® (core lan ore)
tablets and oral solution
|What is the most important information I should know about Corlanor?
Corlanor may cause serious side effects in adults and children, including:
Harm to an unborn baby. Females who are able to get pregnant:
○ Must use effective birth control during treatment with Corlanor.
○ Tell your doctor right away if you become pregnant during treatment with Corlanor.
Increased risk of irregular or rapid heartbeat (atrial fibrillation or heart rhythm problems).Tell your doctor if you feel any of the following symptoms of an irregular or rapid heartbeat:
○ heart is pounding or racing (palpitations).
○ chest pressure.
○ worsened shortness of breath.
○ near fainting or fainting.
Slower than normal heart rate (bradycardia). Tell your doctor if you have:
○ a slowing of heart rate,
○ symptoms of a slow heart rate such as dizziness, fatigue, lack of energy. In young children signs and symptoms of slow heart rate may include: poor feeding, difficulty breathing or turning blue.
|What is Corlanor?
Corlanor is a prescription medicine used:
- to treat adults who have chronic (lasting a long time) heart failure, with symptoms, to reduce their risk of hospitalization for worsening heart failure.
- to treat certain children 6 months of age and older who have stable heart failure, with symptoms, that is due to an enlarged heart (dilated cardiomyopathy).
|Who should not take Corlanor?
Do not take Corlanor if you have:
Ask your doctor if you are not sure if you have any of the medical conditions listed above.
- symptoms of heart failure that recently worsened
- very low blood pressure (hypotension)
- certain heart conditions: sick sinus syndrome, sinoatrial block, or 3
rd degree atrioventricular block
- a slow resting heart rate before treatment with Corlanor. Ask your doctor what a slow resting heart rate is for you.
- certain liver problems
- been prescribed any medicines that can increase the effects of Corlanor.
|What should I tell my doctor before taking Corlanor?
Before you take Corlanor, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over the counter medicines, vitamins, and herbal supplements. Corlanor may affect the way other medicines work, and other medicines may affect how Corlanor works. This could cause serious side effects.
- have any other heart problems, including heart rhythm problems, a slow heart rate, or a heart conduction problem.
- are breastfeeding or planning to breastfeed. It is not known if Corlanor passes into breast milk. You and your doctor should decide if you will take Corlanor or breastfeed; do not do both.
- are pregnant or planning to become pregnant.
See “What is the most important information I should know about Corlanor? - Harm to an unborn baby” section.
|How should you take Corlanor?
- Take Corlanor exactly as your doctor tells you.
Do not stop taking Corlanor without talking with your doctor.
- Corlanor comes as a tablet or as an oral solution.
○ Tell your doctor if you have trouble swallowing tablets.
○ Your doctor may change your dose of Corlanor during treatment
- If you are prescribed Corlanor oral solution, see the
Instructions for Use that comes with your medicine for important information about how to prepare, and give or take a dose of Corlanor oral solution.
- Take Corlanor 2 times each day with food.
- If you miss a dose of Corlanor, do not give another dose. Give the next dose at the usual time.
- If you or your child take too much Corlanor, call your doctor or go to the nearest emergency room right away.
|What should you avoid while taking Corlanor?
- Avoid drinking grapefruit juice and taking St. John’s wort during treatment with Corlanor. These can affect the way Corlanor works and may cause serious side effects.
|What are the possible side effects of Corlanor?
Corlanor may cause serious side effects.See “What is the most important information I should know about Corlanor?”
The most common side effects of Corlanor are:
These are not all the side effects of Corlanor. Ask your doctor or pharmacist for more information.
- increased blood pressure
- temporary brightness in part of your field of vision. This is usually caused by sudden changes in light (luminous phenomena). This brightness usually happens within the first 2 months of treatment with Corlanor and may go away during or after treatment with Corlanor. Be careful when driving or operating machinery where sudden changes in light can happen, especially when driving at night.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
|How should I store Corlanor?
Keep Corlanor and all medicines out of the reach of children.
- Store Corlanor at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep Corlanor ampules in the unopened child-resistant foil pouch until ready to use, to protect from light.
- Do not save or reuse any leftover Corlanor oral solution. Corlanor oral solution is sterile and does not contain a preservative.
|General information about the safe and effective use of Corlanor.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Corlanor for a condition for which it was not prescribed. Do not give Corlanor to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about Corlanor that is written for health professionals.
|What are the ingredients in Corlanor?
Active ingredient: ivabradine
Tablet:colloidal silicon dioxide, glycerol, hypromellose, lactose monohydrate, magnesium stearate, maize starch, maltodextrin, polyethylene glycol 6000, red iron oxide, titanium dioxide, yellow iron oxide
Oral Solution:Maltitol and water