Twynsta · 4.6 Fertility, pregnancy and lactation · 1

HOS-095700 · has-adverse-reaction-information · PDF-Seite 66

Summary of the safety profile The most common adverse reactions include dizziness and peripheral oedema. Serious syncope may occur rarely (less than 1 case per 1,000 patients). Adverse reactions previously reported with one of the individual components (telmisartan or amlodipine) may be potential adverse reactions with Twynsta as well, even if not observed in clinical trials or during the post-marketing period. Tabulated list of adverse reactions The safety and tolerability of Twynsta has been evaluated in five controlled clinical studies with over 3,500 patients, over 2,500 of whom received telmisartan in combination with amlodipine. Adverse reactions have been ranked under headings of frequency 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, adverse reactions are presented in order of decreasing seriousness. System Organ Twynsta Telmisartan Amlodipine Class Infections and infestations Uncommon upper respiratory tract infection including pharyngitis and sinusitis, urinary tract infection including cystitis Rare cystitis sepsis including fatal outcome1 Blood and lymphatic system disorders: 66 Uncommon anaemia Rare thrombocytopenia, eosinophilia Very rare leukocytopenia, thrombocytopenia Immune system disorders: Rare hypersensitivity, anaphylactic reaction Very rare

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095694 · has-adverse-reaction-information · PDF-Seite 47

Summary of the safety profile The most common adverse reactions include dizziness and peripheral oedema. Serious syncope may occur rarely (less than 1 case per 1,000 patients). Adverse reactions previously reported with one of the individual components (telmisartan or amlodipine) may be potential adverse reactions with Twynsta as well, even if not observed in clinical trials or during the post-marketing period. Tabulated list of adverse reactions The safety and tolerability of Twynsta has been evaluated in five controlled clinical studies with over 3,500 patients, over 2,500 of whom received telmisartan in combination with amlodipine. Adverse reactions have been ranked under headings of frequency 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, adverse reactions are presented in order of decreasing seriousness. System Organ Twynsta Telmisartan Amlodipine Class Infections and infestations Uncommon upper respiratory tract infection including pharyngitis and sinusitis, urinary tract infection including cystitis Rare cystitis sepsis including fatal outcome1 Blood and lymphatic system disorders: Uncommon anaemia 47 Rare thrombocytopenia, eosinophilia Very rare leukocytopenia, thrombocytopenia Immune system disorders: Rare hypersensitivity, anaphylactic reaction Very rare

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095682 · has-adverse-reaction-information · PDF-Seite 9

Summary of the safety profile The most common adverse reactions include dizziness and peripheral oedema. Serious syncope may occur rarely (less than 1 case per 1,000 patients). Adverse reactions previously reported with one of the individual components (telmisartan or amlodipine) may be potential adverse reactions with Twynsta as well, even if not observed in clinical trials or during the post-marketing period. Tabulated list of adverse reactions The safety and tolerability of Twynsta has been evaluated in five controlled clinical studies with over 3,500 patients, over 2,500 of whom received telmisartan in combination with amlodipine. Adverse reactions have been ranked under headings of frequency 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, adverse reactions are presented in order of decreasing seriousness. System Organ Twynsta Telmisartan Amlodipine Class Infections and infestations Uncommon upper respiratory tract infection including pharyngitis and sinusitis, urinary tract infection including cystitis Rare cystitis sepsis including fatal outcome1 Blood and lymphatic system disorders: 9 Uncommon anaemia Rare thrombocytopenia, eosinophilia Very rare leukocytopenia, thrombocytopenia Immune system disorders: Rare hypersensitivity, anaphylactic reaction Very rare

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095688 · has-adverse-reaction-information · PDF-Seite 28

