natgillin/translations-raw huggingface dataset:
28 Elderly patients: no dosage adjustment of CoAprovel is necessary in elderly patients.
28 Starostniki: pri starostnikih odmerka zdravila CoAprovel ni treba prilagajati.
29 Hyperuricaemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.
29 Med zdravljenjem s tiazidnimi diuretiki se lahko zvečajo vrednosti holesterola in trigliceridov.
30 Lactose: this medicinal product contains lactose.
30 Laktoza: zdravilo vsebuje laktozo.
31 Alcohol: potentiation of orthostatic hypotension may occur;
Alkohol: pojavi se lahko ortostatska hipotenzija.
Colestyramine and Colestipol resins: absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins;
31 Holestiramin in holestipol: absorpcija hidroklorotiazida je zaradi anionskih izmenjevalnih smol motena.
Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see also sections 4.3 and 4.4).
32 Otroke, katerih matere so prejemale antagoniste angiotenzina II, je treba pozorno spremljati zaradi možnosti pojava hipotenzije (glejte poglavji 4. 3 in 4. 4).
Common:
omotica
syncope, hypotension, tachycardia, oedema dizziness orthostatic dizziness headache
ortostatska omotica glavobol tinitus
abnormal urination 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)
Metabolism and nutrition disorders:
Bolezni mišično- skeletnega
swelling extremity arthralgia, myalgia hyperkalaemia
artralgija, mialgija hiperkaliemija
flushing
Pogosti:
Common:
Neznana:
fatigue
primeri preobčutljivostnih reakcij, kot so angioedem, izpuščaj, urtikarija
Immune system disorders:
Bolezni jeter, žolčnika in žolčevodov:
cases of hypersensitivity reactions such as angioedema, rash, urticaria
hepatitis, motnje delovanja jeter
Hepatobiliary disorders:
Motnje reprodukcije in dojk:
hepatitis, abnormal liver function sexual dysfunction, libido changes
motnje pri spolnosti, spremembe libida
Psychiatric disorders:
Bolezni jeter, žolčnika in žolčevodov:
jaundice (intrahepatic cholestatic jaundice) depression, sleep disturbances
depresija, motnje spanja
34 4.9 Overdose
34 4. 9 Preveliko odmerjanje
The addition of 12.5 mg hydrochlorothiazide to 300 mg irbesartan once daily in patients not adequately controlled on 300 mg irbesartan alone resulted in further placebo-corrected diastolic blood pressure reductions at trough (24 hours post-dosing) of
Diastolični krvni tlak se je pri bolnikih, pri katerih zdravljenje s 300 mg irbesartana ni bilo dovolj učinkovito in so začeli jemati tudi po 12, 5 mg hidroklorotiazida enkrat na dan, 24 ur po zaužitju odmerka znižal za povprečno 6, 1 mmHg bolj kot po uporabi placeba.
The combination of 300 mg irbesartan and 12.5 mg hydrochlorothiazide resulted in an overall placebo-subtracted systolic/ diastolic reductions of up to 13.6/ 11.5 mm Hg.
35 Med kombiniranim zdravljenjem s 300 mg irbesartana in 12, 5 mg hidroklorotiazida se je sistolični krvni tlak znižal do 13, 6 mmHg, diastolični pa do 11, 5 mmHg bolj kot po uporabi placeba.
Forty-seven percent (47.2%) of patients on the combination achieved trough SeDBP < 90 mmHg compared to 33.2% of patients on irbesartan (p = 0.0005).
Vrednost SeDBP < 90 mmHg je bila dosežena pri sedeminštiridesetih odstotkih (47, 2%) bolnikov, ki so se zdravili s kombinacijo in 33, 2%
36 The types and incidences of adverse events reported for patients treated with the combination were similar to the adverse event profile for patients on monotherapy.
Pri bolnikih, ki so se zdravili s kombinacijo, so poročali o enaki vrsti in pogostnosti neželenih učinkov kot pri bolnikih, ki so se zdravili samo z eno zdravilno učinkovino.
37 5.3 Preclinical safety data
37 5. 3 Predklinični podatki o varnosti
Hydrochlorothiazide: although equivocal evidence for a genotoxic or carcinogenic effect was found in some experimental models, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
Hkrati pa tudi izkušnje z uporabo hidroklorotiazida pri ljudeh niso potrdile povezanosti med tem zdravilom in pogostejšim pojavom neoplazem.
