Consumer Information for: SEPTA-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

Septa-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.

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

What it does

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

  • You are allergic to amlodipine (the active ingredient in amlodipine besylate tablets), 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

Microcrystalline cellulose, sodium starch glycolate type A, sodium acid citrate, croscarmellose sodium, crospovidone and magnesium stearate.

What dosage form it comes in

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

Warnings and precautions

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

Septa-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 Septa- 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.

Septa-Amlodipine tablets are 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.

Drug-Drug interaction:

Drugs that may interact with Septa-Amlodipine include:

  • Cyclosporin
  • Erythromycin, an antibiotic
  • Diltiazem
  • Azole antifungals (e.g. ketoconazole, itraconazole)
  • HIV protease inhibitors (e.g. ritonavir)
  • Beta-blockers
  • Sildenafil (VIAGRA)
  • Simvastatin

Drug-Herb interaction:

  • St-John Wort

Drug-Food interaction:

  • Do not eat grapefruit or drink grapefruit juice while on Septa- Amlodipine.
    • Proper use of this medication

    Take Septa-Amlodipine tablets 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 Septa-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 Septa- Amlodipine include swelling (oedema) 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

    Serious side effects, how often they happen and what to do about them
    Symptom / effect Talk with your doctor or pharmacist only if severe Talk with your doctor or pharmacist in all cases Stop taking drug and call your doctor or pharmacist
    Common
    Flushing (hot or warm feeling in your face) ✔    
    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) or heart attack   ✔  
    Jaundice (yellowing of the skin or eye, dark urine, nausea & vomiting, loss of appetite)   ✔  
    Allergic reactions (rash, hives, swelling of the face, throat, lips, difficulty breathing or swallowing)   ✔ ✔

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

    How to store

    Keep Septa-Amlodipine tablets out of the reach and sight of children. Store Septa-Amlodipine tablets at room temperature (between 15°C-30°C). Protect Septa-AMlodipine from light.

    Reporting 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 three 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 0701E
        Ottawa ON K1A 0K9

    Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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

    This document plus the full product monograph prepared for health professional can be obtained by contacting the distributor/manufacturer, Septa Pharmaeuticals Inc., at 905-564-5665 or by email, at: [email protected]

    This leaflet was prepared by Septa Pharmaceuticals Inc.

    Date of Preparation: May 28, 2014

    Date modified: