Novo-Veramil: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

NOVO-VERAMIL tablets may be used in the treatment of:

1. 1. Chronic stable angina of effort. (Chest pain)
2. 2. Angina resulting from coronary artery spasm. (Chest pain)
3. 3. Obstructive hypertrophic cardiomyopathy where surgery is not otherwise indicated.
4. 4. Atrial fibrillation or flutter with rapid ventricular response not otherwise controllable with digitalis preparations. (Irregular heart beat)
5. 5. Follow-up treatment to the use of injectable verapamil in paroxysomal supraventricular tachycardia. (Irregular heart beat)
6. 6. Mild to moderate essential hypertension (high blood pressure).

NOVO-VERAMIL SR is used to treat hypertension (high blood pressure).

What it does:

Verapamil hydrochloride is a calcium channel blocker. Calcium channel blockers change the amount of calcium getting into the muscle cells of your heart and blood vessels. This can change the strength and speed at which your heart beats. It also opens up the blood vessels so that blood can be pumped around your body more easily. This helps to lower your blood pressure.

When it should not be used:

NOVO-VERAMIL & NOVO-VERAMIL SR should not be used if:

• you are allergic to any component of NOVO-VERAMIL & NOVO-VERAMIL SR, including the active ingredient or the nonmedicinal ingredients. See (What the nonmedicinal ingredients are).
• you have certain serious heart disease or problems.

• you feel faint when you get up.

  • you have symptoms such as rapid pulse and breathing, anxiety, weakness, decreased urine production, cool hands and feet and loss of alertness. See your doctor immediately.
  • you have had a heart attack.
  • You have slow heartbeat or irregular heartbeat.

  • you are breast-feeding while taking this medication.

Ask your doctor for advice.

What the medicinal ingredient is:

NOVO-VERAMIL & NOVO-VERAMIL SR contains verapamil hydrochloride.

What the important non-medicinal ingredients are:

NOVO-VERAMIL 80 mg and 120 mg: Colloidal Silicon Dioxide, Microcrystalline Cellulose, Magnesium Stearate, Povidone, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate.

NOVO-VERAMIL 80 mg coating: 3A Alcohol, D&C yellow #10, FD&C yellow #6, Hydroxypropyl Cellulose, Hypromellose, Polydextrose, Polyethylene Glycol, Talc, Titanium Dioxide, Triacetin and Triethyl Citrate.

NOVO-VERAMIL 120 mg coating: Hypromellose, Methanol, Polydextrose, Polyethylene Glycol, Talc, Titanium Dioxide and Triethyl Citrate.

NOVO-VERAMIL SR 240 mg: Magnesium Stearate, Microcrystalline Cellulose, Sodium Alginate and Povidone.

NOVO-VERAMIL SR 240 mg coating: D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Hypromellose, Polyethylene Glycol, Polysorbate and Titanium Dioxide.

What dosage forms it comes in:

NOVO-VERAMIL is available in tablets in the following strengths: 80 mg, 120 mg.

NOVO-VERAMIL SR is available as sustained-release tablets in the following strengths: 240 mg.

WARNINGS AND PRECAUTIONS

BEFORE you use NOVO-VERAMIL & NOVO-VERAMIL SR talk to your doctor or pharmacist if:

• you are pregnant or planning to become pregnant.
• you have any heart disease.
• you have kidney disease.
• you have liver disease.
• you are taking beta-blockers. See (Interactions With This
• Medication).
• you have neuromuscular disease (i.e. myasthenia gravis or Duchenne muscular dystrophy).

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with NOVO-VERAMIL & NOVO-VERAMIL SR include:

• beta-blockers (e.g., propranolol, metoprolol, atenolol, timolol);

• any other treatment for hypertension (high blood pressure) or an arrhythmia (abnormal heart beat) (e.g.,

  hydrochlorothiazide, disopyramide, flecainide, quinidine, prazosin, terazosin);

• digoxin, digitoxin, cimetidine, lithium, rifampin, theophylline, sulfinpyrazone, clarithromycin, erythromycin, telithromycin, glyburide, almotriptan, colchicine;
• carbamazepine and phenobarbital;
• any of the group of medicines known as major tranquilizers, or an antidepressant of the tricyclic group (e.g. imipramine);
• any of the group of medicines known as benzodiazepines or other anti-anxiety treatment (e.g. buspirone, midazolam);
• any of the group of medicines known as non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid);
• anti-cancer medication (e.g. doxorubicin);
• some medication that can affect your immune system (e.g. cyclosporine, sirolimus, tacrolimus);any neuromuscular blocking agent (e.g., atracurium);
• some anti-cholesterol products (e.g., simvastatin, atorvastatin, lovastatin);
• some HIV-antiviral medication (e.g., ritonavir);
• grapefruit juice;
• alcohol;
• St John’s Wort.

PROPER USE OF THIS MEDICATION

Usual dose:

Angina Pectoris (Chest pain): Usual starting dose in adults is 80 mg of NOVO-VERAMIL Tablets 3 to 4 times daily.

Paroxysmal Supraventricular Tachycardias (Irregular heart beat): In adults, use the same dosage schedule as for angina pectoris.

Atrial Fibrillation and Flutter with Rapid Ventricular Response (Irregular heart beat): The same dosage as for angina pectoris can be used.

Obstructive Hypertrophic Cardiomyopathy: Usual starting dose is 80 to 120 mg 3 to 4 times daily.

Mild to Moderate Essential Hypertension (High blood pressure): Dosage must be individualized.

Initial dose for NOVO-VERAMIL is usually 80 mg three times a day.

NOVO-VERAMIL SR should be taken once-a-day at the same time every day. The usual adult dose NOVO-VERAMIL SR is 180 to 240 mg/day.

Take NOVO-VERAMIL & NOVO-VERAMIL SR with food to help it work better.

NOVO-VERAMIL & NOVO-VERAMIL SR tablets should not be divided, crushed or chewed.

Overdose:

If you or someone you know accidentally takes more than stated dose, contact your doctor immediately or go to the nearest hospital with the tablets.

In case of accidental drug overdose, contact a health care practitioner, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. Tell your doctor or hospital how much was taken. Treat even small overdoses seriously.

Missed Dose:

If you forget to take one tablet, take another as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed tablet at all.

Never double-up on a missed dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its needed effects, a medicine may cause some unwanted effects. These are referred to as “side effects”. Although not all of these side effects may occur, if they do occur they may need medical attention.

The most common side effects with NOVO-VERAMIL & NOVO-VERAMIL SR are constipation, dizziness and feeling sick (nausea). Other less common side effects may include headache and tiredness.

Check with your physician or pharmacist if you experience any unexpected effects, or are concerned by the above side effects.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

This is not a complete list of side effects. For any unexpected effects while taking NOVO-VERAMIL & NOVO-VERAMIL SR, contact your doctor or pharmacist.

HOW TO STORE IT

Keep NOVO-VERAMIL & NOVO-VERAMIL SR and all other medicines out of reach of children.

NOVO-VERAMIL & NOVO-VERAMIL SR tablets should be stored between 15°- 30°C and protected from light. Unit Dose strips should be stored between 15°- 25°C, and protected from high humidity and light.

Do not take your tablets after the expiry date shown on the label.

It is important to keep the NOVO-VERAMIL & NOVO-VERAMIL SR tablets in the original package.

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 0701C

  Ottawa, ON K1A 0K9

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

This document plus the full Product Monograph, prepared for health professionals can be obtained by contacting the sponsor, Teva Canada Limited at:

1-800-268-4127 ext. 5005 (English);

1-877-777-9117 (French)

or druginfo@tevacanada.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: May 28, 2013