ENALAPRIL MALEATE/HYDROCHLOROTHIAZIDE

Posology The recommended dose is one tablet daily. 5 mg Tablets can be administered in a single dose/day with or without food. Individual dose titration with both active substances can be recommended. When clinically appropriate, direct change from ACE inhibitor monotherapy to the fixed combination may be considered.

5 mg. Renal impairment Creatinine clearance greater than 30 ml/min The dose of enalapril should be titrated in patients with renal impairment whose creatinine clearance is ≥ 30 ml/min before switching to the fixed combination. Loop diuretics are preferred to thiazides in this population.

4). g. 4). Creatinine clearance < 30 ml/min: see section

Enalapril/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/hydrochlorothiazide were headache and cough.

The following undesirable effects have been reported for enalapril/hydrochlorothiazide, enalapril alone or hydrochlorothiazide alone either during clinical studies or after the medicinal product was marketed include: Very common (≥ 1/10) Common (≥ 1/100 up to < 1/10) Uncommon (≥ 1/1,000 up to < 1/100) Rare (≥ 1/10,000 up to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from the available data) Table 1: Undesirable effects with enalapril maleate/hydrochlorothiazide System organ class Very common Common Uncommon Rare Very rare Not known System organ class Very common Common Uncommon Rare Very rare Not known Infections and infestations Sialadenitis Neoplasms benign, malignant and unspecified (incl.

4) Diaphoresis, pruritus, urticaria, alopecia, photosensitiz ation Erythema multiform e, Stevens- Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, purpura, cutaneous lupus erythemat osus, erythroder ma, pemphigu s A symptom complex has been reported which may include some or all of the following: fever, serositis, vasculitis, myalgia/m yositis, arthralgia/ arthritis, a positive ANA, elevated ESR, eosinophil ia, and leucocytos is.

Rash, photosensiti vity or other dermatologi c manifestati ons may occur. Musculoskel etal, connective tissue, and bone disorders Muscle cramps† Arthralgia* Renal and urinary disorders Renal dysfunction, renal failure, proteinuria Oliguria, interstitial nephritis System organ class Very common Common Uncommon Rare Very rare Not known Reproductiv e system and breast disorders Impotence Gynaecomas tia General disorders and administrati on site conditions Asthenia Chest pain, fatigue Malaise, fever Investigatio ns Hyperkalaem ia, increases in serum creatinine Increases in blood urea, hyponatraem ia 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. 5 mg and 25 mg, whereas, the frequency of the event is uncommon as it pertains to 6 mg doses of hydrochlorothiazide. 1). 4) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the […]

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 ischaemic 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 renal dysfunction. In these patients, therapy must be started under medical supervision preferably in a hospital and the patients must be followed closely whenever the dose of enalapril and/or diuretic is adjusted.

9 % solution). 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. After volume repletion and establishment of satisfactory blood pressure, treatment can be reinstituted, either at a lower dose or either of the components may be used appropriately alone.

In some patients with heart failure who have normal or low blood pressure, additional lowering of systematic blood pressure may occur with enalapril. 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 may be necessary.

Renal impairment Enalapril maleate/Hydrochlorothiazide should not be administered to patients with renal insufficiency (creatinine clearance <80 ml/min. 2). 4 Enalapril maleate, Renal impairment; Hydrochlorothiazide, Renal impairment).

5 mg Tablets should be discontinued. 4 Enalapril maleate, Renovascular hypertension ). 4, Enalapril Maleate, Hyperkalaemia). However, the combination of an ACE inhibitor and non-potassium-sparing diuretic does not preclude the development of hypokalaemia, in particular in diabetic or renally impaired patients.

Plasma potassium must be regularly monitored. 5). Lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Sodium This medicinal products 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 hemodynamically 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, Enalapril maleate- Hydrochlorothiazide, Renal impairment; Hydrochlorothiazide, Renal impairment).

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 with low doses, careful titration 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.

Hepatic failure Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice or hepatitis and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is not understood.

Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue […]

3. Special population In salt/volume depleted patients, the starting dose is 5 mg enalapril or lower. Individual dose titration with enalapril and hydrochlorothiazide is recommended. Elderly The use in the elderly has been shown to be as good as in younger hypertensive patients.

In case of physiological renal impairment, titration with the mono-component enalapril is recommended prior to using the fixed combination. 5mg Tablets in children and adolescents has not been established. Method of administration Oral use.

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

6). • Severe hepatic impairment/hepatic encephalopathy. 1). • Concomitant use with sacubitril/valsartan therapy. 5).