Riva-Carvedilol: Uses, Side Effects and Dosage

Serious Warnings and Precautions

RIVA-CARVEDILOL can cause your heart failure to worsen. The risk of worsening heart failure is increased when you first start to take RIVA-CARVEDILOL and when your dose is increased. To decrease your risk of having side effects, make sure you always take RIVA-CARVEDILOL exactly as your healthcare professional has told you to.

What is RIVA-CARVEDILOL used for?

RIVA-CARVEDILOL is used to treat heart failure in adults.

How does RIVA-CARVEDILOL work?

RIVA-CARVEDILOL works by relaxing and widening your blood vessels. This makes it easier for your heart to pump blood around your body. This helps reduce your blood pressure and the strain on your heart.

What are the ingredients in RIVA-CARVEDILOL?

Medicinal ingredient: Carvedilol

Non-medicinal ingredients: Crospovidone, Lactose Monohydrate, Magnesium Stearate, Povidone, Silica Colloidal Anhydrous, Sucrose.

Coating contains: Hypromellose, Polyethylene Glycol 400, Polysorbate 80, Titanium Dioxide.

RIVA-CARVEDILOL comes in the following dosage forms:

Film-coated Tablet: 3.125 mg, 6.25 mg, 12.5 mg and 25 mg.

Do not use RIVA-CARVEDILOL if:

• Your doctor did not prescribe it for you.
• You are allergic to carvedilol or any of the other ingredients in RIVA-CARVEDILOL.
• You have severe heart failure that requires you to be in the hospital for treatment.
• You have asthma, wheezing, bronchitis or other breathing problems.
• You have an abnormal heartbeat and do not have a permanent pacemaker in place.
• You have severe heart damage and your heart is not able to pump enough blood to meet your body’s needs.
• You have very low blood pressure.
• You have a very slow heartbeat.
• You have heart valve problems (primary obstructive valvular heart disease).
• You have severe liver disease.
• You have problems making decisions (for example, if you have dementia, alcohol or drug problems). Do not use RIVA-CARVEDILOL unless you are being cared for by an appropriate caregiver.

• Have one of the following rare hereditary diseases because RIVA-CARVEDILOL contains lactose:

  • Galactose intolerance
  • Lapp lactase deficiency
  • Glucose-galactose malabsorption
• You are 18 years or younger.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take RIVA-CARVEDILOL. Talk about any health conditions or problems you may have, including if you:

• have a history of heart problems or disease.
• have or had kidney or liver problems.
• have low blood pressure.
• are pregnant or thinking of becoming pregnant.
• are breastfeeding.
• have diabetes. You could become less aware of the symptoms of hyperglycemia (high blood sugar) and you should monitor your blood sugar levels more carefully.
• have thyroid problems.
• have Reynaud’s syndrome. RIVA-CARVEDILOL may increase the symptoms of coldness and/or spasms in your hands and feet or cramping pains in the legs when exercising.
• have psoriasis (scaly red patches on your skin).
• have problems with blood flow to your feet and legs (peripheral artery disease). RIVA-CARVEDILOL can make your symptoms worse.
• have a condition called pheochromocytoma (a tumour of the adrenal gland).
• have allergic reactions or allergies.
• are having a planned surgery and will be given an anesthetic.
• wear contact lenses. You may suffer from eye dryness while using RIVA-CARVEDILOL.

Other warnings you should know about:

Pregnancy: RIVA-CARVEDILOL is not usually recommended for use during pregnancy. Your doctor will consider the benefit to you versus the risk to your unborn baby.

Breastfeeding: RIVA-CARVEDILOL can pass into breast milk. Do not use RIVA-CARVEDILOL if you are breastfeeding.

Driving and using machines: Before doing tasks that require special attention, wait until you know how you respond to RIVA-CARVEDILOL.

Do not drink alcohol while taking RIVA-CARVEDILOL.

You should have regular eye exams while taking RIVA-CARVEDILOL.

Tell your health professional if you notice that your heart failure symptoms are getting worse, like an increase in shortness of breath, tiredness, dizziness, or swelling of the ankles. This may occur when your dose is increased and may indicate that your dose needs to be changed.

Do not stop taking RIVA-CARVEDILOL all of a sudden. Under the care of your healthcare professional, it should be stopped slowly over 2 weeks.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with RIVA-CARVEDILOL:

• Alcohol
• Antidepressants used in the treatment of depression and mood disorders
• Antidiabetic drugs including insulin and oral medications
• Blood pressure drugs such as clonidine
• Cyclosporine used after organ transplants
• Digoxin, a heart medication
• Drugs used to treat stomach acid or heartburn (such as cimetidine)
• Drugs used to treat hypertension and irregular heartbeat (such as diltiazem and verapamil)
• Fingolimod, a medicine used to treat multiple sclerosis
• Grapefruit juice
• MAO inhibitors such as selegiline (Parkinson’s Disease), tranylcypromine (depression)
• Nitroglycerin used to treat chest pain
• Rifampin used to treat tuberculosis
• Warfarin used to prevent blood clots

How to take RIVA-CARVEDILOL:

Swallow the tablet whole with water. DO NOT chew, crush or break the tablet.

Take RIVA-CARVEDILOL:

• exactly as prescribed
• every day
• twice a day, at about the same time every day

• with food

Usual dose:

Starting dose: 3.125 mg twice a day for 2 weeks

Maximum daily dose: 25 mg twice a day

Your doctor may start you on a different dose or change your dose over time depending on how RIVA-CARVEDILOL works for you.

Do not stop taking RIVA-CARVEDILOL without consulting your doctor. This can be dangerous.

Overdose:

If you think you, or a person you are caring for, have taken too much RIVA-CARVEDILOL, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed Dose:

If you miss a dose, take it as soon as you remember. You can take your next dose at the normal time, but do NOT take 2 doses within 6 hours of each other.

If you miss more than 2 doses of RIVA-CARVEDILOL, contact your healthcare professional. Do NOT restart taking RIVA-CARVEDILOL until you have spoken to your healthcare professional.

What are possible side effects from using RIVA-CARVEDILOL?

These are not all possible side effects you may have when taking RIVA-CARVEDILOL. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• Headache
• Trouble sleeping
• Drowsiness
• Weakness
• Cough, stuffy and runny nose
• Rash, itching
• Abdominal pain, diarrhea, indigestion, nausea, vomiting
• Back pain

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting 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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

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

Storage:

• Store at room temperature (15°C to 30°C).
• Do not use the medicine if it has expired.

Keep out of reach and sight of children.

If you want more information about RIVA-CARVEDILOL:

• Talk to your healthcare professional.
• Find the full Product Monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.labriva.com, or by calling 1-800-363-7988.