Summary of the safety profile The most common adverse reactions include dizziness and peripheral oedema. Serious syncope may occur rarely (less than 1 case per 1,000 patients). Adverse reactions previously reported with one of the individual components (telmisartan or amlodipine) may be potential adverse reactions with Twynsta as well, even if not observed in clinical trials or during the post-marketing period. Tabulated list of adverse reactions The safety and tolerability of Twynsta has been evaluated in five controlled clinical studies with over 3,500 patients, over 2,500 of whom received telmisartan in combination with amlodipine. Adverse reactions have been ranked under headings of frequency 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, adverse reactions are presented in order of decreasing seriousness. System Organ Twynsta Telmisartan Amlodipine Class Infections and infestations Uncommon upper respiratory tract infection including pharyngitis and sinusitis, urinary tract infection including cystitis Rare cystitis sepsis including fatal outcome1 Blood and lymphatic system disorders: 28 Uncommon anaemia Rare thrombocytopenia, eosinophilia Very rare leukocytopenia, thrombocytopenia Immune system disorders: Rare hypersensitivity, anaphylactic reaction Very rare

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095690 · has-contraindication-information · PDF-Seite 41

• Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1 • Second and third trimesters of pregnancy (see sections 4.4 and 4.6) • Biliary obstructive disorders and severe hepatic impairment • Shock (including cardiogenic shock) • Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis) • Haemodynamically unstable heart failure after acute myocardial infarction The concomitant use of telmisartan/amlodipine with aliskiren-containing medicinal products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m 2) (see sections 4.5 and 5.1).

HOS-095684 · has-contraindication-information · PDF-Seite 22

• Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1 • Second and third trimesters of pregnancy (see sections 4.4 and 4.6) • Biliary obstructive disorders and severe hepatic impairment • Shock (including cardiogenic shock) • Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis) • Haemodynamically unstable heart failure after acute myocardial infarction The concomitant use of telmisartan/amlodipine with aliskiren-containing medicinal products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m 2) (see sections 4.5 and 5.1).

HOS-095678 · has-contraindication-information · PDF-Seite 3

• Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1 • Second and third trimesters of pregnancy (see sections 4.4 and 4.6) • Biliary obstructive disorders and severe hepatic impairment • Shock (including cardiogenic shock) • Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis) • Haemodynamically unstable heart failure after acute myocardial infarction The concomitant use of telmisartan/amlodipine with aliskiren-containing medicinal products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m 2) (see sections 4.5 and 5.1).

HOS-095696 · has-contraindication-information · PDF-Seite 60

• Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1 • Second and third trimesters of pregnancy (see sections 4.4 and 4.6) • Biliary obstructive disorders and severe hepatic impairment • Shock (including cardiogenic shock) • Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis) • Haemodynamically unstable heart failure after acute myocardial infarction The concomitant use of telmisartan/amlodipine with aliskiren-containing medicinal products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m 2) (see sections 4.5, and 5.1).

HOS-095689 · has-indication-information · PDF-Seite 40

Treatment of essential hypertension in adults: Add on therapy Twynsta 80 mg/5 mg is indicated in adults whose blood pressure is not adequately controlled on Twynsta 40 mg/5 mg. Replacement therapy Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Twynsta containing the same component doses.

HOS-095695 · has-indication-information · PDF-Seite 59

Treatment of essential hypertension in adults: Add on therapy Twynsta 80 mg/10 mg is indicated in adults whose blood pressure is not adequately controlled on Twynsta 40 mg/10 mg or Twynsta 80 mg/5 mg. Replacement therapy Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Twynsta containing the same component doses.

HOS-095683 · has-indication-information · PDF-Seite 21

Treatment of essential hypertension in adults: Add on therapy Twynsta 40 mg/10 mg is indicated in adults whose blood pressure is not adequately controlled on amlodipine 10 mg alone. Replacement therapy Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Twynsta containing the same component doses.

HOS-095677 · has-indication-information · PDF-Seite 2

Treatment of essential hypertension in adults: Add on therapy Twynsta 40 mg/5 mg is indicated in adults whose blood pressure is not adequately controlled on amlodipine 5 mg alone. Replacement therapy Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Twynsta containing the same component doses.

