natgillin/translations-raw huggingface dataset:
Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
110 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Irbesartan BMS indeholder:
What Irbesartan BMS contains The active substance is irbesartan.
Aktivt stof: irbesartan.
Each tablet of Irbesartan BMS 75 mg contains 75 mg irbesartan.
Hver filmovertrukken Irbesartan BMS- tablet 75 mg indeholder 75 mg irbesartan Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose, croscarmellosenatrium, hypromellose, silicondioxid, magnesiumstearat, titandioxid (E171), macrogol 3000, carnaubavoks.
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax.
111 SANOFI WINTHROP INDUSTRIE 30- 36 Avenue Gustave Eiffel, BP 7166 F- 37071 Tours Cedex 2 - Frankrig
SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel, BP 7166 F-37071 Tours Cedex 2 - France
112 Hvis du vil have yderligere oplysninger om Irbesartan BMS, skal du henvende dig til den lokale repræsentant.
111 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
113 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε. Π. Ε.
112 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε .Π .Ε.
114 INDLÆGSSEDDEL:
113 PACKAGE LEAFLET:
INFORMATION TIL BRUGEREN Irbesartan BMS 150 mg filmovertrukne tabletter irbesartan
INFORMATION FOR THE USER Irbesartan BMS 150 mg film-coated tablets irbesartan
Dette gælder også medicin, som ikke er købt på recept.
114 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
116 Den sædvanlige dosis er 150 mg 1 gang dagligt.
Patients with high blood pressure The usual dose is 150 mg once a day.
Patienter med højt blodtryk og type 2- diabetes med nyresygom Hos patienter med højt blodtryk og type 2 diabetes er 300 mg 1 gang dagligt (to tabletter dagligt) den foretrukne vedligeholdelsesdosis til behandling af ledsagende nyresygdom.
115 Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
117 led - og muskelsmerter, unormal leverfunktion, forhøjet mængde af kalium i blodet, nedsat nyrefunktion samt betændelseslignende tilstand i de små blodkar, der primært påvirker huden (en tilstand der kaldes leukocytoklastisk vaskulitis).
These undesirable effects are: headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).
Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
116 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Aktivt stof: irbesartan.
Each tablet of Irbesartan BMS 150 mg contains 150 mg irbesartan.
Hver filmovertrukken Irbesartan BMS- tablet 150 mg indeholder 150 mg irbesartan Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose, croscarmellosenatrium, hypromellose, silicondioxid, magnesiumstearat, titandioxid (E171), macrogol 3000, carnaubavoks.
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax.
118 SANOFI WINTHROP INDUSTRIE 30- 36 Avenue Gustave Eiffel, BP 7166 F- 37071 Tours Cedex 2 - Frankrig
SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel, BP 7166 F-37071 Tours Cedex 2 - France
119 Hvis du vil have yderligere oplysninger om Irbesartan BMS, skal du henvende dig til den lokale repræsentant.
118 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
120 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε. Π. Ε.
119 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε .Π .Ε.
INFORMATION TIL BRUGEREN Irbesartan BMS 300 mg filmovertrukne tabletter irbesartan
INFORMATION FOR THE USER Irbesartan BMS 300 mg film-coated tablets irbesartan
Dette gælder også medicin, som ikke er købt på recept.
121 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
123 Den sædvanlige dosis er 150 mg 1 gang dagligt.
Patients with high blood pressure The usual dose is 150 mg once a day.
Patienter med højt blodtryk og type 2- diabetes med nyresygom Hos patienter med højt blodtryk og type 2 diabetes er 300 mg 1 gang dagligt den foretrukne vedligeholdelsesdosis til behandling af ledsagende nyresygdom.
122 Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.
124 led - og muskelsmerter, unormal leverfunktion, forhøjet mængde af kalium i blodet, nedsat nyrefunktion samt betændelseslignende tilstand i de små blodkar, der primært påvirker huden (en tilstand der kaldes leukocytoklastisk vaskulitis).
