Each tablet of ANGIORIL® H contains: 

• Enalapril maleate         20 mg 
• Hydrochlorothiazide              12.5 mg

ANGIORIL® H is indicated in:

• Treatment of hypertensive patients who have insufficiently responded to treatment with Enalapril or a diuretic as single therapy.

ANGIORIL® H is contraindicated in patients:

• Who are hypersensitive to any component of this product.
• With a history of angioneurotic edema relating to previous treatment With an angiotensin-converting enzyme inhibitor and hereditary or idiopathic 
• angioedema.
• Anuria.
• Hypersensitivity to other sulfonamide-derived drugs.
• Stenosis of the renal arteries.

• The combination of Enalapril with betablockers, methyldopa, or calcium entry blockers has been shown to improve the efficacy of lowering the blood pressure.
• When administered concurrently the following drugs may interact with thiazide diuretics: Alcohol, Barbiturates, or Narcotic Analgesics - potentiation of orthostatic hypotension may occur.
• Antidiabetic Drugs (oral agents and insulin) dosage adjustment of the antidiabetic drug may be required, since Thiazide  therapy   may impair glucose tolerance.
• Cholestyramine and colestipol resins: Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal  tract by up to 85 and 43 percent respectively.
• Corticosteroids, ACTH: intensified electrolyte depletion particularly 
  hypokalemia.
• Prostaglandin Synthetase Inhibitors: can reduce the diuretic, natriuretic, and antihypertensive effects of diuretics.
• Serum  Potassium: The  potassium-losing effect of thiazide diuretics  is usually attenuated by the effect  of  Enalapril. Serum  potassium  usually remains with-in normal limits.
• Lithium: Diuretics or ACE inhibitors reduce the renal clearance and add a high risk of lithium toxicity, concomitant use is not recommended.
• Non-Steroidal Anti-Inflammatory Drugs: reduce the antihypersensitive effect of an ACE inhibitor.
• Non-Depolarizing Muscle Relaxants: Thiazides may increase the responsiveness to tubocurarin.

• ANGIORIL® H should  be  discontinued, unless  it  is considered  life-saving for the  mother. 
• ANGIORIL® H is not recommended during first trimester, and contraindicated during the second and third trimester.
• Enalapril and thiazide 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.

• The most common clinical side effects were

1. dizziness
2. fatigue

which generally responded to dosage  reduction and seldom required discontinuation of therapy.

• Less common which occurred either during controlled trials or during marketing use include:

1. Cardiovascular: syncope, non-orthostatic hypotension, palpitation, tachycardia and chest pain.
2. Gastrointestinal: pancreatitis, diarrhea, vomiting, dyspepsia, abdominal pain, flatulence, constipation.
3. Nervous System/Psychiatric: insomnia, somnolence, paresthesia, vertigo, nervousness.
4. Respiratory: dyspnea.
5. Skin: Stevens-Johnson syndrome, rash, pruritus, diaphoresis.
6. Other: renal dysfunction, renal failure, decreased libido, dry mouth,gout, tinnitus, arthralgia.

Overdose :

• Treatment is symptomatic and supportive. Suggested measures  include

1. induction of emesis.
2. administration of active charcoal.
3. administration of  a laxative and/or gastric lavage if ingestion is recent
4. correction  of  dehydration, electrolyte imbalance and  hypotension  by established procedures.

• ANGIORIL® H can be taken with or without food. 
• If patients are started on ANGIORIL® H after the use of a diuretic as previous sole therapy, the diuretic therapy should be stopped for 2 - 3days before ANGIORIL® H is started. These patients should be closely observed for signs or symptoms of hypotension after the initial dose of ANGIORIL® H.
• The initial dosage is one half tablet, administered once daily. If necessary the dose may be increased to one tablet, administered once daily. The maximum dosage is two tablets, administered once daily.
• ANGIORIL® H should not be given as initial dosage to patients with renal insufficiency and renovascular hypertension 

• Symptomatic hypotension may occur occasionally following the initial dose of ANGIORIL® H. In hypertensive patients, hypotension is more likely to occur if the patient has been volume-depleted, e.g. by prior of simultaneous use of diuretics, dietary salt restriction, dialysis, diarrhea or vomiting, or in the event of serious renin-dependent hypotension. Periodic determination of serum electrolytes should be performed at appropriate intervals in such patients.
• Particular consideration should be given when therapy is administered to patients with ischemic heart or cerebrovascular disease because 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 contraindication to further doses, but care should be  observed. Treatment with ANGIORIL® H can be initiated only when blood volume and blood pressure have been effectively restored, in which case reinstitution of therapy at reduced dosage may be possible; or either of the components may be used appropriately alone.
• Aortic Stenosis/Hypertrophic Cardiomyopathy: As with all vasodilators, ACE inhibitors should be given with caution to patients with obstruction in the outflow tract of the left ventricle.
• Renal Function Impairment:

1. Thiazides may not be appropriate diuretics for use in patients with renal impairment, and are ineffective at creatinine clearance values of 30 ml/min or below (i.e., moderate or severe renal insufficiency).
2. ANGIORIL® H should not be administered to patients with renal insufficiency (creatinine clearance < 80 ml/min) until titration of the individual components has shown the need for the doses present in the combination tablet. In these cases ANGIORIL® H should not be used as initial therapy since the recommended initial dosage of enalapril amounts to 5 mg or less in these patients. During the use of ANGIORIL® H in patients with renal insufficiency it is desirable to monitor renal function.

• Renovascular Hypertension: ANGIORIL® H should not be administered to patients with renovascular hypertension  until titration of the individual 
  components has shown the need for the doses present in the combination tablet.
• Hepatic Disease: Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
• Congestive Heart Failure: ANGIORIL® H should not be used as initial therapy in patients with hypertension and concomitant congestive heart failure in connection with the lower initial dosage of enalapril. Also one should be alert to deterioration of renal function.
• Hypersensitivity/Angioneurotic Edema: Angioneurotic edema of the face, extremities, lips, tongue, glottis and/or larynx has been reported rarely in patients treated with angiotensin-converting enzyme inhibitors, including enalapril.
• Cough: Cough has been reported with the use of ACE inhibitors.
• Thiazides:

1. Thiazides may decrease  urinary calcium excretion.
2. Thiazides may cause intermittent  and  slight elevation  of serum  calcium. Marked hypercalcemia  may  be evidence  of hidden hyperparathyroidism. Thiazides should be discontinued before carrying  out tests  for  parathyroid function. 
3. Increases in cholesterol and  triglyceride levels  may be associated  with thiazide diuretic therapy.
4. Thiazide therapy may  precipitate hyperuricemia and/or  gout  in certain patients.

• Blister of 10 tablets, pack of 2 blisters. 

• Store in a dry place below 25°C.