Concerta (methylphenidate hcl) 18mg x30s Tabs
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Product ID : concerta_18mg
Manufacturer: McNEIL LABS
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Description
CONCERTA {methylphenidate}
Patient Education - English
- Generic Name: methylphenidate (oral)
- Pronounced: METH il FEN i date
- Brand Names: Concerta, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin LA, Ritalin-SR
What is the most important information I should know about methylphenidate?
Do not use methylphenidate if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you use methylphenidate before the MAO inhibitor has cleared from your body.
Do not use this medication if you are allergic to methylphenidate or if you have glaucoma, overactive thyroid, severe high blood pressure, tics or Tourette's syndrome, angina, heart failure, heart rhythm disorder, recent heart attack, a hereditary condition such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency, or severe anxiety, tension, or agitation.
Methylphenidate may be habit-forming and should be used only by the person it was prescribed for. Never share methylphenidate with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
What is methylphenidate?
Methylphenidate is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.
Methylphenidate is used to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and narcolepsy.
Methylphenidate may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking methylphenidate?
Do not take methylphenidate if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you use methylphenidate before the MAO inhibitor has cleared from your body.
Do not use this medication if you are allergic to methylphenidate or if you have:
- glaucoma;
- overactive thyroid;
- severe high blood pressure;
- angina (chest pain), heart failure, heart rhythm disorder, or recent heart attack;
- a personal or family history of tics (muscle twitches) or Tourette's syndrome;
- severe anxiety, tension, or agitation (methylphenidate can make these symptoms worse); or
- a hereditary condition such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency.
Some stimulants have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Tell your doctor if you have a congenital heart defect.
If you have any of these other conditions, you may need a dose adjustment or special tests:
- a congenital heart defect;
- a personal or family history of mental illness, psychotic disorder, bipolar illness, depression, or suicide attempt;
- epilepsy or other seizure disorder; or
- a history of drug or alcohol addiction.
FDA pregnancy category C. It is not known whether methylphenidate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
It is not known whether methylphenidate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Long-term use of methylphenidate can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.
Do not give methylphenidate to a child younger than 6 years old without the advice of a doctor.
How should I take methylphenidate?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Take this medication at least 30 minutes before a meal. The extended-release forms of methylphenidate (Ritalin-SR, Metadate ER, Metadate CD, Methylin ER, Concerta) can be taken with or without food.
The chewable tablet must be chewed before you swallow it.
Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.
You may open the extended-release capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.
Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
To prevent sleep problems, take this medication early in the day, no later than 6:00 pm.
If you need to have any type of surgery, tell the surgeon ahead of time that you are using methylphenidate. You may need to stop using the medicine the day of your surgery.
Store at room temperature away from moisture and heat.
Keep track of the amount of medicine used from each new bottle. Methylphenidate is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is later than 6:00 p.m. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of methylphenidate can be fatal.
Overdose can cause vomiting, agitation, tremors, muscle twitching, seizure (convulsions), confusion, hallucinations, sweating, fast or pounding heartbeat, blurred vision, dry mouth and nose, and fainting.
What should I avoid while taking methylphenidate?
Methylphenidate may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
What are the possible side effects of methylphenidate?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking methylphenidate and call your doctor at once if you have a serious side effect such as:
- fast, pounding, or uneven heartbeats;
- feeling like you might pass out;
- fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
- aggression, restlessness, hallucinations, unusual behavior, or motor tics (muscle twitches);
- easy bruising, purple spots on your skin; or
- dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious side effects may include:
- stomach pain, nausea, vomiting, loss of appetite;
- vision problems, dizziness, mild headache;
- sweating, mild skin rash;
- numbness, tingling, or cold feeling in your hands or feet;
- nervous feeling, sleep problems (insomnia); or
- weight loss.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect methylphenidate?
Tell your doctor about all other medicines you use, especially:
- a blood thinner such as warfarin (Coumadin);
- clonidine (Catapres);
- dobutamine (Dobutrex), epinephrine (EpiPen), or isoproterenol (Isuprel);
- cold/allergy medicine that contains phenylephrine (a decongestant);
- potassium citrate (Urocit-K, Twin-K), sodium acetate, sodium bicarbonate (Alka-Seltzer), citric acid and potassium citrate (Cytra-K, Poly-Citra), or sodium citrate and citric acid (Bicitra, Oracit);
- medications to treat high or low blood pressure;
- stimulant medications or diet pills;
- seizure medicine such as phenytoin (Dilantin), phenobarbital (Luminal), primidone (Mysoline); or
- an antidepressant such as amitriptyline (Elavil, Vanatrip), citalopram (Celexa), doxepin (Sinequan), fluoxetine (Prozac, Sarafem), nortriptyline (Pamelor) paroxetine (Paxil), sertraline (Zoloft), and others.
This list is not complete and other drugs may interact with methylphenidate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Where can I get more information?
Your pharmacist can provide more information about methylphenidate.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Pill Pictures
 Concerta (methylphenidate) 54 mg/24 hr
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 Concerta (methylphenidate) 27 mg/24 hr
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 Concerta (methylphenidate) 18 mg/24 hr
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 Concerta (methylphenidate) 36 mg/24 hr
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Concerta-Generic Name: Methylphenidate (METH-il-FEN-i-date)Concerta Extended-Release Tablets are used for:Treating attention deficit hyperactivity disorder (ADHD). It may also be used for other conditions as determined by your doctor.
Concerta is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.Concerta is used to treat attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD). It should be used as an integral part of a treatment program that includes psychological, educational, and social measures.
Patient Counseling Information
See Medication Guide
Information for Patients
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with methylphenidate and should counsel them in its appropriate use. A patient Medication Guide is available for Concerta®. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Patients should be informed that Concerta® should be swallowed whole with the aid of liquids. Tablets should not be chewed, divided, or crushed. The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate. The tablet shell, along with insoluble core components, is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet.
Stimulants may impair the ability of the patient to operate potentially hazardous machinery or vehicles. Patients should be cautioned accordingly until they are reasonably certain that Concerta® does not adversely affect their ability to engage in such activities.
Patient Counseling Information
Manufactured for:
McNeil Pediatrics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560
10180601
Revised: June 2009
MEDICATION GUIDE
Concerta® (kon SER-ta)
(methylphenidate HCl) Extended-release Tablets CII
Read the Medication Guide that comes with Concerta® before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about you or your child's treatment with Concerta®.
What is the most important information I should know about Concerta®?
The following have been reported with use of methylphenidate HCl and other stimulant medicines:
1. 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 you 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®.
2. 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.
What Is Concerta®?
Concerta® is a central nervous system stimulant prescription medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). Concerta® may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
Concerta® should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
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.
Who should not take Concerta®?
Concerta® should not be taken 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®. See the end of this Medication Guide for a complete list of ingredients.
Concerta® should not be used in children less than 6 years old because it has not been studied in this age group.
Concerta® may not be right for you or your child. Before starting Concerta® tell your or your child's doctor about all health conditions (or a family history of) including:
- heart problems, heart defects, or 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)
- esophagus, stomach, or small or large intestine problems
Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.
Can Concerta® be taken with other medicines?
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.
How should Concerta® be taken?
- 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.
- If you or your child takes too much Concerta® or overdoses, call your doctor or poison control center right away, or get emergency treatment.
What are possible side effects of Concerta®?
See "What is the most important information I should know about Concerta®?" for information on reported heart and mental problems.
Other serious side effects include:
- slowing of growth (height and weight) in children
- seizures, mainly in patients with a history of seizures
- eyesight changes or blurred vision
- blockage of the esophagus, stomach, small or large intestine in patients who already have a narrowing in any of these organs
Common side effects include:
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Stimulants may impair the ability of you or your child to operate potentially hazardous machinery or vehicles. You or your child should exercise caution until you/your child is reasonably certain that Concerta® does not adversely affect your/your child's ability to engage in such activities.
Talk to your doctor if you or your child has side effects that are bothersome or do not go away.
This is not a complete list of possible 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 FDA at 1-800-FDA-1088.
You may also report side effects to McNeil Pediatrics at 1-888-440-7903.
How should I store Concerta®?
- Store Concerta® in a safe place at room temperature, 59 to 86° F (15 to 30° C). Protect from moisture.
- Keep Concerta® and all medicines out of the reach of children.
General information about Concerta®
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Concerta® for a condition for which it was not prescribed. Do not give Concerta® to other people, even if they have the same condition. It may harm them and it is against the law.
This Medication Guide summarizes the most important information about Concerta®. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Concerta® that was written for healthcare professionals. For more information about Concerta® call 1-888-440-7903.
What are the ingredients in Concerta®?
Active Ingredient: methylphenidate HCl
Inactive Ingredients: butylated hydroxytoluene, carnuba wax, cellulose acetate, hypromellose, lactose, phosphoric acid, poloxamer, polyethylene glycol, polyethylene oxides, povidone, propylene glycol, sodium chloride, stearic acid, succinic acid, synthetic iron oxides, titanium dioxide, and triacetin.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured for:
McNeil Pediatrics
Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., Titusville, NJ 08560
10180601
Revised: June 2009
Label Image for 36mg 90 Count Bottle
MANUFACTURER INFORMATION
Manufactured By:
McNEIL PEDIATRICS, DIVISION OF ORTHO-McNEIL-JANSSEN PHARMACEUTICALS, INC.
MFR. FOR: McNEIL PEDIATRICS, DIVISION OF ORTHO-McNEIL-JANSSEN PHARMACEUTICALS,INC
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