HOS-095686 · has-interaction-information · PDF-Seite 25

No interactions between the two components of this fixed dose combinations have been observed in clinical studies. Interactions linked to the combination No drug interaction studies have been performed. To be taken into account with concomitant use Other antihypertensive medicinal products The blood pressure lowering effect of telmisartan/amlodipine can be increased by concomitant use of other antihypertensive medicinal products. Medicinal products with blood pressure lowering potential Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including this medicinal product, e.g. baclofen, amifostine, neuroleptics or antidepressants. Furthermore, orthostatic hypotension may be aggravated by alcohol. Corticosteroids (systemic route) Reduction of the antihypertensive effect. Interactions linked to telmisartan Concomitant use not recommended Potassium sparing diuretics or potassium supplements Angiotensin II receptor blockers such as telmisartan, attenuate diuretic induced potassium loss. Potassium sparing diuretics e.g. spirinolactone, eplerenone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes may lead to a significant increase in serum potassium. If concomitant use is indicated because of documented hypokalaemia, they should be used with caution and with frequent monitoring of serum potassium. Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with angiotensin II receptor blockers, including telmisartan. If use of the combination proves necessary, careful monitoring of serum lithium levels is recommended. Other antihypertensive agents acting on the renin-angiotensin-aldosterone system (RAAS) 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). 25 Concomitant use requiring caution Non-steroidal anti-inflammatory medicinal products NSAIDs (i.e. ace

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095692 · has-interaction-information · PDF-Seite 44

No interactions between the two components of this fixed dose combinations have been observed in clinical studies. Interactions linked to the combination No drug interaction studies have been performed. To be taken into account with concomitant use Other antihypertensive medicinal products The blood pressure lowering effect of telmisartan/amlodipine can be increased by concomitant use of other antihypertensive medicinal products. Medicinal products with blood pressure lowering potential Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including this medicinal product, e.g. baclofen, amifostine, neuroleptics or antidepressants. Furthermore, orthostatic hypotension may be aggravated by alcohol. Corticosteroids (systemic route) Reduction of the antihypertensive effect. Interactions linked to telmisartan Concomitant use not recommended Potassium sparing diuretics or potassium supplements Angiotensin II receptor blockers such as telmisartan, attenuate diuretic induced potassium loss. Potassium sparing diuretics e.g. spirinolactone, eplerenone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes may lead to a significant increase in serum potassium. If concomitant use is indicated because of documented hypokalaemia, they should be used with caution and with frequent monitoring of serum potassium. Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with angiotensin II receptor blockers, including telmisartan. If use of the combination proves necessary, careful monitoring of serum lithium levels is recommended. Other antihypertensive agents acting on the renin-angiotensin-aldosterone system (RAAS) 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). 44 Concomitant use requiring caution Non-steroidal anti-inflammatory medicinal products NSAIDs (i.e. ace

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095680 · has-interaction-information · PDF-Seite 6

No interactions between the two components of this fixed dose combinations have been observed in clinical studies. Interactions linked to the combination No drug interaction studies have been performed. To be taken into account with concomitant use Other antihypertensive medicinal products The blood pressure lowering effect of telmisartan/amlodipine can be increased by concomitant use of other antihypertensive medicinal products. Medicinal products with blood pressure lowering potential Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including this medicinal product, e.g. baclofen, amifostine, neuroleptics or antidepressants. Furthermore, orthostatic hypotension may be aggravated by alcohol. Corticosteroids (systemic route) Reduction of the antihypertensive effect. Interactions linked to telmisartan Concomitant use not recommended Potassium sparing diuretics or potassium supplements Angiotensin II receptor blockers such as telmisartan, attenuate diuretic induced potassium loss. Potassium sparing diuretics e.g. spirinolactone, eplerenone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes may lead to a significant increase in serum potassium. If concomitant use is indicated because of documented hypokalaemia, they should be used with caution and with frequent monitoring of serum potassium. Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with angiotensin II receptor blockers, including telmisartan. If use of the combination proves necessary, careful monitoring of serum lithium levels is recommended. Other antihypertensive agents acting on the renin-angiotensin-aldosterone system (RAAS) 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). 6 Concomitant use requiring caution Non-steroidal anti-inflammatory medicinal products NSAIDs (i.e. ace