These undesirable effects are: headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).
Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
123 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Aktivt stof: irbesartan.
Each tablet of Irbesartan BMS 300 mg contains 300 mg irbesartan.
Hver filmovertrukken Irbesartan BMS- tablet 300 mg indeholder 300 mg irbesartan Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose, croscarmellosenatrium, hypromellose, silicondioxid, magnesiumstearat, titandioxid (E171), macrogol 3000, carnaubavoks.
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax.
125 SANOFI WINTHROP INDUSTRIE 30- 36 Avenue Gustave Eiffel, BP 7166 F- 37071 Tours Cedex 2 - Frankrig
SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel, BP 7166 F-37071 Tours Cedex 2 - France
126 Hvis du vil have yderligere oplysninger om Irbesartan BMS, skal du henvende dig til den lokale repræsentant.
125 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
127 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε. Π. Ε.
126 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε .Π .Ε.
128
127
300 mg irbesartan og 25 mg hydrochlorothiazid).
300 mg irbesartan and 25 mg hydrochlorothiazide).
Essentiel betyder, at det forhøjede blodtryk ikke er forårsaget af nogen anden sygdomstilstand.
Irbesartan Hydrochlorothiazide BMS is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on irbesartan or hydrochlorothiazide alone. ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
Irbesartan Hydrochlorothiazide BMS er ikke blevet undersøgt hos patienter under 18 år.
Irbesartan Hydrochlorothiazide BMS has not been tested in patients below 18 years of age.
Irbesartan Hydrochlorothiazide BMS indtages gennem munden og kan tages med eller uden føde.
Irbesartan Hydrochlorothiazide BMS is taken by mouth, with or without food.
Det anbefales ikke at anvende doser på mere end 300 mg irbesartan og 25 mg hydrochlorothiazid én gang daglig.
Doses higher than 300 mg irbesartan and 25 mg hydrochlorothiazide once a day are not recommended.
Irbesartan Hydrochlorothiazide BMS indeholder to aktive stoffer irbesartan og hydrochlorothiazid.
Irbesartan Hydrochlorothiazide BMS contains two active substances, irbesartan and hydrochlorothiazide.
Irbesartan er en ’ angiotensin II- receptorantagonist ’, hvilket betyder, at den blokerer virkningen af et hormon i kroppen, der kaldes angiotensin II.
Irbesartan is an ‘ angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II.
Reproduction is authorised provided the source is acknowledged Kombinationen af disse to aktive stoffer har en additiv virkning og mindsker blodtrykket mere end ved anvendelse af blot det ene af disse to lægemidler.
Reproduction is authorised provided the source is acknowledged.
Ved en sådan blodtryksnedsættelse reduceres risikoen for skader på grund af forhøjet blodtryk, såsom slagtilfælde.
The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone.
Irbesartan alene har været godkendt i EU navnene Karvea og Aprovel siden 1997.
Irbesartan on its own has been approved in the EU since 1997 under the names Karvea and Aprovel.
De undersøgelser, der blev foretaget med Karvea/ Aprovel i kombination med hydrochlorothiazid som enkelttabletter, blev brugt til at understøtte brugen af Irbesartan Hydrochlorothiazide BMS.
The studies of Karvea/ Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of Irbesartan Hydrochlorothiazide BMS.
Der blev også gennemført yderligere undersøgelser med doser på 300 mg irbesartan i kombination med 25 mg hydrochlorothiazid.
Further studies were also carried out with doses of 300 mg irbesartan in combination with 25 mg hydrochlorothiazide.
Irbesartan Hydrochlorothiazide BMS var mere effektiv end placebo (virkningsløs behandling) og hydrochlorothiazid som enkeltmiddelbehandling med hensyn til at reducere det diastoliske blodtryk.
Irbesartan Hydrochlorothiazide BMS was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure.
