Enalapril/HCTZ: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• ENALAPRIL/HCTZ lowers blood pressure

What it does:

ENALAPRIL/HCTZ contains a combination of 2 drugs, enalapril and hydrochlorothiazide.

Enalapril is an angiotensin converting enzyme (ACE) inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in ‘-PRIL’. It lowers blood pressure.

Hydrochlorothiazide is diuretic, or a “water pill” that increases urination. This lowers blood pressure.

This medicine does not cure high blood pressure, it helps to control it. Therefore, it is important to continue taking ENALAPRIL/HCTZ regularly even if you feel fine.

When it should not be used:

Do not take ENALAPRIL/HCTZ if you:

• Are allergic to enalapril and hydrochlorothiazide or any non-

  medicinal ingredient in the formulation.

• Are allergic to sulphonamide-derived drugs (sulfa drugs);

  most of them have a medicinal ingredient that ends in “-MIDE.

• Have experienced an allergic reaction (angioedema) with

  swelling of the hands, feet, or ankles, face, lips, tongue, throat, or sudden difficulty breathing or swallowing to any ACE inhibitor or without a known cause. Be sure to tell your doctor, nurse, or pharmacist that this has happened to you.

• Have been diagnosed with hereditary angioedema: an

  increased risk of getting an allergic reaction that is passed down through families. This can be triggered by different factors, such as surgery, flu, or dental procedures.

• Have difficulty urinating or produce no urine.

• Are pregnant or intend to become pregnant. Taking

  ENALAPRIL/HCTZ during pregnancy can cause injury and even death to your baby.

• Are breastfeeding. ENALAPRIL/HCTZ passes into breast

  milk.

  • Are already taking a blood pressure-lowering medicine that contains aliskiren (such as RASILEZ) and you have diabetes or kidney disease.

  • Have one of the following rare hereditary diseases:

    • Galactose intolerance
    • Lapp lactase deficiency
    • Glucose-galactose malabsorption

Because lactose is a non-medicinal ingredient in ENALAPRIL/HCTZ.

What the medicinal ingredients are:

enalapril maleate (as enalapril sodium) and hydrochlorothiazide.

What the non-medicinal ingredients are:

Corn starch, lactose, magnesium stearate, pregelatinized starch, sodium bicarbonate and red ferric oxide.

What dosage forms it comes in:

Tablet; enalapril 10 mg/ hydrochlorothiazide 25 mg.

WARNINGS AND PRECAUTIONS

Serious warnings and precautions - Pregnancy

ENALAPRIL/HCTZ should not be used during pregnancy. If you discover that you are pregnant while taking

ENALAPRIL/HCTZ, stop the medication and contact your doctor, nurse or pharmacist as soon as possible.

BEFORE you use ENALAPRIL/HCTZ talk to your doctor, nurse, or pharmacist if you:

• Are allergic to any drug used to lower blood pressure or penicillin.
• Have bronchial asthma

• Are taking a medicine that contains aliskiren, such as

  RASILEZ, used to lower high blood pressure. The combination with ENALAPRIL/HCTZ is not recommended.

• Are taking an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”.
• Are taking anti-cancer (temsirolimus, everolimus) or anti-rejection (sirolimus) medications. Use of ACE inhibitors, such as ENALAPRIL/HCTZ, with these drugs may increase the chance of having an allergic reaction (angioedema).
• Have recently received or are planning to get allergy shots for bee or wasp stings.
• Have narrowing of an artery or a heart valve
• Have had a heart attack or stroke
• Have heart failure
• Have diabetes, liver or kidney disease.
• Have lupus or gout.
• Are on dialysis.
• Are dehydrated or suffer from excessive vomiting,

diarrhea, or sweating.

• Are taking a salt substitute that contains potassium,

  potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill”).

• Are on a low-salt diet.
• Are receiving gold (sodium aurothiomalate) injections.
• Are less than 18 years old.

Hydrochlorothiazide in ENALAPRIL/HCTZ can cause Sudden Eye Disorders:

• Myopia: sudden nearsightedness or blurred vision.

• Glaucoma: an increased pressure in your eyes, eye pain.

  Untreated, it may lead to permanent vision loss.

These eye disorders are related and can develop within hours to weeks of starting ENALAPRIL/HCTZ.

