ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE

Posology The recommended dosage is one tablet, taken once daily. Individual dose titration with both active substances may be recommended. When clinically appropriate, direct change from ACE inhibitor monotherapy to the fixed combination may be considered.

5 mg should be used only after titration of the individual components. Loop diuretics are preferred to thiazides in this population. 4). g. 4). In patients with creatinine clearance of < 30 ml/min, see section

4). uncommon: diaphoresis, pruritus, urticaria, alopecia rare: erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, purpura, cutaneous lupus erythematosus, erythroderma, pemphigus not known: psoriasis, psoriasis aggravation A symptom complex has been reported which may include some or all of the following: fever, serositis, vasculitis, myalgia/myositis, arthralgia/arthritis, a positive ANA (antinuclear antibody), elevated ESR (antinuclear antibody), eosinophilia, and leukocytosis.

Rash, photosensitivity or other dermatologic manifestations may occur. 5 mg Tablets and 25 mg. 5 mg Tablets and 25 mg, whereas, the frequency of the event is uncommon as it pertains to 6 mg doses of hydrochlorothiazide. 1). Metabolism and nutrition disorders: glycosuria Nervous system disorders: lightheadedness.

Disorders of skin tissue and subcutaneous: anaphylaxis. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Enalapril Maleate-Hydrochlorothiazide Hypotension and Electrolyte Fluid Imbalance Symptomatic hypotension is rarely seen in uncomplicated hypertensive patients. 8). Regular determination of serum electrolytes should be performed at appropriate intervals in such patients.

Special attention should be paid 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. In hypertensive patients with heart failure, with or without associated renal insufficiency, symptomatic hypotension has been observed.

This is most likely to occur in those patients with more severe degrees of heart failure, as reflected by the use of high doses of loop diuretics, hyponatraemia or functional renal impairment. In these patients, therapy should be started under medical supervision and the patients should be followed closely whenever the dose of Enalapril/hydrochlorothiazide and/or diuretic is adjusted.

If hypotension occurs, the patient should be placed in the supine position and, if necessary, should receive an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further doses, which can be given usually without difficulty once the blood pressure has increased after volume expansion.

In some patients with heart failure with normal or low blood pressure, additional lowering of systemic blood pressure may occur with enalapril/hydrochlorothiazide. This effect is expected and is usually not a reason to stop treatment.

If hypotension becomes symptomatic, a dose reduction and/or discontinuation of the diuretic and/or enalapril may be necessary. 2). 4). If this occurs, therapy with enalapril/hydrochlorothiazide should be discontinued. 4). 3). 4). 5). Paediatric population The safety and efficacy of this product have not been demonstrated in controlled studies in children.

Excipients This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Enalapril Maleate Aortic Stenosis/Hypertrophic Cardiomyopathy As with all vasodilators, ACE inhibitors should be given with caution in patients with left ventricular valvular outflow tract obstruction and avoided in cases of cardiogenic shock and haemodynamically significant obstruction.

Renal Impairment Renal failure has been reported in association with enalapril and has been mainly in patients with severe heart failure or underlying renal disease, including renal artery stenosis. 4). Routine monitoring of potassium and creatinine should be part of normal medical practice for these patients.

Renovascular Hypertension There is an increased risk of hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with ACE inhibitors.

Loss of renal function may occur with only mild changes in serum creatinine. In these patients, therapy should be initiated under close medical supervision and monitoring of renal function. Kidney Transplantation There is no experience regarding the administration of enalapril in patients with a recent kidney transplantation.

Treatment with enalapril is therefore not recommended. Haemodialysis Patients The use of enalapril is not indicated in patients requiring dialysis for renal failure. , AN 69®) and treated concomitantly with an ACE inhibitor. In these patients consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent.

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 […]

3. Special populations In patients with sodium/volume depletion, the initial dose is 5 mg of enalapril or lower. An individual and progressive introduction of enalapril and hydrochlorothiazide is recommended. Elderly In clinical studies the efficacy and tolerability of enalapril maleate and hydrochlorothiazide, administered concomitantly, were similar in both elderly and younger hypertensive patients.

In case of physiological renal impairment, titration with enalapril alone is recommended prior to using the fixed combination. 5 mg Tablets in children and adolescents aged under 18, has not been established. Method of administration For oral administration with or without food.

1. • Severe renal impairment (creatinine clearance ≤30 ml/min). • Anuria. • History of angioneurotic oedema associated with previous ACE-inhibitor therapy. • Hereditary or idiopathic angioedema. • Concomitant use with sacubitril/valsartan therapy.

5). • Hypersensitivity to sulfonamide-derived drugs. 6). • Severe hepatic impairment. 1).