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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.
Intravascular hypovolaemia: 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, diarrhea or vomiting. Such conditions should be corrected before the administration of Telmisartan + Amlodipine besilate.
Dual blockade of the renin-angiotensin-aldosterone system: As a consequence of inhibiting the renin-angiotensin-aldosterone system changes in renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system.
Telmisartan + Amlodipine besilate can be administered with other antihypertensive drugs, however dual blockade of the renin-angiotensin-aldosterone system (e.g. by adding on ACE inhibitor or the direct renin-inhibitor aliskiren to an angiotensin II receptor antagonist) is not recommended and should therefore be limited to individually defined cases with close monitoring of renal function (see Contraindications).
Other conditions with stimulation of the renin-angiotensin aldosterone system: In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure.
Primary aldosteronism: Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system. Therefore, the use of telmisartan is not recommended. Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Unstable angina pectoris, acute myocardial infarction: There are no data to support the use of Telmisartan + Amlodipine besilate in unstable angina pectoris and during or within one month of a myocardial infarction.
Heart failure: In a long-term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV heart failure of non-ischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo.
Hyperkalaemia: During treatment with medicinal products that affect the renin-angiotensin-aldosterone system hyperkalaemia may occur, especially in the presence of renal impairment and/or heart failure. Monitoring of serum potassium in patients at risk is recommended.
Based on experience with the use of medicinal products that affect the renin-angiotensin system, concomitant use with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase the potassium level (heparin, etc.) may lead to an increase in serum potassium and should therefore be co-administered cautiously with telmisartan.
Diabetes mellitus: In diabetic patients with an additional cardiovascular risk, i.e. patients with diabetes mellitus and coexistent coronary artery disease (CAD), the risk of fatal myocardial infarction and unexpected cardiovascular death may be increased when treated with blood pressure lowering agents such as ARBs or ACE-inhibitors. In patients with diabetes mellitus CAD may be asymptomatic and therefore undiagnosed.
Patients with diabetes mellitus should undergo appropriate diagnostic evaluation, e.g. exercise, stress testing, to detect and to treat CAD accordingly before initiating treatment with Telmisartan + Amlodipine besilate.
Other: Telmisartan + Amlodipine besilate was effective when treating black patients (usually a low-renin population). As with any antihypertensive agent, excessive reduction of blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Driving and using machines: No studies on the effects on the ability to drive and use machines have been performed. However, patients should be advised that they may experience undesirable effects such as syncope, somnolence, dizziness, or vertigo during treatment. Therefore, caution should be recommended when driving a car or operating machinery. If patients experience these adverse experiences, they should avoid potentially hazardous tasks such as driving or operating machinery.
Hepatic impairment: Telmisartan is mostly eliminated in the bile.
Patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance. Furthermore as with all calcium antagonists, amlodipine half-life is prolonged in patients with impaired liver function and dosage recommendations have not been established. Telmisartan + Amlodipine besilate should therefore be used with caution in these patients.
Renal impairment and kidney transplant: When Telmisartan + Amlodipine besilate 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 besilate in patients with a recent kidney transplant.
Telmisartan and amlodipine besilate are not dialyzable.
Use in Pregnancy: Angiotensin II receptor antagonists should not be initiated during pregnancy.
Unless continued, angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and if appropriate, alternative therapy should be started.
