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|Focalin XR Extended-Release Capsules

Focalin XR Extended-Release Capsules

Focalin XR Extended-Release Capsules is used for:

Treating attention deficit hyperactivity disorder (ADHD). It may also be used for other conditions as determined by your doctor.

Focalin XR Extended-Release Capsules is a central nervous system (CNS) stimulant. Exactly how it works is not known.

Do NOT use Focalin XR Extended-Release Capsules if:

• you are allergic to any ingredient in Focalin XR Extended-Release Capsules
• you have severe anxiety, agitation, or tension
• you have glaucoma
• you have motor tics (involuntary movements), Tourette syndrome, or a family history of Tourette syndrome
• you have serious heart problems (eg, heart defect, irregular heartbeat)
• you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken an MAOI within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Focalin XR Extended-Release Capsules:

Some medical conditions may interact with Focalin XR Extended-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of high blood pressure, heart problems (eg, heart failure, fast or irregular heartbeat), or recent heart attack, or if a family member has a history of irregular heartbeat or sudden death
• if you have a history of seizures or abnormal electroencephalograms (EEGs)
• if you have a history of overactive thyroid or chronic fatigue
• if you have a history of mood or mental problems (eg, agitation, anxiety, bipolar disorder, depression, psychosis, tension), abnormal thoughts, hallucinations, suicidal thoughts or attempts, or alcohol or other substance abuse or dependence, or if a family member has a history of any of these problems

Some MEDICINES MAY INTERACT with Focalin XR Extended-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• MAOIs (eg, phenelzine) because severe high blood pressure may occur
• Clonidine because serious side effects may occur
• Pressor agents (eg, norepinephrine) because the risk of high blood pressure may be increased
• Anticoagulants (eg, warfarin), certain anticonvulsants (eg, phenobarbital, phenytoin, primidone), phenylbutazone, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or tricyclic antidepressants (eg, imipramine) because the risk of their side effects may be increased by Focalin XR Extended-Release Capsules
• Guanethidine or other medicines for high blood pressure because their effectiveness may be decreased by Focalin XR Extended-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Focalin XR Extended-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Focalin XR Extended-Release Capsules:

Use Focalin XR Extended-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Focalin XR Extended-Release Capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Focalin XR Extended-Release Capsules refilled.
• Take Focalin XR Extended-Release Capsules by mouth in the morning. Talk with your doctor about how you should take Focalin XR Extended-Release Capsules with regard to food.
• Swallow Focalin XR Extended-Release Capsules whole. Do not break, crush, or chew before swallowing.
• If you cannot swallow the capsule whole, you may open it and sprinkle the contents over a spoonful of applesauce. Mix the medicine with the applesauce and swallow the mixture right away, followed by a glass of water. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use.
• If you take an antacid, H₂ antagonist (eg, ranitidine), or proton pump inhibitor (eg, omeprazole), ask your doctor or pharmacist how to take it with Focalin XR Extended-Release Capsules.
• If you miss a dose of Focalin XR Extended-Release Capsules, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Focalin XR Extended-Release Capsules.

Important safety information:

• Focalin XR Extended-Release Capsules may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Focalin XR Extended-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do NOT take more than the recommended dose without checking with your doctor.
• If your symptoms do not get better within 1 month or if they get worse, check with your doctor.
• Serious side effects, including heart attack, stroke, and sudden death, have occurred with the use of stimulant medicines in patients with heart defects or other serious heart problems. If you have a heart defect or other serious problem, talk with your doctor about other therapies to treat your condition.
• Lab tests, including blood pressure, heart function, complete blood cell counts, and platelet counts, may be performed while you use Focalin XR Extended-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Focalin XR Extended-Release Capsules may affect growth rate and weight gain in CHILDREN and teenagers in some cases. They may need regular growth and weight checks while they take Focalin XR Extended-Release Capsules.
• Caution is advised when using Focalin XR Extended-Release Capsules in CHILDREN; they may be more sensitive to its effects, especially loss of appetite, stomach pain, weight loss, trouble sleeping, and fast heartbeat.
• Focalin XR Extended-Release Capsules should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Focalin XR Extended-Release Capsules while you are pregnant. It is not known if Focalin XR Extended-Release Capsules is found in breast milk. If you are or will be breast-feeding while you use Focalin XR Extended-Release Capsules, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Focalin XR Extended-Release Capsules may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Focalin XR Extended-Release Capsules stops working well. Do not take more than prescribed.

Some people who use Focalin XR Extended-Release Capsules for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. Do not suddenly stop taking Focalin XR Extended-Release Capsules. If you stop taking Focalin XR Extended-Release Capsules suddenly, you may have WITHDRAWAL symptoms. These may include depression or other mental problems.

Possible side effects of Focalin XR Extended-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety, dizziness; drowsiness; dry mouth; headache; indigestion; loss of appetite; nausea; nervousness; stomach pain; trouble sleeping.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; joint pain; purple or brownish red spots on the skin); behavior changes (eg, aggression, hostility); blurred vision or other vision problems; chest pain; confusion; dark urine; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; mental or mood changes (eg, agitation, depression, irritability, persistent crying, severe or persistent anxiety, unusual sadness); seizures; severe or persistent dizziness or headache; suicidal thoughts or attempts; uncontrolled speech or muscle movements; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include confusion; dilated pupils; fast or irregular heartbeat; fever; flushing; hallucinations; loss of consciousness; muscle twitching; seizures; severe or persistent headache or vomiting; tremors; unusual sweating.

Store Focalin XR Extended-Release Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Focalin XR Extended-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Focalin XR Extended-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Focalin XR Extended-Release Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Focalin XR Extended-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.