ENALAPRIL/HYDROCHLOROTHIAZIDE

Posology The dosage of Enalapril / 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 / 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 / Hydrochlorothiazide.

e. moderate or severe renal insufficiency). In patients with creatinine clearance of >30 and <80 ml/min, Enalapril / 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 has not been established. Method of administration Oral use.

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 side effects have been reported for Enalapril / Hydrochlorothiazide, enalapril alone or hydrochlorothiazide alone either during clinical studies or after the drug was marketed. 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: 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, elevated ESR, eosinophilia, and leucocytosis.

Rash, photosensitivity or other dermatologic manifestations may occur. Musculoskeletal, Connective Tissue and Bone Disorders common: muscle cramps uncommon: arthralgia** Renal and Urinary Disorders uncommon: renal dysfunction, renal failure, proteinuria rare: oliguria, interstitial nephritis Reproductive System and Breast Disorders uncommon: impotence rare: gynaecomastia General Disorders and Administration Site Conditions very common: asthenia common: chest pain, fatigue uncommon: malaise, fever Investigations common: hyperkalaemia, increases in serum creatinine uncommon: increases in blood urea, hyponatremia rare: elevations of liver enzymes, elevations of serum bilirubin *Incidence rates were comparable to those in the placebo and active control groups in the clinical trial.

5 mg and 25 mg.

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 / Hydrochlorothiazide Choroidal effusion, acute myopia and secondary angle-closure glaucoma Sulfonamide or sulfonamide derivative drugs can cause an idiosyncratic reaction resulting in choroidal effusion with visual field defect, transient myopia and acute angle-closure glaucoma.

Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue drug intake as rapidly as possible.

Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy. 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 disease 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 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, hyponatremia 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. Similar considerations may apply to patients with ischaemic heart or cerebrovascular disease in whom an excessive fall in blood pressure could result in 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 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 who have normal or low blood pressure, additional lowering of systematic blood pressure may occur with Enalapril / 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 / Hydrochlorothiazide may be necessary. Renal functional 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.

If recognised promptly and treated appropriately, renal failure when associated with therapy with enalapril is usually reversible. 2). 4). If this occurs, therapy with Enalapril / Hydrochlorothiazide should be discontinued. This situation should raise the possibility of underlying renal artery stenosis (see Special warnings and precautions for use.

4). 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, hyperkalemia 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 blockers should not be used concomitantly in patients with diabetic nephropathy.

4). 5). Lactose Enalapril / Hydrochlorothiazide contains lactose. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose- galactose malabsorption should not take this medicinal product.

Paediatric population The safety and efficacy in children has not been established. Enalapril Maleate Aortic stenosis/hypertrophic cardiomyopathy As with all vasodilators, ACE inhibitors should be given with caution in patients with left ventricular valvular and outflow tract obstruction and avoided in cases of cardiogenic shock and haemodynamically significant obstruction.

Renal function impairment Renal failure has been reported in association with enalapril, and has been mainly in […]

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

5).