Manda-Amlodipine Tablets: Uses, Side Effects and Dosage

What the medication is used for:

Manda- 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.

Manda- Amlodipine can be used by itself or with other medicines to treat these conditions.

What it does:

Manda- Amlodipine is a type of medicine known as a calcium channel blocker (CCB).

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

Manda- 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 Manda- Amlodipine if:

• You are allergic to amlodipine (the active

  ingredient in Manda- 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 nonmedicinal ingredients are:

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

What dosage forms it comes in:

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

WARNINS AND PRECAUTIONS

BEFORE you use Manda- 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.

• Manda- Amlodipine should not be used during pregnancy unless your doctor tells you otherwise.
• You are breast-feeding. Do not breast-feed while taking Manda- Amlodipine.
• You are older than 65 years.

Manda- 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 Manda- Amlodipine 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.

Manda- 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 Manda- 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 Manda- Amlodipine.

PROPER USE OF THIS MEDICATION

Take Manda- 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 Manda- Amlodipine is 5 mg once daily. If necessary, your doctor may increase your dose to a maximum dose of 10 mg once daily.

IMPORTANT: PLEASE READ

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 Manda-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 Manda-Amlodipine, contact your doctor or pharmacist.

HOW TO STORE IT

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

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

------------------------------------------------------------

• Report online at

  www.healthcanada.gc.ca/medeffect

• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting

  Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701D

    Ottawa, Ontario

    K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at

www.healthcanada.gc.ca/medeffect .

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

Manda-Amlodipine are manufactured by Manda Pharma Inc.,

Date of Preparation: August 11, 2011.