Details for: APTIOM
Company: SUNOVION PHARMACEUTICALS CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02426862 | APTIOM | ESLICARBAZEPINE ACETATE | 200 MG | TABLET | ORAL |
| 02426870 | APTIOM | ESLICARBAZEPINE ACETATE | 400 MG | TABLET | ORAL |
| 02426889 | APTIOM | ESLICARBAZEPINE ACETATE | 600 MG | TABLET | ORAL |
| 02426897 | APTIOM | ESLICARBAZEPINE ACETATE | 800 MG | TABLET | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
APTIOM (eslicarbazepine acetate) is a prescription medicine used to treat partial-onset seizures. APTIOM can be taken on its own or together with other seizure medicines in adults. APTIOM can be taken together with other seizure medicines in children above 6 years of age.
What it does
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.
When it should not be used
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).
What the medicinal ingredient is
eslicarbazepine acetate
What the non-medicinal ingredients are
croscarmellose sodium, magnesium stearate and povidone
What dosage form it comes in
Tablets: 200 mg, 400 mg, 600 mg, 800 mg
Warnings and precautions
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. Tell your doctor about all the medicines you take, just in case you aren’t sure.
- Have a condition known as PR prolongation (heart block).
- Have kidney problems. Your doctor may need to adjust the dose.
- Have liver problems.
- Have blood 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. Information on the registry can also be found at the website: http://www.aedpregnancyregistry.org/.
- Are nursing or plan to nurse your baby. Do not breastfeed while you are taking APTIOM because it could seriously harm your baby.
- 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.
- Have had a serious allergic reaction while taking carbamazepine or oxcarbazepine. If you have, you should not take APTIOM.
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.
- APTIOM may cause a decrease in the salt levels in your blood. This may happen especially if you take other drugs that may also decrease the salt levels in your blood. Your doctor may monitor your blood salt levels, especially if you get the following symptoms:
- Nausea and/or vomiting
- Feeling unwell or tired
- Headache
- Lack of energy (feeling lethargic)
- Feeling confused, irritated and/or less alert
- Muscle weakness or spasms
- Increase in seizures or increase in the severity of the seizures
- There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures in patients on long-term treatment with APTIOM.
- APTIOM may cause your thyroid gland to be less active. Your doctor may monitor your thyroid hormone levels while you are taking APTIOM.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The following may interact with APTIOM:
- Hormonal/oral contraceptives
- Other anti-epileptic drugs including carbamazepine, oxcarbazepine, 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.
Proper use of this medication
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.
- 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.
Usual Dose
- You will be given a lower dose of APTIOM if you have moderate to severe kidney problems.
- You will take a usual dose of APTIOM if you have mild to moderate liver problems. APTIOM is not recommended in patients with severe liver problems.
- If you are 65 years of age or older, the recommended maximum dose is 1200 mg per day.
When you take APTIOM on its own (Adults only):
The usual starting dose of APTIOM is 400 mg once daily. Your dose should be increased to 800 mg
once daily after one or two weeks. Depending on how you respond to APTIOM, your dose may be
increased to 1200 mg once daily. Most patients have their symptoms controlled with 800 to 1200 mg
of APTIOM once daily. The maximum dose is 1600 mg once daily.
When you take APTIOM with other seizure medicines:
Adults and children with a body weight over 40 kg
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.
Children above 6 years of age
The usual starting dose of APTIOM is based on weight. The recommended starting dose is 10 mg per
kilogram of body weight per day, taken once daily. The dosage will be increased each week or every
two weeks up to 30 mg per kilogram of body weight per day. The change in dosage will be based on
weight and your response to APTIOM. The maximum dose is 1200 mg once daily
Overdose
Missed Dose
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.
Side effects and what to do about them
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:
- Dizziness
- Sleepiness/drowsiness
- Headache
- Nausea
- Double vision, blurred vision
- Vomiting
- Feeling tired/fatigue
- Poor coordination
- Shakiness
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Unknown | |||
| Serious skin reactions (any combination of itchy skin rash, redness, blistering and peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals) | ✔ | ||
| Serious allergic reactions (potential symptoms include swelling of the face, throat, hand, feet, ankles, or lower legs) | ✔ | ||
| Rare | |||
| Thoughts of suicide or hurting yourself | ✔ | ||
| Allergic reactions (potential symptoms include swelling of face, eyes, lips, or tongue, trouble swallowing or breathing, skin rash) | ✔ | ||
| Decrease red and white blood cells (potential symptoms include tiredness, shortness of breath when exercising, looking pale, headache, chills, dizziness, frequent infections leading to fever, sore throat, mouth ulcers) | ✔ | ||
| Decrease blood platelets (potential symptoms include bleeding or bruising more easily than normal, nose bleeds, reddish or purplish patches, or unexplained blotches on the skin) | ✔ | ||
| Uncommon | |||
| Cardiac arrhythmias (potential symptoms include irregular pulse, slow pulse, rapid pulse, feeling of lightheadedness, fainting, palpitations, shortness of breath) | ✔ | ||
| Liver problems (symptoms like yellowing of your skin or the whites of your eyes, nausea or vomiting, loss of appetite, stomach pain, dark urine etc.) | ✔ | ||
| Common | |||
| Low sodium level in blood (potential symptoms include lack of energy, confusion, muscular twitching or convulsions) | ✔ | ||
| Nervous system problems (symptoms like dizziness, trouble walking or with coordination, feeling sleepy and tired, trouble concentrating, vision problems etc.) | ✔ | ||
| Allergic reactions that typically present with fever, rash and swollen lymph nodes, and may be associated with signs and symptoms involving other 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.
How to store
Store at room temperature (15 to 30oC).
Keep out of reach and sight of children.
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 (https://www.canada.ca/en/health-canada/services/drugs-healthproducts/medeffect-canada.html) ;
- 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.
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.
More information
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 (https://healthproducts.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website http://www.sunovion.ca; or, by calling 1-866-260-6291
This leaflet was prepared by Sunovion Pharmaceuticals Canada Inc
Last Revised: July 11, 2019