natgillin/translations-raw huggingface dataset:
Date of first authorisation: 15 October 1998 Date of latest renewal: 15 October 2008
Datum pridobitve dovoljenja za promet: 15 oktober 1998 Datum zadnjega podaljšanja: 15 oktober 2008
Risk Management Plan (RMP)
• Načrt za obvladovanje tveganja (RMP)
CoAprovel should be taken at least one hour before or four hours after these medications;
CoAprovel je treba jemati vsaj eno uro pred ali štiri ure po jemanju teh zdravil.
Do not store above 30°C.
Shranjujte pri temperaturi do 30°C.
What CoAprovel is and what it is used for
Kaj je zdravilo CoAprovel in za kaj ga uporabljamo
* These limits are not applicable for batches where more than one of the above N-nitrosamines has been identified simultaneously; such batches should be rejected.
* Te meje ne veljajo za serije, v katerih so hkrati ugotovili več kot enega od zgornjih N-nitrozaminov; take serije je treba zavrniti.
Investigations:
Preiskave:
63.09 17404 Riells i Viabrea (Girona) - Spain
63.09 17404 Riells i Viabrea (Girona) Španija
See also information under the heading “Do not take CoAprovel”.
Glejte tudi informacije pod naslovom “Ne jemljite zdravila CoAprovel”.
Please see section 2 “CoAprovel contains lactose”.
Prosimo glejte poglavje 2 »Zdravilo CoAprovel vsebuje laktozo«.
2) After the transitional period of 2 years, a limit for NDMA and NDEA of maximum 0.03 ppm should be implemented.
2) Po dveletnem prehodnem obdobju je treba za NDMA in NDEA uvesti mejo največ 0,03 ppm.
It is important that you continue to take CoAprovel until your doctor tells you otherwise.
Pomembno je, da zdravilo CoAprovel jemljete redno, vse dokler vam zdravnik ne predpiše drugače.
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalca, odgovornega za sproščanje zadevne serije.
Children and adolescents CoAprovel should not be given to children and adolescents (under 18 years).
Otroci in mladostniki Zdravila CoAprovel otroci in mladostniki (mlajši od 18 let) ne smejo jemati.
if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
če ste imeli kožnega raka ali če se vam med zdravljenjem pojavijo nepričakovane kožne spremembe.
Other medicines and CoAprovel
Druga zdravila in zdravilo CoAprovel
At the time of Commission Decision.
Ob sprejetju sklepa Komisije
Such conditions should be corrected before initiating therapy with CoAprovel.
Ta stanja je treba popraviti pred začetkom zdravljenja z zdravilom CoAprovel.
sexual dysfunction, libido changes
motnje pri spolnosti, spremembe libida
If you forget to take CoAprovel
Če ste pozabili vzeti zdravilo CoAprovel
Children should not take CoAprovel
Otroci ne smejo jemati zdravila CoAprovel
Excipient with known effect:
Pomožne snovi z znanim učinkom:
2112 Veresegyház - Hungary
2112 Veresegyház - Madžarska
2112 Veresegyhaz Hungary
2112 Veresegyhaz Madžarska
If CoAprovel is used during breast feeding, doses should be kept as low as possible.
Če se zdravilo CoAprovel uporablja med dojenjem, je treba uporabiti najmanjši možni odmerek.
You should discontinue CoAprovel treatment and seek medical attention.
Prenehajte z jemanjem zdravila CoAprovel in poiščite zdravniško pomoč.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v prilogi V.
If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev (npr. laktoze), se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
PRILOGA POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
The mean age of patients was 52.5 years, 13% were ≥ 65 years of age, and just 2% were ≥ 75 years of age.
Srednja starost bolnikov je bila 52,5 let, 13% bolnikov je bilo starih 65 let ali starejših.
The recommended dose of CoAprovel is one or two tablets a day.
Priporočeni odmerek zdravila CoAprovel je ena ali dve tableti na dan.
Irbesartan AUC and Cmax values were also somewhat greater in older subjects (≥ 65 years) than those of young subjects (18-40 years).
Vrednosti AUC in Cmax za irbesartan sta pri starejših osebah (≥ 65 let) nekoliko večji kot pri mlajših (18 do 40 let).
See leaflet for further information.
Za dodatne informacije glejte navodilo za uporabo.
The study recruited 58% males.
V študijo je bilo vključenih 58% bolnikov moškega spola.
If you take more CoAprovel than you should If you accidentally take too many tablets, contact your doctor immediately.
