Patient Medication Information: uses, side effects, how to take - AA-Verap

What are AA-VERAP Tablets used for?

AA-VERAP tablets are used to treat:

Chest pain (angina);
Swelling of the heart muscles (obstructive hypertrophic cardiomyopathy);
Irregular and rapid heart rate (atrial fibrillation or flutter);
Abnormal heart rhythms (paroxysmal supraventricular tachycardia), as a follow-up treatment to injectable verapamil;
High blood pressure (hypertension).

How does AA-VERAP work?

Verapamil hydrochloride belongs to a group of medicines called calcium channel blockers. Calcium channel blockers change the amount of calcium getting into the muscle cells in your heart and blood vessels. This can change the strength and speed with which your heart beats. It also opens up the blood vessels so blood can be pumped around the body more easily. This helps more oxygen to get to your heart muscle and can lower your blood pressure.

What are the ingredients in AA-VERAP?

Medicinal ingredients: Verapamil hydrochloride

Non-medicinal ingredients: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake 14-18% and FD&C yellow #6 aluminum lake (in 80 mg tablet only), hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide

AA-VERAP comes in the following dosage forms:

Tablets: 80 mg and 120 mg

Do not use AA-VERAP if:

you are allergic to verapamil hydrochloride or any of the other ingredients of this medicine.
you have recently had a severe heart attack.
you have severe heart failure.
you have low blood pressure (hypotension).
You have severe problems with the impulses and rhythms of the heart (second or third degree atrioventricular block or sick sinus syndrome).
you suffer from a slow heart rate (bradycardia).
you have an irregular or rapid heartbeat (atrial fibrillation/flutter).
you have an electrical abnormality of the heart causing periods of very fast heartbeat (Wolff-Parkinson-White syndrome, Lown-Ganong-Levine syndrome).
you are breastfeeding.
you are taking ivabradine, flibanserin or beta-blockers.
you drink grapefruit juice.

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

have angina or arrhythmia (irregular heartbeat) and taking other medicines for high blood pressure.
have ever suffered from heart failure or heart attack.
are taking beta blockers.
have obstructive hypertrophic cardiomyopathy (swelling of the heart muscles).
have a disorder that weakens your muscles (such as Myasthenia gravis, Lambert-Eaton syndrome or Duchenne’s muscular dystrophy).
have impaired liver function.
have impaired kidney function.
have low levels of calcium in your blood.
have neuro-muscular disease (i.e. Duchenne’s muscular dystrophy).
are pregnant or planning to become pregnant.
are breast feeding or planning to breastfeed. AA-VERAP can transfer to your baby through breastmilk. You should stop breastfeeding while taking AA-VERAP.

Other warnings you should know about:

Laboratory Testing: Your doctor may order tests to help monitor your liver while you take AA-VERAP.

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

Serious drug interactions

Serious drug interactions with AA-VERAP include:

ivabradine, a medicine used to treat chronic heart failure by lowering the heart rate. Do not take AA-VERAP if you are taking ivabradine.
flibanserin, a medicine used to treat a condition known as hypoactive sexual desire disorder (HSDD) in women. Do not take AA-VERAP if you are taking or have recent taken (within 2 days) discontinuing flibanserin. In addition, if you plan to start taking flibanserin, you must wait at least 2 weeks after your last dose of AA-VERAP.

The following may also interact with AA-VERAP:

Anti-cancer drugs used to treat cancer.
Aspirin used to relieve pain and reduce fever or to prevent blood clots.
Apixaban, edoxaban, rivaroxaban used to prevent blood clots.
Atorvastatin, lovastatin, simvastatin used to reduce the risk of heart attack.
Azole antifungals used to treat fungal infections.
Beta blockers or other drugs used to treat high blood pressure.
Cimetidine used to treat stomach ulcers.
Clarithromycin, erthromycin, telithromycin used to treat infections.
Colchicine used to treat gout.
Cyclosporine used to prevent organ transplant rejection.
Dabigatran used to treat blood clots and prevent stroke.
Digoxin used to treat heart failure.
Disopyramide, flecainide and quinidine used to treat abnormal heart rhythm.
Erythromycin, rifampin used to treat infections.
Everolimus, sirolimus, tacrolimus used to prevent organ transplant rejection.
Terfenadine used for the treatment of allergic conditions.
Inhalation anaesthetics used for general anaesthesia.
Imipramine used to treat depression.
Lithium used to treat depression.
Phenytoin, carbamazepine and phenobarbital used to treat convulsions or seizures.
Metformin used to treat diabetes.
Neuromuscular blocking agents such as vecuronium used to relax the muscles.
NSAIDS (Acetylsalicylic acid) used to treat pain and inflammation.
Rifampin used to treat infections.
Sulfinpyrazone used to treat gout.
Theophylline used to treat asthma.
Warfarin used to prevent the formation of blood clots.

