natgillin/translations-raw huggingface dataset:
Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloremia, hyponatraemia) and dehydration resulting from excessive diuresis.
Predoziranje hidroklorotiazidom povezano je s manjkom elektrolita (hipokalijemija, hipokloremija,
Ear and labyrinth disorders
Poremećaji uha i labirinta:
Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Trudnoća Tijekom trudnoće ne smiju se uvoditi antagonisti receptora angiotenzina II.
Suomi/Finland ratiopharm Oy Puh/Tel: +358 201805900
Finnland Puh/Tel: +358 201805900
One side of the tablet is debossed with the number “93” and the other side of the tablet is debossed with the number “7239”.
Na jednoj strani tablete je utisnut broj "93", a na drugoj strani tablete je utisnut broj "7239".
With hydrochlorothiazide, onset of diuresis occurs in 2 hours, and peak effect occurs at about 4 hours, while the action persists for approximately 6-12 hours.
S hidroklorotiazidom početak diureze nastupa nakon 2 sata, vršni učinak postiže se nakon
Irbesartan/hydrochlorothiazide
Irbesartan/Hidroklorotiazid
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.
Kao što je to slučaj i s ostalim vazodilatatorima, poseban oprez indiciran je u bolesnika s aortnom ili mitralnom stenozom ili opstruktivnom hipertrofičnom kardiomiopatijom.
Adequate monitoring of serum potassium in patients at risk is recommended (see section
Preporučuje se pratiti razinu kalija u serumu kod rizičnih bolesnika (vidjeti dio 4.4).
Indigotine (Indigo carmine aluminium lake FD&C blue #2) Iron Oxide Black
(makrogol), polietilenglikol 400 (makrogol), crveni željezov oksid, indigotin (Indigo carmine aluminium lake FD&C plava #2) i crni željezov oksid.
Undesirable effects where the frequency is not known are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired kidney function, increased level of potassium in your blood and allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat.
Nuspojave čija učestalost nije poznata: glavobolja, zvonjenje u ušima, kašalj, poremećaji okusa, probavne tegobe, bol u zglobovima i mišićima, abnormalna funkcija jetre, oslabljena funkcija bubrega,
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance) Second and third trimester of pregnancy (see sections 4.4 and 4.6) Severe renal impairment (creatinine clearance < 30 ml/min) Refractory hypokalaemia, hypercalcaemia
• Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1. ili na druge tvari koje su derivati sulfonamida (hidroklorotiazid je derivat sulfonamida)
Common side effects (may affect up to 1 in 10 people): nausea/vomiting abnormal urination fatigue dizziness (including when getting up from a lying or sitting position) blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine).
Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba) mučnina/povraćanje poremećaji mokrenja umor omaglica (uključujući onu koja se javlja nakon dizanja iz ležećeg ili sjedećeg položaja) krvnim pretragama dokazane povišene vrijednosti enzima koji određuje funkciju srca i mišića
Most of the above mentioned effects appear to be due to the pharmacological activity of irbesartan (blockade of angiotensin-II-induced inhibition of renin release, with stimulation of the renin-producing cells) and occur also with angiotensin converting enzyme inhibitors.
(blokada angiotenzin-II-inducirane inhibicije otpuštanja renina, uz stimulaciju stanica koje proizvode renin) te da se pojavljuju i pri primjeni inhibitora angiotenzin konvertirajućeg enzima.
The other side of the tablet debossed with the number "7239".
Na drugoj strani tablete je utisnut broj "7239".
Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
celuloza, mikrokristalična karmelozanatrij, umrežena silicijev dioksid, koloidni, bezvodni magnezijev stearat
How to take Irbesartan/Hydrochlorothiazide Teva
Kako uzimati Irbesartan/Hidroklorotiazid Teva
Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets
Irbesartan/Hidroklorotiazid Teva 150 mg/12,5 mg filmom obložene tablete Irbesartan/Hidroklorotiazid Teva 300 mg/12,5 mg filmom obložene tablete Irbesartan/Hidroklorotiazid Teva 300 mg/25 mg filmom obložene tablete
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Tijekom istodobne primjene litija i inhibitora angiotenzin konvertirajućeg enzima zabilježen je reverzibilni porast koncentracija serumskog litija i njegove toksičnosti.
Dosage adjustments of antigout medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Budući da hidroklorotiazid može povisiti razinu mokraćne kiseline u serumu, može biti potrebno prilagoditi dozu lijekova za liječenje gihta.
