natgillin/translations-raw huggingface dataset:
Når en direkte ændring fra monoterapi til de faste kombinationer påtænkes, bør følgende retningslinjer overvejes:  CoAprovel 150 mg/12,5 mg kan gives til patienter, hvis blodtryk ikke kan reguleres tilstrækkeligt med hydrochlorthiazid eller irbesartan 150 mg alene;  CoAprovel 300 mg/12,5 mg kan gives til patienter, der er utilstrækkeligt regulerede med irbesartan 300 mg eller med CoAprovel 150 mg/12,5 mg.  CoAprovel 300 mg/25 mg kan gives til patienter, der er utilstrækkeligt regulerede med 
CoAprovel 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; CoAprovel 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by CoAprovel 150 mg/12.5 mg.
I to epidemiologiske studier baseret på det danske Cancerregister er der observeret øget risiko for non-melanom hudkræft (basalcellekarcinom og pladecellekarcinom) ved en stigende kumulativ dosis af hydrochlorthiazid. 
An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide (HCTZ) exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry.
Rød og gul jernoxid Carnaubavoks. 
Red and yellow ferric oxides Carnauba wax
Ved meget store doser (≥ 500 mg/kg/dag) inducerede irbesartan degenerative forandringer i nyrerne (fx interstitiel nefritis, tubulær udvidelse, basofile tubuli, øgede plasmakoncentrationer af carbamid og kreatinin) hos rotter og makakaber. 
At very high doses (≥ 500 mg/kg/day) degenerative changes in the kidneys (such as interstitial nephritis, tubular distention, basophilic tubules, increased plasma concentrations of urea and creatinine) were induced by irbesartan in the rat and the macaque and are considered secondary to the hypotensive effects of the medicinal product which led to decreased renal perfusion.
Mikrokrystallinsk cellulose Croscarmellosenatrium Lactosemonohydrat Magnesiumstearat Silica 
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hypromellose Silicon dioxide Magnesium stearate
Non-steroide antiinflammatoriske lægemidler: Administration af et non-steroidt antiinflammatorisk lægemiddel kan reducere den diuretiske, natriuretiske og antihypertensive virkning af thiaziddiuretika hos nogle patienter; 
Non-steroidal anti-inflammatory drugs: the administration of a non-steroidal anti-inflammatory drug may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics in some patients; Pressor amines (e.g. noradrenaline): the effect of pressor amines may be decreased, but not sufficiently to preclude their use;
Øget serum carbamid, kreatinin og kreatinkinase 
increases in blood urea nitrogen (BUN), creatinine and creatine kinase
Forholdet mellem den laveste og den maksimale effekt var henholdsvis 68% og 76% for CoAprovel 150 mg /12,5 mg og CoAprovel 300 mg /12,5 mg, når effekten blev målt med blodtryksmanchet ved kontrolbesøg. 
The trough to peak effects measured by cuff during office visits were 68% and 76% for CoAprovel 150 mg/12.5 mg and CoAprovel 300 mg/12.5 mg, respectively.
CoAprovel bør tages mindst en time før eller fire timer efter disse lægemidler; Kortikosteroider, ACTH: Elektrolytdepletion, specielt hypokaliæmi, kan forstærkes; Digitalisglykosider: Thiazidinduceret hypokaliæmi eller hypomagnesiæmi øger forekomsten af digitalisinducerede kardielle arytmier (se pkt. 
Corticosteroids, ACTH: electrolyte depletion, particularly hypokalaemia, may be increased; Digitalis glycosides: thiazide induced hypokalaemia or hypomagnaesemia favour the onset of digitalis-induced cardiac arrhythmias (see section 4.4);
Rød og sort jernoxid Carnaubavoks. 
Red and black ferric oxides Carnauba wax
Dosering 1 gang dagligt med 150 mg irbesartan og 12,5 mg hydrochlorthiazid gav en systolisk/diastolisk gennemsnitlig placebojusteret blodtryksreduktion ved laveste måling (24 timer efter dosis) på 12,9/6,9 mmHg hos patienter med let til moderat hypertension. 
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 mm Hg in patients with mild-to-moderate hypertension.
