Zym-Amlodipine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Zym-AMLODIPINE has been prescribed to you for the treatment of mild to moderate essential hypertension (high blood pressure) or for the management of chronic stable angina (chest pain).

What it does:

Zym-AMLODOPINE relaxes the blood vessels that carry blood away from the heart and increases the supply of blood and oxygen to the heart, while reducing its workload.

When it should not be used:

You should not use Zym-AMLODIPINE if you:

C are hypersensitive to this drug or other

dihydropyridines, or to any ingredient in the formulation or component of the container (consult list of non-medicinal ingredients). C have a low blood pressure (less than 90 mmHg

systolic).

What the medicinal ingredient is:

Amlodipine Besylate

What the nonmedicinal ingredients are:

Dibasic calcium phosphate anhydrous, Magnesium stearate, Microcrystalline Cellulose and Sodium starch glycolate.

What dosage forms it comes in:

Tablets: 5 mg & 10 mg amlodipine (from amlodipine besylate)

WARNINGS AND PRECAUTIONS

BEFORE you use Zym-AMLODIPINE, talk to your doctor or pharmacist if you / the patient you are caring for:

• have/has a history of stroke, mini-strokes or high cholesterol;
• have/has a history of kidney or liver problems;
• have/has a history of problems with your heart and/or blood vessels;

• are/is pregnant or planning to become pregnant;

• are/is breast-feeding;
• are taking or planning to take any other medicines (prescription, over-the-counter medicines or herbal remedies);

• drink/drinks alcoholic beverages or use/uses drugs.

Beta-blocker withdrawal:

Zym-AMLODIPINE should be discontinued gradually by slowly reducing the dose of the drug.

Use in Children: The use of Zym-AMLODIPINE is not recommended in children less than 6 years of age.

Use in the elderly: Adverse reactions include swelling, muscle cramps and dizziness. Zym-AMLODIPINE should be used cautiously in elderly patients.

INTERACTIONS WITH THIS MEDICATION

If you are taking any medication, prescription, non-prescription and/or herbal, please inform your doctor before starting treatment with this medicine. Concomittant use of Zym-AMLODIPINE with other drugs may require surveillance and dosage adjustments.

Taking amlodipine with other drugs which are eliminated by the body through the same mechanism may result in altered bioavailability of amlodipine or these drugs. Dosages of similarly metabolized drugs, and especially in patients with renal and/or hepatic impairment, may require adjustment when starting or stopping medication.

Medications known or susceptible to interact with this medication include: azole antifungals, cimetidine, cyclosporine, erythromycin, quinidine, terfenadine, warfarin, Phenobarbital, phenytoin, rifampin, benzodiazepines, flecainide, imipramine, propafenone and theophylline.

When beta-adrenergic receptor blocking drugs are administered concomitantly with amlodipine, patients should be carefully monitored since blood pressure lowering effect of beta-blockers may be augmented by amlodipine.

PROPER USE OF THIS MEDICATION

Take this medication exactly as prescribed by your physician. Do not stop taking your medication without having first informed your doctor.

The dose of Zym-AMLODIPINE will be different for different patients. Do not give it to anybody else, even if their condition seems similar to yours, as they may experience undesirable effects, which may be serious.

For both high blood pressure and chest pain, the initial dose of Zym-AMLODIPINE is 5 mg once daily. If necessary, the dose can be increased after 1-2 weeks to a maximum dose of 10 mg once daily.

Use in the Elderly or in Patients with Impaired Renal Function

The recommended initial dose in patients over 65 years of age or patients with impaired renal function is 5 mg once daily. If required, increasing in the dose should be done gradually and with caution (see WARNING AND PRECAUTIONS).

Use in Patients with Impaired Hepatic Function When Zym-AMLODIPINE is used in these patients, the dosage should be carefully and gradually adjusted depending on patients tolerance and response. A lower starting dose of 2.5 mg once daily should be considered (see WARNINGS AND PRECAUTIONS).

Use in Children

The effective antihypertensive oral dose in pediatric patients ages 6-17 years is 2.5 mg to 5 mg once daily.

Overdose

If you take / give too much, immediately contact the doctor or go / take the patient to the nearest hospital emergency department, Do this even if there are no signs of discomfort.

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, try not to miss any more. DO NOT TAKE / GIVE TWO DOSES AT ONCE.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The most common side effects of Zym-AMLODIPINE are: edema (swelling), headache, fatigue, dizziness and nausea.

This is not a complete list of side effects. If you have any unexpected effects while taking this drug, contact your doctor or pharmacist.

REPORTING SIDE EFFECTS

HOW TO STORE IT

• Do not use this product after the expiry date written on the package.
• Store between 15-30°C, protected from light.
• Keep this and all medicines in a safe place away from children.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting Zymcan Pharmaceuticals Inc.:

By post: Zymcan Pharmaceuticals Inc. 6111 avenue Royalmount, #100 Montreal, QC H4P 2T4

Zymcan Pharmaceuticals Inc.

Date of Preparation: April 1, 2010.