You may become sensitive to the sun while taking ENALAPRIL/HCTZ. Exposure to sunlight should be minimized until you know how you respond.

If you are going to have surgery and will be given an anesthetic, be sure to tell your doctor or dentist that you are taking ENALAPRIL/HCTZ.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to ENALAPRIL/HCTZ. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.

INTERACTIONS WITH THIS MEDICATION

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with ENALAPRIL/HCTZ:

• Adrenocorticotropic hormone (ACTH) used to treat West

  Syndrome

• Alcohol, barbiturates (sleeping pills), or narcotics (strong

  pain medications). They may cause low blood pressure and dizziness when you go from lying or sitting to standing up.

• Amphotericin B, an antifungal drug.

• Anticancer drugs, including cyclophosphamide and

  methotrexate

• Antidepressants, in particular selective serotonin reuptake

  inhibitors (SSRIs), including citalopram, escitalopram, and sertraline.

• Antidiabetic drugs, including insulin and oral medicines.
• Bile acid resins used to lower cholesterol.
• Calcium or vitamin D supplements.

• Corticosteroids used to treat joint pain and swelling.

  • Digoxin, a heart medication.
  • Diuretics or “water pills”
  • Drugs that slow down or speed up bowel function, including atropine, metoclopramide, and domperidone.
  • Drugs used to treat epilepsy, including carbamazepine and topiramate.
  • Blood pressure-lowering drugs, including diuretics (“water pills”), aliskiren-containing products (e.g. RASILEZ), or angiotensin receptor blockers (ARBs).
  • Gout medications (allopurinol, uricosurics, xanthine oxidase inhibitors)
  • Lithium used to treat bipolar disease.
  • Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
  • Other blood pressure lowering drugs. When taken in combination with ENALAPRIL/HCTZ they may cause excessively low blood pressure.
  • Potassium-containing medicines, potassium supplements or 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/HCTZ or monitor your blood level of potassium.
  • Certain pain and arthritis medicines, including gold therapy

  • Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.

    mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy. Taking these drugs together could increase the risk for an allergic reaction called angioedema.

PROPER USE OF THIS MEDICATION

ENALAPRIL/HCTZ is not for initial therapy. You must first be stabilized on the individual components (enalapril and hydrochlorothiazide) of ENALAPRIL/HCTZ. If your dosage matches the dosages in ENALAPRIL/HCTZ, your doctor may prescribe ENALAPRIL/HCTZ taken once a day (instead of each component as a separate pill).

Take ENALAPRIL/HCTZ exactly as prescribed. It is recommended to take your dose at about the same time every day.

ENALAPRIL/HCTZ can be taken with or without food. If ENALAPRIL/HCTZ causes upset stomach, take it with food or milk.

Usual Adult dose:

• The maximum daily dosage should not exceed two tablets of

  ENALAPRIL/HCTZ 10 mg/25 mg.

Overdose:

If you think you have taken too much ENALAPRIL/HCTZ contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison control Centre immediately, even

if there are no symptoms.

Missed Dose:

• If you have forgotten to take your dose during the day, carry on with the next one at the usual time. Do not double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects may include:

• Dizziness
• Drowsiness, fatigue, weakness
• Cough
• Rash
• Headache
• Abdominal pain, upset stomach, decreased appetite, constipation
• Muscle pain
• Sore throat
• Impotence
• Tingling of the skin

If any of these affects you severely, tell your doctor, nurse or pharmacist.

ENALAPRIL/HCTZ can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

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

HOW TO STORE IT

Store your tablets at 15°C - 30°C, away from heat and direct light, and out of damp places, such as the bathroom or kitchen.

Keep all medicines out of the reach and sight of children.

Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report:

• Online at MedEffect;
• By calling 1-866-234-2345 (toll-free);

• By completing a Consumer Side Effect Reporting

  Form and sending it by:

  • Fax to 1-866-678-6789 (toll-free), or

  • Mail to: Canada Vigilance Program

    Health Canada, Postal Locator 0701E

    Ottawa, ON

    K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

If you want more information about ENALAPRIL/HCTZ:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website or by calling FROSST, a division of Merck Canada at 1-800-567-2594

To report an adverse event related to ENALAPRIL/HCTZ, please contact 1-800-567-2594.

Last Revised: March 21, 2016

©2013, 2016 FROSST, a division of Merck Canada Inc., All rights reserved