Øvrige indholdsstoffer: mikrokrystallinsk cellulose, croscarmellosenatrium, lactosemonohydrat, magnesiumstearat, kolloid silica, prægelatineret majsstivelse, rød og gul jernoxid (E172). 
The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, red and yellow ferric oxides (E172).
Non-melanom hudkræft: Tilgængelige data fra epidemiologiske studier viser en kumulativ dosisafhængig forbindelse mellem hydrochlorthiazid og non-melanom hudkræft (se også pkt. 
Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dose dependent association between HCTZ and NMSC has been observed (see also sections 4.4 and 5.1).
CoAprovel indeholder: 
What CoAprovel contains
Ortostatisk svimmelhed 
orthostatic dizziness
6.1 eller over for andre sulfonamidderivater (hydrochlorthiazid er et sulfonamidderivat) Graviditet i 2. eller 3. trimester (se pkt. 
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 trimesters of pregnancy (see sections 4.4 and 4.6) Severe renal impairment (creatinine clearance < 30 ml/min) Refractory hypokalaemia, hypercalcaemia
LÆGEMIDLETS NAVN CoAprovel 300 mg/25 mg filmovertrukne tabletter. 
NAME OF THE MEDICINAL PRODUCT CoAprovel 300 mg/25 mg film-coated tablets.
Patienter, der planlægger at blive gravide, bør ændre til anden antihypertensiv behandling hvor sikkerhedsprofilen for anvendelse under graviditet er veletableret, medmindre fortsat behandling med AIIRA skønnes nødvendig. 
Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose, croscarmellosenatrium, hypromellose, silica, magnesiumstearat, titaniumdioxid (E 171), macrogol 3350, rød, gul og sort jernoxid, prægelatiniseret majsstivelse, carnaubavoks. 
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3350, red, yellow and black ferric oxides, pregelatinised starch, carnauba wax.
Nyrer og urinveje: 
Renal and urinary disorders:
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) 
MARKETING AUTHORISATION NUMBERS
Hovedpine 
headache
Det er især tilfældet ved nyrefunktionsnedsættelse og/eller hjertesygdom og diabetes mellitus. 
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.
Disse resultater er også relevante for andre ACE-hæmmere og angiotensin-II-receptorblokkere grundet de identiske farmakodynamiske egenskaber. 
Given their similar pharmacodynamic properties, these results are also relevant for other ACE-inhibitors and angiotensin II receptor blockers.
Der er hverken observeret rebound-hypertension for irbesartan eller hydrochlorthiazid. 
Although not specifically studied with the CoAprovel, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
Kartoner med 56 x 1 tablet i PVC/PVDC/perforerede aluminiumblistere med enkeltdosis. 
Cartons of 56 x 1 tablets in PVC/PVDC/Aluminium perforated unit dose blisters.
Kontakt lægen, før du tager CoAprovel, hvis du oplever følgende: hvis du får hyppig opkastning eller diarré hvis du lider af nyreproblemer eller er nyretransplanteret hvis du lider af hjerteproblemer hvis du lider af leverproblemer hvis du lider af sukkersyge hvis du lider af erytematøs lupus (også kaldet lupus eller systemisk lupus erythematosus) hvis du lider af primær aldosteronisme (tilstand med høj produktion af hormonet aldosteron, som gør, at der ophobes natriumsalt i kroppen, og blodtrykket derfor stiger) hvis du tager en af følgende lægemidler, der anvendes til at behandle forhøjet blodtryk: o en ACE-hæmmer (f.eks. enalapril, lisinopril, ramipril) især hvis du har nyreproblemer, der skyldes diabetes. 
Talk to your doctor before taking CoAprovel and if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems or have a kidney transplant if you suffer from heart problems if you suffer from liver problems o 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).
Hver tablet indeholder 26,65 mg lactose (som lactosemonohydrat). 
Each tablet contains 26.65 mg of lactose (as lactose monohydrate).
Et randomiseret, dobbeltblindt, aktivt kontrolleret, parallelt multicenterforsøg af 8 ugers varighed har evalueret effekten og sikkerheden af CoAprovel som inital behandling ved svær hypertension (defineret som SeDBT ≥ 110 mmHg). 
