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Telmisartan Teva Pharma is a brand name for Telmisartan. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Hypertension Treatment of essential hypertension in adults. 3 Cardiovascular prevention Reduction of cardiovascular morbidity in adults with: • manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or • type 2 diabetes mellitus with documented…
Verbatim from this product's EMA label. Tap a section to expand.
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 have 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 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. 3). 4). Elderly No dose adjustment is necessary for elderly patients.
Paediatric population The safety and efficacy of Telmisartan Teva Pharma in children and adolescents aged below 18 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.
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 21642 patients treated with telmisartan for the reduction of cardiovascular morbidity for up to six years.
Tabulated list 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 extremetis, tendon pain (tendinitis like symptoms) Renal and urinary disorders Uncommon: Renal impairment including acute renal failure 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 creatine phosphokinase increased 1, 2, 3, 4: for further descriptions, please see sub-section ”Description of selected adverse reactions”.
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.
6). 3) since telmisartan is mostly eliminated with the bile. These patients can be expected to have reduced hepatic clearance for telmisartan. Telmisartan Teva Pharma 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 Teva Pharma 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 Teva Pharma in patients with recent kidney transplantation.
Intravascular hypovolaemia Symptomatic hypotension, especially after the first dose of Telmisartan Teva Pharma, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting.
Such conditions should be corrected before the administration of Telmisartan Teva Pharma. Volume and/or sodium depletion should be corrected prior to administration of Telmisartan Teva Pharma. 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).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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10 Description of selected adverse reactions Sepsis In the PRoFESS trial, an increased incidence of sepsis was observed with telmisartan compared with placebo. 1). Hypotension This adverse reaction was reported as common in patients with controlled blood pressure who were treated with telmisartan for the reduction of cardiovascular morbidity on top of standard care.
Hepatic function abnormal / liver disorder Most cases of hepatic function abnormal / liver disorder from post-marketing experience occurred in Japanese patients. Japanese patients are more likely to experience these adverse reactions.
Interstitial lung disease Cases of interstitial lung disease have been reported from post-marketing experience in temporal association with the intake of telmisartan. However, a causal relationship has not been established. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
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.
g. 8). Primary aldosteronism 5 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. Diabetic patients treated with insulin or antidiabetics In these patients hypoglycaemia may occur under telmisartan treatment.
Therefore, in these patients an approptiate blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required, when indicated. Hyperkalaemia The use of medicinal products that affect the renin-angiotensin-aldosterone system may cause hyperkalaemia.
In the elderly, in patients with renal insufficiency, 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-angiotensinaldosterone system, the benefit risk ratio should be evaluated. The main risk factors for hyperkalaemia to be considered are: - Diabetes mellitus, renal impairment, age (>70 years) - Combination with one or more other medicinal products that affect the renin-angiotensinaldosterone system and/or potassium supplements.
Medicinal products or therapeutic classes of medicinal products that may provoke hyperkalaemia are 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.
g. g. acute limb ischemia, rhabdomyolysis, extend trauma). 5). Ethnic differences As observed for angiotensin converting enzyme inhibitors, telmisartan and the other angiotensin II receptor 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 in the black hypertensive population.
Other As with any antihypertensive agent, […]