ABILIFY

Indications for: Schizophrenia. Tourette's disorder, Psychosis.

Adult Dosage:Orally disintegrating tabs: Dissolve on tongue; take without liquids. Initially 10 mg or 15 mg once daily; may increase after at least 2 weeks; usual range 10–15 mg/day; max 30mg/day. Concomitant strong CYP3A4 or CYP2D6 inhibitors, or CYP2D6 poor metabolizer: reduce aripiprazole dose by 1⁄2. Concomitant strong CYP3A4 inducers: double aripiprazole dose (max 30mg/day) over 1–2 weeks. Adjust dose to normal range when these drugs are withdrawn. Other dose adjustments: see full labeling.

Children Dosage:Schizophrenia: 13–17yrs: initially 2mg daily, then increase to 5mg after 2 days, then increase to target dose of 10mg after 2 days. Subsequent doses may be adjusted by increments of 5mg/day; max 30mg/day. Tourette's disorder: 6–18yrs: <50kg: initially 2mg/day, then increase to target dose of 5mg/day after 2 days. May increase to 10 mg/day if optimal control of tics not achieved. Adjust doses at ≥1 week intervals. ≥50kg: initially 2 mg/day for 2 days, then increase to 5 mg/day for 5 days, then increase to target dose of 10mg/day on day 8. May increase to 20mg/day if optimal control of tics not achieved. Adjust dose by 5mg/day at ≥1 week intervals.

Boxed Warning: Increased mortality in elderly patients with dementia-related psychosis. Suicidal thoughts and behaviors with antidepressant drugs.

ABILIFY Warnings/Precautions:

Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults; monitor closely for worsening or unusual changes in behavior in all patients. Cardio- or cerebrovascular disease. Risk of neuroleptic malignant syndrome, hypotension, aspiration pneumonia, seizures, or diabetes (do baseline fasting blood sugar). Pre-existing low WBC/ANC or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; consider discontinuation if clinically significant decline in WBC occurs. Discontinue if severe neutropenia occurs (ANC <1000/mm3). Exposure to extreme heat. Dehydration. Perform fall risk assessments when initiating and recurrently on long-term therapy. Monitor for hyperglycemia, dyslipidemia, weight gain. Suicidal tendencies. Pathological gambling and other compulsive behaviors: consider dose reduction or discontinuation if develops. CYP2D6 poor metabolizers. Reevaluate periodically. Write ℞ for smallest practical amount. Labor & delivery. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers.

ABILIFY Classification: Atypical antipsychotic.

ABILIFY Interactions: See Adult. Potentiated by CYP3A4 inhibitors (eg, itraconazole, clarithromycin) or CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine). Antagonized by CYP3A4 inducers (eg, carbamazepine, rifampin). Potentiates antihypertensives. Caution with drugs that interfere with temperature regulation (eg, anticholinergics). Monitor with lorazepam.

Adverse Reactions: Headache, anxiety, insomnia, constipation, nausea, vomiting, somnolence, fatigue, sedation, dizziness, restlessness, akathisia, orthostatic hypotension, blurred vision, tremor, pyrexia, salivary hypersecretion, nasopharyngitis, EPS, neuroleptic malignant syndrome, tardive dyskinesia (consider discontinuation if occurs), weight gain, hyperglycemia, dyslipidemia, others. Inj: local reactions.

Note: Register patients in the National Pregnancy Registry for Atypical Antipsychotics (866) 961-2388.

Generic Drug Availability: Tabs, soln, orally disintegrating tabs (YES); Maintena, MyCite (NO)

How Supplied: Tabs 2mg—30; 5mg, 10mg, 15mg, 20mg, 30mg—30, 100; Prefilled Dual Chamber Syringe—1 (w. supplies); Single-use vials—1 (w. supplies); Oral soln, orally disintegrating tabs—contact supplier; MyCite kits (1-component patch)—30 tabs + 7 patches; MyCite kits (2-component patch)—Starter kit (30 tabs + 1 pod + 7 strips); Maintenance kit (30 tabs + 7 strips)

ACIPHEX ® (a-se-feks) (rabeprazole sodium) delayed-release tablets. 

This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.

What is the most important information I should know about ACIPHEX?

ACIPHEX may help your acid-related symptoms, but you could still have serious stomach problems.

Talk with your doctor.

ACIPHEX can cause serious side effects, including:

• Diarrhea. ACIPHEX may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.

