Mylan-Carvedilol: Uses, Side Effects and Dosage

What is MYLAN-CARVEDILOL used for?

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

How does MYLAN-CARVEDILOL work?

MYLAN-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 MYLAN-CARVEDILOL?

Medicinal ingredient: carvedilol

Non-medicinal ingredients (in alphabetical order): Clear opadry (HPMC 2910/Hypromellose 6cP, Macrogol/PEG 400 and 8000), colloidal silicone dioxide, crospovidone, magnesium stearate/ sodium lauryl sulfate, microcrystalline cellulose, pregelatinized starch, and white opadry II (Titanium Dioxide, Polydextrose, HPMC 2910/Hypromellose 3cP, 6cP and 50cP, Macrogol/PEG 400 and 8000).

MYLAN-CARVEDILOL comes in the following dosage forms: MYLAN-CARVEDILOL is available as 3.125 mg, 6.25 mg, 12.5 mg and 25 mg white oval tablets.

Do not use MYLAN-CARVEDILOL if:

• Your doctor did not prescribe it for you
• You are allergic to carvedilol or any of the other ingredients in MYLAN-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 heart beat 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 heart beat
• You have heart valve problems (primary obstructive valvular disease)
• You have severe liver disease
• You have problems making decisions (for example, if you have dementia, alcohol or drug problems). Do not use MYLAN-CARVEDILOL unless you are being cared for by an appropriate caregiver.

• Have one of the following rare hereditary diseases:

  • Galactose intolerance
  • Lapp lactase deficiency
  • Glucose-galactose malabsorption
• If you are 18 years or younger

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MYLAN-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. MYLAN-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). MYLAN-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 MYLAN-CARVEDILOL.

Other warnings you should know about:

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

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

Do not drink alcohol while taking MYLAN-CARVEDILOL.

You should have regular eye exams while taking MYLAN-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 MYLAN-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 MYLAN-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 MYLAN-CARVEDILOL:

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

Take MYLAN-CARVEDILOL:

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

• with food

Usual adult 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 MYLAN-CARVEDILOL works for you.

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

Overdose:

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 MYLAN-CARVEDILOL, contact your healthcare professional. Do NOT restart taking MYLAN-CARVEDILOL until you have spoken to your healthcare professional.

What are possible side effects from using MYLAN-CARVEDILOL?

These are not all possible side effects you may feel when taking MYLAN-CARVEDILOL. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

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, talk to your healthcare professional.

Reporting Side Effects

Storage:

Store your tablets at room temperature (between 15°and 30°C) in a dry place. Protect from light and moisture

Keep container tightly closed.

The expiry date of MYLAN-CARVEDILOL is printed on the label. Do not use the medicine after this date.

Keep out of reach of children.

If you want more information about MYLAN-CARVEDILOL:

This document can be found at: www.mylan.ca.

The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379

Etobicoke, Ontario M8Z 2S6

Revised on: April 19, 2017

Mylan Pharmaceuticals ULC Etobicoke, ON M8Z 2S6 1-800-575-1379 www.mylan.ca