MicardisPlus

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 Micardis 80 mg Elderly 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 MicardisPlus should be administered with caution. For telmisartan, the posology should not exceed 40 mg once daily. 3). 4). Paediatric population The safety and efficacy of MicardisPlus has not been established in patients aged below 18 years.

Use of MicardisPlus is not recommended in children and adolescents. Method of administration MicardisPlus tablets are for once-daily oral administration and should be swallowed whole with liquid. MicardisPlus can be taken with or without food.

Precautions to be taken before handling or administering the medicinal product MicardisPlus 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/HCTZ was comparable to those reported with telmisartan alone in randomised controlled trials involving 1 471 patients randomised to receive telmisartan plus HCTZ (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 HCTZ 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/HCTZ.

Adverse reactions previously reported with one of the individual components may be potential adverse reactions with MicardisPlus, 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. 11 Table 1: Tabulated list of adverse reactions (MedDRA) from placebo-controlled studies and from post-marketing experience MedDRA System Organ Class Adverse Reactions Frequency MicardisPlus 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.

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 Cholestasis rare 13 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 Hepatic enzyme increased rare rare Haemoglobin rare 14 decreased 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.

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/HCTZ 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/HCTZ 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/HCTZ in patients with recent kidney transplantation. Experience with telmisartan/HCTZ 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 MicardisPlus. Isolated cases of hyponatraemia accompanied by neurological symptoms (nausea, progressive disorientation, apathy) have been observed with the use of HCTZ.

1. • Hypersensitivity to other sulphonamide-derived substances (since HCTZ 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).