Vaseretic (Enalapril/HCTZ)

Serious Warning 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 withVASERETIC 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 asVASERETIC, 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.

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.

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

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.

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.

Overdose:

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.

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.