Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop) · 4.4 Special warnings and precautions for use · 2

HOS-094752 · has-adverse-reaction-information · PDF-Seite 44

Irbesartan/hydrochlorothiazide combination Among 898 hypertensive patients who received various doses of irbesartan/hydrochlorothiazide (range: 37.5 mg/6.25 mg to 300 mg/25 mg) in placebo-controlled trials, 29.5% of the patients experienced adverse reactions. The most commonly reported ADRs were dizziness (5.6%), fatigue (4.9%), nausea/vomiting (1.8%), and abnormal urination (1.4%). In addition, increases in blood urea nitrogen (BUN) (2.3%), creatine kinase (1.7%) and creatinine (1.1%) were also commonly observed in the trials. Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled trials. The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Table 1: Adverse Reactions in Placebo-Controlled Trials and Spontaneous Reports Investigations: Common: increases in blood urea nitrogen (BUN), creatinine and creatine kinase Uncommon: decreases in serum potassium and sodium Cardiac disorders: Uncommon: syncope, hypotension, tachycardia, oedema Nervous system disorders: Common: dizziness Uncommon: orthostatic dizziness Not known: headache Ear and labyrinth disorders: Not known: tinnitus Respiratory, thoracic and Not known: cough mediastinal disorders: Gastrointestinal disorders: Common: nausea/vomiting Uncommon: diarrhoea Not known: dyspepsia, dysgeusia Renal and urinary disorders: Common: abnormal urination Not known: impaired renal function including isolated cases of renal failure in patients at risk (see section 4.4) Musculoskeletal and connective Uncommon: swelling extremity tissue disorders:

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HOS-094740 · has-adverse-reaction-information · PDF-Seite 10

Irbesartan/hydrochlorothiazide combination Among 898 hypertensive patients who received various doses of irbesartan/hydrochlorothiazide (range: 37.5 mg/6.25 mg to 300 mg/25 mg) in placebo-controlled trials, 29.5% of the patients experienced adverse reactions. The most commonly reported ADRs were dizziness (5.6%), fatigue (4.9%), nausea/vomiting (1.8%), and abnormal urination (1.4%). In addition, increases in blood urea nitrogen (BUN) (2.3%), creatine kinase (1.7%) and creatinine (1.1%) were also commonly observed in the trials. Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled trials. The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Table 1: Adverse Reactions in Placebo-Controlled Trials and Spontaneous Reports Investigations: Common: increases in blood urea nitrogen (BUN), creatinine and creatine kinase Uncommon: decreases in serum potassium and sodium Cardiac disorders: Uncommon: syncope, hypotension, tachycardia, oedema Nervous system disorders: Common: dizziness Uncommon: orthostatic dizziness Not known: headache Ear and labyrinth disorders: Not known: tinnitus Respiratory, thoracic and Not known: cough mediastinal disorders: Gastrointestinal disorders: Common: nausea/vomiting Uncommon: diarrhoea Not known: dyspepsia, dysgeusia Renal and urinary disorders: Common: abnormal urination Not known: impaired renal function including isolated cases of renal failure in patients at risk (see section 4.4) Musculoskeletal and connective Uncommon: swelling extremity tissue

Auszug; vollständigen Abschnitt im Original lesen.

HOS-094746 · has-adverse-reaction-information · PDF-Seite 27

Irbesartan/hydrochlorothiazide combination Among 898 hypertensive patients who received various doses of irbesartan/hydrochlorothiazide (range: 37.5 mg/6.25 mg to 300 mg/25 mg) in placebo-controlled trials, 29.5% of the patients experienced adverse reactions. The most commonly reported ADRs were dizziness (5.6%), fatigue (4.9%), nausea/vomiting (1.8%), and abnormal urination (1.4%). In addition, increases in blood urea nitrogen (BUN) (2.3%), creatine kinase (1.7%) and creatinine (1.1%) were also commonly observed in the trials. Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled trials. The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Table 1: Adverse Reactions in Placebo-Controlled Trials and Spontaneous Reports Investigations: Common: increases in blood urea nitrogen (BUN), creatinine and creatine kinase Uncommon: decreases in serum potassium and sodium Cardiac disorders: Uncommon: syncope, hypotension, tachycardia, oedema Nervous system disorders: Common: dizziness Uncommon: orthostatic dizziness Not known: headache Ear and labyrinth disorders: Not known: tinnitus Respiratory, thoracic and Not known: cough mediastinal disorders: Gastrointestinal disorders: Common: nausea/vomiting Uncommon: diarrhoea Not known: dyspepsia, dysgeusia Renal and urinary disorders: Common: abnormal urination Not known: impaired renal function including isolated cases of renal failure in patients at risk (see section 4.4) Musculoskeletal and connective Uncommon: swelling extremity tissue

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HOS-094748 · has-contraindication-information · PDF-Seite 37

 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  Severe hepatic impairment, biliary cirrhosis and cholestasis  The concomitant use of Irbesartan Hydrochlorothiazide Zentiva with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73 m²) (see sections 4.5 and 5.1).

