Apo-Verap SR: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• APO-VERAP SR is used to treat hypertension (high

  blood pressure).

What it does:

APO-VERAP SR 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:

APO-VERAP SR should not be used if:

• you are allergic to any component of APO-VERAP 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.

• you are taking ivabradine, a drug that lowers your heart rate.

• you are taking flibanserin, a medicine to treat generalized

  hypoactive sexual desire disorder. You must wait at least 2 weeks after your last dose of APO-VERAP SR before starting flibanserin. You must wait at least 2 days after your last dose of flibanserin before starting APO-VERAP SR.

Ask your doctor for advice.

What the medicinal ingredient is:

APO-VERAP SR contains verapamil hydrochloride.

What the non-medicinal ingredients are:

carnauba wax, colloidal silicon dioxide, hydroxyethyl

cellulose, magnesium stearate, polyethylene glycol, sodium alginate, and titanium dioxide. The 180 mg tablet also contains the non-medicinal ingredient ferric oxide red. The 240 mg tablet also contains the non-medicinal ingredients brilliant blue FCF AL Lake and ferric oxide yellow.

For a full listing of non-medicinal ingredients see PART I of the Product Monograph.

What dosage forms it comes in:

APO-VERAP SR is available as sustained-release tablets in the following strengths: 120 mg, 180 mg, 240 mg.

WARNINGS AND PRECAUTIONS

BEFORE you use APO-VERAP 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 INTERACTIONS WITH THIS MEDICATIO Drugs that may interact with APO-VERAP 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);

• dabigatran rivaroxaban, apixaban, and edoxaban ( blood thinner);
• digoxin, digitoxin, cimetidine, lithium, rifampicin, theophylline, sulfinpyrazone, clarithromycin, erythromycin, telithromycin, glyburide, almotriptan, colchicine;
• carbamazepine, phenobarbital, phenytoin;

• 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, everolimus);

• 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.
• ivabradine (a drug that lowers your heart rate).

PROPER USE OF THIS MEDICATION

Usual dose:

Always take your tablets exactly as your doctor has told you. The usual starting adult dose for APO-VERAP SR is 180 to 240 mg per day, taken at the same time every day. Dosage is individualized and your doctor will adjust your dose as needed. The maximum dose to treat high blood pressure is 480 mg each day. This is usually taken as one APO-VERAP SR 240 mg tablet in the morning and one in the evening, leaving a gap of about 12 hours between each dose.

Tablets should be taken with sufficient liquid, preferably with or shortly after meals. Do not crush or chew the tablets.

The APO-VERAP SR 180 mg and 240 mg tablets are scored. Only the 240 mg tablets may be cut in half without damaging the modified release formulation.

Overdose:

If you think you have taken too much APO-VERAP SR, contact your healthcare professional, hospital emergency department or regional Poison Control Centre

immediately, even if there are no symptoms.

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 APO-VERAP 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.

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

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

  (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.

STORAGE

Keep APO-VERAP SR and all other medicines out of reach of children.

APO-VERAP SR tablets should be stored at 15°C to 30°C. Protect from light.

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

It is important to keep the APO-VERAP SR tablets in the original package.

MORE INFORMATION

If you want more information about APO-VERAP SR :

• 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). Find the Consumer Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.

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Date of Revision: September 3, 2020