De mest almindelige bivirkninger ved Irbesartan Hydrochlorothiazide BMS (set hos 1 og 10 patienter ud af 100) er svimmelhed, kvalme eller opkastninger, uregelmæssig vandladning, træthed, stigninger i urinkvælstof (BUN, et spaltningsprodukt af protein), forhøjede kreatininniveauer (et spaltningsprodukt af musklerne) og kreatininkinase (et enzym i musklerne).
The most common side effects with Irbesartan Hydrochlorothiazide BMS (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscle).
Irbesartan Hydrochlorothiazide BMS bør ikke anvendes til personer, som kan være overfølsomme (allergiske) over for irbesartan, hydrochlorothiazid, sulfonamider eller nogen af de øvrige indholdsstoffer.
Irbesartan Hydrochlorothiazide BMS should not be used in people who may be hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Irbesartan Hydrochlorothiazide BMS må heller ikke gives til patienter, som har svære lever -, nyre - eller galdeproblemer, for lavt indhold af kalium i blodet eller for højt indhold af kalcium i blodet.
Irbesartan Hydrochlorothiazide BMS should also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Irbesartan Hydrochlorothiazide BMS er større end risiciene ved behandling af essentiel hypertension hos patienter, hvis blodtryk ikke kan reguleres tilfredsstillende ved hjælp af irbesartan eller hydrochlorothiazid alene.
The Committee for Medicinal Products for Human Use (CHMP) decided that Irbesartan Hydrochlorothiazide BMS’ s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Irbesartan Hydrochlorothiazide BMS til Bristol- Myers Squibb Pharma EEIG den 19. januar 2007.
The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan Hydrochlorothiazide BMS to Bristol-Myers Squibb Pharma EEIG on 19 January 2007.
Blister (PVC/ PVDC/ Aluminium)
Blister (PVC/ PVDC/ Alu)
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12, 5 mg tabletter
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12.5 mg tablets.
26, 65 mg lactosemonohydrat per tablet.
26.65 mg of lactose monohydrate per tablet.
5. 1).
This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1).
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12, 5 mg kan gives til patienter, hvis blodtryk ikke kan reguleres tilstrækkeligt med hydrochlorthiazid eller irbesartan 150 mg alene; Irbesartan Hydrochlorothiazide BMS 300 mg/ 12, 5 mg kan gives til patienter, der er utilstrækkeligt regulerede med irbesartan 300 mg eller med Irbesartan Hydrochlorothiazide BMS 150 mg/ 12, 5 mg.
Irbesartan Hydrochlorothiazide BMS 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 Hydrochlorothiazide BMS 300 mg/ 12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irbesartan Hydrochlorothiazide BMS 150 mg/ 12.5 mg.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg kan gives til patienter, der er utilstrækkeligt regulerede med Irbesartan Hydrochlorothiazide BMS 300 mg/ 12, 5 mg.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg may be administered in patients insufficiently controlled by Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg.
4. 5).
When necessary, Irbesartan Hydrochlorothiazide BMS may be administered with another antihypertensive medicinal product (see section 4.5).
På grund af hydrochlorthiazid- komponenten anbefales Irbesartan Hydrochlorothiazide BMS ikke til patienter med alvorlig nyreinsufficiens (kreatininclearance < 30 ml/ min).
Renal impairment: due to the hydrochlorothiazide component, Irbesartan Hydrochlorothiazide BMS is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/ min).
Hypovolæmi og/ eller hyponatriæmi skal korrigeres forud for behandling med Irbesartan Hydrochlorothiazide BMS.
Intravascular volume depletion: volume and/ or sodium depletion should be corrected prior to administration of Irbesartan Hydrochlorothiazide BMS.
2 Leverfunktionsnedsættelse:
2 Hepatic impairment:
Irbesartan Hydrochlorothiazide BMS er ikke indiceret til patienter med svært nedsat leverfunktion.
Irbesartan Hydrochlorothiazide BMS is not indicated in patients with severe hepatic impairment.
4. 3).