• Bone fractures. People who take multiple daily doses of Proton Pump Inhibitor (PPI) medicines for a long period of time (1 year or longer) may have an increased risk of fractures of the hip, wrist, or spine.

You should take

ACIPHEX exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take ACIPHEX.

What is ACIPHEX?

ACIPHEX is a prescription medicine called a Proton Pump Inhibitor (PPI).

ACIPHEX reduces the amount of acid in your stomach.

ACIPHEX is used in adults: for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE) and to relieve symptoms, such as heartburn pain.

If needed, your doctor may decide to prescribe another 8 weeks of ACIPHEX. to maintain the healing of the esophagus and relief of symptoms related to EE.

It is not known if ACIPHEX is safe and effective if used longer than 12 months (1 year). for up to 4 weeks to treat daytime and nighttime heartburn and other symptoms that happen with Gastroesophageal Reflux Disease (GERD).

GERD happens when acid in your stomach backs up into the tube (esophagus) that connects your mouth to your stomach.

This may cause a burning feeling in your chest or throat, sour taste, or burping. for up to 4 weeks for the healing and relief of duodenal ulcers.

The duodenal area is the area where food passes when it leaves the stomach, for 7 days with certain antibiotic medicines to treat an infection caused by bacteria called H. pylori . Sometimes H. pylori bacteria can cause duodenal ulcers. The infection needs to be treated to prevent the ulcers from coming back. for the long-term treatment of conditions where your stomach makes too much acid.

This includes a rare condition called Zollinger-Ellison syndrome. ACIPHEX is used in adolescents 12 years of age and older to treat symptoms of Gastroesophageal Reflux Disease (GERD) for up to 8 weeks.

It is not known if ACIPHEX is safe and effective in children to: heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE)  maintain the healing of the esophagus and relief of symptoms related to EE treat symptoms that happen with Gastroesophageal Reflux Disease (GERD)  heal duodenal ulcers  treat an infection caused by bacteria called H. pylori to reduce the risk of duodenal ulcers from coming back  treat conditions where your stomach makes too much acid, including Zollinger-Ellison Syndrome. ACIPHEX delayed-release tablets should not be used in children under 12 years of age.

Who should not take ACIPHEX?

Do not take ACIPHEX if you: are allergic to rabeprazole or any of the other ingredients in ACIPHEX.

See the end of this Medication Guide for a complete list of ingredients in ACIPHEX. are allergic to any other Proton Pump Inhibitor (PPI) medicine

are taking a medicine that contains rilpivirine (Edurant, Complera) used to treat HIV-1 (Human Immunodeficiency Virus)

What should I tell my doctor before taking ACIPHEX?

Before you take ACIPHEX tell your doctor if you: have been told that you have low magnesium levels in your blood, have liver problems, have any allergies, have any other medical conditions, are pregnant or plan to become pregnant. It is not known if ACIPHEX can harm your unborn baby. Talk to your doctor about the possible risks to an unborn baby if ACIPHEX is taken during pregnancy. are breastfeeding or plan to breastfeed.

It is not known if ACIPHEX passes into your breast milk or if it will affect your baby or your breast milk. Talk to your doctor about the best way to feed your baby if you take ACIPHEX.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

ACIPHEX may affect how other medicines work, and other medicines may affect how ACIPHEX works.  Especially tell your doctor if you take an antibiotic that contains clarithromycin or amoxicillin or if you take warfarin (COUMADIN, JANTOVEN) or methotrexate (Otrexup, Rasuvo, Trexall).

Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take ACIPHEX?

Take ACIPHEX exactly as prescribed. Your doctor will prescribe the dose that is right for you and your medical condition. Do not change your dose or stop taking ACIPHEX unless you talk to your doctor. Take ACIPHEX for as long as it is prescribed even if you feel better. ACIPHEX is usually taken 1 time each day. Your doctor will tell you the time of day to take ACIPHEX, based on your medical condition. 

ACIPHEX can be taken with or without food. Your doctor will tell you whether to take this medicine with or without food based on your medical condition. Swallow each ACIPHEX tablet whole. Do not chew, crush, or split ACIPHEX tablets. Tell your doctor if you cannot swallow tablets whole. If you miss a dose of ACIPHEX, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your normal schedule.

