PRIJE NEGO POČNETE PRIMJENJIVATI DORZOL?

Nemojte primjenjivati Dorzol

ako ste alergični na dorzolamid ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu

6.).

ako imate teško oštećenje funkcije bubrega ili poteškoće s bubrezima ili ste imali

bubrežne kamence.

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego primijenite Dorzol.

Obavijestite

svog

liječnika

zdravstvenim

tegobama

koje

imate

imali

uključujući

probleme s očima ili operativni zahvat na očima te o reakcijama preosjetljivosti (alergijama) na

bilo koji lijek.

Ako primijetite da Vam je oko nadraženo ili se pojave smetnje kao što su crvenilo oka ili

oticanje očnih kapaka, odmah se obratite liječniku.

H A L M E D

27-05-2016

O D O B R E N O

Ako sumnjate da je zbog primjene ovog lijeka došlo do reakcije preosjetljivosti (npr. kožni osip,

teške kožne reakcije ili svrbež kože) prestanite uzimati lijek i odmah se obratite liječniku.

Djeca

Kapi za oko koje sadrže dorzolamid ispitane su u dojenčadi i djece do 6 godina s povišenim

očnim tlakom ili glaukomom. Za dodatne informacije pitajte svog liječnika.

Starije osobe

Učinci Dorzol kapi za oko slični su u starijih i u mlađih osoba.

Bolesnici s oštećenjem funkcije jetre

Obavijestite svog liječnika ako imate ili ste ikada imali poteškoće s jetrom.

Drugi lijekovi i Dorzol

Obavijestite svog liječnika ili ljekarnika ako uzimate, ste nedavno uzeli ili biste mogli uzeti bilo

koje druge lijekove (uključujući i kapi za oči).

Osobito je važno da vaš liječnik zna ako uzimate druge inhibitore karboanhidraze, poput

acetazolamida ili sulfa lijekove.

Trudnoća i dojenje

Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate trudnoću, obratite se svom

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Dorzol se ne smije primjenjivati u trudnoći.

Dojenje se ne preporuča ako je korištenje ovog lijeka neophodno. Obavijestite svog liječnika ako

dojite ili planirate dojiti.

Upravljanje vozilima i strojevima

Nisu provedena klinička ispitivanja o utjecaju na sposobnost upravljanja vozilima ili rada sa

strojevima. Pri uporabi Dorzol kapi za oko moguće su nuspojave poput omaglice i zamućenog

vida, koje mogu utjecati na sposobnost upravljanja vozilima i rada sa strojevima. Nemojte voziti

ili raditi na stroju ako se ne osjećate dobro ili dok Vam se ne razbistri vid.

Dorzol sadrži benzalkonijev klorid

Benzalkonijev klorid je konzervans koji može nadražiti oči. Izbjegavajte kontakt s mekim

kontaktnim lećama. Uklonite kontaktne leće prije primjene lijeka te pričekajte najmanje 15

minuta prije ponovnog stavljanja leća. Poznato je da benzalkonijev klorid mijenja boju mekih

kontaktnih leća.

3. KAKO PRIMJENJIVATI DORZOL?

Uvijek primijenite ovaj lijek točno onako kako Vam je rekao Vaš liječnik. Provjerite s Vašim

liječnikom ili ljekarnikom ako niste sigurni.

Vaš liječnik će Vam propisati odgovarajuću dozu i trajanje liječenja.

Ako primjenjujete samo ovaj lijek, doza je po jedna kap u zahvaćeno oko (oči), tri puta dnevno

(ujutro, poslijepodne i navečer).

H A L M E D

27-05-2016

O D O B R E N O

Uzimate li Dorzol istodobno s drugim kapima za oko koje sadržavaju beta-blokator, Dorzol se

primjenjuje po jedna kap u zahvaćeno oko (oči), dva puta dnevno (ujutro i navečer).

Uzimate li Dorzol istodobno s drugim kapima za oči, između primjene jednih i drugih kapi mora

proći najmanje 10 minuta.

Pazite da vrhom kapaljke ne dotaknete oko ni područje oko njega. Vrh se može onečistiti

bakterijama koje mogu izazvati infekcije oka, zbog čega su moguća oštećenja oka, pa i gubitak

vida. Da biste izbjegli moguće onečišćenje bočice, operite ruke prije primjene lijeka i pazite da

vrhom kapaljke ne dodirujete nikakvu površinu. Ako smatrate da je lijek onečišćen ili da ste

dobili infekciju oka, javite se odmah liječniku zbog nastavka korištenja bočice.

