MEDICATION GUIDE
FOCALIN® (foh-kuh-lin)
(dexmethylphenidate hydrochloride)
tablets for oral use, CII
What is the most important information I should know about FOCALIN?
FOCALIN may cause serious side effects, including:
- • Abuse, misuse, and addiction. FOCALIN has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of FOCALIN, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of FOCALIN or when it is used in ways that are not approved, such as snorting or injection.
- oYour healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with FOCALIN and will monitor you or your child during treatment.
- oFOCALIN may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
- oDo not give FOCALIN to anyone else. See “What is FOCALIN?” for more information.
- oKeep FOCALIN in a safe place and properly dispose of any unused medicine. See “How should I store FOCALIN?” for more information.
- oTell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
- • Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease.
Your healthcare provider should check you or your child carefully for heart problems before starting FOCALIN. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.
Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems, such as chest pain, shortness of breath, or fainting while taking FOCALIN.
- • Increased blood pressure and heart rate. Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with FOCALIN.
- • Mental (psychiatric) problems:
- All Patients
- onew or worse behavior and thought problems
- onew or worse bipolar illness
- onew psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms
Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide,
bipolar illness, or depression.
Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or
problems while taking FOCALIN, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
What is FOCALIN?
- •FOCALIN is a central nervous system stimulant (CNS) prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). FOCALIN may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
- •FOCALIN should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
FOCALIN is a federally controlled substance (CII) because it contains dexmethylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep FOCALIN in a safe place to protect it from theft. Never give your FOCALIN to anyone else because it may cause death or harm them. Selling or giving away FOCALIN may harm others and is against the law.
Who should not take FOCALIN?
FOCALIN should not be taken if you or your child:
- •are allergic to methylphenidate hydrochloride, or any of the ingredients in FOCALIN. See the end of this Medication Guide for a complete list of ingredients in FOCALIN.
- •are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor (MAOI).
FOCALIN may not be right for you or your child. Before starting FOCALIN, tell your or your child’s healthcare provider about all health conditions (or a family history of), including:
- •heart problems, heart disease, heart defects, or high blood pressure
- •mental problems, including psychosis, mania, bipolar illness, or depression
- •circulation problems in fingers or toes
- •have eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness)
- •have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome.
- •if you are pregnant or plan to become pregnant. It is not known if FOCALIN will harm your unborn baby.
- oThere is a pregnancy registry for females who are exposed to ADHD medications, including FOCALIN during pregnancy. The purpose of the registry is to collect information about the health of females exposed to FOCALIN and their baby. If you or your child becomes pregnant during treatment with FOCALIN, talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD medications at 1-866- 961-2388 or visit online at https://womensmentalhealth.org/adhd-medications/.
- •if you are breastfeeding or plan to breastfeed. FOCALIN passes into your breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with FOCALIN.
Tell your healthcare provider about all of the medicines that you or your child takes, including prescription and over-the- counter medicines, vitamins, and herbal supplements. FOCALIN and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking FOCALIN.
Your healthcare provider will decide whether FOCALIN can be taken with other medicines.
Especially tell your healthcare provider if you or your child takes:
- •blood pressure medicines (anti-hypertensive)
Know the medicines that you or your child takes. Keep a list of your medicines with you to show your healthcare provider and pharmacist.
- •You should not take FOCALIN on the day of your operation if a certain type of anesthetic is used. This is because there is a chance of a sudden rise in blood pressure and heart rate during the operation.
Do not start any new medicine while taking FOCALIN without talking to your healthcare provider first.
How should FOCALIN be taken?
- •Take FOCALIN exactly as prescribed. Your healthcare provider may adjust the dose until it is right for you or your child.
- •Take FOCALIN twice daily, at least 4 hours apart.
- •FOCALIN may be taken with or without food.
- •Your healthcare provider may do regular checks of the blood, heart, and blood pressure while taking FOCALIN.
- •Children should have their height and weight checked often while taking FOCALIN. FOCALIN treatment may be stopped if a problem is found during these check-ups.
If you or your child take too much FOCALIN, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
What are the possible side effects of FOCALIN?
FOCALIN may cause serious side effects, including:
- •see “What is the most important information I should know about FOCALIN?” for information on reported heart and mental problems.
- • painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develops priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a healthcare provider immediately.
- • circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon):
- ofingers or toes may feel numb, cool, painful
- ofingers or toes may change color from pale, to blue, to red
Tell your healthcare provider if you or your child have, numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.
- • Call your healthcare provider right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking FOCALIN.
- • Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with FOCALIN. FOCALIN treatment may be stopped if your child is not growing or gaining weight.
- • Eye problems (increased pressure in the eye and glaucoma). Call your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness.
- • New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with FOCALIN.
- • Common side effects include:
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 FOCALIN?
- •Store FOCALIN in a safe place and in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C).
- •Protect from light and moisture.
- •Dispose of remaining, unused, or expired FOCALIN by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, mix FOCALIN with an undesirable, nontoxic substance, such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container, such as a sealed plastic bag and throw away FOCALIN in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
- •Keep FOCALIN and all medicines out of the reach of children.
General information about the safe and effective use of FOCALIN.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about FOCALIN that is written for healthcare professionals. Do not use FOCALIN for a condition for which it was not prescribed. Do not give FOCALIN to other people, even if they have the same symptoms that you have. It may harm them and it is against the law.
What are the ingredients in FOCALIN?
Active ingredient: dexmethylphenidate hydrochloride
Inactive ingredients: FD&C blue no.1 #5516 aluminum lake (2.5 mg tablets), D&C yellow #10 aluminum lake (5 mg tablets), the 10 mg tablet contains no dye; lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate.
Manufactured by
Mikart, LLC, Atlanta, GA 30318 for
Sandoz Inc., Princeton, NJ 08540
For additional medication guide please go to www.us.sandoz.com or call 1-800-525-8747.