ENALAPRIL MALEATE/HYDROCHLOROTHIAZIDE

Posology The dosage of this medicine should be determined primarily by the experience with the enalapril maleate component.

Adults:

Essential hypertension The usual dosage is one tablet, taken once daily. If necessary, the dosage may be increased to two tablets, taken once daily. Prior diuretic therapy: symptomatic hypotension may occur following the initial dose of this medicine; this is more likely in patients who are volume and/or salt depleted as a result of prior diuretic therapy.

The diuretic therapy should be discontinued for 2-3 days prior to initiation of therapy with this medicine. e. moderate or severe renal insufficiency). In patients with creatinine clearance of >30 mL/min and <80 mL/min this medicine should be used only after titration of the individual components.

Elderly In clinical studies the efficacy and tolerability of enalapril maleate and hydrochlorothiazide, administered concomitantly, were similar in both elderly and younger hypertensive patients. Paediatric population Safety and effectiveness in children have not been established.

Method of administration:

Oral use.

Summary of the safety profile Enalapril maleate / Hydrochlorothiazide Tablets are usually well-tolerated. In clinical studies, side effects have usually been mild and transient, and in most instances have not required interruption of therapy.

The most common side effects reported during clinical study with Enalapril maleate / Hydrochlorothiazide Tablets were headache and cough. The following undesirable side effects have been reported for enalapril alone or hydrochlorothiazide alone either during clinical studies or after the drug was marketed.

Tabulated list of adverse reactions Table 1. 4) urticaria, alopecia Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, purpura, cutaneous lupus erythematosus, erythroderma, pemphigus been reported which may include some or all of the following: fever, serositis, vasculitis, myalgia/myo sitis, arthralgia/art hritis, a positive ANA, elevated ESR, eosinophilia, and leucocytosis.

Rash, photosensitivi ty or other dermatologic manifestation s may occur. Psoriasis and psoriasiform dermatitis. Musculoskele tal, connective tissue, and bone disorders Muscle cramps† Arthralgia** Renal and urinary disorders Renal dysfunction, renal failure, proteinuria Oliguria, interstitial nephritis Reproductive system and breast disorders Impotence Gynecomastia General disorders and administratio n site conditions Asthenia Chest pain, fatigue Malaise, fever Investigations Hyperkala emia, increases in serum creatinine Increases in blood urea, hyponatremia Elevations of liver enzymes, elevations of serum bilirubin * Incidence rates were comparable to those in the placebo and active control groups in the clinical trials.

5 mg and 25 mg, whereas, the frequency of the event is uncommon as it pertains to 6 mg doses of hydrochlorothiazide. 1). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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 this medicine and/or diuretic is adjusted.

Similar considerations may apply to patients with ischaemic heart or cerebrovascular disease in whom an excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular accident. 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 contra-indication 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 who have normal or low blood pressure, additional lowering of systemic blood pressure may occur with this medicine.

This effect is anticipated, and usually is not a reason to discontinue treatment. If hypotension becomes symptomatic, a reduction of dose and/or discontinuation of the diuretic and/or this medicine may be necessary. Renal Function 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.

1). • Combination with sacubitril/valsartan due to the increased risk of angioedema. Do not administer this medicine within 36 hours of switching to or from sacubitril/valsartan, a product containing a neprilysin inhibitor. 5).