Lactose monohydrate Hypromellose Titanium dioxide Macrogol 3000 Red and yellow ferric oxides Carnauba wax
Filmska obloga: laktoza monohidrat hipromeloza titanov dioksid makrogol 3000 Rdeči in rumeni železov oksid karnauba vosek
Cartons of 14 film-coated tablets; 1 blister card of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
Škatle s 14 filmsko obloženimi tabletami; 1 pretisni omot iz PVC/ PVDC/ aluminija s 14 filmsko obloženimi tabletami.
Cartons of 28 film-coated tablets; 2 blister cards of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
Škatle z 28 filmsko obloženimi tabletami; 2 pretisna omota iz PVC/ PVDC/ aluminija s 14 filmsko obloženimi tabletami.
Cartons of 30 film-coated tablets; 2 blister cards of 15 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
Škatle s 30 filmsko obloženimi tabletami; 2 pretisna omota iz PVC/ PVDC/ aluminija s 15 filmsko obloženimi tabletami.
Cartons of 56 film-coated tablets; 4 blister cards of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
Škatle s 56 filmsko obloženimi tabletami; 4 pretisni omoti iz PVC/ PVDC/ aluminija s 14 filmsko obloženimi tabletami.
Cartons of 84 film-coated tablets; 6 blister cards of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
Škatle s 84 filmsko obloženimi tabletami; 6 pretisnih omotov iz PVC/ PVDC/ aluminija s 14 filmsko obloženimi tabletami.
Cartons of 90 film-coated tablets; 6 blister cards of 15 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
Škatle z 90 filmsko obloženimi tabletami; 6 pretisnih omotov iz PVC/ PVDC/ aluminija s 15 filmsko obloženimi tabletami.
Cartons of 98 film-coated tablets; 7 blister cards of 14 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
Škatle z 98 filmsko obloženimi tabletami; 7 pretisnih omotov iz PVC/ PVDC/ aluminija s 14 filmsko obloženimi tabletami.
Cartons of 56 x 1 film-coated tablets; 7 blister cards of 8 x 1 film-coated tablets each in PVC/ PVDC/ Aluminium perforated unit dose blisters.
Škatle s 56 x 1 filmsko obloženo tableto; 7 pretisnih omotov z 8 x 1 filmsko obloženo tableto, vsaka v perforiranem enoodmernem pretisnem omotu iz PVC/ PVDC/ aluminija.
6.6 Special precautions for disposal
39 6. 6 Posebni varnostni ukrepi za odstranjevanje
CoAprovel 300 mg/ 12.5 mg film-coated tablets.
CoAprovel 300 mg/ 12, 5 mg filmsko obložene tablete
Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Ena filmsko obložena tableta vsebuje 300 mg irbesartana in 12, 5 mg hidroklorotiazida.
Each film-coated tablet contains 89.5 mg of lactose (as lactose monohydrate).
Ena filmsko obložena tableta vsebuje 89, 5 mg laktoze (v obliki laktoze monohidrata).
41 Elderly patients: no dosage adjustment of CoAprovel is necessary in elderly patients.
41 Starostniki: pri starostnikih odmerka zdravila CoAprovel ni treba prilagajati.
42 Hyperuricaemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.
42 Med zdravljenjem s tiazidnimi diuretiki se lahko zvečajo vrednosti holesterola in trigliceridov.
43 Lactose: this medicinal product contains lactose.
43 Laktoza: zdravilo vsebuje laktozo.
44 Alcohol: potentiation of orthostatic hypotension may occur;
Alkohol: pojavi se lahko ortostatska hipotenzija.
Colestyramine and Colestipol resins: absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins;
44 Holestiramin in holestipol: absorpcija hidroklorotiazida je zaradi anionskih izmenjevalnih smol motena.
Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see also sections 4.3 and 4.4).
45 Otroke, katerih matere so prejemale antagoniste angiotenzina II, je treba pozorno spremljati zaradi možnosti pojava hipotenzije (glejte poglavji 4. 3 in 4. 4).
47 4.9 Overdose
47 4. 9 Preveliko odmerjanje
The combination of 300 mg irbesartan and 12.5 mg hydrochlorothiazide resulted in an overall placebo-subtracted systolic/ diastolic reductions of up to 13.6/ 11.5 mm Hg.
48 Med kombiniranim zdravljenjem s 300 mg irbesartana in 12, 5 mg hidroklorotiazida se je sistolični krvni tlak znižal do 13, 6 mmHg, diastolični pa do 11, 5 mmHg bolj kot po uporabi placeba.
