Consumer Information for: LANCORA

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

LANCORATM is a medication used to treat stable chronic heart failure. LANCORATM should be used in adults who have a heart rate that is equal to or above 77 beats per minute. LANCORATM will be used in combination with standard heart failure therapy. LANCORATM will only be prescribed by doctors who are experienced in treating heart failure.

What it does

LANCORATM works on specific cells in the heart to slow down your heart rate.

What the medicinal ingredient is

ivabradine

What the non-medicinal ingredients are
    Core tablet: colloidal anhydrous silica, lactose monohydrate, magnesium stearate, maize starch, maltodextrin.
    Tablet coating: hypromellose, macrogol 6000, glycerol, magnesium stearate, red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172).
What dosage form it comes in

5 mg and 7.5 mg film-coated tablets.

  • 5mg:
    • tablets are salmon-coloured and are rod shaped.
    • engraved with “5” on one face and on the other.
    • The 5 mg tablet can be broken in half to make two halves of 2.5 mg each.
  • 7.5mg:
    • tablets are salmon-coloured and triangular.
    • engraved with “7.5” on one face and on the other.
When it should not be used
  • you are allergic (hypersensitive) to ivabradine or any of the other ingredients of LANCORATM
  • your resting heart rate before treatment is too slow (below 70 beats per minute)
  • you have a heart condition or heart disease such as:
    • a recent heart attack
    • your heart suddenly can’t pump enough blood (cardiogenic shock)
    • severe heart failure that requires you to be in the hospital for treatment
    • problems with the rhythm of your heart or the electrical system in your heart (congenital long QT syndrome, sick sinus syndrome, sino-atrial block, third degree atrioventricular block)
    • very low blood pressure (<90/50 mmHg)
    • you need a pacemaker to beat your heart for you
  • you have severe liver problems
  • you are taking the following medications:
    • ketoconazole, itraconazole (to treat fungal infections)
    • clarithromycin, josamycin (antibiotics)
    • nelfinavir, ritonavir, atazanavir (to treat HIV infections)
    • nefazodone (to treat depression)
    • diltiazem, verapamil (used for high blood pressure or angina)
  • you are a woman able to have children and not using reliable contraception; you are pregnant or trying to become pregnant or breast-feeding
  • you are lactose intolerant or have a rare hereditary disease that means you should not have milk.
    LANCORATM contains lactose, a natural ingredient in milk. These diseases include:
    • Galactose intolerance
    • Lapp lactase deficiency
    • Glucose-galactose malabsorption.

LANCORATM is not intended for use in children younger than 18 years old.

Warnings and precautions

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LANCORATM. Talk about any health conditions or problems you may have, including if you:

  • have heart problems such as:
    • irregular heartbeat or heart rhythm
    • an abnormally rapid heart rate
    • unexpected fainting
    • heart palpitations (feeling like your heart has skipped a beat or added an extra beat)
    • increase in chest pain
    • lower than normal level of potassium in your blood
    • one of the valves in your heart is more narrow (aortic stenosis)
    • a heart device such as a pacemaker, cardioverter defibrillator or cardiac resynchronizer
    • high or low blood pressure
    • a reduced heart rate with shortness of breath or tiredness. This could mean that your heart slowed down too much.
    • severe heart failure or heart failure with an electrocardiogram (ECG) abnormality called ‘bundle branch block’
  • have a family history of problems of electrocardiogram (ECG) abnormality called “Long QT syndrome”
  • have had a recent stroke
  • have moderate liver problems
  • have severe kidney problems.

Other warnings you should know about:

Risk of harm to fetus
If you are a woman of child-bearing potential, you should use appropriate birth control measures to avoid getting pregnant while taking LANCORATM. If you get pregnant while taking LANCORATM, your fetus could be harmed or could die.

Monitoring before taking LANCORATM and when your dose is changed
Your doctor will monitor your heart rate on at least three separate visits before you start treatment with LANCORATM and whenever your dose is changed. Your doctor may also monitor your heart rate and rhythm at other times during your treatment.

Blood pressuring monitoring
If you have high blood pressure and need treatment with LANCORATM, your doctor:

  • will regularly monitor your blood pressure.
  • may need to change your blood pressure medication.

Irregular heart rhythm
LANCORATM may cause an irregular heart rhythm. This has happened more in patients taking certain medications like amiodarone. Your doctor will monitor your heart rhythm and the electrical system of your heart with an electrocardiogram (ECG).

Tell your doctor if you have any of the following symptoms of an irregular heart rhythm:

  • fast or irregular heartbeat
  • feeling like your heart is skipping a beat
  • thumping in your chest
  • discomfort, pain or pressure in your chest
  • shortness of breath
  • less ability to exercise
  • feeling tired, weak, dizzy or light-headed
  • confusion

Abnormally slow heart rate
LANCORATM may lower your heart rate too much. This may happen more in patients:

  • taking other heart rate lowering drugs
  • who are elderly (75 years of age or older).

Your doctor will monitor your heart rate. Tell your doctor if you have any of the following symptoms of a heart rate that is too low:

  • nearly fainting or fainting
  • weakness or fatigue
  • dizziness
  • shortness of breath
  • chest pain
  • feeling confused or having memory problems

Effects on Vision
LANCORATM may cause temporary visual symptoms. You may:

  • have blurry vision
  • see halos or stars of light
  • see rapid pulses light
  • see colored bright lights
  • see moving and twisting colours of light
  • find that you have moments of brightness that come and go in only certain portions of what you see with your eyes

You may notice that these symptoms happen when there are sudden changes in light intensity in your environment. For example, you may have symptoms if you walk into a bright room from a dark room. These symptoms usually go away on their own. These symptoms typically happen in the first two months of treatment.

