Enalapril (Cobalt Pharmaceuticals): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

ENALAPRIL is available only on prescription from your physician.

What the medication is used for:

ENALAPRIL is used for:

$ reducing high blood pressure

When blood pressure is high, the workload of the heart and arteries increases so that over time, these organs may not function as they should. In turn, this could lead to damage of the “vital organs”: brain

• heart – kidneys, and result in stroke, heart failure, heart attack, blood vessel disease or kidney disease.

ENALAPRIL is used for:

$ treating patients with heart failure

Enalapril may also be used to treat patients with heart failure. This is a condition where the heart cannot pump adequate amounts of blood to satisfy the needs of the body.

If your physician has recommended a particular diet, for instance- less salt- follow the diet carefully. This could help your medicine to better control your blood pressure. Your physician may also recommend weight loss. Do follow these suggestions.

What it does:

Enalapril is part of a class of medicines known as angiotensin converting enzyme (ACE) inhibitors. They lower blood pressure by specifically blocking a naturally occurring substance called angiotensin II. Angiotensin II normally tightens your blood vessels. Enalapril allows them to relax and therefore help lower high blood pressure.

This medicine does not cure high blood pressure, but does help control it. So, it is important to continue taking the tablets regularly to keep your blood pressure down. You may have to take high blood pressure medicine for life.

Keep your regular appointments with your physician, even if you feel well. High blood pressure may not be easily recognized by you, because you may not “feel any symptoms”; but your physician can measure your blood pressure very easily, and check how the medicine is controlling it.

Read the following information carefully. If you need any explanations or further information, ask your physician or pharmacist.

When it should not be used:

Do not take ENALAPRIL if you:

• are allergic to enalapril or any other component of

  ENALAPRIL (see What the important non-medicinal ingredients are).

• have a history of swelling of the face, lips, tongue, throat, or sudden difficulty breathing or swallowing.
• have been diagnosed with swelling of the face, lips, tongue, throat, or sudden difficulty breathing or swallowing due to genetic factors or unknown reasons (please refer to Side Effects and What to do About Them).

What the medicinal ingredient is:

Each tablet of ENALAPRIL is made with enalapril maleate that appears as enalapril sodium in the tablets.

What the important nonmedicinal ingredients are:

ENALAPRIL contains the following non-medicinal ingredients: lactose monohydrate, maize starch, magnesium stearate (vegetable grade), pregelatinized maize starch and sodium bicarbonate.

Colourants are present in the tablets as follows:

10 mg tablets also contain iron oxide red

20 mg tablets also contain iron oxide yellow & iron oxide red

What dosage forms it comes in:

ENALAPRIL is available in 4 strengths, namely: tablets 2.5 mg (white, oval-shaped), 5 mg (white, rounded triangle-shaped), 10mg (peach, rounded triangle-shaped), and 20 mg (salmon, rounded triangle-shaped).

WARNINGS AND PRECAUTIONS

This medicine may not be suitable for certain people. Tell your physician or pharmacist if you think any of the following applies to you:

• You have previously taken enalapril or other medication of the same type -Angiotensin Converting Enzyme (ACE) inhibitors such as enalapril, lisinopril, captopril, and you were allergic or reacted badly to it, particularly if you experienced swelling of the face, lips, tongue, or throat, or had sudden difficulty breathing or swallowing. These are symptoms of conditions called hereditary angioedema or idiopathic angioedema.
• You should not take this medicine if you have been diagnosed with hereditary angioedema or idiopathic angioedema (angioedema of unknown cause).

• Dizziness or drowsiness may occasionally occur when taking medications to lower blood pressure. Therefore, before you perform tasks which may require special attention (driving a car or operating dangerous machinery), wait until you know how you respond to your medicine. Serious Warning and Precautions

ENALAPRIL should not be used during pregnancy. If you discover that you are pregnant while taking ENALAPRIL, stop the medication and contact your physician as soon as possible.

• You should be aware that black patients are at increased

  risk of these types of reactions to ACE inhibitors. ③ You are pregnant, breast-feeding or thinking of

  becoming pregnant. Taking ENALAPRIL during pregnancy can cause injury and even death to your developing baby. This medicine should not be used during pregnancy. If you become pregnant while taking ENALAPRIL, stop the medication and report to your physician as soon as possible. It is possible that ENALAPRIL passes into breast milk. You should not breast-feed while taking ENALAPRIL.

