NTP-Ramipril: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

For Patients with High Blood Pressure

Your doctor has prescribed NTP-RAMIPRIL, a medication that helps to control blood pressure.

Managing your lifestyle

Keeping your blood pressure controlled

But it takes more than just medication to reduce blood pressure. Discuss the risk factors, and how they apply to your lifestyle, with your doctor. You may have to modify some of your daily habits to keep your blood pressure down.

Exercise regularly. It will help to keep your weight down, make you feel more energetic and is a good way to deal with stress. If you are not exercising regularly, be sure to discuss a fitness plan with your doctor.

Remember, hypertension is a long-term disease without symptoms. Just because you feel fine does not mean you can stop taking your medication. If you stop, serious complications of the disease may occur. Therefore, you should continue to take NTP-RAMIPRIL regularly, as prescribed by your doctor.

The “lifestyle” part of your treatment is as important as your medication. By working as a team with your doctor, you can help reduce the risk of complications to maintain the style of life you are accustomed to.

Alcohol: Avoid alcoholic beverages until you have discussed their use with your doctor. Alcohol consumption may alter your blood pressure and/or increase the possibility of dizziness or fainting.

Diet: Generally, avoid fatty foods and food that is high in salt or cholesterol.

Smoking: Avoid it completely.

What it does:

NTP-RAMIPRIL opens blood vessels to reduce blood pressure, just like the way opening a hose reduces water pressure. It is not, however, a cure.

When it should not be used:

If:

• You have had an allergic reaction to ramipril and/or any components of NTP-RAMIPRIL capsules (see what are the important non-medicinal ingredients) or to any other medication of the same group of medicines called ACE (angiotensin converting enzyme) inhibitors. (see Warnings and Precautions).

• You have a history of a condition called angioedema

  (disfiguring type of temporary swelling which can be hazardous) (see Side Effects).

• You are pregnant or breastfeeding

• You have narrowing of the arteries to one or both kidneys

  (renal artery stenosis).

• You have hypotension (low blood pressure).

What the medicinal ingredient is:

Ramipril

What the nonmedicinal ingredients are:

The qualitative formulation for all potencies of NTP-RAMIPRIL is: ramipril, calcium phosphate (dibasic), colloidal silicon dioxide, magnesium hydroxide, magnesium stearate, pregelatinized starch, talc and empty gelatin capsules.

Empty gelatin capsules for all potencies of NTP-RAMIPRIL are composed of gelatin, titanium dioxide and colouring agents specific to each potency (see below).

2.5 mg: Empty gelatin capsules colouring agents: D & C Yellow No.10, FD & C Red No.40, gelatin & titanium dioxide.

5.0 mg: Empty gelatin capsules colouring agents: D & C Red No. 33, FD & C Blue No. 1, FD & C Red No. 40, gelatin & titanium dioxide.

10.0 mg: Empty gelatin capsules colouring agents: D&C Red No. 28, FD & C Blue No. 1, FDA/E172 Black Iron Oxide, gelatin & titanium dioxide.

What dosage forms it comes in: NTP-RAMIPRIL (ramipril) is available as a 2.5 mg, 5

mg and 10 mg capsule.

Capsules should be swallowed whole. DO NOT open, crush or chew the capsules.

WARNINGS AND PRECAUTIONS

Serious Warning and Precautions

NTP-RAMIPRIL should not be used during pregnancy. If you discover that you are pregnant while taking NTP-RAMIPRIL, stop the medication and please contact your physician as soon as possible.

BEFORE you use NTP-RAMIPRIL talk to your doctor or pharmacist if:

You are currently taking any other medications, whether on prescription or otherwise (see Interactions with this Medication)?

You should not be taking salt substitutes, potassium supplements or potassium containing medicine without the advice of your doctor. If you have to undergo any dental or other surgery, inform the dentist or physician in charge that you are taking this medicine.

You suffer from any other condition?

The presence of other medical problems may affect the use of NTP-RAMIPRIL. If you have developed heart failure after a heart attack, you may have to limit your physical activities: before you begin exercising, be sure to consult with your doctor. Make sure you tell your doctor if you have any other medical problems, especially if you have diabetes, liver disease, kidney disease, heart or blood vessel disease.

You are pregnant, breast-feeding or thinking of becoming pregnant?