Driving and Using Machines:
LANCORATM may make you:

  • feel dizzy, tired or weak
  • have blurry vision
  • see spots or stars of light in your eyes
  • have other problems with your vision because of halos, patches of brightness in your vision or pulses of light.

Be careful when driving or using machines. Know how you feel while taking LANCORATM before you drive or use machines.

Interactions with this medication

Tell your healthcare professional about all the medications you take, including any drugs, vitamins, minerals, natural supplements or alternative medications. The following may interact with LANCORATM:

  • diltiazem, verapamil (for high blood pressure or angina)
  • ketoconazole, itraconazole, fluconazole (to treat fungal infections)
  • rifampicin, clarithromycin, josamycin (antibiotics)
  • nelfinavir, atazanavir, ritonavir (to treat HIV infections)
  • nefazodone (to treat depression)
  • barbiturates (for difficult sleeping or epilepsy)
  • phenytoin (for epilepsy)
  • St John’s Wort (herbal treatment for depression)
  • Medications that may affect the heart rate or the electrical system of the heart, such as:
    • quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders)
    • pimozide, ziprasidone, imipramine (to treat anxiety, depression, schizophrenia)
    • mefloquine (malarial medication)
    • erythromycin IV (an antibiotic)
    • pentamidine (an antiparasitic medication)
  • furosemide, hydrochlorothiazide, indapamide (to treat edema, high blood pressure).
  • simvastatin (used to lower cholesterol).

Do not consume grapefruit juice during treatment with LANCORATM.

Proper use of this medication
  • You should take LANCORATM two times per day:
    • Once in the morning with food, and
    • 12 hours later in the evening with food.
  • Always take LANCORATM exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.
  • Only stop taking LANCORATM if your doctor tells you to.
  • If you think that the effect of LANCORATM is too strong or too weak, talk to your doctor or pharmacist.

Usual dose

  • Your doctor will decide the right dose for you. Your doctor will adjust your dose based on your heart rate.
  • The usual recommended starting dose is one 5mg tablet of LANCORATM twice a day. Your doctor may increase your dose to one 7.5mg tablet twice a day.
  • In some cases, you may start your treatment with a lower dose of 2.5mg twice a day. Your doctor may recommend this dose if you are elderly (≥75 years old) or are taking some specific medications. To take this dose, you will need to break one 5mg tablet into two, and take one half in the morning with food and the other half in the evening with food.

If you received LANCORATM in blister packaging:
Each blister card contains 14 tablets, with two in each row and seven rows in total. Each row has the day of the week on it to help you keep track of your daily doses.

Overdose

Your heart rate could be very lowered by a large dose of LANCORATM. You may feel breathless or tired.

If you think you have taken too much LANCORATM, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you forget to take a dose of LANCORATM, take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

Side effects and what to do about them
  • Dizziness
  • Visual symptoms (blurred vision, seeing light spots and flashes, etc.)
  • Fatigue, malaise, feeling tired and weak
  • Nausea, diarrhea
  • Constipation, abdominal pain
  • Feeling cold in extremities (fingers and toes)
  • Joint pain
  • Headache, generally during the first month of treatment
  • Red and itchy skin
  • Muscle spasms

These are not all the possible side effects you may feel when taking LANCORATM. If you experience any side effects not listed here, contact your healthcare professional.

Like all medications, LANCORATM may have side effects, although not everybody gets them.

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
Abnormally slow heart beat (heart rate below 50 beats per minute): nearly fainting or fainting, weakness or fatigue, dizziness, shortness of breath, chest pain   ✔  
Abnormally fast heart beat (fast heart rate)   ✔  
UNCOMMON
Angioedema: swelling of the face, eyelids, lips, tongue or throat, difficulty swallowing or breathing     ✔
Blood pressure increase : severe headache, fatigue, confusion, vision problems, chest pain, difficulty breathing   ✔  
Cramping in the lower leg(s)   ✔  
Fainting : temporary loss of consciousness due to sudden drop in blood flow to the brain   ✔  
Heart attack : chest pain that feels like a tight ache, pressure or squeezing, upper body pain, shortness of breath, feeling dizzy or like you will pass out     ✔
Mini-stroke : numbness or muscle weakness - usually on one side of the body, trouble speaking or understanding words, dizziness or loss of balance, double vision or loss of vision     ✔
Problem with the electrical system of the heart : rapid, slow or irregular heartbeat or increased fatigue, swelling of legs and feet and shortness of breath   ✔  
Sudden drop in blood pressure : feeling of lightheadedness or dizziness   ✔  
VERY RARE
Irregular heart rhythm : fast or slow heartbeat, irregular heartbeat, discomfort, pain or pressure in the chest, shortness of breath   ✔  

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting side effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

  • Online at MedEffect (www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
      Health Canada, Postal Locator 1908C
      Ottawa, ON
      K1A 0K9
    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect MededEffect.

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.

How to store
  • LANCORATM should be stored at room temperature (15 to 30°C).
  • Keep out of reach and sight of children.
  • Use LANCORATM before the expiry date stated on the bottle, carton and blister strip. The expiry date refers to the last day of that month.
  • Do not throw any medication into the garbage, or down the toilet or sink. Ask your pharmacist how to throw away medications you no longer use. This can help protect the environment.
More information
  • 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 (www.hc-sc.gc.ca); the manufacturer’s website (www.servier.ca), or by calling 1-800-363-6093.

This leaflet was prepared by Servier Canada Inc.

Last Revised:
May 14, 2018

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