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Aptiom (Generic Eslicarbazepine)

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Why is this medication prescribed?

To manage focal (partial) seizures, eslicarbazepine is used with other drugs (seizures that involve only one part of the brain). Eslicarbazepine belongs to the group of drugs known as anticonvulsants. It functions by reducing excessive cerebral excitation.

How should this medicine be used?

Eslicarbazepine is available as an oral tablet. Any section you don’t understand will typically need to be explained by your doctor or pharmacist. Follow the prescription for eslicarbazepine strictly. Never take it in larger or less amounts or more frequently than directed by your doctor.

The tablets can be broken or swallowed whole.

Eslicarbazepine will likely be prescribed to you at a low dosage by your doctor, who will then likely raise it after a week. In order to control your seizures, your doctor may increase your dose once more at least a week later.

Eslicarbazepine may aid in seizure management but it won’t treat your problem. Even if you feel good, keep taking the eslicarbazepine medication. Even if you have severe side effects such odd changes in behaviour or mood, you should not discontinue taking eslicarbazepine without first consulting your doctor. Eslicarbazepine withdrawal can cause seizures to worsen or occur more frequently. Your dose will likely be gradually reduced by your doctor.

The manufacturer’s patient information sheet (Medication Guide) will be sent to you by your doctor or pharmacist when you start taking eslicarbazepine and each time you get a prescription refill. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking eslicarbazepine,

  • If you have any allergies to any medications, including eslicarbazepine, oxcarbazepine (Oxtellar XR, Trileptal), food, or any of the substances in eslicarbazepine tablets, notify your doctor and pharmacist right away. For a list of the ingredients, consult your pharmacist or the Medication Guide.
  • Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Incorporate any of the following: hormonal contraceptives (birth control pills, patches, rings, injections, and intrauterine devices); anticoagulants (also known as “blood thinners”); warfarin (Coumadin, Jantoven); hormonal contraceptives; additional medications for seizures such as carbamazepine (Carbatrol, Equetro, Epitol, Tegretol, Teril); clobazam (Onfi); oxcarbazepine (Oxtellar XR, Tri (Crestor). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • If you have or have previously had liver or kidney disease, let your doctor know.
  • If you are breastfeeding a child or intend to become pregnant, let your doctor know. You should be aware that hormonal birth control may not be effective when used with eslicarbazepine if you use it. When taking eslicarbazepine, hormonal contraceptives shouldn’t be your only method of birth control. Discuss effective birth control options with your doctor. Call your doctor if you get pregnant while taking eslicarbazepine.
  • You must to be aware that eslicarbazepine might make you sleepy. Prior to understanding how this medication affects you, avoid using machinery or driving a car.
  • You should be aware that when taking eslicarbazepine for the treatment of epilepsy, mental illness, or other illnesses, your mental health may alter in unexpected ways and you may become suicidal (thinking about injuring or killing oneself, preparing to do so, or trying to do so). In clinical studies, a small percentage of patients using anticonvulsants like eslicarbazepine to treat various conditions—about 1 in 500 adults and children aged 5 and older—became suicidal while receiving medication. Some of these individuals started exhibiting suicidal thoughts and actions as little as one week after beginning the medicine. If you take an anticonvulsant drug like eslicarbazepine, there is a chance that your mental state may change, but there is also a chance that your condition will not be addressed and that your mental state will change. Whether the hazards of using an anticonvulsant drug outweigh the dangers of not using it will be decided by you and your doctor. Any of the following symptoms should prompt you, your family, or your carer to call your doctor immediately away: panic attacks, agitation or restlessness, as well as newly-appearing or worsening irritation, worry, or depression; Acting on risky impulses, trouble falling or staying asleep, aggressive, angry or violent behaviour, mania (frenzied, abnormally excited mood), talking or thinking about wanting to harm 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 behaviour or mood are all signs of a mental health problem. Make sure your family or carer is aware of any symptoms that could be significant so they can contact the doctor on your behalf if you are unable to call for help.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

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

  • Dizziness
  • Problems with equilibrium
  • Uncontrollable rapid eye motions that occur repeatedly
  • Excessive fatigue
  • Sleepiness
  • Weakness
  • Loss of memory or forgetfulness
  • Difficulty paying attention
  • Sluggish thinking or motion
  • Speech issues
  • Shakiness
  • Body part shaking that is uncontrollable
  • Nausea
  • Vomiting
  • Constipation
  • Abdominal pain

Some adverse effects can be very harmful. Call your doctor right away if you encounter any of these symptoms, or seek emergency care:

  • Infections that recur frequently or persist
  • Fever
  • Blisters
  • Rash
  • Enlarged glands
  • Having mouth sores or eyelid sores
  • Hives
  • Eye, face, lip, tongue, mouth, or throat swelling
  • Hoarseness
  • Breathing or swallowing challenges
  • Seizures that occur more frequently or worsen than usual
  • Having trouble walking
  • Headache
  • Confusion
  • Irritability
  • A weakened or spasmed muscle
  • Abnormal bleeding or bruising
  • The skin or eyes turning yellow
  • Reduced appetite
  • Upper right stomach region discomfort
  • Double or blurry vision

Eslicarbazepine can have other negative effects. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Dizziness
  • Nausea
  • Vomiting
  • Sleepiness
  • Abnormally positive mood
  • Tongue tingling or feeling numb
  • Walking challenges or issues with coordination
  • Dual perception
  • Seizures that occur more frequently or worsen than usual
  • Weakness
  • Headache
  • Confusion
  • Irritability
  • A weakened or spasmed muscle

What other information should I know?

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to eslicarbazepine, your doctor will request specific lab tests.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Aptiom®
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