49 The types and incidences of adverse events reported for patients treated with the combination were similar to the adverse event profile for patients on monotherapy.
Pri bolnikih, ki so se zdravili s kombinacijo, so poročali o enaki vrsti in pogostnosti neželenih učinkov kot pri bolnikih, ki so se zdravili samo z eno zdravilno učinkovino.
50 5.3 Preclinical safety data
50 5. 3 Predklinični podatki o varnosti
Cartons of 30 film-coated tablets; 3 blister cards of 10 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
Škatle s 30 filmsko obloženimi tabletami; 3 pretisni omoti iz PVC/ PVDC/ aluminija z 10 filmsko obloženimi tabletami.
Cartons of 90 film-coated tablets; 9 blister cards of 10 film-coated tablets in PVC/ PVDC/ Aluminium blisters.
Škatle z 90 filmsko obloženimi tabletami; 9 pretisnih omotov iz PVC/ PVDC/ aluminija z 10 filmsko obloženimi tabletami.
6.6 Special precautions for disposal
52 6. 6 Posebni varnostni ukrepi za odstranjevanje
CoAprovel 300 mg/ 25 mg film-coated tablets.
CoAprovel 300 mg/ 25 mg filmsko obložene tablete
Each film-coated tablet contains 53.3 mg of lactose (as lactose monohydrate).
Ena filmsko obložena tableta vsebuje 53, 3 mg laktoze (v obliki laktoze monohidrata).
54 Elderly patients: no dosage adjustment of CoAprovel is necessary in elderly patients.
54 Starostniki: pri starostnikih odmerka zdravila CoAprovel ni treba prilagajati.
55 Hyperuricaemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.
55 Med zdravljenjem s tiazidnimi diuretiki se lahko zvečajo vrednosti holesterola in trigliceridov.
56 Lactose: this medicinal product contains lactose.
56 Laktoza: zdravilo vsebuje laktozo.
57 Alcohol: potentiation of orthostatic hypotension may occur;
Alkohol: pojavi se lahko ortostatska hipotenzija.
Colestyramine and Colestipol resins: absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins;
57 Holestiramin in holestipol: absorpcija hidroklorotiazida je zaradi anionskih izmenjevalnih smol motena.
Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see also sections 4.3 and 4.4).
58 Otroke, katerih matere so prejemale antagoniste angiotenzina II, je treba pozorno spremljati zaradi možnosti pojava hipotenzije (glejte poglavji 4. 3 in 4. 4).
60 4.9 Overdose
60 4. 9 Preveliko odmerjanje
The combination of 300 mg irbesartan and 12.5 mg hydrochlorothiazide resulted in an overall placebo-subtracted systolic/ diastolic reductions of up to 13.6/ 11.5 mm Hg.
61 Med kombiniranim zdravljenjem s 300 mg irbesartana in 12, 5 mg hidroklorotiazida se je sistolični krvni tlak znižal do 13, 6 mmHg, diastolični pa do 11, 5 mmHg bolj kot po uporabi placeba.
62 The types and incidences of adverse events reported for patients treated with the combination were similar to the adverse event profile for patients on monotherapy.
Pri bolnikih, ki so se zdravili s kombinacijo, so poročali o enaki vrsti in pogostnosti neželenih učinkov kot pri bolnikih, ki so se zdravili samo z eno zdravilno učinkovino.
63 5.3 Preclinical safety data
63 5. 3 Predklinični podatki o varnosti
Lactose monohydrate Hypromellose Titanium dioxide Macrogol 3350 Red and black ferric oxides Carnauba wax
Filmska obloga: laktoza monohidrat hipromeloza titanov dioksid makrogol 3350 Rdeči in črni železov oksid karnauba vosek
65 6.6 Special precautions for disposal
65 6. 6 Posebni varnostni ukrepi za odstranjevanje
66 ANNEX II
66 DODATEK II
Sanofi-Synthelabo Limited Edgefield Avenue Fawdon Newcastle Upon Tyne Tyne & Wear NE3 3TT United Kingdom
Sanofi- Synthelabo Limited Edgefield Avenue, Fawdon Newcastle Upon Tyne, Tyne & Wear NE3 3TT Velika Britanija
Sanofi Winthrop Industrie 30-36, avenue Gustave Eiffel 37100 Tours France
Sanofi Winthrop Industrie 30- 36, avenue Gustave Eiffel 37100 Tours Francija
68 ANNEX III
68 DODATEK III
70 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
70 PODATKI NA ZUNANJI OVOJNINI
CoAprovel 150 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
CoAprovel 150 mg/ 12, 5 mg tablete irbesartan/ hidroklorotiazid
Each tablet contains: irbesartan 150 mg and hydrochlorothiazide 12.5 mg
Ena tableta vsebuje 150 mg irbesartana in 12, 5 mg hidroklorotiazida.
