Ratio-Lisinopril Z: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

ratio-LISINOPRIL Z is available only on prescription from your doctor.

What the medication is used for:

• reducing high blood pressure

• treating patients with heart failure, which is a

  condition where the heart cannot pump adequate amounts of blood to satisfy the needs of the body

• improving survival after heart attack

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. As a consequence, this could lead to the damage of the "vital organs": brain - heart - kidneys, resulting in stroke, heart failure, heart attack, blood vessel disease or kidney disease.

What it does:

ratio-LISINOPRIL Z is one of a class of medicines known as angiotensin converting enzyme (ACE) inhibitors.

ratio-LISINOPRIL Z tablets can lower blood pressure by preventing the effect of angiotensin II - a natural substance in your body that narrows your blood vessels. This narrowing can increase your blood pressure and force your heart to work harder.

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 ratio-LISINOPRIL Z if you:

• are allergic to lisinopril or any component of

  this product (see What the important non-medicinal ingredients are)

• are allergic to angiotensin converting enzyme

  inhibitors (medication of the same type with the names usually ending with 'pril' such as lisinopril, enalapril, captopril, etc.)

  • have a history of angioneurotic edema

    (symptoms such as swelling of face, extremities, eyes, lips, tongue, difficulty in swallowing or breathing) relating to previous treatment with an ACE-inhibitors.

  • have been diagnosed with hereditary (family history) or idiopathic (unknown origin) angioneurotic edema (please refer to Side Effects and What to do About Them)

What the medicinal ingredient is:

Lisinopril

What the important non-medicinal ingredients are:

Dibasic calcium phosphate dihydrate, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and red iron oxide.

What dosage forms it comes in:

Tablets of 5 mg, 10 mg and 20 mg strengths.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

ratio-LISINOPRIL Z should not be used during pregnancy. If you discover that you are pregnant while taking ratio-LISINOPRIL Z, stop the medication and please contact your doctor as soon as possible.

BEFORE you use ratio-LISINOPRIL Z talk to your doctor or pharmacist if:

• You have previously taken lisinopril or other medication of the same type - angiotensin-converting enzyme (ACE) inhibitors with the names usually ending with 'pril' such as lisinopril, enalapril, captopril, etc., 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. You should not take ratio-LISINOPRIL Z if you have had these types of reactions without a known cause or if you have been diagnosed with hereditary or idiopathic angioedema (symptoms such a swelling of face, extremities, eyes, lips, tongue, difficulty in swallowing or breathing).
• You are pregnant, breast-feeding or thinking of becoming pregnant. Taking ratio-LISINOPRIL Z 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 ratio-LISINOPRIL Z, stop the medication and report to your physician as soon as possible. It is possible that ratio-LISINOPRIL Z passes into breast milk. You should not breast-feed while taking ratio-LISINOPRIL Z.
• You suffer from low blood pressure (you may notice this as faintness or dizziness, especially when standing)
• You are undergoing dialysis
• You have to undergo any dental or other surgery

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

INTERACTIONS WITH THIS MEDICATION

Do not take any other medicines unless you have discussed the matter with your doctor 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 ratio-LISINOPRIL Z tablets.

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

• Diuretics or "water pills", such as spironolactone,

  triamterene or amiloride

• Other medicines to reduce the blood pressure;

• Potassium-containing medicines, potassium

  supplements, salt substitutes that contain potassium

• Lithium (a drug used to treat a certain kind of

  depression)

• Pain and arthritis medicines, such as ibuprofen,

  indomethacin, diclofenac etc.

PROPER USE OF THIS MEDICATION

Usual Dose:

• Take this medicine exactly as your doctor 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 maximum daily dose for ratio-LISINOPRIL Z

  oral administration is 80 mg.

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 doctor can measure your blood pressure very easily, and check how the medicine is controlling it.

If your doctor 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 doctor may also recommend weight loss. Do follow these suggestions.

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.

Overdose:

In case of an overdose, contact your doctor 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 6 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.

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

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its intended action, any medication, including ratio-LISINOPRIL Z, 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, such as: 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 fever, malaise, muscle pain, rash, itching, abdominal pain, nausea, vomiting, diarrhea, jaundice, loss of appetite

Stop taking the medication and contact your doctor 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/job requiring alertness. Use extra care during exercise or hot weather.

• 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

• Dry cough, sore throat
• Unusual tiredness and/or weaknes
• Headache
• Less or no urine being produced

IF YOU NOTICE ANY OF THE ABOVE OR HAVE OTHER SIDE EFFECTS, CONTACT YOUR DOCTOR OR 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 ratio-LISINOPRIL Z, contact your doctor or pharmacist.

HOW TO STORE IT

Store at room temperature between 15 and 25°C in tightly closed container, away from heat and direct light and out of damp places, such as a bathroom or kitchen. Protect from moisture and humidity.

Keep all medicines out of reach of children.

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: 866-234-2345 toll-free fax 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.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, ratiopharm inc., at: 1-800-337-2584.

Last revised: September 20, 2007.