Ava-Amlodipine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

AVA-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.

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

What it does:

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

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

AVA-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 AVA-AMLODIPINE if:

• You are allergic to amlodipine (the active

  ingredient in AVA-AMLODIPINE), or to the inactive ingredients listed under “What the nonmedicinal ingredients are” below.

• You have ever had an allergic reaction to a

  similar type of drug.

• You have very low blood pressure (less than 90

  mmHg systolic).

What the medicinal ingredient is:

Amlodipine besylate.

What the non-medicinal ingredients are: AVA-AMLODIPINE tablets contain the following non-medicinal ingredients: microcrystalline cellulose, starch and magnesium stearate.

What dosage form it comes in:

AVA-AMLODIPINE, 5 mg and 10 mg is available in bottles of 100 tablets.

WARNINGS AND PRECAUTIONS

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

• You ever had heart or blood vessel diseases.
• You have aortic stenosis (narrowing of a valve of your heart).
• You have liver or kidney problems.
• You have very low blood pressure (less than 90 mmHg systolic).

• You are pregnant, or plan to become pregnant.

  AVA-AMLODIPINE should not be used during pregnancy unless your doctor tells you otherwise.

• You are breast-feeding. Do not breast-feed while taking AVA-AMLODIPINE.
• You are older than 65 years.

AVA-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 AVA-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.

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

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacists about all drugs you are taking including prescription, non-prescription medicines and natural or herbal remedies. Also mention if you drink alcoholic beverages or use drugs.

Drugs that may interact with AVA-AMLODIPINE include:

• Erythromycin, an antibiotic
• Diltiazem

• Azole antifungals (e.g. ketoconazole,

  itraconazole)

• HIV protease inhibitors (e.g. ritonavir)
• St John's wort
• Beta-blockers
• Sildenafil (VIAGRA)

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

PROPER USE OF THIS MEDICATION

Take AVA-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:I

For both high blood pressure and chest pain, the recommended initial dose of AVA-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

Along with its intended action, any medication may cause undesirable effects. The most common side effects of AVA-AMLODIPINE include swelling (edema) and headaches.

However, check with your doctor or pharmacist promptly if any of the following persist or become troublesome:

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

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

HOW TO STORE IT

Store at room temperature (15°-30°F). Protect from light.

Reporting Suspected Side Effects

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

For more information, please contact your doctor, pharmacist or other healthcare professional.

This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Avanstra Inc. at:

1-855-708-3678 or medinfo@avanstra.com

Last revised: October 5, 2011

Avanstra Inc.

Calgary, Alberta

T3N 0A4

medinfo@avanstra.com

www.avanstra.com