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Amlodipine Tablets (Nora Pharma): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Current status: Cancelled Post Market
Strength:
2.5 mg, 5 mg, 10 mg
Active ingredient:
ATC code:
Similar drugs:

Source: Health Canada – Drug Product Database (DPD) and product monographs · About this document

Patient Medication Information: uses, side effects, how to take - Amlodipine Tablets (Nora Pharma)

What the medicinal ingredient is:

Amlodipine (as Amlodipine Besylate)

What the nonmedicinal ingredients are:

Colloidal silicon dioxide, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

What dosage forms it comes in:

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

What the medication is used for:

AMLODIPINE Tablets 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 Tablets can be used by itself or with other medicines to treat these conditions.

What it does:

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

AMLODIPINE Tablets relaxes your blood vessels, which lets your blood flow more easily and helps lower your blood pressure.

AMLODIPINE Tablets 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 Tablets if you:

  • Are allergic to amlodipine (the active ingredient in

    AMLODIPINE Tablets), 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).

  • Have been diagnosed with aortic stenosis

    (narrowing of the aortic heart valve).

  • Have been diagnosed with unstable heart failure

    after a heart attack.

    BEFORE you use AMLODIPINE Tablets 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 Tablets should not be used during pregnancy unless your doctor tells you otherwise.

    • Are older than 65 years.

AMLODIPINE Tablets 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 Tablets 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 Tablets is not recommended for use in children less than 6 years of age.

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

ABOUT THIS MEDICATION WARNINGS AND PRECAUTIONS

INTERACTIONS WITH THIS MEDICATION

Drug-Drug interaction:

Drugs that may interact with AMLODIPINE Tablets 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
  • Dantrolene

Drug-Herb interaction:

St-John Wort

Drug-Food interaction:

Do not eat grapefruit or drink grapefruit juice while on AMLODIPINE Tablets.

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 include:

  • Headaches
  • Tiredness, extreme sleepiness
  • Stomach pain, nausea
  • Dizziness

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

Take AMLODIPINE Tablets 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 Tablets 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:

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

PROPER USE OF THIS MEDICATION

If you think you, or a person you are caring for, have taken too much AMLODIPINE Tablets contact a health care professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN
AND WHAT TO DO ABOUT THEM
Symptom / effectTalk with your doctor, nurse or pharmacistStop taking drug and seek immediate medical help.
Only if severeIn all cases
Common

Flushing: Hot or warm

feeling in your face

✓

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

✓

Heart

Attack: Pain, fullness

and/or

squeezing of the chest, jaw

✓

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

Keep AMLODIPINE Tablets out of the reach and sight of children. Store AMLODIPINE Tablets at room temperature (between 15-300C). Protect AMLODIPINE Tablets from light.

HOW TO STORE IT

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: 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

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN
AND WHAT TO DO ABOUT THEM
Symptom / effectTalk with your doctor, nurse or pharmacist

Stop

taking

drug and seek

immediate medical help.

Only if

severe

In all cases
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,

lightheadedne ss May occur when you go from lying or sitting to

standing up

✓
Unknown

Extrapyrami dal

symptoms:

Muscle

stiffness, body spasms,

upward eye rolling,

exaggeration of reflexes, drooling,

difficulty

moving how and when you want.

✓

If you want more information about AMLODIPINE Tablets:

  • 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://www.canada.ca/en/health- canada/services/drugs-health-products/drug- products/drug-product-database.html); or by contacting

    Nora Pharma Inc.

    40 Prince-Arthur, Suite 310

    Saint-Lambert, Quebec

    J4P 1X2

Last revised: April 7, 2022

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02444445

Revision date stated in the text: April 7, 2022

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Amlodipine Tablets (Nora Pharma)

Rx or OTC
Prescription (Rx)?
DIN 02444445, 02444453, 02444461
Schedule(s) PRESCRIPTION
Active ingredient(s) Amlodipine (amlodipine besylate)
Dosage form(s) Tablet
Route(s) of administration Oral
Drug class (WHO ATC)
  1. C Cardiovascular system drugs
    1. C08 Calcium channel blockers
      1. C08C Selective calcium channel blockers with mainly vascular effects
        1. C08CA Dihydropyridine derivative selective calcium channel blockers with mainly vascular effects
          1. C08CA01 Amlodipine
Company NORA PHARMA INC
Current status Cancelled Post Market
Current status date July 25, 2022
Strengths and forms
DIN Strength Dosage form(s) Current status
02444445 2.5 MG Tablet Cancelled Post Market July 25, 2022
02444453 5 MG Tablet Cancelled Post Market July 25, 2022
02444461 10 MG Tablet Cancelled Post Market July 25, 2022

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.