No dosage adjustment of Irbesartan Hydrochlorothiazide BMS is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
Dosisjustering af Irbesartan Hydrochlorothiazide BMS til ældre patienter er ikke nødvendig.
Elderly patients: no dosage adjustment of Irbesartan Hydrochlorothiazide BMS is necessary in elderly patients.
Der er ingen erfaring med brug til børn og unge.
Children and adolescents: there is no experience in children and adolescents.
6. 1) eller over for andre sulfonamidderivater (hydrochlorthiazid er et sulfonamidderivat).
Hypersensitivity to the active substances, to any of the excipients (see section 6.1), or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance).
Alvorlig nyrefunktionsnedsættelse (kreatininclearance < 30 ml/ min), Refraktær hypokaliæmi, hypercalcæmi, Alvorlig leverfunktionsnedsættelse, biliær cirrhose og cholestase.
Severe renal impairment (creatinine clearance < 30 ml/ min), Refractory hypokalaemia, hypercalcaemia, Severe hepatic impairment, biliary cirrhosis and cholestasis.
Irbesartan Hydrochlorothiazide BMS er kun sjældent blevet associeret med symptomatisk hypotension hos hypertensive patienter uden andre risikofaktorer for hypotension.
Irbesartan Hydrochlorothiazide BMS has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension.
Når Irbesartan Hydrochlorothiazide BMS anvendes til patienter med nedsat nyrefunktion, anbefales periodisk monitorering af serum- kalium, serum - kreatinin og serum- urinsyre- niveauer.
Renal impairment and kidney transplantation: when Irbesartan Hydrochlorothiazide BMS is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Patienter med primær aldosteronisme responderer generelt ikke på antihypertensive stoffer, der virker gennem hæmning af renin- angiotensinsystemet.
3 Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti- hypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Der er dog rapporteret minimal eller ingen effekt ved en dosis på 12, 5 mg, som findes i Irbesartan Hydrochlorothiazide BMS.
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in Irbesartan Hydrochlorothiazide BMS, minimal or no effects were reported.
Det er især tilfældet ved nyrefunktionsnedsættelse og/ eller hjertesygdom og diabetes mellitus.
Conversely, due to the irbesartan component of Irbesartan Hydrochlorothiazide BMS hyperkalaemia might occur, especially in the presence of renal impairment and/ or heart failure, and diabetes mellitus.
4. 5).
Potassium-sparing diuretics, potassium supplements or potassium-containing salts substitutes should be co-administered cautiously with Irbesartan Hydrochlorothiazide BMS (see section 4.5).
4. 5).
Lithium: the combination of lithium and Irbesartan Hydrochlorothiazide BMS is not recommended (see section 4.5).
4 Graviditet:
4 Pregnancy:
Dette lægemiddel indeholder lactose.
Lactose: this product contains lactose.
Irbesartan Hydrochlorothiazide BMSs antihypertensive virkning kan øges ved samtidig administration af andre antihypertensive stoffer.
Other antihypertensive agents: the antihypertensive effect of Irbesartan Hydrochlorothiazide BMS may be increased with the concomitant use of other antihypertensive agents.
4. 4).
Therefore, the combination of lithium and Irbesartan Hydrochlorothiazide BMS is not recommended (see section 4.4).
Det anbefales at måle serum- kalium periodisk, når Irbesartan Hydrochlorothiazide BMS administreres sammen med lægemidler, der påvirkes af serum- kaliumforstyrrelser (fx digitalisglykosider, antiarytmika).
Medicinal products affected by serum potassium disturbances: periodic monitoring of serum potassium is recommended when Irbesartan Hydrochlorothiazide BMS is administered with medicinal products affected by serum potassium disturbances (e. g. digitalis glycosides, antiarrhythmics).
Der er ikke observeret signifikante farmakokinetiske eller farmakodynamiske interaktioner ved samtidig administration af irbesartan og warfarin, et lægemiddel, som metaboliseres af CYP2C9.
No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered with warfarin, a medicinal product metabolised by
5 farmakokinetik er ikke evalueret.
