Consumer Information for: DOM-AMLODIPINE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Dom-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.
Dom-AMLODIPINE can be used by itself or with other medicines to treat these conditions.
What it does

Dom-AMLODIPINE is a type of medicine known as a calcium channel blocker (CCB).
Dom-AMLODIPINE relaxes your blood vessels, which lets your blood flow more easily and helps lower your blood pressure.
Dom-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 Dom-AMLODIPINE if:

  • Are allergic to amlodipine (the active ingredient in Dom- 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).
  • Are breast-feeding. Do not breast-feed while taking Dom- AMLODIPINE.
What the medicinal ingredient is

Amlodipine besylate

What the non-medicinal ingredients are

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

What dosage form it comes in

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

Warnings and precautions

BEFORE you use Dom-AMLODIPINE talk to your doctor or pharmacist if:

  • 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. Dom-AMLODIPINE should not be used during pregnancy unless your doctor tells you otherwise.
  • Are breast-feeding. Do not breast-feed while taking Dom- AMLODIPINE.
  • Are older than 65 years.

Dom-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 Dom-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.

Dom-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 Dom-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)
  • Sirolimus, temsirolimus, everolimus

Drug-Herb interaction:

  • St-John Wort

Drug-Food interaction

Do not eat grapefruit or drink grapefruit juice while on DomAMLODIPINE.

Proper use of this medication

Take Dom-AMLODIPINE exactly as prescribed by your physician. 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 Dom-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

In case of drug overdose, contact a health care practitioner, 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:

  • 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
Symptom / effect Talk with your doctor, nurse, or pharmacist Only if severe Talk with your doctor, nurse, or pharmacist In all cases Stop taking drug and seek immediate emergency medical help
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 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, lightheadedness, may occur when you go from lying or sitting to standing up ✔    
Unknown
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 Dom-AMLODIPINE, contact your doctor or pharmacist

How to store

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

Store Dom-AMLODIPINE tablets at room temperature (between 15 and 30°C). Protect from light.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

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 Dominion Pharmacal at 1-888-550-6060.

This leaflet was prepared by:
        Dominion Pharmacal
        Montreal, Quebec
        H4P 2T4

Last revised: June 6, 2018

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