Aptiom (Eslicarbazepine Acetate)

(es'' li kar baz' e peen)

Eslicarbazepine is used in combination with other medications to control focal (partial) seizures (seizures that involve only one part of the brain). Eslicarbazepine is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.

Eslicarbazepine comes as a tablet to take by mouth. It is usually take your doctor or pharmacist to explain any part you do not understand. Take eslicarbazepine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. You can swallow the tablets whole or you can crush them. Your doctor will probably start you on a low dose of eslicarbazepine and increase your dose after 1 week. Your doctor may increase your dose again at least 1 week later if necessary to control your seizures. Eslicarbazepine may help control your seizures but will not cure your condition. Continue to take eslicarbazepine even if you feel well. Do not stop taking eslicarbazepine without talking to your doctor even if you experience serious side effects such as unusual changes in behavior or mood. If you suddenly stop taking eslicarbazepine, your seizures may happen more often or may become worse. Your doctor will probably decrease your dose gradually.

Before taking eslicarbazepine,
• tell your doctor and pharmacist if you are allergic to eslicarbazepine, oxcarbazepine (Oxtellar XR, Trileptal), any other medications, or any of the ingredients in eslicarbazepine tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); hormonal contraceptives (birth control pills, patches, rings, implants, injections, and intrauterine devices); other medications for seizures such as carbamazepine (Carbatrol, Equetro, Epitol, Tegretol, Teril), clobazam (Onfi), oxcarbazepine (Oxtellar XR, Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), or primidone (Mysoline); omeprazole (Prilosec, in Zegerid); simvastatin (Zocor, in Simcor, in Vytorin); and rosuvastatin (Crestor). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had liver or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you are using hormonal contraceptives, you should know that this type of birth control may not work well when used with eslicarbazepine. You should not use hormonal contraceptives as your only method of birth control while you are taking eslicarbazepine. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking eslicarbazepine, call your doctor.
• you should know that eslicarbazepine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking eslicarbazepine for the treatment of epilepsy, mental illness, or other conditions. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants such as eslicarbazepine to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as one week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an anticonvulsant medication such as eslicarbazepine, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; withdrawing from friends and family; preoccupation with death and dying; giving away prized possessions; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Eslicarbazepine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dizziness
• difficulty with balance
• fast, repeated eye movements that you cannot control
• excessive tiredness
• sleepiness
• weakness
• forgetfulness or memory loss
• difficulty concentrating
• slowed thinking or movement
• speech problems
• shakiness
• uncontrollable shaking of a part of the body
• nausea
• vomiting
• constipation
• stomach pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• infections that come and go or do not go away
• fever
• blisters
• rash
• swollen glands
• sores in the mouth or around the eyes
• hives
• swelling of the eyes, faces, lips, tongue, mouth, or throat
• hoarseness
• difficulty breathing or swallowing
• seizures that happen more often or are worse than before
• difficulty walking
• headache
• confusion
• irritability
• muscle weakness or spasms
• unusual bruising or bleeding
• yellowing of the skin or eyes
• loss of appetite
• pain in the upper right part of the stomach
• blurred or double vision

Eslicarbazepine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to eslicarbazepine. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.