Patient Medication Information: uses, side effects, how to take - Amlodipine Besylate

ABOUT THIS MEDICATION

What the medication is used for:

Amlodipine Besylate Tablets USP has been prescribed to you for:

The treatment of high blood pressure (hypertension), or
The management of a type of chest pain called angina. Amlodipine Besylate Tablets USP can be used by itself or with other medicines to treat these conditions.

What it does:

Amlodipine besylate is a type of medicine known as a calcium channel blocker (CCB).

Amlodipine besylate relaxes your blood vessels, which lets your blood flow more easily and helps lower your blood pressure.

Amlodipine besylate controls chest pain by improving the supply of blood and oxygen to the heart and by reducing its workload.

When it should not be used:

Do not use Amlodipine Besylate Tablets USP if you:

Are allergic to amlodipine (the active ingredient in
Amlodipine Besylate Tablets USP), or to the inactive ingredients listed under “What the nonmedicinal ingredients are” below.
Have ever had an allergic reaction to a similar type
of drug.
Have very low blood pressure (less than 90 mmHg
systolic).
Are breast-feeding. Do NOT breast-feed while taking
Amlodipine Besylate Tablets USP.

What the medicinal ingredient is:

Amlodipine besylate

What the nonmedicinal ingredients are:

Magnesium stearate, microcrystalline cellulose, sodium starch glycolate and trisodium citrate.

What dosage forms it comes in:

Tablets 2.5 mg, 5 mg and 10 mg amlodipine (as amlodipine besylate).

WARNINGS AND PRECAUTIONS

BEFORE you use Amlodipine Besylate Tablets USP talk to your doctor, nurse or pharmacist if you:

Ever had heart or blood vessel diseases.
Have aortic stenosis (narrowing of a valve of your heart).
Have liver or kidney problems.
Are pregnant, or plan to become pregnant.
Amlodipine Besylate Tablets USP should not be used during pregnancy unless your doctor tells you otherwise.
Are older than 65 years.

Amlodipine besylate may occasionally cause low blood pressure (hypotension). Your blood pressure should be carefully monitored, especially if you have had a stroke or take other drugs to lower your blood pressure.

If you take Amlodipine Besylate Tablets USP together with a drug known as beta-blockers (e.g. acebutolol, atenolol, metoprolol, nadolol), do not suddenly stop using the beta-blocker. If your doctor advises you to discontinue use of the beta-blocker, your dose should be decreased slowly, as recommended by your doctor, before stopping it completely.

Amlodipine Besylate Tablets USP is not recommended for use in children less than 6 years of age.

INTERACTIONS WITH THIS MEDICATION

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines. Also, mention if you drink alcoholic beverages.

Drug-Drug interaction:

Drugs that may interact with amlodipine besylate include:

Cyclosporin
Clarithromycin, Erythromycin (antibiotics)
Diltiazem
Azole antifungals (e.g. ketoconazole, itraconazole)
HIV protease inhibitors (e.g. ritonavir)
Beta-blockers
Sildenafil (VIAGRA)
Statin drugs used to treat high cholesterol (e.g.
Simvastatin, Atorvastatin)
Tacrolimus (an anti-rejection drug)
Sirolimus, temsirolimus, everolimus

Drug-Herb interaction:

St-John Wort

Drug-Food interaction:

Do not eat grapefruit or drink grapefruit juice

IMPORTANT: PLEASE READ

while on Amlodipine Besylate Tablets USP.

PROPER USE OF THIS MEDICATION

Take Amlodipine Besylate Tablets USP exactly as prescribed by your doctor, nurse or pharmacist. It may be easier to take your dose if you do it at the same time every day, such as with breakfast or dinner, or at bedtime. Do not stop taking your medication without having first informed your doctor.

Usual dose:

For both high blood pressure and chest pain, the recommended initial dose of Amlodipine Besylate Tablets USP is 5 mg once daily. If necessary, your doctor may increase your dose to a maximum dose of 10 mg once daily.

Use in Patients with liver disease:

The starting dose is 2.5 mg once daily and can be gradually increased by your doctor.

Use in Children (6-17 years old):

The recommended dose is 2.5 mg to 5 mg once daily.

Overdose:

If you think you have taken too much Amlodipine Besylate Tablets USP contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison control Centre immediately, even if there are no symptoms.

One or more of the following signs may occur in an overdose: Low blood pressure and rapid heartbeat.

Missed Dose:

If you miss a dose, take it as soon as you remember. If it has been more than 12 hours since you missed your last dose, skip the missed dose and continue with the next dose at your regular time. Do not take double doses.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects include:

Headaches
Tiredness, extreme sleepiness
Stomach pain, nausea
Dizziness

If any of these affects you severely, tell your doctor, nurse or pharmacist.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY
HAPPEN AND WHAT TO DO ABOUT THEM
Symptoms / Effects		Talk with your Doctor, nurse or pharmacist		Stop taking drug and seek immediate emergency medical help
Symptoms / Effects		Only if severe	In all cases	Stop taking drug and seek immediate emergency medical help
Common	Flushing: Hot or warm feeling in your face	√
Common	Edema: Swelling of your legs or ankles	√
Uncommon	Arrhythmia: Rapid, slow or irregular heartbeat		√
	Increased frequency, severity, duration of angina: pressing or squeezing pain in your chest) or heart attack		√
	Heart Attack: Pain, fullness and/or squeezing of the chest, jaw pain and/or arm pain, shortness of breath			√
	Liver Disorder: Yellowing of the skin or eye, dark urine, abdominal pain nausea, vomiting, loss of appetite		√
	Allergic Reactions: rash, hives, swelling of the face, lips, tongue or throat, difficulty breathing or swallowing			√
	Low Blood Pressure: Dizziness, fainting, lightheadednes s May occur	√

IMPORTANT: PLEASE READ

SERIOUS SIDE EFFECTS, HOW OFTEN THEY
HAPPEN AND WHAT TO DO ABOUT THEM
Symptoms / Effects		Talk with your Doctor, nurse or pharmacist		Stop taking drug and seek immediate emergency medical help
Symptoms / Effects		Only if severe	In all cases	Stop taking drug and seek immediate emergency medical help
	when you go from lying or sitting to standing up
Unknown	Extrapyramid al symptoms: Muscle stiffness, body spasms, upward eye rolling, exaggeration of reflexes, drooling, difficulty moving how and when you want.			√

This is not a complete list of side effects. For any unexpected effects while taking Amlodipine Besylate Tablets USP, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

Keep Amlodipine Besylate Tablets USP out of the reach and sight of children. Store Amlodipine Besylate Tablets USP at room temperature (between 15-30ºC). Protect Amlodipine Besylate Tablets USP from light.

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.

MORE INFORMATION

Last revised: August 12, 2020

J4P 1X2

Saint-Lambert, Quebec

40 rue Prince-Arthur, Suite 310 Nora Pharma Inc.

•

Find the full product monograph that is prepared

•

Talk to your healthcare professional

Tablets USP:

Amlodipine Besylate: Uses, Side Effects and Dosage