Each tablet of ANGIORIL® contains: 

• Enalapril maleate  10 mg.

ANGIORIL® is indicated in:

• Treatment of Hypertension
• Treatment of Symptomatic Heart Failure
• Prevention of Symptomatic Heart Failure in patients with Asymptomatic Left Ventricular Dysfunction (ejection fraction_35%).

ANGIORIL® is contraindicated in:

• Hypersensitivity to enalapril, to any of the excipients or any other ACE inhibitor.
• History of angioedema associated with previous ACE-inhibitor therapy.
• Hereditary or idiopathic angioedema.
• Second and third trimesters of pregnancy.

Lithium:

• Administration of ACE inhibitors increases the risk of lithium toxicity due to reduction of the renal clearance of lithium with administration of these agents, so lithium should  not be given with  ACE inhibitors.

Potassium sparing diuretics or potassium supplements: 

• ACE inhibitors attenuate diuretic induced potassium loss. Potassium sparing diuretics, potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum  potassium. If concomitant use is indicated because of demonstrated hypokalaemia they should be used with caution and with frequent monitoring of serum potassium.

Diuretics (thiazide or loop diuretics):

• Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with enalapril .  

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):

• Chronic administration of NSAIDs may reduce the antihypertensive effect of an ACE inhibitor.
• NSAIDs and ACE inhibitors exert an additive effect on the increase in serum potassium, and may result in a deterioration of renal function.

Antidiabetics Administration:

• Concurrent administration with ACE inhibitors increases the risk of hypoglycaemia, especially in first weeks of the treatment.

Sympathomimetics:

• Sympathomimetics may reduce the antihypertensiveeffects of ACE inhibitors.

Tricyclic antidepressants / Antipsychotics /Anesthetics / Narcotics:

• Concomitant use of certain anesthetic medicinal products, tricyclic antidepressants and antipsychotics with ACE inhibitors may result in further reduction of blood pressure.

Other antihypertensive agents:

• Concomitant use of these agents may increase the hypotensive effects of enalapril. Concomitant use with nitroglycerine and other nitrates, or other vasodilators, may further reduce blood pressure.

Acetyl salicylic acid, thrombolytics and ß-blockers:

• Enalapril can be safely administered concomitantly with acetyl salicylic acid (at cardiologic doses), thrombolytics and ß-blockers.

Alcohol:

• They may enhance orthostatic hypotension if concurrently administered with ANGIORIL®

• ANGIORIL® is contraindicated in the second and third trimesters of pregnancy. ANGIORIL® should not be used during the first trimester of pregnancy.
• Enalapril and enalaprilat are excreted in breast milk but their effect on the nursing infant has not been determined. Consequently, use of enalapril is not recommended during breast-feeding. 

• ANGIORIL® is mostly well tolerated.
• The common clinical side effects was (dizziness, headache, depression, blurred vision, dry cough, dyspnea, fatigue and hypotension including orthostatic hypotension, nausea, diarrhoea, abdominal pain, taste alteration, rash, asthenia, hyperkalaemia, increases in serum creatinine).
• Angioneurotic oedema of face, the extremities, lips, glottis, tongue and/or larynx has been reported.

• The absorption of  ANGIORIL® is not affected by food.  
• The dose should be individualized according to patient profile and blood pressure response. 

Hypertension.

• The initial dose is 5 mg to maximally 20 mg, depending on the degree of hypertension and the condition of the patient. ANGIORIL® is given once daily. In mild hypertension, the recommended initial dose is 5 to 10 mg. Patients with a strongly activated renin-angiotensin-aldosterone system (e.g., renovascular hypertension, salt and/or volume depletion, cardiac decompensation, or severe hypertension) may experience an excessive blood  pressure fall following the initial dose. A starting dose of 5 mg or lower is recommended in such patients and the initiation of treatment should take place under medical supervision.
• The usual maintenance dose is 20 mg daily. The maximum maintenance dose is 40 mg daily.

• Hypotension and electrolyte/fluid imbalance, more likely in the presence of fluid or electrolyte imbalance, e.g. volume depletion, hyponatraemia, hypochloraemic alkalosis, hypomagnesaemia or hypokalaemia which may occur from prior diuretic therapy, dietary salt restriction, dialysis, or during intercurrent diarrhoea or vomiting.
• As with other vasodilators, ANGIORIL® should be given with caution to patients with aortic stenosis  or hypertrophic cardiomyopathy.
• ANGIORIL® In cases of renal impairment (creatinine clearance <80 ml/min) the initial enalapril dosage should be adjusted according to the patient’s creatinine clearance.
• ANGIORIL® should be used with caution in patients with impaired hepatic function. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.
• Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes (e.g.,AN 69®) and treated concomitantly with an ACE inhibitor. In thesepatients consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent.
• In patients undergoing major surgery or during anesthesia with agents that produce hypotension. 
• ANGIORIL® may block angiotensin II formation secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.
• ANGIORIL® should be discontinued in case of angioedema of the face, extremities, lips, tongue, glottis and/or larynx.
• Cough has been reported with the use of ACE inhibitors.Characteristically, the cough is non-productive, persistent and resolves after discontinuation of therapy.
• ANGIORIL® should be used with extreme caution in patients with collagen vascular disease, combination of these complicating factors, especially if there is pre-existing impaired renal function.
• Patients receiving ACE inhibitors during desensitisation treatment (e.g. hymenoptera venom) have sustained anaphylactoid reactions, these reactions have been avoided when ACE inhibitors were temporarily withheld but they have reappeared upon inadvertent re-administration of the medicinal product.
• The use of potassium supplements, potassium-sparing agents or potassium-containing salt substitutes, particularly in patients with impaired renal function, may lead to a significant increase in serum potassium. Therefore, frequent control of serum potassium is recommended. 

Effects on ability to drive and use machines:

• When driving vehicles or operating machines it should be taken into account that dizziness or weariness or tiredness may occur.

• Blister of 10 tablets, pack of 2 blisters.

• Store in a dry place below 25°C.