Do not take 2 doses at the same time. If you take too much ACIPHEX, call your doctor or your poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room. Your doctor may prescribe antibiotic medicines with ACIPHEX to help treat a stomach infection and heal stomach (duodenal) ulcers that are caused by bacteria called H. pylori. Make sure you read the patient information that comes with an antibiotic before you start taking it.

What are the possible side effects of ACIPHEX?

ACIPHEX may cause serious side effects, including:  See “What is the most important information I should know about ACIPHEX?”

Interaction with warfarin. Taking warfarin with a Proton Pump Inhibitor (PPI) may lead to an increased risk of bleeding and death.

If you take warfarin, your doctor may check your blood to see if you have an increased risk of bleeding.

If you take warfarin during treatment with ACIPHEX, tell your doctor right away if you have any signs or symptoms of bleeding, including unexpected bleeding or bleeding that lasts a long time, such as: nosebleeds that happen often unusual bleeding from the gums, menstrual bleeding that is heavier than normal or unusual vaginal bleeding, bleeding that is severe or that you cannot control, red, pink or brown urine bright red or black stools (looks like tar) coughing up blood or blood clots  vomiting blood or your vomit looks like “coffee grounds” headaches, feel dizzy or weak,  Vitamin B-12 deficiency. ACIPHEX reduces the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B-12 properly. Talk with your doctor about the possibility of vitamin B-12 deficiency if you have been on ACIPHEX for a long time (more than 3 years). Low magnesium levels in your body.  this problem can be serious. Low magnesium can happen in some people who take a Proton Pump inhibitor (PPI) medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.

Tell your doctor right away and get medical care if you have any of these symptoms: seizures, dizziness, abnormal or fast heart beat jitteriness, jerking movements or shaking (tremors), muscle weakness, spasms of the hands and feet, cramps or muscle aches, spasm of the voice box

Your doctor may check the level of magnesium in your body before you start taking ACIPHEX, during treatment, or if you will be taking ACIPHEX for a long period of time. The most common side effects of ACIPHEX in adults include: pain,  sore throat, gas, infection, constipation. The most common side effects of ACIPHEX in adolescents 12 years of age and older include: headache, diarrhea, nausea,  vomiting, stomach-area (abdomen) pain 

Other side effects: Serious allergic reactions.

Tell your doctor if you get any of the following symptoms with ACIPHEX: rash. face swelling, throat tightness, difficulty breathing.

Your doctor may stop ACIPHEX if these symptoms happen.

These are not all of the possible side effects of ACIPHEX.  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 ACIPHEX?

Store ACIPHEX Tablets in a dry place at room temperature between 68° F to 77° F (20° C to 25° C). 

Keep ACIPHEX and all medicines out of the reach of children.

What are the ingredients in ACIPHEX?

Active ingredient:

rabeprazole sodium

Inactive ingredients : carnauba wax, crospovidone, diacetylated monoglycerides, ethylcellulose, hydroxypropyl cellulose, hypromellose phthalate, magnesium stearate, mannitol, propylene glycol, sodium hydroxide, sodium stearyl fumarate, talc, and titanium dioxide. Iron oxide yellow is the coloring agent for the tablet coating.  Iron oxide red is the ink pigment.

Distributed by Eisai Inc., Woodcliff Lake, NJ 07677

All brand names are the trademarks of their respective owners.

For more information, go to http://www.aciphex.com/ or call 1-888-4-ACIPHEX.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: April 2016

MEDICATION GUIDE

ABILIFY MYCITE®  (a BIL ĭ fī - Mi SIHYT)  (aripiprazole tablets with sensor), for oral use

Important: If you are taking ABILIFY MYCITE with other medicines for treatment of major depressive disorder (MDD), you should also read the Medication Guides or Patient Information that comes with the other medicines.

The ABILIFY MYCITE System has 4 parts: 

1. Aripiprazole tablet with an Ingestible Event Marker (IEM) sensor inside it (ABILIFY MYCITE). 

2. MYCITE Patch (wearable sensor) that picks up (detects) the signal from the IEM sensor after you take the ABILIFY MYCITE tablet and sends the information to a smartphone.

3. MYCITE App, which is a smartphone application (app) that is used with a compatible smartphone to show information about when you take your ABILIFY MYCITE tablet.

4. Web-based portal for healthcare providers and caregivers.

Download the MYCITE App before using the ABILIFY MYCITE System. Always follow the instructions provided within the MYCITE App when using the ABILIFY MYCITE System. 