Uputa za uporabu / rukovanje

Operite ruke.

Skinite čep s bočice.

Glavu zabacite prema natrag i donji kapak lagano povucite da nastane džep između

donjeg kapka i oka te ukapajte jednu kap u oko. Lagani pritisak u području suzne vrećice

(unutarnji kut oka uz nos) odmah nakon primjene kapi smanjiti će mogućnost apsorpcije

lijeka u tijelo. Držite pritisak jednu minutu i neka oko bude zatvoreno.

PAZITE DA VRHOM KAPALJKE NE DOTAKNETE OKO ILI KAPAK.

Postupak ponovite s drugim okom, ako Vas je tako uputio liječnik.

Bočicu zatvorite čepom odmah nakon primjene.

Ako primijenite više Dorzola nego što ste trebali

Ako nakapate previše kapi ili progutate sadržaj bočice, odmah se javite liječniku.

Ako ste zaboravili primijeniti Dorzol

Važno je da primjenjujete ovaj lijek kako Vam je liječnik propisao.

Ako ipak propustite dozu, primijenite je što prije možete. Međutim, ako je uskoro vrijeme za

novu

dozu,

propuštenu

dozu

jednostavno

preskočite

nastavite

primjenjivati

lijek

prema

uobičajenom rasporedu.

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

Ako prestanete primjenjivati Dorzol

Ako želite prekinuti primjenjivati ovaj lijek, obratite se svom liječniku.

U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom ovog lijeka, obratite se svom

liječniku ili ljekarniku.

4. MOGUĆE NUSPOJAVE

Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće razviti kod svakoga.

Ako

se

pojave

reakcije

preosjetljivosti

pri

primjeni

Dorzol

kapi za

oko,

uključujući

koprivnjaču, oticanje lica, usana, jezika i/ili grla koje može uzrokovati teškoće pri disanju

ili gutanju, prestanite primjenjivati lijek i odmah potražite medicinsku pomoć.

H A L M E D

27-05-2016

O D O B R E N O

Zabilježene su sljedeće nuspojave tijekom kliničkih ispitivanja ili nakon stavljanja lijeka u

promet:

Vrlo često

(mogu se javiti u više od 1 na 10 osoba)

Žarenje i peckanje u očima.

Često

(mogu se javiti u manje od 1 na 10 osoba)

Bolesti rožnice s bolovima u oku i zamućenim vidom (površinski točkasti keratitis), suzenje i

svrbež oka (konjunktivitis), upala/nadražaj očnog kapka, zamućen vid, glavobolja, mučnina,

gorak okus u ustima i umor.

Manje često

(mogu se javiti u manje od 1 na 100 osoba)

Upala šarenice.

Rijetko

(mogu se javiti u manje od 1 na 1000 osoba)

Trnci ili utrnulost dlanova ili stopala, privremena kratkovidnost koja može prestati nakon

prestanka uzimanja lijeka, pojava tekućine ispod mrežnice (odvajanje žilnice nakon filtracijskog

operativnog zahvata), bol u oku, ljuskanje (kruste) očnog kapka, nizak očni tlak, oticanje rožnice

(sa znakovima poremećenog vida), nadražaj oka s crvenilom, bubrežni kamenci, omaglica,

krvarenje iz nosa, nadražaj grla, suha usta, ograničeni kožni osip (kontaktni dermatitis), teške

kožne reakcije, znakovi alergije poput osipa, koprivnjače, svrbeža, u rijetkim slučajevima

mogućeg oticanja usana, očiju, usta, nedostatak zraka i zviždanja u prsima.

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika. Ovo

uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti

izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5. KAKO ČUVATI DORZOL?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Čuvati na temperaturi ispod 30˚C, u originalnom pakiranju, zaštićeno od svjetlosti.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza

kratice EXP.

Nakon prvog otvaranja bočice, rok valjanosti otopine je 28 dana.

Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad. Pitajte svog ljekarnika

kako baciti lijekove koje više ne koristite. Ove će mjere pomoći u očuvanju okoliša.

