Teva-Enalapril/HCTZ: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

ABOUT THIS MEDICATION

TEVA-ENALAPRIL/HCTZ is the brandname for the combination of the substances - enalapril and hydrochlorothiazide. Enalapril is one of a class of medicines known as angiotensin converting enzyme inhibitors and

hydrochlorothiazide is a thiazide diuretic, often termed a "water pill". This combination is available only on prescription from your physician. It is usually prescribed to reduce high blood pressure.

What the medication is used for:

• reducing high blood pressure

What it does:

When blood pressure is high, the workload of the heart and arteries increases so that over time, these 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.

TEVA-ENALAPRIL/HCTZ does not cure high blood pressure, but does help control it. Enalapril is one of a class of medicines known as angiotensin converting enzyme inhibitors (ACE). Its action is to lower blood pressure by blocking the vasoconstrictor and aldosterone-secreting effects of angiotensin II. Hydrochlorothiazide is a diuretic (water pill) that helps reduce angioedema (the swelling caused by water retention).

When it should not be used:

Do not take TEVA-ENALAPRIL/HCTZ if you:

• are allergic to TEVA-

  ENALAPRIL/HCTZ or any of its components

• 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).
• have a history of angioneurotic edema
• have a hereditary or idiopathic angioedema

What the medicinal ingredients are:

Enalapril maleate and Hydrochlorothiazide. Each tablet is made with 5 or 10 mg of enalapril maleate that appears as 4 or 8 mg of enalapril sodium, and 12.5 mg or 25 mg of hydrochlorothiazide, respectively.

What the important nonmedicinal ingredients are:

Corn starch, lactose, magnesium stearate, pregelatinized starch, sodium bicarbonate and the following colouring agents: the 5/12.5 mg tablets contain FD&C Blue No. 2 Aluminum Lake and yellow ferric oxide and the 10/25 mg tablets contain red ferric oxide.

What dosage forms it comes in:

Tablet 5/12.5 mg (green), 10/25 mg (rust).

WA

WARNINGS AND PRECAUTIONS

RNINGS A Serious Warning and Precautions

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

ENALAPRIL/HCTZ, please discuss stopping this medication with your physician. ND PRECAUTIONS

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

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

• You have previously taken any of the

  following and were allergic or reacted badly to it: hydrochlorothiazide or any other diuretic or "water pill";

  sulfonamides (sulfa medicine); enalapril or any other medication of the same type - Angiotensin Converting Enzyme (ACE) inhibitors with the names usually ending with 'pril' such as enalapril, lisinopril, captopril, particularly if you experienced swelling of the face, eyes, lips, tongue and/or throat, hands or feet, or had sudden difficulty breathing or swallowing.

• You should also not take this medicine if you have been diagnosed with hereditary angioedema or idiopathic angioedema (angioedema of unknown cause).

• You are pregnant, breast-feeding or thinking of becoming pregnant.

  Taking TEVA-ENALAPRIL/HCTZ 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 TEVA-

  ENALAPRIL/HCTZ, stop the medication and report to your physician as soon as possible. It is possible that TEVA-ENALAPRIL/HCTZ passes into breast milk. You should not breast-feed while taking TEVA-

  ENALAPRIL/HCTZ.

• You suffer from low blood pressure

  (you may notice this as faintness or dizziness, especially when standing). Tell your physician if you experience lightheadedness especially during the first few days of therapy. If actual fainting occurs, discontinue the drug until having consulted with your prescribing physician.

• You are undergoing dialysis.

• You have any of these conditions:

  • diabetes
  • heart or blood vessel disease
  • liver disease
  • kidney disease, or difficulty in producing urine
  • bronchial asthma
  • lupus erythematosus or a history of this condition

  • gout or history of gout

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

You should also inform your physician or pharmacist if you are vomiting or have severe diarrhea.

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.

This medicine is not recommended for children.

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 pressure, for example, non-prescription preparations for appetite control, asthma, colds, coughs, hay fever and sinus problems.

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

Your physician or pharmacist also needs to know if you are taking any other medication, whether they be prescription medications or over-the-counter products. 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
• Potassium-containing medicines, potassium supplements, or salt substitutes that contain potassium
• Diabetes medicine and/or insulin
• Lithium (a drug used to treat a certain kind of depression)

• Non-steroidal anti-inflammatory drugs

  (NSAIDs) used to relieve pain

• Alcohol

• Corticosteroids

• Cholestyramine and colestipol resins (to

  treat high cholesterol)

• Probenecid (a drug used to treat gout)
• D-tubocurarine (a muscle relaxant)
• Barbiturates
• Narcotics

PROPER USE OF THIS MEDICATION

PROPER USE OF THIS MEDICATION

Usual dose:

• Take this medicine exactly as your

  physician ordered.

• 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.

• The usual dosage range is between 10-

  40 mg, taken once or twice daily as per your physician’s instructions.

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 pressure very easily, and check how the medicine is controlling it.

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

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.

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 with hydrochlorothiazide, may cause side effects. Most people do not experience any problem when taking this medicine; but if you notice any of the following, medical attention may be needed.

• Symptoms of angioedema include: sudden difficulty in breathing or swallowing, swelling of face, eyes, lips, tongue and/or throat, hands or feet. You should be aware that black patients are at increased risk of these types of reactions to ACE inhibitors.
• Dizziness, lightheadedness or fainting following exercise, and/or when it is hot and you have lost a lot of water by sweating.

• Flu-like symptoms such as sore throat, fever, malaise, muscle pain, rash, itching, abdominal pain, nausea, vomiting, diarrhea, jaundice, loss of appetite.

  Stop taking the medication and contact your physician or pharmacist at once. You may require immediate care. If condition worsens seek medical attention.

  If any fainting occurs, stop taking the medicine. If dizzy, avoid driving or any activity/jobs requiring alertness. Use extra care during exercise or hot weather.

  • You may experience increased skin sensitivity to sunlight. Avoid too much sunlight and do not use a sunlamp.
  • Dry cough, sore throat
  • Unusual tiredness and/or weakness
  • Chest pain
  • Impotence
• Headache
• Palpitations
• Tingling of the skin

If you notice any of the above or have other side effects, contact your physician or your pharmacist. If the condition persists or worsens, seek medical attention.

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

Store your tablets at 15ºC - 30ºC, away from heat and direct light, and out of damp places, such as the bathroom or kitchen. Keep all medicines out of the reach of children.

MORE INFORMATION

This document plus the full Product Monograph prepared for health professionals can be found by contacting Teva Canada Limited at:

1-800-268-4127 ext. 1255005

or druginfo@tevacanada.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

www.tevacanada.com

Last revised: July 23, 2015

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

Toll-free telephone: 1-866-234-2345 Toll-free fax: 1-866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate Tunney’s Pasture, AL 0701C

Ottawa, ON K1A 0K9

NOTE: Before contacting Health Canada you should contact your physician or pharmacist.