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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.
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 + Amlodipine besilate (TWYNSTA).
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; dosage 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 besilate (TWYNSTA) 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.
Renal impairment and kidney transplant: When Telmisartan + Amlodipine besilate (TWYNSTA) 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 (TWYNSTA) in patients with a recent kidney transplant.
Telmisartan is not removed from blood by hemofiltration and is not dialyzable. Amlodipine is not dialyzable.
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 (TWYNSTA) can be administered with other antihypertensive drugs, however dual blockade of the renin-angiotensin-aldosterone system (e.g. by adding an ACE-inhibitor or the direct renin-inhibitor aliskiren to an angiotensin II receptor blocker) 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 (TWYNSTA) in unstable angina pectoris and during or within one month of a myocardial infarction.
Patients with cardiac failure: In an amlodipine long-term, placebo controlled study in patients with severe heart failure (NYHA class III and IV) the reported incidence of pulmonary oedema was higher in the amlodipine treated group than in the placebo group. Therefore, patients with heart failure should be treated with caution.
Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.
Sodium: Telmisartan + Amlodipine besilate (TWYNSTA) tablets 40/5 mg,40/10 mg, 80/5 mg and 80/10 mg contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
Sorbitol: Telmisartan + Amlodipine besilate (TWYNSTA) tablets 40/5 mg and 40/10 mg contain 168.64 mg sorbitol in each tablet.
Telmisartan + Amlodipine besilate (TWYNSTA) tablets 80/5 mg and 80/10 mg contain 337.28 mg sorbitol in each tablet.
Sorbitol is a source of fructose. Telmisartan + Amlodipine besilate (TWYNSTA) tablets 80/5mg and 80/10 mg are not recommended for use in patients with hereditary fructose intolerance (HFI).
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 (TWYNSTA).
Ethnic differences: Telmisartan + Amlodipine besilate (TWYNSTA) was effective when treating black patients (usually a low-renin population).
Ischaemic heart disease: 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, when driving vehicles or operating machinery it should be taken into account that syncope, somnolence, dizziness, or vertigo may occasionally occur when taking antihypertensive therapy.
If patients experience these adverse events, they should avoid potentially hazardous tasks such as driving or operating machinery.
Use in Pregnancy: See Use in Pregnancy & Lactation section for further information.
Use in the Elderly: The increase of the amlodipine dosage should take place with care in the geriatric patients (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions).