HOS-094742 · has-contraindication-information · PDF-Seite 20

 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  Severe hepatic impairment, biliary cirrhosis and cholestasis  The concomitant use of Irbesartan Hydrochlorothiazide Zentiva with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73 m²) (see sections 4.5 and 5.1).

HOS-094736 · has-contraindication-information · PDF-Seite 3

 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  Severe hepatic impairment, biliary cirrhosis and cholestasis  The concomitant use of Irbesartan Hydrochlorothiazide Zentiva with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73 m²) (see sections 4.5 and 5.1).

HOS-094747 · has-indication-information · PDF-Seite 36

Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1).

HOS-094735 · has-indication-information · PDF-Seite 2

Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1).

HOS-094741 · has-indication-information · PDF-Seite 19

Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1).

HOS-094738 · has-interaction-information · PDF-Seite 6

Other antihypertensive agents The antihypertensive effect of Irbesartan Hydrochlorothiazide Zentiva may be increased with the concomitant use of other antihypertensive agents. Irbesartan and hydrochlorothiazide (at doses up to 300 mg irbesartan/25 mg hydrochlorothiazide) have been safely administered with other antihypertensive agents including calcium channel blockers and beta-adrenergic blockers. Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with irbesartan with or without thiazide diuretics unless the volume depletion is corrected first (see section 4.4). Aliskiren-containing products or ACE-inhibitors 6 Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1). Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Similar effects have been very rarely reported with irbesartan so far. Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with Irbesartan Hydrochlorothiazide Zentiva. Therefore, the combination of lithium and Irbesartan Hydrochlorothiazide Zentiva is not recommended (see section 4.4). If the combination proves necessary, careful monitoring of serum lithium levels is recommended. Medicinal products affecting potassium The potassium-depleting effect of hydrochlorothiazide is attenuated by the potassium-sparing effect of irbesartan. However, this effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia (e.g. other kaliuretic diuretics, laxatives, amphotericin, carbenoxolone, penicillin G sodium). Conversely, based on the experience with the use of other medicinal products that blunt the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increa

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HOS-094744 · has-interaction-information · PDF-Seite 23

Other antihypertensive agents The antihypertensive effect of Irbesartan Hydrochlorothiazide Zentiva may be increased with the concomitant use of other antihypertensive agents. Irbesartan and hydrochlorothiazide (at doses up to 300 mg irbesartan/25 mg hydrochlorothiazide) have been safely administered with other antihypertensive agents including calcium channel blockers and beta-adrenergic blockers. Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with irbesartan with or without thiazide diuretics unless the volume depletion is corrected first (see section 4.4). Aliskiren-containing products or ACE-inhibitors 23 Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1). Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Similar effects have been very rarely reported with irbesartan so far. Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with Irbesartan Hydrochlorothiazide Zentiva. Therefore, the combination of lithium and Irbesartan Hydrochlorothiazide Zentiva is not recommended (see section 4.4). If the combination proves necessary, careful monitoring of serum lithium levels is recommended. Medicinal products affecting potassium The potassium-depleting effect of hydrochlorothiazide is attenuated by the potassium-sparing effect of irbesartan. However, this effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia (e.g. other kaliuretic diuretics, laxatives, amphotericin, carbenoxolone, penicillin G sodium). Conversely, based on the experience with the use of other medicinal products that blunt the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increa

Auszug; vollständigen Abschnitt im Original lesen.

HOS-094750 · has-interaction-information · PDF-Seite 40

Other antihypertensive agents The antihypertensive effect of Irbesartan Hydrochlorothiazide Zentiva may be increased with the concomitant use of other antihypertensive agents. Irbesartan and hydrochlorothiazide (at doses up to 300 mg irbesartan/25 mg hydrochlorothiazide) have been safely administered with other antihypertensive agents including calcium channel blockers and beta-adrenergic blockers. Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with irbesartan with or without thiazide diuretics unless the volume depletion is corrected first (see section 4.4). Aliskiren-containing products or ACE-inhibitors Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1). 40 Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Similar effects have been very rarely reported with irbesartan so far. Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with Irbesartan Hydrochlorothiazide Zentiva. Therefore, the combination of lithium and Irbesartan Hydrochlorothiazide Zentiva is not recommended (see section 4.4). If the combination proves necessary, careful monitoring of serum lithium levels is recommended. Medicinal products affecting potassium The potassium-depleting effect of hydrochlorothiazide is attenuated by the potassium-sparing effect of irbesartan. However, this effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia (e.g. other kaliuretic diuretics, laxatives, amphotericin, carbenoxolone, penicillin G sodium). Conversely, based on the experience with the use of other medicinal products that blunt the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase

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HOS-094739 · has-pregnancy-information · PDF-Seite 8

Pregnancy Angiotensin II Receptor Antagonists (AIIRAs) The use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4). The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4). 8 Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs. 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. When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started. Exposure to AIIRA therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3). Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4). Hydrochlorothiazide There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester. Animal studies are insufficient. Hydrochlorothiazide crosses the placenta. Based on the pharmacological mechanism of action of hydrochlorothiazide its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia. Hydrochlorothiazide should not be used for gestational oedema, gestational hypertension or preeclampsia due to the risk of decreased plasma volume and placental hypoperfusion, without a beneficial effect on the course of the disease. Hydrochlorothiazide should not be used for essential hypertension in pregnant women except in rare situations where no other treatment could be used. Since Irbesartan Hydrochlorothiazide Zentiva contains hydro

Auszug; vollständigen Abschnitt im Original lesen.

