|Information For Patients And Care Givers:
One of the most popular stories on the Vidyya site is from 04 August 2000 and concerns a once-a-day medication approved in August for attention-deficit-hyperactivity disorder. In response to the popularity of the article, Vidyya has gone in search of more in-depth information on the drug, Concerta®. Two articles in today's issue focus on Concerta, its prescribing information and information for patients that was not immediately available at the time of the medication's approval. Patients and practitioners will want to take note, that Concerta is not the only once-a-day medication for ADHD and that several others are on the way and will be approved early in 2001.
Information For Patients
Taking Concerta® Or Their Parents Or Caregivers
HCl) Extended-release Tablets CII
This information is for patients
or their parents or caregivers taking Concerta® Extended-release tablets
CII for the treatment of Attention Deficit Hyperactivity Disorder.
Please read this before you
start taking Concerta®. Remember, this information does not take the place
of your doctor's instructions. If you have any questions about this information
or about Concerta®, talk to your doctor or pharmacist.
What is Concerta®?
Concerta® is a once-a-day treatment for Attention Deficit Hyperactivity
Disorder, or ADHD. Concerta® contains the drug methylphenidate, a central
nervous system stimulant that has been used to treat ADHD for more than
30 years. Concerta® is taken by mouth, once each day in the morning.
What is Attention Deficit
ADHD has three main types of symptoms: inattention, hyperactivity, and
impulsiveness. Symptoms of inattention include not paying attention, making
careless mistakes, not listening, not finishing tasks, not following directions,
and being easily distracted. Symptoms of hyperactivity and impulsiveness
include fidgeting, talking excessively, running around at inappropriate
times, and interrupting others. Some patients have more symptoms of hyperactivity
and impulsiveness while others have more symptoms of inattentiveness.
Some patients have all three types of symptoms.
Many people have symptoms like
these from time to time, but patients with ADHD have these symptoms more
than others their age. Symptoms must be present for at least 6 months
to be certain of the diagnosis.
How does Concerta® work?
Part of the Concerta® tablet dissolves right after you swallow it in the
morning, giving you an initial dose of methylphenidate. The remaining
drug is slowly released during the day to continue to help lessen the
symptoms of ADHD. Methylphenidate, the active ingredient in Concerta®,
helps increase attention and decrease impulsiveness and hyperactivity
in patients with ADHD.
Who should NOT take Concerta®?
You should NOT take Concerta® if:
- You have significant anxiety,
tension, or agitation since Concerta® may make these conditions worse.
- You are allergic to methylphenidate
or any of the other ingredients in Concerta®.
- You have glaucoma, an eye
- You have tics or Tourette's
Syndrome, or a family history of Tourette's Syndrome.
Talk to your doctor if you
believe any of these conditions apply to you.
How should I take Concerta®?
Do not chew, crush, or divide the tablets.
Swallow Concerta® tablets whole with the help of water or other liquids,
such as milk or juice.
Take Concerta® once each day
in the morning.
You may take Concerta® before
or after you eat.
Take the dose prescribed by
your doctor. Your doctor may adjust the amount of drug you take until
it is right for you. From time to time, your doctor may interrupt your
treatment to check your symptoms while you are not taking the drug.
What are the possible side
effects of Concerta®?
In the clinical studies with patients using Concerta®, the most common
side effects were headache, stomach pain, sleeplessness, and decreased
appetite. Other side effects seen with methylphenidate, the active ingredient
in Concerta®, include nausea, vomiting, dizziness, nervousness, tics,
allergic reactions, increased blood pressure and psychosis (abnormal thinking
This is not a complete list
of possible side effects. Ask your doctor about other side effects. If
you develop any side effect, talk to your doctor.
What must I discuss with
my doctor before taking Concerta®?
Talk to your doctor before taking Concerta® if you:
- Are being treated for depression
or have symptoms of depression such as feelings of sadness, worthlessness,
- Have motion tics (hard-to-control,
repeated twitching of any parts of your body) or verbal tics (hard-to-control
repeating of sounds or words).
- Have someone in your family
with motion tics, verbal tics, or Tourette's syndrome.
- Have abnormal thoughts or
visions, hear abnormal sounds, or have been diagnosed with psychosis.
- Have had seizures (convulsions,
epilepsy) or abnormal EEGs (electroencephalograms).
- Have high blood pressure.
- Have a narrowing or blockage
of your gastrointestinal tract (your esophagus, stomach, or small or
Tell your doctor immediately
if you develop any of the above conditions or symptoms while taking Concerta®.
Can I take Concerta® with
Tell your doctor about all medicines that you are taking.
Your doctor should decide whether you can take Concerta® with other medicines.
Other medicines that a doctor
Medicines that you buy yourself without a prescription.
Any herbal remedies that you may be taking.
You should not take Concerta®
with monoamine oxidase (MAO) inhibitors.
While on Concerta®, do not
start taking a new medicine or herbal remedy before checking with your
Concerta® may change the way
your body reacts to certain medicines. These include medicines used to
treat depression, prevent seizures, or prevent blood clots (commonly called
"blood thinners"). Your doctor may need to change your dose of these medicines
if you are taking them with Concerta®.
Other Important Safety Information
Abuse of methylphenidate can lead to dependence.
Tell your doctor if you have
ever abused or been dependent on alcohol or drugs, or if you are now abusing
or dependent on alcohol or drugs.
Concerta®, tell your doctor if you are pregnant or plan on becoming pregnant.
If you take methylphenidate, it may be in your breast milk. Tell your
doctor if you are nursing a baby.
Tell your doctor if you have
blurred vision when taking Concerta®.
Slower growth (weight gain
and/or height) has been reported with long-term use of methylphenidate
in children. Your doctor will be carefully watching your height and weight.
If you are not growing or gaining weight as your doctor expects, your
doctor may stop your Concerta® treatment.
Call your doctor immediately
if you take more than the amount of Concerta® prescribed by your doctor.
What else should I know
Concerta® has not been studied in children under 6 years of age.
The Concerta® tablet does not
dissolve completely after all the drug has been released, and you may
sometimes notice it in your stool. This is normal.
Concerta® may be a part of
your overall treatment for ADHD. Your doctor may also recommend that you
have counseling or other therapy.
As with all medicines, never
share Concerta® with anyone else and take only the number of Concerta®
tablets prescribed by your doctor.
Concerta® should be stored
in a safe place at room temperature (between 59°-86° F). Do not store
this medicine in hot, damp, or humid places.
Keep out of the reach of children.
For more information call 1-888-440-7903
or visit www.concerta.net
and marketed by ALZA Corporation, Mountain View, CA 94043. Marketed by
McNeil Consumer Healthcare, Fort Washington, PA 19034.