72 Agege Motor Road, Alakara, Mushin.
Tel: 01-81507361, 2663986, 234-8033018912, 08033054541
Dexel Ltd, A Dexon Company, Or-Akiva, P.O.B. 50, Hadera 38100, Israel.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablet (NRN: 04-7199): Enalapril (as maleate) 5 mg; white tablet.
Pack size: 30's.
Tablet (NRN: 04-6267): Enalapril (as maleate) 10 mg; pink tablet.
Pack size: 30's.
Enalapril, after hydrolysis to enalaprilat, inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. The beneficial effects of enalapril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion. Although the latter decrease is small, it results in small increases of serum potassium. In hypertensive patients treated with enalapril alone for up to 48 weeks, mean increases in serum potassium of approximately 0.2 mEq/L were observed. In patients treated with enalapril plus a thiazide diuretic, there was essentially no change in serum potassium. Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity.
ACE is identical to kininase, an enzyme that degrades bradykinin. Whether increased levels of bradykinin, a potent vasodepressor peptide, play a role in the therapeutic effects of enalapril remains to be elucidated.
An ACE inhibitor for the treatment of hypertension and congestive heart failure.
Hypersensitivity to one of its ingredients.
Pregnancy or breastfeeding.
Do not use this medicine if you have suffered in the past from edema in the face and throat accompanied by difficulties in swallowing or breathing (angioedema) following treatment with another ACE inhibitor drug.
Do not use this drug without consulting your physician if you have a deficiency of the enzyme G6PD (sensitivity to beans), or if you are suffering, or have suffered in the past, from impaired function of the heart, the vascular system, the kidney (including patients on dialysis), from hyperkalemia or from diabetes (risk of rise in potassium levels).
Use of this medicine may impair alertness and/or cause blurred vision. Caution should therefore be exercised when engaging in activities such as driving a car, operating dangerous machinery and in any other activity which requires mental alertness and/or visual acuity. Avoid drinking large quantities of alcoholic beverages during treatment with this drug.
Use of this medicine may cause blurred vision. During treatment with this medicine, blood, liver and kidney function tests should be performed. Inform your doctor if you are aware of any sensitivity to foods or drugs before taking this medicine. You should not become pregnant while on treatment with this medicine. Consult your doctor regarding use of adequate contraceptive measures. If you do become pregnant, discontinue the use of Enaladex and refer to your doctor immediately.
If you plan to undergo surgery (even dental) or any other procedure requiring anesthesia, inform the anesthetist that you are taking this medicine. During treatment with this medicine, you must consult your physician before using salt substitutes containing potassium. Excessive perspiration or loss of fluids as in the case of vomiting or diarrhea may cause a decrease in blood pressure. In this case, you should inform your treating physician.
If during treatment with this drug you have been stung by a bee or wasp etc, inform your doctor immediately.
Notify your doctor if you are using: Antihypertensives, diuretics, lithium or drugs that cause a rise in potassium blood level, potassium supplements or salt substitutes containing potassium.
In addition to the desired effect of the drug, some side effects may appear such as: constipation, nausea, blurred vision, cough or headache.
Side effects requiring special attention: Pruritus or skin rash, jaundice, angioedema (swelling of the face and throat accompanied by difficulty in swallowing or breathing), swelling of hands and feet, fall in blood pressure, fainting, dizziness, symptoms of toxicity of white blood cells (agranulocytosis) characterised by fatigue, weakness for 2-3 days, followed by fever and throat ache, chest pain, difficulty in swallowing, irregular heartbeat, fever or shortness of breath (rare); discontinue treatment and refer to your doctor immediately.
Dosage & Administration
According to physician's instructions only. Do not exceed the recommended dosage. This medicine is to be taken at regular intervals. If you have forgotten to take a dose, take it as soon as you remember, but never take two doses together.
Directions for use: Do not chew. Swallow the tablet with a small amount of water.
Store in a cool and dry place.