Adequate monitoring of serum potassium in patients at risk is recommended.
U rizičnih bolesnika preporučuje se odgovarajuća kontrola razine kalija u serumu.
In this regard, a limit of quantification of 0.03 ppm for NDMA and NDEA would be achievable according to the available data on analytical methods.
U tom pogledu, na temelju dostupnih podataka o analitičkim metodama mogla bi se postići granična vrijednost kvantifikacije od 0,03 ppm za tvari NDMA i NDEA.
Due to the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Teva, 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.
Irbesartan/Hidroklorotiazid Teva možete imati pojačan osjećaj omaglice prilikom ustajanja, posebno kod ustajanja iz sjedećeg položaja.
N-nitrosamines belong to a “cohort of concern” compounds in this guideline.
U Smjernicama su Nnitrozamini uvršteni u kohortu spojeva koji izazivaju zabrinutost.
Anticholinergic agents (e.g. atropine, beperiden) may increase the bioavailability of thiazide-type diuretics by decreasing gastrointestinal motility and stomach emptying rate.
Smanjujući gastrointestinalni motilitet i brzinu pražnjenja želuca, antikolinergične tvari (primjerice atropin, beperiden) mogu povećati bioraspoloživost tiazidskih diuretika.
Thiazide diuretics may increase serum calcium levels due to decreased excretion.
Zbog smanjene ekskrecije, tiazidi mogu povisiti razinu kalcija u serumu.
Each film-coated tablet contains 300 mg irbesartan and 25 mg hydrochlorothiazide
Jedna filmom obložena tableta sadrži 300 mg irbesartana i 25 mg hidroklorotiazida
Postural hypotension
Posturalna hipotenzija
Medicinal products affecting potassium
Lijekovi koji utječu na razinu kalija
Once daily dosing with 150 mg irbesartan and 12.5 mg hydrochlorothiazide gave systolic/diastolic mean placebo-adjusted blood pressure reductions at trough (24 hours post-dosing) of 12.9/6.9 mmHg in patients with mild-to-moderate hypertension.
U bolesnika s blagom do srednje teškom hipertenzijom doza od 150 mg irbesartana i 12,5 mg hidroklorotiazida jedanput na dan dovela je do sniženja sistoličkog/dijastoličkog krvnog tlaka za 12,9/6,9 mm Hg (korigirano za rezultate placebo skupine) u vrijeme najniže koncentracije u krvi (24
Implement a control strategy to detect and control N-nitrosamine impurities in the API (or intermediate, if justified).
N-nitrozaminskih nečistoća u aktivnim farmaceutskim sastojcima (ili, ako je opravdano, u međuproizvodu).
Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg
Irbesartan/Hidroklorotiazid Teva 150 mg/12,5 mg
Tablet coating for 150 mg/12.5 mg strength: hypromellose, titanium dioxide, polyethylene glycol 6000 (macrogol), polyethylene glycol 400 (macrogol), iron oxide red, iron oxide yellow and iron oxide black.
Film ovojnica tablete od 150 mg/12,5 mg i 300 mg/12,5 mg: hipromeloza titanijev dioksid polietilenglikol 6000 (makrogol) polietilenglikol 400 (makrogol) željezov oksid, crveni željezov oksid, žuti željezov oksid, crni
EU/1/09/583/049-072 EU/1/09/583/075 EU/1/09/583/078
EU/1/09/583/049-072 EU/1/09/583/075
However, another angiotensin-II antagonist affected fertility parameters in animal studies when given alone.
Rezultati studija na životinjskim modelima pokazali su, međutim, da je jedan drugi antagonist receptora angiotenzina II primijenjen sam utjecao na parametre fertilnosti.
Teva GmbH Tel: +49 73140208
Tel: +49 73140208
Depression, sleep disturbances
ošamućenost, nemir
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in the irbesartan and hydrochlorothiazide combination, minimal or no effects were reported.
12,5 mg koliko sadrži kombinacija irbesartana i hidroklorotiazida, zabilježeni su minimalni učinci ili ih uopće nije bilo.
• Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg may be administered in patients insufficiently controlled by Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg.
• Irbesartan/Hidroklorotiazid Teva 300 mg/25 mg može se propisati bolesnicima čiji se krvni tlak ne može na odgovarajući način kontrolirati lijekom Irbesartan/Hidroklorotiazid Teva 300 mg/12,5 mg.
Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg
Irbesartan/Hidroklorotiazid Teva 300 mg/12,5 mg
Sexual dysfunction, libido changes
Seksualna disfunkcija, promjene sustava i dojki:
The carcinogenic potential of irbesartan and hydrochlorothiazide in combination has not been evaluated in animal studies.
ispitivanjima na životinjama nije procijenjen karcinogeni potencijal kombinacije irbesartana i hidroklorotiazida.
Irbesartan/Hydrochlorothiazide Teva is a combination of two active substances, irbesartan and hydrochlorothiazide.
Teva je kombinacija dvije djelatne tvari, irbesartana i hidroklorotiazida.
• stomach discoloration, ulcers and focal necrosis of gastric mucosa were observed in few rats in a
• diskoloracija želuca, ulceracije i fokalna nekroza sluznice želuca, primijećene su u nekoliko štakora tijekom šestomjesečne studije toksičnosti nakon doza od 90 mg/kg/dan irbesartana, 90
EU/1/09/583/025-048 EU/1/09/583/074 EU/1/09/583/077
EU/1/09/583/025-048 EU/1/09/583/074
A total of 697 patients were randomised in a 2:1 ratio to either irbesartan/hydrochlorothiazide 150 mg/12.5 mg or to irbesartan 150 mg and systemically force-titrated (before assessing the response to the lower dose) after one week to irbesartan/hydrochlorothiazide 300 mg/25 mg or irbesartan 300 mg, respectively.
Nakon jednog tjedna doze su sustavno forsirano titrirane (prije procjene odgovora na nisku dozu) na irbesartan/hidroklorotiazid 300 mg/25 mg, odnosno irbesartan 300 mg.
Each film-coated tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide
Jedna filmom obložena tableta sadrži 150 mg irbesartana i 12,5 mg hidroklorotiazida
The use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4).
Uzimanje antagonista receptora angiotenzina II ne preporučuje se tijekom prvog tromjesečja trudnoće (vidjeti dio 4.4.), a kontraindicirana je tijekom drugog i trećeg tromjesečja (vidjeti dijelove 4.3. i 4.4.).
Povidone
Doziranje
Hyperuricaemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.
U određenih bolesnika koji uzimaju tiazide može se pojaviti hiperuricemija ili se može ubrzati razvoj klinički izraženog gihta.
Tel: +39 028917981
Teva Italia S.r.l. Tel: +39 028917981
However, in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min but < 60 ml/min) this fixed dose combination should be administered with caution.
Međutim kombinaciju fiksne doze treba oprezno primjenjivati u bolesnika koji imaju blago do umjereno oštećenom funkciju bubrega (klirens kreatinina ≥ 30 ml/min, ali < 60 ml/min).
How to store Irbesartan/Hydrochlorothiazide Teva
Kako čuvati Irbesartan/Hidroklorotiazid Teva
EU/1/09/583/001-024 EU/1/09/583/073 EU/1/09/583/076
EU/1/09/583/001-024 EU/1/09/583/073
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) ODGOVORAN (ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
Pancreatitis, anorexia, diarrhoea, constipation, gastric irritation, sialadenitis, loss of appetite
Pankreatitis, anoreksija, proljev,
Special Populations
Posebne skupine bolesnika
Respiratory, thoracic and mediastinal disorders:
Poremećaji dišnog sustava, prsišta i sredoprsja:
Reproductive system and breast disorders:
Poremećaji bubrega i mokraćnog sustava:
Each film-coated tablet contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide
Jedna filmom obložena tableta sadrži 300 mg irbesartana i 12,5 mg hidroklorotiazida
Irbesartan/hydrochlorothiazide combination
Irbesartan/hidroklorotiazid u kombinaciji
Irbesartan/Hydrochlorothiazide Teva is unlikely to affect your ability to drive or use machines.
Teva ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
Thiazide diuretic-associated azotaemia may occur in patients with impaired renal function.
U bolesnika s oštećenom funkcijom bubrega može se pojaviti azotemija povezana s uzimanjem tiazidskih diuretika.
Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Irbesartan/Hidroklorotiazid Teva 300 mg/25 mg filmom obložene tablete irbesartan/hidroklorotiazid
Not known
“Nemojte uzimati
No dosage adjustment of Irbesartan/Hydrochlorothiazide Teva is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
Za bolesnike s blago ili umjereno oštećenom funkcijom jetre nije potrebna prilagodba doze lijeka Irbesartan/Hidroklorotiazid Teva (vidjeti dio 4.3).
• Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone;
• Irbesartan/Hidroklorotiazid Teva 150 mg/12,5 mg može se propisati bolesnicima čiji se krvni tlak ne može na odgovarajući način kontrolirati samo hidroklorotiazidom ili irbesartanom u dozi od 150 mg; • Irbesartan/Hidroklorotiazid Teva 300 mg/12,5 mg može se propisati bolesnicima čiji se krvni tlak ne može na odgovarajući način kontrolirati irbesartanom u dozi od 300 mg ili lijekom
Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets are light pink to pink, film coated capsule shaped tablets.
Irbesartan/Hidroklorotiazid Teva 150 mg/12,5 mg filmom obložene tablete su svijetlo ružičaste do ružičaste, filmom obložene tablete u obliku kapsula.
Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Irbesartan/Hidroklorotiazid Teva 150 mg/12,5 mg filmom obložene tablete irbesartan/hidroklorotiazid
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).
lijekove za kontrolu srčanog ritma lijekove za šećernu bolest (oralni pripravci ili inzulin) karbamazepin (lijek za liječenje epilepsije).
Fertility
Litij
Each Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablet contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Jedna Irbesartan/Hidroklorotiazid Teva 300 mg/25 mg filmom obložena tableta sadrži 300 mg irbesartana i 25 mg hidroklorotiazida.
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Sadržaj pakiranja idruge informacije
Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Irbesartan/Hidroklorotiazid Teva 300 mg/12,5 mg filmom obložene tablete irbesartan/hidroklorotiazid
General disorders and administration site conditions:
Opći poremećaji i reakcije na mjestu primjene:
Package leaflet: information for the patient Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets irbesartan / hydrochlorothiazide
Uputa o lijeku: Informacija za korisnika Irbesartan/Hidroklorotiazid Teva 300 mg/25 mg filmom obložene tablete irbesartan / hidroklorotiazid
Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
Irbesartan/Hidroklorotiazid Teva 300 mg/25 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 300 mg irbesartana i 25 mg hidroklorotiazida.
Each Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Jedna Irbesartan/Hidroklorotiazid Teva 150 mg/12,5 mg filmom obložena tableta sadrži 150 mg irbesartana i 12,5 mg hidroklorotiazida.
Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Irbesartan/Hidroklorotiazid Teva 150 mg/12,5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 150 mg irbesartana i 12,5 mg hidroklorotiazida.
Drug substance
Trombocitopenija
The trough to peak effects measured by cuff during office visits were 68 % and 76 % for irbesartan/hydrochlorothiazide 150 mg/12.5 mg and irbesartan/hydrochlorothiazide 300 mg/12.5 mg, respectively.
Učinci najniže i najviše koncentracije na sniženje krvnog tlaka nakon primjene irbesartana/hidroklorotiazida u dozama od 150 mg/12,5 mg, odnosno 300 mg/12,5 mg, prema mjerenjima manžetom za vrijeme kontrolnog pregleda, iznosili su 68%, odnosno 76%.
Medicinal products affected by serum potassium disturbances Periodic monitoring of serum potassium is recommended when Irbesartan/Hydrochlorothiazide Teva is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics).
Pri istodobnoj primjeni lijeka Irbesartan/Hidroklorotiazid Teva i drugih lijekova na čije djelovanje utječu poremećaji kalija (primjerice glikozidi digitalisa, antiaritmici) preporučuje se periodičko praćenje razine kalija u serumu.
Package leaflet: information for the patient Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets irbesartan / hydrochlorothiazide
Uputa o lijeku: Podaci za korisnika Irbesartan/Hidroklorotiazid Teva 150 mg/12,5 mg filmom obložene tablete irbesartan / hidroklorotiazid
Loop diuretics are preferred to thiazides in this population.
Toj se skupini bolesnika preporučuju diuretici Henleove petlje umjesto tiazida.
Each Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablet contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Jedna Irbesartan/Hidroklorotiazid Teva 300 mg/12,5 mg filmom obložena tableta sadrži 300 mg irbesartana i 12,5 mg hidroklorotiazida.
Package leaflet: information for the patient Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets irbesartan / hydrochlorothiazide
Uputa o lijeku: Informacija za korisnika Irbesartan/Hidroklorotiazid Teva 300 mg/12,5 mg filmom obložene tablete irbesartan / hidroklorotiazid
Hepatic impairment
Poremećaji reproduktivnog
Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Irbesartan/Hidroklorotiazid Teva 300 mg/12,5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 300 mg irbesartana i 12,5 mg hidroklorotiazida.
Aplastic anaemia, bone marrow depression, neutopenia/agranulocytosis, haemolytic anaemia, leucopenia, thrombocytopenia
Aplastična anemija, depresija koštane srži,
Irbesartan 300
150 mg.
Flushing
Omaglica
Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets EU/1/09/583/049-072
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/583/049-072
Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled.
Ako se očni tlak i dalje ne može staviti pod kontrolu, možda će trebati razmotriti hitno liječenje lijekovima ili kirurški zahvat.
The other ingredients are:
Budući da:
Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets are pink to dark pink, film coated capsule shaped tablet.
Kako Irbesartan/Hidroklorotiazid Teva izgleda i sadržaj pakiranja Irbesartan/Hidroklorotiazid Teva 300 mg/25 mg filmom obložene tablete su ružičaste do tamnoružičaste filmom obložene tablete u obliku kapsula.
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan/Hydrochlorothiazide Teva” and “Warnings and precautions”).
Irbesartan/Hidroklorotiazid” i “Upozorenja i mjere opreza”).
The pharmacokinetic of digoxin was not altered by co-administration of irbesartan.
Pri istodobnoj primjeni irbesartana i digoksina, farmakokinetika digoksina nije se promijenila.
Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets are light pink to pink, film coated capsule shaped tablets.
Kako Irbesartan/Hidroklorotiazid Teva izgleda i sadržaj pakiranja Irbesartan/Hidroklorotiazid Teva 300 mg/12,5 mg filmom obložene tablete su svijetlo ružičaste do ružičaste filmom obložene tablete u obliku kapsula.
The recommended dose of Irbesartan/Hydrochlorothiazide Teva is one or two tablets a day.
Teva je jedna ili dvije tablete na dan.
Renal artery stenosis - Renovascular hypertension
Stenoza aortnog ili mitralnom zaliska, opstruktivna hipertrofična kardiomiopatija
Tel: +421 257267911
Teva Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911
MARKETING AUTHORISATION NUMBER(S)
BROJ (EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
Dizziness
Dojenje
Uncommon side effects (may affect up to 1 in 100 people): diarrhoea low blood pressure fainting heart rate increased flushing swelling sexual dysfunction (problems with sexual performance) blood tests may show lowered levels of potassium and sodium in your blood.
proljev nizak krvni tlak nesvjestica ubrzani otkucaji srca crvenilo praćeno osjećajem vrućine oticanje seksualna disfunkcija (problemi sa seksualnom izvedbom)
If you take more Irbesartan/Hydrochlorothiazide Teva than you should
Ako uzmete više lijeka Irbesartan/Hidroklorotiazid
Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets EU/1/09/583/025-048
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/583/025-048
Irbesartan/Hydrochlorothiazide Teva is available in pack sizes of 7, 14, 15, 20, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets in non-perforated blisters; pack sizes of 50 x 1 film coated tablet in unit dose blisters and pack size of 28 film-coated tablets in non-perforated calendar blisters.
i 100 filmom obloženih tableta u neperforiranim blisterima; pakiranje od 50 x 1 filmom obloženom tabletom u blisterima djeljivi na jedinične doze i pakiranje od 28 filmom obloženih tableta u neperforiranim blisterima u kalendarskom pakiranju.
Cardiac disorders:
Srčani poremećaji:
Your doctor may need to change your dose and/or to take other precautions:
Liječnik će Vam možda morati promijeniti dozu i/ili poduzeti druge mjere opreza: Ako uzimate ACE inhibitor ili aliskiren (vidjeti također informacije pod naslovima
Use in adults, including the elderly
Primjena u odraslih, uključujući starije osobe
Povidone (K30)
Povidon (K30)
Risk Management Plan (RMP)
Plan upravljanja rizikom (RMP)
- Put yourself in a comfortable and stable position.
- Udobno se smjestite i zauzmite stabilan položaj.
Pack of 1 bottle.
Pakiranje od 1 bočice.
Ask your pharmacist how to throw away of medicines you no longer use.
Pitajte svog ljekarnika kako baciti lijekove koje više ne koristite.
Always use this medicine exactly as your doctor has told you.
Uvijek primjenjujte ovaj lijek točno onako kako Vam je rekao Vaš liječnik.
Use a single dose as soon as you remember.
Uzmite jednu dozu čim se sjetite.
- Tilt your head back.
- Nagnite glavu unatrag.