Sandoz Ramipril (Sandoz Canada, Tablet): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

High Blood Pressure (Hypertension)

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

Following a Recent Heart Attack

Sandoz Ramipril reduces the effort required by your heart to pump blood. This is to compensate for the reduced pumping power that may have resulted from your heart attack. Sandoz Ramipril has been shown to improve survival and reduce hospitalizations for heart failure in patients that are now clinically stable and recovering from recent heart attacks.

For the Management of Patients at Increased Risk of Cardiovascular Events

Your doctor has prescribed Sandoz Ramipril because:

• You have coronary heart disease (such as chest pains or

  angina, or have had a heart attack in the past)

• You had a stroke

• You have peripheral vascular disease (poor blood

  circulation)

• You have diabetes and at least one of the following

  physical conditions: high blood pressure, elevated total cholesterol levels, low high-density lipoprotein (HDL) levels, cigarette smoking or documented tiny amounts of albumin from your blood detected in your urine (microalbuminuria).

Sandoz Ramipril may lower the risk of heart attack, stroke, or death from heart disease in some patients who have a heart problem or poor blood circulation.

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 Sandoz 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:

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

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

When it should not be used:

Do not take Sandoz 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 Sandoz

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

• Are breastfeeding. Sandoz Ramipril passes into breast milk.
• Are taking ENTRESTO ^® (sacubitril/valsartan), due to the increased risk of serious allergic reaction which causes swelling of the face or throat (angioedema) when taken with Sandoz Ramipril. You must wait at least 36 hours after your last dose of sacubitril/valsartan before taking Sandoz Ramipril.
• 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).

• are already taking a blood pressure-lowering medicine that

  containing aliskiren (such as Rasilez) and you have one of the following conditions:

• diabetes
• kidney disease
• high potassium levels
• heart failure combined with low blood pressure

• Are taking an angiotensin receptor blocker (ARB), another

  medicine to treat your high blood pressure, or another ACE inhibitor and have one of the following conditions:

• diabetes with end organ damage
• kidney disease
• high potassium levels
• heart failure combined with low blood pressure

You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”.

What the medicinal ingredient is:

Ramipril

What the nonmedicinal ingredients are:

Hypromellose, microcrystalline cellulose, pregelatinized starch, sodium hydrogen carbonate and sodium stearyl fumarate.

What dosage forms it comes in:

Tablets 1.25 mg, 2.5 mg, 5 mg and 10 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions - Pregnancy Sandoz Ramipril should not be used during pregnancy. If you discover that you are pregnant while taking ramipril, stop the medications and please contact your doctor, nurse, or pharmacist as soon as possible.

BEFORE you use Sandoz 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, a potassium-sparing diuretic (a specific kind of “water pill”), or other medicinal products that may increase potassium. Use of Sandoz 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 Sandoz 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 Sandoz Ramipril is not recommended.

  • Are taking drugs such as:

    • Temsirolimus and everolimus (used to treat cancer),
    • Sirolimus (used to prevent organ rejection after a transplant),
    • Sitagliptin or other gliptins (used to treat Type II diabetes),
    • A neutral endopeptidase inhibitor.

Taking ACE inhibitors, such as Sandoz Ramipril, with these types of drugs may increase your chances of having an allergic reaction (angioedema). You may become sensitive to the sun while taking Sandoz 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 Sandoz Ramipril.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to Sandoz 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 Sandoz 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”), or other medicinal products that may increase potassium. Use of Sandoz Ramipril with these medicines is not recommended.
• Alcohol
• Allopurinol used to treat gout.
• Antidiabetic drugs, including insulin and oral medicines, such as gliptins (e.g. sitagliptin)
• 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
• Cytostatic medicines used to treat certain types of cancer

• mTOR inhibitors used to lower the body’s ability to reject a

  transplant (e.g. sirolimus) or to treat certain types of cancer (e.g. tersirolimus, everolimus)

• Neutral endopeptidase (NEP) inhibitors.

PROPER USE OF THIS MEDICATION

Take Sandoz 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 Sandoz Ramipril is 2.5 mg once daily. Your doctor will determine the appropriate dosage.

Following a Recent Heart Attack: The recommended initial dosage of Sandoz 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 Sandoz Ramipril is 1.25 mg daily.

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

Overdose:

If you think you have taken too much Sandoz Ramipril 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.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects may include:

• dizziness difficulty in maintaining your balance while standing
• 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.

Sandoz 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 Sandoz Ramipril, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

Store in original container between 15 and 30°C, protect from light and moisture and do not use after the expiry date indicated on the container.

Keep out of reach of and sight of children.

Reporting Suspected Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting

  (https://www.canada.ca/en/health-

  canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

If you want more information about Sandoz Ramipril:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website ( https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.sandoz.ca, or by calling 1-800-361-3062.

or by written request at:

110 Rue de Lauzom

Boucherville, (QC), Canada

J4B 1E6

or by e-mail at :

medinfo@sandoz.com

Last revised: October 19, 2020