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.
Hver tablet indeholder: irbesartan 300 mg og hydrochlorthiazid 25 mg 
Each tablet contains: irbesartan 300 mg and hydrochlorothiazide 25 mg
Hver filmovertrukken tablet indeholder 89,5 mg lactose (som lactosemonohydrat). 
Each film-coated tablet contains 89.5 mg of lactose (as lactose monohydrate).
Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose, croscarmellosenatrium, hypromellose, silica, magnesiumstearat, titaniumdioxid (E 171), macrogol 3000, rød og gul jernoxid, carnaubavoks. 
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, red and yellow ferric oxides, carnauba wax.
Hver filmovertrukken tablet indeholder 53,3 mg lactose (som lactosemonohydrat). 
Each film-coated tablet contains 53.3 mg of lactose (as lactose monohydrate).
Hver tablet indeholder: irbesartan 150 mg og hydrochlorthiazid 12,5 mg 
Each tablet contains: irbesartan 150 mg and hydrochlorothiazide 12.5 mg
Tilgængelige data fra epidemiologiske studier viser en kumulativ dosis- afhængig forbindelse mellem hydrochlorthiazid og non-melanom hudkræft. 
Based on available data from epidemiological studies, cumulative dosedependent association between HCTZ and NMSC has been observed.
Vaskulære sygdomme: 
Vascular disorders:
CoAprovel 150 mg/12,5 mg tabletter leveres i blisterpakninger af 14, 28, 56 eller 98 tabletter. 
CoAprovel 150 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Hver tablet indeholder 65,8 mg lactose (som lactosemonohydrat). 
Each tablet contains 65.8 mg of lactose (as lactose monohydrate).
Hver tablet af CoAprovel 300 mg/25 mg tabletter indeholder 300 mg irbesartan og 25 mg hydrochlorthiazid. 
Each film-coated tablet of CoAprovel 300 mg/25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Hver tablet indeholder: irbesartan 300 mg og hydrochlorthiazid 12,5 mg 
Each tablet contains: irbesartan 300 mg and hydrochlorothiazide 12.5 mg
Anaphylactic reaction including anaphylactic shock Tabel 3: Bivirkninger rapporteret ved anvendelse af hydrochlorthiazid alene 
Anaphylactic reaction including anaphylactic shock
CoAprovel 300 mg/12,5 mg tabletter leveres i blisterpakninger af 14, 28, 56 eller 98 tabletter. 
CoAprovel 300 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Dog skal denne faste dosis-kombination gives med forsigtighed til patienter med mild til moderat nedsat nyrefunktion (kreatininclearance ≥ 30 ml/min, men < 60 ml/min). 
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.
samme tidspunkt hver dag. 
Try to take your daily dose at about the same time each day.
Lyserød, bikonveks, oval, med et hjerte præget på den ene side, og nummeret 2788 præget på den anden side. 
Pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Indehaver af markedsføringstilladelsen sanofi-aventis groupe 54, rue La Boétie, 
Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - France
LÆGEMIDLETS NAVN CoAprovel 150 mg/12,5 mg tabletter 
NAME OF THE MEDICINAL PRODUCT CoAprovel 150 mg/12.5 mg tablets.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP LÆGEMIDLETS NAVN CoAprovel 150 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN sanofi-aventis groupe UDLØBSDATO 
NAME OF THE MEDICINAL PRODUCT CoAprovel 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
LÆGEMIDLETS NAVN CoAprovel 300 mg/12,5 mg filmovertrukne tabletter. 
NAME OF THE MEDICINAL PRODUCT CoAprovel 300 mg/12.5 mg film-coated tablets.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP LÆGEMIDLETS NAVN CoAprovel 300 mg/25 mg tabletter irbesartan/hydrochlorthiazid NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN sanofi-aventis groupe UDLØBSDATO 
NAME OF THE MEDICINAL PRODUCT CoAprovel 300 mg/25 mg tablets irbesartan/hydrochlorothiazide NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Hver tablet af CoAprovel 150 mg/12,5 mg tabletter indeholder 150 mg irbesartan og 12,5 mg hydrochlorthiazid. 
