PHL-Amlodipine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

phl-AMLODIPINE has been prescribed to you for:

• The treatment of high blood pressure (hypertension), or
• The management of a type of chest pain called angina. phl-AMLODIPINE can be used by itself or with other medicines to treat these conditions.

What it does:

phl-AMLODIPINE is a type of medicine known as a calcium channel blocker (CCB).

phl-AMLODIPINE relaxes your blood vessels, which lets your blood flow more easily and helps lower your blood pressure. phl-AMLODIPINE 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 phl-AMLODIPINE if you:

• Are allergic to amlodipine (the active ingredient in phl-

  AMLODIPINE), or to the inactive ingredients listed under “What the non medicinal 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).

What the medicinal ingredient is:

Amlodipine besylate

What the non medicinal ingredients are:

Dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

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 phl-AMLODIPINE 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.

  phl-AMLODIPINE should not be used during pregnancy

  unless your doctor tells you otherwise.

  • Are breast-feeding. Do not breast-feed while taking phl-

    AMLODIPINE.

  • Are older than 65 years.

phl-AMLODIPINE 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 phl-AMLODIPINE 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.

phl-AMLODIPINE 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 phl-AMLODIPINE include:

• Cyclosporin
• Clarithromycin, erythromycin (antibiotics)
• Diltiazem
• Azole antifungals (e.g. ketoconazole, itraconazole)
• HIV protease inhibitors (e.g. ritonavir)
• Beta-blockers
• Sildenafil

• Statin drugs used to treat high cholesterol (e.g. Simvastatin,

  Atorvastatin)

• Tacrolimus (an anti-rejection drug)

Drug-Herb interaction:

• St-John Wort

Drug-Food interaction:

Do not eat grapefruit or drink grapefruit juice while on phl-AMLODIPINE.

PROPER USE OF THIS MEDICATION

Take phl-AMLODIPINE 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 phl-AMLODIPINE 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 phl-AMLODIPINE 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.

This is not a complete list of side effects. For any unexpected effects while taking phl-AMLODIPINE, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

Store between 15^oC and 30^oC. Protect from light.

Keep phl-AMLODIPINE out of the reach and sight of children.

REPORTING SUSPECTED SIDE EFFECTS

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report:

• Online at MedEffect;
• By calling 1-866-234-2345 (toll-free);

• By completing a Consumer Side Effect Reporting

  Form and sending it by:

  -Fax to 1-866-678-6789 (toll-free), or -Mail to: Canada Vigilance Program Health Canada, Postal Locator 0701E Ottawa, ON

  K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

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

This document plus the full product monograph, prepared for health professionals can be obtained by contacting Pharmel Inc. at 1-888-550-6060.

Pharmel Inc.

Montréal, Québec

H4P 2T4

Last revised: March 21, 2016