VEXOPRIL-5Each uncoated tablet contains Enalapril maleate 5mg

VEXOPRIL-10 Each uncoated tablet contains Enalapril Maleate 10mg

VEXOPRIL-20 Each uncoated tablet contains Enalapril Maleate 20mg

 Pharmacological classification   Antihypertensive 

MECHANISM OF ACTIONEnalapril, 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. 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 maleate alone for up to 48 weeks, mean increases in serum potassium of approximately 0.2 mEq/L were observed. 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.While the mechanism through which enalapril lowers blood pressure is believed to be primarily suppression of the renin-angiotensin-aldosterone system, enalapril is antihypertensive even in patients with low-renin hypertension.  

PHARMACOKINETICS  Following oral administration of enalapril maleate, peak serum concentrations of enalapril occur within about one hour. Based on urinary recovery, the extent of absorption of enalapril is approximately 60 %. Enalapril absorption is not influenced by the presence of food in the gastrointestinal tract. Following absorption, enalapril is hydrolyzed to enalaprilat, which is a more potent angiotensin converting enzyme inhibitor than enalapril; enalaprilat is poorly absorbed when administered orally. Peak serum concentrations of enalaprilat occur three to four hours after an oral dose of enalapril maleate. Excretion of enalaprilat and enalapril is primarily renal. Approximately 94 percent of the dose is recovered in the urine and feces as enalaprilat or enalapril. The principal components in urine are enalaprilat, accounting for about 40 percent of the dose, and intact enalapril. There is no evidence of metabolites of enalapril, other than enalaprilat.The serum concentration profile of enalaprilat exhibits a prolonged terminal phase, apparently representing a small fraction of the administered dose that has been bound to ACE. The amount bound does not increase with dose, indicating a saturable site of binding. The effective half-life for accumulation of enalaprilat following multiple doses of enalapril maleate is 11 hours. 

INDICATIONS: VEXOPRIL is indicated in Hypertension, all grades of essential hypertension
renovascular hypertension
- Heart failure
VEXOPRIL is indicated for the treatment of symptomatic congestive cardiac failure, usually in combination with digitalis and diuretics. In these patients enalapril improves symptoms, increases survival and decreases the frequency of hospitalization.Asymptomatic Left Ventricular dysfunction
In clinically stable asymptomatic patients with left ventricular dysfunction (ejection function = 35 percent), enalapril decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure.    

 Patient information 

_{BEFORE YOU TAKE VEXOPRIL} 

Do not take VEXOPRIL if:You have an allergy to enalapril, or any of the ingredients Symptoms of an allergic reaction may include skin rash, itchiness, shortness of breath, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, muscle pain or tenderness or joint pain.you have taken any other ACE inhibitor medicine before, which caused your face, lips, tongue, throat, hands or feet to swell up, or made it hard for you to breathe.If you have had an allergic reaction to an ACE inhibitor before, you may be allergic to VEXOPRIL. You have a history or you have a family history of swelling of the face, lips, tongue, throat, hands or feet for no apparent reason.You are pregnant.You are breast-feeding.Do not take VEXOPRIL after the expiry date printed on the pack.You have kidney problems, or are having dialysis, heart problems, low blood pressure, which you may notice as dizziness or, light-headedness, diabetes, high levels of potassium in your blood, cerebrovascular diseaseSystemic Lupus Erythematosus (SLE), scleroderma or other autoimmune diseasesTell your doctor if you are following a very low salt diet.Tell your doctor if you are about to receive desensitisation therapy for an allergy.Tell your doctor if you plan to have surgery.

 HOW TO TAKE VEXOPRILSwallow VEXOPRIL whole with a full glass of water. Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

How much to takeYour doctor will tell you how many tablets you will need to take each day. This depends on your condition and whether you are taking any other medicines. Take VEXOPRIL only when prescribed by your doctor. For high blood pressure:For most patients, the usual starting dose is 5mg taken once a day. Some patients may need a lower starting dose. The dose may need to be increased depending on your blood pressure. Most patients take between 10 to 40mg each day.

For heart failure: The usual starting dose is 2.5mg taken once a day. Depending on your response, this dose may need to be gradually increased up to 20mg a day. This dose may be taken once a day or divided into two doses per day.When to take itTake each dose of VEXOPRIL at about the same time each day.Taking each dose of your tablets at the same time each day will have the best effect. It will also help you remember when to take the tablets. It does not matter if you take VEXOPRIL before or after food.How long to take itVEXOPRIL helps control your condition, but does not cure it. Therefore you must take VEXOPRIL every day. Continue taking your medicine for as long as your doctor tells you. 

IF YOU MISS A DOSEIf it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally. Do not take a double dose to make up for the dose that you missed.

WHAT TO DO IF AN OVERDOSE IS TAKEN

In that case do not delay ask your doctor immediately or the Poisons Information Centre Emergency at the nearest hospital, if you think that you or anyone else may have taken too much VEXOPRIL. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.If you take too much VEXOPRIL, you may feel light-headed, dizzy or you may faint. T

AKING OTHER MEDICINETell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines and VEXOPRIL may interfere with each other. These include:other medicines used to treat high blood pressure, diuretics, non-steroidal anti-inflammatory drugs, medicines used to relieve pain, swelling and other symptoms of inflammation potassium supplements or potassium-containing salt substitutes lithium, a medicine used to treat mood swings and some types of depression general anaesthetics medicines which lower your immune system, such as corticosteroids, cyclosporin or medicines used to treat cancer (including radiation therapy) some medicines which are used to treat coughs, colds, hay fever or sinus problems. These medicines may be affected by VEXOPRIL, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking VEXOPRIL. 

SIDE EFFECTSTell your doctor or pharmacist as soon as possible if you do not feel well while you are taking VEXOPRILAll medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.Tell your doctor or pharmacist if you notice any of the following and they worry you: feeling light-headed, dizzy or faint due to low blood pressure, dry cough, headache, unusual tiredness or weakness, feeling sick (nausea) or vomiting, stomach pain, diarrhea, indigestion, flushed/pale skin, constipation, loss of appetite, aching, tender or weak muscles not caused by exercise, muscle cramps, pain in the joints, difficulty in sleeping, drowsiness, difficulty in getting or maintaining an erection, ringing or buzzing in the ears, hair loss or thinning, runny nose, taste disturbances, confusion or nervousnessTell your doctor immediately if you notice any of the following:Disturbed/blurred vision symptoms of sunburn, yellowing of the skin and/or eyes fast or irregular heart beats, numbness, tingling and colour change in the fingers or toes when exposed to the cold, severe upper stomach pain, often, with nausea and vomiting, signs of worrying or frequent infections such as fever, severe chills, sore throat or mouth ulcers, passing little or no urine, excessive sweating If any of the following happen, stop taking VEXOPRIL and either tell your doctor immediatelyor go to Accident and Emergency at your nearest hospital:Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if younotice anything that is making you feel unwell. 

STORING Keep your tablets in the pack until it is time to take them. If you take the tablets out of the packthey will not keep well. Keep your tablets in a cool dry place where the temperature stays below 25⁰C.Do not store VEXOPRIL or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.