Your healthcare provider should show you how to use the ABILIFY MYCITE System before you use it for the first time. 

What is the most important information I should know about ABILIFY MYCITE?

ABILIFY MYCITE may cause serious side effects, including:

Increased risk of death in elderly people with dementia-related psychosis. Medicines like

ABILIFY MYCITE can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ABILIFY MYCITE is not approved for the treatment of people who have lost touch with reality (psychosis) due to confusion or memory loss (dementia).

Increased risk of suicidal thoughts or actions in children and young adults. Antidepressant medicines may increase suicidal thoughts or actions in some children and young adults within the first few months of treatment and when the dose is changed. It is not known if ABILIFY MYCITE is safe and effective for use in children.

How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.

Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

What is ABILIFY MYCITE?

ABILIFY MYCITE is a prescription medicine of aripiprazole tablets with an Ingestible Event Marker (IEM) sensor inside it used:

To treat adults with schizophrenia.

To treat bipolar I disorder: short-term (acute) treatment of adults with manic or mixed episodes alone or when used with the medicine lithium or valproate maintenance treatment of adults alone or when used with the medicine lithium or valproate. To treat adults with major depressive disorder (MDD) along with other antidepressant medicines   The ABILIFY MYCITE System is meant to track if you have taken your ABILIFY MYCITE.

It is not known if ABILIFY MYCITE can improve how well you take your aripiprazole (patient compliance) or for changing your dose of aripiprazole. 

There may be a delay in the detection of the ABILIFY MYCITE tablet and sometimes the detection of the tablet might not happen at all. ABILIFY MYCITE is not for use as real-time or emergency  monitoring.  

It is not known if ABILIFY MYCITE is safe or effective for use in children. 

Do not take ABILIFY MYCITE if you are allergic to aripiprazole or any of the ingredients in ABILIFY MYCITE. See the end of this Medication Guide for a complete list of ingredients in ABILIFY MYCITE.

Before taking ABILIFY MYCITE, tell your healthcare provider about all your medical conditions, including if you:

• have diabetes or high blood sugar or have a family history of diabetes or high blood sugar. Your healthcare provider should check your blood sugar before you start and during treatment with ABILIFY MYCITE.

• have or had seizures (convulsions)

• have or had low or high blood pressure

• have or had heart problems or stroke

• have or had a low white blood cell count

• are pregnant or plan to become pregnant. Talk to your healthcare provider about the risk to your unborn baby if you take ABLIFY MYCITE during pregnancy.

Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with ABILIFY MYCITE. 

If you become pregnant during treatment with ABILIFY MYCITE, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinicaland-research-programs/pregnancyregistry/.

If you are breastfeeding or plan to breastfeed. ABILIFY MYCITE can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ABILIFY MYCITE.

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

ABILIFY MYCITE and other medicines may affect each other causing possible serious side effects. ABILIFY MYCITE may affect the way other medicines work, and other medicines may affect how ABILIFY MYCITE works.

Your healthcare provider can tell you if it is safe to take ABILIFY MYCITE with your other medicines. Do not start or stop any other medicines during treatment with ABILIFY MYCITE without talking to your healthcare provider first. 

Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

How should I take ABILIFY MYCITE?

See the MYCITE App for instructions about how to apply and wear the MYCITE Patch and how to use the ABILIFY MYCITE System the right way.

• Take ABILIFY MYCITE exactly as your healthcare provider tells you to take it. Do not change the dose or stop taking ABILIFY MYCITE without first talking to your healthcare provider.

• Take ABILIFY MYCITE by mouth with or without food.

• Swallow ABILIFY MYCITE tablets whole. Do not divide, crush, or chew ABILIFY MYCITE tablets. 

• The ABILIFY MYCITE tablet is usually detected within 30 minutes after you take it, but there may be a delay of more than 2 hours for the smartphone app and web portal to detect that you have taken ABILIFY MYCITE, and sometimes the ABILIFY MYCITE tablet might not be detected at all. If the tablet is not detected after you take it, do not repeat the dose.  

• If over-exposure occurs, call your poison control center at 1-800-222-1222.

What should I avoid while taking ABILIFY MYCITE?

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how ABILIFY MYCITE affects you. ABILIFY MYCITE may make you drowsy.

• Do not become too hot or dehydrated during treatment with ABILIFY MYCITE.

• Do not exercise too much.

• In hot weather, stay inside in a cool place if possible.