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095698 · has-interaction-information · PDF-Seite 63

No interactions between the two components of this fixed dose combinations have been observed in clinical studies. Interactions linked to the combination No drug interaction studies have been performed. To be taken into account with concomitant use Other antihypertensive medicinal products The blood pressure lowering effect of telmisartan/amlodipine can be increased by concomitant use of other antihypertensive medicinal products. Medicinal products with blood pressure lowering potential Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including this medicinal product, e.g. baclofen, amifostine, neuroleptics or antidepressants. Furthermore, orthostatic hypotension may be aggravated by alcohol. Corticosteroids (systemic route) Reduction of the antihypertensive effect. Interactions linked to telmisartan Concomitant use not recommended Potassium sparing diuretics or potassium supplements Angiotensin II receptor blockers such as telmisartan, attenuate diuretic induced potassium loss. Potassium sparing diuretics e.g. spirinolactone, eplerenone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes may lead to a significant increase in serum potassium. If concomitant use is indicated because of documented hypokalaemia, they should be used with caution and with frequent monitoring of serum potassium. Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with angiotensin II receptor blockers, including telmisartan. If use of the combination proves necessary, careful monitoring of serum lithium levels is recommended. Other antihypertensive agents acting on the renin-angiotensin-aldosterone system (RAAS) 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). 63 Concomitant use requiring caution Non-steroidal anti-inflammatory medicinal products NSAIDs (i.e. ace

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095699 · has-pregnancy-information · PDF-Seite 65

Pregnancy There are limited data from the use of telmisartan/amlodipine in pregnant women. Animal reproductive toxicity studies with telmisartan/amlodipine have not been performed. Telmisartan The use of angiotensin II receptor blockers is not recommended during the first trimester of pregnancy (see section 4.4). The use of angiotensin II receptor blockers is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4). Studies with telmisartan in animals have shown reproductive toxicity (see section 5.3). 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 blockers, similar risks may exist for this class of medicinal products. Unless continued angiotensin II receptor blocker 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 angiotensin II receptor blockers should be stopped immediately, and, if appropriate, alternative therapy should be started. Exposure to angiotensin II receptor blocker therapy 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) (see section 5.3). Should exposure to angiotensin II receptor blockers have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken angiotensin II receptor blockers should be closely observed for hypotension (see sections 4.3 and 4.4). Amlodipine The safety of amlodipine in human pregnancy has not been established. In animal studies, reproductive toxicity was observed at high doses (see section 5.3). Breast-feeding Amlodipine is excreted in human milk. The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3 – 7%, with a maximum of 15%. The effect of amlodipine on infants is unknown. 65 Because no information is available regarding the use of telmisartan during breast-feeding, telmisartan

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095681 · has-pregnancy-information · PDF-Seite 8

Pregnancy There are limited data from the use of telmisartan/amlodipine in pregnant women. Animal reproductive toxicity studies with telmisartan/amlodipine have not been performed. Telmisartan The use of angiotensin II receptor blockers is not recommended during the first trimester of pregnancy (see section 4.4). The use of angiotensin II receptor blockers is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4). Studies with telmisartan in animals have shown reproductive toxicity (see section 5.3). 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 blockers, similar risks may exist for this class of medicinal products. Unless continued angiotensin II receptor blocker 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 angiotensin II receptor blockers should be stopped immediately, and, if appropriate, alternative therapy should be started. Exposure to angiotensin II receptor blocker therapy 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) (see section 5.3). Should exposure to angiotensin II receptor blockers have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken angiotensin II receptor blockers should be closely observed for hypotension (see sections 4.3 and 4.4). Amlodipine The safety of amlodipine in human pregnancy has not been established. In animal studies, reproductive toxicity was observed at high doses (see section 5.3). Breast-feeding Amlodipine is excreted in human milk. The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3 – 7%, with a maximum of 15%. The effect of amlodipine on infants is unknown. 8 Because no information is available regarding the use of telmisartan during breast-feeding, telmisartan/