Each tablet of CoAprovel 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Kartoner med 56 tabletter i PVC/PVDC/aluminiumblistere. 
Cartons of 56 tablets in PVC/PVDC/Aluminium blisters.
Amning 
flushing
Hævelse af ekstremiteter 
swelling extremity
CoAprovel 300 mg/25 mg filmovertrukne tabletter er lyserød, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2788 på den anden side. 
What CoAprovel looks like and contents of the pack CoAprovel 300 mg/25 mg film-coated tablets are pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP LÆGEMIDLETS NAVN CoAprovel 300 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN sanofi-aventis groupe UDLØBSDATO 
NAME OF THE MEDICINAL PRODUCT CoAprovel 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
CoAprovel 300 mg/25 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid 
CoAprovel 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 300 mg irbesartan og 25 mg hydrochlorthiazid. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
CoAprovel 300 mg/25 mg filmovertrukne tabletter leveres i blisterpakninger af 14, 28, 30, 56, 84, 90 eller 98 filmovertrukne tabletter. 
CoAprovel 300 mg/25 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
EU/1/98/086/008 - 14 tabletter EU/1/98/086/004 - 28 tabletter EU/1/98/086/005 - 56 tabletter EU/1/98/086/010 - 56 x 1 tabletter EU/1/98/086/006 - 98 tabletter 
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
Forholdet mellem den laveste og den maksimale effekt af CoAprovel 150 mg /12,5 mg var 100%, når blodtrykket blev monitoreret ambulant. 
When measured by ambulatory blood pressure monitoring, the trough to peak effects of CoAprovel 150 mg/12.5 mg were 100%.
LÆGEMIDLETS NAVN CoAprovel 300 mg/12,5 mg tabletter 
NAME OF THE MEDICINAL PRODUCT CoAprovel 300 mg/12.5 mg tablets.
Hyperkalæmi 
Hypromellose
Det skal du vide, før du begynder at tage CoAprovel Sådan skal du tage CoAprovel Bivirkninger 
What CoAprovel is and what it is used for What you need to know before you take CoAprovel How to take CoAprovel
Hver tablet af CoAprovel 300 mg/12,5 mg tabletter indeholder 300 mg irbesartan og 12,5 mg hydrochlorthiazid. 
Each tablet of CoAprovel 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
CoAprovel 150 mg/12,5 mg filmovertrukne tabletter leveres i blisterpakninger af 14, 28, 30, 56, 84, 90 eller 98 filmovertrukne tabletter. 
CoAprovel 150 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Kartoner med 14 tabletter i PVC/PVDC/aluminiumblistere. 
Cartons of 14 tablets in PVC/PVDC/Aluminium blisters.
EU/1/98/086/007 - 14 tabletter EU/1/98/086/001 - 28 tabletter EU/1/98/086/002 - 56 tabletter EU/1/98/086/009 - 56 x 1 tabletter EU/1/98/086/003 - 98 tabletter 
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
CoAprovel 300 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid 
CoAprovel 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Indlægsseddel: Information til brugeren CoAprovel 300 mg/25 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid 
Package leaflet: Information for the patient CoAprovel 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Kartoner med 28 tabletter i PVC/PVDC/aluminiumblistere. 
Cartons of 28 tablets in PVC/PVDC/Aluminium blisters.
CoAprovel 150 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid 
CoAprovel 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Dyspepsi, smagsforstyrrelse 
dyspepsia, dysgeusia
CoAprovel 300 mg/12,5 mg filmovertrukne tabletter leveres i blisterpakninger af 14, 28, 30, 56, 84, 90 eller 98 filmovertrukne tabletter. 
CoAprovel 300 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Brug ikke lægemidlet efter den udløbsdato, der står påæsken og blisterpakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned. 
The expiry date refers to the last day of that month.
Lactosemonohydrat Mikrokrystallinsk cellulose Croscarmellosenatrium Prægelatiniseret majsstivelse Silica 
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Pregelatinised starch Silicon dioxide Magnesium stearate Red and yellow ferric oxides
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 150 mg irbesartan og 12,5 mg hydrochlorthiazid. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Kartoner med 98 tabletter i PVC/PVDC/aluminiumblistere. 
