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Amlodipine Besylate Tablets, 5mg: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Current status: Cancelled Pre Market
Strength:
5 mg, 10 mg
ATC code:

Patient Medication Information: uses, side effects, how to take - Amlodipine Besylate Tablets, 5mg

What the medicinal ingredient is:

Amlodipine besylate

What the nonmedicinal ingredients are:

Magnesium stearate and microcrystalline cellulose (Avicel PH 112).

What dosage forms it comes in:

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

WARNINGS AND PRECAUTIONS

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

  • Are older than 65 years.

Amlodipine Besylate 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 Besylate Tablets together with a drug known as betablockers (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 are 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.

ABOUT THIS MEDICATION

What the medication is used for:

Amlodipine Besylate Tablets have 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 can be used by itself or with other medicines to treat these conditions.

What it does:

Amlodipine Besylate Tablets are a type of medicine known as a calcium channel blocker (CCB).

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

Amlodipine Besylate 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 Besylate Tablets if you:

  • Are allergic to amlodipine (the active ingredient in Amlodipine Besylate 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.
  • Experience shock including cardiogenic shock.
  • Are breast-feeding. Do not breast-feed while taking Amlodipine Besylate Tablets.
IMPORTANT: PLEASE READ

Drug-Drug interaction:

Drugs that may interact with Amlodipine Besylate 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 Besylate Tablets.

PROPER USE OF THIS MEDICATION

Take Amlodipine Besylate 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 Besylate 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:

If you think you, or a person you are caring for, have taken too much Amlodipine Besylate Tablets, contact a healthcare professional, 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 and what to do about them

Symptom / effectTalk to your healthcare professionalStop taking drug and get immediate medical help
Only if severeIn all cases
CommonFlushing: Hot or warm feeling in your face√

Edema:

Swelling of your legs or ankles

√
IMPORTANT: PLEASE READ

Serious side effects and what to do about them

Symptom / effectTalk to your healthcare professionalStop taking drug and get immediate medical help
Only if severeIn all cases
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 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

√

Serious side effects and what to do about them

Symptom / effectTalk to your healthcare professionalStop taking drug and get immediate medical help
Only if severeIn all cases
Uncommon

Low Blood

Pressure:

Dizziness, fainting, lightheadedness

May occur when you go from lying or sitting to standing up

√

Extrapyramidal 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, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

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

IMPORTANT: PLEASE READ

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 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

If you want more information about Amlodipine Besylate Tablets:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professional and includes this Consumer Information by visiting Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer's website (www.drreddys.com), or by calling 1-855-845-1739.

Last revised: October 24, 2022

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02339374

Revision date stated in the text: October 24, 2022

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

Drug information for Amlodipine Besylate Tablets, 5mg

Rx or OTC
Prescription (Rx)?
DIN 02339374, 02339382
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 DR. REDDY'S LABORATORIES INC
Current status Cancelled Pre Market
Current status date June 27, 2023
Strengths and forms
DIN Strength Dosage form(s) Current status
02339374 5 MG Tablet Cancelled Pre Market June 27, 2023
02339382 10 MG Tablet Cancelled Pre Market June 27, 2023

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.