EU/ 1/ 98/ 086/ 007 14 tablets EU/ 1/ 98/ 086/ 001 28 tablets EU/ 1/ 98/ 086/ 002 56 tablets EU/ 1/ 98/ 086/ 009 56 x 1 tablets EU/ 1/ 98/ 086/ 003 98 tablets
EU/ 1/ 98/ 086/ 007 14 tablet EU/ 1/ 98/ 086/ 001 28 tablet EU/ 1/ 98/ 086/ 002 56 tablet EU/ 1/ 98/ 086/ 009 56 x 1 tableta EU/ 1/ 98/ 086/ 003 98 tablet
72 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
72 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
OTHER
5 DRUGI PODATKI
73 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
73 PODATKI NA ZUNANJI OVOJNINI
CoAprovel 300 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
CoAprovel 300 mg/ 12, 5 mg tablete irbesartan/ hidroklorotiazid
Each tablet contains: irbesartan 300 mg and hydrochlorothiazide 12.5 mg
Ena tableta vsebuje 300 mg irbesartana in 12, 5 mg hidroklorotiazida.
EU/ 1/ 98/ 086/ 008 14 tablets EU/ 1/ 98/ 086/ 004 28 tablets EU/ 1/ 98/ 086/ 005 56 tablets EU/ 1/ 98/ 086/ 010 56 x 1 tablets EU/ 1/ 98/ 086/ 006 98 tablets
EU/ 1/ 98/ 086/ 008 14 tablet EU/ 1/ 98/ 086/ 004 28 tablet EU/ 1/ 98/ 086/ 005 56 tablet EU/ 1/ 98/ 086/ 010 56 x 1 tableta EU/ 1/ 98/ 086/ 006 98 tablet
75 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
75 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
76 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
76 PODATKI NA ZUNANJI OVOJNINI
CoAprovel 150 mg/ 12.5 mg film-coated tablets irbesartan/ hydrochlorothiazide
CoAprovel 150 mg/ 12, 5 mg filmsko obložene tablete irbesartan/ hidroklorotiazid
77 Store in the original package in order to protect from moisture.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
EU/ 1/ 98/ 086/ 011 14 tablets EU/ 1/ 98/ 086/ 012 28 tablets EU/ 1/ 98/ 086/ 029 30 tablets EU/ 1/ 98/ 086/ 013 56 tablets EU/ 1/ 98/ 086/ 014 56 x 1 tablets EU/ 1/ 98/ 086/ 021 84 tablets EU/ 1/ 98/ 086/ 032 90 tablets EU/ 1/ 98/ 086/ 015 98 tablets
EU/ 1/ 98/ 086/ 011 14 tablet EU/ 1/ 98/ 086/ 012 28 tablet EU/ 1/ 98/ 086/ 029 30 tablet EU/ 1/ 98/ 086/ 013 56 tablet EU/ 1/ 98/ 086/ 014 56 x 1 tableta EU/ 1/ 98/ 086/ 021 84 tablet EU/ 1/ 98/ 086/ 032 90 tablet EU/ 1/ 98/ 086/ 015 98 tablet
78 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
78 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
79 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
79 PODATKI NA ZUNANJI OVOJNINI
CoAprovel 300 mg/ 12.5 mg film-coated tablets irbesartan/ hydrochlorothiazide
CoAprovel 300 mg/ 12, 5 mg filmsko obložene tablete irbesartan/ hidroklorotiazid
80 Store in the original package in order to protect from moisture.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
EU/ 1/ 98/ 086/ 016 14 tablets EU/ 1/ 98/ 086/ 017 28 tablets EU/ 1/ 98/ 086/ 030 30 tablets EU/ 1/ 98/ 086/ 018 56 tablets EU/ 1/ 98/ 086/ 019 56 x 1 tablets EU/ 1/ 98/ 086/ 022 84 tablets EU/ 1/ 98/ 086/ 033 90 tablets EU/ 1/ 98/ 086/ 020 98 tablets
EU/ 1/ 98/ 086/ 016 14 tablet EU/ 1/ 98/ 086/ 017 28 tablet EU/ 1/ 98/ 086/ 030 30 tablet EU/ 1/ 98/ 086/ 018 56 tablet EU/ 1/ 98/ 086/ 019 56 x 1 tableta EU/ 1/ 98/ 086/ 022 84 tablet EU/ 1/ 98/ 086/ 033 90 tablet EU/ 1/ 98/ 086/ 020 98 tablet
81 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
81 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
82 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