Če ste vzeli večji odmerek zdravila CoAprovel, kot bi smeli Če ste pomotoma vzeli preveč tablet, se nemudoma posvetujte s svojim zdravnikom.
What you need to know before you take CoAprovel
Kaj morate vedeti, preden boste vzeli zdravilo CoAprovel
What CoAprovel is and what it is used for What you need to know before you take CoAprovel How to take CoAprovel
Kaj je zdravilo CoAprovel in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo CoAprovel Kako jemati zdravilo CoAprovel Možni neželeni učinki
Plasma protein binding of irbesartan is approximately 96%, with negligible binding to cellular blood components.
Na plazemske beljakovine se veže približno 96% irbesartana, na celične sestavine krvi pa zanemarljivo malo.
Ambarès & Lagrave F-33565 Carbon Blanc Cedex - France
Ambarès & Lagrave F-33565 Carbon Blanc Cedex - Francija
MARKETING AUTHORISATION NUMBERS
ŠTEVILKE DOVOLJENJ ZA PROMET
Alcohol: potentiation of orthostatic hypotension may occur;
Alkohol: pojavi se lahko ortostatska hipotenzija.
When necessary, CoAprovel may be administered with another antihypertensive medicinal product (see sections 4.3, 4.4, 4.5 and 5.1).
Kadar je nujno, smejo bolniki poleg zdravila CoAprovel jemati tudi drug antihipertenziv (glejte poglavja 4.3, 4.4, 4.5 in 5.1).
The MAH must ensure that the manufacturing processes of the drug substances used for their drug products are reviewed for the potential risk of formation of Nnitrosamines and changed as necessary to minimise nitrosamine contamination as much as possible.
Imetnik dovoljenja za promet z zdravilom mora pregledati postopke proizvodnje učinkovin, uporabljenih za svoja zdravila, glede morebitnega tveganja za nastajanje N-nitrozaminov in jih po potrebi spremeniti tako, da se onesnaženje z nitrozamini čim bolj zmanjša.
Not known (frequency cannot be estimated from the available data): skin and lip cancer (nonmelanoma skin cancer).
Neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): kožni rak in rak ustnice (nemelanomski kožni rak).
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
The recommended dose of CoAprovel is one tablet a day.
Priporočeni odmerek zdravila CoAprovel je ena tableta na dan.
The major circulating metabolite is irbesartan glucuronide (approximately 6%).
Glavni presnovek v obtoku je irbesartanov glukuronid (približno 6%).
As with any antihypertensive agent, excessive blood pressure decrease in patients with ischemic cardiopathy or ischemic cardiovascular disease could result in a myocardial infarction or stroke.
Kot pri vseh antihipertenzivih lahko preveliko znižanje krvnega tlaka pri bolnikih z ishemično kardiopatijo ali ishemično kardiovaskularno boleznijo povzroči miokardni infarkt ali kap.
increases in blood urea nitrogen (BUN), creatinine and creatine kinase
zvišanje vrednosti dušika sečnine v krvi (BUN), kreatinina in kreatin-kinaze
Based on its pharmacodynamic properties, CoAprovel is unlikely to affect the ability to drive and use machines.
Na osnovi farmakodinamičnih lastnosti je malo verjetno, da bi zdravilo CoAprovel vplivalo na sposobnost vožnje in upravljanja s stroji.
Efficacy and safety of CoAprovel as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicentre, randomized, double-blind, active-controlled, 8-week, parallel-arm study.
Učinkovitost in varnost zdravila CoAprovel kot začetnega zdravila za zdravljenje hude hipertenzije (definirana kot diastolični tlak v sedečem položaju (SeDBP) ≥ 110 mmHg) sta bili ovrednoteni z multicentrično, randomizirano, dvojno slepo, z učinkovino nadzorovano, 8-tedensko študijo paralelnih skupin.
The most commonly reported ADRs were dizziness (5.6%), fatigue (4.9%), nausea/vomiting (1.8%), and abnormal urination (1.4%).
Neželeni učinki, o katerih so najpogosteje poročali, so bili omotica (5,6 %), utrujenost (4,9 %), navzea/bruhanje (1,8 %) in motnje uriniranja (1,4 %).
Pharmacotherapeutic group: angiotensin-II antagonists, combinations ATC code: C09DA04.
Farmakoterapevtska skupina: antagonisti angiotenzina II, kombinacije oznaka ATC: C09DA04
In addition, increases in blood urea nitrogen (BUN) (2.3%), creatine kinase (1.7%) and creatinine (1.1%) were also commonly observed in the trials.