6. SADRŽAJ PAKIRANJA I DRUGE INFORMACIJE

Što Dorzol sadrži?

Djelatna tvar je dorzolamid.

1 ml otopine sadrži 20 mg dorzolamida u obliku dorzolamidklorida.

Pomoćne tvari su: benzalkonijev klorid, otopina; manitol; natrijev citrat; natrijev hidroksid;

hidroksietilceluloza; voda, pročišćena.

Kako Dorzol izgleda i sadržaj pakiranja?

Bistra, bezbojna otopina.

Plastična bočica s 5 ml otopine, uloženim nastavkom za kapanje i čepom, u kutiji.

H A L M E D

27-05-2016

O D O B R E N O

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

JADRAN-GALENSKI LABORATORIJ d.d., Svilno 20, 51000 Rijeka

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidiranu u svibnju 2016.

H A L M E D

27-05-2016

O D O B R E N O

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EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

17-9-2018

Agenda:  Agenda - CHMP agenda of the 17-20 September 2018 meeting

Agenda: Agenda - CHMP agenda of the 17-20 September 2018 meeting

Europe - EMA - European Medicines Agency

4-9-2018

Agenda:  Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda: Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda of CHMP written procedure*20-23 August 2018

Europe - EMA - European Medicines Agency

23-8-2018

 Minutes of the CAT meeting 18-20 April 2018

Minutes of the CAT meeting 18-20 April 2018

Europe - EMA - European Medicines Agency

22-8-2018

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye:  http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz . pic.twitter.com/ecJErFeiSH

FDA - U.S. Food and Drug Administration

22-8-2018

Cholib (Mylan IRE Healthcare Ltd)

Cholib (Mylan IRE Healthcare Ltd)

Cholib (Active substance: fenofibrate / simvastatin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5632 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2559/T/20

Europe -DG Health and Food Safety

15-8-2018

Orbactiv (Rempex London Ltd)

Orbactiv (Rempex London Ltd)

Orbactiv (Active substance: oritavancin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5556 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3785/T/20

Europe -DG Health and Food Safety

6-8-2018

Otezla (Celgene Europe B.V.)

Otezla (Celgene Europe B.V.)

Otezla (Active substance: apremilast) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5391 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3746/T/20

Europe -DG Health and Food Safety

30-7-2018

Esmya (Gedeon Richter Plc.)

Esmya (Gedeon Richter Plc.)

Esmya (Active substance: ulipristal) - Referral - Commission Decision (2018)5101 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2041/A-20

Europe -DG Health and Food Safety

22-7-2018

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. ht

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. ht

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. https://www.bloomberg.com/news/articles/2018-07-20/bayer-to-stop-selling-contraceptive-implant-after-threats-by-fda …

FDA - U.S. Food and Drug Administration

20-7-2018

Agenda:  Agenda - CAT agenda of the 18-20 July 2018 meeting

Agenda: Agenda - CAT agenda of the 18-20 July 2018 meeting

Committee for Advanced Therapies (CAT) agenda for the meeting on 18-20 July 2018

Europe - EMA - European Medicines Agency

4-7-2018

Lemtrada (Genzyme Therapeutics Ltd)

Lemtrada (Genzyme Therapeutics Ltd)

Lemtrada (Active substance: Alemtuzumab) - Centralised - Renewal - Commission Decision (2018) 4348 of Wed, 04 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3718/R/20

Europe -DG Health and Food Safety

29-6-2018

A past diagnosis of asthma is also associated with #COPD in 20% of the cases. Visit  https://bit.ly/1xErH2t  to learn more. #FactFridaypic.twitter.com/JWK672XtdI

A past diagnosis of asthma is also associated with #COPD in 20% of the cases. Visit https://bit.ly/1xErH2t  to learn more. #FactFridaypic.twitter.com/JWK672XtdI

A past diagnosis of asthma is also associated with #COPD in 20% of the cases. Visit https://bit.ly/1xErH2t  to learn more. #FactFriday pic.twitter.com/JWK672XtdI

FDA - U.S. Food and Drug Administration

29-6-2018

EU/3/18/2030 (Biophytis)

EU/3/18/2030 (Biophytis)

EU/3/18/2030 (Active substance: 20-hydroxyecdysone) - Orphan designation - Commission Decision (2018)4175 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/18

Europe -DG Health and Food Safety