Ramipril-2.5: Uses, Side Effects and Dosage

What the medication is used for:

High Blood Pressure (Hypertension)

RAMIPRIL lowers high blood pressure. It can be used alone or together with a diuretic (“water pill”).

Managing your lifestyle

Keeping your blood pressure controlled

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 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:

RAMIPRIL is an angiotensin converting enzyme (ACE) inhibitor. You can recognize ACE inhibitors because their medicinal ingredient end in ‘-PRIL’.

This medicine does not cure your disease. It helps to control it. Therefore, it is important to continue taking RAMIPRIL regularly even if you feel fine.

When it should not be used:

Do not take RAMIPRIL if you:

• Are allergic to ramipril or to any non-medicinal ingredient in the formulation.

• 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.

• Are pregnant or intend to become pregnant. Taking

  RAMIPRIL during pregnancy can cause injury and even death to your baby.

• Are breastfeeding. RAMIPRIL passes into breast milk.

• Have narrowing of the arteries to one or both kidneys

  (renal artery stenosis).

• Have hypotension (low blood pressure).
• Are on dialysis or LDL apheresis (a treatment to remove LDL cholesterol from the blood).

• Have diabetes or kidney disease and are already taking:

  • a blood pressure-lowering medicine that contains aliskiren (such as Rasilez®)
  • an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”.

What the medicinal ingredient is:

Ramipril.

What the important non-medicinal ingredients are:

Lactose monohydrate (spray-dried), magnesium stearate, talc and empty gelatin capsules (which are composed of titanium dioxide and/ or yellow iron oxide and / or FD & C red no. 40 and/or D & C red no. 28 and/or FD & C blue no. 1 and/ or D & C yellow no.10 and/or Black iron oxide).

What dosage forms it comes in:

Capsules: 2.5 mg, 5.0 mg and 10.0 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions - Pregnancy

RAMIPRIL should not be used during pregnancy. If you discover that you are pregnant while taking RAMIPRIL, stop the medication and please contact your doctor, nurse, or pharmacist as soon as possible.

BEFORE you use RAMIPRIL talk to your doctor, nurse or pharmacist if you:

• Are allergic to any drug used to lower blood pressure.
• 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.

• Are on dialysis or LDL apheresis (a treatment to

  remove LDL cholesterol from the blood).

• Are dehydrated or suffer from excessive vomiting,

  diarrhea, or sweating.

• Are taking a salt substitute that contains potassium,

  potassium supplements, or potassium-sparing diuretic (a specific kind of “water pill”). Use of RAMIPRIL with these medicines is not recommended.

• Are on a low-salt diet.

• Are receiving gold (sodium aurothiomalate)

  injections.

• Are less than 18 years old.

• Are taking a medicine that contains aliskiren, such as

  Rasilez, used to lower high blood pressure. The combination with RAMIPRIL is not recommended.

• Are taking an angiotensin receptor blocker (ARB).

  You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”. The combination with RAMIPRIL is not recommended.

You may become sensitive to the sun while taking RAMIPRIL. 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 RAMIPRIL.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to RAMIPRIL. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.

Raynaud's phenomenon is a condition resulting from poor circulation in the extremities (i.e., fingers and toes). It may begin or get worse.

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 RAMIPRIL

• Agents increasing serum potassium, such as a salt

  substitute that contains potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill”). Use of RAMIPRIL with these medicines is not recommended.

• Alcohol.
• Allopurinol used to treat gout.

• Antidiabetic drugs, including insulin and oral

  medicines, in particular vildagliptin.

• Lithium used to treat bipolar disease.
• Gold for the treatment of rheumatoid arthritis.

• Nonsteroidal anti-inflammatory drugs (NSAIDs),

  used to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.

  • Blood pressure lowering drugs, including diuretics

    (“water pills”) aliskiren-containing products (e.g. Rasilez), or angiotensin receptor blockers (ARBs).

  • Nitrates used to treat angina (chest pain).
  • Acetylsalicylic acid (aspirin).
  • Heparin used to prevent and treat blood clots.
  • Immunosuppressants used to lower the body’s ability to reject a transplanted organ.
  • Corticosteroids used to treat joint pain and swelling or for other conditions.
  • Procainamide used to treat irregular heartbeat.
  • Cytostatics-medicines used to treat certain types of cancer.
  • mTOR inhibitors (e.g. temsirolimus) used to lower the body’s ability to reject a transplant or to treat certain types of cancer.

PROPER USE OF THIS MEDICATION

Take RAMIPRIL exactly as prescribed. It is recommended to take your dose at about the same time every day.

Usual adult dose:

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

Following a Recent Heart Attack: The recommended initial dosage of RAMIPRIL is 2.5 mg given twice a day in the morning and in the evening for patients with clinical signs of heart failure (a condition in which the heart has difficulty pumping enough blood to the body's other organs). Treatment should be started under close medical supervision.

For patients taking diuretics (“water pills”) or with impaired kidney function: The recommended initial dosage of RAMIPRIL is 1.25 mg daily.

Management of Patients at Increased Risk of Cardiovascular Events: The recommended initial dosage of RAMIPRIL is 2.5 mg once daily. Your doctor will determine the appropriate dosage.

Overdose:

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.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects may include:

• Dizziness, difficulty in maintaining your balance while standing

  If you think you have taken too much RAMPIRIL, contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison control Centre immediately, even if there are no symptoms.

• Drowsiness, fatigue, weakness

• Cough, nasal or sinus congestion, swollen lymph

  nodes, bronchitis, aggravated asthma

• Rash, itching, flushing, inflammation of the eye (pink

  eye), skin inflammation or red skin, burning sensation, inflammation of the mouth or tongue

• Headache
• Abdominal pain

• Sad mood, difficulty with sleep, restlessness,

  attention disturbances

• Loss of hair

• Taste modifications or loss of taste, vision or hearing

  modifications

• Impotence/reduced libido, breast enlargement in

  males

If any of these affects you severely, tell your doctor, nurse or pharmacist.

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

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

HOW TO STORE IT

Store in original container at room temperature between 15-30°C, (59-86°F) in a well-closed container and not beyond the expiry date

Keep this medication out of the reach and sight 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: 0701E

  Ottawa, Ontario

  K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^TM Canada Web site at

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

For more information, please contact your doctor, pharmacist or other healthcare professional.

This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting Sivem Pharmaceuticals ULC at: 1-855-788-3153.

This leaflet can also be found at: http://www.sivem.ca

Date of Revision: January 12, 2016

RASILEZ® is a trade-mark of Novartis AG, Switzerland.