The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated.
Der kan forekomme forstærket ortostatisk hypotension;
Alcohol: potentiation of orthostatic hypotension may occur;
Patienter, der planlægger at blive gravide, bør ændre til anden antihypertensiv behandling hvor sikkerhedsprofilen for anvendelse under graviditet er veletableret, medmindre fortsat behandling med AIIRAer skønnes nødvendig.
When
Ved konstateret graviditet, bør behandling med AIIRAer seponeres øjeblikkeligt, og hvis det skønnes hensigtsmæssigt bør anden behandling iværksættes.
6 pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
6 Der er kendt at behandling med AIIRAer under anden og tredje trimester kan inducere human føtotoksicitet (nedsat nyrefunktion, oligohydramnios, hæmning af kraniets knogledannelse) og neonatal toksicitet (nyresvigt, hypotension, hyperkalæmi) (se pkt.
AIIRAs therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Irbesartan Hydrochlorothiazide BMS er kontraindiceret under amning.
Irbesartan Hydrochlorothiazide BMS is contraindicated during breast-feeding.
Hyppigheden af uønskede hændelser anført nedenfor defineres i henhold til følgende konventioner:
The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000).
Meget almindelig (≥ 1/ 10); almindelig (≥ 1/ 100, < 1/ 10); usædvanlig (≥ 1/ 1. 000, < 1/ 100); sjælden (≥ 1/ 10. 000, < 1/ 1. 000); meget sjælden (< 1/ 10. 000).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Der er i placebokontrollerede undersøgelser med hypertensive patienter ikke set nogen forskel i den samlede bivirkningshyppighed i irbesartan/ hydrochlorthiazidgrupperne og placebogrupperne.
In placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the irbesartan/ hydrochlorothiazide and the placebo groups.
Seponering på grund af kliniske eller laboratoriemæssige bivirkninger forekom mindre hyppigt for irbesartan/ hydrochlorthiazid- behandlede patienter end for placebo- behandlede patienter.
Discontinuation due to any clinical or laboratory adverse event was less frequent for irbesartan/ hydrochlorothiazide-treated patients than for placebo-treated patients.
Bivirkningshyppigheden havde ingen relation til dosis (inden for det rekommanderede dosisinterval), køn, alder eller race.
The incidence of adverse events was not related to gender, age, race, or dose within the recommended dose range.
Følgende bivirkninger er rapporteret i placebokontrollerede studier, hvor 898 hypertensive patienter blev behandlet med forskellige doser (interval:
In placebo-controlled trials in which 898 hypertensive patients received various doses (range:
37, 5 mg/ 6, 25 mg til 300 mg/ 25 mg irbesartan/ hydrochlorthiazid):
37.5 mg/ 6.25 mg to 300 mg/ 25 mg irbesartan/ hydrochlorothiazide), the following adverse reactions were reported:
Svimmelhed Ortostatisk svimmelhed
dizziness orthostatic dizziness
Syncope, hypotension, takykardi, ødem
syncope, hypotension, tachycardia, oedema
Kvalme/ opkastning Diarré
nausea/ vomiting diarrhoea
Sygdomme i bevægeapparatet, bindevæv og knogler:
7 Musculoskeletal, connective tissue and bone disorders:
7 Sygdomme i nyrer og urinveje:
Renal and urinary disorders:
Almindelige lidelser og reaktioner på indgivelsesstedet:
General disorders and administration site conditions:
Patienter, der behandles med irbesartan/ hydrochlorthiazid, fik ændrede laboratorieprøveværdier, som sjældent var klinisk signifikante Almindelig:
Investigations: patients treated with irbesartan/ hydrochlorothiazide had changes in laboratory test parameters which were rarely clinically significant Common:
Øget serum- carbamid, kreatinin og kreatinkinase Fald i serum- kalium og - natrium
increases in BUN, creatinine and creatine kinase decreases in serum potassium and sodium