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VERAPAMIL Hcl / TRANDOLAPRIL VERAPAMIL HCl / TRANDOLAPRIL TARKA® 180 mg / 2 mg tablet Anti-hypertensive QUALITATIVE AND QUANTITATIVE COMPOSITION Verapamil HCl + Trandolapril (Tarka) is supplied as tablets containing immediate release trandolapril and sustained release verapamil. Each bilayer tablet contains 180 mg verapamil hydrochloride and 2 mg trandolapril. Excipient: Each 2 mg/180 mg bilayer tablet contains up to 108.625 mg lactose (as lactose monohydrate). PHARMACEUTICAL FORM Verapamil HCl + Trandolapril (Tarka) 180 mg / 2 mg, bilayer tablet CLINICAL PARTICULARS Therapeutic indications Verapamil HCl + Trandolapril (Tarka) is indicated for the treatment of essential hypertension in patients whose blood pressure has been normalized with the individual components in the same proportion of doses or in patients whose blood pressure is not adequately controlled on trandolapril or verapamil alone. Posology and method of administration For oral use Posology Adults: The usual dosage is one tablet daily. Special Populations Pediatric population: The safety and efficacy of Verapamil HCl + Trandolapril (Tarka) in children and adolescents have not yet been established. Therefore use in this age group is not recommended. Geriatric: Verapamil HCl + Trandolapril (Tarka) has been studied in a limited number of elderly hypertensive patients only. Pharmacokinetic data show that the systemic availability of Verapamil HCl + Trandolapril (Tarka) is higher in elderly compared to younger hypertensives. Some elderly patients might experience a more pronounced blood pressure lowering effect than others. Method of administration The bilayer tablets should be swallowed whole with water ideally in the morning after food. Contraindications Verapamil HCl + Trandolapril (Tarka) is contraindicated in: • Hypersensitivity to the active substances or to the excipients • Use in children and adolescents (<18 years) • Patients concomitantly treated with intravenous β-adrenoreceptor antagonists (exception: intensive care unit). Because of the verapamil hydrochloride component, Verapamil HCl + Trandolapril (Tarka) is contraindicated in: • Cardiogenic shock • Second or third degree atrioventricular block (except in patients with a functioning artificial pacemaker) • Sick sinus syndrome (except in patients with a functioning artificial pacemaker) • Heart failure with reduced ejection fraction of less than 35%, and/or pulmonary wedge pressure above 20 mm Hg • Atrial fibrillation/flutter in the presence of an accessory bypass tract (e.g., Wolff- Parkinson- White, Lown-Ganong-Levine syndromes). These patients are at risk to develop ventricular tachyarrhythmia including ventricular fibrillation if verapamil hydrochloride is administered. Because of the trandolapril component, Verapamil HCl + Trandolapril (Tarka) is contraindicated in: • History of angioedema associated with administration of an ACE inhibitor • Hereditary/idiopathic angioedema • Second and third trimester of pregnancy (see sections Special warnings and precautions for use and Pregnancy/Lactation) • Severe renal impairment (creatinine clearance < 30 ml/min) • Dialysis • Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections Interaction with other medicinal products and other forms of interaction and Pharmacodynamic properties). • Liver cirrhosis with ascites Special warnings and precautions for use Because of the trandolapril component, the following warnings apply to Verapamil HCl + Trandolapril (Tarka): Angioedema Trandolapril may cause angioedema that includes swelling of the face, extremities, tongue, glottis and/or larynx. ACE inhibitors have been shown to cause a higher rate of angioedema in black patients than in non-black patients. Intestinal angioedema has also been reported in patients treated with ACE inhibitors. This should be considered in patients on trandolapril presenting with abdominal pain (with or without nausea or vomiting). Patients experiencing angioneurotic edema must immediately discontinue the therapy and be monitored until edema resolution. Angioedema of the face will usually resolve spontaneously. Edema involving not only the face but also the glottis may be life-threatening because of the risk of airway obstruction. Angioedema involving the tongue, glottis or larynx requires immediate subcutaneous administration of 0.3-0.5ml of adrenaline solution (1:1000) along with other therapeutic measures as appropriate. Patients with renovascular hypertension ACE inhibitors may be of use until curative treatment of the renovascular hypertension can be effected, or if such a procedure is not to be carried out. The risk of severe arterial hypotension and renal insufficiency is increased when patients with prior unilateral or bilateral renal artery stenosis are treated with an ACE inhibitor. Diuretics may further increase the risk. Loss of renal function may occur with only small changes in the serum creatinine, even in patients with unilateral renal artery stenosis. For these patients treatment should be initiated in the hospital under close medical supervision with low doses and careful dose adjustment. Diuretic treatment should be discontinued, and renal function and serum potassium monitored during the early weeks of treatment. Renal impairment Patients with a creatinine clearance less than 30 mL/min may require reduced doses of trandolapril. Evaluation of hypertensive patients should always include assessment of renal function. In patients with renal insufficiency, congestive heart failure or bilateral renal artery stenosis, or unilateral renal artery stenosis in individuals with a single functioning kidney (e.g., renal transplant patients), there is a risk of impairment of renal function. Some hypertensive patients with no apparent pre-existing renal disease may develop increases in blood urea nitrogen and serum creatinine when trandolapril is given concomitantly with a diuretic. Proteinuria Proteinuria may occur particularly in patients with existing renal function impairment or on relatively high doses of ACE inhibitors. 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, hyperkalemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections Interaction with other medicinal products and other forms of interaction and Pharmacodynamic properties). 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. Hyperkalemia Verapamil HCl + Trandolapril (Tarka) may produce hyperkalemia in hypertensive patients, especially those with renal dysfunction. Risk factors for the development of hyperkalemia include renal insufficiency, potassium-sparing diuretics, the concomitant use of agents to treat hypokalemia, diabetes mellitus and/or left ventricular dysfunction after myocardial infarction. Cough During treatment with an ACE inhibitor, a dry and non-productive cough may occur which disappears after discontinuation. Pregnancy ACE inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitor 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. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections contraindications and Pregnancy/Lactation). Lactation The use of trandolapril/verapamil is not recommended in women who are breastfeeding (see section Pregnancy and Lactation). Symptomatic Hypotension In patients with uncomplicated hypertension, symptomatic hypotension has been observed after the initial dose of trandolapril, as well as after increasing the dose of trandolapril. It is more likely to occur in patients who have been volume- and salt-depleted by prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea or vomiting. Therefore, in these patients, diuretic therapy should be discontinued and volume and/or salt depletion should be corrected before initiating therapy with trandolapril. Agranulocytosis and Bone Marrow Depression In patients on ACE inhibitors, agranulocytosis and bone marrow depression have been seen. The risk of neutropenia appears to be dose-and type-related and is dependent on the patient's clinical status. These reactions are more frequent in patients with renal impairment, especially those with a collagen vascular disease. However, regular monitoring of white blood cell counts and protein levels in urine should be considered in patients with collagen vascular disease (e.g. lupus erythematosus and scleroderma), especially associated with impaired renal function and concomitant therapy, particularly with corticosteroids and antimetabolites. It is reversible after discontinuation of the ACE inhibitor. Aortic stenosis/outflow obstruction Trandolapril should not be used in patients with aortic stenosis or outflow obstruction. Impaired liver function As trandolapril
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