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095693 · has-pregnancy-information · PDF-Seite 46

Pregnancy There are limited data from the use of telmisartan/amlodipine in pregnant women. Animal reproductive toxicity studies with telmisartan/amlodipine have not been performed. Telmisartan The use of angiotensin II receptor blockers is not recommended during the first trimester of pregnancy (see section 4.4). The use of angiotensin II receptor blockers is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4). Studies with telmisartan in animals have shown reproductive toxicity (see section 5.3). 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 blockers, similar risks may exist for this class of medicinal products. Unless continued angiotensin II receptor blocker 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 angiotensin II receptor blockers should be stopped immediately, and, if appropriate, alternative therapy should be started. Exposure to angiotensin II receptor blocker therapy 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) (see section 5.3). Should exposure to angiotensin II receptor blockers have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken angiotensin II receptor blockers should be closely observed for hypotension (see sections 4.3 and 4.4). Amlodipine The safety of amlodipine in human pregnancy has not been established. In animal studies, reproductive toxicity was observed at high doses (see section 5.3). Breast-feeding Amlodipine is excreted in human milk. The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3 – 7%, with a maximum of 15%. The effect of amlodipine on infants is unknown. 46 Because no information is available regarding the use of telmisartan during breast-feeding, telmisartan

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095687 · has-pregnancy-information · PDF-Seite 27

Pregnancy There are limited data from the use of telmisartan/amlodipine in pregnant women. Animal reproductive toxicity studies with telmisartan/amlodipine have not been performed. Telmisartan The use of angiotensin II receptor blockers is not recommended during the first trimester of pregnancy (see section 4.4). The use of angiotensin II receptor blockers is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4). Studies with telmisartan in animals have shown reproductive toxicity (see section 5.3). 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 blockers, similar risks may exist for this class of medicinal products. Unless continued angiotensin II receptor blocker 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 angiotensin II receptor blockers should be stopped immediately, and, if appropriate, alternative therapy should be started. Exposure to angiotensin II receptor blocker therapy 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) (see section 5.3). Should exposure to angiotensin II receptor blockers have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken angiotensin II receptor blockers should be closely observed for hypotension (see sections 4.3 and 4.4). Amlodipine The safety of amlodipine in human pregnancy has not been established. In animal studies, reproductive toxicity was observed at high doses (see section 5.3). Breast-feeding Amlodipine is excreted in human milk. The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3 – 7%, with a maximum of 15%. The effect of amlodipine on infants is unknown. 27 Because no information is available regarding the use of telmisartan during breast-feeding, telmisartan

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095691 · has-warning-information · PDF-Seite 41

Pregnancy Angiotensin II receptor blockers should not be initiated during pregnancy. Unless continued angiotensin II receptor blocker therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. 41 When pregnancy is diagnosed, treatment with angiotensin II receptor blockers should be stopped immediately, and, if appropriate, alternative therapy should be started (see section 4.3 and 4.6). Hepatic impairment Telmisartan is mostly eliminated in the bile. Patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance. The half-life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dose recommendations have not been established. Amlodipine should therefore be initiated at the lower end of the dosing range and caution should be used, both on initial treatment and when increasing the dose. Telmisartan/amlodipine should therefore be used with caution in these patients. 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 medicinal products that affect the renin-angiotensin-aldosterone system (RAAS). Renal impairment and kidney transplantation When telmisartan/amlodipine is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended. There is no experience regarding the administration of telmisartan/amlodipine in patients with a recent kidney transplant. Amlodipine is not dialysable and telmisartan is not removed from blood by haemofiltration and not dialysable. Volume and/or sodium depleted patients Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by e.g. vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of telmisartan. If hypotension occurs with telmisartan/amlodipine, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. Treatment can be continued once blood pressure has been stabilised. Dual blockade of the renin-angiotensin-aldosterone s