Cartons of 98 tablets in PVC/PVDC/Aluminium blisters.
EU/1/98/086/023 - 14 tabletter EU/1/98/086/024 - 28 tabletter EU/1/98/086/031 - 30 tabletter EU/1/98/086/025 - 56 tabletter EU/1/98/086/028 - 56 x 1 tabletter EU/1/98/086/026 - 84 tabletter EU/1/98/086/034 - 90 tabletter EU/1/98/086/027 - 98 tabletter 
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
Dosisjustering er ikke nødvendig til patienter med nedsat nyrefunktion, hvis den renale kreatinin-clearance er  30 ml/min (se pkt. 
No dosage adjustment is necessary in patients with renal impairment whose renal creatinine clearance is ≥ 30 ml/min (see sections 4.3 and 4.4).
EU/1/98/086/011 - 14 tabletter EU/1/98/086/012 - 28 tabletter EU/1/98/086/029 - 30 tabletter EU/1/98/086/013 - 56 tabletter EU/1/98/086/014 - 56 x 1 tabletter EU/1/98/086/021 - 84 tabletter EU/1/98/086/032 - 90 tabletter EU/1/98/086/015 - 98 tabletter 
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
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 300 mg irbesartan og 12,5 mg hydrochlorthiazid. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
CoAprovel 300 mg/12,5 mg tabletter er ferskenfarvet, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2776 på den anden side. 
What CoAprovel looks like and contents of the pack CoAprovel 300 mg/12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2776 engraved on the other side.
Begrænsede kliniske data (7 patienter ud af 22) tyder på, at patienter, som ikke er tilstrækkelig regulerede med 300 mg/12,5 mg-kombinationen, kan respondere ved dosisøgning til 300/25 mg. Der er hos disse patienter observeret en øgning i blodtryksreduktionen for såvel systolisk blodtryk (SBP) som diastolisk blodtryk (DBP) (henholdsvis 13,3 mmHg og 8,3 mmHg). 
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.
EU/1/98/086/016 - 14 tabletter EU/1/98/086/017 - 28 tabletter EU/1/98/086/030 - 30 tabletter EU/1/98/086/018 - 56 tabletter EU/1/98/086/019 - 56 x 1 tabletter EU/1/98/086/022 - 84 tabletter EU/1/98/086/033 - 90 tabletter EU/1/98/086/020 - 98 tabletter 
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
Om nødvendigt kan CoAprovel kombineres med andre antihypertensiva (se pkt. 
When necessary, CoAprovel may be administered with another antihypertensive medicinal product (see sections 4.3, 4.4, 4.5 and 5.1).
CoAprovel 300 mg/12,5 mg filmovertrukne tabletter er ferskenfarvet, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2876 på den anden side. 
What CoAprovel looks like and contents of the pack CoAprovel 300 mg/12.5 mg film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876 engraved on the other side.
CoAprovel 150 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid 
CoAprovel 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
CoAprovel 150 mg/12,5 mg filmovertrukne tabletter er ferskenfarvet, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2875 på den anden side. 
What CoAprovel looks like and contents of the pack CoAprovel 150 mg/12.5 mg film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2875 engraved on the other side.
CoAprovel 150 mg/12,5 mg tabletter er ferskenfarvet, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2775 på den anden side. 
What CoAprovel looks like and contents of the pack CoAprovel 150 mg/12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.
Indlægsseddel: Information til brugeren CoAprovel 300 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid 
Package leaflet: Information for the patient CoAprovel 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
CoAprovel 300 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid 
CoAprovel 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Indlægsseddel: Information til brugeren CoAprovel 150 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid 
Package leaflet: Information for the patient CoAprovel 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Kartoner med 90 tabletter i PVC/PVDC/aluminiumblistere. 
Cartons of 90 film-coated tablets in PVC/PVDC/Aluminium blisters.
Kartoner med 30 tabletter i PVC/PVDC/aluminiumblistere. 
Cartons of 30 film-coated tablets in PVC/PVDC/Aluminium blisters.