Poleg tega so v študijah pogosto opazili tudi zvišanje vrednosti dušika sečnine v krvi (BUN) (2,3 %), kreatin-kinaze (1,7 %) in kreatinina (1,1 %).
Lactose: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Laktoza: Bolniki z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
It is also important to tell your doctor if you are taking other medicines to reduce your blood pressure, steroids, medicines to treat cancer, pain killers, arthritis medicines, or colestyramine and colestipol resins for lowering blood cholesterol.
Pomembno je, da zdravnika obvestite tudi, če jemljete druga zdravila za zniževanje krvnega tlaka, kortikosteroide, zdravila za zdravljenje raka, lajšanje bolečin, zdravila proti artritisu ali zdravili holestiramin in holestipol za zniževanje holesterola v krvi.
Hydrochlorothiazide is 68% protein-bound in the plasma, and its apparent volume of distribution is 0.83-1.14 l/kg.
Na plazemske beljakovine se veže približno 68% hidroklorotiazida; njegov porazdelitveni volumen je 0,83 do 1,14 l/kg.
There is no difference in response to CoAprovel, regardless of age or gender.
Odziv na zdravljenje z zdravilom CoAprovel ni odvisen od starosti ali spola.
Limited accumulation of irbesartan (< 20%) is observed in plasma upon repeated once-daily dosing.
Omejeno kopičenje irbesartana v plazmi (< 20%) se pojavi po več dneh jemanja irbesartana enkrat na dan.
Table 2: Adverse reactions reported with the use of irbesartan alone
Tabela 2: Neželeni učinki, o katerih so poročali pri uporabi irbesartana samega
Since CoAprovel contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy.
Zdravilo CoAprovel vsebuje hidroklorotiazid, zato njegova uporaba v prvem trimesečju nosečnosti ni priporočena.
30 - 56 x 1 - 90 tablets
30 - 56 x 1 - 90 tablet
respiratory distress (including pneumonitis and pulmonary oedema)
respiratorni distres (vključno s pljučnico in pljučnim edemom)
Excipients: also contains lactose monohydrate.
Pomožne snovi: vsebuje tudi laktozo monohidrat.
Pregnancy: angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Nosečnost: zdravljenja z antagonisti angiotenzina II se ne sme začeti med nosečnostjo.
CoAprovel can be taken once daily, with or without food.
Bolniki lahko zdravilo CoAprovel jemljejo enkrat na dan skupaj s hrano ali brez nje.
Do not throw away any medicines via wastewater or household waste.
Tega zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
Your doctor will normally advise you to stop taking CoAprovel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of CoAprovel.
Zdravnik vam bo praviloma svetoval, da zdravljenje z zdravilom CoAprovel prekinete še preden zanosite ali takoj, ko se izkaže, da ste zanosili in vam predpisal zdravljenje z drugim zdravilom.
If you accidentally miss a daily dose, just take the next dose as normal.
Če ste pozabili vzeti dnevni odmerek, vzemite le naslednji predvideni odmerek ob običajnem času.
Antidiabetic medicinal products (oral agents and insulins): dosage adjustment of the antidiabetic medicinal product may be required (see section 4.4);
Antidiabetiki (peroralna zdravila in insulini): morda bo treba prilagoditi odmerek antidiabetika (glejte poglavje 4.4).
Therefore, the use of CoAprovel is not recommended.
Uporaba zdravila CoAprovel pri njih zato ni priporočena.
Table 1: Adverse Reactions in Placebo-Controlled Trials and Spontaneous Reports
Tabela 1: Neželeni učinki v s placebom nadzorovanih kliničnih študijah in spontana poročila
If a readministration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.
V kolikor je ponovna uporaba diuretika nujna, je izpostavljene dele kože priporočljivo zaščititi pred soncem ali umetnim UVA sevanjem.
CoAprovel will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough.
Zdravnik vam je zdravilo CoAprovel predpisal zato, ker se med dosedanjim zdravljenjem vaš krvni tlak ni dovolj znižal.
If you get any of the above symptoms or get short of breath, stop taking CoAprovel and contact your doctor immediately.
Če opazite katerega koli od zgoraj navedenih simptomov ali če se pojavi občutek težkega dihanja, zdravilo CoAprovel takoj prenehajte jemati in nemudoma poiščite zdravniško pomoč.
electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides
neravnovesje elektrolitov (vključno s hipokaliemijo in hiponatriemijo, glejte poglavje 4.4), hiperurikemija, glikozurija, hiperglikemija in zvišanje vrednosti holesterola ter trigliceridov
At least 61% of the oral dose is eliminated unchanged within 24 hours.