HOS-094745 · has-pregnancy-information · PDF-Seite 25

Pregnancy Angiotensin II Receptor Antagonists (AIIRAs) The use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4). The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4). 25 Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs. 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. When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started. Exposure to AIIRA therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3). Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4). Hydrochlorothiazide There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester. Animal studies are insufficient. Hydrochlorothiazide crosses the placenta. Based on the pharmacological mechanism of action of hydrochlorothiazide its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia. Hydrochlorothiazide should not be used for gestational oedema, gestational hypertension or preeclampsia due to the risk of decreased plasma volume and placental hypoperfusion, without a beneficial effect on the course of the disease. Hydrochlorothiazide should not be used for essential hypertension in pregnant women except in rare situations where no other treatment could be used. Since Irbesartan Hydrochlorothiazide Zentiva contains hydr

Auszug; vollständigen Abschnitt im Original lesen.

HOS-094751 · has-pregnancy-information · PDF-Seite 42

Pregnancy Angiotensin II Receptor Antagonists (AIIRAs) The use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4). The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4). Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs. 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. When 42 pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started. Exposure to AIIRA therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3). Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4). Hydrochlorothiazide There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester. Animal studies are insufficient. Hydrochlorothiazide crosses the placenta. Based on the pharmacological mechanism of action of hydrochlorothiazide its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia. Hydrochlorothiazide should not be used for gestational oedema, gestational hypertension or preeclampsia due to the risk of decreased plasma volume and placental hypoperfusion, without a beneficial effect on the course of the disease. Hydrochlorothiazide should not be used for essential hypertension in pregnant women except in rare situations where no other treatment could be used. Since Irbesartan Hydrochlorothiazide Zentiva contains hydr

Auszug; vollständigen Abschnitt im Original lesen.

HOS-094737 · has-warning-information · PDF-Seite 3

Hypotension – Volume-depleted patients Irbesartan Hydrochlorothiazide Zentiva has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension. Symptomatic hypotension may be expected to occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before initiating therapy with Irbesartan Hydrochlorothiazide Zentiva. Renal artery stenosis – Renovascular hypertension There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists. While this is not documented with Irbesartan Hydrochlorothiazide Zentiva, a similar effect should be anticipated. Renal impairment and kidney transplantation When Irbesartan Hydrochlorothiazide Zentiva is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended. There is no experience regarding the administration of Irbesartan Hydrochlorothiazide Zentiva in patients with a recent kidney transplantation. Irbesartan Hydrochlorothiazide Zentiva should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) (see section 4.3). Thiazide diuretic- associated azotaemia may occur in patients with impaired renal function. No dosage adjustment is 3 necessary in patients with renal impairment whose creatinine clearance is ≥ 30 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. Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring

Auszug; vollständigen Abschnitt im Original lesen.

HOS-094749 · has-warning-information · PDF-Seite 37

Hypotension – Volume-depleted patients Irbesartan Hydrochlorothiazide Zentiva has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension. Symptomatic hypotension may be expected to occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before initiating therapy with Irbesartan Hydrochlorothiazide Zentiva. Renal artery stenosis – Renovascular hypertension There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists. While this is not documented with Irbesartan Hydrochlorothiazide Zentiva, a similar effect should be anticipated. Renal impairment and kidney transplantation When Irbesartan Hydrochlorothiazide Zentiva is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended. There is no experience regarding the administration of Irbesartan Hydrochlorothiazide Zentiva in patients with a recent kidney transplantation. Irbesartan Hydrochlorothiazide Zentiva should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) (see section 4.3). Thiazide diuretic- associated azotaemia may occur in patients with impaired renal function. No dosage adjustment is necessary in patients with renal impairment whose creatinine clearance is ≥30 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. 37 Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of

Auszug; vollständigen Abschnitt im Original lesen.

HOS-094743 · has-warning-information · PDF-Seite 20

Hypotension – Volume-depleted patients Irbesartan Hydrochlorothiazide Zentiva has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension. Symptomatic hypotension may be expected to occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before initiating therapy with Irbesartan Hydrochlorothiazide Zentiva. Renal artery stenosis – Renovascular hypertension There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists. While this is not documented with Irbesartan Hydrochlorothiazide Zentiva, a similar effect should be anticipated. Renal impairment and kidney transplantation When Irbesartan Hydrochlorothiazide Zentiva is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended. There is no experience regarding the administration of Irbesartan Hydrochlorothiazide Zentiva in patients with a recent kidney transplantation. Irbesartan Hydrochlorothiazide Zentiva should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min) (see section 4.3). Thiazide diuretic- associated azotaemia may occur in patients with impaired renal function. No dosage adjustment is 20 necessary in patients with renal impairment whose creatinine clearance is ≥30 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. Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring o

Auszug; vollständigen Abschnitt im Original lesen.