Taking NTP-RAMIPRIL during pregnancy can cause injury and even death to your baby. This medicine should not be used during pregnancy. If you become pregnant while taking NTP-RAMIPRIL, stop the medication and report promptly to your doctor as soon as possible. It is possible that NTP-RAMIPRIL passes into breast milk. You should not breast-feed while taking NTP-RAMIPRIL.

Remember

Use this drug as directed by your doctor. All drugs can have both helpful and harmful effects. Both depend on the person and his or her condition. This leaflet alerts you to some of the times you should call your doctor. Other situations which cannot be predicted can arise. Nothing in this leaflet should stop you from calling your doctor or pharmacist with any questions or concerns you have about NTP-RAMIPRIL.

INTERACTIONS WITH THIS MEDICATION

Some drugs may have negative effect on NTP-

AMIPRIL or NTP-RAMIPRIL may have a negative

fect on other drugs. If you are currently taking any other medications, whether on prescription or otherwise, inform your doctor or pharmacist. This is especially important if you are taking diuretics (water pills) or any other medication to reduce blood pressure which may add to the blood pressure lowering effect of NTP-RAMIPRIL.

Drugs that may interact with NTP-RAMIPRIL include also agents increasing serum potassium: such as potassium supplements, salt substitutes or medicines which contain potassium. These should be used with caution.

Other drugs that may affect the efficacy of NTP-RAMPRIL include: nitrates, ASA (aspirin), heparin, allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other substances that may change the normal results expected to be measured on a routine blood test.

PROPER USE OF THIS MEDICATION

Usual dose:

It is important to take it at the same time every day as prescribed by your doctor.

High Blood Pressure: The recommended initial dosage of NTP-RAMIPRIL is 2.5 mg once daily. Your doctor will determine the appropriate dosage.

For patients taking diuretics or with impaired kidney function: The recommended initial dosage of NTP-RAMIPRIL is 1.25 mg daily.

Overdose:

In case of overdose, contact a health professional, hospital emergency department or regional Poison Control centre immediately, even if there are no symptoms

If possible, take your NTP-RAMIPRIL package with you to show the doctor.

Missed Dose:

If you forgot to take your NTP-RAMIPRIL capsule, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its intended action, any medication, including NTP-RAMIPRIL, may cause side effects. After you have started taking NTP-RAMIPRIL, it is important that you tell your doctor at once about any unexplained symptom you might experience. Examples of this are unexplained fever, rash, itching, any sign of infection, viral-like symptoms, flu-like symptoms, coughing, sore throat, abdominal pain, loss of appetite, sad mood, jaundice, dizziness, fatigue, or nausea. These side effects may disappear once your system becomes used to the medication. If they persist, discuss this with your doctor. Your medication might have to be reduced or changed.

Dizziness or lightheadedness may occur after the first dose of this medicine. Make sure you know how you react to this medicine before you drive, operate machinery, or do anything requiring you to be alert. If fainting occurs after using NTP-RAMIPRIL, discontinue use and consult your doctor.

If you are suffering from excessive sweating, vomiting or diarrhea, this may cause you to lose too much water and lead to problems with low blood pressure. See your doctor.

Other side effects may include: difficulty in maintaining your balance while standing, nasal or sinus congestion, swollen lymph nodes, bronchitis, loss of hair, muscle cramps, impotence/reduced libido, difficulty with sleep, restlessness, depressed mood, inflammation of the eye (pink eye), taste modifications or loss of taste, vision or hearing modifications, attention disturbances, skin inflammation or red skin, burning sensation, inflammation of the mouth or tongue, aggravated asthma, breast enlargement in males.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN

This is not a complete list of side effects. For any unexpected effects while taking NTP-RAMIPRIL, contact your doctor or pharmacist.

HOW TO STORE IT

Store in original container: bottles between 15ºC to 30ºC, blister packs between 15ºC to 25ºC, and not beyond the date indicated on the container. Keep this medication out of the reach of children.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways: -----------------------------------------------------------------------------

$ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345

$ Complete a Canada Vigilance Reporting Form and:

• Fax toll-free to 1-866-678-6789, or

• Mail to: Canada Vigilance Program Health Canada

  Postal Locator 0701C

  Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, NT Pharma Canada Limited at: 1-800-268-4127 ext. 5005

or druginfo@tevacanada.com

NT Pharma Canada Limited

5691 Main Street

Stouffville, Ontario

Canada, L4A 1H5

Last revised: June 12, 2012