Apo-Nebivolol: Uses, Side Effects and Dosage

What is APO-NEBIVOLOL used for?

APO-NEBIVOLOL is used to treat high blood pressure (also known as hypertension) in adults. It can be used alone or with other medicines.

How does APO-NEBIVOLOL work?

APO-NEBIVOLOL belongs to a group of drugs called “beta blockers.”

• It makes your heart beat more slowly and less forcefully.
• It lowers your blood pressure by relaxing your blood vessels so that your blood flows more easily.

This medicine does not cure your disease but helps to control it.

What are the ingredients in APO-NEBIVOLOL?

Medicinal ingredients: nebivolol (as nebivolol hydrochloride).

on-medicinal ingredients: co-povidone, crospovidone, ferric oxide red (5 mg only), indigotine Al lake, iron oxide yellow (5 mg only), lactose monohydrate, magnesium stearate and pregelatinized starch.

APO-NEBIVOLOL comes in the following dosage forms:

Tablets: 2.5 mg (light blue), 5 mg (beige) and 20 mg (light blue)

Do not use APO-NEBIVOLOL if you:

• Are allergic to nebivolol or any of the other ingredients in APO-NEBIVOLOL.
• Have heart failure and you notice that your symptoms are getting worse. For example you feel more tired, are out of breath more often, or have swelling of the ankles.
• Have severe heart damage and your heart is not able to pump enough blood to meet your body’s needs.
• Have a slow or irregular heart beat.
• Have an abnormal heart rate or rhythm.
• Have a problem with your heart’s electrical conduction (that causes you to have chest pain, difficulty breathing, nausea, fatigue and fainting).
• Have severe liver disease.

• Have serious problems with blood flow in your feet and legs (peripheral artery disease).

  • Have one of the following rare hereditary diseases:
  • Galactose intolerance
  • Lapp lactase deficiency
  • Glucose-galactose malabsorption
• You are 18 years and younger.

To make sure you take the drug properly and don’t have side effects, talk to your healthcare professional before you take APO-NEBIVOLOL. Talk about any health conditions or problems you may have, including if you:

• Have asthma or other lung problems (like bronchitis or emphysema).
• Have a history of heart problems.
• Have a history of fainting.
• Have diabetes and take medicine to control your blood sugar or have low blood sugar (hypoglycemia).
• Have a condition called pheochromocytoma (a tumour of the adrenal gland).
• Have thyroid problems.
• Have liver or kidney problems.
• Have had allergic reactions or have allergies.

• Are pregnant or trying to become pregnant. APO-NEBIVOLOL is not usually recommended for use during pregnancy. Your doctor will consider the benefit to you versus the risk to your unborn baby.

• Are breastfeeding. You should not breastfeed while using APO-NEBIVOLOL.
• Are scheduled for surgery and will be given an anesthetic.
• Develop a skin rash while taking APO-NEBIVOLOL.

Other warnings you should know about:

Do not stop taking APO-NEBIVOLOL suddenly. This could cause chest pain or a heart attack. If your doctor decides that you should stop taking APO-NEBIVOLOL, your dose may be reduced so that you need to use less and less before you stop the medication completely.

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

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

The following drugs may interact with APO-NEBIVOLOL:

• Drugs used for lowering blood pressure:

  • ACE inhibitors (such as lisinopril)
  • Calcium channel blockers (such as verapamil and diltiazem)
  • Clonidine
• Drugs used to treat depression and mood disorders (such as fluoxetine, paroxetine, and venlafaxine)
• Anesthetic drugs used during surgery (such as ether and cyclopropane)
• Drugs used to treat diabetes such as insulin and oral medicines. You could become less aware of the symptoms of low blood sugar.
• Drugs used to treat heartburn and ulcers (such as cimetidine)

• Antidiuretic drugs used to reduce the fluid build-up in your body (such as hydrochlorothiazide,

  • furosemide and spironolactone)
• Sildenafil, a drug used to treat erectile dysfunction
• Drugs used to treat HIV/AIDS
• Drugs used to treat heart rhythm disorders (such as amiodarone, disopyramide, flecainide digoxin)
• Dexamethasone, a steroid drug used to treat inflammation
• Rifampin used to treat tuberculosis
• Fingolimod, a medicine used to treat multiple sclerosis

How to take APO-NEBIVOLOL:

Take APO-NEBIVOLOL:

• Exactly as prescribed
• Everyday
• Once a day, at about the same time each day

• With or without food

Usual Adult dose:

Starting daily dose: 5 mg once a day Maximum daily dose: 20 mg once a day

Your doctor may:

• start you on a different dose or change your dose over time depending on how

  APO-NEBIVOLOL works for you.

• add another medicine like a diuretic (water pill) or an ACE inhibitor for you to take along with APO-NEBIVOLOL to treat your high blood pressure.

Do NOT stop taking APO-NEBIVOLOL or change your dose without consulting your doctor. This can be dangerous.

Overdose:

Missed Dose:

If you have forgotten to take your dose, carry on and take your next dose at the usual time. Do NOT double the dose.

What are the possible side effects from taking APO-NEBIVOLOL?

These are not all the possible side effects you may feel when you are taking APO-NEBIVOLOL. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• Cough
• Diarrhea
• Dizziness
• Dry mouth
• Headache
• Joint and back pain
• Nausea
• Stuffy nose and colds
• Tiredness
• Trouble sleeping

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 between 15°C to 30°C.

Keep out of reach and sight of children.

If you want more information about APO-NEBIVOLOL:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website https://health-products.canada.ca/dpd-bdpp/index-eng.jsp; the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.

Last Prepared: September 23, 2019