• Stay out of the sun. 

• Do not wear too much clothing or heavy clothing.

• Drink plenty of water.

What are the possible side effects of ABILIFY MYCITE?

ABILIFY MYCITE may cause serious side effects, including:

See “What is the most important information I should know about ABILIFY MYCITE?” 

Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death.  

Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:

• high fever 

• stiff muscles 

• confusion 

• sweating

• changes in pulse, heart rate, and blood pressure 

Uncontrolled body movements (tardive dyskinesia). ABILIFY MYCITE may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking ABILIFY MYCITE. Tardive dyskinesia may also start after you stop taking ABILIFY MYCITE.

Problems with your metabolism such as:

high blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take ABILIFY MYCITE. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start and during your treatment with ABILIFY MYCITE. 

Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with ABILIFY MYCITE:

feel very thirsty

need to urinate more than usual

feel very hungry

feel weak or tired

feel sick to your stomach

feel confused, or your breath smells fruity o   increased fat levels (cholesterol and triglycerides) in your blood.

weight gain. You and your healthcare provider should check your weight regularly.

Unusual urges. Some people taking ABILIFY MYCITE have had unusual urges, such as gambling, binge eating or eating that you cannot control (compulsive), compulsive shopping and sexual urges. If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.

Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.

Falls

Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with ABILIFY MYCITE.

Seizures (convulsions)

Problems controlling your body temperature so that you feel too warm. See “What should I avoid while taking ABILIFY MYCITE?”

Difficulty swallowing 

The most common side effects of ABILIFY MYCITE in adults include:

• restlessness or need to move (akathisia)

• dizziness 

• nausea 

• insomnia

• shaking (tremor)

• anxiety

• constipation

• sedation

These are not all the possible side effects of ABILIFY MYCITE. 

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800FDA-1088.

How should I store ABILIFY MYCITE?

• Store ABILIFY MYCITE tablets at room temperature, between 68°F to 77°F (20°C to 25°C). 

• Store MYCITE Patches between 41°F to 81°F (5°C to 27°C).

• Keep ABILIFY MYCITE tablets and MYCITE Patches (wearable sensor) dry. Do not store ABILIFY MYCITE tablets and Patches (wearable sensor) in places with high humidity.

• Keep ABILIFY MYCITE and all medicines out of the reach of children.

General information about the safe and effective use of ABILIFY MYCITE.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ABILIFY MYCITE for a condition for which it was not prescribed. Do not give ABILIFY MYCITE to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about ABILIFY MYCITE that was written for healthcare professionals.

What are the ingredients in ABILIFY MYCITE?

Active ingredient: aripiprazole

Inactive ingredients: cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose, and Ingestible Event Marker (IEM). Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. Ingredients of the IEM include aluminum, cuprous chloride, ethyl cellulose, gold, hydroxypropyl cellulose, magnesium, silicon, silicon dioxide, silicon nitride, titanium-tungsten, titanium and triethyl citrate.

Manufactured by:

Tablets with embedded IEM sensors Manufactured by Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan MYCITE Patches Manufactured for Otsuka America Pharmaceutical, Inc. 3956 Point Eden Way, Hayward, CA 94545 USA Distributed and marketed by Otsuka America Pharmaceutical, Inc., Rockville, MD 20850 USA ABILIFY MYCITE®  and MYCITE®  are registered trademarks of Otsuka Pharmaceutical Company.

© 2020, Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan For more information about ABILIFY MYCITE go to www.abilifymycite.com or call 1-844-692-4834.  

MEDICATION GUIDE

APTIOM (ap tee' om) (eslicarbazepine acetate) tablets

What is the most important information I should know about APTIOM?

Do not stop taking APTIOM without first talking to your healthcare provider. Stopping APTIOM suddenly can cause serious problems.

Stopping a seizure medicine suddenly in a patient who has epilepsy may cause seizures that will not stop (status epilepticus).

Like other antiepileptic drugs, APTIOM may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

thoughts about suicide or dying

attempt to commit suicide

new or worse depression

new or worse anxiety

feeling agitated or restless

panic attacks o trouble sleeping (insomnia)

new or worse irritability

acting aggressive, being angry, or violent

acting on dangerous impulses

an extreme increase in activity and talking (mania)

other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?

Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.

Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions may be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

APTIOM may cause allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells.

