Aptiom - Consumer Medicine Information
|Manufacture:||Sunovion Pharmaceuticals Inc.|
|Ingredients:||eslicarbazepine acetate, croscarmellose sodium, magnesium stearate, povidone|
Eslicarbazepine Acetate Tablets
Read this carefully before you start taking APTIOM and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about APTIOM.
What is APTIOM used for?
APTIOM (eslicarbazepine acetate) is a prescription medicine used to treat partial-onset seizures when taken together with other seizure medicines in adults.
How does APTIOM work?
APTIOM works in the brain to block the spread of seizure activity. The precise way that APTIOM works to treat partial-onset seizures is unknown.
What are the ingredients in APTIOM?
Medicinal ingredients: eslicarbazepine acetate
Non-medicinal ingredients: croscarmellose sodium, magnesium stearate and povidone
APTIOM comes in the following dosage forms
Tablets: 200 mg, 400 mg, 600 mg, 800 mg
Do not use APTIOM if:
- You are allergic to the active substance (eslicarbazepine acetate), to other carboxamide derivatives (e.g., carbamazepine or oxcarbazepine which are other medicines used to treat epilepsy) or to any of the other ingredients.
- You have a certain type of heart rhythm disorder (second- or third-degree atrioventricular block).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APTIOM. Talk about any health conditions or problems you may have, including if you:
- Are taking any medicine that may have an impact on the way your heart beats; or have a condition known as PR prolongation (heart block).
- Are not sure that the medicines you are taking could have this effect, discuss this with your doctor.
- Have kidney problems. Your doctor may need to adjust the dose.
- Have liver problems.
- Suffer from seizures that begin with a widespread electric discharge that involves both sides of the brain.
- Suffer from severe heart disease such as heart rhythm disorder, heart failure or heart attack.
- Have pacemaker problems.
- Are pregnant or planning to become pregnant. You must only take APTIOM during pregnancy if your doctor tells you to.
- If you become pregnant while taking APTIOM, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.
- Are nursing or plan to nurse your baby. Do not breastfeed while you are taking APTIOM.
- Are taking oral contraceptives or other hormonal contraceptives. APTIOM may make hormonal contraceptives such as the contraceptive pill less effective. Therefore, it is recommended that you use other forms of safe and effective contraception when taking APTIOM up to the end of the current menstrual cycle after stopping treatment.
- Are taking medicines which reduce the level of sodium in your blood, e.g., diuretics.
- Are taking “statin” medicines to lower cholesterol.
Other warnings you should know about:
- A small number of people being treated with anti-epileptics have had thoughts of harming or killing themselves. If at any time you have these thoughts when taking APTIOM, contact your doctor immediately.
- APTIOM may cause double vision, blurred vision, or impaired vision. If you experience visual disturbances while taking APTIOM, notify your doctor.
- APTIOM may make you feel dizzy, drowsy and affect your coordination. If this happens to you, do not drive or use any tools or machines. Take special care when taking APTIOM to avoid accidental injury (fall). Be careful until you are used to the effects this medicine might have.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with APTIOM:
- Hormonal/oral contraceptives
- Other anti-epileptic drugs including carbamazepine, phenytoin, and phenobarbital
- Medications used to lower cholesterol (“statins”)
- Medications used to treat a heart condition such as beta-blocker (e.g., propranolol), and antiarrhythmics (e.g., amiodarone, verapamil) etc.
How to take APTIOM
Take APTIOM once a day, at about the same time every day, unless your doctor tells you otherwise. Taking APTIOM at the same time each day will have the best effect on controlling your seizures. It will also help you to remember when to take APTIOM.
- Do not stop taking APTIOM without talking to your healthcare provider. Stopping APTIOM suddenly can cause serious problems, including seizures that will not stop. Your doctor will decide how long you should take APTIOM for. Should your doctor decide to stop your treatment with APTIOM your dose will usually be reduced gradually.
The usual starting dose of APTIOM is 400 mg once daily. Your dose should be increased to 800 mg after one or two weeks. Depending on how you respond to APTIOM, your dose may be increased to a maximum dose of 1200 mg once daily.
If you have certain kidney problems, you will be given a lower dose of APTIOM. You will be started on 400 mg every other day for two weeks followed by 400 mg once daily. Your dose may be increased to a maximum dose of 600 mg once daily.
APTIOM can be taken with or without food and the tablets can be taken whole or crushed. There are many ways to crush a tablet. For example, a mortar and pestle may be used or a store-bought tablet crusher. If you are unsure how to crush your tablets, talk with your doctor or pharmacist. Once crushed, sprinkle all the powder and pieces of the crushed tablet on applesauce or some other soft food and consume within 10 minutes, with a glass of water. The drug/food mixture should not be stored for future use.
|If you think you have taken too much APTIOM, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
If you missed a dose of this medication, take it as soon as you remember. If it is close to your next dose, take APTIOM at your next regular time.
What are possible side effects from using APTIOM?
These are not all the possible side effects you may feel when taking APTIOM. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.
The most common side effects associated with the use of APTIOM are:
- Double vision, blurred vision
- Feeling tired/fatigue
- Poor coordination
|Serious Side Effects and What to do About Them|
|Symptom / effect||Talk to your Healthcare
|Only if Severe||In all Cases|
|Rare||Thoughts of suicide|
or hurting yourself
include swelling of
face, eyes, lips, or
breathing, skin rash)
pulse, slow pulse,
rapid pulse, feeling
shortness of breath)
yellowing of your
skin or the whites of
your eyes, nausea or
vomiting, loss of
pain, dark urine etc.)
|Common||Low sodium level in|
lack of energy,
trouble walking or
feeling sleepy and
that typically present
with fever, rash and
nodes, and may be
associated with signs
organs, e.g., liver
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;
- 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
0701E Ottawa, ON
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.
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.
Store at room temperature (15 to 30oC).
Keep out of reach and sight of children.
If you want more information about APTIOM
- 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 (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website http://www.sunovion.ca; or, by calling 1-866-260-6291