Focalin XR is an extended-release medication containing the active ingredient dexmethylphenidate hydrochloride, which is a CNS stimulant. The drug comes in the form of extended-release capsules with dosage strengths of 5 mg to 40 mg and is taken orally. It combines immediate and delayed-release beads to provide a bi-modal release of the active ingredient. Key inactive ingredients include ammonio methacrylate copolymer, gelatin, and titanium dioxide. Focalin XR is intended to utilize its CNS stimulant properties through this delivery method.

How should I use this medication?

Take this medication by mouth with a glass of water. Take it as directed on the prescription label at the same time every day. Do not crush, cut, or chew this medication. Swallow the capsules whole. You may open the capsule and put the contents in 1 tablespoon of cool applesauce. Do not put it on warm applesauce or this may result in improper dosing. Swallow the medication and applesauce right away. Do not chew the medication or applesauce. Drink some fluids (water, milk, or juice) after taking the medication with applesauce. You can take this medication with or without food. Do not take your medication more often than directed. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 6 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. This medication can be abused. Keep it in a safe place to protect it from theft. Do not share it with anyone. It is only for you. Selling or giving away this medication is dangerous and against the law. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep the container tightly closed. Get rid of any unused medication after the expiration date. This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it or it is expired. You can do this in two ways: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded -Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing -Increase in blood pressure -Irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizure, chills, vomiting, diarrhea, which may be signs of serotonin syndrome -Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression -Prolonged or painful erection -Raynaud syndrome—cool, numb, or painful fingers or toes that may change color from pale, to blue, to red -Seizures -Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision -Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -Dry mouth -Headache -Loss of appetite with weight loss -Nausea -Stomach pain -Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Circulation problems in fingers or toes -Hardening or blockages of the arteries or heart blood vessels -Heart disease or a heart defect -High blood pressure -History of stroke -Mental health conditions -Substance use disorder -Suicidal thoughts, plans, or attempt by you or a family member -An unusual or allergic reaction to dexmethylphenidate, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following: -MAOIs, such as Marplan, Nardil, and Parnate -Ozanimod This medication may also interact with the following: -Certain medications for blood pressure, heart disease, irregular heartbeat -Certain medications for depression, anxiety, or other mental health conditions -Certain medications that cause drowsiness before a procedure, such as isoflurane -Linezolid -Methylene blue -Opioids -Risperidone -St. John's wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. This medication requires a new prescription from your care team every time it is filled at the pharmacy. This medication can be abused and cause your brain and body to depend on it after high doses or long term use. Your care team will assess your risk and monitor you closely during treatment. Long term use of this medication may cause your brain and body to depend on it. You may be able to take breaks from this medication during weekends, holidays, or summer vacations. Talk to your care team about what works for you. If your care team wants you to stop this medication permanently, the dose may be slowly lowered over time to reduce the risk of side effects. Tell your care team if this medication loses its effects, or if you feel you need to take more than the prescribed amount. Do not change your dose without talking to your care team. Do not take this medication close to bedtime. It may prevent you from sleeping. Loss of appetite is common when starting this medication. Eating small, frequent meals or snacks can help. Talk to your care team if appetite loss persists. Children should have height and weight checked often while taking this medication. Tell your care team right away if you notice unexplained wounds on your fingers and toes while taking this medication. You should also tell your care team if you experience numbness or pain, changes in the skin color, or sensitivity to temperature in your fingers or toes. Contact your care team right away if you have an erection that lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage. If you are going to need surgery, a MRI, CT, or other procedure, tell your care team that you are using this medication. You may need to stop taking this medication before the procedure.

What are the most serious risks of this medication?

Misuse of this medicine can cause tolerance or dependence with abnormal behavior. Psychotic episodes have been reported with misuse. Severe depression may occur during withdrawal from misuse. Take this medicine exactly as prescribed. Do not cut, break, crush, dissolve, snort, or inject it. Store it in a safe place to prevent stealing or abuse. It is illegal to sell it or give it away.