You may or may not have a rash with these types of reactions. Call your healthcare provider right away if you have any of the following:

swelling of your face, eyes, lips, or tongue

trouble swallowing or breathing

a skin rash

hives

fever, swollen glands, or sore throat that do not go away or come and go

painful sores in the mouth or around your eyes

yellowing of your skin or eyes

unusual bruising or bleeding

severe fatigue or weakness

severe muscle pain

frequent infections or infections that do not go away

APTIOM may cause the level of sodium in your blood to be low.

Symptoms of low blood sodium include:

nausea

tiredness, lack of energy

irritability

confusion

muscle weakness or muscle spasms

more frequent or more severe seizures Some medicines can also cause low sodium in your blood. Be sure to tell your healthcare provider about all the other medicines that you are taking.

What is APTIOM?

APTIOM is a prescription medicine used to treat partial-onset seizures. It is not known if APTIOM is safe and effective in children under 4 years of age.

Who should not take APTIOM?

Do not take APTIOM if you are allergic to eslicarbazepine acetate, any of the other ingredients in APTIOM, or oxcarbazepine. See the end of this Medication Guide for a complete list of ingredients in APTIOM.

What should I tell my healthcare provider before taking APTIOM?

Before taking APTIOM, tell your healthcare provider about all your medical conditions, including if you:

have or have had suicidal thoughts or actions, depression or mood problems

have liver, kidney, or blood problems

are allergic to oxcarbazepine. Some people who are allergic to oxcarbazepine may also be allergic to APTIOM.

use birth control medicine. APTIOM may cause your birth control medicine to be less effective. Talk to your healthcare provider about the best birth control method to use.

If you are pregnant or plan to become pregnant. APTIOM may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking APTIOM. You and your healthcare provider will decide if you should take APTIOM while you are pregnant.

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.

If you are breastfeeding or plan to breastfeed. APTIOM passes into breast milk. You and your healthcare provider should discuss whether you should take APTIOM or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking APTIOM with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Especially tell your healthcare provider if you take:

oxcarbazepine

carbamazepine

simvastatin

omeprazole

clobazam

phenobarbital

phenytoin

birth control medicine

rosuvastatin

primidone

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take APTIOM?

Take APTIOM exactly as your healthcare provider tells you to take it.

Do not stop taking APTIOM without talking to your healthcare provider. Stopping APTIOM suddenly can cause serious problems, including seizures that will not stop (status epilepticus).

Your healthcare provider may change your dose.

Your healthcare provider will tell you how much APTIOM to take.

APTIOM can be taken with or without food.

APTIOM can be taken as a whole tablet or crushed.

If you take too much APTIOM, call your healthcare provider or go to the nearest hospital emergency room right away.

Talk with your healthcare provider about what you should do if you miss a dose.

What should I avoid while taking APTIOM?

Do not drive, operate heavy machinery, or do dangerous activities until you know how APTIOM affects you. APTIOM may slow your thinking and motor skills.

What are the possible side effects of APTIOM? See “What is the most important information I should know about APTIOM?”

APTIOM may cause other serious side effects including:

Nervous system problems. APTIOM may cause problems that can affect your nervous system.

Symptoms of nervous system problems include:

dizziness

trouble walking or with coordination

feeling sleepy and tired

trouble concentrating

vision problems

Liver problems. APTIOM may affect your liver.

Symptoms of liver problems include:

yellowing of your skin or the whites of your eyes

nausea or vomiting

loss of appetite

stomach pain

dark urine

Get medical help right away if you have any of the symptoms listed above or listed in

“What is the most important information I should know about APTIOM?”

The most common side effects of APTIOM include:

dizziness

sleepiness

nausea

headache

double vision

vomiting

feeling tired

blurred vision

shakiness

problems with coordination

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of APTIOM. For more information, ask your healthcare provider or pharmacist. 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 APTIOM?

Store APTIOM at 68o F to 77o F (20o C to 25o C).  Safely throw away medicine that is out of date or no longer needed. Keep APTIOM and all medicines out of reach of children.

What are the ingredients in APTIOM?

Active ingredient: eslicarbazepine acetate

Inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone

General information about the safe and effective use of APTIOM. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

Do not use APTIOM for a condition for which it was not prescribed.

Do not give APTIOM to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about APTIOM. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about APTIOM that is written for health professionals. For more information, go to www.aptiom.com or call 1-888-394-7377.

Manufactured for: Sunovion Pharmaceuticals Inc., Marlborough, MA 01752 USA