Generic Name: Dexmethylphenidate Tablets (dex METH il FEN i date)
Brand Name: Focalin
- This medicine may be habit-forming. Use Focalin (dexmethylphenidate tablets) as you were told by your doctor. Tell your doctor if you have a history of drug or alcohol abuse. Misuse of this medicine may cause it to not work as well. Mood or behavior changes may also happen.
- Do not stop taking Focalin all of a sudden without calling your doctor. You may have a greater risk of mood changes like very low mood (depression). If you need to stop this medicine, you may need to slowly stop it as told by your doctor.
Uses of Focalin:
- It is used to treat attention deficit problems with hyperactivity.
- It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take Focalin?
- If you have an allergy to dexmethylphenidate, methylphenidate, or any other part of Focalin.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you or a family member have any of these health problems: Blood vessel disease, high blood pressure, heart structure problems or other heart problems, or Tourette's syndrome or tics.
- If you have any of these health problems: Glaucoma; nervous, anxious, or tense state; or overactive thyroid.
- If you have ever had any of these health problems: Drug abuse or stroke.
- If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.
- If you are taking any of these drugs: Linezolid or methylene blue.
This is not a list of all drugs or health problems that interact with Focalin.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Focalin?
- Tell all of your health care providers that you take Focalin. This includes your doctors, nurses, pharmacists, and dentists.
- Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
- If you have been taking Focalin for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this medicine stops working well. Do not take more than ordered.
- You may have some heart tests before starting Focalin. Talk with your doctor.
- If you have seizures, talk with your doctor.
- This medicine may cause high blood pressure.
- Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
- Heart attacks, strokes, and sudden deaths have happened in adults taking this medicine. Sudden deaths have also happened in children with very bad heart problems or heart defects. Call your doctor right away if you have a change in strength on 1 side that is greater than the other, trouble speaking or thinking, change in balance, drooping on 1 side of the face, change in eyesight, chest pain or pressure, shortness of breath, or very bad dizziness or passing out.
- If you are taking Focalin (dexmethylphenidate tablets) and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
- Limit your use of caffeine (for example, tea, coffee, cola) and chocolate. Use with this medicine may cause nervousness, shakiness, and a fast heartbeat.
- Avoid drinking alcohol while taking Focalin.
- A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
- This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Focalin while you are pregnant.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
How is this medicine (Focalin) best taken?
Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- To gain the most benefit, do not miss doses.
- Keep taking Focalin as you have been told by your doctor or other health care provider, even if you feel well.
- Take with or without food.
What do I do if I miss a dose?
- Skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Joint pain.
- Purple patches on the skin or mouth.
- Fast or slow heartbeat.
- A heartbeat that does not feel normal.
- Very bad headache.
- Very upset stomach or throwing up.
- Blurred eyesight.
- Change in eyesight.
- Dark urine or yellow skin or eyes.
- Fever or chills.
- Sore throat.
- Trouble controlling body movements.
- Sweating a lot.
- Feeling very tired or weak.
- Change in color of hands or feet from pale to blue or red.
- Numbness, pain, tingling, or cold feeling of the hands or feet.
- Any sores or wounds on the fingers or toes.
- Not able to pass urine or change in how much urine is passed.
- Muscle pain or weakness.
- Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.
- New or worse behavior and mood changes like change in thinking, anger, and hallucinations have happened with this medicine. Tell your doctor if you or a family member have any mental or mood problems like low mood (depression) or bipolar illness, or if a family member has killed themselves. Call your doctor right away if you have hallucinations; change in the way you act; or signs of mood changes like low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
What are some other side effects of Focalin?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Feeling sleepy.
- Nervous and excitable.
- Belly pain.
- Weight loss.
- Not hungry.
- Not able to sleep.
- Dry mouth.
- Upset stomach or throwing up.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Focalin?
- Store at room temperature.
- Protect from light.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
Consumer Information Use and Disclaimer
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Focalin is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
This information should not be used to decide whether or not to take Focalin or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Focalin. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Review Date: November 1, 2017
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- Drug class: CNS stimulants