Grapefruit juice can increase the amount of AA-VERAP in your blood. Do not drink grapefruit juice while taking AA-VERAP.

Drinking alcohol while taking AA-VERAP may cause the effects of alcohol to last longer. Do not drive a vehicle or operate heavy machinery if your ability to react is impaired.

How to take AA-VERAP:

Follow the directions given to you by your healthcare professional. Your healthcare professional will decide your dose based on your current condition and health.
Take AA-VERAP tablets by mouth.
AA-VERAP tablets should be taken with food.
Swallow the tablets whole with water, without chewing or crushing them.

Usual dose:

Angina Pectoris and Atrial fibrillation:

The usual starting dose of AA-VERAP Tablets in adults is 80 mg 3 to 4 times daily. Your healthcare professional may increase the dose to 120 mg 3 to 4 times daily based on your health condition.
The maximum dose should not exceed 480 mg per day.

Obstructive Hypertrophic Cardiomyopathy:

The usual starting dose is 80 to 120 mg 3 to 4 times daily. If required, your healthcare professional may increase dose up to 600-720 mg/day.

Mild to Moderate Essential Hypertension

Your healthcare professional will adjust your dosage based on how you respond to AA-VERAP.
The usual initial adult dose is 80 mg 3 times per day. The maximum dose should not exceed 480 mg per day.

Overdose:

If you think you, or a person you are caring for, have taken too much AA-VERAP, 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 forget to take a dose, take it as soon as you remember. If it is nearly time for the next dose, skip the missed dose and take the next dose at the right time. Do NOT take a double dose to make up for a forgotten dose.

What are possible side effects from using AA-VERAP?

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

Side Effects Include:

bruising
claudication (pain in your thigh, calf, or buttocks that happens when you walk)
confusion, dizziness, feeling like you are going to fall
constipation
diarrhea
dry mouth
flushing (reddening of the skin)
frequent urination
gynecomastia (enlargement of breast in men)
hair loss
hyperkeratosis (thickening of skin)
hyperkinesis (a state of overactive restlessness)
impotence
macules (a flat, distinct, discolored area of skin less than a centimeter wide)
muscle cramps or fatigue
numbness of arms or legs
oligomenorrhea (infrequent menstrual periods)
pain or discomfort in the stomach
paresthesia (pins and needles)
purpura (purple-colored spots and patches that occur on the skin)
painful coldness
rotary nystagmus (involuntary, rapid, and repetitive movement of the eyes)
sleepiness
sleeping difficulties
shakiness
spotty menstruation
sweating
swelling of the gums
vertigo (sudden dizziness)
vomiting

Serious side effects and what to do about them

Serious side effects and what to do about them
Symptom / effect	Talk to your healthcare professional	Stop taking drug and get immediate medical help
Symptom / effect	Talk to your healthcare professional	Stop taking drug and get immediate medical help
Only if severe	In all cases
Only if severe	In all cases
COMMON
Atrial fibrillation / Rapid Ventricular Response (abnormal heart rhythm which is rapid and irregular): chest discomfort with unpleasant awareness of your heartbeat, fainting, shortness of breath, weakness			√
A-V Block (Heart Block): Fainting, dizziness, chest pain, feeling tired, shortness of breath, heart palpitations, rapid breading, nausea.			√
Heart failure (heart does not pump blood as well as it should): shortness of breath, fatigue and weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise			√
Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up)			√
Pulmonary edema (excess fluid in the lungs): difficulty breathing that worsens with activity or when lying down, extreme shortness of breath, wheezing or gasping for breath, cold clammy skin, irregular heartbeat, cough that produces frothy sputum, blue-tinged lips			√
UNCOMMON
Angina pectoris (chest pain or discomfort due to coronary heart disease)			√
Stroke (bleeding or blood clot in the brain): sudden numbness, weakness or tingling of the face, arm, or leg, particularly on one side of the body, sudden headache, blurry vision, difficulty swallowing or speaking, or lethargy, dizziness, fainting, vomiting, trouble understanding, trouble with walking and loss of balance			√
Psychotic symptoms (mental illness): depression		√
Stevens-Johnson syndrome (SJS) (severe skin rash): redness, blistering and/or peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands			√
Jaundice (build up of bilirubin in the blood): yellowing of the skin and eyes, dark urine, light coloured stool, itching all over your body		√
RARE
Allergic Reaction: difficulty swallowing or breathing, wheezing, nausea, vomiting, hives or rash, swelling of the face, lips, tongue or throat.			√

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

Storage:

Store at controlled room temperature (15°C-30°C).

Protect from light.

Keep out of reach and sight of children.

If you want more information about AA-VERAP:

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://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html). Find the Patient Medication Information on the manufacturer’s website (https://www.aapharma.ca/en/), or by calling 1-877-998-9097.

AA-Verap: Uses, Side Effects and Dosage