SEVIKAR HCT

Posology Adults The recommended dose of Sevikar HCT is 1 tablet per day. 5 mg may be administered in patients whose blood pressure is not adequately controlled on olmesartan medoxomil 20 mg and amlodipine 5 mg taken as dual-component combination.

5 mg. 5 mg. 5 mg. 5 mg or by Sevikar HCT 40 mg/5 mg/25 mg. A step-wise titration of the dosage of the individual components is recommended before changing to the triple-component combination. When clinically appropriate, direct change from dual-component combination to the triple-component combination may be considered.

Substitution therapy Patients controlled on stable doses of olmesartan medoxomil, amlodipine and hydrochlorothiazide taken at the same time as a dual-component (olmesartan medoxomil and amlodipine or olmesartan medoxomil and hydrochlorothiazide) and a single-component formulation (hydrochlorothiazide or amlodipine) may be switched to Sevikar HCT containing the same component doses.

The maximum recommended dose of Sevikar HCT is 40 mg/10 mg/25 mg per day. Elderly (age 65 years or over) Caution, including more frequent monitoring of blood pressure, is recommended in elderly people, particularly at the maximum dose of Sevikar HCT 40 mg/10 mg/25 mg per day.

2). Very limited data are available on the use of Sevikar HCT in patients aged 75 years or older. Extreme caution, including more frequent monitoring of blood pressure, is recommended. 5 mg, owing to limited experience of the 40 mg olmesartan medoxomil dosage in this patient group.

Monitoring of serum concentrations of potassium and creatinine is advised in patients with moderate renal impairment. 2). 2). 5 mg once daily. Close monitoring of blood pressure and renal function is advised in patients with hepatic impairment.

As with all calcium antagonists, amlodipine’s half-life is prolonged in patients with impaired liver function and dosage recommendations have not been established. Sevikar HCT should therefore be administered with caution in these patients.

The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment. Amlodipine should be initiated at the lowest dose and titrated slowly in patients with impaired liver function. 3). Paediatric population Sevikar HCT is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.

Method of administration:

The tablet should be swallowed with a sufficient amount of fluid (e. g. one glass of water). The tablet should not be chewed and should be taken at the same time each day. Sevikar HCT can be taken with or without food.

The safety of Sevikar HCT was investigated in clinical trials in 7826 patients receiving olmesartan medoxomil in combination with amlodipine and hydrochlorothiazide. Adverse reactions from clinical trials, post-authorization safety studies and spontaneous reporting are summarized in table 1 for Sevikar HCT as well as for the individual components olmesartan medoxomil, amlodipine and hydrochlorothiazide based on the known safety profile of the single components.

The most commonly reported adverse reactions during treatment with Sevikar HCT are peripheral oedema, headache and dizziness. ) Not known Eye disorders Choroidal effusion Not known Vertigo Uncommon Uncommon RareEar and labyrinth disorders Tinnitus Uncommon Palpitations Common Common Tachycardia Uncommon Myocardial infarction Very rare Arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation) Uncommon Rare Cardiac disorders Angina pectoris Uncommon Uncommon (incl.

4) Very rare Hepatitis Very rare Jaundice (intrahepatic cholestatic icterus) Very rare Rare Acute cholecystitis Rare Hepatobiliary disorders Autoimmune hepatitis* Not known Alopecia Uncommon Angioedema Rare Very rare Allergic dermatitis Uncommon Erythema multiforme Very rare Erythema Uncommon Cutaneous lupus erythematodes-like reactions Rare Exanthema Uncommon Uncommon Exfoliative dermatitis Very rare Hyperhydrosis Uncommon Skin and subcutaneous tissue disorders Photosensitivity reactions Very rare Uncommon Pruritus Uncommon Uncommon Uncommon Purpura Uncommon Uncommon Quincke oedema Very rare Rash Uncommon Uncommon Uncommon Reactivation of cutaneous lupus erythematodes Rare Toxic epidermal necrolysis Not known Rare Skin discoloration Uncommon Stevens-Johnson syndrome Very rare Urticaria Uncommon Uncommon Uncommon Muscle spasm Common Rare Common Joint swelling Common Muscular weakness Uncommon Rare Ankle swelling Common Arthralgia Uncommon Arthritis Common Back pain Common Uncommon Paresis Rare Myalgia Uncommon Uncommon Musculoskeletal and connective tissue disorders Skeletal pain Common Pollakiuria Common Increased urinary frequency Uncommon Acute renal failure Rare Haematuria Common Micturition disorder Uncommon Nocturia Uncommon Interstitial nephritis Rare Renal and urinary disorders Renal insufficiency Rare Rare Erectile dysfunction Uncommon Uncommon UncommonReproductive system and breast disorders Gynaecomastia Uncommon Asthenia Common Uncommon Common Peripheral oedema Common Common Fatigue Common Common Common Chest pain Common Uncommon Fever Rare Influenza-like symptoms Common Lethargy Rare Malaise […]

Patients with hypovolaemia or sodium depletion:

Symptomatic hypotension may occur in patients who are volume and/or sodium depleted as a result of vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting, especially after the first dose. Correction of this condition prior to administration of Sevikar HCT or close medical supervision at the start of the treatment is recommended.

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 medicinal products that affect this system has been associated with acute hypotension, azotaemia, oliguria or, rarely, acute renal failure.

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 Sevikar HCT is used in patients with impaired renal function, periodic monitoring of serum concentrations of potassium and creatinine is recommended. 2). Thiazide diuretic-associated azotaemia may occur in patients with impaired renal function.

If progressive renal impairment becomes evident, careful reappraisal of therapy is necessary, with consideration given to discontinuing diuretic therapy. There is no experience of the administration of Sevikar HCT in patients with a recent kidney transplant or in patients with end-stage renal impairment (i.

e. creatinine clearance < 12 mL/min).

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. 2). Furthermore, minor alterations of fluid and electrolyte balance during thiazide therapy may precipitate hepatic coma in patients with impaired hepatic function or progressive liver disease.

Care should be taken when Sevikar HCT is administered in patients with mild to moderate hepatic impairment. 2). In patients with impaired hepatic function, amlodipine should be initiated at the lower end of the dosing range and caution should be used, both on initial treatment and when increasing the dose.

3).

Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy:

Due to the amlodipine component of Sevikar HCT, as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.

Primary aldosteronism:

Patients with primary aldosteronism generally will not respond to anti- hypertensive medicinal products acting through inhibition of the renin- angiotensin system. Therefore, the use of Sevikar HCT is not recommended in such patients.

Metabolic and endocrine effects:

Thiazide therapy may impair glucose tolerance. 5). Latent diabetes mellitus may become manifest during thiazide therapy. Increases in cholesterol and triglyceride levels are undesirable effects known to be associated with thiazide diuretic therapy.

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). 5). Conversely, due to antagonism at the angiotensin-II receptors (AT1) through the olmesartan medoxomil component of Sevikar HCT hyperkalaemia may occur, especially in the presence of renal impairment and/or heart failure, and diabetes mellitus.

Close monitoring of serum potassium in patients at risk is recommended. Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes and other medicinal products that may […]

1. 2). Refractory hypokalaemia, hypercalcaemia, hyponatraemia and symptomatic hyperuricaemia. 2). 6). 1). Due to the amlodipine component, Sevikar HCT is contraindicated in patients with: - Shock (including cardiogenic shock). g. high grade aortic stenosis).

- Haemodynamically unstable heart failure after acute myocardial infarction.