• You suffer from low blood pressure (you may notice this as

  faintness or dizziness, especially when standing). ③ You are undergoing dialysis

• You have any of these conditions:

  • diabetes
  • heart or blood vessel disease
  • liver disease
  • kidney disease

• You are receiving gold (sodium aurothiomalate) injections. ③ You are taking “water pills” or potassium supplements. ③ You use potassium containing salt substitutes with your

  food.

You should also inform your physician or pharmacist if you have recently suffered from excessive vomiting or diarrhea.

If you have diabetes and are taking oral medicines to treat diabetes or insulin, you should closely monitor for low blood glucose levels, especially during the first month of treatment with ENALAPRIL.

If you have to undergo any dental or other surgery, inform the dentist or the physician in charge that you are taking this medicine.

Remember – This medicine is prescribed for the particular condition that you have. Do not give this medicine to other people, nor use it for any other condition.

Do not use outdated medicine.

INTERACTIONS WITH THIS MEDICATION

Do not take any other medicines unless you have discussed the matter with your physician or pharmacist. Certain medications tend to increase your blood pressure, for example, non-prescription preparations for appetite control, asthma, colds, coughs, hay fever and sinus problems, or may also react badly with ENALAPRIL.

Your physician or pharmacist also needs to know if you are taking any other medication, whether on prescription or otherwise. It is particularly important to inform your physician or pharmacist if you are taking:

• Diuretics or “water pills”; any other medicines to reduce

  blood pressure.

• Diabetes medicine and/or insulin

• Potassium-containing medicines, potassium supplements. ③ Salt substitutes that contain potassium, as these may lead to

  increased levels of potassium in the blood which can be

  serious. In these cases, your physician may need to adjust the dosage of ENALAPRIL or monitor your blood level of potassium.

  • Lithium (a drug used to treat a certain kind of depression). ③ Certain pain and arthritis medicines, including gold therapy and non-steroidal anti-inflammatory drugs.

PROPER USE OF THIS MEDICATION

Usual dose:

• Take this medicine exactly as your physician ordered. ③ The absorption of this medicine is not affected by food; so it can be taken with or without a meal.
• Try to take your medicine every day at the same time. This way it becomes easy to remember your doses. ③ The splitting of ENALAPRIL tablets is not advised.

For patients with high blood pressure:

Adults:

Your physician may adjust the dose according to your blood pressure response. The usual dose range is 10 mg to 40 mg per day given in a single dose or two divided doses. The maximum daily dose for ENALAPRIL is 40 mg.

Children (less than 16 years):

The usual starting dose is up to 5 mg once daily. Doses above 40 mg have not been studied.

For patients with congestive heart failure:

The initial dose is 2.5 mg taken once a day. Your physician will closely monitor you to determine the initial effect on your blood pressure. The usual daily dose is 5 mg to 20 mg given in a single dose or two divided doses. The maximum daily dose is 40 mg.

Overdose:

• In case of an overdose, contact your physician or pharmacist immediately so that medical attention may be given promptly. The most likely symptom would be a feeling of lightheadedness or dizziness due to a sudden or excessive drop in blood pressure.

For management of a suspected drug overdose, contact your regional Poison Control Center.

Missed Dose:

• If you miss a dose of this medicine, take it as soon as possible.

  However, if no more than six hours have elapsed since the missed dose, you may take that day's dose of medication and then go back to your regular dosing schedule. Do not take a double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its intended action, any medication, including ENALAPRIL, may cause side effects. Most people do not experience any problem when taking these medicines; but if you notice any of the following, have other side effects or if the

condition persists or worsens, seek medical attention.

• Dry cough, sore throat.

• The initial dose may cause a greater fall in blood pressure

  than will occur following continued treatment. You may notice this as faintness or dizziness and it may help to lie down. If concerned, please consult your physician or pharmacist.

This is not a complete list of side effects. For any unexpected effects while taking ENALAPRIL, contact your doctor or pharmacist.

HOW TO STORE IT

ENALAPRIL should be stored at room temperature between 15 - 30EC. Keep container tightly closed, away from heat and direct light,

and out of damp places, such as the bathroom or kitchen. Protect from moisture.

Note: 100 and 500 tablet bottle: discard remaining tablets six months after opening bottle.

Keep all medicines out of the reach of children.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

---------------------------------------------------------------------------- $ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345

$ Complete a Canada Vigilance Reporting Form and:

• Fax toll-free to 1-866-678-6789, or

• Mail to: Canada Vigilance Program Health Canada

  Postal Locator 0701C

  Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Cobalt Pharmaceuticals Inc. at: 1-866-254-6111.