V 24 urah se v nespremenjeni obliki izloči najmanj 61% peroralnega odmerka hidroklorotiazida.
CoAprovel with food and drink CoAprovel can be taken with or without food.
Zdravilo CoAprovel skupaj s hrano in pijačo Zdravilo CoAprovel lahko jemljete skupaj s hrano ali brez nje.
AngiotensinII is a substance produced in the body that binds to receptors in blood vessels causing them to tighten.
Angiotenzin II je snov, ki nastaja v telesu in se veže na receptorje v krvnih žilah, kar povzroči njihovo zoženje.
Electrolyte imbalance: as for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Elektrolitsko neravnovesje: kot pri vseh bolnikih, ki dobivajo diuretike, je treba periodično preverjati serumsko vrednost elektrolitov, v primernih časovnih intervalih.
Psychiatric disorders:
Psihiatrične motnje:
You can take CoAprovel with or without food.
Zdravilo CoAprovel lahko jemljete s hrano ali brez nje.
Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake “Uporabno do”.
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Ob potrjeni nosečnosti je treba zdravljenje z antagonisti angiotenzina II takoj prekiniti in, če je primerno, začeti alternativno zdravljenje (glejte poglavji 4.3 in 4.6).
Renal impairment and kidney transplantation: when CoAprovel is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Ledvična okvara in presaditev ledvic: če se zdravilo CoAprovel uporablja pri bolnikih z okvarjeno ledvično funkcijo, je priporočena redna kontrola serumske koncentracije kalija, kreatinina in sečne kisline.
Anaphylactic reaction including anaphylactic shock
anafilaktična reakcija vključno z anafilaktičnim šokom
Limited clinical data (7 out of 22 patients) suggest that patients not controlled with the 300 mg/12.5 mg combination may respond when uptitrated to 300 mg/25 mg.
Omejeni klinični podatki (7 od 22 bolnikov) kažejo, da se lahko bolniki, ki niso urejeni s kombinacijo 300 mg/12,5 mg, odzovejo na povečanje na 300 mg/25 mg.
You may need to have blood checks if you take: potassium supplements salt substitutes containing potassium potassium sparing medicines or other diuretics (water tablets) some laxatives medicines for the treatment of gout therapeutic vitamin D supplements medicines to control heart rhythm medicines for diabetes (oral agents or insulins) carbamazepine (a medicine for the treatment of epilepsy).
Morda bodo potrebne krvne preiskave, če jemljete: pripravke s kalijem nadomestke soli, ki vsebujejo kalij zdravila, ki varčujejo s kalijem ali druge diuretike (tablete za odvajanje vode) nekatera odvajala zdravila za zdravljenje protina dodatke vitamina D zdravila za uravnavanje srčnega ritma zdravila za zdravljenje sladkorne bolezni (peroralni pripravki ali insulin) karbamazepin (zdravilo za zdravljenje epilepsije)
Among 898 hypertensive patients who received various doses of irbesartan/hydrochlorothiazide (range: 37.5 mg/6.25 mg to 300 mg/25 mg) in placebo-controlled trials, 29.5% of the patients experienced adverse reactions.
Med 898 bolniki s hipertenzijo, ki so v s placebom nadzorovanih študijah prejemali različne odmerke kombinacije irbesartan/hidroklorotiazid (razpon: 37,5 mg/6,25 mg do 300 mg/25 mg), je 29,5 % bolnikov izkusilo neželene učinke.
Diuretic agents such as the hydrochlorothiazide contained in CoAprovel may have an effect on other medicines.
Diuretiki, med katere spada tudi hidroklorotiazid, ki ga vsebuje zdravilo CoAprovel, lahko vplivajo na delovanje drugih zdravil.
fatigue
utrujenost
Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès & Lagrave F-33565 Carbon Blanc Cedex France
Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès & Lagrave F-33565 Carbon Blanc Cedex Francija
Hepatic impairment: thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Jetrna okvara: tiazidne diuretike je treba dajati še posebej previdno bolnikom z okvarjeno jetrno funkcijo ali napredujočo jetrno boleznijo, saj lahko že majhna sprememba ravnovesja tekočin in elektrolitov povzroči jetrno komo.
4.6 Fertility, pregnancy and lactation Pregnancy
4.6 Plodnost, nosečnost in dojenje Nosečnost
For all N-nitrosamines the MAH must ensure a control strategy is in place in drug substance batches used for their drug products.