82 PODATKI NA ZUNANJI OVOJNINI
CoAprovel 300 mg/ 25 mg film-coated tablets irbesartan/ hydrochlorothiazide
CoAprovel 300 mg/ 25 mg filmsko obložene tablete irbesartan/ hidroklorotiazid
83 Store in the original package in order to protect from moisture.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
EU/ 1/ 98/ 086/ 023 14 tablets EU/ 1/ 98/ 086/ 024 28 tablets EU/ 1/ 98/ 086/ 031 30 tablets EU/ 1/ 98/ 086/ 025 56 tablets EU/ 1/ 98/ 086/ 028 56 x 1 tablets EU/ 1/ 98/ 086/ 026 84 tablets EU/ 1/ 98/ 086/ 034 90 tablets EU/ 1/ 98/ 086/ 027 98 tablets
EU/ 1/ 98/ 086/ 023 14 tablet EU/ 1/ 98/ 086/ 024 28 tablet EU/ 1/ 98/ 086/ 031 30 tablet EU/ 1/ 98/ 086/ 025 56 tablet EU/ 1/ 98/ 086/ 028 56 x 1 tableta EU/ 1/ 98/ 086/ 026 84 tablet EU/ 1/ 98/ 086/ 034 90 tablet EU/ 1/ 98/ 086/ 027 98 tablet
84 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
84 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
CoAprovel 300 mg/ 25 mg tablets irbesartan/ hydrochlorothiazide
CoAprovel 300 mg/ 25 mg tablete irbesartan/ hidroklorotiazid
INFORMATION FOR THE USER CoAprovel 150 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
86 NAVODILO ZA UPORABO CoAprovel 150 mg/ 12, 5 mg tablete irbesartan/ hidroklorotiazid
What CoAprovel is and what it is used for 2.
Kaj je zdravilo CoAprovel in za kaj ga uporabljamo 2.
Before you take CoAprovel 3.
Kaj morate vedeti, preden boste vzeli zdravilo CoAprovel 3.
How to take CoAprovel 4.
Kako jemati zdravilo CoAprovel 4.
How to store CoAprovel 6.
Shranjevanje zdravila CoAprovel 6.
WHAT COAPROVEL IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO COAPROVEL IN ZA KAJ GA UPORABLJAMO
CoAprovel is used in the treatment of high blood pressure (essential hypertension), when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.
Zdravilo CoAprovel uporabljamo za zdravljenje zvišanega krvnega tlaka (esencialne hipertenzije), če pri zdravljenju samo z irbesartanom ali samo s hidroklorotiazidom krvni tlak ni bil zadostno nadzorovan.
BEFORE YOU TAKE COAPROVEL
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO COAPROVEL
Do not take CoAprovel if you are allergic (hypersensitive) to irbesartan and hydrochlorothiazide, or any of the other ingredients of CoAprovel or to medicines chemically related to sulfonamide (ask your doctor or pharmacist for further clarification) during the last 6 months of pregnancy, see section Pregnancy and breastfeeding if you are breast-feeding if you have severe liver or kidney problems if you have difficulty in producing urine if you have a condition which is associated with persistently high calcium or low potassium levels in your blood
Ne jemljite zdravila CoAprovel če ste alergični na (preobčutljivi za) irbesartan, hidroklorotiazid ali katerokoli sestavino zdravila CoAprovel ali zdravila, ki so kemično sorodna sulfonamidom (za dodatna pojasnila se obrnite na svojega zdravnika ali farmacevta) če ste noseči že več kot tri mesece (glejte poglavje Nosečnost in dojenje) če dojite če imate hudo okvaro jeter ali ledvic če imate težave z odvajanjem seča če imate bolezen, ki je povezana s stalno zvečano koncentracijo kalcija ali zmanjšano koncentracijo kalija v krvi
CoAprovel should not be given to children and adolescents (under 18 years).
