Telgen 40 & 80 40 or 80 mg Tablet.

Treatment of mild to moderate hypertension, either alone or in combination with hydrochlorothiazide. Reduction of cardiovascular morbidity and mortality in patients 55 years or older at high risk of cardiovascular disease; the benefit of treatment is evident after at least 6 months of continued treatment.

Posology
Adults
Treatment of essential hypertension in adults: The recommended dose is 40 mg once daily. In cases where the target blood pressure is not achieved, the TELGENu00ae dose can be increased to a maximum of 80 mg once daily. Alternatively, TELGENu00ae may be used in combination with a low dose thiazide diuretic such as hydrochlorothiazide 12,5 mg, which has been shown to have an additive blood pressure lowering effect with TELGENu00ae. When considering raising the dose, it must be borne in mind that the maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment.
Reduction of cardiovascular morbidity and mortality: The recommended dose is 80 mg once daily. It is not known whether doses lower than 80 mg of TELGENu00ae are effective in reducing cardiovascular morbidity and mortality.
When initiating TELGENu00ae therapy for the reduction of cardiovascular morbidity and mortality, monitoring of blood pressure is recommended and, if appropriate, adjustment of medications that lower blood pressure may be necessary. The benefit of treatment is evident only after 6 months of continued treatment.
Special populations
Renal impairment: No dosage adjustment is required for patients with mild to moderate renal impairment. TELGENu00ae is not removed from blood by haemofiltration.
Hepatic impairment: In patients with mild to moderate hepatic impairment the dosage should not exceed 40 mg once daily.
Elderly: No dosing adjustment is necessary.
Paediatric population
Children and adolescents up to 18 years: There are no data on the safety and efficacy of TELGENu00ae in children and adolescents up to 18 years.

• Hypersensitivity to any of the components of TELGENu00ae listed in section 6.1.
• A history of angioedema related to previous therapy with ACE inhibitors or angiotensin receptor blockers (ARBs): Such patients must never again be given these medicines.
• Hereditary or idiopathic angioedema.
• Hypertrophic obstructive cardiomyopathy (HOCM).
• Severe renal function impairment (creatinine clearance less than 30 mL/min).
• Bilateral renal artery stenosis.
• Renal artery stenosis in patients with a single kidney.
• Aortic stenosis.
• Concomitant therapy with potassium sparing diuretics such as spironalactone, triamterene, amiloride (See section 4.4).
• Porphyria.
• Lithium therapy: Concomitant administration with TELGENu00ae may lead to toxic blood concentrations of lithium (see section 4.5).
• Pregnancy and lactation (see Section 4.4 and 4.6)
• Severe hepatic impairment
• Obstructive biliary disorders
• In case of rare hereditary conditions that may be incompatible with sorbitol, an excipient of the product, the use of TELGENu00ae is contra-indicated (see Section 4.4).
• The concomitant use of TELGENu00ae with aliskiren-containing products is contraindicated (see Section 4.4 and 4.5).
• Concomitant use of fluoroquinolones with ACE inhibitors/renin-angiotensin blockers is contraindicated in patients with moderate to severe renal impairment (Creatinine Clearance u226430 mL/min) and in elderly patients.

