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Details for: APO-AMLODIPINE

Company: APOTEX INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02273373APO-AMLODIPINEAMLODIPINE (AMLODIPINE BESYLATE)5 MGTABLETORAL
02273381APO-AMLODIPINEAMLODIPINE (AMLODIPINE BESYLATE)10 MGTABLETORAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

APO-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.

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

What it does

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

  • Are allergic to amlodipine (the active ingredient in APO-AMLODIPINE), 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 APO-AMLODIPINE
What the medicinal ingredient is

Amlodipine besylate.

What the non-medicinal ingredients are

APO-AMLODIPINE tablets contain the following non-medicinal ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and starch.

What dosage form it comes in

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

Warnings and precautions

BEFORE you use APO-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. APO-AMLODIPINE should not be used during pregnancy unless your doctor tells you otherwise.
  • Are older than 65 years

APO-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 APO-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.

APO-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 APO-AMLODIPINE 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 while on APO-AMLODIPINE.

Proper use of this medication

Take APO-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 APO-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 to 17 years old):
The recommended dose is 2.5 mg to 5 mg once daily.

Overdose

If you think you have taken too much APOAMLODIPINE 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 and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate 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:Yello wing 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 when you go from lying or sitting to standing up.    
Very rare
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 APOAMLODIPINE, contact your doctor, nurse or pharmacist

How to store

Keep APO-AMLODIPINE out of the reach and sight of children. Store at room temperature (15°C to 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

If you want more information about APOAMLODIPINE:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this patient medication information by visiting the Health Canada website ( https://www.canada.ca/en/healthcanada/services/drugs-healthproducts/drug-products/drug-productdatabase.html); the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.

This leaflet was prepared by Apotex Inc, Toronto, Ontario, M9L 1T9.

Last revised: April 17, 2018

Date modified: