Concerta

Concerta is a prescription medication used to treat Attention-Deficit Hyperactivity Disorder (ADHD). Concerta belongs to a group of drugs called central nervous system (CNS) stimulants, which works by changing the amount of natural substances in the brain to decrease impulsiveness and hyperactivity.

This medication comes in an extended release tablet and is usually taken once a a day in the morning. The extended release tablets should be taken 30 to 45 minutes before a meal.

Do not chew, divide, or break Concerta tablets. Swallow Concerta tablets whole.

Common side effects of Concerta are headache, decreased appetite, and stomach ache.

Concerta is a prescription medication used to treat attention-deficit hyperactivity disorder (ADHD).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Janssen Pharmaceuticals, Inc.

Serious side effects have been reported with Concerta. See “Concerta Precautions” section.

Concerta may cause serious side effects, including:

• seizures, mainly in patients with a history of seizures
• slowing of growth (weight and height)
• eyesight changes or blurred vision

The most common side effects of Concerta include:

• poor appetite
• nausea
• vomiting
• stomach pain
• weight loss
• tics
• trouble sleeping
• mood swings
• dizziness

This is not a complete list of Concerta side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Concerta 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 Concerta.

Your doctor will decide whether Concerta can be taken with other medicines.

Especially tell your doctor if you or your child takes:

• anti-depression medicines including MAOIs
• seizure medicines
• blood thinner medicines
• blood pressure medicines
• cold or allergy medicines that contain decongestants

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking Concerta without talking to your doctor first.

The following have been reported with use of Concerta and other stimulant medicines.

• Heart-related problems:
  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor should check you or your child carefully for heart problems before starting Concerta.

Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with Concerta.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Concerta.

• Mental (psychiatric) problems:
  • All Patients
    • new or worse behavior and thought problems
    • new or worse bipolar illness
    • new or worse aggressive behavior or hostility
  • Children and Teenagers
  • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Concerta, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

Do not take Concerta if you or your child:

• are very anxious, tense, or agitated
• have an eye problem called glaucoma
• have tics or Tourette’s syndrome, or a family history of Tourette's syndrome. Tics are hard to control repeated movements or sounds.
• are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
• are allergic to anything in Concerta dosage forms

Concerta should not be used in children less than 6 years old because it has not been studied in this age group.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Concerta, there are no specific foods that you must exclude from your diet when receiving Concerta.

Before starting Concerta, tell your or your child's doctor about all health conditions (or a family history of) including:

• heart problems, heart defects, high blood pressure
• mental problems including psychosis, mania, bipolar illness, or depression
• tics or Tourette's syndrome
• seizures or have had an abnormal brain wave test (EEG)

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Concerta will harm your unborn baby.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Concerta falls into category C. There are no adequate animal or human studies; or studies in animals have shown a harmful and undesired effect on the unborn baby, yet there are no adequate and well-controlled studies in pregnant women.

This medication may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Concerta is excreted in human breast milk or if it will harm your nursing baby.

Take Concerta exactly as prescribed by your doctor. Follow the directions on your prescription label carefully

• Take Concerta exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
• Do not chew, crush, or divide the tablets. Swallow Concerta tablets whole with water or other liquids. Tell your doctor if you or your child cannot swallow Concerta whole. A different medicine may need to be prescribed.
• Concerta can be taken with or without food.
• Take Concerta once each day in the morning. Concerta is an extended-release tablet. It releases medication into your/your child's body throughout the day.
• The Concerta tablet does not dissolve completely in the body after all the medicine has been released. You or your child may sometimes notice the empty tablet in a bowel movement. This is normal.
• From time to time, your doctor may stop Concerta treatment for a while to check ADHD symptoms.
• Your doctor may do regular checks of the blood, heart, and blood pressure while taking Concerta. Children should have their height and weight checked often while taking Concerta. Concerta treatment may be stopped if a problem is found during these check-ups.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

• For children and adolescents new to Concerta (methylphenidate), the recommended starting dosage is 18 mg once daily. Dosage may be increased by 18 mg/day at weekly intervals and should not exceed 54 mg/day in children and 72 mg/day in adolescents.
• For adult patients new to Concerta (methylphenidate), the recommended starting dose of Concerta (methylphenidate) is 18 or 36 mg/day. Dosage may be increased by 18 mg/day at weekly intervals and should not exceed 72 mg/day for adults.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

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

Concerta is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Concerta in a safe place to prevent misuse and abuse. Selling or giving away Concerta may harm others, and is against the law.

Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Drug Dependence

Concerta should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use, since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.