TELMISARTAN BRISTOL LABORATORIES

Posology Treatment of essential hypertension The usually effective dose is 40 mg once daily. Some patients may already benefit at a daily dose of 20 mg. In cases where the target blood pressure is not achieved, the dose of telmisartan can be increased to a maximum of 80 mg once daily.

Alternatively, telmisartan may be used in combination with thiazide-type diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure lowering effect with telmisartan. 1). Cardiovascular prevention The recommended dose is 80 mg once daily.

It is not known whether doses lower than 80 mg of telmisartan are effective in reducing cardiovascular morbidity. When initiating telmisartan therapy for the reduction of cardiovascular morbidity, close monitoring of blood pressure is recommended, and if appropriate adjustment of medications that lower blood pressure may be necessary.

Special populations Patients with renal impairment Limited experience is available in patients with severe renal impairment or haemodialysis. 4). No posology adjustment is required for patients with mild to moderate renal impairment.

Telmisartan is not removed from blood by hemofiltration and is not dialyzable. 3). 4). Elderly patients No dose adjustment is necessary for elderly patients. Paediatric population The safety and efficacy of telmisartan in children and adolescents aged below 18 years have not been established.

2 but no recommendation on a posology can be made. Method of administration Telmisartan tablets are for once-daily oral administration and should be taken with liquid, with or without food. Precautions to be taken before handling or administering the medicinal product Telmisartan should be kept in the sealed blister due to the hygroscopic property of the tablets.

6).

Summary of the safety profile Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to <1/1,000), and acute renal failure. 9 %) in controlled trials in patients treated for hypertension.

The incidence of adverse reactions was not dose related and showed no correlation with gender, age or race of the patients. The safety profile of telmisartan in patients treated for the reduction of cardiovascular morbidity was consistent with that obtained in hypertensive patients.

The adverse reactions listed below have been accumulated from controlled clinical trials in patients treated for hypertension and from post-marketing reports. The listing also takes into account serious adverse reactions and adverse reactions leading to discontinuation reported in three clinical long-term studies including 21,642 patients treated with telmisartan for the reduction of cardiovascular morbidity for up to six years.

Tabulated summary of adverse reactions 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).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. g. sciatica), muscle spasms, myalgia Rare: Arthralgia, pain in extremity, tendon pain (tendonitis like symptoms) Renal and urinary disorders Uncommon: Renal impairment (including acute kidney injury) General disorders and administration site conditions Uncommon: Chest pain, asthenia (weakness) Rare: Influenza-like illness Investigations Uncommon: Blood creatinine increased Rare: Haemoglobin decreased, blood uric acid increased, hepatic enzyme increased, blood creatinine phosphokinase increased 1, 2, 3, 4: for further descriptions, please see sub-section “Description of selected adverse reactions” Description of selected adverse reactions Sepsis In the PRoFESS trial, an increased incidence of sepsis was observed with telmisartan compared with placebo.

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 antihypertensive treatments which have an established safety profile for use in pregnancy.

6). 3) since telmisartan is mostly eliminated with the bile. These patients can be expected to have reduced hepatic clearance for telmisartan. This medicine should be used only with caution in patients with mild to moderate hepatic impairment.

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 transplantation When telmisartan is used in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended. There is no experience regarding the administration of telmisartan in patients with recent kidney transplantation.

Telmisartan is not removed from blood by hemofiltration and is not dialyzable. g. vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting. Such conditions should be corrected before the administration of telmisartan.

Volume and/or sodium depletion should be corrected prior to administration of telmisartan. 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).

1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.

1).