Pregnancy:
TELGENu00ae should not be initiated during pregnancy.
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 (see Section 4.3).
Renal impairment and kidney transplant:
When TELGENu00ae is used in patients with moderate impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended. There is no experience regarding the administration of TELGENu00ae in patients with a recent kidney transplant (see Section 4.3).
Intravascular volume depletion:
Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of TELGENu00ae. Volume and/or sodium depletion should be corrected prior to administration of TELGENu00ae.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS):
There is evidence that the concomitant use of ace-inhibitors, angiotensin II receptor blockers (ARBS) or aliskiren may increase the risk of hypotension and hyperkalaemia, and decrease renal function (including acute renal failure). Dual blockade of RAAS through the combined use of TELGENu00ae and aliskiren is therefore contra-indicated (see Section 4.3).
Should a woman become pregnant while receiving TELGENu00ae, the treatment should be stopped promptly and an alternate antihypertensive medicine used (see Section 4.3 and Section 4.6).
TELGENu00ae should not be used concomitantly with aliskiren (see Section 4.3).
ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
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 other medicinal products that affect this system, such as TELGENu00ae, has been associated with acute hypotension, hyperureamia, hyperazotaemia, oliguria, or rarely acute renal failure (see Section 4.3).
Concomitant use of fluoroquinolones:
Concomitant use of fluoroquinolones and ACE inhibitors/Angiotensin receptor blockers may precipitate acute kidney injury in patients, especially those with moderate to severe renal impairment and elderly patients. (See Section 4.3). Renal function should be assessed before initiating treatment and monitored during treatment with fluoroquinolones or ACE inhibitors/Angiotensin receptor blockers whether used separately and/or concomitantly.
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 TELGENu00ae is not recommended.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: See section 4.3.
Diabetic patients treated with insulin or antidiabetics:
In these patients hypoglycaemia may occur under telmisartan treatment. Therefore, in these patients an appropriate blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required, when indicated.
In diabetic patients with an additional cardiovascular risk, i.e. patients with diabetes mellitus and co-existent 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 TELGENu00ae.
Hyperkalaemia:
During treatment with products that affect the renin-angiotensin-aldosterone system such as TELGENu00ae, hyperkalaemia may occur, especially in the presence of renal impairment and/or heart failure. Monitoring of serum potassium in patients at risk is recommended. In the elderly, in diabetic patients, in patients concomitantly treated with other medicinal products that may increase potassium levels, and/or in patients with intercurrent events, hyperkalaemia may be fatal. Before considering the concomitant use of medicinal products that affect the renin-angiotensin-aldosterone system, the benefit risk ratio should be evaluated. The main risk factors for hyperkalaemia - Diabetes mellitus, age (>70 years). 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.) ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), immunosuppressives (cyclosporin or tacrolimus), and trimethoprim may lead to an increase in serum potassium and should therefore not be co-administered with TELGENu00ae.
to be considered are:
- Intercurrent events, in particular dehydration, acute cardiac decompensation, metabolic acidosis, worsening of renal function, sudden worsening of the renal condition (e.g. infectious diseases), cellular lysis (e.g. acute limb ischemia, rhabdomyolysis, extend trauma). Close monitoring of serum potassium in at risk patients is recommended.
Hepatic impairment:
TELGENu00ae is mostly eliminated in the bile. Patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance. TELGENu00ae should be used with caution in these patients (see Section 4.3). TELGENu00ae should be used only with caution in patients with mild to moderate hepatic impairment.
Active gastric or duodenal ulcer or gastro-intestinal pathologies:
In clinical trials with telmisartan as in TELGENu00ae, gastro-intestinal adverse events apparently occurred more frequently than with placebo and gastro-intestinal bleedings have been reported infrequently and this has occurred mainly in patients with baseline gastro-intestinal disease. Therefore, caution should be exercised when administering TELGENu00ae to this group of patients.
Other:
As observed for angiotensin converting enzyme inhibitors, TELGENu00ae and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states the black hypertensive population. Excessive reduction in blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke. Concomitant use of fluoroquinolones and ACE inhibitors/renin-angiotensin receptor blockers may precipitate acute kidney injury in patients, especially those with moderate to severe renal impairment and elderly patients (see Section 4.3). Renal function should be assessed before initiating treatment, and monitored during treatment, with fluoroquinolones or ACE inhibitors/renin-angiotensin receptor blockers.
Sorbitol:
TELGENu00ae 40 and TELGENu00ae 80 tablets contain 176,64 mg and 349,28 mg sorbitol, respectively. Patients with the rare hereditary condition of sorbitol intolerance should not take TELGENu00ae.