Zdravila CoAprovel ne smejo jemati otroci in mladostniki (mlajši od 18 let).
Take special care with CoAprovel Tell your doctor if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems, including kidney transplantation if you suffer from heart problems
Bodite posebno pozorni pri jemanju zdravila CoAprovel Obvestite svojega zdravnika, če se karkoli od naslednjega nanaša na vas: če začnete prekomerno bruhati ali dobite hudo drisko če imate težave z ledvicami ali presajeno ledvico
87 if you suffer from liver problems if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) if you suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).
87 če imate težave s srcem če imate težave z jetri če imate sladkorno bolezen če imate eritematozni lupus (znan tudi kot lupus ali sistemski eritematozni lupus) če imate primarni aldosteronizem (stanje, povezano s čezmernim izločanjem hormona aldosterona, kar povzroči zastajanje natrija in posledično zvišanje krvnega tlaka)
You must tell your doctor if you think that you are (or might become) pregnant.
Zdravniku morate povedati, če mislite, da ste noseči, ali če načrtujete nosečnost.
CoAprovel is not recommended in early pregnancy and may cause serious harm to your baby after 3 months of pregnancy, see section Pregnancy and breastfeeding.
Uporaba zdravila CoAprovel ni priporočljiva v zgodnjem obdobju nosečnosti, po tretjem mesecu nosečnosti pa lahko povzroči resno škodo vašemu otroku (glejte poglavje Nosečnost in dojenje).
You should also tell your doctor: if you are on a low-salt diet if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in CoAprovel) if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal if you are going to have an operation (surgery) or be given anaesthetics
Svojemu zdravniku morate tudi povedati: če imate dieto z zmanjšanim vnosom soli če imate znake, kot so nenormalna žeja, suha usta, splošna oslabelost, zaspanost, bolečine ali krči v mišicah, siljenje na bruhanje, bruhanje ali nenormalno hiter srčni utrip, ki so lahko posledica prevelikega učinka hidroklorotiazida (ki ga vsebuje zdravilo CoAprovel) če vaša koža postane bolj občutljiva na sonce oziroma se znaki sončnih opeklin (kot so pordelost, srbenje, otekline, pojav mehurjev) pojavijo hitreje kot normalno če imate predvideno operacijo (kirurški poseg) ali boste prejeli anestetik
Hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test.
Zaradi hidroklorotiazida, ki ga zdravilo vsebuje, je lahko test za ugotavljanje jemanja nedovoljenih substanc (antidopinški test) pozitiven.
Preparations containing lithium should not be taken with CoAprovel without close supervision by your doctor.
Zdravila, ki vsebujejo litij, smete z zdravilom CoAprovel jemati le pod strogim zdravniških nadzorom.
Taking CoAprovel with food and drink CoAprovel can be taken with or without food.
Jemanje zdravila CoAprovel skupaj s hrano in pijačo Zdravilo CoAprovel lahko jemljete skupaj s hrano ali brez nje.
Appropriate antihypertensive drug must usually replace CoAprovel before starting a pregnancy.
Zdravnik vam bo praviloma svetoval jemanje drugega zdravila namesto zdravila CoAprovel, saj jemanje zdravila CoAprovel v zgodnjem obdobju nosečnosti ni priporočljivo in lahko po tretjem mesecu nosečnosti povzroči resno škodo vašemu otroku.
The product should not be used during the 2nd and 3rd trimester of pregnancy, or while breast-feeding.
V primeru načrtovanja nosečnosti je treba praviloma preiti na
88 Your doctor will normally advise you to stop taking CoAprovel as soon as you know you are pregnant.
88 drugo vrsto zdravljenja proti zvišanemu krvnemu tlaku.
If you become pregnant during therapy with CoAprovel, please inform and see your doctor without delay.
Zdravila CoAprovel ne smete jemati v drugem in tretjem trimesečju nosečnosti ali če dojite.
Driving and using machines No studies on the effects on the ability to drive and use machines have been performed.
Zdravnik vam bo praviloma svetoval, da prekinete z jemanjem zdravila CoAprovel takoj, ko izveste, da ste noseči.
CoAprovel is unlikely to affect your ability to drive or use machines.
Če zanosite med zdravljenjem z zdravilom CoAprovel, takoj obvestite svojega zdravnika.
However, occasionally dizziness or weariness may occur during treatment of high blood pressure.
Možnost, da bi zdravilo CoAprovel vplivalo na sposobnost za upravljanje vozil in strojev je majhna.