Vaseretic - Consumer Medicine Information
|Manufacture:||Merck and Co., Inc.|
|Condition:||Heart Failure (Congestive Heart Failure), High Blood Pressure (Hypertension)|
|Class:||ACE inhibitors with thiazides|
|Ingredients:||enalapril maleate (as enalapril sodium), hydrochlorothiazide, corn starch, lactose, magnesium stearate, pregelatinized starch, sodium bicarbonate and red ferric oxide|
enalapril and hydrochlorothiazide tablets
About this Medication
What the Medication is Used For
VASERETIC lowers blood pressure.
What it Does
VASERETIC 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 a 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 VASERETIC regularly even if you feel fine.
When it Should not be Used
Do not take VASERETIC 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 VASERETIC during pregnancy can cause injury and even death to your baby.
- Are breastfeeding. VASERETIC 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 VASERETIC
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
VASERETIC should not be used during pregnancy. If you discover that you are pregnant while taking VASERETIC, stop the medication and contact your doctor, nurse or pharmacist as soon as possible.
BEFORE you use VASERETIC 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 VASERETIC 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 VASERETIC, 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 VASERETIC 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 VASERETIC.
You may become sensitive to the sun while taking VASERETIC. 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 VASERETIC.
Driving and Using Machines
Before you perform tasks which may require special attention, wait until you know how you respond to VASERETIC. 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 VASERETIC:
- 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 VASERETIC, 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 VASERETIC 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
VASERETIC is not for initial therapy. You must first be stabilized on the individual components (enalapril and hydrochlorothiazide) of VASERETIC. If your dosage matches the dosages in VASERETIC, your doctor may prescribe VASERETIC taken once a day (instead of each component as a separate pill).
Take VASERETIC exactly as prescribed. It is recommended to take your dose at about the same time every day.
VASERETIC can be taken with or without food. If VASERETIC causes upset stomach, take it with food or milk.
Usual Adult dose
The maximum daily dosage should not exceed two tablets of VASERETIC 10 mg/25 mg.
|If you think you have taken too much VASERETIC contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison control Centre immediately, even if there are no symptoms.|
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:
- Drowsiness, fatigue, weakness
- Abdominal pain, upset stomach, decreased appetite, constipation
- Muscle pain
- Sore throat
- Tingling of the skin
If any of these affects you severely, tell your doctor, nurse or pharmacist.
VASERETIC can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
|Symptom/effect||Talk with your doctor, nurse, or pharmacist||Stop taking|
|Common||Low Blood Pressure:dizziness, fainting, lightheadedness may occur when you go from lying or sitting to standing up or especially following exercise, and/or when it is hot and you have lost a lot of water by sweating||✓|
|Decreased or increased levels of potassium in the blood: irregular heartbeats, muscle weakness, generally feeling unwell||✓|
|Breathing problems, shortness of breath||✓|
|Uncommon||Allergic Reaction / Angioedema: rash/itching, hives, swelling of the face, eyes, lips, tongue or throat, hands or feet, difficulty swallowing or breathing||✓|
|Kidney Disorder: decreased urination, nausea, vomiting, swelling of extremities, fatigue||✓|
|Liver Disorder: yellowing of the skin or eyes (jaundice), dark urine, abdominal pain, nausea, vomiting, loss of appetite||✓|
|Increased blood sugar: frequent urination, thirst, and hunger||✓|
|Electrolyte Imbalance: weakness, drowsiness, muscle pain or cramps, irregular heartbeat||✓|
|Rare||Decreased White Blood Cells: infections, fatigue, fever, aches, pains, and flu-like symptoms (malaise, muscle pain, rash, itching, abdominal pain, nausea, vomiting, diarrhea, jaundice, or lack of appetite)||✓|
|Decreased Platelets: bruising, bleeding, fatigue and weakness||✓|
|Very Rare||Toxic Epidermal Necrolysis: severe skin peeling, especially in mouth and eyes||✓|
- Myopia: sudden near sightedness or blurred vision
- Glaucoma: increased pressure in your eyes, eye pain
|Anemia: fatigue, loss of energy, weakness, shortness of breath||✓|
|Inflammation of the Pancreas: abdominal pain that lasts and gets worse when you lie down, nausea, vomiting||✓|
This is not a complete list of side effects. For any unexpected effects while taking VASERETIC, 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 Suspected 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
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.
If you want more information about VASERETIC:
- 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 Merck Canada web site www.merck.ca or by calling Merck Canada at 1-800-567-2594
To report an adverse event related to VASERETIC, please contact 1-800-567-2594.