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Tolucombi is a brand name for Telmisartan. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of essential hypertension. Tolucombi fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide and 80 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.
Verbatim from this product's EMA label. Tap a section to expand.
Posology The fixed dose combination should be taken in patients whose blood pressure is not adequately controlled by telmisartan alone. Individual dose titration with each of the two components is recommended before changing to the fixed dose combination.
When clinically appropriate, direct change from monotherapy to the fixed combination may be considered. 5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by telmisartan 40 mg. 5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by telmisartan 80 mg.
Elderly 3 No dose adjustment is necessary for elderly patients. Renal impairment Experience in patients with mild to moderate renal impairment is modest but has not suggested adverse renal effects and dose adjustment is not considered necessary.
4). 3). Telmisartan is not removed from blood by haemofiltration and is not dialysable. Hepatic impairment In patients with mild to moderate hepatic impairment Tolucombi should be administered with caution. For telmisartan, the posology should not exceed telmisartan 40 mg once daily.
3). 4). Paediatric population The safety and efficacy of Tolucombi has not been established in patients aged below 18 years. Use of Tolucombi is not recommended in children and adolescents. Method of administration Tolucombi tablets are for once-daily oral administration and should be swallowed whole with liquid.
Tolucombi can be taken with or without food. Precautions to be taken before handling or administering the medicinal product Tolucombi should be kept in the sealed blister due to the hygroscopic property of the tablets. 6).
Summary of the safety profile The most commonly reported adverse reaction is dizziness. Serious angioedema may occur rarely (≥ 1/10 000 to < 1/1 000). The overall incidence of adverse reactions reported with telmisartan/hydrochlorothiazide was comparable to those reported with telmisartan alone in randomised controlled trials involving 1 471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636).
Dose-relationship of adverse reactions was not established and they showed no correlation with gender, age or race of the patients. 05) with telmisartan plus hydrochlorothiazide than with placebo are shown below according to system organ class.
Adverse reactions known to occur with each component given singly but which have not been seen in clinical trials may occur during treatment with telmisartan/hydrochlorothiazide. Adverse reactions previously reported with one of the individual components may be potential adverse reactions with Tolucombi, even if not observed in clinical trials with this product.
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), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1:
Tabulated list of adverse reactions (MedDRA) from placebo-controlled studies and from post-marketing experience 11 MedDRA System Organ Class Adverse Reactions Frequency Telmisartan/ hydrochlorot hiazide Telmisartana Hydrochlorothiazide Infections and infestations Sepsis including fatal outcome rare2 Bronchitis rare Pharyngitis rare Sinusitis rare Upper respiratory tract infection uncommon Urinary tract infection uncommon Cystitis uncommon Neoplasms benign, malignant and unspecified (incl.
Pregnancy Angiotensin II receptor blockers should not be initiated during pregnancy. Unless continued angiotensin II receptor blocker 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 in the bile. These patients can be expected to have reduced hepatic clearance for telmisartan. In addition, telmisartan/hydrochlorothiazide should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
There is no clinical experience with telmisartan/hydrochlorothiazide in patients with 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.
3). There is no experience regarding the administration of telmisartan/hydrochlorothiazide in patients with recent kidney transplantation. Experience with telmisartan/hydrochlorothiazide is modest in the patients with mild to moderate renal impairment, therefore periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Thiazide diuretic-associated azotaemia may occur in patients with impaired renal function. Telmisartan is not removed from blood by haemofiltration and is not dialysable. 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 vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Such conditions, especially volume and/or sodium depletion, should be corrected before the administration of Tolucombi. Isolated cases of hyponatraemia accompanied by neurological symptoms (nausea, progressive disorientation, apathy) have been observed with the use of hydrochlorothiazide.
1. - Hypersensitivity to other sulphonamide-derived substances (since hydrochlorothiazide is a sulphonamide-derived medicinal product). 6). - Cholestasis and biliary obstructive disorders. - Severe hepatic impairment. - Severe renal impairment (creatinine clearance < 30 mL/min), anuria.
- Refractory hypokalaemia, hypercalcaemia. 1).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Telmisartan in European Union.
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4) very rare Gastrointestinal disorders Diarrhoea uncommon uncommon common Dry mouth uncommon rare Flatulence uncommon uncommon Abdominal pain rare uncommon Constipation rare rare Dyspepsia rare uncommon Vomiting rare uncommon common Gastritis rare Abdominal discomfort rare rare Nausea common Pancreatitis very rare Hepatobiliary disorders Abnormal hepatic function/liver disorder rare2 rare2 Jaundice rare 13 Cholestasis rare Skin and subcutaneous tissue disorders Angioedema (including fatal outcome) rare rare Erythema rare rare Pruritus rare uncommon Rash rare uncommon common Hyperhidrosis rare uncommon Urticaria rare rare common Eczema rare Drug eruption rare Toxic skin eruption rare Lupus-like syndrome very rare Photosensitivity reaction rare Toxic epidermal necrolysis very rare Erythema multiforme not known Muscoloskeletal, connective tissue and bone disorders Back pain uncommon uncommon Muscle spasms (cramps in leg) uncommon uncommon not known Myalgia uncommon uncommon Arthralgia rare rare Pain in extremity (leg pain) rare rare Tendon pain (tendonitis-like symptoms) rare Systemic lupus erythematosus rare1 very rare Renal and urinary disorders Renal impairment uncommon not known Acute renal failure uncommon uncommon Glucosuria rare Reproductive system and breast disorders Erectile dysfunction uncommon common General disorders and administration site conditions Chest pain uncommon uncommon Influenza-like illness rare rare Pain rare Asthenia (weakness) uncommon not known Pyrexia not known Investigations Blood uric acid increased uncommon rare Blood creatinine increased rare uncommon Blood creatine phosphokinase increased rare rare 14 Hepatic enzyme increased rare rare Haemoglobin decreased rare 1 Based on post-marketing experience 2 See subsections below for additional information a Adverse reactions occurred with similar frequency in placebo and telmisartan treated patients.
9%) in placebo controlled trials. The adverse reactions listed above have been accumulated from all clinical trials […]
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.
g. 8). 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/hydrochlorothiazide 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 5 stenosis, or obstructive hypertrophic cardiomyopathy. Metabolic and endocrine effects Thiazide therapy may impair glucose tolerance, whereas hypoglycaemia may occur in diabetic patients under insulin or antidiabetic therapy and telmisartan treatment.
Therefore, in these patients blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required, when indicated. Latent diabetes mellitus may become manifest during thiazide therapy. 5 mg dose contained in the medicinal product, minimal or no effects were reported.
Hyperuricaemia may occur or frank gout may be precipitated in some patients receiving thiazide therapy. Electrolyte imbalance As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (including hypokalaemia, hyponatraemia and hypochloraemic alkalosis). 8). - Hypokalaemia Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with telmisartan may reduce diuretic-induced hypokalaemia.
The risk of hypokalaemia is greater in […]