TELGENu00ae may increase the hypotensive effect of other antihypertensive agents. Co-administration of telmisartan did not result in a clinically significant interaction with digoxin, warfarin, hydrochlorothiazide, glibenclamide, paracetamol, ibuprofen, simvastatin and amlodipine. For digoxin a 20 % increase in median plasma digoxin trough concentration has been reported (in a single case a 39 %). Monitoring of plasma digoxin levels should be considered. As with other medicinal products acting on the renin-angiotensin-aldosterone system, telmisartan may provoke hyperkalaemia (see Section 4.4). The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia [salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin immunosuppressives (cyclosporin or tacrolimus), and trimethoprim]. In one reported study the co-administration of telmisartan and ramipril led to an increase of up to 2,5 fold in the AUC 0-24 and C max of ramipril and ramiprilat. The clinical relevance of this observation is not known. Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Increased serum levels have also been reported with telmisartan. Careful monitoring of serum lithium levels is recommended during concomitant use. Concomitant treatment with NSAIDs (including aspirin at anti-inflammatory dosage regimens, COX-2 inhibitors and non-selective NSAIDs) is associated with the potential for acute renal insufficiency in patients who are dehydrated. Compounds acting on the Renin-Angiotensin-System like telmisartan may have synergistic effects. Patients receiving NSAIDs and telmisartan should be adequately hydrated and be monitored for renal function at the beginning of combined treatment. A reduced effect of antihypertensive medicines like telmisartan by inhibition of vasodilating prostaglandins has been reported during combined treatment with NSAIDs. Dual blockade of the RAAS with ARBs, ACE inhibitors or aliskiren Reported 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 (see Section 4.3 and 4.4).

Safety in pregnancy and lactation has not been established (see Section 4.3). When pregnancy is planned or confirmed, TELGENu00ae should be discontinued. Medicines affecting the rennin-angiotensin system, such as TELGENu00ae, can cause embryonal toxicity, foetal and neonatal morbidity and mortality when administered to pregnant women. Women of childbearing age should ensure effective contraception. Exposure to angiotensin II receptor antagonist 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 antagonists 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 antagonists should be closely observed for hypotension (see sections 4.3 and 4.4).

No studies on the effect on the ability to drive and use machines have been performed. However, when driving vehicles or operating machinery it must be borne in mind that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy, such as TELGENu00ae.

System Organ Class Frequency Side effect Infections and infestations: Frequent: Urinary tract infections (including cystitis), upper respiratory tract infections including pharyngitis and sinusitis Blood and the lymphatic systemic disorders: Less frequent: Eosinophilia, thrombocytopenia, anaemia Immune system disorders: Less frequent: Hypersensitivity, Angioedema (with fatal outcome) Psychiatric disorders: Less frequent: Anxiety, depression, insomnia. Nervous system disorders: Less frequent: Faintness/ syncope, somnolence Eye disorders: Less frequent: Abnormal vision Ear and labyrinth disorders: Less frequent: Vertigo Cardiac disorders: Less frequent: Bradycardia, tachycardia Vascular disorders: Less frequent: Hypotension, orthostatic hypotension Respiratory, thoracic and mediastinal disorders: Frequent: Less frequent: Cough, dyspnoea, interstitial lung disease Gastro-intestinal disorders: Less frequent: Abdominal pain, diarrhoea, dyspepsia, stomach upset, nausea, vomiting, dry mouth, flatulence, dysgeusia Skin and subcutaneous tissue disorders: Less frequent: Eczema, increased sweating (hyperhidrosis), rash, erythema, pruritus, urticaria, drug eruption, toxic skin eruption, angioedema (also with fatal outcome) Musculoskeletal, connective tissue and bone disorders: Frequent: Less frequent: Arthralgia, myalgia, back pain, muscle spasms (cramps in legs or leg pain), Tendinitis like symptoms, weakness Renal and urinary disorders: Less frequent: Renal impairment including acute renal failure General disorders and administration site conditions: Less frequent: Chest pain, influenza-like symptoms, asthenia (weakness), lack of efficacy Investigations: Less frequent: Blood creatinine increased, haemoglobin decreased, blood uric acid increased, hepatic enzymes increased, blood creatine phosphokinase increased.

See Section 4.8 Undesirable effects. No data are available with regard to overdose in humans. The most prominent manifestations of TELGENu00ae overdose were hypotension and tachycardia; bradycardia also occurred. If symptomatic hypotension should occur, supportive treatment should be instituted. TELGENu00ae is not removed by haemodialysis.