1 SUMMARY of PRODUCT CHARACTERISTICS 1. NAME of the MEDICINAL PRODUCT [Nationally Completed Name] 5 Mg Film-Coated Tablets [Nati

SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT [nationally completed name] 5 mg film-coated tablets [nationally completed name] 10 mg film-coated tablets [nationally completed name] 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 5/10/20 mg Benazepril hydrochloride. For the full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet [nationally completed name] 5 mg film-coated tablets: Oval (4 x 8 mm), light yellow film-coated tablets with score on both sides. [nationally completed name] 10 mg film-coated tablets: Oval (11 x 5.5 mm) yellow film-coated tablets with score on both sides. [nationally completed name] 20 mg film-coated tablets: Oval (11 x 5.5 mm) light red film-coated tablet with score on both sides. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Essential hypertension, congestive heart failure - in addition to diuretics and especially to digitalis glycosides in cases of severe congestive heart failure 4.2 Posology and method of administration Posology Paediatric population [nationally completed name] is not recommended for use in children due to insufficient data on safety and efficacy (see section 4.4). Essential hypertension 10 to 20 mg daily divided in one or two doses. Maximum daily dose is 40 mg. Congestive heart failure Initially 2.5 mg daily. After 2-4 weeks the dosage can be increased to 5 mg daily. Maximum dose is 20 mg daily. Dosage at renal impairment For the treatment of essential hypertension the dose should be reduced if creatinine clearance is below 30 ml/min. At renal impairment as well as in patients with heart failure a dose of 10 mg should not be exceeded. 1 Method of administration: The tablets can be taken with or without food with a sufficient amount of fluid (e.g. a glass of water). The daily dose of [nationally completed name] should be taken in the morning as a single dose; however it can be divided into two single doses to be taken in the morning and in the evening. 4.3 Contraindications Hypersensitivity to benazepril hydrochloride, other ACE-inhibitors or to any of the other excipients. history of angioneurotic oedema associated with previous ACE inhibitor therapy hereditary/idiopathic angioneurotic oedema bilateral renal artery stenosis kidney transplantation hemodynamic relevant aortic and mitral valve stenosis / hypertrophic cardiomyopathy primary hyperaldosteronism Second and third trimesters of pregnancy (see sections 4.4 and 4.6). The concomitant use of [nationally completed name] with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1). 4.4 Special warnings and precautions for use Anaphylactoid and related reactions Because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including benazepril) may experience a variety of anaphylactoid and related reactions, some of them serious. Angioedema Angioneurotic oedema has been reported rarely with ACE inhibitors including benazepril. Angioedema may occur during the first weeks of treatment. In rare cases, however, angioedema may occur after long-term use. In some cases symptoms have been observed up to 2 years after initiation of treatment. Such reactions should be regarded as an indication to discontinue therapy immediately and the patient closely monitored. If antihypertensive treatment is necessary, therapy should be continued using a non-ACE- inhibitor drug. Where swelling is confined to the face, lips and mouth, the condition will usually resolve without further treatment, although antihistamines may be useful in relieving symptoms. These patients should be followed carefully until the swelling has resolved. However, where there is involvement of the tongue, glottis or larynx, likely to cause airways obstruction, appropriate therapy such as subcutaneous adrenaline (0.5mil 1:1000) should be administered promptly when indicated. Angioedema with laryngeal oedema can be fatal. Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor (see section 4.3). Other hypersensitivity reactions have been reported. The incidence of angioedema during ACE inhibitor therapy has been reported to be higher in black patients of African origin than in non-black patients. Concomitant use of mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus) 2 Patients taking concomitant mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus) therapy may be at increased risk for angioedema (e.g. swelling of the airways or tongue, with or without respiratory impairment) (see section 4.5). Anaphylactoid reactions during desensitisation Two patients undergoing desensitising treatment with Hymenoptera venom while receiving ACE inhibitors had life-threatening anaphylactoid reactions. In the same patients, these reactions were avoided when ACE inhibitors were temporarily withheld, but they reappeared upon inadvertent rechallenge. Anaphylactoid reactions during membrane exposure / Dialysis Anaphylactoid reactions have been reported in patients dialysed with high-flux membranes while receiving an ACE inhibitor. Symptoms can be facial swelling, flushing, hypotension and dyspnoea and can occur within a few minutes after initiation of the dialysis. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulphate absorption. Symptomatic hypotension Benazepril may cause a profound fall in blood pressure, especially after the first dose. As with other ACE inhibitors, symptomatic hypotension has been observed in rare cases, typically in patients with volume or salt depletion as a result of prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhoea or vomiting. Volume and/or salt depletion should be corrected before starting therapy with benazepril. If hypotension occurs, the patient should be placed in the supine position and if necessary given physiological saline iv. Treatment with benazepril can be continued once blood pressure and volume have returned to normal. In patients with severe congestive heart failure, ACE inhibitor therapy can cause excessive hypotension which may be associated with oliguria and/or progressive azotaemia and (rarely) with acute renal failure. In such patients, therapy should be started under close medical supervision; they should be followed closely for the first 2 weeks of treatment and whenever the dose of benazepril or diuretic is increased. Similar considerations may apply to patients with ischemic heart or cerebrovascular disease in whom an excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular accident. Blood pressure and laboratory parameters should be carefully monitored, especially in patients with sodium depletion or hypovolaemia severe cardiac decompensation renal dysfunction patients older than 65 years severe hypertension Ethnic differences As with other ACE inhibitors, benazepril may be less effective in lowering blood pressure in black patients than in non-blacks, possibly because of a higher prevalence of low-renin states in the black hypertensive population. Patients with renovascular hypertension There is an increased risk of severe hypotension and renal insufficiency when patients with renovascular hypertension and pre-existing bilateral renal artery stenosis or stenosis of the artery to a solitary kidney are treated with benazepril. Treatment with diuretics may be a contributory factor. Loss of renal function may occur with only minor changes in serum creatinine even in patients with unilateral renal artery stenosis. In these patients the treatment 3 should be initiated at hospital under close medical supervision and with low doses and careful dose titration. Diuretic treatment should be discontinued and renal function should be monitored during the first weeks of the treatment. Impaired renal function Changes in renal function may occur in susceptible patients. In patients with severe congestive heart failure, whose renal function may depend on the activity of the renin-angiotensin- aldosterone system, treatment with ACE inhibitors may be associated with oliguria and/or progressive azotaemia and (rarely) acute renal failure. In a small study of hypertensive patients with renal artery stenosis in one kidney or bilateral renal artery stenosis, treatment with benazepril was associated with increases in blood urea nitrogen, and serum creatinine; these increases were reversible on discontinuation of benazepril or diuretic therapy, or both. If such patients are treated with ACE inhibitors, renal function should be monitored during the first few weeks of therapy. Some hypertensive patients with no apparent pre-existing renal vascular disease have developed elevated blood urea nitrogen and serum creatinine levels (usually minor and transient), especially when benazepril was given with a diuretic. This is more likely to occur in patients with pre-existing renal impairment. Dosage reduction of benazepril and/or discontinuation of the diuretic may be required. Evaluation of the hypertensive patient should always include assessment of renal function (see section 4.2). Agranulocytosis/Neutropenia Neutropenia/agranulocytosis, thrombocytopenia and anaemia have been

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