Imetnik dovoljenja za promet z zdravilom mora za vse N-nitrozamine izvesti strategijo nadzora za serije učinkovin, ki se uporabljajo v njegovih zdravilih.
In non-clinical safety studies, high doses of irbesartan (≥ 250 mg/kg/day in rats and ≥ 100 mg/kg/day in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
V predkliničnih varnostnih študijah so veliki odmerki irbesartana (≥ 250 mg/kg/dan pri podganah in ≥ 100 mg/kg/dan pri opicah) povzročili zmanjšanje parametrov rdečih krvnih celic (eritrociti, hemoglobin, hematokrit).
non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma)
nemelanomski kožni rak (bazalnocelični karcinom in ploščatocelični karcinom)
sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - France
sanofi-aventis groupe 54, rue La Boétie, F-75008 Paris - Francija
Uncommon: Not known:
Občasni: Neznana:
cases of hypersensitivity reactions such as angioedema, rash, urticaria
primeri preobčutljivostnih reakcij, kot so angioedem, izpuščaj, urtikarija
Sanofi Winthrop Industrie 30-36, avenue Gustave Eiffel, BP 7166 F-37071, 37100 Tours France
Sanofi Winthrop Industrie 30-36, avenue Gustave Eiffel, BP 7166 F-37071, 37100 Tours Francija
Conversely, due to the irbesartan component of CoAprovel hyperkalaemia might occur, especially in the presence of renal impairment and/or heart failure, and diabetes mellitus.
Nasprotno pa se lahko zaradi irbesartana, ki ga vsebuje zdravilo CoAprovel, pojavi hiperkaliemija, zlasti pri bolnikih z ledvično okvaro in/ali srčnim popuščanjem ter sladkorno boleznijo.
impaired renal function including isolated cases of renal failure in patients at risk (see section 4.4)
okvara delovanja ledvic, vključno s posameznimi primeri odpovedi ledvic pri bolnikih s tveganjem (glejte poglavje 4.4)
Table 3: Adverse reactions reported with the use of hydrochlorothiazide alone
Tabela 3: Neželeni učinki, o katerih so poročali pri uporabi hidroklorotiazida samega
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Stenoza aortne in mitralne zaklopke, obstruktivna hipertrofična kardiomiopatija: tako kot pri zdravljenju z drugimi vazodilatatorji je potrebna pri bolnikih z aortno ali mitralno stenozo ali obstruktivno hipertrofično kardiomiopatijo posebna previdnost.
Due to the hydrochlorothiazide contained in CoAprovel, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, specially when getting up from a sitting position.
Če med zdravljenjem z zdravilom CoAprovel uživate alkoholne pijače, lahko hidroklorotiazid, ki ga vsebuje zdravilo CoAprovel, povzroči omotico v stoječem položaju, še posebej po vstajanju iz sedečega položaja.
CoAprovel is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Zdravila CoAprovel ne smete jemati, če ste noseči dlje kot 3 mesece, saj lahko zdravilo v tem obdobju resno škoduje vašemu otroku (glejte poglavje o nosečnosti).
SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel 37100 Tours - France
SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel 37100 Tours - Francija
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take CoAprovel” and “Warnings and precautions”).
Zdravnik vam bo morda moral spremeniti odmerek in/ali uporabiti druge previdnostne ukrepe: Če jemljete zaviralec ACE ali aliskiren (glejte tudi informacije pod naslovoma "Ne jemljite zdravila CoAprovel" in "Opozorila in previdnostni ukrepi").
How to take CoAprovel
Kako jemati zdravilo CoAprovel
Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4).
Otroke, katerih matere so prejemale antagoniste angiotenzina II, je treba pozorno spremljati zaradi možnosti pojava hipotenzije (glejte poglavji 4.3 in 4.4).
CoAprovel 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.
Zdravila CoAprovel ne smete jemati, če ste noseči dlje kot 3 mesece, saj lahko zdravilo po tretjem mesecu nosečnosti resno škoduje vašemu otroku.
Lithium: the combination of lithium and CoAprovel is not recommended (see section 4.5).
Litij: kombinacija litija in zdravila CoAprovel ni priporočena (glejte poglavje 4.5).
The degree to which hydrochlorothiazide is removed by haemodialysis has not been established.
Koliko hidroklorotiazida se izloči s hemodializo, niso ugotavljali.
No specific information is available on the treatment of overdose with CoAprovel.
O zdravljenju posledic prevelikega odmerjanja zdravila CoAprovel ni specifičnih podatkov.