ENALAPRIL AND HYDROCHLOROTHIAZIDE

Posology The dosage of Enalapril and Hydrochlorothiazide 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 Enalapril and Hydrochlorothiazide ; 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 Enalapril and Hydrochlorothiazide.

e. moderate or severe renal insufficiency). In patients with creatinine clearance of >30 and <80 ml/min, Enalapril and Hydrochlorothiazide should be used only after titration of the individual components. Use in the 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.

Enalapril and Hydrochlorothiazide is 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 and Hydrochlorothiazide were headache and cough.

The following undesirable side effects have been reported for Enalapril and Hydrochlorothiazide, enalapril alone or hydrochlorothiazide alone either during clinical studies or after the drug was marketed. Table 1. 4) eosinophilia, and leucocytosis.

Rash, photosensitivi ty or other dermatologic manifestation s may occur. Musculos keletal, connective tissue, and bone disorders Muscle cramps† Arthralgia* * Renal and urinary disorders Renal dysfunction, renal failure, proteinuria Oliguria, interstitial nephritis Reproduct ive system and breast disorders Impotence Gynecomastia General disorders and administra tion site conditions Astheni a Chest pain, fatigue Malaise, fever Investigati ons Hyperkalae mia, increases in serum creatinine Increases in blood urea, hyponatremi a 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.

Description of Selected Adverse Reactions Non-melanoma skin cancer:

Based on available data from epidemiological studies, cumulative dose-dependent association between hydrochlorothiazide and NMSC has been observed. 1). 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store”.

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 and Hydrochlorothiazide and/or diuretic is adjusted.

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. 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 Enalapril and Hydrochlorothiazide.

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 Enalapril and Hydrochlorothiazide may be necessary.

1. • Severe renal impairment (creatinine clearance ≤30 ml/min). • Anuria. • History of angioneurotic oedema associated with previous ACE-inhibitor therapy. • Hereditary or idiopathic angioedema. • Hypersensitivity to sulfonamide-derived drugs.

6). • Severe hepatic impairment. 1). • Combination with sacubitril/valsartan due to the increased risk of angioedema. Do not administer Enalapril and Hydrochlorothiazide within 36 hours of switching to or from sacubitril/valsartan, a product containing a neprilysin inhibitor.

5).