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095685 · has-warning-information · PDF-Seite 22

Pregnancy Angiotensin II receptor blockers should not be initiated during pregnancy. Unless continued angiotensin II receptor blocker therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. 22 When pregnancy is diagnosed, treatment with angiotensin II receptor blockers should be stopped immediately, and, if appropriate, alternative therapy should be started (see section 4.3 and 4.6). Hepatic impairment Telmisartan is mostly eliminated in the bile. Patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance. The half-life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dose recommendations have not been established. Amlodipine should therefore be initiated at the lower end of the dosing range and caution should be used, both on initial treatment and when increasing the dose. Telmisartan/amlodipine should therefore be used with caution in these patients. 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 medicinal products that affect the renin-angiotensin-aldosterone system (RAAS). Renal impairment and kidney transplantation When telmisartan/amlodipine is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended. There is no experience regarding the administration of telmisartan/amlodipine in patients with a recent kidney transplant. Amlodipine is not dialysable and telmisartan is not removed from blood by haemofiltration and not dialysable. Volume and/or sodium depleted patients Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by e.g. vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of telmisartan. If hypotension occurs withtelmisartan/amlodipine, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. Treatment can be continued once blood pressure has been stabilised. Dual blockade of the renin-angiotensin-aldosterone sy

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095679 · has-warning-information · PDF-Seite 3

Pregnancy Angiotensin II receptor blockers should not be initiated during pregnancy. Unless continued angiotensin II receptor blocker therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. 3 When pregnancy is diagnosed, treatment with angiotensin II receptor blockers should be stopped immediately, and, if appropriate, alternative therapy should be started (see section 4.3 and 4.6). Hepatic impairment Telmisartan is mostly eliminated in the bile. Patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance. The half-life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dose recommendations have not been established. Amlodipine should therefore be initiated at the lower end of the dosing range and caution should be used, both on initial treatment and when increasing the dose. Telmisartan/amlodipine should therefore be used with caution in these patients. 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 medicinal products that affect the renin-angiotensin-aldosterone system (RAAS). Renal impairment and kidney transplantation When telmisartan/amlodipine is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended. There is no experience regarding the administration of telmisartan/amlodipine in patients with a recent kidney transplant. Amlodipine is not dialysable and telmisartan is not removed from blood by haemofiltration and not dialysable. Volume and/or sodium depleted patients Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by e.g. vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of telmisartan. If hypotension occurs with telmisartan/amlodipine, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. Treatment can be continued once blood pressure has been stabilised. Dual blockade of the renin-angiotensin-aldosterone sy

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095697 · has-warning-information · PDF-Seite 60

Pregnancy Angiotensin II receptor blockers should not be initiated during pregnancy. Unless continued angiotensin II receptor blocker therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in 60 pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor blockers should be stopped immediately, and, if appropriate, alternative therapy should be started (see section 4.3 and 4.6). Hepatic impairment Telmisartan is mostly eliminated in the bile. Patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance. The half-life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dose recommendations have not been established. Amlodipine should therefore be initiated at the lower end of the dosing range and caution should be used, both on initial treatment and when increasing the dose. Telmisartan/amlodipine should therefore be used with caution in these patients. 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 medicinal products that affect the renin-angiotensin-aldosterone system (RAAS). Renal impairment and kidney transplantation When telmisartan/amlodipine is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended. There is no experience regarding the administration of telmisartan/amlodipine in patients with a recent kidney transplant. Amlodipine is not dialysable and telmisartan is not removed from blood by haemofiltration and not dialysable. Volume and/or sodium depleted patients Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by e.g. vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of telmisartan. If hypotension occurs with telmisartan/amlodipine, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. Treatment can be continued once blood pressure has been stabilised. Dual blockade of the renin-angiotensin-aldosterone s

Auszug; vollständigen Abschnitt im Original lesen.